Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source
Applicant
Schoelly Fiberoptic GmbH
Product Code
GCJ · Gastroenterology, Urology
Decision Date
Feb 23, 2023
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Indications for Use
Camera System: The Camera System is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery whenever a laparoscope/ endoscope/ arthroscope is indicated for use. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectomy, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Small joint arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Pleural biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass, Coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement. The users of the Camera System are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists. NIR FI Light Source: The NIR FI Light Source and NIR FI Light Guide are indicated for use to provide real-time endoscopic visible and near-infrared fluorescence imaging. The NIR FI Light Source and NIR FI Light Guide enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the NIR FI Light Source and NIR FI Light Guide is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.
Device Story
System provides real-time endoscopic white light (WLI) and near-infrared (NIR) fluorescence imaging (FI) using ICG. Components: Camera Control Unit (CCU), Camera Head, NIR FI Light Source, Light Guide, and fiberoptic laparoscope. Operation: Light from LEDs/laser diode projected through fiberoptic scope to tissue; optical signals converted to electrical signals by CMOS sensors; processed for display. Used in OR by surgeons for visualization of anatomy and tissue perfusion. Output: Real-time video on display; aids surgical decision-making by highlighting vessels and biliary ducts. Benefits: Enhanced visualization during minimally invasive procedures.
Clinical Evidence
Bench testing only. No clinical data provided. Performance testing included reprocessing validation (cleaning/sterilization per AAMI TIR12/TIR30/ISO 17665), electrical safety (IEC 60601-1, IEC 60601-2-18), and electromagnetic compatibility (IEC 60601-1-2). Non-clinical performance testing confirmed design outputs meet requirements for endoscopic white light and NIR fluorescence imaging.
Technological Characteristics
System components: CCU, Camera Head, NIR FI Light Source, Light Guide. Materials: Reusable medical device components. Sensing: CMOS image sensor. Energy: RGB LEDs and near-infrared laser diode. Connectivity: USB/remote storage. Sterilization: Moist heat (autoclave). Software: Moderate level of concern, managed per IEC 62304.
Indications for Use
Indicated for patients undergoing general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery. Used by general, gynecological, cardiac, thoracic, plastic, orthopedic, ENT, and urological surgeons for visualization and assessment of vessels, blood flow, tissue perfusion, and biliary ducts (cystic, common bile, common hepatic) during minimally invasive surgery. Not for standalone biliary duct visualization.
Regulatory Classification
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
Predicate Devices
Stryker AIM (Advanced Imaging Modality) System (K182160)
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February 23, 2023
Schoelly Fiberoptic GmbH % Pamela Papineau Regulatory Affairs Consultant (Alternate Application Contact) Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, Massachusetts 01432
Re: K221591
Trade/Device Name: Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ, FET, OWN, FCW Dated: January 24, 2023 Received: January 27, 2023
Dear Pamela Papineau:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
# Jianting Wang -S
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K221591
#### Device Name
Near-Infrared (NIR) Fluorescence Imaging (FI) System: Camera Control Unit, Camera Head to be coupled to a fiberoptic scope); NIR FI Light Source
#### Indications for Use (Describe)
#### Camera System:
The Camera System is indicated for use in general laparoscopy, ear endoscopy, ear endoscopy, sinuscopy, and plastic surgery whenever a laparoscope/ endoscope/ arthroscope is indicated for use. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectomy, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Pleural biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement. The users of the Camera System are general surgeons, gynecologists, cardiac surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
## NIR FI Light Source:
The NIR FI Light Source and NIR FI Light Guide are indicated for use to provide real-time endoscopic visible and nearinfrared fluorescence imaging. The NIR FI Light Source and NIR FI Light Guide enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with the NIR FI Light Source and NIR FI Light Guide is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.
| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| <span style="padding-right: 5px;"> <div style="display:inline-block;">☒</div> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="padding-left: 5px;"> <div style="display:inline-block;">☐</div> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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FORM FDA 3881 (6/20)
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23 May 2022 NIR FI System
# 005 510(k) Summary - K221591
# A. GENERAL INFORMATION
| 510(k) Sponsor: | Schoelly Fiberoptic GmbH |
|--------------------------|--------------------------------------------------------|
| Address: | Robert-Bosch-Str. 1 – 3<br>79211 Denzlingen<br>Germany |
| FDA Registration Number: | 8043903 |
| Telephone Number: | +49-7666-980-0 |
| Fax Number: | +49-7666-908-380 |
| Contact Person: | Dr. Sandra Baumann |
| Date Prepared: | 23 May 2022 |
# B. DEVICE IDENTIFICATION
The subject device is the SCHOELL Y Near-Infrared (NIR) Fluorescence Imaging (FI) System that is specifically comprised of the flowing components:
| Trade Name | Camera System<br>(Camera Control Unit, Camera Head to be coupled to a<br>fiberoptic scope) |
|------------------------------|------------------------------------------------------------------------------------------------------------------|
| Common Name | Video Camera<br>(Camera Control Unit, Camera Head to be coupled to a<br>fiberoptic scope) |
| Classification Name | Laparoscope, General & Plastic Surgery<br>Endoscopic Video Imaging System/Component,<br>Gastroenterology-Urology |
| Product Code | GCJ<br>FET |
| Regulation Number | 21 CFR 876.1500 |
| Regulation Name | Endoscope and accessories |
| Device Classification | Class II |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panels | General & Plastic Surgery<br>Gastroenterology/Urology |
| Trade Name | NIR FI Light Source |
|---------------------|---------------------------|
| Common Name | Light Source, Illuminator |
| Classification Name | Confocal Optical Imaging1 |
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| | Light Source, Fiberoptic, Routine2 |
|------------------------------|------------------------------------|
| Product Code | OWN1 |
| | FCW2 |
| Regulation Number | 21 CFR 876.1500 |
| Regulation Name | Endoscope and accessories |
| Device Classification | Class II |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panels | General & Plastic Surgery1 |
| | Gastroenterology/Urology2 |
1 when used for assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extrahepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using NIR Fluorescence Imaging 2 when used to emit light in the visible range of the spectrum to support standard endoscopic imaging
## Indications for Use
## Camera System
The Camera System is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery whenever a laparoscope/ endoscope/ arthroscope is indicated for use. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection. Laparoscopically assisted hysterectomy. Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Small joint arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Pleural biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass, Coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement. The users of the Camera System are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
## NIR FI Light Source
The NIR FI Light Source and NIR FI Light Guide are indicated for use to provide real-time endoscopic visible and near-infrared fluorescence imaging. The NIR FI Light Source and NIR FI Light Guide enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with the NIR FI Light Source and NIR FI Light Guide is intended for use with standard-of-care white light and, when indicated, intraoperative
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cholangiography. The devices are not intended for standalone use for biliary duct visualization.
# C. PREDICATE DEVICE
The predicate device is the STRYKER AIM (Advanced Imaging Modality) System:
| 510(k) Sponsor: | Stryker Endoscopy |
|-----------------|-------------------|
| 510(k) Number: | K182160 |
The predicate device is specifically comprised of the flowing components:
| Trade Name | 1688 4k Camera System<br>(1688 Camera Control Unit; 1688 AIM 4K Camera<br>Head, C-Mount; 1688 AIM 4K Camera Head with<br>Integrated Coupler; AIM 4K Coupler, 20mm, C-Mount) |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | 3-Chip Video Camera<br>(Camera Control Unit, Camera Head and accessories to<br>be coupled to a fiberoptic scope) |
| Classification Name | Laparoscope, General & Plastic Surgery |
| Product Code | GCJ |
| Regulation Number | 21 CFR 876.1500 |
| Regulation Name | Endoscope and accessories |
| Device Classification | Class II |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panels | General & Plastic Surgery |
| Trade Name | L11 LED Light Source with Advanced Imaging Modality |
|---------------------|--------------------------------------------------------------------------------------------------------|
| Common Name | Light Source, Illuminator |
| Classification Name | Confocal Optical Imaging1<br>Light Source, Fiberoptic, Routine2<br>Fiberoptic light ureteral catheter3 |
| Product Code | OWN1<br>FCW2<br>FCS3 |
| Regulation Number | 21 CFR 876.15001<br>21 CFR 876.40202,3 |
| Regulation Name | Endoscope and accessories |
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| Device Classification | Class II |
|------------------------------|------------------------------------------------------------|
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panels | General & Plastic Surgery1<br>Gastroenterology/Urology2, 3 |
## Indications for Use
# 1688 4K Camera System with Advance Imaging Modality
The 1688 Video Camera is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery whenever a laparoscope/ endoscope/ arthroscope is indicated for use. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectorny, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Small joint arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Pleural biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass, Coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement. The users of the 1688 Video Camera are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
# L11 LED Light Source with Advanced Imaging Modality
The L11 AIM Light Source and SafeLight™ Cable are indicated for use to provide real-time endoscopic visible and near-infrared fluorescence imaging. The L11 AIM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with the L11 AIM Light Source and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.
