(62 days)
The SPSmedical SporView® PA Culture Set is intended for use with the STERIS System 1® sterilizer using STERIS® 20 sterilant only. The STERIS System 1® is a liquid chemical sterilization process. The SporView PA Culture Set provides independent confirmation that sterilization conditions were achieved during the STERIS System 1® processing cycle. A reduced incubation time of 24 hours has been validated for the Spor View PA Culture Set using SPSmedical's SporView® culture media.
Spor View PA Culture Set is intended to monitor the STERIS System 1® peracetic acid sterilization process using the STERIS® 20 sterilant. The product contains paper strips the are inoculated with G. stearothermophilus spores (formally known as Bacillus stearothermonities) at a nominal population of 1 x 10 per strip. Sterile tubes of Spor View Culture Media mopiditied soybean casein broth) and a transfer clip are included. The product is intended to be uned in en identical manner as the Castle® SPOR-TEST PA Biological Indicator Kit.
The provided text is a 510(k) summary statement for a medical device and the FDA's clearance letter. It does not contain a detailed study report with specific acceptance criteria or an analysis of device performance against those criteria in the format requested. The document primarily focuses on establishing substantial equivalence to a predicate device.
However, based on the information provided, here's a breakdown of what can be inferred and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Predicate Equivalence & Intended Use) | Reported Device Performance |
|---|---|
| Survival Time: Survive at 41 seconds when tested at 1,000 ppm peracetic acid, 50 ℃. | "When tested at 1,000 ppm peracetic acid, 50 ℃ the Spor View PA Culture Set will survive at 41 seconds..." |
| Kill Time: Be killed at 6 minutes when tested at 1,000 ppm peracetic acid, 50 ℃. | "...and will be killed at 6 minutes." |
| Growth Media Compatibility: Compatible with SporView® Culture Media. | "The SporViews PA Culture Set was qualified using Spor View" Culture Media." |
| Microorganism: Inoculated with G. stearothermophilus spores at a nominal population of 1 x 10^5 per strip. | "The product contains paper strips the are inoculated with G. stearothermophilus spores (formally known as Bacillus stearothermonities) at a nominal population of 1 x 10 per strip." |
| Incubation Time: Reduced incubation time of 24 hours. | "A reduced incubation time of 24 hours has been validated for the Spor View PA Culture Set using SPSmedical's SporView® culture media." |
| Exclusivity of Use: Exclusively used to monitor the STERIS System 1® peracetic acid process. | "The SporView® PA Culture Set is only intended to monitor the STERIS System 1® liquid chemical sterilization system using STERIS® 20 sterilant." |
| Substantial Equivalence: Equivalent to the Castle® SPOR-TEST PA Biological Indicator Kit (K020205). | "The SporView PA Culture Set is substantially equivalent the Castle® SPOR-TEST PA Biological Indicator Kit for monitoring the STERIS System 19 peracetic acid process." |
Missing Information:
- Quantitative Performance Metrics for Endpoints: While survival and kill times are stated, the specific statistical methods, confidence intervals, or number of passes/failures observed to "prove" these times are not provided.
- Specific Acceptance Thresholds: For example, what percentage of biological indicators must survive at 41 seconds and be killed at 6 minutes to meet the self-declared criteria?
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not mentioned. The document states "The product contains paper strips the are inoculated with G. stearothermophilus spores... at a nominal population of 1 x 10 per strip." This refers to the spore load on each individual indicator, not the number of indicators used in a test.
- Data Provenance: Not explicitly stated, but assumed to be internal testing conducted by SPSmedical Supply Corp. as part of their 510(k) submission. It would be retrospective relative to the submission date, but the document doesn't confirm if it was specifically a "study" with a defined protocol or ongoing product testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This device is a biological indicator for sterilization. Ground truth is established by the known conditions of the sterilization process (e.g., concentration of sterilant, temperature, time) and the inherent resistance of the microbial spores. It does not involve human expert interpretation of device output in the same way, for example, a diagnostic imaging device would.
4. Adjudication Method for the Test Set
- Not Applicable. See point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is not relevant for this type of device. This device is a direct indicator of sterilization efficacy, not an interpretation tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes (Implicitly). This device is a standalone biological indicator. Its performance is assessed directly (survival/kill) under specified conditions, without human interpretation of complex data or an AI algorithm. The "human-in-the-loop" aspect exists only in the reading of the culture media for growth/no-growth, which is a direct observation, not an "interpretation" requiring human expertise for adjudication of ground truth.
7. The Type of Ground Truth Used
- Known Biological Resistance to Sterilant: The ground truth is the established resistance of G. stearothermophilus spores to specific concentrations and exposure times of peracetic acid at a given temperature (1,000 ppm peracetic acid, 50°C). The "kill" and "survival" times are based on the known lethality of the sterilization process to these spores.
8. The Sample Size for the Training Set
- Not Applicable / Not Mentioned. There is no "training set" in the context of this device. This is not an AI/ML device that requires data for training an algorithm.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. See point 8.
§ 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).