(89 days)
The Celerity™ 20 Steam Challenge Pack is used for qualification, routine microbial monitoring, and load monitoring of steam sterilizers.
The validated steam sterilization cycles include:
- 270°F (132°C) 4-minute dynamic air removal (Prevac, SFPP) .
- 275°F (135°C) 3-minute dynamic air removal (Prevac, SFPP) .
The Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles (PCD), contains a Celerity 20 Steam Biological Indicator (BI) and a VERIFY Steam Integrating Indicator - Short, sealed within a plastic tray with foil cover. The tray has a molded channel which serves as the tortuous pathway for air removal/steam penetration during steam sterilization. The PCD is designed and validated to be equivalent to the standard 16-towel test pack described in ANSI/AAMI ST79.
The STERIS Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles underwent nonclinical testing to demonstrate its performance and substantial equivalence to a predicate device.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Simulated Use | ||
| Performance of BI in PCD vs. AAMI pack | Performance of the BI in the PCD is equivalent to the performance of the BI in the AAMI reference pack in their respective sterilization processes. | PASS |
| Performance of chemical integrator in PCD vs. AAMI pack | Performance of the chemical integrator in the PCD is equivalent to the performance of the chemical integrator in AAMI reference pack in their respective processes. | PASS |
| Challenge level of PCD vs. AAMI pack | PCD provides an equivalent or greater challenge than the AAMI standardized test pack. | PASS |
| BI in pack vs. BI outside of pack | PCD provides a greater challenge to the process than the BI itself. | PASS |
| CI in pack vs. CI outside of pack | PCD provides a greater challenge to the process than the integrator by itself. | 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. However, it indicates "Performance testing" was completed, implying a sufficient number of samples were tested to draw conclusions.
The data provenance is from nonclinical testing conducted by STERIS Corporation. The document does not specify country of origin for the data, but STERIS Corporation is based in Mentor, OH, USA. The study is prospective in nature, as it is testing a new device's performance against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to the performance testing of a Process Challenge Device (PCD). The "ground truth" in this context is established by adherence to recognized standards like ANSI/AAMI ST79, which defines the challenging conditions that a sterilization process indicator should withstand. The performance is measured objectively through indicators (Biological Indicators and Chemical Integrators) directly, rather than relying on expert subjective evaluation of a test set.
4. Adjudication Method for the Test Set
Not applicable. The performance is objectively measured based on the response of the biological and chemical indicators. There is no human adjudication of "results" in the typical sense. The indicators either show inactivation/pass (for biological indicators) or appropriate color change/pass (for chemical integrators), or they do not.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or similar devices where multiple human readers interpret results, and the AI's impact on their performance is assessed. This is not relevant for a sterilization process indicator.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies performed are standalone studies. The performance of the device (PCD containing a Biological Indicator and a Chemical Integrator) is evaluated directly against established standards and predicate devices without human interpretation as part of its core function. The "algorithm" here is the physical design of the PCD and the response of the indicators within it.
7. The Type of Ground Truth Used
The ground truth used is based on established industry standards and regulatory requirements, specifically:
- ANSI/AAMI ST79: "Comprehensive guide to steam sterilization and sterility assurance in health care facilities." This standard defines the 'AAMI standardized test pack' which serves as a reference for challenge levels.
- The inherent performance characteristics of Biological Indicators (BI) (e.g., spore inactivation) and Chemical Integrators (CI) (e.g., color change at specific sterilization parameters).
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this device. This is a physical device that relies on chemical and biological reactions, not a machine learning algorithm that requires a training dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this 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).