The VSn system 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.

Device Description

Visionsense Stereoscopic Vision System (VSu) consists of a proprietary CCD camera, embedded in the distal end of a rigid metal endoscope. An array of miniature lenses - the Lenticular Array (LA) - built onto the CCD surface during the wafer fabrication process, captures the image from slightly different angles, thus mimicking the natural human 'Stereo vision' obtained when the cycs simultaneously pick up two different images of the same object (right and left). The captured image is subsequently transmitted to a PC workstation, processed and presented on a stereoscopic display panel. Images are recorded and may be later downloaded for further analysis.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary for the VISIONSENSE Stereoscopic Vision System (VSII), primarily focusing on demonstrating substantial equivalence to a predicate device for an expanded indication (neurosurgical procedures).

The key information available covers:

Device Information: Trade name, common name, classification, review panel, product code, device class.
Predicate Devices: K073279 (VSII General Surgery) and K964281 (Aesculap Angled Neuroendoscopes).
Intended Use/Indications for Use: Viewing internal surgical sites during general surgical procedures and visualization of ventricles and structures within the brain during neurological surgical procedures.
Technological Characteristics/Principles of Operation: Proprietary CCD camera, Lenticular Array for stereoscopic vision, PC workstation processing, stereoscopic display.
Substantial Equivalence: Claimed based on technological similarity to the previously cleared general surgery VSII and to other neurosurgical endoscopic devices (Aesculap).

The document explicitly states: "No performance standards or special controls have been developed under Section 514 of the Federal Food, Drug, and Cosmetic Act ("FDC Act") for endoscopes. However, the VSII system and its components comply with international standards for electrical safety, electromagnetic compatibility, and biocompatibility."

This indicates that specific performance acceptance criteria for the expanded neurosurgical indication were not established or assessed in the traditional sense of a clinical performance study with predefined metrics. The submission relies on substantial equivalence to existing devices and compliance with general safety and electromagnetic standards rather than a study demonstrating meeting specific clinical performance acceptance criteria.

Therefore, I cannot populate the table or provide information for points 2 through 9 as requested, as these details are not present in the provided text.

Summary

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KOSILOZ

………

SECTION 5: 510(k) Summary

VISIONSENSE

MAY 2 9 2008

Submitter

Visionsense Ltd (Previously known as Envision Advanced Medical Systems) 20 Hamagshimim Street P.O. Box 7149 Petach Tikva 49348 Israel Owner/Operator Number: 9042467 Establishment Registration Number: 9616637

Contact Person(s)

Gerard J. Prud'homme Partner Hogan & Hartson LLP 555 13th Street, NW Washington, DC 20004-1108 Tel: (202) 637-5735 Fax: (202) 637-5910 E-mail: GJPrudhomme@hhhlaw.com

OR

Benny Arazy Arazy Group Mizpe Aviv, Industrial Park 13 M. P. Misgav 20187, ISRAEL Tel: +972 (4) 994-7880 Fax: +972 (4) 994-4224 E-mail: benny(@arazygroup.com

Date Prepared

April 15, 2008

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Device Information

Trade name: VSH Common name: Visionsense Stereoscopic Vision System Classification Name: Neurological Endoscope Review Panel: Neurology Product Code: GWG Device Class: Class II

Predicate Devices

510(k) number	Trade or propriety name	Manufacturer
K073279	VSII (General Surgery)	Visionsense Ltd.
K964281	Aesculap Angled Neuroendoscopes	Aesculap Inc.

Intended Use/Indications for Use

Technological Characteristics/Principles of Operation

Substantial Equivalence

Visionsense's VS1 was previously cleared by FDA for general surgery (K073279). The subject device is technologically similar to the one for which FDA has granted marketing clearance, except -- Visionsense is now seeking to expand the indication so it includes neurosurgical procedures as well.

Visionsense's VSu system is also substantially equivalent to other neurosurgical endoscopic devices, namely the Aesculap Angled Neuroendoscopes (K964281). Performance data, to support this claim, is included in the body of the submission file. Thus, the VSn System is substantially equivalent to the identified predicate devices.

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Performance

No performance standards or special controls have been developed under Section 514 of the Federal Food, Drug, and Cosmetic Act ("FDC Act") for endoscopes. However, the VS;j system and its components comply with international standards for electrical safety, electromagnetic compatibility, and biocompatibility.

4 - ৮৮

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 9 2008

Visionsense Ltd % Hogan & Hartson LLP Mr. Gerard J. Prud'homme 555 13th Street, Northwest Washington, District of Columbia 20004-1108

Rc: K081102

Trade/Device Name: VSn-Visionsense Stereoscopic Vision System Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological endoscope Regulatory Class: II Product Code: GWG Dated: April 17, 2008 Received: April 17, 2008

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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Page 2 - Mr. Gerard J. Prud'homme

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Mulhearn

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

KOSHOZ 510(k) Number:

Device Name:

VSII - Visionsense Stereoscopic Vision System

Indications for Use:

The VSu system 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.

Prescription Use __ V (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR (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)

Page 1 of 1

Neil Koch for mkn
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number_ < 08 | l 02

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).