DISPOSABLE HEATING TUBING SET #7642HSES by WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH

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 Description

Laparoscopic Insufflator: Disposable Heating Tubing Set #7642 HSES

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a medical device: a Disposable Heating Tubing Set #7642 HSES, used with a laparoscopic insufflator. This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The 510(k) clearance process primarily establishes substantial equivalence to a legally marketed predicate device, rather than requiring detailed performance studies with acceptance criteria in the same way a Premarket Approval (PMA) would.

Therefore, I cannot fulfill your request for the specific details you outlined based on the given input text.

Summary

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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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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.

(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)

Over-The-Counter Use

(Optional Format 1-2-96)

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

Regulation Number and Section

§ 884.1730 Laparoscopic insufflator.

(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.