HI-FLO THERME PNEU 45, WISAP #7083, 7083V

K031014 · Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh · HIF · Jun 27, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K031014
• Device Name: HI-FLO THERME PNEU 45, WISAP #7083, 7083V
• Applicant: Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: Jun 27, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1730
• Device Class: Class 2

Indications for Use

The WISAP Multi Hi-Flo Therme Pneu 45 may only be used for building up a pneumoperitoneum with CO2Gas for diagnostic or operative Pelviscopy/Laparoscopy. The Flow-Therme integrated in the appliance preheats the insufflation gas to body temperature.

Device Story

The WISAP Multi Hi-Flo Therme Pneu 45 is a laparoscopic insufflator used to create pneumoperitoneum for surgical procedures. It utilizes CO2 gas as the insufflation medium. A key feature is the integrated Flow-Therme system, which preheats the CO2 gas to body temperature before delivery to the patient. The device is intended for use in clinical settings by trained medical professionals during diagnostic or operative pelviscopy/laparoscopy. By maintaining gas at body temperature, the device aims to reduce potential patient discomfort or physiological impact associated with cold gas insufflation. The device is operated by clinicians to control gas flow and pressure during surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Laparoscopic insufflator; CO2 gas source; integrated gas heating system (Flow-Therme) to reach body temperature; 21 CFR 884.1730; Class II; Product Code 85 HIF.

Indications for Use

Indicated for building up pneumoperitoneum with CO2 gas for diagnostic or operative pelviscopy/laparoscopy.

Regulatory Classification

Identification

A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 7 2003

Mr. Horst Semm General Manager WISAP Gesellschaft Fur Wissenschaft Rudolf-Diesel-Ring 20 Sauerlach, D-82054 GERMANY

Re: K031014 Trade/Device Name: HI-FLO Therme Pneu 45, #7083, 7083V Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: 85 HIF Dated: March 27, 2003 Received: March 31, 2003

Dear Mr. Semm:

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.

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

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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: HI-FLO Therme Pneu 45, WISAP #7083, 7083V

Indications For Use:

The WISAP Multi Hi-Flo Therme Pneu 45 may only be used for building up a pneumoperitoneum with CO2Gas 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)

Odmil R. Segnon

(Division Sign-Off) Division of Reproduct and Radiological I 510(k) Num

(Optional Format 3-10-98)

*Prescription Use*