(239 days)
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
| Acceptance Criteria / Performance Claim | Reported Device Performance |
|---|---|
| High-level Disinfection Efficacy: | |
| Sporicidal Efficacy | Demonstrated |
| Tuberculocidal Efficacy | Demonstrated |
| Fungicidal Efficacy | Demonstrated |
| Virucidal Efficacy | Demonstrated |
| Bactericidal Efficacy | Demonstrated |
| Usage Conditions (Manual): | |
| Minimum Recommended Concentration (MRC) | 0.35% OPA |
| Immersion Time | At least 10 minutes |
| Minimum Temperature | 20°C |
| Reuse Period | Not to exceed 28 days |
| Usage Conditions (Automatic Endoscope Reprocessors): | |
| Minimum Recommended Concentration (MRC) | 0.35% OPA |
| Immersion Time | At least 5 minutes |
| Minimum Temperature | 25°C |
| Reuse Period | Not to exceed 28 days |
| Physical/Chemical Properties: | pH between 7.5 and 8.0 |
| 0.575% nominal OPA concentration | |
| Shelf-life (unopened) | 24 months |
| Use-period (open bottle) | 75 days |
| Other Performance Characteristics: | |
| Simulated-use tests | Demonstrated |
| In-use tests | Demonstrated |
| Rinse Residual | Demonstrated |
| Biocompatibility | Demonstrated |
| Toxicity evaluation | Demonstrated |
| Material compatibility | Demonstrated |
| Stability | Demonstrated |
| Test strip performance | Demonstrated |
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:
- Sample sizes used for the test set and data provenance (e.g., country of origin, retrospective/prospective).
- Number of experts used to establish ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- 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.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for test set.
- The sample size for the training set.
- 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.
§ 880.6885 Liquid chemical sterilants/high level disinfectants.
(a)
Identification. A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.(b)
Classification. Class II (special controls). Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants/High Level Disinfectants, and user information and training.