VERRESCOPE, LIGHT CABLE - LIGHT SOURCE ADAPTOR

K971836 · CooperSurgical, Inc. · HET · Nov 7, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K971836
• Device Name: VERRESCOPE, LIGHT CABLE - LIGHT SOURCE ADAPTOR
• Applicant: CooperSurgical, Inc.
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Nov 7, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2

Intended Use

The VerreScope is intended for use during laparoscopic minimally invasive surgery to provide access for use of operative and diagnostic instrumentation.

Device Story

VerreScope is a laparoscopic device used during minimally invasive surgery. It provides visual access to the surgical site, allowing for the introduction and use of operative and diagnostic instrumentation. The device is constructed from stainless steel and utilizes fiber optics for visualization. It is intended for use by physicians in a clinical or surgical setting. The device functions as a conduit and visualization tool to facilitate surgical procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Stainless steel. Visualization: Fiber optics. Form factor: Laparoscopic instrument. Energy source: Not specified (passive visualization).

Indications for Use

Indicated for use during laparoscopic minimally invasive surgery to provide sight access for operative and diagnostic instrumentation. Prescription use only.

Regulatory Classification

Identification

A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.

Predicate Devices

• Gynescope Laparoscopes

Submission Summary (Full Text)

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E ATTACHMENT

## SUMMARY OF SAFETY AND EFFECTIVENESS COOPER VERRESCOPE

NOV - 7 1997

(971836

PIGI

The Summary of Safety and Effectiveness on VerreScope reflects data available and presented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies may require alterations of the conclusions or recommendations set forth.

## Intended Use

The VerreScope is intended for use during laparoscopic minimally invasive surgery to provide access for use of operative and diagnostic instrumentation.

## Caution

Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.

## Substantial Equivalency Information

The VerreScope is similar to the Gynescope Laparoscopes.

| | Gynescope<br>Laparoscopes | VerreScope |
|-----------|---------------------------|-----------------|
| Material: | Stainless Steel | Stainless Steel |
| Optics: | Rod Lens | Fiber Optics |

The intended use and technological characteristics of these devices do not vary significantly. The safety and effectiveness of the CooperSurgical's VerreScope are comparable to that of the Gynescope Laparoscope.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Image /page/1/Picture/4 description: The image shows the date November 7, 1997. The month is abbreviated to NOV. The day is 7 and the year is 1997. The text is in bold font.

Ms. Debra A. Pekar Manager of Quality Assurance and Regulatory Affairs CooperSurgical 15 Forest Parkway Shelton, Connecticut 06484

Re: K971836

VerreScope Light Cable - Light Source Adaptor Dated: October 6, 1997 Received: October 7, 1997 Regulatory class: II 21 CFR §884.1720/Product code: 85 HET

Dear Ms. Pekar:

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 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 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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ATTACHMENT C

ol Page

510(k) Number (if known): _ K971836 VerreScope Device Namc:

Indications For Usc:

For laparoscopic minimally invasive surgery to provide sight access for use with operative and diagnostic instrumentation.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Deler D. Suthuy
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K971836

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Formal 1-2-96)