(76 days)
The STATIM 5000 Cassette Autoclave with Extended Cassette is a table-top steam sterilizer designed for the reprocessing of reusable instruments in a clinical setting. The extended cassette will accommodate unwrapped stainless steel instruments of a longer and more complex construction to a weight of up to 1.5 kg. With the addition of the extended cassette, the STATIM 5000 unit will now accommodate longer length rigid scopes of up to 49 cm or 19". The unit will process such instruments at a sterilization cycle of 132 ° C for 10 minutes.
STATIM 5000 Cassette Autoclave with Extended Cassette is a table-top steam sterilizer.
The provided text is a 510(k) clearance letter from the FDA for a device called "STATIM 5000 Cassette Autoclave with Extended Cassette". This document indicates that the device has been found substantially equivalent to a legally marketed predicate device.
The document does not contain any information regarding specific acceptance criteria, reported device performance, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
Therefore, I cannot answer your request based on the provided input. There is no study described in this document that proves the device meets specific acceptance criteria using the metrics you've listed. This type of FDA clearance relies on demonstrating equivalence to an existing device, rather than presenting a detailed performance study with quantifiable metrics as you've outlined.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 4 1999
Ms. Brenda Murphy Requlatory Affairs Manager SciCan 1440 Don Mills Road Toronto, Ontario CANADA M3B 3P9
Re: K983679 STATIM 5000 Cassette Autoclave Trade Name: Requlatory Class: II Product Code: FLE Dated: December 4, 1998 Received: December 7, 1998
Dear Ms. Murphy:
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 aqainst 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 requlations 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. 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 - Ms. Murphy
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 leqally 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), please contact the Office of Compliance at (301) 594-4692. 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.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Directd Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510 (K) Number:
K983679
Device Name:
STATIM 5000 Cassette Autoclave with Extended Cassette
Indications for Use:
The STATIM 5000 Cassette Autoclave with Extended Cassette is a table-top steam sterilizer designed for the reprocessing of reusable instruments in a clinical setting.
The extended cassette will accommodate unwrapped stainless steel instruments of a longer and more complex construction to a weight of up to 1.5 kg. With the addition of the extended cassette, the STATIM 5000 unit will now accommodate longer length rigid scopes of up to 49 cm or 19".
The unit will process such instruments at a sterilization cycle of 132 ° C for 10 minutes.
Now Puschill Trom
Basued for Chin.
ivision of Dental, Infection Control, and General Hospital Devices
510(k) Number K982679
6 - 1
§ 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).