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The RAPICIDE OPA-28 Test Strip is a chemical indicator for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in RAPICIDE OPA-28 Solution, is above or below the established Minimum Recommended Concentration (MRC) of 0.35%.

The device is a qualitative, single use, reagent test strip made up of a 0.40 inch square indicator pad that has been chemically treated to detect OPA. The pad is affixed to one end of a 3.25 inch by 0.40 inch white opaque polystyrene strip.

The SERIM Research Corporation RAPICIDE OPA-28 Test Strip is a chemical indicator designed to determine if the concentration of ortho-phthalaldehyde (OPA), the active ingredient in RAPICIDE OPA-28 Solution, is above or below its established Minimum Recommended Concentration (MRC) of 0.35%.

Here's an analysis of its acceptance criteria and supporting studies:

1. Acceptance Criteria and Reported Device Performance

The provided document indicates the device must reliably indicate if the OPA concentration is above or below the MRC of 0.35%.
The clinical study demonstrated that the device met these criteria through comparative performance with a predicate device.

2. Sample Size and Data Provenance

The document does not explicitly state the exact sample size (number of test strips or OPA solution samples) used for the blind studies.
The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a diagnostic device, it is highly likely that the studies were prospective, conducted at the manufacturer's facilities.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts used or their qualifications for establishing ground truth. For chemical indicators like this, the "ground truth" would likely be established through analytical chemistry methods (e.g., spectrophotometry or titration) to precisely determine the OPA concentration in the test solutions, rather than human interpretation of the strips themselves as the primary ground truth.

4. Adjudication Method

The document does not describe an adjudication method. For a qualitative chemical indicator where the "ground truth" is a defined chemical concentration, judgment calls by multiple experts with an adjudication method are typically not required. The comparison is against an analytical standard.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. This type of study is typically relevant for interpretative devices where human variability in reading results is a significant factor. For a chemical indicator, the reading is expected to be relatively straightforward (color change), reducing the need for such a complex reader study. The study focused on the performance of the device itself rather than human improvement with AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done. The "Performance" section explicitly states that "The performance of the RAPICIDE OPA-28 Test Strips was evaluated in OPA solutions of Rapicide OPA-28 at the MRC and above in blind studies." This evaluation determines the device's ability to accurately indicate the OPA concentration without human-in-the-loop assistance in the interpretation of the color change.

7. Type of Ground Truth Used

The ground truth used would be analytical determination of OPA concentration. The study involved evaluating the test strips in "OPA solutions of Rapicide OPA-28 at the MRC and above." This implies that the OPA concentrations in these solutions were precisely known through validated analytical chemistry methods, serving as the objective ground truth against which the test strip's performance was measured.

8. Sample Size for the Training Set

The document does not provide information about a "training set" or its sample size. This is common for chemical indicators of this type, which are typically developed based on chemical principles rather than machine learning algorithms requiring explicit training data. The development process would involve formulation and optimization of the reagents to achieve the desired color change at the target concentration.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a "training set" in the context of machine learning, there is no corresponding ground truth establishment method described. The development of the test strip would rely on chemical formulation and empirical testing against analytically prepared OPA solutions with known concentrations.

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Rapicide OPA-28 is a high level disinfectant solution for reprocessing of heat sensitive semicritical medical devices for which sterilization is not suitable. Rapicide OPA-28 may be used at or above its minimum recommended concentration (MRC) of 0.35% OPA as determined by Rapicide OPA-28 test strips in manual device reprocessing with an immersion time of at least 10 minutes at a minimum temperature of 20℃ for a reuse period not to exceed 28 days. Rapicide OPA-28 may also be used in compatible legally marketed automatic endoscope reprocessors at or above its MRC as determined by Rapicide OPA-28 test strips with an immersion time of at least 5 minutes at a minimum temperature of 25℃ for a reuse period not to exceed 28 days.

Rapicide OPA-28 is a reusable liquid ortho-Phthalaldehyde (OPA) based high level disinfectant solution intended for reprocessing of heat sensitive semi-critical medical devices for which sterilization is not suitable. Rapicide OPA-28 may be used in manual reprocessing or in compatible legally marketed automatic endoscope reprocessors at the appropriate labeled use conditions. Rapicide OPA-28 is a clear liquid chemical germicide solution with a pH between 7.5 and 8.0. The active microbicidal ingredient ortho-Phthalaldehyde is formulated at a nominal concentration of 0.575% together with a solvent, buffers, surfactants, an antifoaming agent and water to create Rapicide OPA-28 solution. Rapicide OPA-28 is labeled with an unopened bottle shelf-life of 24 months, an open bottle use-period of 75 days and a reuse period not to exceed 28 days. The germicide must be used at or above its MRC, as determined by Rapicide OPA-28 test strips, with the indicated immersion time, use temperature and reuse period. Rapicide OPA-28 is supplied in cases containing high density polyethylene plastic bottles. Individual bottles are labeled with all information necessary to use the device safely.

The provided text describes the regulatory clearance of a medical device, Rapicide OPA-28, a high-level disinfectant, rather than an AI/ML powered device. As such, many of the requested criteria for AI/ML device studies are not applicable.

However, I can extract information related to the device's performance, indications for use, and the types of studies performed as outlined in the submission.

Here's a breakdown of the relevant information:

Device: Rapicide OPA-28 High Level Disinfectant

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The studies performed were intended to demonstrate substantial equivalence to legally marketed predicate devices, as per the FDA's Guidance for Content and Format of Premarket Notification [510(k)] Submission for Liquid Chemical Sterilants/High Level Disinfectants (Jan 2000).

The types of data/information provided included:

• Detailed description of physical and chemical properties.
• Proposed labeling.
• Sporicidal, tuberculocidal, fungicidal, virucidal, and bactericidal efficacy.
• Simulated-use and in-use tests.
• Rinse Residual and biocompatibility.
• Toxicity evaluation.
• Material compatibility.
• Stability.
• Test strip performance.

Non-Applicable Information for this type of Medical Device (Chemical Disinfectant):

The following requests are specific to AI/ML powered devices and are not applicable to this 510(k) submission for a liquid chemical germicide:

2. Sample sizes used for the test set and data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs. without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for test set.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This 510(k) submission focuses on the chemical efficacy and safety of the disinfectant itself through laboratory and simulated-use testing, rather than the performance of an interpretive or diagnostic algorithm.

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