The system is intended for viewing internal surgical sites during general surgical procedures, 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 large joint arthroscopic procedures.

Device Description

The VS3 ETV endoscope is the same endoscope as the predicate VS3 with the addition of 3 working channels. The endoscope is designed and manufactured the same way. The endoscope is a rigid metal shaft that uses a proximal sensor module which is mounted onto a camera block on the proximal side of the endoscope (the handle). The endoscope uses stereoscopic images which are transmitted from the visual field at the distal end of the scope through an optical transmission (for left and right channels). The endoscope camera sensor module picks up the left and right images of the scene inside the body and delivers them to the external display. The endoscope incorporates fiber optic threads that transfer the light from the illumination unit to the surgical scene. The VS3 ETV endoscope contains 3 working channels. The endoscope utilizes the same principle of operation, software, system architecture, camera and visual viewing technologies, illumination sources, display monitors, carts, CCU and couplers as the predicate VS3.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the VS3-ETV device:

The provided text is a 510(k) summary for the VS3-ETV, which is a modified version of the predicate device, the VS3 Stereoscopic High Definition Vision System (K141002). This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone clinical study with detailed acceptance criteria and performance metrics for clinical outcomes.

Therefore, many of the requested details about a study proving the device meets acceptance criteria are not available in this type of document because the submission strategy is based on comparing technological characteristics and non-clinical performance to a cleared predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are essentially derived from the technological characteristics of the predicate device and the established recognized standards the device conforms to. The "reported device performance" are the stated characteristics of the proposed device, which are shown to be equivalent to the predicate.

Feature/Parameter	Acceptance Criteria (from Predicate VS3, K141002)	Reported Device Performance (Proposed VS3-ETV)
Able to function with no camera	No	No
Working distance range	8mm - 70mm	8mm - 70mm
Field Of View	70° - 95°	70° - 95°
Direction of view	0º - 70º	0º - 70º
Horizontal resolution	>199 lpf	>199 lpf
Vertical resolution	>199 lpf	>199 lpf
Identification	Support functionality to permit the system to identify scope	Support functionality to permit the system to identify scope
Irrigation Sheath	Support an optional irrigation sheath with a standard Storz-style connector	Support an optional irrigation sheath with a standard Storz-style connector
Endoscope diameter	4 - 5.5 mm	4 - 5.5 mm
Endoscope length	175 - 300 mm (±5 mm)	175 - 300 mm (±5 mm)
Depth of field	7 - 30mm and 15 - 60mm	7 - 30mm and 15 - 60mm
Working Channels	No	Yes (Addition of 3 working channels is the key change)
Additional Standards Conformance:	IEC 60601-1-2 (EMC)IEC 60601-1 (Basic Safety)IEC 60601-1-4 (Programmable Medical Systems)	Conforms to these standards (implied by statement "The subject device conforms to the following recognized standards")
Reuse Validation	Demonstrated safe reuse of predicate device	Performed to demonstrate no changes compared to predicate
Cleaning & Disinfection Validation	Demonstrated effective predicate disinfection	Performed to demonstrate no changes compared to predicate
Autoclave & Sterilization Validation	Demonstrated effective predicate sterilization	Performed to demonstrate no changes compared to predicate

Explanation of "Acceptance Criteria" in this context: For a 510(k) submission showing substantial equivalence, the "acceptance criteria" are not typically clinical performance metrics with target values (e.g., sensitivity, specificity). Instead, they are the demonstration that the modified device's technological characteristics and non-clinical performance (e.g., safety, sterilization) are either identical or equivalent to the predicate device, or that any differences do not raise new questions of safety or effectiveness.

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

Sample Size: The document does not describe a clinical "test set" in terms of patient data. The "performance testing" mentioned refers to non-clinical tests like reuse validation, cleaning, disinfection, and sterilization. The sample size for these non-clinical tests (e.g., number of instruments tested for sterilization cycles) is not provided.
Data Provenance: Not applicable as it's not a clinical study on patient data. The non-clinical tests were likely conducted by the manufacturer, Visionsense Ltd., in Israel or a contract testing lab.

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

Number of Experts/Qualifications: Not applicable. There is no mention of a human-read clinical test set or ground truth established by experts in this 510(k) summary. The performance data presented are physical/technical specifications and results from non-clinical validation tests.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No clinical test set requiring adjudication is described.

