VSU - VISIONSENSE STEREOSCOPIC VISION SYSTEM

K081102 · Visionsense, Ltd. · GWG · May 29, 2008 · Neurology

Device Facts

• Record ID: K081102
• Device Name: VSU - VISIONSENSE STEREOSCOPIC VISION SYSTEM
• Applicant: Visionsense, Ltd.
• Product Code: GWG · Neurology
• Decision Date: May 29, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1480
• Device Class: Class 2

Intended Use

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 Story

Visionsense Stereoscopic Vision System (VSn) is a rigid metal endoscope featuring a distal CCD camera with an integrated lenticular array (LA). The LA captures images from multiple angles to mimic natural human stereoscopic vision. The system transmits captured images to a PC workstation for processing and presentation on a stereoscopic display panel. Used in OR settings by surgeons to visualize internal surgical sites and brain structures. Output allows surgeons to view depth-perceived images, aiding in surgical navigation and decision-making during general and neurological procedures. Images can be recorded and downloaded for further analysis.

Clinical Evidence

No clinical data provided. The submission relies on bench testing and compliance with international standards for electrical safety, electromagnetic compatibility, and biocompatibility.

Technological Characteristics

Rigid metal endoscope; proprietary CCD camera; lenticular array (LA) for stereoscopic image capture; PC workstation for image processing; stereoscopic display panel. Complies with international standards for electrical safety, electromagnetic compatibility, and biocompatibility.

Indications for Use

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

Regulatory Classification

Identification

A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.

Predicate Devices

• VSII (General Surgery) (K073279)
• Aesculap Angled Neuroendoscopes (K964281)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] E-mail: [e-mail]

#### OR

Benny Arazy Arazy Group Mizpe Aviv, Industrial Park 13 M. P. Misgav 20187, ISRAEL Tel: [phone] Fax: [phone] 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

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.

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#### Technological Characteristics/Principles of Operation

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.

#### 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.

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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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] 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)

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Neil Koch for mkn
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number_ < 08 | l 02