(26 days)
The Raven Bacterial Spore Strip (single species B. stearothermophilus ATCC#7953 or dual species B. stearothermophilus ATCC #7953 and B. subtilis ATCC #9372) is intended for use in testing the efficacy of Steam sterilization cycles at 121°C . A reduced incubation time of 48 hours at 55-60℃ has been validated for Steam sterilization when the Raven Bacterial Spore Strip (either the single species B. stearothermophilus spore strip or the dual species spore strip) is used in conjunction with Raven's Modified Tryptic Soy Broth with Bromocresol Purple.
Raven Bacterial Spore Strip is a 1.5" x 0.25" Schleicher and Schuell #470 cotton paper filter spore strip inoculated with either single species (B. stearothermophilus ATCC #7953) or dual species (B. stearothermophilus ATCC #7953 and B. subtilis ATCC #19372) bacterial spores. The strip is packaged in a #30 blue glassine peel open pouch.
Here's an analysis of the provided text to extract the acceptance criteria and details about the study.
Acceptance Criteria and Device Performance
| Acceptance Criteria (Stated Goal) | Reported Device Performance |
|---|---|
| Reduced incubation time for Steam sterilization cycles. | "48 hour reduced incubation period for monitoring Steam Sterilization of Systems Modified Tryptic Soy Broth with Bromocresol Purple." (from conclusion) and "a reduced incubation time for Steam has been validated at 48 hours." (from operational principles). |
| Efficacy of Steam sterilization cycles at 121°C. | The device is intended for "determining the efficacy of the sterilization process" at 121°C. While the document implies efficacy, it doesn't state a numerical performance metric for this, rather that the reduced incubation time was validated for this purpose. The successful color change or turbidity after 48 hours would indicate a failed sterilization cycle, thereby confirming the indicator's ability to monitor efficacy. No specific numerical success rate for detecting failed cycles is given, but the overall conclusion implies it met the expectations for monitoring efficacy with the reduced incubation time. |
| Substantial equivalence in composition and function to predicate device. | "The Raven Bacterial Spore Strip is substantially equivalent in composition and function to the Legally Marketed Raven Bacterial Spore Strip, a Pre-amendment device..." |
| When used with Raven's Modified Tryptic Soy Broth with Bromocresol Purple (MTSB w/ BCP). | The reduced incubation time of 48 hours was validated specifically "when used in conjunction with Raven's Modified Tryptic Soy Broth with Bromocresol Purple." |
Study Information
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: "three lots each of newly manufactured spore strips, spore strips nearing expiry, newly manufactured Modified Tryptic Soy Broth with Bromocresol Purple (MTSB w/ BCP) and MTSB w/ BCP nearing expiry."
- This means 3 lots of new spore strips, 3 lots of expiring spore strips, 3 lots of new media, and 3 lots of expiring media.
- The exact number of individual spore strips or media vials tested within these lots is not specified.
- Data Provenance: Not explicitly stated, but given the submitter is Raven Biological Laboratories, Inc. in Omaha, NE, and the document is for FDA submission, it's highly probable the testing was conducted in the USA by the manufacturer or a contracted lab. The study is retrospective in the sense that the testing has already been completed to support the 510(k) submission.
- Test Set Sample Size: "three lots each of newly manufactured spore strips, spore strips nearing expiry, newly manufactured Modified Tryptic Soy Broth with Bromocresol Purple (MTSB w/ BCP) and MTSB w/ BCP nearing expiry."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This study does not involve human expert interpretation of results, but rather a direct biological outcome (bacterial growth/no growth, indicated by color change/turbidity). The determination of growth is objective.
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Adjudication method for the test set: Not applicable. The "ground truth" (presence or absence of bacterial growth) is determined directly by objective observation (color change, turbidity) of incubated media. There's no subjective interpretation requiring adjudication among human readers.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not a study involving human readers or AI. It's a performance validation of a biological indicator.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a biological indicator, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth is the biological outcome of bacterial growth or inhibition, as evidenced by a color change (purple to yellow) and/or turbidity in the growth media after incubation. This result directly indicates whether sterilization was successful or not.
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The sample size for the training set: Not applicable. This is a biological indicator validation, not a machine learning model, so there is no training set in the conventional sense.
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How the ground truth for the training set was established: Not applicable, as there is no training set. The "ground truth" for the validation study (test set) was established by observing bacterial growth/no growth.
§ 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).