K221252 · Scivita Medical Technology Co., Ltd. · GCJ · Jan 13, 2023 · Gastroenterology, Urology
Device Facts
Record ID
K221252
Device Name
Scivita 4KINSIGHT ICG Imaging System
Applicant
Scivita Medical Technology Co., Ltd.
Product Code
GCJ · Gastroenterology, Urology
Decision Date
Jan 13, 2023
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Indications for Use
The Scivita 4KINSIGHT ICG Imaging System consists of a 4KINSIGHT UHD Fluorescence Imaging System, a Near-Infrared LED Light Source, and a 4K UHD LAPAROSCOPE. Upon intravenous administration of TRADENAME (ICG drug product), the Scivita 4KINSIGHT ICG Imaging System is used with TRADENAME to perform intraoperative fluorescence angiography, and it is also indicated for use in fluorescence imaging of biliary ducts, and when indicated, during intraoperative cholangiography. The Scivita 4KINSIGHT ICG Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. The Scivita 4KINSIGHT ICG Imaging System enables surgeons to perform minimally invasive surgery using standard endoscope visible 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 or common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the Scivita 4KINSIGHT ICG Imaging System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization. Upon interstitial administration of TRADENAME (ICG drug product), the Scivita 4KINSIGHT ICG Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Device Story
The Scivita 4KINSIGHT ICG Imaging System is a 4K endoscopic fluorescence imaging platform used in minimally invasive surgery. It consists of a 4K fluorescence camera control unit, camera head, near-infrared (NIR) LED light source, and a rigid 4K UHD laparoscope. The system captures white light and NIR fluorescence images simultaneously following intravenous or interstitial ICG administration. The NIR LED excites the ICG, and the CMOS-based camera head converts reflected light and fluorescence into electrical signals. These are processed by the control unit and displayed on a 4K monitor. Surgeons use the real-time visual feedback to assess blood flow, tissue perfusion, and biliary or lymphatic anatomy. The device is operated by surgeons in clinical settings to aid intraoperative decision-making, potentially improving surgical precision and patient outcomes.
Clinical Evidence
No clinical data. Bench testing only, including compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, ISO 8600-1, ISO 8600-5, and IEC 62471. Performance testing compared image intensity, depth of field, and optical resolution against the predicate.
Technological Characteristics
System includes 4K UHD fluorescence camera control unit, camera head (CMOS sensor), NIR LED light source (785nm), and rigid 4K UHD laparoscopes (5.5mm/10mm, 0°/30°/45°). Connectivity via HDMI and SDI. Reusable device, sterilized before use. Complies with ISO 8600 and IEC 60601 standards.
Indications for Use
Indicated for patients undergoing minimally invasive surgery requiring intraoperative fluorescence angiography, biliary duct visualization (including cystic, common bile, or common hepatic ducts), or lymphatic system visualization (vessels and nodes) using ICG contrast agent.
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
PINPOINT Endoscopic Fluorescence Imaging System (K182606)
Submission Summary (Full Text)
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January 13, 2023
Scivita Medical Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 China
Re: K221252
Trade/Device Name: Scivita 4KINSIGHT ICG Imaging System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ, IZI Dated: December 12, 2022 Received: December 15, 2022
Dear Diana Hong:
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, Ph.D. 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) K221252
#### Device Name
Scivita 4KINSIGHT ICG Imaging System
## Indications for Use (Describe)
The Scivita 4KINSIGHT ICG Imaging System consists of a 4KINSIGHT UHD Fluorescence Imaging System, a Near-Infrared LED Light Source, and a 4K UHD LAPAROSCOPE.
Upon intravenous administration of TRADENAME (ICG drug product), the Scivita 4KINSIGHT ICG Imaging System is used with TRADENAME to perform intraoperative fluorescence angiography, and it is also indicated for use in fluorescence imaging of biliary ducts, and when indicated, during intraoperative cholangiography.
The Scivita 4KINSIGHT ICG Imaging System is indicated for use to provide real time endoscopic visible and nearinfrared fluorescence imaging. The Scivita 4KINSIGHT ICG Imaging System enables surgeons to perform minimally invasive surgery using standard endoscope visible 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 or common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with the Scivita 4KINSIGHT ICG Imaging System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.
