Intended for viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures.

Device Description

The VS3 Stereoscopic High Definition Vision System, Model VS3-NE consists of the following components: Endoscope, Light source, Camera Control Unit (CCU), Camera, Display monitors, 2D Endoscope coupler. The VS3 Stereoscopic High Definition ("3DHD") Vision System, Model VS3-NE is based on the proximal HD camera concept with a stereoscopic camera block located on the proximal side of the endoscope (the handle). This allows high resolution capture of the 3D video stream. The stereoscopic images are transmitted from the visual field at the distal tip of the endoscope to the proximal camera block containing the HD sensor module. The VS3 Stereoscopic High Definition Vision System, Model VS3-NE allows for separation of the camera module with image sensor module and electronics from the endoscope shaft housing optical relay components and light fibers. The VS3 Stereoscopic High Definition Vision System, Model VS3-NE also includes 2D coupler capability that allows the VS3 Stereoscopic High Definition Vision System, Model VS3-NE to be used with FDA-cleared, third party 2D scopes at user sites to display monocular video.

AI/ML Overview

This submission describes a Substantial Equivalence (SE) determination for a medical device, meaning the device's acceptable performance is demonstrated by its similarity to already legally marketed predicate devices, rather than through independent studies with specific acceptance criteria. Therefore, most of the requested information (acceptance criteria, study details, ground truth, expert involvement, etc.) is not applicable in the context of this 510(k) summary.

Here's a breakdown of what can be extracted and why other parts are not available:

1. A table of acceptance criteria and the reported device performance

Not Applicable. In a 510(k) for substantial equivalence, the "acceptance criteria" are effectively that the new device's technological characteristics, indications for use, and principles of operation are sufficiently similar to those of a legally marketed predicate device such that no new questions of safety or effectiveness are raised. The performance is "reported" by showing these similarities, not by meeting specific quantifiable performance metrics in independent studies for this particular submission.

Instead, the submission presents a comparison table demonstrating the similarities between the subject device (VS3-NE) and its predicate devices (VSII System K081102 and VS3 K123467).

Characteristic	VS3-NE (subject device)	VSII System (K081102) (primary predicate)	VS3 for General Surgery (K123467) (secondary predicate)
Manufacturer	Visionsense Ltd.	Visionsense Ltd.	Visionsense Ltd.
Classification	Endoscope, Neurological 21 C.F.R. §882.1480 Product code GWG	Endoscope, Neurological 21 C.F.R. §882.1480 Product code GWG	Laparoscope, General & Plastic Surgery 21 C.F.R. §876.1500 Product code GCJ
Indications for Use	Intended for viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures	Intended for viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures	Intended for viewing internal surgical sites during general endoscopic and laparoscopic surgical procedures
Endoscope type	Rigid Stainless Steel	Rigid Stainless Steel	Rigid Stainless Steel
Endoscope diameter	4 - 5.5 mm	4 - 5 mm	4 - 5.5 mm
Endoscope length	175 - 300 mm (±5 mm)	175 - 300 mm (±5 mm)	175 - 300 mm (±5 mm)
Field of view	70°-95°	70°	70°-95°
Direction of view	0° - 70°	0° - 70°	0° - 70°

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This 510(k) submission does not include a clinical or performance test set in the conventional sense (i.e., a set of medical images or patient data used to evaluate algorithm performance). The "test" for substantial equivalence is the comparison of the device's specifications and intended use against predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. No ground truth establishment by experts is described in this submission, as it focuses on substantial equivalence to existing devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. There is no test set or adjudication process described as this is a substantial equivalence submission.

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

Not Applicable. This device is a stereoscopic high definition vision system (an endoscopic camera system), not an AI algorithm designed to assist human readers or perform diagnostic tasks. Therefore, an MRMC study related to AI assistance is not relevant to this submission.

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

Not Applicable. This is a hardware vision system, not an algorithm, so standalone algorithm performance is not relevant.

