The Endoscope Module of the VS3-IR-MMS System is intended for viewing internal surgical sites during general surgical procedures, for use in visualization of ventricles and structures within the brain during neurological surgical procedures, viewing internal surgical sites during anterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, and shoulder and knee arthroscopic procedures. The Iridium Module of the VS3-IR-MMS System is intended for capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures.

Device Description

The VS3-IR-MMS System consists of the cleared base system and the Iridium Module that is the subject of this submission. The currently marketed VS3 system with endoscope functionality was cleared under the following product codes: GCJ (General Surgery Endoscope), GWG (Neurological Endoscope), and HRX (Orthopedic Arthroscope). The cleared base system consists of the following components and accessories: High Definition 3D Endoscope, High Definition 3D Camera with 3 control buttons and a focus adjustment knob, 2D Coupler, CCU, Light Source, and Display Monitor. The VS3-IR-MMS System that is the subject of this submission contains the previously cleared components of the cleared base system listed above, as well as a High Definition IR Fluorescence Scope (MMS), a Laser Light Source (LLS), associated software and VS, Iridium IR Fluorescence Kit. The new Iridium Module, which uses the newly added High Definition IR Fluorescence Scope (MMS) and a Laser Light Source (LLS), as well as the cleared High Definition 3D Camera, Camera Control Unit (CCU), and Display Monitor, is used to generate florescence excitation illumination for external use in capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures.

AI/ML Overview

The document describes the VS3-IR-MMS System and its Iridium Module, which is intended for capturing and viewing fluorescent images for the visual assessment of blood flow as an adjunctive method. The submission focuses on demonstrating substantial equivalence to a predicate device, the Novadaq Technologies SPY Imaging System (K063345), rather than setting specific performance acceptance criteria for the new module.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for the Iridium Module's performance in terms of metrics like sensitivity, specificity, or accuracy. Instead, it relies on demonstrating that the device "functions as intended" and "met all performance acceptance criteria" based on bench testing and limited human subject evaluations. The primary "acceptance criteria" presented are related to regulatory standards compliance and functional equivalence to the predicate.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with IEC 60601-1-2 EMC Standard	Conforms to standard
Compliance with IEC 60601-1 Basic Safety Standard	Conforms to standard
Compliance with IEC 60601-1-4 Programmable Medical Systems	Conforms to standard
Compliance with IEC 60825-1 Laser Safety Standard	Conforms to standard
System software performs as intended	Software validated and performs as intended
Detect and visualize anatomy and blood flow (Iridium Module)	Bench testing (ICG in water, ICG through chicken skin) showed "good quality imaging." "Functions as intended" in human hand simulation and free flaps.
Functions as intended with human subjects (no adverse events)	Demonstrated in human subjects with "no adverse events reported"
Substantially equivalent to predicate device (K063345)	Concluded as substantially equivalent based on technological characteristics and performance data.
Imaging device has no direct or indirect patient contact	No direct or indirect patient contact
Light source is Infrared Laser	Infrared Laser
Excitation Wavelength is 805nm	805nm
Emission Band is 825nm to 850nm	825nm to 850nm
Emission Capture using IR camera	IR camera

2. Sample Size Used for the Test Set and Data Provenance

Bench Testing:
- ICG in sterile water: A single sample of 10mg ICG diluted to 2 ug/ml.
- ICG through chicken skin: A single sample of ICG in sterile water covered with chicken skin.
Human Simulation: A human hand was used. (Sample size: 1)
Human Subjects: "Several human subjects" were evaluated in free flaps. (Exact sample size not specified, but implied to be small).
Data Provenance: The human hand simulation and human subject evaluations were conducted "outside of the United States." The context suggests these were prospective evaluations, albeit limited.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number or qualifications of experts used to establish ground truth for the test sets. The interpretations of "good quality imaging" during bench testing and "functions as intended" or "no adverse events" during human evaluations were likely made by the researchers or clinical personnel involved in the studies, but their specific expert qualifications are not detailed.