The L11 AIM Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
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# D. REFERENCE DEVICE
SCHOELLY's TipVision™ Videoscope System serves as a reference device in this submission:
| 510(k) Sponsor: | Schoelly Fiberoptic GmbH |
|-----------------|--------------------------|
| 510(k) Number: | K201617 |
The reference device is specifically comprised of the flowing components:
| Trade Name | EleVision™ HD 2 Camera Control Unit |
|------------------------------|-------------------------------------------|
| Common Name | Camera Control Unit |
| Classification Names | Endoscopic Video Imaging System/Component |
| Product Codes | FET |
| Regulation Numbers | 21 CFR 876.1500 |
| Regulation Name | Endoscope and accessories |
| Device Classification | Class II |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panels | Gastroenterology/Urology |
| Trade Name | TipVision™ Videoscope |
|------------------------------|--------------------------------------------------------------------------------------|
| Common Name | Video Laparoscope<br>(Camera Head) |
| Classification Names | Laparoscope, Gynecologic (and Accessories)<br>Laparoscope, General & Plastic Surgery |
| Product Codes | HET, GCJ |
| Regulation Numbers | 21 CFR 884.1720<br>21 CFR 876.1500 |
| Regulation Name | Endoscope and accessories |
| Device Classification | Class II |
| Regulation Medical Specialty | Obstetrics/Gynecology<br>Gastroenterology/Urology |
| Review Panels | Obstetrics / Gynecology<br>General & Plastic Surgery |
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## Indications for Use:
The TipVision™ 0°/30° Videoscopes and the other EleVision™ / TipVision™ components are indicated for visualization during general laparoscopy, gynecological laparoscopy, urological laparoscopy, and video-assisted minimally invasive thoracic surgical procedures.
SCHOELLY's Schoelly Laparoscope serves as a further reference device in this submission:
| 510(k) Sponsor: | Schoelly Fiberoptic GmbH |
|-----------------|--------------------------|
| 510(k) Number: | K143221 |
| Trade Name | Schoelly Laparoscope |
|------------------------------|----------------------------------------|
| Common Name | Laparoscope |
| Classification Names | Laparoscope, General & Plastic Surgery |
| Product Codes | GCJ |
| Regulation Numbers | 21 CFR 876.1500 |
| Regulation Name | Endoscope and accessories |
| Device Classification | Class II |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panels | General & Plastic Surgery |
## Indications for Use:
The Schoelly Laparoscope is indicated for examination of body cavities, hollow organs, and canals, and using additional accessories, to perform various diagnostic and therapeutic procedures.
# E. DEVICE DESCRIPTION
The individual components of the subject device, SCHOELL Y's NIR FI System, form a system to provide real-time endoscopic visible imaging (wight light imaging, WLI) and near-infrared (NIR) illumination and imaging (fluorescence imaging, FI) using indocyanine green (ICG):
- Camera System suitable for processing and recordings visible light images as well as NIR images. The Camera System consists of a Camera Control Unit (CCU) and a Camera Head for connection to a fiberoptic scope;
- . Light Source and Light Guide for use with a fiberoptic scope for emitting light within the visible spectrum as well as in the NIR spectrum to cause fluorescence;
- . Fiberoptic Laparoscope suitable for visible light and NIR light illumination and imaging;
The imaging agent (ICG) is not provided by SCHOELLY as part of the subject system.
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# F. INDICATIONS FOR USE
## Camera System:
The Camera System is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery whenever a laparoscope/ arthroscope/ arthroscope is indicated for use. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectorny, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectomy, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Small joint arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Pleural biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass, Coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement. The users of the Camera System are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
# NIR FI Light Source:
The NIR FI Light Source and NIR FI Light Guide are indicated for use to provide real-time endoscopic visible and near-infrared fluorescence imaging. The NIR FI Light Source and NIR FI Light Guide enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with the NIR FI Light Source and NIR FI Light Guide is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.
