(534 days)
The STERRAD® 100NX™ EXPRESS Cycle Test Pack is used for routine monitoring of the STERRAD® 100NX™ EXPRESS Sterilization cycle and is also used for the periodic testing of a STERRAD® 100NXTM System EXPRESS Cycle using hospital-defined loads.
The STERRAD® 100NX™ EXPRESS Cycle Test Pack consists of the CycleSure® Self-Contained Biological Indicator (biological and chemical indicator), and a pouch for holding the vial during the sterilization cycle.
This document is a 510(k) summary for the STERRAD® 100NX™ EXPRESS Cycle Test Pack, a biological indicator used to monitor sterilization cycles. It describes non-clinical tests performed to demonstrate the device's substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| The Test Pack must be at least as resistant to the EXPRESS sterilization process as the biological model. | Survival curves for three lots of CycleSure Biological Indicator in the Test Pack configuration were compared to survival curves for the biological models. The Test Pack configuration was found to be at least as resistant as the biological model. |
| Fraction negative data for the Test Pack must indicate it is at least as resistant as the biological models. | Fraction negative data collected using three lots of CycleSure BI in the Test Pack configuration showed it to be at least as resistant as the biological models when exposed to increasing volumes of peroxide in the EXPRESS Cycle. |
| The chemical indicator in the Test Pack must demonstrate appropriate indicative functionality. | Indicative functionality of the chemical indicator was evaluated using half-cycle parameters of the EXPRESS Cycle, and the response was determined to be appropriate. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The tests involved "three lots of CycleSure Biological Indictor" and "three lots of CycleSure BI." (Specific numerical sample sizes within each lot are not provided in the summary).
- Data Provenance: The data is retrospective, as it was collected as part of a non-clinical test performed by the manufacturer to demonstrate substantial equivalence to existing predicate devices. The country of origin of the data is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This study did not involve human experts establishing ground truth in the typical sense of medical image analysis or diagnostic studies. The evaluation was based on direct measurements of biological indicator survival and chemical indicator functionality under defined sterilization conditions. Therefore, this section is not applicable in the context of expert review.
4. Adjudication Method for the Test Set
- Not applicable, as the evaluation was based on objective, quantitative measurements rather than subjective expert interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance
- Not applicable. This device is a biological indicator for sterilization monitoring, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This study's primary focus was on the standalone performance of the biological indicator (Test Pack) itself. The "device" in question is the test pack, which functions autonomously to indicate sterilization effectiveness.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- The ground truth used was the established "biological models developed for the EXPRESS Cycle." These models represent the expected resistance of biological organisms to the sterilization process. The Test Pack's performance was compared directly against these established biological models as the gold standard for effectiveness.
8. The Sample Size for the Training Set
- Not applicable. This is a non-clinical study for a physical device (biological indicator), not a machine learning model requiring a training set. The "models" referred to are biological models for sterilization efficacy, not AI training models.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there was no "training set" in the context of an AI/machine learning model. The "biological models" serving as ground truth were "developed for the EXPRESS Cycle," implying they were established through prior scientific validation and testing to characterize the resistance of microorganisms to the specific STERRAD sterilization process.
§ 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).