DISPOSABLE HEATING TUBING SET #7642HSES

K990662 · Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh · HIF · Sep 24, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K990662
• Device Name: DISPOSABLE HEATING TUBING SET #7642HSES
• Applicant: Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: Sep 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1730
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

This device is restricted to use by authorized expert personnel/physicians. The WISAP Disposable Heating Tube 7642HSE is a laparoscopic accessory to be used in connection with the WISAP (02 insufflator. This system serves for building up a pneumoperitoneum during diagnostic-operative Pelviscopy/Laparoscopy. The insufflation gas is preheated to body temperature by the disposable tubing.

Device Story

Disposable heating tubing set accessory for WISAP CO2 insufflator; used during diagnostic/operative laparoscopy/pelviscopy. Device preheats insufflation gas to body temperature before delivery to patient. Operated by physicians/expert personnel in clinical/OR settings. Benefits patient by reducing potential for hypothermia or thermal discomfort associated with cold gas insufflation during abdominal procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable tubing set; heating element integrated for gas temperature regulation to body temperature; compatible with WISAP CO2 insufflator; non-sterile/sterile status not specified; mechanical accessory.

Indications for Use

Indicated for use by authorized expert personnel/physicians during diagnostic or operative pelviscopy/laparoscopy to build up a pneumoperitoneum by delivering preheated insufflation gas.

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

SEP 2 4 1999

Mr. S. Grünwald Quality Management WISAP Gesellschaft für wissenschaftlichen Apparatebau mbH Rudolf-Diesel-Ring 20 D-82054 Sauerlach b. München GERMANY

Re: K990662

Laparoscopic Insufflator: Disposable Heating Tubing Set #7642 HSES Dated: September 1, 1999 Received: September 9, 1999 Requlatory Class: II 21 CFR §884.1730/Procode: 85 HIF

Dear Mr. Grünwald:

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 Requlations, 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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), piease 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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510(k) Number (if known): K990662

Disposable Heating Tubing Set #7642 HSES Device Name:

Indications For Use:

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

The WISAP Disposable Heating Tube 7642HSE is a laparoscopic accessory to be used in connection with the WISAP (02 insufflator. This system serves for building up a pneumoperitoneum during diagnostic-operative Pelviscopy/Laparoscopy. The insufflation gas is preheated to body temperature by the disposable tubing.

(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)

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