K203550 · Activ Surgical, Inc. · OWN · Apr 8, 2021 · Gastroenterology, Urology
Device Facts
Record ID
K203550
Device Name
ActivSight Intraoperative Imaging System
Applicant
Activ Surgical, Inc.
Product Code
OWN · Gastroenterology, Urology
Decision Date
Apr 8, 2021
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Indications for Use
ActivSight is intended to provide real-time endoscopic fluorescence and near infrared imaging. ActivSight enables surgeons to visually assess vessels, blood flow, and related tissue perfusion using fluorescence and near infrared imaging, and at least one of the major bile ducts (cystic duct, common bile duct, or common hepatic duct) using fluorescence, all during minimally invasive surgery. Fluorescence imaging of biliary ducts with ActivSight is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for stand-alone use for biliary duct visualization.
Device Story
ActivSight is an intraoperative imaging accessory for existing laparoscopic systems. It consists of an imaging module (optics/sensing) attached between a third-party laparoscope and camera, a light engine for laser fluorescence/near-infrared illumination, and a light cable. It processes video input from the third-party camera and its own module, outputting to a surgical monitor. Used in surgical environments by surgeons to assess blood flow, tissue perfusion, and biliary anatomy. It utilizes ICG fluorescence and laser speckle contrast imaging (LSCI) to provide real-time visual feedback. The system aids surgeons in intraoperative decision-making by providing perfusion and vessel visualization, potentially improving surgical outcomes. It includes a sterile drape and calibration target for each use.
Clinical Evidence
Bench testing included basic safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), human factors/usability (IEC 62366-1), software lifecycle (ANSI AAMI IEC 62304), laser safety (IEC 60825-1), and endoscopic equipment safety (IEC 60601-2-18). Clinical evidence includes an animal study comparing ActivSight's speckle laser and ICG fluorescence modes against the predicate's ICG mode for visualizing blood flow and perfusion.
Technological Characteristics
Components: Imaging module (optics/CMOS sensor), light engine (laser diodes), Y-shaped bifurcated light cable, stainless-steel sterilization tray. Sensing: IR-sensitive camera, 852 nm laser for speckle imaging. Connectivity: Interoperable with third-party laparoscopes/cameras. Sterilization: Steam sterilization for light cable and tray; disposable sterile drape and calibration target. Software: Class II device, software lifecycle per ANSI AAMI IEC 62304.
Indications for Use
Indicated for patients undergoing minimally invasive surgery requiring real-time endoscopic fluorescence and near-infrared imaging for visual assessment of vessels, blood flow, tissue perfusion, and major bile ducts (cystic, common bile, or common hepatic). Not for stand-alone 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 Infrared Fluorescence (IRF) Imaging System (K142310)
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Activ Surgical, Inc. Matthew King Director of Regulatory Affairs and Quality Assurance 840 Summer Street Boston, Massachusetts 02127
April 8, 2021
Re: K203550
Trade/Device Name: ActivSight Intraoperative Imaging System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ, OWN, DPT, Dated: March 8, 2021 Received: March 9, 2021
Dear Matthew King:
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.
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
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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 mediation-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.
Image /page/1/Picture/5 description: The image shows the name "Neil R.P. Ogden" in a large, bold font. To the right of the name, there is the text "Digitally s" followed by "Neil R.P. O" and "Date: 202" and "19:43:42 -". The text on the right appears to be part of a digital signature.
Digitally signed by Neil R.P. Ogden Date: 2021.04.08 19:43:42 -04'00'
Neil R.P. Ogden Assistant Director. THT4A4 DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known)
#### K203550
Device Name ActivSight
#### Indications for Use (Describe)
ActivSight is intended to provide real-time endoscopic fluorescence and near infrared imaging. ActivSight enables surgeons to visually assess vessels, blood flow, and related tissue perfusion using fluorescence and nearing, and at least one of the major bile duct, common bile duct or common hepatic duct) using fluorescence, all during minimally invasive surgery.
Fluorescence imaging of biliary ducts with ActivSight is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for stand-alone use for biliary duct visualization.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Activ Surgical. The word "ACTIV" is in large, blue, sans-serif font. Below that, the word "SURGICAL" is in a smaller, light gray, sans-serif font. The logo is simple and modern.
