GYNECARE LAPAROSCOPIC MORCELLATOR

K993801 · ETHICON, Inc. · HET · Feb 7, 2000 · Obstetrics/Gynecology

Device Facts

• Record ID: K993801
• Device Name: GYNECARE LAPAROSCOPIC MORCELLATOR
• Applicant: ETHICON, Inc.
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Feb 7, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Gynecare Laparoscopic Morcellator is intended for gynecologic, urologic, and general surgical endoscopic use by trained professionals in hospital environments.

Device Story

Disposable laparoscopic morcellator; consists of rotating cylindrical razor blade with blade guard; powered by external Motor Drive Unit (MDU) via flexible drive cable. Physician operates device via foot pedal; nurse controls MDU speed/direction outside sterile field. Tissue grasped by standard grasper instrument through central lumen; drawn into rotating cutter for coring action. Used in hospital environments for laparoscopic procedures; facilitates tissue extraction through small incisions. Benefits patient by enabling minimally invasive removal of large tissue masses.

Clinical Evidence

No clinical data deemed necessary; bench testing deemed unnecessary. Published literature cited to support use of laparoscopic morcellation for hysterectomies.

Technological Characteristics

Rotating cylindrical razor blade; powered by external variable-speed, reversible Motor Drive Unit (MDU). User-selectable speed and rotation direction. Disposable, sterile device.

Indications for Use

Indicated for cutting, coring and extracting tissue in operative laparoscopy, including laparoscopic general surgical procedures, laparoscopic urologic procedures such as nephrectomy, and laparoscopic gynecologic procedures such as myomectomy and hysterectomy.

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

• Gynecare Laparoscopic Morcellator

Submission Summary (Full Text)

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FEB 7 2000

#### SECTION 7

## SUMMARY OF SAFETY AND EFFECTIVENESS

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510(k) Summary of Safety and Effectiveness

Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.

| MODIFIED DEVICE NAME: | Gynecare Laparoscopic Morcellator |
|------------------------|-----------------------------------|
| PREDICATE DEVICE NAME: | Gynecare Laparoscopic Morcellator |

510(k) SUMMARY

Device Description

The modified Laparoscopic Morcellator is comprised of two major components: the Laparoscopic Morcellator and the Motor Drive Unit (MDU). The Gynecare Laparoscopic Morcellator is a disposable device which is provided sterile. It is essentially a rotating, cylindrical (tubular) razor blade, with a blade guard, which allows tissue to be grasped with a standard grasper type instrument extending through the central lumen of the device and then drawn up inside the rotating cutter as the cutter cuts with a coring action. The cutting is powered by the Gynecare Laparoscopic Motor Drive Unit (MDU) via a flexible drive cable (see drawing). The physician can turn the Gynecare Laparoscopic Morcellator on and off via a foot pedal. The direction and speed of rotation are controlled on the face of the MDU by a nurse outside the sterile field.

Continued on next page

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## SUMMARY OF SAFETY AND EFFECTIVENESS, Continued ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| Device Description,<br>Continued | The variable-speed, reversible MDU is an integral part of the<br>Gynecare Laparoscopic Morcellator since it drives the rotation of<br>the cutter/Morcellator at a controlled speed and torque. The<br>Gynecare Motor Drive Unit provides a user-selectable speed range<br>at which to drive (rotate) the cutter/Morcellator. The torsional<br>output of the motor is sufficient at all speeds to drive the cutter<br>while cutting tough tissue. The direction of rotation of the motor is<br>user-selectable. | |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Indications For Use | Indicated for cutting, coring and extracting tissue in operative<br>laparoscopy, including laparoscopic general surgical procedures,<br>laparoscopic urologic procedures such as nephrectomy, and<br>laparoscopic gynecologic procedures such as myomectomy and<br>hysterectomy. | |
| Intended Use | The Gynecare Laparoscopic Morcellator is intended for<br>gynecologic, urologic, and general surgical endoscopic use by<br>trained professionals in hospital environments. | |
| Technological<br>Characteristics | The modified device has identical technological characteristics to<br>the predicate device. | |
| Performance Data | Nonclinical laboratory was deemed unnecessary. | |
| Clinical Data | No clinical data was deemed necessary to support this premarket<br>notification; however, published literature is available to support<br>the use of a laparoscopic morcellation device for laparoscopic<br>hysterectomies. | |
| | Continued on next page | |

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#### SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

Conclusions

Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the new device is substantially equivalent to the Predicate Device under the Federal Food, Drug, and Cosmetic Act.

.

Contact

Gregory R. Jones Director, Regulatory Affairs ETHICON, Inc. Rt. #22, West Somerville, NJ 08876-0151

Date

November 8, 1999

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

7 2000 FEB

Mr. Gregory R. Jones Director, Regulatory Affairs Ethicon, Inc., a Johnson & Johnson Co. P.O. Box 151 Somerville, NJ 08876-0151

Re: K993801

Gynecare Laparoscopic Morcellator Dated: November 8, 1999 Received: November 9, 1999 Requlatory Class: II 21CFR §884.1720/Procode: 85 HET

Dear Mr. Jones:

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 dass 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.

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 requlation 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.

CAPT Daniel G. Schultz, M.D. Acting 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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# INDICATION FOR USE

K993801 510(k) Number (if known):

Device Name:

Laparoscopic Morcellator

Indications For Use:

Indicated for cutting, coring and extracting tissue in operative laparoscopy, including laparoscopic general surgical procedures, laparoscopic urologic procedures such as nephrectomy, and laparoscopic gynecologic procedures such as myomectomy and hysterectomy.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

× Prescription Use (Per 21 CFR 801.109)

OR

Over-The Counter Use _

David G. Elynn

(Divisio): ... . . . - Off) 'eproductive, Abdominal, ENT. Division ! and Radiolo leal I 510(k) Number

Modified Laparoscopic Morcellator Gynecare/ETHICON, Inc.

(Optional Format 1-2-9G)

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