(487 days)
The STERRAD® CYCLESURE® 24 Biological Indicator is intended to be used as a standard method for frequent monitoring of the following STERRAD® Sterilization Systems and Cycles:
- STERRAD® 100S
- STERRAD® 50
- STERRAD® 200
- STERRAD® NX®
- STERRAD® 100NX® (Standard, Flex and Express Cycles)
- For STERRAD® 100NX® DUO Cycle, the STERRAD® CYCLESURE® 24 Biological Indicator should only be used in a test pack configuration (REF 20243).
The STERRAD® CYCLESURE® 24 Biological Indicator is a self-contained standalone biological monitor intended for the routine monitoring of the STERRAD® Sterilization Process. It consists of a glass fiber disc containing a minimum of 1x10^6 Geobacillus stearothermophilus spores, a glass ampoule containing nutrient growth medium, a cap and liner closing the vial and a chemical indicator on top of the cap. The cap contains two small circular openings that allow for diffusion of hydrogen peroxide vapor into the vial. The relatively small size of the circular openings serves as a restriction to this diffusion. There are no changes to the STERRAD® CYCLESURE® 24 Biological Indicator from the device cleared in K102884. The change is to the labeling to add the STERRRAD® 100NX® DUO Cycle to the CYCLESURE® 24 Biological Indicator Indications for Use Statement.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study for the STERRAD® CYCLESURE® 24 Biological Indicator:
1. Table of Acceptance Criteria and Reported Device Performance
The summary states that the device "meets the same performance criteria as the predicate devices." While specific numerical acceptance criteria for each test (e.g., specific thresholds for reduction, growth rates, etc.) are not explicitly detailed in the provided text, the categories of performance criteria tested are:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Evaporation | Passed |
| Verification of Positive BI Color | Passed |
| Bacteriostasis | Passed |
| BI Validation in the STERRAD® Sterilization Systems (Dose Response) | Passed |
2. Sample Size Used for the Test Set and Data Provenance
The summary does not provide specific sample sizes for the test set for each of the studies listed. It states: "Therefore, only following performance data related to the DUO Cycle are included in this submission." This implies that the tests were conducted specifically for the DUO Cycle.
- Sample Size: Not specified.
- Data Provenance: The document implies the data was generated specifically for this submission to support the new DUO Cycle, so it would be prospective data, likely collected in a laboratory setting at Advanced Sterilization Products. The country of origin of the data is not explicitly stated, but given the applicant's address, it's highly probable to be United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (a biological indicator for sterilization) does not typically involve human expert interpretation in the same way as medical imaging devices. The "ground truth" for a biological indicator is based on microbiological culturing results (i.e., presence or absence of Geobacillus stearothermophilus growth), which is an objective outcome rather than a subjective interpretation. Therefore, the concept of "experts establishing ground truth" as it applies to subjective assessments is not relevant here.
4. Adjudication Method for the Test Set
As the "ground truth" for a biological indicator is objective microbiological growth, there is no adjudication method (like 2+1 or 3+1 consensus) required for the test set. The outcome is determined by scientific observation of bacterial growth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is a biological indicator for monitoring sterilization processes, not a diagnostic imaging device that involves human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable or performed for this device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, in a sense. The "device" itself (the biological indicator) is a standalone entity that provides an objective output (color change in the chemical indicator and potential microbiological growth). The performance studies evaluate the indicator's ability to accurately reflect sterilization efficacy without human intervention during the "reading" of the growth. The "algorithm" here is the biological process itself, not a computer algorithm.
7. Type of Ground Truth Used
The ground truth used for evaluating the performance of a biological indicator is microbiological growth/non-growth.
- For the "BI Validation in the STERRAD® Sterilization Systems (Dose Response)" test, the ground truth would be the known efficacy of the sterilization parameters (e.g., specific hydrogen peroxide exposure levels, time, temperature) to kill bacterial spores, and the subsequent observation of whether the Geobacillus stearothermophilus spores in the BI were killed or survived. This is essentially outcomes data in a controlled experimental setting.
- For "Verification of Positive BI Color" and "Bacteriostasis," the ground truth would be the expected visual change or lack of inhibitory effect on growth based on standard microbiological techniques.
8. Sample Size for the Training Set
The concept of a "training set" is not relevant for this device. Biological indicators do not use machine learning or AI algorithms that require training data. Their function is based on established biological principles of spore resistance and growth in response to sterilization, which are inherently fixed properties, not learned ones.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" for this biological indicator, this question is not applicable. The device's performance relies on its inherent biological properties and manufacturing consistency, not on an algorithm trained on data.
§ 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).