(259 days)
The True Indicating Self-Contained Biological Indicator is intended for monitoring the efficacy of saturated steam sterilization processes. The True Indicating Self-Contained Biological Indicator has a validated reduced incubation time of 10 hours and may be used in the following steam sterilization cycles: 121°C, 30 minutes (Gravity), 132°C, 4 minutes (Pre-Vacuum), and 135°C, 3 minutes (Pre-Vacuum).
The True Indicating Self-Contained Biological Indicator (SCBI) consists of a 6 - mm filter paper disc inoculated with Geobacillus stearothermophilus ATCC® 7953, at a minimum of 105 bacterial spores encased within a polypropylene cap, and a polypropylene vial which includes a glass ampule hermetically sealed containing a nutrient broth culture medium modified with a pH indicator, Bromocresol Purple.
The provided document is a 510(k) premarket notification for a medical device: the True Indicating Self-Contained Biological Indicator. This device is a biological indicator used to monitor the efficacy of steam sterilization processes. The document outlines the device's characteristics, intended use, and the non-clinical testing performed to demonstrate its substantial equivalence to a predicate device.
It's crucial to understand that this document describes the validation of a physical, in-vitro biological indicator, not an AI-powered diagnostic device or software. Therefore, many of the requested fields related to AI/MRMC studies, number of experts for ground truth establishment, data provenance for test/training sets, and adjudication methods are not applicable to this type of device and its validation.
Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text, with explicit notes where information is not applicable:
Acceptance Criteria and Device Performance for True Indicating Self-Contained Biological Indicator
1. Table of Acceptance Criteria and Reported Device Performance
| Name of Test | Purpose | Acceptance Criteria | Subject Device Result |
|---|---|---|---|
| Viable Spore Population | Determine the spore population per the manufacturer's procedure following ISO 11138-1 | ≥10^5 or greater | PASS: 1.0 - 4.8 x 10^5 Spore/SCB |
| D value | Determine the resistance of the BI following ISO 11138-1 and 11138-3 | D121 ≥ 1.5 min | |
| D132 ≥ 10 s | |||
| D135 ≥ 8 s | PASS: D121 ≥ 1.7 min | ||
| D132 ≥ 18 s | |||
| D135 ≥ 12 s | |||
| z value | Determine the z-value of the BI per ISO 11138-1 and 11138-3 | ≥10 | PASS: ≥11.6 |
| Survival Time | Determine the exposure time for all BI's to retain viable spores (Survival Time) per ISO 11138-1, 11138-3 and Guidance for Industry and Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submission | Meets the longer of FDA and ISO 11138-3 requirements | PASS: 121°C ≥ 5.9 min |
| 132°C ≥ 1.1 min | |||
| 135°C ≥ 42 sec | |||
| Kill Time | Determine the exposure time for all BI's to inactivate all spores (Kill Time) per ISO 11138-1, 11138-3 and Guidance for Industry and Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submission | Meets the shorter of FDA and ISO 11138-3 requirements | PASS: 121°C ≤ 28.0 min |
| 132°C ≤ 2.8 min | |||
| 135°C ≤ 1.8 min | |||
| Reduced Incubation Time (RIT) | Determine the Reduced Incubation Time outlined in Guidance for Industry and Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submission | Meets FDA's requirement of > 97% alignment of the 10 hour results with the conventional incubation time of 7 days | PASS: Minimum of 10 Hours |
| Carrier growth inhibition / media growth promotion | Determine the carrier growth inhibition/media growth promotion per ISO 11138-1 and 11138-3 | Positive growth of less than 100 spores after primary packaging and media are subject to worst case steam exposure | PASS |
| Hold Time | Determine the length of time that an exposed BI can be held before incubation (Hold Time) per Guidance for Industry and Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submission | Performance not affected if incubated within 72 hours of exposure to steam sterilization | PASS |
| Simulated Use | Determine the simulated use of the BI in a sterilizer per Guidance for Industry and Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submission | Demonstrate growth when exposed to abbreviated cycle, all kill in a full cycle and a half cycle. All cycles utilized full loads using porous, non-porous, and mixed load material | PASS: Abbreviated cycle - growth |
| Half cycle - no growth | |||
| Full cycle - no growth |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify exact numerical sample sizes (e.g., number of BIs tested) for each test. Instead, it refers to conducting tests "using multiple lots of True Indicating SCBI for Steam over the range of the shelf life." This implies a sufficient number of units were tested to meet the requirements of the referenced ISO standards (ISO 11138-1:2017, ISO 11138-3:2017) and FDA guidance for BI submissions.
- Data Provenance: The data is generated from non-clinical laboratory testing of the physical medical device. The document does not specify country of origin for the testing itself, but the submission is to the U.S. FDA, and tested against international (ISO) and U.S. (FDA) standards. This is not retrospective or prospective in the sense of clinical study data; it's product performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a non-clinical device that relies on a physical, chemical, and biological reaction (spore inactivation and subsequent growth/no-growth). The ground truth is objective and established by the physical and biological properties of the system (e.g., spore count, thermal resistance characteristics, visual color change indicating growth) under controlled experimental conditions according to recognized international and national standards. There are no human "experts" establishing a "ground truth" through interpretation in the way there would be for an AI diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As this involves objective, quantifiable laboratory measurements of a physical device's performance, judicial adjudication methods are not relevant. The results are determined by the specified test protocols and acceptance criteria.
5. 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 an AI-powered device or a diagnostic device that involves human readers interpreting images or data. Therefore, MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical biological indicator, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth is established through objective laboratory measurements and biological principles as defined by recognized standards (ISO 11138 series) and FDA guidance documents for biological indicators. For example:
- Viable Spore Population: Determined quantitatively by plating and counting colony-forming units.
- D-value and Z-value: Calculated from survival curves generated under controlled sterilization conditions.
- Survival/Kill Time: Demonstrated by whether spores survive or are inactivated after specific exposure times, verified by incubation and visible growth/no growth.
- Reduced Incubation Time: Verified by statistical alignment (greater than 97%) of 10-hour results with conventional 7-day incubation results, where growth (yellow media) indicates sterilization failure and no growth (purple media) indicates success.
- Simulated Use: Demonstrated by objective growth/no-growth results after exposure to specific sterilization cycles (abbreviated cycle = growth, half cycle = no growth, full cycle = no growth), ensuring the indicator performs as expected under varied challenge levels.
8. The sample size for the training set
- Not Applicable for this type of device. Training sets are relevant for machine learning algorithms. This device is a physical biological indicator validated through non-clinical performance testing.
9. How the ground truth for the training set was established
- Not Applicable for this type of device. See point 8.
§ 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).