VS-VISIONSENSE STEREOSCOPIC VISION SYSTEM

K073279 · Visionsense, Ltd. · GCJ · Mar 5, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K073279
• Device Name: VS-VISIONSENSE STEREOSCOPIC VISION SYSTEM
• Applicant: Visionsense, Ltd.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Mar 5, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The VSn System is intended for viewing internal surgical sites during general endoscopic and laparoscopic surgical procedures.

Device Story

VSn System is a stereoscopic vision system for endoscopic and laparoscopic surgery. Device captures internal surgical site images via stereoscopic laparoscope; processes signals to provide 3D visualization; outputs images to display for surgeon. Used in OR by surgeons to facilitate visualization of internal anatomy during minimally invasive procedures. Enhances depth perception compared to standard 2D systems, aiding surgical navigation and decision-making.

Clinical Evidence

No clinical data provided; substantial equivalence supported by performance data.

Technological Characteristics

Stereoscopic laparoscope system. Provides 3D visualization for endoscopic/laparoscopic procedures. Class II device (21 CFR 876.1500).

Indications for Use

Indicated for viewing internal surgical sites during general endoscopic and laparoscopic surgical procedures. No specific patient population, age, or gender restrictions provided.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• ELRAN 01 Stereoscopic Laparoscope (K002431)

Submission Summary (Full Text)

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### Visionsense Ltd.'s VSII System 510(k) Summary

## MAR - 5 201

| Name of Device | VSII - Visionsense Stereoscopic Vision System |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common or Usual Name | Laparoscope system |
| Classification Names | Laparoscopes and accessories (21 C.F.R. § 876.1500) |
| Product Codes | GCJ |
| Submitter | Visionsense Ltd.<br>20 Hamagshimim Street<br>P.O. Box 7149<br>Petach Tikva 49348<br>Israel<br>Phone: [phone]<br>Facsimile: 011-972-3-924-4335 |
| Contact Person: | Gerard J. Prud'homme<br>Hogan & Hartson LLP<br>555 13TH Street, NW<br>Washington, DC 20004<br>Phone: [phone]<br>Facsimile: [phone] |
| Date Prepared: | November 20, 2007 |

#### Predicate Devices

ELRAN 01 Stereoscopic Laparoscope (K002431), Visionsense Ltd. (previously known as Envision Advanced Medical Systems Ltd.)

#### Intended Use

The VSn System is intended for viewing internal surgical sites during general endoscopic and laparoscopic surgical procedures.

#### Substantial Equivalence

The VSn System is a modification to the ELRAN 01 Stereoscopic Laparoscope (K002431). The VSn System has the same intended use and similar indications, principles of operation, and technological characteristics as the ELRAN 01 Stereoscopic Laparoscope. The minor differences in the modified device's technological characteristics do not raise any new questions of safety or effectiveness. Performance data demonstrates that the VSn System is as safe and effective as the ELRAN 01 Stereoscopic Laparoscope. Thus, the VSn System is substantially equivalent to its predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K073279

Trade/Device Name: VSn - Visionsense Stereoscopic Vision System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: February 29, 2008 Received: February 29, 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.

MAR - 5 2008

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

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Page 2 - Mr. Gerard J. Prud'homme

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.

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

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

510(k) Number (if known): K073279 Device Name: VSII - Visionsense Stereoscopic Vision System Indications For Use: The VS』system is intended for viewing internal surgical sites during general endoscopic and laparoscopic surgical procedures.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil RP. Oulun tw mxn

(Division Sign-Off)

Divisio and Neurological Devines

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**510(k) Number** K073279