Upon interstitial administration of TRADENAME (ICG drug product), the Scivita 4KINSIGHT ICG Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------|-----------------------------------------------|
| <span style="font-family:Wingdings;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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# 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K221252
- 1. Date of Preparation: 12/12/2022
- 2. Sponsor Identification
Scivita Medical Technology Co., Ltd. No.8, Zhong Tian Xiang, Suzhou Industrial Park, Suzhou, Jiangsu, 215000, China.
Establishment Registration Number: Not yet registered.
Contact Person: Ruqin Wu Position: Regulation Manager Tel: +86-512-81877788 Fax: +86-512-85187285 Email: wuruqin@scivitamedical.com
- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)
### Mid-Link Consulting Co., Ltd.
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850 Fax: 360-925-3199 Email: info@mid-link.net
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- 4. Identification of Subject device
Trade Name: Scivita 4KINSIGHT ICG imaging system Common Name: 4K Fluorescence Imaging System
Regulatory Information Classification Name: Gastroenterology-urology device Classification: II; Product Code: GCJ Regulation Number: 21 CFR 876.1500 Review Panel: General & Plastic Surgery
Classification Name: Angiographic x-ray system Classification: II; Product Code: IZI Regulation Number: 21 CFR 892.1600 Review Panel: Radiology
Indication for Use:
The Scivita 4KINSIGHT ICG Imaging System consists of a 4KINSIGHT UHD Fluorescence Imaging System, a Near-Infrared LED Light Source, and a 4K UHD LAPAROSCOPE.
Upon intravenous administration of TRADENAME (ICG drug product), the Scivita 4KINSICHT ICG Imaging System is used with TRADENAME to perform intraoperative fluorescence angiography, and it is also indicated for use in fluorescence imaging of biliary ducts, and when indicated, during intraoperative cholangiography.
The Scivita 4KINSIGHT ICG Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. The Scivita 4KINSIGHT ICG Imaging System enables surgeons to perform minimally invasive surgery using standard endoscope visible 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 or common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with the Scivita 4KINSIGHT ICG Imaging System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.
Upon interstitial administration of TRADENAME (ICG drug product), the Scivita 4KINSIGHT ICG Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
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Device Description:
The subject device, Scivita 4KINSIGHT ICG Imaging System is consisting of a 4KINSIGHT UHD Fluorescence Imaging System including a 4K Fluorescence Camera Control Unit and a 4K Fluorescence camera head, a Near-Infrared LED Light Source and a 4K UHD Laparoscope.
The subject device can be offered in multiple configuration based on different combination of component models and subcomponent models. Details refer to Table 1 System Configuration.
| System name | Component name and Model | Subcomponent/ Model | |
|--------------------------------------------|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| Scivita<br>4KINSIGHT ICG<br>Imaging System | 4KINSIGHT<br>UHD<br>Fluorescence<br>Imaging System | 4KIR01 | 4K Fluorescence Camera Control<br>Unit/4KIR321 |
| | | | 4K Fluorescence Camera<br>Head/4KIR320C |
| | | 4KIR07 | 4K Fluorescence Camera Control<br>Unit/4KIR311 |
| | | | 4K Fluorescence Camera<br>Head/4KIR320C |
| | Near-Infrared<br>LED Light<br>Source | LSIR330 | / |
| | 4K UHD<br>Laparoscope | 4K5500R, 4K5530R,<br>4K5545R, 4K1000R,<br>4K1030R, 4K1045<br>(these models have been<br>cleared in <b>K203255</b> ) | / |
| | | 4K5500L, 4K5530L,<br>4K5545L, 4K1000L,<br>4K1030L, 4K1045L, | / |
| | | 4K5500LR, 4K5530LR,<br>4K5545LR, 4K1000LR,<br>4K1030LR, 4K1045LR | / |
Table 1 System Configuration
The component, 4KINSIGHT UHD Fluorescence Imaging System, is designed to be used with endoscopes, light source, monitors, light guide cables and other ancillary equipment for endoscopic diagnosis, treatment and observation. It is comprised of a 4K Fluorescence Camera Control Unit (model: 4KIR321, 4KIR311) and a 4K Fluorescence camera head (model 4KIR320C). The only difference between 4KIR321 and 4KIR3114K is: two HDMI output signal of 4KIR321 both are 4096×2160p; two HDMI output signal of 4KIR311 are respectively 4096×2160p and 1920×1080p.
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The component, 4K UHD Laparoscope, is a rigid endoscope intended to be used for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities. The subject device is also indicated for visualization of transanal and transvaginal applications.
