(152 days)
OPA 30 Solution is a high level disinfectant for reprocessing heat sensitive semi-critical medical devices for which sterilization is not suitable, and when used according to the Directions for Use. OPA 30 Solution may be used of reused at or above its Minimum Recommended Concentration (MRC) of 0.3%, as determined by Opaciden OPA Reagent Strips, in manual reprocessing with an immersion time of at least 12 minutes at a minimum of 20°C (68°F), for a reuse period not to exceed 30 days. OPA 30 Solution may also be used or reused in a legally marketed automatic endoscope reprocessor (that can be set to a minimum of 25°C), at or above its Minimum Recommended Concentration (MRC), as determined by Opaciden OPA Reagent Strips, with an immersion time of at least 5 minutes at a minimum of 25℃ (77ºF), for a reuse period not to exceed 14 days.
The OPA 30 Solution is a clear, pale blue liquid with a pH of 7.5. It contains 0.60% ortho-Phthalaldehyde in an aqueous base containing buffers, chelating agents and a corrosion inhibitor. It is stable at 15-30° C (59-86° F) for its labeled shelf life of 24 months. OPA 30 Solution may be used or reused for manual (up to 30 days) or automated reprocessing (up to 14 days), according to the Directions for Use. OPA 30 Solution must be used at or above its Minimum Recommended Concentration (MRC), as determined by Opaciden OPA Reagent Strips, with the immersion time and temperature specified for the disinfection method.
The provided text describes a 510(k) premarket notification for a medical device called "OPA 30 Solution," a liquid chemical sterilant/high-level disinfectant. The document focuses on demonstrating substantial equivalence to a predicate device (Opaciden® Solution, K070627). Crucially, this document is for a chemical disinfectant, not an AI/ML-driven device, and therefore the concepts of "acceptance criteria," "device performance," "sample size for test set," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," and "sample size for training set" are not applicable in the context of an AI/ML device.
The closest analogous information for a chemical disinfectant would be:
1. A table of acceptance criteria and the reported device performance:
The document implicitly defines "acceptance criteria" through comparison to the predicate device and adherence to FDA guidance for liquid chemical sterilants/high-level disinfectants. The "reported device performance" is largely established by stating that the chemical formulation is identical to the predicate and that previous testing (for the predicate) demonstrated acceptable performance. The key performance outcome tested explicitly for the new device is extended reuse periods.
| Acceptance Criteria (Implied by Predicate & Guidance) | Reported Device Performance (OPA 30 Solution) |
|---|---|
| Microbiological Efficacy: | |
| - Vegetative organisms effectiveness | Effective against: Staphylococcus aureus, Salmonella choleraesuis, Pseudomonas aeruginosa, Mycobacterium bovis (Identical to predicate) |
| - Fungi effectiveness | Effective against: Trichophyton mentagrophytes (Identical to predicate) |
| - Viruses, non-enveloped effectiveness | Effective against: Poliovirus Type 1, Rhinovirus Type 42, Hepatitis A (AER) (Identical to predicate) |
| - Viruses, enveloped effectiveness | Effective against: Avian influenza, Hepatitis B, Influenza Type A (Hong Kong), HIV-1 (Identical to predicate) |
| - Spores effectiveness | Effective against: Herpes simplex Type 1, Clostridium sporogenes, Bacillus subtilis (Identical to predicate) |
| Chemical Composition: | |
| - Active ingredient concentration | 0.60% ortho-Phthalaldehyde (Identical to predicate) |
| - Inert ingredients percentage | 99.40% (Identical to predicate) |
| - pH range | 7.5 (Identical to predicate) |
| - Stability at specified temperature | Stable at 15-30°C (59-86°F) for labeled shelf life (Identical to predicate) |
| Minimum Effective Concentration (MEC): | 0.3% (Identical to predicate) |
| Reuse Period: | |
| - Manual reprocessing reuse period | 30 Days Manual (Expanded from 14 days in predicate, confirmed by "re-use for manual processing" testing) |
| - Automated reprocessing reuse period | 14 Days Automated (Identical to predicate) |
| Toxicity: | Positive for acute oral toxicity, moderate skin irritation. Negative for dermal and cytotoxicity. Probable eye irritant. (Identical to predicate) |
| Device Compatibility: | Olympus and Pentax endoscopes are compatible. (Identical to predicate) |
| - Material compatibility | Materials previously cleared in predicate and Acrylonitrile Butadiene Styrene (ABS) (Expanded from predicate, confirmed by "material compatibility" testing) |
| Shelf Life: | 24 month shelf life for a closed container (Expanded from 15 months in predicate, confirmed by "stability" testing) |
| Chemical Indicator: | Opaciden OPA Reagent Strips (Identical to predicate) |
2. Sample sized used for the test set and the data provenance:
This information is not provided in a way that defines "test set" as it would for an AI/ML device. The document states that performance testing was performed for "stability, re-use for manual processing and material compatibility." However, specific sample sizes (e.g., number of re-use cycles, number of material samples) and the provenance (country of origin, retrospective/prospective) are not detailed. The previous testing for microbiological efficacy was submitted and cleared as part of the predicate device (K070627). This previous testing would have been prospective studies following established disinfectant testing protocols.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable to a chemical disinfectant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable to a chemical disinfectant.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is not an AI/ML device. The "standalone" performance for a chemical disinfectant would be its efficacy in killing microorganisms under specific conditions, which was tested.
7. The type of ground truth used:
For a chemical disinfectant, "ground truth" would relate to the successful inactivation or killing of microorganisms. This is established through standardized laboratory testing (e.g., AOAC methods) where the presence or absence of viable microorganisms after exposure to the disinfectant is directly measured. This is akin to definitive pathology/microbiology laboratory results.
8. The sample size for the training set:
Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable, as this is not an AI/ML device.
§ 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.