PRESTIGE MEDICAL SERIES 2100 CLINICAL AUTOCLAVE by PRESTIGE MEDICAL CORP.

The Models 2100 06 and 2100 07 Clinical Autoclaves are intended to sterilize unwrapped solid instruments (i.e., excluding lumened instruments and dental handpieces) and non-porous loads at cycle parameters of 121° Celsius saturated steam process for 18 minutes

Device Description

The Series 2100 clinical autoclaves by Prestige Medical are Model numbers 2100 07 (extended body) and 2100 06 (standard body). Both are 120 volt autoclaves, which have a 18 minute sterilization cycle at 121°C. The height of the extended body autoclave is slightly greater than that of the standard body (420mm versus 335mm). The devices have substantially the same technological characteristics as the devices cleared under K910789 and K900432, and the identical materials, design, composition and function as the products currently marketed under K910789 and K900432. The slight modification reflected in the subject devices is that the "plug and pintle," which performed air bleed, pressure indicator and excess pressure relief functions, has been replaced by three separate components, each of which fulfills one of the functions formerly performed by the plug and pintle. The three separate components are: an air bleed device; a pressure rise indicator in the lid of the product; and a gasket blow-out slot through which a sealing gasket may extrude if necessary.

AI/ML Overview

I am sorry but this document does not contain the information you are looking for. This document is a 510(k) premarket notification for a medical device (a steam autoclave), which is a regulatory submission to the FDA. It declares the device's substantial equivalence to previously marketed devices. It does not include information about acceptance criteria or a study proving the device meets those criteria, as such detailed performance study information is not typically part of the summary provided in this type of regulatory document.

Summary

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K962903

(1) Submitter:
MAR - 3 1998

Prestige Medical P.O. Box 154 Off Clarendon Road Blackburn, Lancashire BB1 9UG United Kingdom

Contact Person: Robert N. Stevenson

Date Summary Prepared: February 20, 1998

Device Proprietary Name: Prestige Medical Series 2100 Clinical Autoclave (2)

Common Name: autoclave

Classification Name: steam sterilizer

KaVoKlave Steam Autoclave, K910789 (3) Predicates: #M8 Electronic Sterilizer, K900432
Device Description: The Series 2100 clinical autoclaves by Prestige Medical are (4) Model numbers 2100 07 (extended body) and 2100 06 (standard body). Both are 120 volt autoclaves, which have a 18 minute sterilization cycle at 121°C. The height of the extended body autoclave is slightly greater than that of the standard body (420mm versus 335mm).
Intended Use: The autoclaves are intended to sterilize unwrapped solid (5) instruments (i.e., excluding lumened instruments and dental handpieces) and non-porous loads at cycle parameters of 121℃ saturated steam process for 18 minutes.
(6) The devices have substantially the same technological characteristics as the devices cleared under K910789 and K900432, and the identical materials, design, composition and function as the products currently marketed under K910789 and K900432. The slight modification reflected in the subject devices is that the "plug and pintle," which performed air bleed, pressure indicator and excess pressure relief functions, has been replaced by three separate components, each of which fulfills one of the functions formerly performed by the plug and pintle. The three separate components are: an air bleed device; a pressure rise indicator in the lid of the product; and a gasket blow-out slot through which a sealing gasket may extrude if necessary.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine and health.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 3 1998

Mr. Mark A. Heller ·Prestige Medical C/O Hale and Dorr LLP 1455 Pennsylvania Avenue, N.W. Washington, DC 20004

Re: K962903 Trade Name: Prestige Medical Series 2100 Clinical Autoclave Regulatory Class: II Product Code: FLE Dated: December 23, 1997 Received: December 23, 1997

Dear Mr. Heller:

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 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 The general controls provisions of the Act 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. Anno an substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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

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Page 2 - Mr. Heller

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 labelinq regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page _ 1 _ of _ 1

510(k) Number (if known): K962903

Prestige Medical Series 2100 Clinical Autoclaves Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

(FLEASE DO NOT WRITE RELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices

510(k) Number.

(Optional Format 1-2-96)

Over-the-Counter Use

Regulation Number and Section

§ 880.6880 Steam sterilizer.

(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).