The 4K UHD Laparoscope has 18 models which are available in two insertion widths (5.5 mm and 10 mm), four working lengths (290mm, 424mm, 450mm) and three different directions of view (0 ; 30 ° 45 9. The 4K UHD Laparoscope is a reusable device that is cleaned and sterilized before first use and each use.
- Identification of Predicate Device న్.
510(k) Number: K182606 PINPOINT Endoscopic Fluorescence Imaging System Product Name: Manufacturer: Novadaq Technologies ULC (now a part of Stryker)
- 6. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with the following standards:
- > IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+AM1:2012, Medical Electrical Equipment-Part 1: General requirements for basic safety and essential performance, including the US National Differences
- A IEC 60601-1-2:2014 Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests
- > IEC 60601-2-18:2009, Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performanc
- > ISO 8600-1:2015 Endoscopes-Medical endoscopes and endotherapy devices-part 1: General requirements
- > ISO 8600-5:2005 Endoscopes -Medical endoscopes and endotherapy devices--Part 5: Determination of optical resolution of rigid endoscopes with optics
- > ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and System
- > IEC 62471:2006 Photobiological safety of lamps and lamp systems
- 7. Clinical Test Conclusion
No clinical study is included in this submission.
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#### 8. Summary of Technological Characteristics
| ITEM | Subject Device | Predicate Device<br>K182606 | Remark |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product name | Scivita 4KINSIGHT ICG imaging system | PINPOINT Endoscopic<br>Fluorescence Imaging<br>System | / |
| Regulation<br>No. | 21 CFR 876.1500<br>21 CFR 892.1600 | 21 CFR 876.1500<br>21 CFR 892.1600 | Same |
| Product Code | GCJ, IZI | GCJ, IZI | Same |
| Class | II | II | Same |
| Indication for Use | The Scivita 4KINSIGHT ICG<br>Imaging System consists of a<br>4KINSIGHT UHD Fluorescence<br>Imaging System, a Near-Infrared<br>LED Light Source, and a 4K UHD<br>LAPAROSCOPE.<br><br>Upon intravenous<br>administration of TRADENAME<br>(ICG drug product), the Scivita<br>4KINSIGHT ICG Imaging System is<br>used with TRADENAME to perform<br>intraoperative fluorescence<br>angiography, and it is also indicated<br>for use in fluorescence imaging of<br>biliary ducts, and when indicated,<br>during intraoperative<br>cholangiography.<br><br>The Scivita 4KINSIGHT ICG<br>Imaging System is indicated for use<br>to provide real time endoscopic<br>visible and near-infrared fluorescence<br>imaging. The Scivita 4KINSIGHT<br>ICG Imaging System enables<br>surgeons to perform minimally<br>invasive surgery using standard<br>endoscope visible light as well as<br>visual assessment of vessels blood | Upon intravenous administration of<br>TRADENAME (ICG drug product),<br>the PINPOINT Endoscopic<br>Fluorescence Imaging System is used<br>with TRADENAME to perform<br>intraoperative fluorescence<br>angiography, and it is also indicated<br>for use in fluorescence imaging of<br>biliary ducts, and when indicated,<br>during intraoperative<br>cholangiography.<br><br>The PINPOINT Endoscopic<br>Fluorescence Imaging System is<br>indicated for use to provide real time<br>endoscopic visible and near-infrared<br>fluorescence imaging. The<br>PINPOINT System enables surgeons<br>to perform minimally invasive<br>surgery using standard endoscope<br>visible light as well as visual<br>assessment of vessels blood flow | Same |
| | | | |
| | flow and related tissue perfusion, and<br>at least one of the major extra-hepatic<br>bile ducts (cystic duct, common bile<br>duct or common hepatic duct), using<br>near-infrared imaging.<br>Fluorescence imaging of biliary<br>ducts with the Scivita 4KINSIGHT<br>ICG Imaging System is intended for<br>use with standard of care white light,<br>and when indicated, intraoperative<br>cholangiography. The device is not<br>intended for standalone use for<br>biliary duct visualization.<br>Upon interstitial administration of<br>TRADENAME (ICG drug product),<br>the Scivita 4KINSIGHT ICG<br>Imaging System is used to perform<br>intraoperative fluorescence imaging<br>and visualization of the lymphatic<br>system, including lymphatic vessels<br>and lymph nodes. | and related tissue perfusion, and at<br>least one of the major extra-hepatic<br>bile ducts (cystic duct, common bile<br>duct or common hepatic duct), using<br>nearinfrared imaging.<br>Fluorescence imaging of biliary ducts<br>with the PINPOINT System is<br>intended for use with standard of care<br>white light, and when indicated,<br>intraoperative cholangiography. The<br>device is not intended for standalone<br>use for biliary duct visualization.<br>Upon interstitial administration of<br>TRADENAME (ICG drug product),<br>the PINPOINT System is used to<br>perform intraoperative fluorescence<br>imaging and visualization of the<br>lymphatic system, including<br>lymphatic vessels and lymph nodes. | |