### 510(k) SUMMARY (21 CFR 807.92)
### 1. General Information
| Submitter Name: | Activ Surgical, Inc. |
|----------------------|-------------------------------------------------------------------------------------------------|
| Submitter Address: | 840 Summer Street, Suite 108<br>Boston, MA 02127 |
| Contact Person: | Matthew King<br>Director of Regulatory Affairs and Quality<br>Assurance<br>Activ Surgical, Inc. |
| Contact Information: | Email: mking@activsurgical.com<br>Phone: 603-459-9755<br>Fax: 617-977-0992 |
| Submission Type | Traditional 510(k) |
| Date Prepared | December 4, 2020 |
#### 2. Proposed Device
| Proprietary Name | ActivSight Intraoperative Imaging System |
|----------------------------|-------------------------------------------|
| Device Common Name | Light Source, Imaging Module, Light Cable |
| Device Model Number | 450-00001 |
| Device Classification Name | Confocal Optical Imaging |
| Regulation Number | 21 CFR 876.1500 |
| Product Code | OWN |
| Device Classification | II |
| Review Panel | General and Plastic Surgery |
| Premarket Review | General and Surgery Devices (DHT4A) |
### 3. Predicate Device and Reference Device
| | Predicate Device | Reference Device |
|-------------------------------|-------------------------------------------------------|--------------------------------|
| Proprietary Name | Stryker Infrared Fluorescence<br>(IRF) Imaging System | Perimed PeriCam PSI |
| 510(k) Number | K142310 | K120884 |
| Device Classification<br>Name | Confocal Optical Imaging | Extravascular blood flow probe |
| Regulation Number | 21 CFR 876.1500 | 21 CFR 870.2120 |
| Product Code | OWN | DPT |
| Device Classification | II | II |
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Image /page/4/Picture/0 description: The image shows the logo for Activ Surgical. The word "ACTIV" is in blue, with each letter in a bold, sans-serif font. Below "ACTIV" is the word "SURGICAL" in a smaller, light gray, sans-serif font. The logo is simple and modern.
### 4. Device Description:
The ActivSight Intraoperative Imaging System (ActivSight) is an accessory to existing commercial surgical laparoscope systems, including cameras and video processor units. ActivSight provides real-time endoscopic fluorescence and near-infrared imaging. These imaging features allow surgeons to visually assess vessels, blood flow, and tissue perfusion (using fluorescence and near-infrared imaging), and to visually assess at least one of the major bile ducts (cystic duct, common bile duct, or common hepatic duct) using fluorescence. Fluorescence imaging is enabled through use of any commercially available Indocyanine Green (ICG). These visualization features are available for surgeons to use during minimally invasive surgery. ActivSight is intended to be used in a surgical environment.
ActivSight consists of the following reusable components:
- 글 ActivSight Imaging Module, consisting of optics and sensing electronics. The imaging module attaches physically between the third-party laparoscope and the third-party imaging system camera. Reprocessing of this component requires cleaning and disinfection between uses.
- = ActivSight Light Engine, equipment consisting of system electronics that provide laser fluorescence and near-infrared illumination, processing of video input from both the third-party Camera Control Unit (CCI) and the ActivSight lmaging Module, and outputs video to the surgical monitor. This component does not require reprocessing between uses.
- ActivSight Light Cable, component consisting of a Y-shaped bifurcated light a cable that connects to the third party white-light source, the ActivSight Light Engine, and the third party laparoscope light post (providing white-light illumination of the surgical site through the laparoscope). Reprocessing of this component requires cleaning and steam sterilization.
- ActivSight Sterilization Tray, stainless-steel sterilization tray designed to a properly secure the ActivSight Light Cable for disinfection and sterilization. Reprocessing of this component is accomplished in its use- cleaning and steam sterilization.
ActivSight consists of the following disposable components:
- ActivSight Sterile Drape, a sterilized plastic drape that is provided for each use = to provide a sterile barrier between the imaging module and the patient.
- -ActivSight Calibration Target, a sterilized paper imaging target containing a checkerboard pattern for calibration of the ActivSight imaging module prior to each use of the device.
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Image /page/5/Picture/0 description: The image shows the logo for Activ Surgical. The word "ACTIV" is in large, blue, sans-serif font. Below that, in a smaller, light gray, sans-serif font, is the word "SURGICAL". The logo is simple and modern.
