AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608

K982518 · Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh · HET · Jan 14, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K982518
• Device Name: AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608
• Applicant: Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Jan 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The WISAP Aqua-Purator Biotherm 1608 is solely destined for operative therapeutical Pelviscopy/Laparoscopy for lavage of the abdominal cavity with physiological saline solution coming from plastic bags up to 5 1 volume. The irrigation pressure can be preselected; the preheated liquid in the bag is kept at body temperature.

Device Story

The WISAP Aqua-Purator Biotherm 1608 is an irrigation system for operative laparoscopy/pelviscopy. It accepts physiological saline solution from external plastic bags (up to 5L). The device preheats the saline to body temperature and delivers it to the abdominal cavity at a user-preselected irrigation pressure. Used in clinical settings by physicians/expert personnel. The device assists in lavage procedures, providing temperature-controlled irrigation to the surgical site, which aids in maintaining homeostasis and clearing the operative field during minimally invasive abdominal surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Irrigation system for laparoscopic lavage; features pressure preselection and fluid heating to body temperature; compatible with saline bags up to 5L; intended for professional use in operative settings.

Indications for Use

Indicated for operative therapeutic pelviscopy/laparoscopy in patients requiring abdominal cavity lavage with physiological saline solution. Restricted to use by authorized expert personnel/physicians.

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 4 1999

Horst Semm WISAP Gesellschaft Fur Wissenshaftichen Apparatebau mbH Rudolf - Diesel - Ring 20 D-82054 Sauerlach b. Munchen GERMANY

Re: K982518/A1 Aqua Purator - Biotherm, WISAP Model #1608 Dated: October 20, 1998 Received: October 22, 1998 Regulatory Class: II 21 CFR 884.1720/Procode: 85HET

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). 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 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 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

Image /page/0/Picture/15 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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510(k) Number (if known): K982518

Device Name: Aqua-Purator Biotherme 1608

Indications For Use:

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

The WISAP Aqua-Purator Biotherm 1608 is solely destined for operative therapeutical Pelviscopy/Laparoscopy for lavage of the abdominal cavity with physiological saline solution coming from plastic bags up to 5 1 volume. The irrigation pressure can be preselected; the preheated liquid in the bag is kept at 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)

Timid G. Legum

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological D 510(k) Number