VISIONSENSE STEREOSCOPIC VISION SYSTEM

K082355 · Visionsense, Ltd. · HRX · Dec 15, 2008 · Orthopedic

Device Facts

• Record ID: K082355
• Device Name: VISIONSENSE STEREOSCOPIC VISION SYSTEM
• Applicant: Visionsense, Ltd.
• Product Code: HRX · Orthopedic
• Decision Date: Dec 15, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2

Intended Use

The VSII System is intended for viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, as well as 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) provides 3D visualization for surgeons. Device utilizes rigid metal arthroscope with distal CCD camera; proprietary Lenticular Array (LA) on CCD surface captures images from multiple angles to mimic human stereo vision. Input signals transmitted to PC workstation for processing; output presented on stereoscopic display panel. System allows image recording and download for analysis. Used in OR settings by surgeons for spinal, general, and neurological procedures. Provides depth perception to assist in surgical navigation and site visualization.

Clinical Evidence

Bench testing only. System complies with international standards for electrical safety, electromagnetic compatibility, and biocompatibility. No clinical study data provided.

Technological Characteristics

Rigid metal arthroscope; proprietary CCD camera with Lenticular Array (LA) for stereoscopic image capture; PC-based workstation for image processing; stereoscopic display panel. Complies with international standards for electrical safety, electromagnetic compatibility, and biocompatibility.

Indications for Use

Indicated for visualization of internal surgical sites during anterior and posterior spinal procedures (nucleotomy, discectomy, foraminotomy), general surgical procedures, and neurological procedures (visualization of ventricles and brain structures).

Regulatory Classification

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.

Predicate Devices

• VSII - Visionsense Stereoscopic Vision System (K081102, K073279)
• Vista Stereoscope System (K990635)
• THESSYS Multiscope (K051827)

Submission Summary (Full Text)

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K082355

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## 510(k) Summary

# VI-HOUSENSE

#### Submitter

DEC 1 5 2008

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]

#### Date Prepared

December 10, 2008 1

#### Device Information

Trade name: VSu Common name: Visionsense Stereoscopic Vision System Classification Name: Arthroscope Review Panel: Orthopedic Product Code: HRX Device Class: Class II

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K082355

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### Predicate Devices

| 510(k) number | Trade or propriety name | Manufacturer |
|------------------|--------------------------------------------------|-------------------------------|
| K081102, K073279 | VSII - Visionsense Stereoscopic<br>Vision System | Visionsense Ltd. |
| K990635 | Vista Stereoscope System | Vista Medical<br>Technologies |
| K051827 | THESSYS Multiscope | Joimax GmbH |

#### Intended Use/Indications for Use

The VSII System is intended for viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, as well as 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.

#### Technological Characteristics/Principles of Operation

Visionsense Stereoscopic Vision System (VSn) consists of a proprietary CCD camera, embedded in the distal end of a rigid metal arthroscope. An array of miniature lenses - the Lenticular Arrav (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 eyes 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 VSn was previously cleared by FDA 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 (K081102, K073279). The subject device is technologically similar to the one for which FDA has granted marketing clearance, except Visionsense is now expanding the indication to include diagnostic and surgical procedures, such as nucleotomy, discectomy, and foraminotomy.

Visionsense's VSn System is also substantially equivalent to other endoscopes, namely the Joimax THESSYS Multiscope (K051827) and the Vista Stereoscope System (K990635). Performance data to support this claim is included in the body of the submission file. Thus, the VSm System is substantially equivalent to the identified predicate devices.

#### Performance

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

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing service to the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 1 5 2008

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

Re: K082355

Trade/Device Name: VSn Visionsense Stereoscopic Vision System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX, GWG Dated: November 25, 2008 Received: November 25, 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 N. Millican

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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082335-

Indications for Use

510(k) Number:

Device Name:

VSu - Visionsense Stereoscopic Vision System

Indications for Use:

The VSII System is intended for viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, as well as 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 (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)

Page 1 of 1

Neil R. Onken for mkn

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** K082355

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