ENDOSCOPY VIDEO CAMERA SYSTEM

K081585 · Vision Systems Group, A Division of Viking Systems · FET · Jun 20, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K081585
• Device Name: ENDOSCOPY VIDEO CAMERA SYSTEM
• Applicant: Vision Systems Group, A Division of Viking Systems
• Product Code: FET · Gastroenterology, Urology
• Decision Date: Jun 20, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Endoscopy Video Camera System is for use during diagnostic and/or surgical procedures when endoscopic video assistance is required

Device Story

Endoscopy Video Camera System comprises camera head and camera controller; designed for use with commercially available endoscopes, light sources, and video monitors or head-mounted displays. Device captures endoscopic visual data for display to clinicians during diagnostic or surgical procedures. System provides video assistance to facilitate visualization of internal anatomy; aids physician in performing endoscopic interventions. Used in clinical settings; operated by medical professionals.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and testing.

Technological Characteristics

System consists of camera head and controller. Compatible with standard endoscopes, light sources, and displays. Class II device (21 CFR 876.1500).

Indications for Use

Indicated for use during diagnostic and/or surgical procedures requiring endoscopic video assistance. Patient population not specified.

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

• Oktas Endoscopy Video Camera (K941919)

Submission Summary (Full Text)

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Endoscopy Video Camera System Special 510(k) June 3, 2008

JUN 2 0 2008

Kp8/585

### 7. 510(k) Summary

510(k) Summary for Endoscopy Video Camera System

According to the requirements of 21CFR 807.92, the following information provides sufficient detail to understand the basis for determination of substantial equivalence.

Submitter Name, Address, and Contact Information:

Christine Nichols RAC Regulatory Manager Vision Systems Group A Division of Viking Systems Inc. 134 Flanders Road Westboro, MA 01581 Ph: 508-366-3668 X8273

### Device Name and Classincation:

| Proprietary Names: | Endoscopy Video Camera System |
|----------------------|----------------------------------------------|
| Classification name: | Endoscope and/Or Accessories, 21CFR 876.1500 |
| Comon/Usual names: | Endoscope and Accessories, KOG |
| Predicate Devices: | K941919 Oktas Endoscopy Video Camera |

### Device Description:

The Endoscopy Video Camera System consists of a camera head and a camera controller.

The system can be used with commercially available endoscopes and light sources and video monitors or head mounted displays.

## Intended Use:

The Endoscopy Video Camera System is for use during diagnostic and/or surgical procedures when endoscopic video assistance is required

## Substantial Equivalence Information:

The proposed Endosocpy Video Camera System is substantially equivalent to the currently legally marketed Oktas Endoscopy Video Camera System (K941919) in terms of intended use, operating principle, and basic design. Testing demonstrates that the modifications proposed herein do not adversely effect safety and effectiveness.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

# JUN 2 0 2008

Vision Systems Group % Christine E. Nichols, RAC Consultant RCS 10 Greenlawn Avenue SOUTH GRAFTON MA 01560

Re: K081585

Trade/Device Name: Endoscopy Video Camera System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FET Dated: June 3, 2008 Received: June 5, 2008

Dear Ms. Nichols:

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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your Apple rary, to fibe of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/1/Picture/10 description: This image is a circular logo that commemorates the centennial of the FDA from 1906-2006. The letters FDA are in the center of the logo in a bold, sans-serif font. The word "Centennial" is written below the letters FDA. The logo is surrounded by a circular border with stars and text.

Protecting and Promoting Public Health

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### Page 2

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.

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 one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Mishranding 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy Brogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 6. Indications for Use Statement

## Indication for Use

510(k) Number (11 known): Ko81585

Device Name: Endoscopy Video Camera System

Indications For Use:

The Endoscopy Video Camera System is for use during diagnostic and/or surgical procedures when endoscopic video assistance is required.

Prescription Use_ ਮ (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 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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Arzu K. Why

Division of Reproductive, Abdomin and Radiological I 510(k) Number