# G. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Styrker's predicate device, the AIM (Advanced Imaging Modality) System, was cleared in K182160. A detailed comparison of the proposed and predicate system is provided in the substantial equivalence table below. SCHOELLY's TipVision™ Videoscope System cleared in K201617 is cited as a reference device in this submission because it represents an example of a camera system with Product Code FET (endoscopic video imaging system/component) for use in different application fields (not just laparoscopy) and relying on basically the same image processing options for real-time endoscopic visible imaging as the Camera System of the subject device does. The TipVision™ Videoscope System does not include near-infrared fluorescence imaging capability and features an integrated camera head (Videoscope) instead of a camera head connected to a fiberoptic scope.
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| Attribute | Proposed System<br>SCHOELLY's NIR FI<br>System<br>(current submission) | Predicate System<br>Styrker's AIM<br>(Advanced Imaging<br>Modality) System<br>(K182160) | Similarities and<br>Differences |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Endoscopic visible and<br>near-infrared light<br>illumination and imaging | Endoscopic visible and<br>near-infrared light<br>illumination and imaging | Same |
| Indications for Use | NOTE 1 | NOTE 2 | Camera System: Same<br>Light Source: Same;<br>Light source of subject<br>device comprises a<br>subset of the indications<br>for use of the predicate<br>device since subject<br>device is not intended to<br>transilluminate the ureter<br>during open or<br>laparoscopic surgical<br>procedures |
| Imaging Modes | White Light<br>NIR - fluorescence | White Light<br>NIR – fluorescence<br>NIR - transillumination | Same;<br>Subject device comprises<br>a subset of imaging<br>modes as compared to<br>predicate device since<br>subject device is not<br>intended to<br>transilluminate the ureter<br>during open or<br>laparoscopic surgical<br>procedures |
| Safety Standards | IEC 60601-1<br>IEC 60601-2-18<br>IEC 60601-1-2<br>IEC 60825-1 | IEC 60601-1<br>IEC 60601-2-18<br>IEC 60601-1-2<br>IEC 60825-1 | Same |
| System Components | Camera System,<br>Light Source and Light<br>Guide,<br>Laparoscopes | Camera System;<br>Light Source and<br>SafeLight Cable;<br>Laparoscope;<br>IRIS Ureteral Kit;<br>Imaging Agent Kits | Same;<br>Subject system<br>comprises a subset of<br>components as compared<br>to predicate system since<br>imaging agents kits are<br>not within the scope of<br>delivery of the subject<br>system |
| Use Environment | Hospital, Operating room | Hospital, Operating room | Same |
| Camera System | | | |
| Principles of Operation | Via an optical scope, light is transferred to imaging sensors of the camera system and the optical signal is transferred into an electrical signal. Imaging sensors acquire a continuous stream of image data which is further processed for proper viewing on displays. | Via an optical scope and coupler, light is transferred to imaging sensors of the camera system and the optical signal is transferred into an electrical signal. Imaging sensors acquire a continuous stream of image data which is further processed for proper viewing on displays. | Same |
| Image Sensor | CMOS image sensor | CMOS image sensor | Same |
| Image Processing / Video Output | Digital | Digital | Same |
| Data record and storage | Capture images and video recordings to USB or recordings to remote device | Capture images and video recordings to remote device | Similar |
| Resolution | up to 3840 x 2160 | up to 3840 x 2160 | Same |
| Resprocessing | Camera head released for manual or automated cleaning and sterilization | Camera head released for manual or automated cleaning and sterilization | Same |
| Light Source | | | |
| Principles of Operation | An electronic driver controls Red/Green/Blue LEDs & a near-infrared laser diode which are combined through. dichroic mirrors and projected onto an output light collimator. A fiber output bundle can be inserted into the light source to couple light to the distal end and into an endoscope. | An electronic driver controls Red/Green/Blue LEDs & a near-infrared laser diode which are combined through. dichroic mirrors and projected onto an output light collimator. A fiber output bundle can be inserted into the light source to couple light to the distal end and into an endoscope. | Same |
| Light Source / Laser | RGB LEDs<br>Infrared Laser | RGB LEDs<br>Infrared Laser | Same |
| Automatic light control | yes | yes | Same |
# Table 15.1: Technological Characteristics Comparison Table
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#### NOTE 1:
#### Camera System:
The Camera System is indicated for use in general laparoscopy, ear endoscopy, ear endoscopy, simuscopy, and plastic surgery whenever a laparoscope/ arthroscope is indicated for use. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectorny, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectorny, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Small joint arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Pleural biopsy, Dorsal sympathectorny, Pleurodesis, Internal mammary artery dissection for coronary artery bypass, Coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement. The users of the Camera System are general surgeons, gynecologists, cardiac surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
#### NIR FI Light Source:
The NIR FI Light Source and NIR FI Light Guide are indicated for use to provide real-time endoscopic visible and nearinfrared fluorescence imaging. The NIR FI Light Source and NIR FI Light Guide enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with the NIR FI Light Guide is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.
