THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF

K992513 · Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh · HET · Mar 17, 2000 · Obstetrics/Gynecology

Device Facts

• Record ID: K992513
• Device Name: THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF
• 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

Indications for Use

The WISAP THERME-PNEU Computer 7070C/7070CM/7070CM/7070CMF may only be used for building up a pneumoperitoneum with CO2- Gas for diagnostic or operative Pelviscopy/Laparoscopy. The Flow-Therme integrated in the appliance preheats the insufflation gas to body temperature.

Device Story

Therme-Pneu Computer (models 7070C, 7070CF, 7070CM, 7070CMF) is an insufflation device for laparoscopic/pelviscopic surgery. Device connects to CO2 gas source; regulates gas flow to create pneumoperitoneum. Integrated 'Flow-Therme' component preheats insufflation gas to body temperature before delivery to patient. Operated by physicians/expert personnel in clinical/surgical settings. Provides controlled gas delivery to maintain abdominal distension for visualization and instrument access during minimally invasive procedures. Benefits include reduced patient discomfort/hypothermia risk via gas warming.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Insufflation system for CO2 gas; includes integrated gas heating element (Flow-Therme) to reach body temperature. Designed for diagnostic/operative pelviscopy/laparoscopy. Regulates gas flow and pressure for pneumoperitoneum maintenance.

Indications for Use

Indicated for use by authorized expert personnel/physicians for establishing pneumoperitoneum using CO2 gas during diagnostic or operative pelviscopy/laparoscopy 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.

Submission Summary (Full Text)

{0}------------------------------------------------

Public Health Service

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: K992513 Therme Pneu Computer (#7070C, #7070CF, #7070CM, #7070CMF) Dated: January 31, 2000 Received: February 2, 2000 Regulatory Class: 11 21 CFR §884.1730/Procode: 85 HET

Dear Mr. Semm:

We have reviewed vour Section 510k) notification of intent to market the device 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 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 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 regulator, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission 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 predication 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 vitre 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/cdrh/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)

{1}------------------------------------------------

K 992513/A1

Page_1_of_1_

K992513 510(k) Number (if known): _

Therme-Pneu Computer 7070C/7070CF/7070CM/7070CMF Device Name:

Indications For Use:

This decice is restricted to use by authorized expert personnel / physicians!

The WISAP THERME-PNEU Computer 7070C/7070CM/7070CM/7070CMF may only be used for building up a pneumoperitoneum with CO .- Gas for diagnostic or operative Pelviscopy/Laparoscopy. The Flow-Therme integrated in the appliance preheats the insufflation gas to body temperature.

(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)

Daniel A. Seppon

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