4. Adjudication Method for the Test Set

The document does not mention any formal adjudication method (e.g., 2+1, 3+1) for evaluating the test results. The assessment appears to be based on direct observation and qualitative judgment by the study personnel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC comparative effectiveness study was done. This device is not described as an AI-powered diagnostic or assistive tool for human readers in the traditional sense. It's an imaging system for visualizing blood flow.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is an imaging system; it captures and displays images for human interpretation. The concept of "standalone algorithm only" performance, as it applies to AI/ML diagnostic tools, is not relevant here. The system's function is to provide the visual information.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Bench Testing: The ground truth was the known presence and concentration of ICG and the physical setup (ICG solution, ICG under chicken skin). Visual assessment of "good quality imaging" was the outcome.
Human Simulation (Hand): The ground truth was the expected blood flow in a human hand after ICG administration. Visual assessment of corresponding dye fluorescence was the outcome.
Human Subjects (Free Flaps): The ground truth was the actual tissue perfusion and related tissue-transfer circulation in free flaps. The assessment was that the device visualized blood flow and "functions as intended with no adverse events reported." This implies clinical observation of actual perfusion.

8. The Sample Size for the Training Set

No information is provided about a "training set" for the Iridium Module. The document describes a system with specific optical and imaging characteristics, not a machine learning model that requires a training set. The software modifications mentioned are likely for instrument control and image processing, not for AI model training.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned in the context of machine learning, this question is not applicable.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized human figure with three faces in profile, representing health and well-being. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 17, 2015

Visionsense LTD. % Mr. Gerard J. Prud'homme Hogan Lovells US LLP 555 13th Street, North West Washington, District of Columbia 20004

Re: K150018

Trade/Device Name: VS3-IR-MMS System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: OWN Dated: May 19, 2015 Received: May 19, 2015

Dear Mr. Prud'homme:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150018

Device Name

VS3-IR-MMS System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Visionsense's VS3-IR-MMS System

Submitter's Name, Address. Telephone Number, Contact Person and Date Prepared

Visionsense Ltd. 20 Hamagshimim Street Petach Tikva 49348 lsrael Phone: 972-3-9244339 Facsimile: +972-3-9244-335

Contact Person: Alex Chanin, CEO

Date Prepared: May 19, 2015

Name of Device and Name/Address of Sponsor

VS3-IR-MMS Svstem

Common or Usual Name / Classification Name

Surgical Microscope / Angiographic X-ray System / Endoscopes and Accessories

Predicate Device

Novadaq Technologies SPY Imaging System (K063345)

Intended Use / Indications for Use

The Endoscope Module of the VS3-IR-MMS System is intended for viewing internal surgical sites during general surgical procedures, for use in visualization of ventricles and structures within the brain during neurological surgical procedures, viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, and shoulder and knee arthroscopic procedures. The Iridium Module of the VS3-IR-MMS System is intended for capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures.

Technological Characteristics / Principles of Operation

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and a Laser Light Source (LLS), as well as the cleared High Definition 3D Camera, Camera Control Unit (CCU), and Display Monitor, is used to generate florescence excitation illumination for external use in capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures.

In sum, the proposed VS3-IR-MMS System is built on the predicate base VS3 System that has already been cleared for the treatment of viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures, viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, and shoulder and knee arthroscopic procedures (see K123467. K131434. K141002). The Iridium Module added to the cleared base system results in the following changes to the cleared system:

. Addition of a new scope ("MMS"), which is intended to provide a view of the surgical field from 20cm to 45cm above the patient.
. Addition of a Laser Light Source ("LLS") used to generate florescence excitation illumination.
Software modifications to allow the new MMS with LLS to be used with the cleared system.
Addition of the VS, Iridium IR Fluorescence Kit which contains the sterile ICG imaging agent used for fluorescence imaging.
. Additional indications for use with the new Iridium Module, which includes the MMS with LLS and associated software (described above) to include capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surqical procedures.

The Iridium Module that is the subject of this submission is designed to work with the Indocyanine Green (ICG) IR fluorescence imaging agent supplied in the VSg Iridium IR Fluorescence Kit. Each VS . Iridium IR Fluorescence Kit contains the following:

o Six 25mg vials of sterile ICG imaging agent.
o Six 10ml vials of sterile Water for Injection.

