(153 days)
EZTest® - Steam self contained biological indicators are for monitoring the efficacy of saturated steam sterilization processors. Performance characteristics are established in accordance with USP XXIII for the 121 C steam process. Additional saturated steam sterilization conditions are also included in the Certificate of Performance. EZTest® - Steam Bls are also appropriate for use in the high temperature saturated steam processes of 132 C , 134 C and 135 C.
The biological indicator consists of a self-contained unit which includes: bacterial spores inoculated onto a paper carrier, a small glass ampule containing sterile culture medium and color indicator, and a plastic vial that serves as the culture tube. This unit complies to the performance characteristics described in the USP XXIII.
Here's a breakdown of the acceptance criteria and study information for the EZTest® - Steam biological indicator, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (USP XXIII) | Reported Device Performance (as listed in 510(k) summary) |
|---|---|---|
| Spore Population | 0.5 x 10^5 to 5.0 x 10^5 spores for a 10^5 BI | "between 0.5 x 10^5 and 5 x 10^5" (Matches USP guideline) |
| D-value at 121°C | Not explicitly stated in the summary, but implied by USP XXIII. | "D values at 121°C...", evaluated for at least three (3) spore lots using different spore crops and different media lots. (Specific values not provided) |
| Survival/Kill Time | Not explicitly stated in the summary, but implied by USP XXIII. | "Survival/Kill times at 121°C...", evaluated for at least three (3) spore lots using different spore crops and different media lots. (Specific values not provided) |
| D-value at 132°C | Not explicitly stated in the summary, but implied by USP XXIII. | "D values at 132°C...", evaluated for at least three (3) spore lots using different spore crops and different media lots. (Specific values not provided) |
| Survival/Kill Time | Not explicitly stated in the summary, but implied by USP XXIII. | "Survival/Kill times at 132°C...", evaluated for at least three (3) spore lots using different spore crops and different media lots. (Specific values not provided) |
| D-value at 134°C | Not explicitly stated in the summary, but implied by USP XXIII. | "D values at 134°C...", evaluated for at least three (3) spore lots using different spore crops and different media lots. (Specific values not provided) |
| Survival/Kill Time | Not explicitly stated in the summary, but implied by USP XXIII. | "Survival/Kill times at 134°C...", evaluated for at least three (3) spore lots using different spore crops and different media lots. (Specific values not provided) |
| D-value at 135°C | Not explicitly stated in the summary, but implied by USP XXIII. | "D values at 135°C...", evaluated for at least three (3) spore lots using different spore crops and different media lots. (Specific values not provided) |
| Survival/Kill Time | Not explicitly stated in the summary, but implied by USP XXIII. | "Survival/Kill times at 135°C...", evaluated for at least three (3) spore lots using different spore crops and different media lots. (Specific values not provided) |
| Z-value | Not explicitly stated in the summary, but implied by USP XXIII. | "Z values", evaluated for at least three (3) spore lots using different spore crops and different media lots. (Specific values not provided) |
| Spore Species | Bacillus stearothermophilus, ATCC 7953 or equivalent. | Bacillus stearothermophilus, ATCC 7953 or equivalent. (Meets criteria) |
| Sample Purity | Not explicitly stated as an acceptance criterion. | Evaluated as part of performance. (Details not provided) |
| Incubation Readout Time | Implied by CDRH guideline (48 hours). | Validation of 48 hours incubation read out time following the CDRH guideline. (Meets guideline) |
| Shelf Life Stability | Not explicitly stated as an acceptance criterion. | Stability of the product over the eighteen (18) month shelf life claim. (Reported as evaluated) |
| Post-Exposure Recovery | Not explicitly stated as an acceptance criterion. | Evaluation of the effect of holding time after exposure to sterilant until incubation, upon recovery of injured spores. (Reported as evaluated) |
| pH Indicator Effect | Not explicitly stated as an acceptance criterion. | Evaluation of the effect of the pH indicator upon the recovery of injured spores. (Reported as evaluated) |
| Media Support Growth | Not explicitly stated as an acceptance criterion. | Validation of the effect of the sterilization process on the ability of the media to support the growth of injured spores. (Reported as evaluated) |
Note: The summary states that "A significant portion of the quality assurance specification is testing to the performance characteristics of biological indicators as outlined in USP XXIII." and that "Such compliance is required on each lot prior to release." This implies that the specific numeric acceptance criteria for D-values, survival/kill times, and Z-values, although not explicitly listed in the 510(k) summary, are derived from USP XXIII and are met by the device. The summary provides a list of evaluated characteristics rather than specific quantitative performance values.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The summary states that "Claims were evaluated using at least three (3) spore lots using different spore crops and different media lots." This indicates a minimum of three distinct lots were used for testing resistance characteristics. The exact number of individual biological indicators tested within each lot is not specified.
- Data Provenance: The data is generated internally by SGM Biotech, Inc., as part of their "in-process quality control system" and "quality assurance specification." The summary does not provide information on the country of origin of the data or whether it was retrospective or prospective, but it implies a prospective testing approach as part of a release process for each lot.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this device. The ground truth for a biological indicator is inherent to its design and function: the presence or absence of viable spores after a sterilization cycle. The "ground truth" is established by direct microbiological methods (observing growth/color change), not by expert interpretation.
4. Adjudication Method for the Test Set
This is not applicable as the output of a biological indicator (color change, turbidity) is a direct, objective observation of microbial growth or lack thereof, rather than something requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This is not applicable. This device is a biological indicator, not an AI-based diagnostic tool. It does not involve human readers interpreting data or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This is not applicable. This device is a biological indicator for monitoring sterilization, not an algorithm. Its "standalone" performance is its ability to accurately reflect sterilization efficacy based on spore survival.
7. The Type of Ground Truth Used
The ground truth used is based on microbiological growth/viability, specifically the survival and subsequent growth of Bacillus stearothermophilus spores. The change in the pH indicator (bromcresol purple changing from purple to yellow) is a direct, observable proxy for this microbiological activity. This is akin to a pathology/microbiology outcome.
8. The Sample Size for the Training Set
This is not applicable. As a biological indicator, the device does not employ a training set in the typical machine learning sense. Its performance is based on the inherent biological resistance of the spores and the chemical properties of the culture medium.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as point 8. The "ground truth" for its operation is the established science of microbial heat resistance and culture medium efficacy, which is a foundational scientific principle rather than a dataset requiring ground truth establishment.
§ 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).