| Main<br>Configuration | 4K UHD Laparoscope<br>Near-Infrared LED Light Source<br>4K Fluorescence Camera Head<br>4K Fluorescence Camera Control<br>Unit | Surgical laparoscope<br>Illuminator (VPI)<br>Camera head<br>Endoscopic video processor | Different |
| Label/Labeling | Conform with 21 CFR Part 801 | Conform with 21 CFR Part 801 | Same |
| Prescription<br>Use/OTC | Prescription Use | Prescription Use | Same |
## Table 2 General Comparison
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Different - Main Configuration
The naming of main configuration of the subject device is different from the predicate device, while they have the same main configuration. Therefore, the difference on naming of main configuration will not affect the safety and effectiveness of the subject device.
| ITEM | | Subject Device | Predicate Device<br>K182606 | Remark |
|----------------|-------------------|----------------------------|-----------------------------|-----------|
| Endosco<br>pes | Direction of View | 0°, 30°, 45° | 0°, 30°, 45° | Same |
| | Working Length | 29cm (5.5mm, 0°, 30°, 45°) | 300 mm | Different |
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| | | 32cm (10mm, 0 °, 30 °, 45 °) | 302 mm | |
|---------------------------|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| | | | 320 mm | |
| | | | 323 mm | |
| | | | 330 mm | |
| | | | 420 mm | |
| Camera Head | Imager Type | CMOS | CMOS | Same |
| | Zoom | 1x~ 2.5x | 1x~ 2.5x | Same |
| Camera<br>Control<br>Unit | Digital Outputs | HDMI×2<br>SDI-1 BNC terminal ×4<br>SDI-2 BNC terminal ×1 | HD-SDI, 3G-SDI, DVI | Different |
| Light<br>Source | Light<br>Source<br>Type | White light LED and<br>near-infrared light LED | Laser infrared light source | Different |
| Imaging Mechanism | | The patient is injected with<br>ICG imaging agent.<br>Indocyanine green enters the<br>blood through human<br>intravenous injection and<br>reaches various organs and<br>tissues of the human body<br>through human blood<br>circulation. The ICG<br>fluoresces when illuminated<br>through the laparoscope with<br>near-infrared excitation light<br>from the near-infrared LED<br>light source. The 4K<br>fluorescence camera head<br>captures the white light<br>images reflected by human<br>organs or tissues and the<br>fluorescence images excited<br>by indocyanine green. The<br>light signals are collected<br>and converted into electrical<br>signals by the<br>Complementary Metal Oxide<br>Semiconductor (CMOS)<br>inside the 4K fluorescence | The patient is injected with<br>ICG imaging agent.<br>Indocyanine green enters the<br>blood through human<br>intravenous injection and<br>reaches various organs and<br>tissues of the human body<br>through human blood<br>circulation. The ICG<br>fluoresces when illuminated<br>through the laparoscope with<br>excitation light from the laser<br>light source. The 4K<br>fluorescence camera head<br>captures the white light<br>images reflected by human<br>organs or tissues and the<br>fluorescence images excited<br>by indocyanine green. The<br>light signals are collected<br>and converted into electrical<br>signals by the<br>Complementary Metal Oxide<br>Semiconductor (CMOS)<br>inside the 4K fluorescence<br>Camera Head and then | Different |
{10}------------------------------------------------
| Camera Head, and then transmitted to the 4K fluorescence camera control unit through the 4K fluorescence camera head cable. The 4K fluorescence camera control unit can process the image of the received electrical signal and transmit it to the 4K monitor through SDI and HDMI signal lines, and finally present the white light image and near infrared image on the display. | | | transmitted to the 4K fluorescence camera control unit through the 4K fluorescence camera head cable. The 4K fluorescence camera control unit can process the image of the received electrical signal and transmit it to the 4K monitor through SDI and HDMI signal lines, and finally present the white light image and near infrared image on the display. | | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|-------------|------------|
| Contrast agent | Need | Need | Same | | | |
| Contrast agent type | ICG | ICG | Same | | | |
| Image Intensity | Ucorner | 52.5% | 53.7% | Different | | |