ICG in blood has maximum excitation at 805nm and an emission band between 825nm and 850nm. VS, Iridium Module provides excitation light to the surgical field to excite the dye molecules and captures emission from the dye using an IR camera.

The VS3-IR-MMS System permits recording surgical procedures, storing them on removable storage devices, and plaving the procedures back.

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Performance Data

The subject device conforms to the following recognized standards:

Standards No.	StandardsOrganization	Standards Title
60601-1-2		Medical electrical equipment - Part 1-2: General requirements for
(19-2)	IEC	basic safety and essential performance - collateral standard:electromagnetic compatibility - requirements and tests (Edition3).
Standards No.	StandardsOrganization	Standards Title
60601-1		Medical electrical equipment - Part 1: General requirements for
(19-4)	IEC	basic safety and essential performance.
Standards No.	Standards	Standards Title
	Organization
		Medical electrical equipment - Part 1: General requirements for
60601-1-4	IEC	safety, Collateral standard: Programmable electrical medical
		systems.
Standards No.	Standards	Standards Title
	Organization
60825-1		Safety of laser products - Part 1: Equipment classification, and
(12-273)	IEC	requirements.

The system software was validated and performs as intended per the pre-specified requirements.

In addition, bench testing was conducted to verify that the subject device can detect and visualize anatomy and blood flow per the proposed indications for use of the Iridium Module. Specifically, 10mg of ICG was dilated in sterile water to a concentration equal to that of ICG in the blood of a representative human (i.e., 2 ug/ml). Next, the ICG in sterile water diluted to representative human concentration was imaged directly to verify good quality imaging. Then, the sample of ICG in sterile water diluted to representative human concentration was covered with chicken skin and imaged to simulate visualization through skin.

On a related note, outside of the United States, a human hand was used in a simulated use testing environment to demonstrate that the Iridium Module has the capability to visualize blood flow corresponding to ICG dye fluorescence of blood vessels in the skin.

Lastly, an evaluation of the device was performed in free flaps in several human subjects outside the US and demonstrated that the device functions as intended with no adverse events reported using the system.

In all instances, the VS3-IR-MMS System using the Iridium Module functioned as intended and met all performance acceptance criteria.

Substantial Equivalence

The endoscope functionality of the base VS3-IR-MMS System was previously cleared. The proposed Iridium Module of the VS3-R-MMS has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device (K063345). The minor technological differences between the VS3-IR-MMS System Iridium Module and its predicate device do not raise different questions of safety or effectiveness. Performance data demonstrate that the VS3-IR-MMS System Iridium Module is as safe and effective as the predicate device. Thus,

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the VS3-IR-MMS Iridium Module is substantially equivalent. See the below comparison table of the Iridium Module of the updated VS3-IR-MMS and the Novadaq Spy Imaging device (K063345).

Attributes	VS3-IR-MMS (proposed)	Spy (K063345)
Manufacturer	Visionsense Ltd.	Novadaq Technologies Inc
Drape Usage	Yes	Yes
Imaging Agent	IR fluorescence dye (e.g.,Indocyanine Green-ICG)	IR fluorescence dye (e.g.,Indocyanine Green-ICG)
Imaging Head	Silicon Image Sensor	Silicon Image Sensor
Imaging Device	No direct or indirect patient contact	No direct or indirect patientcontact
Light Source	Infrared Laser	Infrared Laser
Excitation Wavelength	805nm	805nm
Field of View	19cm x 14cm(40cm nominal distance)	19cm x 14cm(30cm nominal distance)
Imaging	Fluorescent Imaging	Fluorescent Imaging
Emission Band	825nm to 850nm	825nm to 850nm
Emission Capture	IR camera	IR camera

Conclusions

The VS3-IR-MMS System Iridium Module is substantially equivalent to the predicate device. Performance and clinical testing demonstrates that the newly added components to the proposed device performs substantially equivalent to the predicate device, and any differences in technological characteristics do not raise different questions of safety or efficacy compared to the predicate device.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
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.(b)
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.