(259 days)
The Browne GA Indicator for Cidex Plus™ 28 Day Solution (Browne Cidex Indicator) is a concentration monitor for use in glutaraldehyde-containing germicide solutions with a minimum effective concentration of 2.1%.
The Browne GA Indicator for Cidex Plus™ 28 Day Solution is dedicated for use only with Cidex Plus™ 28 Day Solution.
The Browne Cidex Indicator and the substantially equivalent devices are chemical indicator strips intended to monitor the concentration of glutaraldehyde solutions. The devices indicate, via a color change, if the glutaraldehyde concentration exceeds the MEC of the specific germicide solution they were designed to monitor.
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Browne GA Indicator for Cidex Plus™ 28 Day Solution
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| 100% failure rate in solutions containing 2.1% glutaraldehyde (indicating a FAIL condition for solutions at or below MEC) | 100% failure rate observed in solutions containing 2.1% glutaraldehyde. All 20 indicators tested showed a FAIL condition. |
| Identification of a PASS condition for solutions with glutaraldehyde concentration ≥2.4%. | 17 out of 20 indicators (85%) tested in 2.4% solutions showed a PASS condition. |
| No false positives (i.e., not indicating a PASS when glutaraldehyde is ≤2.1%) | "No false positives were recorded." |
| Performance not affected by detergent, organic, and inorganic contaminants over the 28-day reuse period. | "The performance of the Cidex Plus™ 28 Day Solution Test Strips is not affected by the presence of detergent, organic and inorganic contaminants over the 28 day reuse period." |
2. Sample Size Used for the Test Set and Data Provenance
- Manufacturing Lots Test: 5 manufacturing lots of test strips were used for testing in Cide Plus™ 28 Day Solution.
- Simulated Use Test: 20 indicators (samples) were tested by ten individuals. This means each individual tested 2 strips (one in 2.1% and one in 2.4% solution).
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given the context of a 510(k) submission to the FDA, it is highly likely a prospective study conducted by the manufacturer, Albert Browne Ltd., which is based in the United Kingdom.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- The document does not mention the use of experts to establish ground truth for the test set.
- The ground truth was established by preparing solutions with known glutaraldehyde concentrations (2.1% and 2.4%).
4. Adjudication Method for the Test Set
- None specified. The ground truth was based on the known glutaraldehyde concentrations of the solutions. For the "simulated use" test, the document states "Three of the 20 indicators tested in the 2.4% solution were incorrectly reported as failures. These false negatives were attributed to user inexperience." This implies the actual glutaraldehyde concentration was the definitive truth, and user readings were compared against it.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. The study evaluated the device's performance directly against known concentrations and in a "simulated use" scenario with individual users, rather than comparing human readers with and without AI assistance. The device is the monitoring tool; there's no AI component mentioned in this context.
6. Standalone Performance Study (Algorithm Only)
- Yes, a standalone study was done. The initial performance testing involved "5 manufacturing lots of test strips" in solutions with known glutaraldehyde concentrations. This represents the device (test strip) functioning on its own, independent of a human reader's interpretation for the initial characterization. The human "simulated use" test was a secondary validation of user interpretation.
7. Type of Ground Truth Used
- Known chemical concentration. The ground truth for the test set was established by using Cidex Plus™ 28 Day Solution with precisely known glutaraldehyde concentrations (2.1% and 2.4%).
8. Sample Size for the Training Set
- The document does not explicitly mention a separate "training set" as would be typical for algorithmic or AI device development. The performance testing described appears to be the entire validation for this type of chemical indicator. For such a simple chemical indicator, extensive "training" in the AI sense is not applicable. The device's inherent chemical properties define its response. The performance data presented is for validation.
9. How Ground Truth for the Training Set Was Established
- As a training set is not explicitly mentioned or applicable in the AI sense for this device, a method for establishing its ground truth is also not applicable/not described. The device's "ground truth" is based on the chemical reaction characteristics of glutaraldehyde which lead to the color change.
§ 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).