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

Not Applicable. There is no ground truth, in the sense of medical diagnostic accuracy, required for this substantial equivalence submission. The "ground truth" for a 510(k) is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not Applicable. There is no AI component or training set described in this submission.

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

Not Applicable. As there is no training set mentioned, this question is not applicable.

Summary of the K131434 Submission:

The K131434 submission is for the VS3 Stereoscopic High Definition Vision System, Model VS3-NE, an endoscope. The device's approval is based on its Substantial Equivalence to two predicate devices:

Visionsense Ltd VS (K081102)
Visionsense Ltd VS3 (K123467)

The submission argues for substantial equivalence based on the following:

Same Intended Use/Indications for Use: Viewing internal surgical sites during general surgical procedures and for visualization of ventricles and structures within the brain during neurological surgical procedures.
Similar Principles of Operation: Proximal HD camera concept with a stereoscopic camera block, capturing right and left images for a 3D video stream.
Similar Technological Characteristics: The device shares core components and specifications (e.g., rigid stainless steel endoscope, similar diameter, length, field of view, and direction of view) with the predicate devices.

The submission also notes compliance with several recognized consensus standards for electrical safety, electromagnetic compatibility, and biocompatibility (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-18, ISO 14971, ISO 8600 series). These standards are device-specific performance criteria for safety and manufacturing, not diagnostic acceptance criteria.

Summary

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K 131434

510(k) Summary

Date Prepared: June 17, 2013

Submitter

Visionsense Ltd 20 Hamaqshimim Street Petach Tikva 49348 lsrael

Contact Person(s)

Sponsor:

Azi Ben-Yishai 20 Hamagshimim Street Petach, Tikva 49348 lsrael +972 (3) 9244339 Phone: Facsimile: +972 (3) 9244335

OR

Regulatory Counsel: Gerard J. Prud'homme Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washington, DC 20004 Tel: 202-637-5735 Fax: 202-637-5910

Device Information

Trade name: VS3 Stereoscopic High Definition Vision System, Model VS3-NE Common name: Endoscope Classification Name: Endoscope, Neurological Review Panel: Neurology Product Code: GWG Device Class: Class II Regulation: 21 C.F.R. §882.1480

Predicate Device Information

Visionsense Ltd VS』(K081102) Visionsense Ltd VS3 (K123467)

Intended Use/Indications for Use

The VS3 Stereoscopic High Definition Vision System, Model VS3-NE is intended for viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures.

JUL 1 6 2013

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Technological Characteristics

The VS3 Stereoscopic High Definition Vision System, Model VS3-NE consists of the following components:

. Endoscope
Light source .
Camera Control Unit (CCU) .
Camera .
Display monitors
2D Endoscope coupler ●

The VS3 Stereoscopic High Definition ("3DHD") Vision System, Model VS3-NE is based on the proximal HD camera concept with a stereoscopic camera block located on the proximal side of the endoscope (the handle). This allows high resolution capture of the 3D video stream. The stereoscopic images are transmitted from the visual field at the distal tip of the endoscope to the proximal camera block containing the HD sensor module. The VS3 Stereoscopic High Definition Vision System, Model VS3-NE allows for separation of the camera module with image sensor module and electronics from the endoscope shaft housing optical relay components and light fibers. The VS3 Stereoscopic High Definition Vision System, Model VS3-NE also includes 2D coupler capability that allows the VS3 Stereoscopic High Definition Vision System, Model VS3-NE to be used with FDA-cleared, third party 2D scopes at user sites to display monocular video.

Principles of Operation

During surgical procedures, the surgeon inserts the endoscope into the surgical site, which is illuminated using the internal or external illumination source. The optical array then functions by capturing both right and left images of the surgical site from different angles. Both images are detected by the camera and transmitted to the CCU. Once the images are received by the CCU. the VS3 Stereoscopic High Definition Vision System. Model VS3-NE generates a stereoscopic signal of both the right and left images that can be sent to the display monitor.

