(246 days)
The Raven Biological Spore Strips with Modified Tryptic Soy Broth with Bromocresol Purple (single species G. stearothermophilus ATCC #7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of steam sterilization cycles at 121°C - 135°C. A reduced incubation time of 24 hours at 60°C ± 2°C has been validated for steam sterilization when the Spore Strip (either the single species G. stearothermophilus or the dual species spore strip) is used in conjunction with Raven's Modified Tryptic Soy Broth with Bromocresol Purple.
Raven Biological Spore Strips with Modified Tryptic Soy Broth with Bromocresol Purple
This document is a 510(k) clearance letter for the Raven Biological Spore Strips with Modified Tryptic Soy Broth with Bromocresol Purple. It primarily deals with the regulatory approval of a sterilization process indicator and does not contain detailed information about acceptance criteria, study methodologies, or performance metrics typically associated with AI/ML device evaluations. Therefore, I cannot extract the requested information from the provided text.
The document confirms that:
- Device Name: Raven Biological Spore Strips with Modified Tryptic Soy Broth with Bromocresol Purple
- Indications For Use: Intended for use in testing the efficacy of steam sterilization cycles at 121°C - 135°C. A reduced incubation time of 24 hours at 60°C ± 2°C has been validated for steam sterilization.
- Regulation Number: 880.2800 (Sterilization Process Indicator)
- Regulatory Class: II
- Product Code: FRC
§ 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).