ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES

K982965 · Richard Wolf Medical Instruments Corp. · FWF · Nov 23, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K982965
• Device Name: ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: FWF · General, Plastic Surgery
• Decision Date: Nov 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4160
• Device Class: Class 1

Intended Use

The 1 CCD Endocam 5502 and 3 CCD Endocam 5507 are designed for video endoscopy and video microscopy and can be used for both diagnostic and therapeutic interventions. The camera head is classified as Cardiac Floating (CF) equipment with less than 10uA of leakage current. This permits its use for cardiac visualization procedures when used in conjuction with the proper instrumentation for entry into the cardiac system.

Device Story

Endoscopic video camera system consisting of camera controller and camera head connected by cable. Input: optical images from objective lenses attached to camera head. Processing: 1 CCD Endocam uses mosaic color filter; 3 CCD Endocam uses three CCD converters with prism for RGB separation; signals processed in controller to standard NTSC video output. Output: video displayed on monitors. Used in clinical settings (e.g., OR, clinic) by physicians for diagnostic/therapeutic interventions. Cardiac Floating (CF) classification allows use in cardiac visualization when paired with appropriate entry instrumentation. Benefits: provides real-time visualization for minimally invasive procedures.

Clinical Evidence

No clinical tests performed. Bench testing conducted per IEC601-1, IEC601-1-2, IEC1-1-2, IEC1-2-18, and UL2601-1 standards.

Technological Characteristics

1 CCD Endocam 5502: CCD image converter with mosaic color filter. 3 CCD Endocam 5507: three CCD converters with prism for RGB separation. Output: NTSC video signal. Electrical safety: Type CF (Cardiac Floating) equipment, <10uA leakage current. Standards: IEC601-1, IEC601-1-2, UL2601-1.

Indications for Use

Indicated for video endoscopy and video microscopy, including diagnostic and therapeutic interventions and cardiac visualization procedures, for patients requiring endoscopic or microscopic examination.

Regulatory Classification

Identification

A surgical camera and accessories is a device intended to be used to record operative procedures.

Predicate Devices

• CCD Endocam (K950502)
• CCD Endocam Office (K942817)

Submission Summary (Full Text)

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# NOV 23 K

.

353 Corporate Woods Parkway Vernon Hills, Illinois 60064 Phone: [phone] Fax: [phone]

K 98296

MEDICAL INSTRUMENTS CORPORATION

# 510(k) Summary of Safety and Effectiveness

| Company / Institution name: | Richard Wolf Medical Instruments Corp. |
|---------------------------------------------------------------------|----------------------------------------|
| Division name (if applicable): | N.A. |
| Street address: | 353 Corporate Woods Parkway |
| City: | Vernon Hills |
| State/Province: | Illinois |
| Country: | USA |
| ZIP/Postal Code: | 60061 |
| Contact name: | Mr. Robert L. Casarsa |
| Contact title: | Quality Assurance Manager |
| Date of Preparation: | August 24, 1998 |
| FDA establishment regulation number: | 14 184 79 |
| Phone number (include area code): | [phone] |
| FAX number (include area code): | [phone] |
| Product Information: | |
| Trade name: | 1 CCD Endocam and 3 CCD Endocam |
| Model number: | 5502 and 5507 |
| Common name: | Endoscopic Video Camera System |
| Classification Name: | Endoscope and / or Accessories |
| Information on devices to which substantial equivalence is claimed: | |

| | 510(k) Number | | Trade or proprietary or model name | | Manufacturer |
|---|---------------|---|------------------------------------|---|---------------------|
| 1 | K950502 | 1 | CCD Endocam | 1 | Richard Wolf M.I.C. |
| 2 | K942817 | 2 | CCD Endocam Office | 2 | Richard Wolf M.I.C. |
| 3 | | 3 | | 3 | |
| 4 | | 4 | | 4 | |
| 5 | | 5 | | 5 | |
| 6 | | 6 | | 6 | |

### 1.0 Description

The endoscopic video camera systems include a camera controller and a small camera head which is connected by a camera cable to the controller. Endoscopic procedures are displayed with the objective lenses attached to the camera head and the video monitors connected to the camera controller.

The camera heads are CF Equipment (cardiac floating) according to UL2601-1 / IEC601-1.

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### 2.0 Intended Use

The 1 CCD Endocam 5502 and 3 CCD Endocam 5507 are designed for video endoscopy and video microscopy and can be used for both diagnostic and therapeutic interventions.

The camera head is classified as Cardiac Floating (CF) equipment with less than 10uA of leakage current. This permits its use for cardiac visualization procedures when used in conjuction with the proper instrumentation for entry into the cardiac system.

#### 3.0 Technological Characteristics

The 1 CCD Endocam 5502 has a CCD image converter with mosaic color filter.

The 3 CCD Endocam 5507 has three CCD image converter for red, green and blue colors. separated by a prism. The light that falls onlo the sensor generates a signal which is processed in the camera controller to a standard NTSC video signal.

The camera head is insulated from earth (Type CF-Fquipment, according to UL2601-1 / IEC601-1).

#### 4.0 Substantial Equivalence

The submitted devices pose the same type of questions about safety and effectiveness as existing devices. The new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing 510(k) devices sold by Richard Wolf.

#### રું.......................................................................................................................................................................... Performance Data

Independent laboratories tested Endocam 5502 and 5507 according to specified standard IEC601-1, IEC601-1-2, IEC1-1-2, IEC1-2-18 and UL2601-1 (5507: UL pending).

Camera systems 5502 and 5507 conform to the relevant provisions of Medical Device Directive 93/42/EEC.

#### 6.0 Clinical Tests

No clinical tests performed.

#### 7.0 Conclusions Drawn

These devices are designed and tested to guarantee the safety and effectiveness when used according to the instruction manual.

By: Robert J. Casassa

Robert L. Casarsa Quality Assurance Manager

Date: 9-4-98

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

NOV 2 3 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert L. Casarsa Manager of Quality Assurance Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061

Re: K982965

Trade Name: 1 CCD Endocam 5502 and 3 CCD Endocam 5507 with CF Camera Heads Regulatory Class: II Product Code: FWF Dated: August 24, 1998 Received: August 25, 1998

Dear Mr. Casarsa:

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 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). 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 requirements, 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 - Mr. Robert L. Casarsa

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 your 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/dsma/dsmamain.html".

Sincerely yours,

llydo

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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TO

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K982965

Device Name: _________________________________________________________________________________________________________________________________________________________________

## Intended Use:

The 1 CCD Endocam 5.502 and 3 CCD Endocam 5.507 arc designed for video endoscopy and video microscopy and can be used for both diagnostic and therapeutic interventions.

The camera head is classified as Cardiac Hoating (CF) equipment with less than 10pA of leakage current. This permits its use for cardiac visualization procedures when used in conjunction with the proper instrumentation for entry into the cardiac system.

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Concurrence of CDRH Office of Device Evaluation (ODDE)

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of General Restorative I

Prescription Use
Per 21 CRF 801.109

Over-The Counter_