### 5. Indications for Use
The ActivSight Intraoperative Imaging System (ActivSight) is intended to provide realtime endoscopic fluorescence and near infrared imaging. ActivSight enables surgeons to visually assess vessels, blood flow, and related tissue perfusion using fluorescence and near infrared imaging, and at least one of the major bile ducts (cystic duct, common bile duct, or common hepatic duct) using fluorescence, all during minimally invasive surgery.
Fluorescence imaging of biliary ducts with ActivSight is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for stand-alone use for biliary duct visualization.
### 6. Performance Data
Safety and performance of the ActivSight Intraoperative Imaging System has been evaluated and verified in accordance with design specifications and applicable performance standards, including risk management, basic safety and essential performance, electromagnetic disturbances, human factors and usability, software lifecycle processes, safety of laser products. Activ Surgical has performed design validation in an animal study, comparatively visualizing blood flow and perfusion in specific structures with both ActivSight Perfusion (speckle laser) and ActivSight ICG (fluorescence) modes against the predicate's ICG mode. The following performance testing have also been conducted.
- Basic safety and essential performance testing completed in accordance with . IEC 60601-1:2005/R(2012) and A1:2012: Medical Electrical Equipment- Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1:2005. MOD). Testing indicates that the proposed device conforms to this standard.
- Electrical safety and electromagnetic compatibility testing completed in . accordance with IEC 60601-1-2 Edition 4.0 2014-02 Medical Electrical Equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral Standard: Electromagnetic disturbances: Requirements and tests. Testing indicates that the proposed device conforms to this standard.
- Human factors and usability testing completed in accordance with IEC 62366-1: . 2015 Medical Devices - Application of Usability Engineering to Medical Devices-Evaluation and reporting. Testing indicates that the proposed device presents no unacceptable risk to the user during its intended use, and that the device conforms to this standard.
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Image /page/6/Picture/0 description: The image shows the logo for Activ Surgical. The word "ACTIV" is in a large, sans-serif font and is colored blue. Below "ACTIV" is the word "SURGICAL" in a smaller, sans-serif font and is colored gray. The logo is simple and modern.
- Software development and software life cycle processes competed in accordance with ANSI AAMI IEC 62304:2006/A1:2016 Medical Device Software-Software Life Cycle Processes, Evaluation, Testing, and Reporting. Testing indicates that the proposed device conforms to this standard.
- · Laser safety testing completed in accordance with /EC 60825-1 Ed. 3.0 b:2014 Safety of Laser Products- Part 1: Equipment Classification and Requirements. Testing indicates that the proposed device conforms to this standard.
- Safety of endoscopic equipment testing completed in accordance with IEC . 60601-2-18: Edition 3.0 2009-08 Medical Electrical Equipment- Part 2-18: Particular Requirements for the Basic Safety and Essential Performance of Endoscopic Equipment. Testing indicates that the proposed device conforms to this standard.
The results of these studies demonstrate that the proposed device is as safe and effective as the predicate.
# 7. Substantial Equivalence
The ActivSight Intraoperative Imaging System (subject) is substantially equivalent to the Stryker® Infrared Fluorescence (IRF) Imaging System (predicate).
The subject device and predicate device have nearly identical Indications for Use. Both devices provide real-time endoscopic near-infrared fluorescence imaging during minimally invasive surgery. Both are indicated to enable surgeons visually assess blood flow, tissue perfusion, and at least one of the major bile ducts (cystic duct, common bile duct, or common hepatic duct). Fluorescence imaging of biliary ducts with both devices is intended for use with standard care white light, and when indicated, intraoperative cholangiography.
Both devices achieve their intended use through use of an FDA approved contrast drug agent (indocyanine green (ICG)).
Neither device is intended for stand-alone use for biliary duct visualization.
Differences between the two devices are ActivSight's capability to visualize blood flow and perfusion through speckle laser illumination, and ActivSight does not include laparoscopic equipment or a white light source. Laser speckle illumination is achieved through near-infrared laser diodes, imaging hardware, and imaging software that together display blood flow and perfusion without the aid of an imaging agent, such as ICG. ActivSight is interoperable with the existing laparoscopic equipment of the Stryker Infrared Fluorescence (IRF) Imaging System.
CONFIDENTIAL
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Image /page/7/Picture/0 description: The image shows the logo for Activ Surgical. The logo is blue and features the word "ACTIV" in large, bold letters. Below the word "ACTIV" is the word "SURGICAL" in smaller, thinner letters. The logo is simple and modern.
