POWER-DRIVE, WISAP MODEL #7688PD/7688PD1

K982515 · Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh · HET · Jan 19, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K982515
• Device Name: POWER-DRIVE, WISAP MODEL #7688PD/7688PD1
• Applicant: Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Jan 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is restricted to use by authorized expert personnel/physicians. The WISAP POWER-DRIVE is a laparoscopic accessory to be used in connection with the S*E*M*M*-Set. It allows cutting of tissue cylinders out of myoma and uterion. It allows cutting of tissue cylinders out of myoma and uterion by rotation of the motor drive or additional intermittent manual rotation. The POWER-DRIVE may only be used for horizontal morcellation.

Device Story

Laparoscopic accessory; used with S*E*M*M*-Set for tissue morcellation. Device utilizes motor-driven rotation or intermittent manual rotation to cut tissue cylinders from myoma and uterine tissue. Used in clinical/surgical settings by physicians. Output is mechanical tissue cutting; assists in removal of tissue during laparoscopic surgery. Benefits include facilitated tissue extraction through small incisions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Laparoscopic accessory; motor-driven mechanical rotation system; horizontal morcellation configuration; designed for integration with S*E*M*M*-Set.

Indications for Use

Indicated for use by authorized expert personnel/physicians for horizontal morcellation of myoma and uterine tissue during laparoscopic procedures using the S*E*M*M*-Set.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 9 1999

Mr. Horst Semm President WISAP Gesellschaft fur Wissenchaft Rudolf - Diesel - Ring 20 D-82054 Sauerlach b. Munchen, Germany

Re: K982515 Power-Drive WISAP Model #7688PD/7688PD1 Dated: October 29, 1998 Received: November 2, 1998 Regulatory Class: II 21 CFR 884.1720/Procode: 85 HET

Dear Mr. Semm:

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 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 Requiations, 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 regult 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 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/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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K982515 5 10(k) Number (if known):

POWER-DRIVE 7688PD/7688PD1 Device Name:

Indications For Use:

This device is restricted to use by authorized expert personnel/physicians.

The WISAP POWER-DRIVE is a laparoscopic accessory to be used in connection with the S*E*M*M*-Set.

with the Systems-Set.
It allows cutting of tissue cylinders out of myoma and uterion. It allows cutting of Cissue cyrinkers out intermittent manual rocation.
rotation of the motor drive or additional interest manual rocation. The POWER-DRIVE may only be used for horizontal morcellation.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Ehrich A. Bergman

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