(112 days)
The SteriTec Disposable Biological Test Pack is a steam sterilization monitor designed specifically for biological testing of 121 "C (250" F) gravity or 132" ( (270°F) pre-vacuum steam sterilizers.
The pack consists of a self-contained biological indicator containing B. stearothermophilus spores inside a small package of porous and nonporous materials.
The provided document describes the SteriTec Disposable Biological Test Pack and its 510(k) submission. It focuses on demonstrating equivalence to a predicate device, the AAMI standard biological test pack, rather than establishing specific acceptance criteria for a new performance claim. Therefore, the device performance is reported in terms of equivalence to the predicate, not against specific numerical thresholds.
Here's an analysis based on the provided text, addressing the requested points:
K961721: SteriTec Disposable Biological Test Pack
1. Acceptance Criteria and Reported Device Performance
The submission does not explicitly state numerical "acceptance criteria" in the typical sense (e.g., sensitivity, specificity, accuracy thresholds). Instead, the performance objective was to demonstrate equivalence to the AAMI standard biological test pack. The acceptance was based on the SteriTec pack "paralleling the results" of the AAMI pack.
| Category | Acceptance Criteria | Reported Device Performance (SteriTec Disposable Biological Test Pack) |
|---|---|---|
| Gravity Sterilizer (121°C) | "Paralleled the results of the AAMI standard cloth biological test pack" for survival/kill at various exposure times. | - After 10 minutes exposure: All biologicals survived in both AAMI and SteriTec packs. |
- After 12 minutes exposure: Both packs experienced partial survivors.
- After 15 minutes and 20 minutes exposures: All biologicals were killed in both AAMI and SteriTec packs.
Conclusion: SteriTec pack paralleled AAMI pack results. |
| Prevacuum Sterilizer (132°C) | "Paralleled the results of the AAMI standard cloth biological test pack" for survival/kill at various exposure times. | - After 1 minute and 2 minute exposures: Both packs experienced partial survivors. - After 3 minute exposure: All biologicals were killed in both AAMI and SteriTec packs.
Conclusion: SteriTec pack paralleled AAMI pack results. |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated as a number of devices or runs. The study involved multiple "sterilization runs" and "tests" at different exposure times in two types of sterilizers. For each condition (e.g., 10 min gravity, 1 min prevacuum), it implies at least one AAMI pack and one SteriTec pack were used, with the "biologicals" (presumably multiple biological indicators per pack) being assessed. The phrase "all the biologicals survived" or "all biologicals were killed" suggests individual biological indicators within the packs were sampled. However, the exact number of packs or biological indicators tested for each condition is not quantified.
- Data Provenance: The tests were conducted in a laboratory setting:
- Gravity Sterilizer: "typical hospital gravity sterilizer" (AMSCO, Model 57CR, Type QDS-1624).
- Prevacuum Sterilizer: "specially constructed laboratory prevacuum steam sterilizer built around an Amsco 20" x 20" x 40" chamber."
- This indicates prospective, controlled laboratory testing. The country of origin is implicitly the US, given the FDA 510(k) submission context.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. The ground truth in this study is objective biological growth or no growth of B. stearothermophilus spores, not an expert interpretation of data like imaging.
4. Adjudication Method for the Test Set
Not applicable. The ground truth (biological survival/kill) is determined by objective laboratory culturing methods, not by human adjudication of ambiguous results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, this type of study was not performed. MRMC studies are typically for diagnostic imaging or similar scenarios where human readers interpret cases, often with and without AI assistance. This submission describes a performance equivalence study for a sterilization indicator.
6. Standalone Performance Study
Yes, a standalone study was performed in the sense that the SteriTec Biological Test Pack's performance was evaluated independently in various sterilization conditions. Its performance was then compared to the AAMI standard pack. There is no human-in-the-loop interaction with the device's function itself; the device either indicates effective sterilization or it doesn't.
7. Type of Ground Truth Used
The ground truth used was biological outcome: survival (growth) or kill (no growth) of B. stearothermophilus spores. This is determined by standard microbiological culture techniques where the biological indicator is incubated after sterilization exposure to check for microbial viability.
8. Sample Size for the Training Set
Not applicable. This device is a passive indicator, not an AI/ML algorithm that requires a training set. The study describes physical performance testing.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
§ 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).