Performance

No performance standards or special controls have been developed under Section 514 of the Federal Food, Drug, and Cosmetic Act ("FD&C Act") for endoscopes. However, the VS3 Stereoscopic High Definition Vision System, Model VS3-NE and its components follow FDA recognized consensus standards for electrical safety, electromagnetic compatibility, and biocompatibility:

1. IEC 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance (1998); Amendment 1, 1991-11, Amendment 2, 1995.
IEC 60601-1-1, Medical electrical equipment Part 1-1: General requirements for 2. safety. Collateral standard: Safety requirements for medical electrical systems (2000).
1. IEC 60601-1-2, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance. Collateral standard: Electromagnetic compatibility requirements and tests. (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004).
1. IEC 60601-2-18, Medical electrical equipment Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment (1996). Amendment 1, 2000.
1. ISO 14971. Medical devices Application of risk management to medical devices (2007).
1. ISO 8600, Optics and optical instruments -- Medical endoscopes and

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endoscopic accessories. Part 1:2005; Part 3:1997; Part 4:1997; Part 5:2005; Part 6:2005.

Substantial Equivalence

The Visionsense VS3 Stereoscopic High Definition Vision System, Model VS3-NE has the same intended use and similar indications, principles of operation, and technological characteristics as the cleared VS, (K081102) and VS3 (K123467). Thus, the VS3 Stereoscopic High Definition Vision System, Model VS3-NE is substantially equivalent to its predicate devices.

The following table shows the similarities between the VS3-NE and predicate devices.

	VS3-NE(subject device)	VSII System (K081102)(primary predicate)	VS3 for General Surgery(K123467) (secondarypredicate)
Manufacturer	Visionsense Ltd.	Visionsense Ltd.	Visionsense Ltd.
Classification	Endoscope, Neurological21 C.F.R. §882.1480Product code GWG	Endoscope, Neurological21 C.F.R. §882.1480Product code GWG	Laparoscope, General &Plastic Surgery21 C.F.R. §876.1500Product code GCJ
Indications for Use	Intended for viewinginternal surgical sitesduring general surgicalprocedures and for use invisualization of ventriclesand structures within thebrain during neurologicalsurgical procedures	Intended for viewinginternal surgical sitesduring general surgicalprocedures and for use invisualization of ventriclesand structures within thebrain during neurologicalsurgical procedures	Intended for viewing internalsurgical sites during generalendoscopic and laparoscopicsurgical procedures
Endoscope type	Rigid Stainless Steel	Rigid Stainless Steel	Rigid Stainless Steel
Endoscopediameter	4 - 5.5 mm	4 - 5 mm	4 - 5.5 mm
Endoscope length	175 - 300 mm (±5 mm)	175 - 300 mm (±5 mm)	175 - 300 mm (±5 mm)
Field of view	70°-95°	70°	70°-95°
Direction of view	0° - 70°	0° - 70°	0° - 70°

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized abstract symbol to the right and text arranged in a circular pattern to the left. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA".

July 16, 2013

Public Health Service

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

Visionsense Ltd c/o Mr. Gerard J. Prud'homme Hogan Lovells US LLP 555 Thirteenth Street. NW Washington, DC 20004

Re: K131434

Trade/Device Name: VS3 Stereoscopic High Definition Vision System, Model VS3-NE

Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological endoscope Regulatory Class: Class II Product Code: GWG Dated: June 17, 2013 Received: June 17, 2013

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

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Page 2 - Mr. Gerard J. Prud'homme

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 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers. International and Consumer Assistance 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,

Victor Krauthamer -S

Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): _ K131434

Device Name: Visionsense VS3 Stereoscopic High Definition Vision System, Model VS3-NE

Indications For Use:

Intended for viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Victor Krauthamer -S 2013.07.15 18:35:33-04'00'

(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

K131434 510(k) Number

Page 1 of 1

Regulation Number and Section

§ 882.1480 Neurological endoscope.

(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).