(185 days)
Celerity 5 HP Biological Indicator: The Celerity 5 HP Biological Indicator (BI) is used for routine monitoring of the following sterilizer cycles: • Lumen, Non Lumen, Fast Non Lumen, Fast and Flexible Cycles of the V-PRO 1, 1 Plus, maX 2, 60 and s2 Low Temperature Sterilization Systems - · STERRAD® 100S Sterilizer (Default Cycle) • Standard and Advanced Cycles of the STERRAD® NX® Sterilizer with or without ALLClear® · Standard. FLEX. Express and DUO Cycles of the STERRAD® 100NX® Sterilizer with or without ALLClear®. When used in conjunction with the Celerity® Incubator, the Incubator provides a fluorescent result within 5 minutes.
Celerity 5 HP Challenge Pack: The Celerity 5 HP Challenge Pack is intended for qualification testing of the V-PRO Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs and for routine requalification testing. The Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included. The Challenge Pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the Sterilizers.
Celerity 5 HP Biological Indicator: 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, STERIS Celerity Incubator, within 5 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.
Celerity 5 HP Challenge Pack: The CELERITY 5 HP Challenge Pack (pack), is used by healthcare providers for qualification testing of the V-PRO Low Temperature Sterilization Systems. The pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included. The user places the pack into the V-PRO Sterilizer and performs a sterilization cycle. After cycle completion, the VERIFY HPU Chemical Indicator (CI) and the CELERITY 5 HP Biological Indicator (BI) contained in the pack are retrieved. The CI is assessed for a passing color change immediately and the BI can either be immediately activated or it can be held at room temperature for a maximum of 2 hours prior to activation. The BI is activated by sealing the vial and thus puncturing the cap to release the contained media. The activated BI is incubated at 55-60 ℃ in the CELERITY Incubator for a final determination of viability within 5 minutes of incubation.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Celerity 5 HP Biological Indicator and Celerity 5 HP Challenge Pack
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Acceptance Criteria | Reported Performance |
|---|---|---|
| Viable Spore Population | Average population for each lot of 1.0 x 10^6 - 4.0 x 10^6 CFU/BI | Pass |
| Resistance Characteristics Study (D-Value) | 2-20 seconds | Pass |
| Resistance Characteristics Study (All Survive) | ≤ 4 seconds | Pass |
| Resistance Characteristics Study (All Kill) | ≥ 6 minutes | Pass |
| Carrier and Pack Material Growth Inhibition | All BIs inoculated with Geobacillus stearothermophilus spores demonstrate growth | Pass |
| Holding Time Assessment | 120 minutes | Pass |
| Signal Generation | All BIs will demonstrate a positive fluorescent signal | Pass |
| Simulated Use Testing – V-PRO | All BIs processed in a full cycle will demonstrate a negative signal corresponding to a no-growth result upon seven day incubation. | Pass |
| Simulated Use Testing – STERRAD | All BIs processed in a full cycle will demonstrate a negative signal corresponding to a no-growth result upon seven day incubation. | Pass |
| Population after ALLClear Exposure | Each BI signal evaluation was positive following exposure to the All-Clear precondition treatment. The mean population of each BI exposed to the All-Clear precondition treatment was within 50-300% of the unexposed control mean population. | Pass |
| Reduced Incubation Time | Study will demonstrate that 97% or greater of the positive samples at seven days also gave a positive signal at the claimed RIT time. | Pass |
| Reduced Incubation Time – Engineering Mode | Study will demonstrate that 97% or greater of the positive samples at seven days also gave a positive signal. (Note: The table entry for "Engineering Mode" in the "Reported Performance" column only states "Pass", and the detailed criteria are repeated from the "Reduced Incubation Time", implying it aims to meet similar performance for the 5-minute read time correlation to the 20-minute result and 7-day growth.) | Pass |
| Simulated Use Testing (Challenge Pack) | Demonstrate the pack shows passing results in worst-case load under worst-case sterilization conditions. | Pass |
| Dose Response Testing (Challenge Pack) | The pack provides an equivalent or greater challenge to the claimed cycle than the biological model under worst-case conditions. | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document primarily describes non-clinical tests performed to demonstrate substantial equivalence. It does not provide specific sample sizes for "test sets" in the context of human-involved studies (e.g., retrospective or prospective patient data). The evaluation appears to be based on laboratory testing of the biological indicators themselves.
- Sample Size: Not specified in terms of number of "cases" or patient data points. The tests likely involved multiple units of the biological indicator and challenge pack.
- Data Provenance: The studies are non-clinical, likely conducted in a laboratory setting by the manufacturer (STERIS Corporation). Therefore, there is no country of origin of patient data, nor is it retrospective or prospective in the medical imaging sense.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. The "ground truth" for a biological indicator is based on microbiological assays (e.g., spore viability, D-value, kill time) and engineered test conditions, rather than expert interpretation of medical images or pathologies.
4. Adjudication Method for the Test Set:
Not applicable. As the tests are non-clinical and objective (e.g., measuring spore population, observing growth/no growth), there is no need for expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This device is a biological indicator for monitoring sterilization processes, not a medical imaging or diagnostic device that involves human readers.
- Effect Size: Not applicable.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop):
The device is a standalone biological indicator that produces a result (fluorescent signal) which is then read by the Celerity® Incubator. While humans initiate the process and interpret the incubator's output, the "performance" described in the tests (e.g., D-value, kill time, signal generation) refers to the intrinsic behavior of the biological indicator. In this sense, the tests demonstrate the standalone performance of the BI.
7. Type of Ground Truth Used:
The ground truth used is primarily microbiological and physical measurements based on established standards for biological indicators. This includes:
- Spore population counts: Direct enumeration of viable spores.
- D-value determination: A measure of the resistance of microorganisms to a sterilizing agent.
- Survival and kill times: Time points at which a specified percentage of organisms survive or are killed.
- Growth/no growth observations: The fundamental output of a biological indicator.
- Fluorescent signal detection: Objective detection by the incubator.
- Worst-case sterilization conditions: Established laboratory parameters to rigorously challenge the device's performance.
8. Sample Size for the Training Set:
Not applicable. This device is a physical biological indicator, not an AI/machine learning algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable (as it's not an AI/ML 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).