(76 days)
Not Found
Not Found
No
The summary describes a steam sterilizer and does not mention any AI or ML capabilities.
No.
This device is an autoclave used for sterilizing instruments, not for directly treating a medical condition or disease in a patient.
No
The device is described as a table-top steam sterilizer for reprocessing reusable instruments, not for diagnosing conditions or diseases.
No
The device is a table-top steam sterilizer, which is a physical piece of equipment and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "reprocessing of reusable instruments in a clinical setting." This involves sterilizing medical instruments, not performing tests on biological samples to diagnose diseases or conditions.
- Device Description: The device is described as a "table-top steam sterilizer." This aligns with its function of sterilization, not in vitro diagnostic testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases
Therefore, the STATIM 5000 Cassette Autoclave with Extended Cassette is a medical device used for sterilization, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
FLE
Device Description
STATIM 5000 Cassette Autoclave
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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