CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMF

K992481 · Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh · HET · Mar 17, 2000 · Obstetrics/Gynecology

Device Facts

• Record ID: K992481
• Device Name: CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMF
• Applicant: Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Mar 17, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The WISAP CO2-OP-Pneu Computer 7050C/7050CF/7050CM/7050CMF may only be used for building up a pneumoperitoneum with CO2-Gas for diagnostic or operative Pelviscopy/Laparoscopy.

Device Story

The WISAP CO2-OP-Pneu Computer (models 7050C, 7050CF, 7050CM, 7050CMF) is an electronic insufflator designed to establish and maintain a pneumoperitoneum using CO2 gas. Used in clinical settings during diagnostic or operative laparoscopy/pelviscopy, the device is operated by physicians. It functions by regulating the flow and pressure of CO2 gas into the abdominal cavity to create the necessary space for surgical visualization and instrumentation. The computer-controlled system monitors intra-abdominal pressure and gas flow, providing the surgeon with real-time control over the insufflation process. By automating the maintenance of the pneumoperitoneum, the device facilitates safe surgical access, reduces the risk of over-pressurization, and supports consistent operative conditions throughout the procedure.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electronic CO2 insufflator; computer-controlled pressure and flow regulation; intended for diagnostic and operative laparoscopy/pelviscopy. Specific materials and standards not detailed in the provided documentation.

Indications for Use

Indicated for patients undergoing diagnostic or operative pelviscopy or laparoscopy requiring pneumoperitoneum via CO2 gas insufflation.

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

MAR 1 7 2000

Mr. Horst Semm President WISAP Gesellschaft für wissenschaftlichen Apparatebau mbH Rudolf-Diesel-Ring 20 D-82054 Sauerlach b. München GERMANY

Re: K992481 CO3-OP-Pneu Computer #7050C/ #7050CF/ #7050CM/ #7050CMF Dated: January 31, 2000 Received: February 2, 2000 Regulatory Class: II 21 CFR §884.1730/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 pror to May 26, 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 recistration, listing of devices, good manufacturing and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Aproval), 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 equivalion 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 requlation 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 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" (21CFR 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/odrh/dsmamain.html".

Sincerely yours,

Daniel C. Schultz, M.D.

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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510(k) Number (if known): ___K992481

Device Name: _CO2-OP-Pneu Computer 7050C/7050CF/7050CM/7050CMF

Indications For Use:

The WISAP CO2-OP-Pneu Computer 7050C/7050CF/7050CM/7050CMF may only be used for building up a pneumoperitoneum with CO2-Gas for diagnostic or operative Pelviscopy/Laparoscopy.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Seggos

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

**Prescription Use**
(Per 21 CFR 801.109)