(150 days)
The CELERITY 20 HP Biological Indicator is used for routine monitoring, and qualification of the Non Lumen, Flexible, Lumen and Fast Non Lumen Cycles of the V-PRO 1, 1 Plus, maX, 60 and maX 2 Low Temperature Sterilizers in healthcare facilities.
When used in conjunction with the VERIFY CELERITY 20 HP Incubator, the CELERITY 20 HP Biological Indicator provides a fluorescent result within 20 minutes.
The product is intended to monitor the vapor phased hydrogen peroxide sterilization cycles described in the indications for use. It produces an optical change (signal) that is detected by the STERIS proprietary reader, CELERITY 20 HP Incubator, within 20 minutes to confirm the viability of the biological indicator at the end of a sterilization process. The product consists of Geobacillus stearothermophilus spores and a defined nutrient media in a plastic vial. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.
Based on the provided text, here's a detailed description of the acceptance criteria and the study proving the device meets them:
Device: CELERITY 20 HP Biological Indicator (K172752)
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| New Testing for K172752: | ||
| BI Simulated Use in the V-PRO maX 2 Sterilizer Fast Non Lumen Cycle | All BIs processed in full cycles will be negative for growth | PASS |
| Previously Submitted Testing (K171504) for the Identical BI: | ||
| Reduced Incubation Time (RIT) Testing | Meets FDA's requirement of > 97% alignment of the 20-minute results with the conventional incubation time of 7 days | PASS |
| Viable spore population | 1.0 – 4.0 x 10^6 spore/SCBI | PASS |
| Resistance (D-value) at 9.1 mg/L H2O2 | D-value > 3 sec | PASS |
| Survival Time at 9.1 mg/L H2O2 | Survival Time ≥ 4 sec | PASS |
| Kill Time at 9.1 mg/L H2O2 | Kill Time ≤ 6 min | PASS |
| Carrier growth inhibition / media growth promotion | Positive growth of less than 100 spores inoculated after primary packaging and media were subjected to worst case VHP exposure | PASS |
| Hold Time | Performance not affected if incubated within 72 hours of exposure to VHP sterilization | PASS |
| Simulated Use (for previously cleared features) | Demonstrate no growth when exposed to worst-case cycles | PASS |
2. Sample Size and Data Provenance
- Test Set Sample Size: The document does not explicitly state the numerical sample size for each test. However, it indicates that for the "BI Simulated Use in the V-PRO maX 2 Sterilizer Fast Non Lumen Cycle" test, "All BIs processed in full cycles" were evaluated. This implies quantitative measurements were taken on a set of BIs.
- Data Provenance: The studies are described as "Performance testing" and "Nonclinical Tests" submitted by Steris Corporation. There is no information regarding the country of origin of the data or whether the studies were retrospective or prospective; however, given they are non-clinical hardware tests, they would inherently be prospective laboratory experiments.
3. Number and Qualifications of Experts for Ground Truth
Not applicable. This device is a biological indicator (hardware) for sterilization processes and its performance is measured against objective criteria (e.g., spore viability, D-value, growth/no growth), not subjective expert interpretation of output data like medical images.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for medical image interpretation where multiple human readers assess cases and their interpretations need to be reconciled to establish a ground truth. For a biological indicator, the "ground truth" is determined by objective biological and chemical measurements (e.g., spore growth, fluorescent signal detection).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. An MRMC study assesses the impact of an AI device on human reader performance, usually in diagnostics like radiology. The CELERITY 20 HP Biological Indicator is a standalone device that provides an objective result for sterilization efficacy, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone study was performed. All tests mentioned in the table (Resistance, Survival Time, Kill Time, Reduced Incubation Time, Viable Spore Population, Carrier Growth Inhibition/Media Growth Promotion, Hold Time, and Simulated Use) represent standalone performance evaluations of the Biological Indicator itself, with its specified incubator/reader providing the result. The device's performance is determined by its inherent biological and chemical properties.
7. Type of Ground Truth Used
The ground truth used is based on:
- Biological Activity: The presence or absence of Geobacillus stearothermophilus spore growth, which indicates sterilization failure.
- Physical/Chemical Measurements: D-values, survival times, kill times, and spore population counts determined through standard microbiological and sterilization efficacy testing methods.
- Objective Readouts: The fluorescent signal detected by the CELERITY 20 HP Incubator within 20 minutes, indicating viability or non-viability.
8. Sample Size for the Training Set
Not applicable. This device is a biological indicator, not an AI device developed using machine learning that requires a training set. Its functionality is based on direct biological and chemical reactions.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used for this type of 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).