ENDOSCOPIC CAMERA

K991416 · Genzyme Surgical Product (Genzyme Biosurgery) · GCJ · Jul 20, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K991416
• Device Name: ENDOSCOPIC CAMERA
• Applicant: Genzyme Surgical Product (Genzyme Biosurgery)
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jul 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Genzyme Surgical Products Digital RGB and 3-Chip Digital RGB Endoscopic Cameras are intended to attach to standard commercially available endoscopes for visualization of body cavities, hollow organs, and canals.

Device Story

Endoscopic camera system captures optical images from standard endoscopes; converts light to digital RGB video signals; displays real-time surgical field on color monitor. Components include camera head, control box, cable, and coupler. Used in surgical settings by physicians to visualize internal anatomy. Provides contrast enhancement and edge correction features. Output allows direct visualization, recording, or printing of surgical field to assist clinical decision-making during endoscopic procedures.

Clinical Evidence

Bench testing only. Compliance with EN 55011:03.1991 and EN 60601-1-2:05.1993 standards for electromagnetic compatibility and safety.

Technological Characteristics

Digital RGB and 3-Chip Digital RGB imaging sensors; camera head, control box, and coupler interface; compatible with rigid/flexible endoscopes; contrast enhancement and edge correction processing; standard video output for monitors/printers; tested to EN 55011 and EN 60601-1-2 standards.

Indications for Use

Indicated for visualization of body cavities, hollow organs, and canals during endoscopic procedures using standard commercially available endoscopes. Prescription use only.

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

• Circon Corporation MicroDigital Camera and DirectCoupler (K914883)
• Karl Storz EndoVision XL Endoscopic Camera System (K974391)
• Karl Storz EndoVision Digivideo System (K950974)

Submission Summary (Full Text)

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## 510(k) Summary for

K991416

# Genzyme Surgical Products Digital RGB and 3-Chip Digital RGB Endoscopic Cameras

#### 1. SPONSOR

Genzyme Surgical Products Corporation 5175 South Royal Atlanta Drive Tucker, GA 30084

| Contact Person: | Michelle Johnston |
|-----------------|-------------------|
| Telephone: | 770-723-2725 |

April 21, 1999 Date Prepared:

#### 2. DEVICE NAME

| Proprietary Name: | Endoscopic Camera |
|----------------------|---------------------------|
| Common/Usual Name: | Endoscopic Camera |
| Classification Name: | Accessory to an Endoscope |

#### 3. PREDICATE DEVICES

- . Circon Corporation MicroDigital Camera and DirectCoupler K914883
- . Karl Storz EndoVision XL Endoscopic Camera System K974391
- . Karl Storz EndoVision Digivideo System K950974

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#### 4. DEVICE DESCRIPTION

The Genzyme Surgical Products Digital RGB and 3-Chip Digital RGB Endoscopic Cameras are designed to provide a picture of the surgical field during endoscopic procedures. The Digital RGB and 3-Chip Digital RGB Endoscopic Cameras take the image that would be normally seen by the naked eye, and displays it on a color monitor. The Digital RGB and 3-Chip Digital RGB Endoscopic Cameras provide imaging through standard, commercially available, legally marketed endoscopes.

The Digital RGB and the 3-Chip Digital RGB Endoscopic Cameras both consist of a Camera head, camera control box, and camera cable, camera cable connector soaking cap and coupler accessories. A coupler couples the camera head to the commercially available endoscope.

#### INTENDED USE 5.

The Genzyme Surgical Products Digital RGB and 3-Chip Digital RGB Endoscopic Cameras are intended to attach to standard commercially available endoscopes for visualization of body cavities, hollow organs, and canals.

#### 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The Genzyme Surgical Products Digital RGB and 3-Chip Digital RGB Endoscopic Cameras and the predicate devices are all intended to permit visualization of body cavities, hollow organs and canals. The Genzyme Surgical Products Camera components and the predicate devices are designed to be attached to commercially available endoscopes. The endoscopic image in the proposed and predicate devices can be displayed on any standard operating monitor or stored. A VCR/Video Printer can be used to produce hard copies of images obtained using both the proposed and predicate devices.

Both the Digital RGB and the 3-Chip Digital RGB Endoscopic Cameras and the Karl Storz EndoVision Digivideo System provide contrast enhancement and edge correction and are used in conjunction with cameras attached to rigid or flexible endoscopes.

#### 7. PERFORMANCE TESTING

The devices were tested to EN 55011:03.1991 and EN 60601-1-2:05.1993.

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 20 1999

Genzyme Surgical Products, Inc. c/o Ms. Mary McNamara-Cullinane Medical Device Consultants, Inc. 49 Plain Street North Attleboro. Massachusetts 02760

Re: K991416

> Trade Name: 3-Chip Digital RGB Video Camera Regulatory Class: II Product Code: GCJ Dated: April 21, 1999 Received: April 23, 1999

Dear Ms. McNamara-Cullinane:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Ms. Mary McNamara-Cullinane

This letter will allow you to begin marketing your device as described in your 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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _K a 9141 b

Device Name: Genzyme Surgical Products.

Indications For Use:

The Digital RGB and 3-Chip Digital RGB Endoscopic Cameras are intended to attach to I he Digital KOD und S Only Digital
standard commercially available endoscopes for visualization of body cavities, hollow organs, and canals.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

tcoeees

(Division Sign-Off) (Division Sign-Off)
Division of General Restorative Devices 991416 510(k) Number

Prescription Use
(Per 21 CFR 801/(109)

OR

Over-The-Counter Use __

(Optional Format 1-2-96)