(56 days)
CIDEX® OPA Solution is a high level disinfectant for reprocessing heat sensitive medical devices, for which sterilization is not suitable, and when used according to the Directions for Use.
Manual Processing: High Level Disinfectant at a minimum of 20℃ (68°F): CIDEX® OPA Solution is a high level disinfectant when used or reused, according to the Directions for Use, at or above its Minimum Effective Concentration (MEC) as determined by CIDEX® OPA Solution Test Strips, with an immersion time of at Jeast 12 minutes for a reuse period not to exceed 14 days.
Automatic Endoscope Reprocessors that can be set to 25°C: High Level Disinfectant at a minimum of 25°C (77°F): CIDEX® OPA Solution is a high level disinfectant when used or reused in a legally marketed automatic endoscope reprocessor (that can be set to 25°C) according to the Directions for Use, at or above its Minimum Effective Concentration (MEC) as determined by CIDEX® OPA Solution Test Strips, with an immersion time of at least 5 minutes for a reuse period not to exceed 14 days.
Minimum Effective Concentration (MEC): 0.3%.
Note: If your AER cannot be set to a minimum of 25°C please follow the time and temperature stated in Indications for Use, Manual Processing.
CIDEX® OPA Solution is formulated to contain 0.55% w/v of ortho-phthalaldehyde. The resultant solution contains a corrosion inhibitor, chelating agents, and a dye in a phosphate buffer. ortho-Phthalaldehyde is chemically related to glutaraldehyde in that they are both aldehydes. The mechanism of ortho-phthalaldehyde is postulated to be similar to glutaraldehyde and is based on powerful binding of the aldehyde to the outer cell wall of the organism.
The provided document describes the 510(k) summary for CIDEX® OPA Solution, a liquid chemical germicide, and its efficacy testing. Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Defined by the FDA for high-level disinfectants) | Reported Device Performance (CIDEX® OPA Solution) |
|---|---|
| Sporicidal efficacy | Achieved |
| Mycobactericidal efficacy | Achieved |
| Minimum Effective Concentration (MEC) | 0.3% |
| Stability | 24 months at 15-30°C |
| Biocompatibility (residues) | Levels well below toxic effects in animals |
| Material Compatibility (with endoscopes) | No functional or compatibility issues at 25°C in AER |
Note: The document specifies the efficacy testing was performed with reused CIDEX® OPA Solution at concentrations at or below the MEC of 0.3% for a 5-minute cycle at 25°C. The "acceptance criteria" here are inferred from the types of efficacy and safety tests mandated for such devices to obtain market clearance.
2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific "sample size" in terms of number of devices or number of tests for the efficacy studies. It mentions efficacy testing was performed using a disinfection cycle of 5 minutes at 25°C with reused CIDEX® OPA Solution, and data was generated on the microbiological efficacy.
The data provenance is not explicitly detailed regarding its country of origin. The submission is a 510(k) to the FDA, implying the tests were conducted to meet US regulatory requirements, likely by or for the manufacturer (Advanced Sterilization Products, located in Irvine, CA). The studies appear to be prospective as they were conducted specifically to demonstrate the product's efficacy for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For a liquid chemical germicide, the "ground truth" for efficacy is typically based on standardized microbiological testing protocols against specified microorganisms, rather than expert judgment on individual "cases" in the way an AI model for medical imaging would.
4. Adjudication method for the test set
This information is not applicable and not provided for this type of device and study. Adjudication methods like 2+1 or 3+1 are relevant for studies involving human interpretation of data, typically in diagnostic imaging or clinical trials where multiple readers assess outcomes and discrepancies need to be resolved. This document describes efficacy testing of 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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools that involve human interpretation. CIDEX® OPA Solution is a disinfectant, and its efficacy is determined through laboratory microbiological testing, not human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the efficacy testing described is implicitly a standalone performance evaluation of the chemical disinfectant itself. The "algorithm" here is the chemical formulation and its interaction with microorganisms under specific conditions (5 minutes at 25°C, 0.3% MEC). There is no "human-in-the-loop" once the disinfection cycle is initiated; the chemical acts independently.
7. The type of ground truth used
The ground truth used for this study is based on microbiological efficacy against target organisms (sporicidal and mycobactericidal activity) measured in laboratory settings according to established disinfectant testing standards. This is equivalent to "outcomes data" in a very specific sense, where the outcome is the inactivation or killing of microorganisms.
8. The sample size for the training set
This information is not applicable and not provided. CIDEX® OPA Solution is a chemical disinfectant, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of AI. The formulation and testing of the disinfectant are based on chemical principles and empirical biological studies.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" for a chemical disinfectant. The efficacy (ground truth) is established through standardized laboratory microbiological testing protocols.
§ 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.