COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM

K972630 · CooperSurgical, Inc. · HEX · Feb 2, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K972630
• Device Name: COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM
• Applicant: CooperSurgical, Inc.
• Product Code: HEX · Obstetrics/Gynecology
• Decision Date: Feb 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1630
• Device Class: Class 2

Intended Use

The CooperSurgical Digital Colposcopy System combines a standard colposcope with a computer-based Digital Documentation System. The colposcope is intended to permit direct magnified viewing of the tissues of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy. The Digital Documentation System is intended to provide documentation of the image in the field of view of the colposcope. The image can be viewed on a color monitor, printed on a color printer, or archived for storage and subsequent retrieval.

Device Story

System integrates standard colposcope (stereo microscope, halogen light, green filter) with digital documentation unit (CCD camera, embedded computer, LCD monitor). Operated by physicians in clinical settings for magnified tissue visualization. Digital system captures, stores, and displays images; allows textual entry of patient history and clinical observations; generates integrated reports with images and text. Features include software-based green filter and glare-reduction procedure for wet tissue imaging. Output viewed on monitor or printed for clinical review. Facilitates longitudinal tracking of tissue abnormalities and biopsy site selection.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System comprises a stereo microscope with halogen light source and optional green filter on a mobile base. Digital components include CCD camera, embedded computer, and LCD monitor. Software features include digital image storage, report generation, software-based green filter, and glare-reduction algorithm for wet tissue.

Indications for Use

Indicated for patients requiring colposcopic examination of the vagina, cervix, and external genitalia for the diagnosis of abnormalities and selection of biopsy sites.

Regulatory Classification

Identification

A colposcope is a device designed to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose abnormalities and select areas for biopsy. This generic type of device may include a light source, cables, and component parts.

Special Controls

*Classification.* Class II (special controls). The device, when it is a standard colposcope (or colpomicroscope) that uses only a white light source, does not use filters other than a green filter, does not include image analysis software, and is not smartphone-based, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

Predicate Devices

• Leisegang Model 1D Colposcope (K940094)
• Welch Allyn Model 88000 Video Colposcope (K955635)
• Welch Allyn Model 89000 Video Colposcope (K955635)

Submission Summary (Full Text)

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K 972636

P192

# 510(k) Summary CooperSurgical Digital Colposcopy System

1. Sponsor

FEB - 2 1998

CooperSurgical, Inc. 15 Forest Parkway Shelton, CT 06484 [phone] Telephone: Facsimile: [phone]

John Grasso Contact Person: Vice President, Operations

July 11, 1997 Date Prepared:

#### Device Name 2.

Classification Name: Colposcope, 21 CFR 884.1630, Class II CooperSurgical Digital Colposcopy System Proprietary Name:

#### Intended Use 3.

The CooperSurgical Digital Colposcopy System combines a standard colposcope with a computer-based Digital Documentation System. The colposcope is intended to permit direct magnified viewing of the tissues of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy. The Digital Documentation System is intended to provide documentation of the image in the field of view of the colposcope. The image can be viewed on a color monitor, printed on a color printer, or archived for storage and subsequent retrieval.

### Device Description 4.

The colposcope portion of the CooperSurgical Digital Colposcopy System consists of a stereo microscope with a halogen light source and optional green filter, and is mounted on a mobile base. The Digital Documentation System consists of a CCD camera, an embedded computer, an LCD monitor, a "palm-mouse" pointing

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K972630
PLOL

device, an optional keyboard, and an optional printer. The functional requirements of the Digital Documentation System include:

- Storing digital images for viewing during the colposcopy exam, and for . printing and/or later review
- Storing textual information about a patient's medical history related to . colposcopy
- Storing textual information about observations seen during a colposcopy . examination
- Printing a colposcopy report that integrates images and textual information. .
- Implementation of the software green filter. . .
- A patent-pending procedure to reduce the amount of distracting glare which . is often present in pictures of the cervix and other wet tissue.

## Basis For Substantial Equivalence 5.

The CooperSurgical Digital Colposcopy System is substantially equivalent to the Leisegang Model 1D Colposcope, manufactured by Leisegang Medical, Inc., and the Model 88000 and 89000 Video Colposcopes, manufactured by Welch Allyn, Inc. The Leisegang device received 510(k) premarket notification clearance under K940094 while the Welch Allyn devices were cleared under K955635.

The CooperSurgical, Leisegang and Welch Allyn colposcopes are all intended to permit direct viewing and imaging of the tissues of the vagina and cervix to diagnose abnormalities and select areas for biopsy. While the Leisegang device is video adaptable, the CooperSurgical and Welch Allyn devices contain integrated imaging systems. These imaging systems provide the physician with a means to record pictures of the tissues for review over time.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 2 1998

CooperSurgical, Inc. c/o Ms. Mary McNamara-Cullinane Staff Consultant Medical Device Consultants. Inc. 49 Plain Street North Attleboro, MA 02760

Re: K972630

CooperSurgical Digital Colposcopy System Dated: December 24, 1997 Received: December 29, 1997 Regulatory Class: II 21 CFR 884.1630/Procode: 85 HEX

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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 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 Resultations. 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 Radiation Control provisions, or other Federal laws or regulations.

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 marked 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/dsmamain.html".

Sincerely yours,

W. Liao Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K912630 510(k) Number (if known):

CooperSurgical Digital Colposcopy System Device Name:

Indications For Use:

The CooperSurgical Digital Colposcopy System combines a standard colposcope with a computer-based Digital Documentation System. The colposcope is intended to permit direct magnified viewing of the tissues of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy. The Digital Documentation System is intended to provide documentation of the image in the field of view of the colposcope. The image can be viewed on a color monitor, printed on a color printer, or archived for storage and subsequent retrieval.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Doler R. Ratliff

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 1972630 510(k) Number.

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

CooperSurgical Digital Colposcopy System 510(k)

7/11/97

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