← Product Code [FLE](/productcode/FLE) · K983679 # STATIM 5000 CASSETTE AUTOCLAVE (K983679) _Scican · FLE · Jan 4, 1999 · General Hospital · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K983679 ## Device Facts - **Applicant:** Scican - **Product Code:** [FLE](/productcode/FLE.md) - **Decision Date:** Jan 4, 1999 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 880.6880 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## 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. ## Device Story Table-top steam sterilizer for clinical reprocessing of reusable stainless steel instruments; specifically designed to accommodate longer, complex instruments and rigid scopes up to 49 cm. Device utilizes steam sterilization cycle at 132°C for 10 minutes. Operated by clinical staff to ensure instrument sterility. Benefits include expanded capacity for longer surgical/dental instruments compared to standard cassettes. ## Clinical Evidence Bench testing only. No clinical data provided. ## Technological Characteristics Table-top steam sterilizer; utilizes steam for sterilization; accommodates stainless steel instruments up to 1.5 kg and 49 cm length; operates at 132°C. No software or electronic algorithm components described. ## Regulatory 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. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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 --- **Source:** [https://fda-staging.innolitics.com/device/K983679](https://fda-staging.innolitics.com/device/K983679) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com