Search Results
Found 1 results
510(k) Data Aggregation
(112 days)
The Browne Aldahol Glutaraldehyde Indicator is a glutaraldehyde concentration monitor dedicated for use with Aldahol V High-Level Disinfectant. The purpose of the Browne Aldahol Glutaraldehyde Indicator is to monitor glutaraldehyde concentration greater than 1.8%.
The Browne Aldahol Glutaraldehyde Indicator is a chemical indicator strip consisting of an absorbent paper pad impregnated with the reactive chemicals, which is adhesively bonded to one end of a polymer film. The Browne Aldahol Glutaraldehyde Indicator has been developed to monitor the active glutaraldehyde concentration of Aldahol V High-Level Disinfectant (K113015) solution that has an MRC of 1.8% glutaraldehyde.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study discussing device performance:
Acceptance Criteria and Device Performance Study for Browne Aldahol Glutaraldehyde Indicator
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details various verification activities, their acceptance criteria, and the study results. The device appears to be a chemical indicator strip for monitoring glutaraldehyde concentration.
| Test | Acceptance Criteria (FAIL @ 1.8% Glutaraldehyde) | Acceptance Criteria (PASS @ 2.3% Glutaraldehyde) | Study Result |
|---|---|---|---|
| Performance Testing | 100% | ≥ 80% | Pass |
| Blind Study Testing | 100% | ≥ 80% | Pass |
| Simulated Use (Contaminants) Testing | 100% | ≥ 80% | Pass |
| Test Strip Life Outside the Bottle | 100% | ≥ 80% | Pass |
| Aggressive Chemical Stability Testing | 100% | ≥ 80% | Pass |
| Specificity Testing for glutaraldehyde | 100% | 100% FAIL for Tap Water | Pass |
| Stability Testing in three storage environments | 100% | ≥ 80% | Pass |
| In-Use Stability Testing in three storage environments | 100% | ≥ 80% | Pass |
Interpretation of Acceptance Criteria:
- FAIL @ 1.8%: This likely means that when the glutaraldehyde concentration is at or below the minimum recommended concentration (MRC) of 1.8%, the indicator strip must show a "FAIL" result (e.g., no color change, or a specific color indicating failure) 100% of the time. This is critical for patient safety, ensuring used solutions are not reused.
- PASS @ 2.3%: This indicates that when the glutaraldehyde concentration is above the MRC (e.g., at 2.3% or higher, suggesting a fresh or sufficiently concentrated solution), the indicator strip must show a "PASS" result (e.g., a specific color change indicating usability) at least 80% of the time. This allows for the effective reuse of the solution.
- Specificity Testing for glutaraldehyde (100% FAIL for Tap Water): This is a critical criterion to ensure the indicator strip is truly reactive to glutaraldehyde and not other common substances. A 'FAIL' for tap water means the strip won't erroneously indicate a usable glutaraldehyde concentration when only water is present.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions "Test of 6 Lots" in the table heading. It doesn't explicitly state the number of individual indicator strips or repeated tests performed within each category (e.g., "Performance Testing"). However, the reference to "6 Lots" implies that the tests were conducted across multiple manufacturing batches to account for inter-lot variability. Without further detail, the exact number of test strips used is not specified.
- Data Provenance: The document is a 510(k) summary submitted by STERIS Corporation, with the contact information indicating the company is based in the United Kingdom and the submission is to the US FDA. The studies described are internal verification activities conducted by the manufacturer to support the safety and effectiveness of the device. The data is prospective in the sense that these tests were designed and executed to evaluate the new device prior to its market release. The country of origin of the data is not explicitly stated beyond the company's dual locations, but the study results are presented as part of a regulatory submission to the FDA.
3. Number of Experts Used and Their Qualifications for Test Set Ground Truth
The document does not provide information on:
- The number of experts used to establish the ground truth for the test set.
- The qualifications of any such experts (e.g., specific clinical background or experience).
Given the nature of the device (a chemical indicator), the "ground truth" for glutaraldehyde concentration would likely be established through quantitative chemical analysis (e.g., titration or spectrophotometry) rather than expert human interpretation of the indicator itself.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set. Given that the indicator produces a chemical reaction result (color change) against a known chemical concentration, there is typically less need for human adjudicators comparing their interpretations, unlike in medical imaging where expert consensus is often required. The "Blind Study Testing" mentioned suggests that the evaluators were blinded to the expected result to prevent bias.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. This type of study is more common for diagnostic imaging devices where human readers interpret results, and the goal is to assess improvement with AI assistance. For a simple chemical indicator, this study design is not applicable.
6. Standalone Performance Study (Algorithm Only)
Yes, the studies described are essentially standalone performance studies of the device (indicator strip) itself. The device is not an "algorithm" in the typical sense of AI, but rather a chemical reaction-based indicator. The tests (Performance Testing, Blind Study, Simulated Use, Stability, Specificity) all assess the intrinsic performance of the indicator strip without human intervention in its core interpretive function (i.e., it either changes color as expected or it doesn't). The "reading" of the strip (e.g., visually comparing to a color chart) is implied but the performance reported is for the device's ability to react correctly.
7. Type of Ground Truth Used
The ground truth used for evaluating the Browne Aldahol Glutaraldehyde Indicator is based on known chemical concentrations of glutaraldehyde.
- For the "FAIL @ 1.8%" criteria, the ground truth is a glutaraldehyde solution at or below 1.8% concentration, determined by precise chemical measurement.
- For the "PASS @ 2.3%" criteria, the ground truth is a glutaraldehyde solution at or above 2.3% concentration, also determined by precise chemical measurement.
- For Specificity, the ground truth is tap water (absence of glutaraldehyde).
This is a form of analytical ground truth where the actual chemical composition and concentration of the test solutions are precisely known.
8. Sample Size for the Training Set
The document does not mention a "training set." This terminology typically applies to machine learning or AI models. The Browne Aldahol Glutaraldehyde Indicator is a chemical indicator, not an AI-powered device. Therefore, it does not involve a training phase with a dedicated dataset. The development process would have involved formulation and optimization, but not "training" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for this chemical indicator device, this question is not applicable.
Ask a specific question about this device
Page 1 of 1