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510(k) Data Aggregation
(37 days)
The Browne Sporicidin Glutaraldehyde Indicator for Sporicidin Sterilizing and Disinfecting Solution (Browne Sporicidin Glutaraldehyde Indicator) is a glutaraldehyde concentration monitor for use in glutaraldehyde-containing germicide solutions with a minimum effective concentration (MEC) of 0.6% glutaraldehyde.
The Browne Sporicidin Glutaraldehyde Indicator is dedicated for use with Sporicidin Sterilizing and Disinfecting Solution.
The Browne Sporicidin Glutaraldehyde Indicator for Sporicidin Sterilizing and Disinfecting Solution and the substantially equivalent device are chemical indicator strips intended to monitor the concentration of glutaraldehyde in glutaraldehydecontaining germicide solutions. The devices indicate, via a color change, if the germicide concentration exceeds the MEC for the solution.
The Browne Sporicidin Glutaraldehyde 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 tan to purple in liquid chemical germicides with a glutaraldehyde concentration above the MEC of 0.6%.
The Browne Sporicidin Glutaraldehyde Indicator and the predicate device have a 2-year shelf life from the date of manufacture in the unopened bottle. Containers of both devices have a 90 day in-use life.
Here's a breakdown of the acceptance criteria and the study details for the Browne Sporicidin Glutaraldehyde Indicator, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state formal "acceptance criteria" in a quantitative, pass/fail manner with specific numerical targets. Instead, it describes expected color changes at certain glutaraldehyde concentrations and the device's performance in terms of avoiding false positives and managing false negatives.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Positive Indicator (≥0.7% Glutaraldehyde): Uniform purple color within 1-2 minutes. | At 60 seconds (1 minute), the strip will exhibit a uniform purple color (except for the top 2 mm of the strip) if the concentration of glutaraldehyde is ≥0.7%. From 60 to 120 seconds (1 to 2 minutes) the color of the strip is stable, and a reading must be taken during this time. |
| Below Minimum Effective Concentration (<0.6% Glutaraldehyde): Patchy purple/tan or tan color within 1-2 minutes. | The strip will appear patchy purple/tan or tan if the solution contains <0.6% glutaraldehyde. From 60 to 120 seconds (1 to 2 minutes) the color of the strip is stable, and a reading must be taken during this time. |
| Inconclusive/Borderline (0.61-0.69% Glutaraldehyde): Tan, purple/tan, or purple color within 1-2 minutes. | In the concentration range of 0.61-0.69%, the strip may appear tan, purple/tan or purple. From 60 to 120 seconds (1 to 2 minutes) the color of the strip is stable, and a reading must be taken during this time. |
| Avoidance of False Positives: No purple indication at or below MEC. | No false positives were recorded in solutions containing 0.6% glutaraldehyde, when the testing was performed according to the Instructions for Use. |
| Handling of False Negatives: If false negatives occur, they should not compromise disinfection. | False negatives were observed when the indicators were tested in the presence of high levels of sodium dodecyl sulfate. The false negatives would have caused the user to discard the solution unnecessarily. No disinfection procedure would have been compromised. |
| Overall Effectiveness: Effective monitoring of glutaraldehyde component. | The data demonstrates that the Browne Sporicidin Glutaraldehyde Indicator is an effective monitor for the glutaraldehyde component of the Sporicidin Sterilizing and Disinfecting Solution with a glutaraldehyde MEC of 0.6%. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of indicator strips or tests performed in the performance testing. It states that indicators were "tested in Sporicidin Sterilizing and Disinfecting Solution containing 0.6% and 0.7% glutaraldehyde."
- Data Provenance: The document does not explicitly state the country of origin of the data. It appears to be a submission to the FDA (USA) from a UK-based company (Albert Browne Ltd.), so the testing likely occurred in the UK or under the company's oversight. The data is presented as retrospective for the purpose of this 510(k) submission, as it describes tests already performed to establish performance characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided. The ground truth for the glutaraldehyde concentrations (0.6% and 0.7%) was likely established through chemical analysis or precise formulation of the Sporicidin Sterilizing and Disinfecting Solutions, rather than via expert consensus on visual assessment of the strips.
4. Adjudication Method for the Test Set
- This information is not applicable/provided. The 'adjudication method' typically refers to how disagreements are resolved among multiple human readers when establishing ground truth for diagnostic studies. For a chemical indicator, the output is a direct color change, not subject to individual interpretation in the same way. The ground truth (glutaraldehyde concentration) would have been objectively measured.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is more relevant for diagnostic devices where human interpretation plays a significant role and the device aims to assist or replace human readers. The Browne Sporicidin Glutaraldehyde Indicator is a chemical indicator that produces a direct visual result.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
- Yes, this is essentially a standalone (algorithm only) study, though the "algorithm" is the chemical reaction and color change, not a digital one. The performance described is of the indicator strip itself, based on its chemical reactions to glutaraldehyde concentrations. The color change is a direct physical/chemical output, measured against known concentrations. Human interaction is limited to observing the color change at a specified time.
7. The Type of Ground Truth Used
- The ground truth used was the known, chemically verified glutaraldehyde concentration in the Sporicidin Sterilizing and Disinfecting Solution (0.6% and 0.7%). This is a form of "reference standard" or "gold standard" established by precise chemical formulation or analysis.
8. The Sample Size for the Training Set
- This document does not mention a 'training set.' Chemical indicators do not typically undergo a "training" phase like machine learning algorithms. Their performance is inherent to their chemical formulation. The testing described is a validation of the pre-designed chemical system.
9. How the Ground Truth for the Training Set was Established
- As there is no explicit 'training set' for this chemical indicator in the conventional sense, this question is not applicable. The ground truth for the development of the indicator's chemistry would have been established through iterative chemical formulation and testing against known glutaraldehyde concentrations to achieve the desired color changes at specific thresholds. However, this development process is distinct from the regulatory "training set" concept for AI/ML devices.
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