(114 days)
The STERRAD VELOCITY™ Biological Indicator, in conjunction with the STERRAD VELOCITY Reader, is intended to be used as a standard method for frequent monitoring and periodic testing of the following STERRAD Sterilization Systems:
- · STERRAD® 100NX (STANDARD, FLEX, EXPRESS, and DUO Cycles) with and without ALLClear™ Technology
- STERRAD NX® (STANDARD and ADVANCED Cycles) with and without ALLClear™ Technology
· STERRAD® 100S
The STERRAD VELOCITY Biological Indicator is a self-contained biological indicator, used in conjunction with the STERRAD VELOCITY Reader, that is intended for frequent monitoring and periodic testing of the STERRD Sterilization Cycles, using rapid readout technology that provides a final fluorescence result in 30 minutes at the incubation temperature of 57 ± 2ºC.
The STERRAD VELOCITY BI can also be determined as growth-positive or growth-negative via an optional visual pH-based color change result (using bromocresol purple) if used for frequent monitoring purposes. When using this method, the biological indicator must be cultured in an incubator at 55-60℃ for 5 to 7 days to get a final visual result.
The STERRAD VELOCITY BI consists of a glass fiber disc containing a minimum of 1 x 100 Geobacillus stearothermophilus (ATCC 7953) spores and a glass ampoule containing nutrient growth medium and non-fluorescent substrate, as well as a vial, cap, cap label, insert, and chemical indicator. The spore disc, growth media ampoule, and insert are contained in a clear plastic vial with a vented cap. The cap is designed with sterilant ingress openings which allow for penetration of hydrogen peroxide vapor into the vial during the sterilization process. The chemical indicator (CI), placed on the top of the cap, is a Type 1 process indicator that changes color from red/pink to yellow or yellow with some red/orange/brown dots when exposed to hydrogen peroxide.
The STERRAD VELOCITY BI has the same α-glucosidase enzyme system for the fundamental scientific technology as the predicate device cleared under K170039. The a-glucosidase enzyme, which is generated naturally during growth of G. stearothermophilus and released during spore germination, hydrolyzes the bond between the glucose and 4-methylumbelliferyl (4-MU) moieties of 4-methylumbelliferyl a-D-glucopyranoside (α-MUG). In the combined state, α-MUG is not fluorescent. Once the bond between the glucose and 4-MU is hydrolyzed, the 4-MU component becomes fluorescent when excited with UV light. Therefore, the a-glucosidase enzyme in its active state can be detected by measuring the fluorescence produced by the enzymatic hydrolysis of a-MUG.
The resultant fluorescent by-product (4-MU), is detected by the Reader and the fluorescent signal is used to determine the positive or negative result of the biological indicator. The measured enzyme activity is reduced upon exposure to hydrogen peroxide. As the enzyme activity is directly correlated with the spore outgrowth. the reduction of the enzyme activity below a certain level indicates that all spores have been inactivated. The level of the fluorescence response is determined using the algorithm developed for the STERRAD VELOCITY BI and is used to distinguish between the positive and negative responses.
The provided text describes the acceptance criteria and a study proving the device meets the acceptance criteria for the STERRAD VELOCITY™ Biological Indicator.
Here's a breakdown of the requested information:
Acceptance Criteria and Device Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criterion for the device, as outlined by the "Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions, Section 10, Test Pack, issued on October 4, 2007," appears to be that the resistance of the subject device must be greater than or equal to the biological models for all claimed STERRAD Cycles. Additionally, all fluorescence-negative results during testing must be obtained in triplicate runs.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Resistance of the subject device is greater than or equal to the biological models for all claimed STERRAD Cycles. (Based on testing outlined in FDA Guidance) | "The study results indicated that the resistance of the subject device was greater than the biological model for all claimed STERRAD Cycles." |
| All fluorescence-negative results obtained in triplicate runs. (Based on testing outlined in FDA Guidance) | "all fluorescence-negative results were obtained in triplicate runs." |
| Overall performance in various STERRAD Cycles (passing results in specific performance studies). | All testing yielded passing results. |
- Performance Study in STERRAD 100NX (STANDARD and FLEX Cycles, with/without ALLClear Technology): Pass
- Performance Study in STERRAD 100NX (EXPRESS Cycle, with/without ALLClear Technology): Pass
- Performance Study in STERRAD 100NX (DUO Cycle): Pass
- Performance Study in STERRAD NX (STANDARD and ADVANCED Cycles, with/without ALLClear Technology): Pass
- Performance Study in STERRAD 100S Cycle: Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that "all fluorescence-negative results were obtained in triplicate runs." This implies that for each performance study listed, testing was conducted in triplicate. The exact number of biological indicators (BIs) or runs per condition is not explicitly stated beyond "triplicate runs."
- Data Provenance: The data is from non-clinical performance testing conducted by Advanced Sterilization Products (ASP). There is no explicit mention of the country of origin of the data, but given ASP is based in Irvine, California, it's highly likely the testing was conducted in the United States. The study is inherently prospective as it involves new performance testing of the device for expanded indications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For a biological indicator, the ground truth is typically established by the growth or non-growth of the microbial spores after exposure to a sterilization process, which is an objective measurement. It does not typically involve expert interpretation in the same way as, for example, reading medical images.
4. Adjudication Method for the Test Set
This information is not applicable in the context of biological indicator testing as described. The results (fluorescence-negative or positive, and spore growth/non-growth) are objective measurements based on the device's functionality and the viability of the spores. It does not involve human interpretation that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic devices where human readers interpret medical images or data, and their performance with and without AI assistance is compared. The STERRAD VELOCITY™ Biological Indicator is a standalone device for monitoring sterilization processes and its performance is assessed directly, not in conjunction with human interpretation in an MRMC setting.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the performance study described is essentially a standalone (algorithm only) performance evaluation of the STERRAD VELOCITY™ Biological Indicator. The device, in conjunction with the STERRAD VELOCITY Reader, determines a "positive or negative result" based on the detected fluorescent signal, which is determined using an "algorithm developed for the STERRAD VELOCITY BI." The results presented ("Pass" or "Fail" for the performance studies and the resistance being "greater than" the biological model, and "fluorescence-negative results were obtained in triplicate runs") are indicative of the algorithm's direct performance in identifying effective sterilization.
7. The Type of Ground Truth Used
The ground truth for the biological indicator testing is based on the viability (growth or non-growth) of the Geobacillus stearothermophilus (ATCC 7953) spores after exposure to sterilization cycles, as well as the expected D-value (decimal reduction time) and and absence of growth in fully processed units. This is a biological/microbiological ground truth, directly tied to the primary function of a biological indicator. The "fluorescence-negative" result detected by the reader is directly correlated to the inactivation of spores. The document also mentions the optional visual pH-based color change result after 5-7 days of culture, which further confirms spore viability (or lack thereof).
8. The Sample Size for the Training Set
The document does not specify a training set sample size. This device is a biochemical indicator with an enzymatic detection system, rather than a machine learning or AI model that typically requires a large training dataset for learning patterns from data. The "algorithm developed for the STERRAD VELOCITY BI" likely refers to a pre-defined threshold or logic based on the biochemical reaction, rather than a machine-learned algorithm.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" in the context of machine learning is indicated, the method of establishing ground truth for a training set is not applicable as described in the document. The foundational principles for the device's operation (α-glucosidase enzyme system, spore viability detection) are based on established microbiological and biochemical science. The development of the algorithm would have relied on understanding the relationship between enzyme activity, fluorescence, and spore inactivation, established through scientific studies and threshold determination rather than a traditional machine learning training process with a distinct training set.
§ 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).