(91 days)
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.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a medical device called the "Raven Pro-PACT Peracetic Acid Culture Test Kit." While it confirms the device's substantial equivalence and outlines its indications for use, it does not contain the detailed acceptance criteria or the study data that would prove the device meets those criteria.
Therefore, I cannot provide the requested information based on the given text.
The document essentially states:
- Device Name: Raven Pro-PACT Peracetic Acid Culture Test Kit
- Intended Use: Testing the efficacy of Steris System1™ liquid chemical sterilization system processing cycles.
- Key Validation Point: "A reduced incubation time of 24 hours has been validated for the Raven Pro-PACT Peracetic Acid Culture Test Kit."
To answer your questions, I would need access to the actual 510(k) submission (which often includes performance data and study summaries) or a more detailed technical document about the device's validation.
§ 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).