(29 days)
The STERRAD® BI Test Pack is intended to be used as a standard method for frequent monitoring of the STERRAD® 100 Sterilizer cycle*, It functions as a routine test pack with both a biological sterilization process indicator and a chemical process indicator.
Catalase Reagent is added to the Tryptic Soy Broth (TSB) medium, to neutralize the residual hydrogen peroxide on the biological indictor strip after sterilization.
- See precautionary statement in Instructions For Use concerning the use of this product with the STERRAD 50 Sterilizer which reads in part as follows:
NOTE: The Certificate of Performance that accompanies these BI Test Packs contains data from the STERRAD® 100 Sterilizer. This information is unique to the STERRAD® 100 Sterilizer. The initial validation data submitted, based upon varying hydrogen peroxide concentration in the STERRAD® 50 Sterilizer, indicate that the BI Test Pack is acceptable for use with the STERRAD® 50 Sterilizer. The final performance data (D-value and Survival/Kill times) are not yet complete. Updated performance data for the BI Test Pack in the STERRAD® 50 Sterilizer will be provided by ASP as soon as it is available.
The STERRAD® BI Test Pack (BI Test Pack) consists of a plastic tray with a clear top which contains a STERRAD® Biological Indicator paper strip containing 106 Bacillus subtilis var. niger spores, a STERRAD® BI Test Pack Indicator Strip and a length of latex tubing. The BI spore strip is packaged in a Tyvek/Mylar peel pouch to protect the spore strip during handling.
The narrow opening and channels leading to the interior of the BI Test Pack and the absorptive properties of the latex tubing provide a diffusion restrictive environment which contributes to the effective resistance of the indicator organism. Included with the BI Test Pack are individual BI spore strips in Tyvek/Mylar peel pouches to serve as positive controls in the microbiological testing.
The STERRAD® BI Test Pack Chemical Indicator Strip included in the Test Pack serves as a chemical process indicator (Class A per EN867-1) for the STERRAD® Sterilizer cycle, Exposure of the chemical indicator strip to the STERRAD® Sterilizer cycle results in a recognizable color change from red to yellow.
The provided text describes a 510(k) submission for a modification to the STERRAD® BI Test Pack, primarily concerning a reduced incubation time for the biological indicator and the provision of a catalase reagent. The submission references a study to validate the reduced incubation time.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance
The core of the modification is the reduced incubation time for the STERRAD® BI Test Pack.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Success Metric) | Reported Device Performance |
|---|---|
| At least 97% growth of Bacillus subtilis var. niger spores (biological indicator) within 48 hours for valid tests after partial sterilization cycles. | All valid tests showed at least 97% growth in 48 hours. |
| Catalase concentration confirmed at the end of shelf-life. | Confirmed by stability study (4°C, 25°C, and 40°C). |
| Aseptic fill of catalase vials confirmed. | Confirmed by process validation. |
| Excess catalase does not affect spore growth. | Shown by a Bacteriostasis test. |
Study Details
The study primarily focuses on validating the reduced incubation time of the biological indicator.
-
Sample Size used for the Test Set and Data Provenance:
- Test Set Sample Size: The document mentions that "partial sterilization cycles were based on decrease in diffusion and plasma time." It also states, "Three different spore lots, from three different spore crops, were used for this validation. Each test was performed using a different lot of media."
- Data Provenance: Not explicitly stated, but given it's a submission to the FDA, it's implied that the testing was conducted by Advanced Sterilization Products (ASP), likely in the US, as part of their regulatory compliance. The study design followed the "CDRH Guidance Document Guide For Validation Of Biological Indicator Incubation Time (1986)," indicating adherence to US regulatory guidelines. The data is retrospective in the sense that the testing was completed prior to the submission.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Not applicable to this type of device. The "ground truth" for a biological indicator is determined by the growth or non-growth of spores, which is a microbiological outcome, not an expert visual interpretation.
-
Adjudication Method for the Test Set:
- Not applicable. The outcome (growth or no growth) is an objective, measurable biological phenomenon, not subject to human adjudication in the typical sense.
-
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 a biological indicator device, not an AI-assisted diagnostic tool involving human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not involve an algorithm. The performance is the inherent biological response of the indicator.
-
The type of ground truth used:
- Microbiological Outcome/Pathology: The ground truth is the actual viability (growth or no growth) of the Bacillus subtilis var. niger spores, determined through standard microbiological culture techniques after exposure to partial sterilization cycles. The 97% growth is the performance metric against this ground truth.
-
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires "training data." The validation study uses a test set to confirm the performance of the biological indicator.
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.
§ 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).