(142 days)
The Browne Cidex™ OPA Indicator is a concentration monitor for use in ortho-phthalaldehyde-containing germicide solutions with a minimum effective concentration of 0.3%.
The Browne Cidex™ OPA Indicator is dedicated for use with Cidex™ OPA Solution.
The Browne OPA Indicator and the substantially equivalent device are chemical indicator strips intended to monitor the concentration of liquid chemical germicides. The devices indicate, via a color change, if the concentration of the active ingredient exceeds the MEC (minimum effective concentration) for the solution.
The Browne OPA Indicator consists of a polypropylene strip with an indicator pad on one end. The indicator pad is impregnated with an indicator solution which changes color from light blue to purple in Cidex™ OPA Solution with an ortho-phthaladehyde concentration greater than the MEC for the solution.
Here's a breakdown of the acceptance criteria and study details for the Browne Cidex™ OPA Indicator, based on the provided text:
1. Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Indicate "FAIL" (light blue to light blue with purple mottling) when ortho-phthalaldehyde concentration is ≤ 0.3% (MEC). | All 90 strips tested in 0.3% solution showed a "FAIL" condition (light blue or light blue with purple mottling). |
| Indicate "PASS" (purple color) when ortho-phthalaldehyde concentration is > 0.3% (specifically tested at 0.45%). | All 90 strips tested in 0.45% solution showed a "PASS" condition (purple color). |
| Performance under simulated use conditions: Indicate "FAIL" at 0.3% MEC. | All 30 indicators tested in 0.3% ortho-phthalaldehyde solution showed a "FAIL" condition. |
| Performance under simulated use conditions: Indicate "PASS" at 0.45% above MEC. | All 30 indicators tested in 0.45% solutions showed a "PASS" condition. |
| No false positives or false negatives under simulated use conditions. | No false positives or false negatives were recorded under simulated use conditions. |
| Performance under worst-case germicide solution conditions (end-of-use life, contaminated with 5% serum, 5% salt, and 5% sodium dodecyl sulfate): Indicate "FAIL" at 0.3% MEC. | For each contaminant tested (serum, salt, SDS), all indicator strips exhibited a "FAIL" condition in the 0.3% Cidex™ OPA solution. |
| Performance under worst-case germicide solution conditions: Indicate "PASS" at 0.45% above MEC. | For each contaminant tested, all indicator strips exhibited a "PASS" condition in the 0.45% solution. |
2. Sample Size and Data Provenance
- Test Set Sample Size:
- Initial Testing: 180 Browne OPA Indicators (90 for 0.3% solution, 90 for 0.45% solution).
- Simulated Use Testing: 60 indicators (30 for 0.3% solution, 30 for 0.45% solution).
- Worst-Case Conditions Testing: Not explicitly stated, but implies a sufficient number of strips for each contaminant at both 0.3% and 0.45% concentrations, and included an unadulterated control. The wording "all of the indicator strips" suggests comprehensive testing for each scenario.
- Data Provenance: The document does not explicitly state the country of origin for the data. Given the submitter's address in the United Kingdom, it is plausible the testing was conducted there, or at a contract lab. The study is prospective, as it involves testing new batches of the device under defined conditions.
3. Number of Experts and Qualifications for Ground Truth
The device is a chemical indicator that produces a color change based on chemical concentration. The "ground truth" in this context is the actual chemical concentration of ortho-phthalaldehyde in the solutions. Therefore, there are no human experts involved in establishing the ground truth for the test set in the traditional sense of medical image interpretation or clinical diagnosis. The ground truth is established by chemical measurement of the solution concentration.
4. Adjudication Method for the Test Set
Not applicable. The "readings" are objective color changes (light blue/mottling for FAIL, purple for PASS) directly observed from the chemical reaction. There is no subjective interpretation requiring adjudication by multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is typically performed for diagnostic devices where human readers provide interpretations. The Browne OPA Indicator is a chemical concentration monitor, not a diagnostic imaging or interpretive device that would involve human readers in its primary function.
6. Standalone (Algorithm Only) Performance Study
Yes, the performance testing described is a standalone performance study. The device (chemical indicator strip) operates independently to produce a color change based on the chemical environment. There is no human-in-the-loop during the indication process itself, only for observing and recording the resulting color.
7. Type of Ground Truth Used
Chemical Concentration Measurement. The ground truth for the test solutions (0.3% and 0.45% ortho-phthalaldehyde) is based on the precisely controlled preparation and presumed subsequent measurement of these chemical concentrations.
8. Sample Size for the Training Set
Not applicable. The Browne OPA Indicator is a chemical indicator, not a machine learning or AI-based device, so it does not have a "training set" in the context of an algorithm. Its "learning" is inherent in its chemical formulation.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device. The chemical formulation of the indicator is developed based on known chemical reactions and thresholds for ortho-phthalaldehyde.
§ 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).