(136 days)
The Celerity 20 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles:
• Lumen, Non Lumen, and Flexible Cycles of the V-PRO® Low Temperature Sterilization Systems.
• STERRAD® 100S Sterilizer (Default Cycle)
• Standard and Advanced Cycles of the STERRAD® NX Sterilizer
• Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX Sterilizer
When used in conjunction with the Celerity HP Incubator for the Celerity 20 HP BI provides a fluorescent result within 20 minutes.
The subject device 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 Incubator (originally named "VERIFY Incubator for Assert | VH2O2 | Self Contained Biological Indicator" in K171587), 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. The BI is identical to that submitted in K171504. The current premarket notification is for the addition of claims in STERRAD sterilization cycles.
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the CELERITY 20 HP Biological Indicator:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance (Conclusion) |
|---|---|---|
| BI Half Cycle Performance Evaluation in the STERRAD Sterilizer Cycles | All BIs processed in half cycle will be negative for growth. | PASS |
| BI Growth Inhibition Following Exposure to STERRAD Sterilizer Cycles | All BIs inoculated with low numbers of Geobacillus stearothermophilus spores will demonstrate growth. | PASS |
| BI Simulated Use in the STERRAD Sterilizer Cycles | All BIs processed in full cycles will be negative for growth. | PASS |
| 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) | D-value > 3 sec (at 9.1 mg/L H₂O₂) | PASS |
| Survival Time | Survival Time ≥ 4 sec (at 9.1 mg/L H₂O₂) | PASS |
| Kill Time | Kill Time ≤ 6 min (at 9.1 mg/L H₂O₂) | PASS |
| Carrier growth inhibition / media growth promotion | Positive growth of less than 100 spores after primary packaging and media are subject to worst-case VHP exposure | PASS |
| Hold Time | Performance not affected if incubated within 72 hours of exposure to VHP sterilization | PASS |
| Simulated Use (V-PRO Sterilizers) | Demonstrate no growth when exposed to worst-case cycles | PASS |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each test (e.g., number of BIs per sterilization cycle for half-cycle, growth inhibition, or simulated use tests). It mentions "All BIs" in the acceptance criteria, suggesting a comprehensive evaluation.
The data provenance is from non-clinical testing performed by STERIS Corporation, a manufacturer in the United States (Mentor, Ohio). The studies are prospective as they are conducted to demonstrate the performance of the device for regulatory clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this device. Biological Indicators (BIs) rely on the growth or non-growth of a reference microorganism (Geobacillus stearothermophilus) under controlled conditions to determine sterilization effectiveness. The "ground truth" is established through microbiological principles (presence/absence of live spores and enzyme activity) rather than expert interpretation of complex data (like medical images).
4. Adjudication Method for the Test Set
This is not applicable as the results are based on objective biological and chemical reactions (fluorescence, growth/no growth), not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not performed. This type of study is typically used for diagnostic devices where human readers interpret outputs, often with and without AI assistance. This device is a biological indicator for sterilization monitoring, and its performance is evaluated directly through biological and chemical tests.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the performance evaluation is standalone (algorithm only) in the sense that the device's mechanism (fluorescence detection by the Celerity HP Incubator) operates automatically without human intervention once the BI is placed in the incubator. The results (fluorescent within 20 minutes for growth, or lack thereof) are objective outputs of the system. Human involvement is limited to placing the BI in the incubator and observing the incubator's output indicator.
7. The Type of Ground Truth Used
The ground truth is based on microbiological principles and direct observation of microbial growth or enzyme activity. Specifically:
- For sterilization efficacy, the ground truth is the absence of viable Geobacillus stearothermophilus spores after processing.
- For growth promotion/inhibition, the ground truth is the presence of viable Geobacillus stearothermophilus spores and their ability to grow, or the enzyme reaction leading to fluorescence.
- Reduced Incubation Time (RIT) Testing compared the 20-minute fluorescent results to the conventional 7-day incubation time results (which would involve visual inspection for growth over a longer period).
8. The Sample Size for the Training Set
This information is not provided and is not applicable in the context of this biological indicator. This device does not use machine learning or AI that would require a "training set" in the traditional sense. Its performance is based on established biological and chemical reactions and engineering controls.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for this device, this question is not applicable.
§ 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).