GYNCARE MORCELLEX TISSUE MORCELLATOR

K100280 · ETHICON, Inc. · HET · Mar 24, 2010 · Obstetrics/Gynecology

Device Facts

• Record ID: K100280
• Device Name: GYNCARE MORCELLEX TISSUE MORCELLATOR
• Applicant: ETHICON, Inc.
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Mar 24, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GYNECARE MORCELLEX™ Tissue Morcellator is intended for gynecologic, urologic and general surgical endoscopic use by trained professionals in hospital environments and ambulatory surgery centers.

Device Story

Single-use tissue morcellator for operative laparoscopy; used in hospital/ambulatory settings by trained professionals. Device inserted via obturator; standard grasping instrument extended through central lumen to grasp tissue. Tissue drawn into inner stationary sheath; exposed blade cuts tissue. Physician activates device via foot pedal or handle-mounted trigger. Operates in coring or peeling modes based on blade exposure and rotatable coreguard placement. Includes reducer cap for 5mm instruments. Facilitates tissue extraction through small laparoscopic incisions; benefits patient by enabling minimally invasive surgical removal of tissue.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Single-use mechanical tissue morcellator; includes obturator, central lumen, inner stationary sheath, exposed cutting blade, foot pedal/handle activation, and rotatable coreguard. Design and materials identical to predicate. No software or electronic sensing components.

Indications for Use

Indicated for cutting, coring, and extracting tissue during operative laparoscopy, including laparoscopic general surgical, urologic, and gynecologic procedures.

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 MORCELLEX™ Tissue Morcellator (K061050)

Submission Summary (Full Text)

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## FILI

Johnon company

MAR 2 4 2010

## 510k Summary

| 510(k) Owner | ETHICON, Inc. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information | Bryan A. Lisa<br>Associate Director, Regulatory Affairs<br>ETHICON Inc.<br>PO Box 151<br>Route 22 West<br>Somerville, NJ 08876<br>Telephone: [phone]<br>Facsimile: 908.218.2595<br>Email: [e-mail] |
| Date of Preparation | 29 January 2010 |
| Device Classification | Trade Name: GYNECARE MORCELLEX™ Tissue Morcellator<br>Common Name: Laparoscope, gynecologic (and accessories)<br>Classification Name/Number:<br>Gynecologic laparoscope and accessories<br>Regulation Number: 884.1720<br>Product code: HET |
| Predicate Device | GYNECARE MORCELLEX™ Tissue Morcellator: K061050 |
| Device Description | The GYNECARE MORCELLEX™ Tissue Morcellator is a single-use<br>device. The device is inserted into the patient with the use of the<br>provided single-use obturator. The device allows tissue to be<br>grasped with a standard grasping instrument extended through its<br>central lumen. The tissue can be drawn up inside the device's<br>central lumen into the inner stationary sheath as the exposed blade<br>cuts the tissue. The physician can activate the GYNECARE<br>MORCELLEX™ Tissue Morcellator via a foot pedal or via the dual-<br>function Blade Guard / Activation Trigger on the device's<br>detachable handle. The device can operate in either coring or<br>peeling mode based on the degree of exposure of the blade and<br>placement of the rotatable coreguard. The device is packaged with<br>a single-use reducer cap to allow the optional use of a 5mm<br>instrument. |
| Intended Use | The GYNECARE MORCELLEX™ Tissue Morcellator is intended for<br>gynecologic, urologic and general surgical endoscopic use by<br>trained professionals in hospital environments and ambulatory<br>surgery centers. |
| Indications for Use | The GYNECARE MORCELLEX™ Tissue Morcellator is indicated for<br>cutting, coring, and extracting tissue during operative laparoscopy<br>including laparoscopic general surgical procedures, laparoscopic<br>urologic procedures, and laparoscopic gynecologic procedures. |
| Technological<br>Characteristics | The technological characteristics of GYNECARE MORCELLEX™,<br>including design and materials, are identical to the predicate<br>device, GYNECARE MORCELLEX™. |
| Performance Data | The bench testing data, including insertion and extraction forces,<br>provided in this 510(k) demonstrates that the corrective action on<br>the device design addresses the root cause of device failure. |
| Clinical Data | This 510(k) does not rely on clinical data to demonstrate<br>substantial equivalence. |
| Conclusion | Based on the 510(k) summary and the information provided herein,<br>we conclude that the subject device is substantially equivalent to<br>the predicate devices under the Federal Food, Drug, and Cosmetic<br>Act. |

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

## MAR 2 4 2010

Brian A. Lisa Associate Director, Regulatory Affairs ETHICON, Inc. Route 22 West, P.O. Box 151 SOMERVILLE NJ 08876

Re: K100280

Trade/Device Name: GYNECARE MORCELLEX™ Tissue Morcellator Regulation Number: 21 CFR §884.1720 Regulation Name: Gynecologic laparascope and accessories Regulatory Class: II Product Code: HET Dated: January 29, 2010 Received: February 1, 2010

Dear Mr. Lisa:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related

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adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Form

510(k) Number (if known): _ K ) vo 2 8 C

Device Name: GYNECARE MORCELLEX™ Tissue Morcellator

Indications for Use:

The GYNECARE MORCELLEX Tissue Morcellator is indicated for cutting, coring and extracting tissue during operative laparoscopy, including laparoscopic general surgical procedures, laparoscopic urologic procedures, and laparoscopic gynecologic procedures.

Prescription Use X . Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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