(80 days)
The Celerity 20 Steam Biological Indicator is used for routine monitoring, qualification testing, load monitoring and product testing of the following steam sterilization cycles:
- Dynamic Air Removal 270°F (132°C) 4 minutes
- Dynamic Air Removal 275°F (135°C) 3 minutes
- Gravity 250°F (121°C) 30 minutes
- Gravity 270°F (132°C) 15 minutes.
When used in conjunction with the Celerity™ Steam Incubator, the Incubator provides a fluorescent result within 20 minutes.
The product is intended to monitor the critical parameters of steam sterilization cycles described in the indications for use by producing an optical change (signal) that is detected by the STERIS proprietary reader. Celerity 20 Steam Incubator in 20 minutes to confirm the viability of the biological indicator at the end of a steam sterilization process. The product consists of a biological organism known to be resistant to steam (Geobacillus stearothermophilus) and a defined nutrient media. A reporter enzyme, which is produced by the native organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.
The provided text describes the CELERITY 20 Steam Biological Indicator and its performance testing to demonstrate substantial equivalence to a predicate device. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Reduced Incubation Time (RIT) Testing | Meets FDA's requirement of > 97% alignment of the 40-minute results with the conventional incubation time of 7 days | PASS |
| Viable spore population | 1.0 - 4.0 x 10^6 spore/SCBI | 2.3 - 2.5 x 10^6 spore/SCBI |
| Resistance | D121 ≥ 1.5 min | |
| D132 ≥ 10 s | ||
| D135 ≥ 8 s | D121 ≥ 2.53 min | |
| D132 ≥ 46 s | ||
| D135 ≥ 37 s | ||
| Survival Time | Meets the longer of FDA and ISO 11138-3 requirements | 121 C ≥ 11.11 min |
| 132 C ≥ 3.42 min | ||
| 135 C ≥ 2.77 min | ||
| Kill Time | Meets the shorter of FDA and ISO 11138-3 requirements | 121 C ≤ 31.81 min |
| 132 C ≤ 8.62 min | ||
| 135 C ≤ 7.11 min | ||
| Carrier growth inhibition / media growth promotion | Positive growth of less than 100 spores after primary packaging and media are subject to worst case steam exposure | PASS |
| Hold Time | Performance not affected if incubated within 72 hours of exposure to steam sterilization | PASS |
| Simulated Use | Demonstrate growth when exposed to abbreviated cycle and all kill in a full cycle | Abbreviated cycle - growth |
| Full cycle - no growth |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific "sample size" for each test set in numerical terms (e.g., number of biological indicators tested for RIT). It generally refers to "performance testing" and implicitly describes the methodologies rather than raw counts.
- Data Provenance: The studies were conducted by STERIS Corporation, the manufacturer, as part of their premarket notification to the FDA. The nature of the tests (e.g., RIT, Resistance, Survival/Kill Time, Simulated Use) implies controlled laboratory and simulated clinical environments rather than human patient data from a specific country. Therefore, it's not applicable in the same way as a clinical trial. It's a prospective evaluation of the device's technical performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided because the device is a biological indicator for sterilization processes, not a diagnostic device requiring expert interpretation of results. The "ground truth" (e.g., whether sterilization occurred, spore viability) is determined by the inherent biological and chemical properties of the indicator and reference standards (e.g., ISO 11138-3, FDA guidance) rather than subjective expert consensus.
4. Adjudication Method for the Test Set
Not applicable for this type of device. The results are objective (fluorescence detected by an automated reader, growth/no growth, D-value calculation, etc.) and adhere to predetermined technical criteria. There is no subjective interpretation requiring adjudication among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and the goal is to evaluate the impact of AI on their performance. The CELERITY 20 Steam Biological Indicator is an automated indicator with no direct human-in-the-loop performance component in the diagnostic sense.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the studies described are essentially "standalone" performance evaluations of the device. The device itself, in conjunction with its specific incubator, provides a fluorescent result. The tests (RIT, Viable spore population, Resistance, etc.) evaluate the intrinsic performance of the biological indicator and its detection system without human interpretation as a primary outcome. The "algorithm" here refers to the biological and chemical reaction, and the automated detection by the Celerity™ Steam Incubator.
7. The Type of Ground Truth Used
The ground truth is established through:
- Biological and Chemical Standards: The viability of Geobacillus stearothermophilus spores and their resistance to steam are well-established biological principles and standards.
- International Standards: References to ISO 11138-3 are frequently made for resistance, survival, and kill time requirements.
- FDA Guidance: The RIT testing specifically refers to FDA's requirements.
- Reference Methods: The "conventional incubation time of 7 days" serves as a reference for establishing the accuracy of the reduced incubation time.
- Controlled Sterilization Cycles: For tests like "Simulated Use," the ground truth is predefined by subjecting the indicators to known "abbreviated" (fail) and "full" (pass) sterilization cycles.
8. The Sample Size for the Training Set
This information is not provided. Biological indicators, unlike AI algorithms for image analysis, do not typically undergo a "training set" development in the machine learning sense. Their performance is based on established biological and physical principles, manufacturing consistency, and validation against known standards.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the context of an AI algorithm, this question is not applicable. The device's inherent design and manufacturing process are developed to meet the established biological and regulatory standards, which serve as the "ground truth" for its intended function.
§ 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).