| | Uside | 80.9% | 67.2% | | | |
| Depth of Field | Close view (3mm) | 80.6 lp/mm | 71.8 lp/mm | Different | | |
| | Distant view (250mm) | 1.26 lp/mm | 1.26 lp/mm | | | |
| Image resolution | Near DOF (3mm) | on-axis optical resolution | 80.6 lp/mm | | 71.8 lp/mm | |
| | | off-axis optical resolution | 57.20 lp/mm | | 46.80 lp/mm | |
| | | Working distance (40mm) | on-axis optical resolution | | 8.98 lp/mm | 8.98 lp/mm |
| | | | off-axis optical resolution | | 6.59 lp/mm | 6.37 lp/mm |
{11}------------------------------------------------
| Far<br>DOF<br>(250m<br>m) | on-axis<br>optical<br>resoluti<br>on | 1.26 lp/mm | 1.26 lp/mm | |
|-------------------------------------------------|---------------------------------------|-----------------------------------|--------------|-----------|
| | off-axis<br>optical<br>resoluti<br>on | 1.16 lp/mm | 1.12 lp/mm | |
| Light Source used for<br>Fluorescent excitation | | Near-Infrared LED Light<br>Source | Laser source | Same |
| Wavelength | | 785nm | 805 nm | Different |
#### Different- Working Length
Although the working length of the subject device is not the predicate device, the working length of the subject device is included in the scope of the predicate device. The surgeon will select the proper endoscope based on her/his experiences and clinical conditions. Thus, this difference does not affect substantially equivalence between the subject device and predicate device.
#### Different- Digital Outputs
Although the Digital Outputs of the subject device is different from that of the predicate device, the DVI does not support the 4K signal of 2160mm 108060p, while the subject device belongs to the 4K camera, so the picture quality is higher. Therefore, the performance should be better. Thus, this difference does not affect substantially equivalence between the subject device and predicate device.
#### Different- Light Source
The Light Source Type of the subject device is not the same as that of the predicate device. The subject device uses the LED infrared light source and the predicate device uses laser infrared light. LED is a low-energy light, which is safer than the laser infrared light. Therefore, the subject device than the predicate device on Light Source Type.
#### Different- Imaging Mechanism and Wavelength
The Light Source used for Fluorescent excitation for the subject device is LED infrared light source, and for the predicate device it is the Laser infrared light source. Because the light source type is different, the output wavelength is similar but not the same. The absorption spectrum of ICG in blood is 650nm-850nm, and in one Study, it shows that the infrared light near 765nm produces the most fluorescence. Therefore, we believe this difference on wavelength does not affect substantially equivalence between the subject device and predicate device, and the subject device and predicate device has the same imaging mechanism.
#### Different- Image Intensity
{12}------------------------------------------------
The intensity uniformity of subject device is almost same with predicate device in Ucomer, the intensity uniformity of Uside of subject device is better than predicate device, which demonstrates that the intensity uniformity performance of subject device is better than predicate device. Thus, this difference does not affect substantially equivalence between the subject device and predicate device.
#### Different- Depth of Field
The resolution of subject device and predicate device is almost the same in the testing distance scope (3mm-250mm), although the asserted depth of field of predicate device is 25mm-100mm, but the resolution of subject device and predicate device all meet the depth of field criteria (3mm-250mm), which demonstrates that subject device and predicate device almost have the same depth of field performance. Thus, this difference does not affect substantially equivalence between the subject device and predicate device.
#### Different- Image resolution
Base on the compare analytical data, the on-axis optical resolution and the average off-axis optical resolution of subject device is almost the same with predicate device in the near DOF (3mm), working distance (40mm), far DOF (250mm) which demonstrates that the resolution performance of subject device is almost the same with predicate device. Thus, this difference does not affect substantially equivalence between the subject device and predicate device.
#### 9. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the subject device is determined to be Substantially Equivalent (SE) 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.