### NOTE 2:
#### 1688 4K Camera System with Advance Imaging Modality:
The 1688 Video Camera is indicated for use in general laparoscopy, ear endoscopy, ear endoscopy, sinuscopy, and plastic surgery whenever a laparoscope/ arthroscope is indicated for use. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectorny, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectorny, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Small joint arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Pleural biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass, Coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement. The users of the 1688 Video Camera are general surgeons, gynecologists, cardiac surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
#### L11 LED Light Source with Advanced Imaging Modality:
The L11 AIM Light Source and SafeLightTM Cable are indicated for use to provide real-time endoscopic visible and near-infrared fluorescence imaging. The L11 AIM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with the L11 AIM Light Source and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.
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The L11 AIM Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
Differences in technological characteristics do not raise different questions of safety and effectiveness.
# H. PERFORMANCE DATA
The following performance testing has been performed for the subject device:
# Reprocessing validation
Reprocessing validations were designed and conducted in accordance with FDA's 2015 guidance (including Appendix E revised June 2017) Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.
Cleaning studies were designed and performed in accordance with AAMI TIR12:2010 Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers, AAMI TIR30:2011(R)2016 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable devices.
Sterilization studies were designed and performed in accordance with AAMI TIR12:2010 Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers, and ANSVAAMI/ISO 17665-1:2006 (R)2013 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices. Cleaning and sterilization processes are defined in the device labeling per ISO 17664:2017 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices.
These tests demonstrated that the device successfully passed cleaning, drying and sterilization validations according to the instructions in the user manual.
## Software Documentation
Software documentation for a MODERATE Level of Concern device is provided in support of the proposed device per FDA's 2005 Guidance for the Content of Premarket Submissions for Software Contained in Medical Device. The software lifecycle, including software documentation and validation, is managed in accordance with IEC 62304:2006/A1:2016 Medical Device Software -Software Life Cycle Processes.
# Electrical Safety Testing
The NIR FI System was assessed for conformity with, and was found to comply with, the relevant requirements of IEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 (ed. 3.1, including the US deviations) Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance.
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The NIR FI System was assessed for conformity with, and was found to comply with, the relevant requirements of IEC 60601-2-18:2009 (ed. 3): Medical Electrical Equipment, Part 2: Particular Requirements for the Basic Safety and Essential Performance of Endoscopic Equipment.
# Electromagnetic Compatibility Testing
The NIR FI System was assessed for conformity with, and was found to comply with, the relevant requirements of IEC 60601-1-2:2014 (ed. 4) Medical Electrical Equipment, Part 1-2: General Requirements for Safety – Collateral standard: Electromagnetic Compatibility – Requirements and Tests.
# Non-Clinical Performance Testing
Non-Clinical performance test data demonstrate that the proposed NIR FI System performs substantially equivalent to the Stryker predicate AIM System and that the design output meets the design input requirements for endoscopic white light and near-infrared fluorescence imaging.
#### CONCLUSION I.
Based on a comparison of the proposed SCHOELLY NIR FI System and the Stryker predicate AIM System in terms of indications for use, physical and technological characteristics, and performance specifications the SCHOELLY NIR FI System raises no new issues of safety and effectiveness and is substantially equivalent to the predicate device.
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Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