# Table 5.1: Comparison to Predicate
| | ActivSight Intraoperative<br>Imaging System | Stryker Infrared<br>Fluorescence (IRF) Imaging<br>System (K142310) - Predicate | Perimed PeriCam<br>PSI (K120884) -<br>Reference Device | |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Intended Use | Confocal Optical Imaging<br>(OWN) | Confocal Optical Imaging<br>(OWN) | Probe, Blood-Flow,<br>Extravascular (DPT) | |
| Indications<br>for Use | The ActivSight<br>Intraoperative Imaging<br>System (ActivSight) is<br>intended to provide real-<br>time endoscopic<br>fluorescence and near<br>infrared imaging. ActivSight<br>enables surgeons to<br>visually assess vessels,<br>blood flow, and related<br>tissue perfusion using<br>fluorescence and near<br>infrared imaging, and at<br>least one of the major bile<br>ducts (cystic duct, common<br>bile duct, or common<br>hepatic duct) using<br>fluorescence, all during<br>minimally invasive surgery.<br><br>Fluorescence imaging of<br>biliary ducts with ActivSight<br>is intended for use with<br>standard of care white light,<br>and when indicated,<br>intraoperative<br>cholangiography. The<br>device is not intended for<br>stand-alone use for biliary<br>duct visualization. | The Stryker® IRF Light Source<br>and SafeLight Cable are<br>indicated for use to provide<br>real-time endoscopic visible<br>and near-infrared fluorescence<br>imaging. The Stryker® IRF<br>Light Source and SafeLight<br>Cable enable surgeons to<br>perform minimally invasive<br>surgery using standard<br>endoscope visible light as well<br>as visual assessment of<br>vessels, blood flow and related<br>tissue perfusion, and at least<br>one of the major extra-hepatic<br>bile ducts (cystic duct, common<br>bile duct and common hepatic<br>duct), using near infrared<br>imaging.<br><br>Fluorescence imaging of biliary<br>ducts with the Stryker® IRF<br>Light Source and SafeLight<br>Cable are intended for use with<br>standard of care white light<br>and, when indicated,<br>intraoperative<br>cholangiography. The devices<br>are not intended for standalone<br>use for biliary duct visualization. | The PeriCam PSI is<br>intended for non-<br>invasive two-<br>dimensional imaging<br>of peripheral tissue<br>blood perfusion. | |
| Technological Characteristics | | | | |
| | ActivSight Intraoperative Imaging<br>System<br>ActivSight<br>Perfusion | Stryker Infrared<br>Fluorescence<br>(IRF) Imaging<br>System<br>(K142310) -<br>Predicate | Perimed<br>PeriCam PSI<br>(K120884) -<br>Reference<br>Device | |
| Mode of Action | Laser Speckle | Fluorescence | Laser Speckle | |
| Contrast Agent | None | ICG | None | |
| Information<br>Presentation<br>Format | Heatmap signal<br>overlayed on<br>red/green/blue<br>(RGB) or heatmap<br>signal only | Green Signal<br>overlayed on<br>red/green/blue<br>(RGB) | Green signal<br>overlayed on<br>grayscale | Heatmap signal<br>only with option<br>for adjacent<br>color image. |
| Light Source(s) | Coherent 852 nm<br>laser | 808nm laser | 808nm laser | 785nm laser |
| Light Source<br>Power Rating | Class 3R out of<br>Light Cable, class 1<br>out of scope | Class 3R out of<br>Light Cable, class<br>1 out of scope | Class 1M | Class 1 |
| Light Capture | IR sensitive camera | IR sensitive<br>camera | IR sensitive<br>camera | IR sensitive<br>camera |
| Active Area of<br>imaging sensor | 1/2.9" CMOS,<br>4.98x3.74mm | 1/2.9" CMOS,<br>4.98x3.74mm | 1/3" CMOS,<br>4.8x3.6mm | Unknown |
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Image /page/8/Picture/0 description: The image shows the logo for Activ Surgical. The word "ACTIV" is in large, blue, sans-serif font. Below that, in a smaller, light gray, sans-serif font, is the word "SURGICAL". The logo is simple and modern.
### 8. Conclusion
Based on the information provided in this premarket notification, and based on a comparison to the indications for use, performance testing, and technological characteristics of the predicate, the ActivSight Intraoperative Imaging System is shown to raise no new questions of safety and efficacy, and is substantially equivalent to the Stryker Infrared Fluorescence (IRF) Imaging System.
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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.
