VERRES NEEDLE, CANNULA FOR M820, CANNULA W/TRUMPET VALVE FOR M 820

K971837 · CooperSurgical, Inc. · HET · Aug 6, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K971837
• Device Name: VERRES NEEDLE, CANNULA FOR M820, CANNULA W/TRUMPET VALVE FOR M 820
• Applicant: CooperSurgical, Inc.
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Aug 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Verres Needle and Cannula is intended for use in multiple surgical specialties that utilize minimally invasive surgical procedures to establish pneumoperitoneum and to provide access for operative and diagnostic instrumentation. Federal law (USA) restricts this device to sale by or on the order of a physician.

Device Story

Verres Needle and Cannula is a surgical instrument used in minimally invasive procedures. It functions by establishing pneumoperitoneum and providing access for diagnostic or operative instrumentation. The device features a spring-loaded needle mechanism. It is used by physicians in surgical settings. The device is constructed of stainless steel and is designed to facilitate safe entry into the abdominal cavity for laparoscopic access.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: Stainless steel. Mechanism: Spring-loaded needle. Diameter: 2.0 - 5.0mm. Form factor: Needle/Cannula assembly for laparoscopic access.

Indications for Use

Indicated for patients undergoing laparoscopic surgery requiring pneumoperitoneum establishment and access for operative or diagnostic instrumentation.

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 Trocar and Sleeves
• Marlow Verres Needle

Submission Summary (Full Text)

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## SUMMARY OF SAFETY AND EFFECTIVENESS VERRES NEEDLE AND CANNUI

The Summary of Safety and Effectiveness on Laparoscopic surgery and the instruments used reflects data available and presented at the 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

Verres Needle and Cannula is intended for use in multiple surgical specialties that utilize minimally invasive surgical procedures to establish pneumoperitoneum and to provide access for operative and diagnostic instrumentation.

## Caution

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

## Substantial Equivalency Information

The Verres Needle Cannula is similar to the Gynescope Trocar and Sleeves and the Marlow Verres Needle.

| | Gynescope<br>Trocar and<br>Sleeves | Marlow<br>Verres<br>Needle | Verres Needle<br>and Cannula |
|----------|------------------------------------|----------------------------|------------------------------|
| Material | Stainless Steel | Stainless Steel | Stainless Steel |
| Needle | N/A | Spring-Loaded | Spring-Loaded |
| Diameter | 5.0 - 11.5mm | 2.0 mm | 2.0 - 5.0mm |

The intended use and technological characteristics of these devices do not vary significantly. The safety and effectiveness of the Verres Needle and Cannula are comparable to that of the Gynescope Trocar and Sleeves and the Marlow Verres Needle.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing the body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 6 1997

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

Re: K971837

VerreScope Verres Needle and Cannula . Dated: May 16, 1997 Received: May 19, 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 Device 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 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 (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 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 question 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

Sincerely yours,

Lillian Yin, Ph.D.

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

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510(k) Number (if known):

Verres Needle / Cannula Device Name: _

Indications For Use:

Verres Needle and Cannula 1s intended for use in laparoscopic surgery that utilizes minimally invasive surgical procedures to establish pneumoperitoneum and to provide access for operative and diagnostic instrumentation.

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

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Concurrence of CDRH, Office of Device Evaluation (ODE) productive, Abdominal, ENT, Prescription lise > Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR (Per 21 CFR 801.109)

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