THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF by WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH

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.

Device Description

Not Found

AI/ML Overview

The provided FDA document is a 510(k) clearance letter for the WISAP Therme Pneu Computer. It primarily focuses on regulatory approval based on substantial equivalence to a predicate device. This type of document does not contain the detailed information required to answer your questions about acceptance criteria and performance studies.

The letter states: "We have reviewed your Section 510k) notification of intent to market the device and we have determined the device is substantially equivalent... to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means that the device's clearance was likely based on a comparison to an existing device, rather than a new clinical performance study with specific acceptance criteria as you've outlined.

Therefore, I cannot provide the requested information because it is not present in the given text.

To answer your questions, one would need access to the full 510(k) submission document, which would detail any performance testing conducted, if applicable to this type of device and regulatory pathway. For many Class I and Class II devices cleared via the 510(k) pathway, extensive "acceptance criteria" and "study data" as you've described for AI/diagnostic devices are not typically required beyond demonstrating functional equivalence and safety to a predicate device.

Summary

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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 (301) 594-4591. 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" (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 (800) 638-2041 or (301) 443-6597 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)

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K 992513/A1

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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!

(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)

Daniel A. Seppon

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

Regulation Number and Section

§ 884.1720 Gynecologic laparoscope and accessories.

(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. 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.