(91 days)
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No
The summary describes a chemical test kit for sterilization efficacy and contains no mention of AI or ML.
No.
The device is a test kit used to evaluate the efficacy of a sterilization system, not to provide treatment or therapy.
No
The device is a test kit used to evaluate the efficacy of a sterilization system, not to diagnose a medical condition in a patient.
No
The device is described as a "Culture Test Kit," which strongly implies the presence of physical components (e.g., culture media, vials, etc.) for performing a biological test, not solely software.
Based on the provided information, the Raven Pro-PACT Peracetic Acid Culture Test Kit is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "testing the efficacy of Steris System1™, a liquid chemical sterilization system, processing cycles." This involves testing a sample (likely from the sterilization process) in vitro (outside of a living organism) to determine the effectiveness of the sterilization.
IVDs are defined as devices intended for use in the collection, preparation, and examination of specimens taken from the human body or other sources for the purpose of providing information for the diagnosis, treatment, or prevention of disease. While this specific test isn't directly diagnosing a human condition, it's testing the efficacy of a process that is critical for preventing disease transmission in a healthcare setting. Testing the efficacy of sterilization is a key part of ensuring the safety of medical devices used on patients, which falls under the broader scope of IVD regulation.
The fact that it's a "Culture Test Kit" further supports this, as culture tests are a common type of in vitro diagnostic method.
N/A
Intended Use / Indications for Use
The Raven Pro-PACT Peracetic Acid Culture Test Kit is intended for use in testing the efficacy of Steris System1 , a liquid chemical sterilization system, processing cycles. A reduced incubation time of 24 hours has been validated for the Raven Pro-PACT Peracetic Acid Culture Test Kit.
Product codes
MRB
Device Description
Raven Pro-PACT Peracetic Acid Culture Test Kit
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 5 2006
Ms. Wendy Royalty-Hann QA/RA Manager Raven Biological Laboratories, Incorporated 8607 Park Drive Omaha, Nebraska 68127
Re: K053212
Trade/Device Name: Raven Pro-PACT Peracetic Acid Culture Test Kit Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization process indicator Regulatory Class: II Product Code: MRB Dated: February 1, 2006 Received: February 2, 2006
Dear Ms. Royalty-Hann:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave to revea your and 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 mershate commerce press that have been reclassified in accordance with the provisions of Amendinens, of to de researche Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents of 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Mrs), it may of subject to back of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or routish further announcements concerning your device in the Federal Register.
1
Page 2 - Ms. Royalty-Hann
Please be advised that FDA's issuance of a substantial equivalence determination does not r least that FDA has made a determination that your device complies with other requirements moun that I Dr may Federal statutes and regulations administered by other Federal agencies. or the Fiel of all , vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and instills (21 CF rear 801), systems (QS) regulation (21 CFR Part 820); and if requirelies as bet 1011 product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) rms reter notification. The FDA finding of substantial equivalence of your device to a promarket notification. The 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 regulation (21 CFR Part 801), n you desire specific acritic at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You entitiou, "Therefitance in information on your responsibilities under the Act from the maj Sount Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Runne
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indications for Use Statement
| 510(k) Number | |
|---|---|
| Device Name | Raven Pro-PACT Peracetic Acid Culture Test Kit |
| Indications for Use | The Raven Pro-PACT Peracetic Acid Culture Test Kit is intended for use in testing the efficacy of Steris System1 TM , a liquid chemical sterilization system, processing cycles. A reduced incubation time of 24 hours has been validated for the Raven Pro-PACT Peracetic Acid Culture Test Kit. |
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shula R. Murphy, MD 2/14/06
General Hospital,
Dental Devices
K053212