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

MRMC Study / Effect Size: Not applicable. This device is an endoscope/vision system, not an AI diagnostic algorithm for image interpretation. There is no mention of AI assistance for human readers or an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Standalone Performance: Not applicable. This is a hardware device (endoscope system), not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Ground Truth: Not applicable in the traditional sense of a diagnostic device. For the technical performance characteristics, the "ground truth" would be established by direct measurement with calibrated instruments (e.g., optical resolution charts for horizontal/vertical resolution, rulers for working distance). For the non-clinical tests like sterilization, the ground truth is established by validated laboratory methods (e.g., biological indicators for sterility assurance).

8. The sample size for the training set

Training Set Sample Size: Not applicable. This is a hardware device, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable. (See #8)

Summary of Device and Study Focus:

The VS3-ETV is an endoscope system. The 510(k) submission focuses on demonstrating that the modified device (VS3-ETV, with added working channels) is substantially equivalent to a previously cleared predicate device (VS3, K141002). This means the primary "study" involved comparing the technical specifications and conducting non-clinical performance tests (reuse, cleaning, disinfection, sterilization) to show that the addition of working channels does not introduce new safety or effectiveness concerns compared to the predicate. The reference device K983365 (Aesculap Minop System) was used to establish precedence for the irrigation and working channels concept itself. There is no mention of clinical trials or studies involving patient data to establish new clinical performance criteria for this modification.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles incorporated into the design.

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

February 22, 2016

Visionsense Ltd % Raymond Kelly Licensale Inc 57 Lazy Brook Rd Monroe, Connecticut 06468

Re: K153548

Trade/Device Name: VS3 Stereoscopic High Definition Vision System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX, GWG Dated: December 25, 2015 Received: January 8, 2016

Dear Mr. Kelly:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

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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" (21 CFR 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,

David Krause -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)

K153548

Device Name

VS3-ETV

Indications for Use (Describe)

The system is intended for viewing internal surgical sites during general surgical procedures, 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, and foraminotomy, and shoulder and large joint arthroscopic procedures.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

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510(k) Summary Visionsense VS3-ETV

Submitter's Name, Address, Telephone Number,

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

Contact Person and Date Prepared

Raymond Kelly 57 Lazy Brook Rd Monroe, CT 06468 USA Phone: (203) 880-4091

Date Prepared: October 25, 2015

Name of Device

VS3-ETV

Common or Usual Name / Classification Name Neurological Endoscope / Arthroscope

Product Code /	Regulation Number
GWG / HRX	882.1480 / 888.1100

Review Panel Neurology / Orthopedic

Device Class: Class II

Predicate Device

VS3 Stereoscopic High Definition Vision System, Model VS3 (K141002)

Intended Use / Indications for Use

Principles of Operation / Conditions of Use

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Technological Characteristics / Performance Data

StandardsNo.	StandardsOrganization	Standards Title
60601-1-2	IEC	Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essential performance -collateral standard: electromagnetic compatibility -requirements and tests (Edition 3).
60601-1	IEC	Medical electrical equipment - Part 1: General requirementsfor basic safety and essential performance.
60601-1-4	IEC	Medical electrical equipment - Part 1: General requirementsfor safety, Collateral standard: Programmable electricalmedical systems.

The subject device conforms to the following recognized standards:

Performance testing consisting of reuse validation, cleaning and disinfection validation, autoclave and sterilization were performed to demonstrate the additional working channels do not present changes in reuse handling and processing compared to the predicate device. No new biocompatibility assessments or electrical safety or EMC testing was required as the only modification to the VS3 system was the addition of 3 working channels.

Feature/Parameter	Proposed VS3-ETV	Predicate VS3 (K141002)
Able to function with nocamera	No	No
Working distance range	8mm - 70mm	8mm - 70mm
Field Of View	70° - 95°	70° - 95°
Direction of view	0º - 70º	0° - 70°
Horizontal resolution	>199 Ipf	>199 Ipf
Vertical resolution	>199 lpf	>199 lpf
Identification	Support functionality to permitthe system to identify scope	Support functionality to permitthe system to identify scope
Irrigation Sheath	Support an optional irrigationsheath with a standard Storz-style connector	Support an optional irrigationsheath with a standard Storz-style connector
Endoscope diameter	4 - 5.5 mm	4 - 5.5 mm
Endoscope length	175 - 300 mm (±5 mm)	175 - 300 mm (±5 mm)
Depth of field	7 - 30mm and 15 - 60mm	7 - 30mm and 15 - 60mm
Working Channels	yes	no

Substantial Equivalence

Working/Irrigation Channels Reference Device

K983365 (Aesculap Minop System) cleared December 1998 is used as reference device to show precedence of the irrigation and working channels.

Conclusions

The VS3-ETV is substantially equivalent to the predicate device. Performance testing demonstrates that the modified 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

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.