(163 days)
CIDEX® OPA Solution is a high level disinfectant for reprocessing heat sensitive medical devices, and when used according to the Directions for Use.
High Level Disinfectant: 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, at 20° C (68° F) with an immersion time of at least 12 minutes for a reuse period not to exceed 14 days.
Minimum Effective Concentration (MEC): 0.3%.
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 action 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.
Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:
Device Name: CIDEX® OPA Solution (0.55% ortho-phthalaldehyde Solution)
Intended Use: High level disinfectant for reprocessing heat-sensitive medical devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Defined by Intended Use/Claims) | Reported Device Performance and Test Methods |
|---|---|
| High-level Disinfection Efficacy: The solution must function as a high-level disinfectant at or above its Minimum Effective Concentration (MEC) of 0.3%, at 20°C (68°F), with an immersion time of at least 12 minutes, for a reuse period not exceeding 14 days. This implies: | Efficacy Testing: CIDEX® OPA Solution was tested using a "standard array of microbiology tests for germicidal efficacy." |
| * Bactericidal Efficacy: Effective at killing bacteria. | * Bactericidal: Demonstrated (implicitly by the general efficacy claim and the Mycobacterium terrae test). |
| * Fungicidal Efficacy: Effective at killing fungi. | * Fungicidal: Demonstrated. |
| * Tuberculocidal Efficacy: Effective at killing Mycobacterium (e.g., M. terrae), which is a key indicator for high-level disinfection. | * Tuberculocidal: Demonstrated. Specifically tested in "Simulated Use" against Mycobacterium terrae in artificial soil at MEC of 0.3% and 20°C, and found effective. |
| * Virucidal Efficacy: Effective at inactivating viruses. | * Virucidal: Demonstrated. |
| * Sporicidal Efficacy: While high-level disinfectants are not expected to kill all spores, some level of sporicidal activity is often evaluated. The document specifically mentions a sporicidal claim. | * Sporicidal: Demonstrated as a sporicidal agent as defined by the AOAC Sporicidal Activity Test with an exposure time of at least 32 hours at 20°C. Note: The 32 hours for sporicidal activity is significantly longer than the 12-minute high-level disinfection time, indicating sporicidal claim is separate or for specific conditions. |
| Minimum Effective Concentration (MEC): The lowest concentration at which the disinfectant is effective, stated as 0.3%. | Throughout the reported efficacy tests (e.g., Simulated Use, general efficacy), the solution was tested at its "MEC concentration of 0.3% conditions" and found effective. |
| Biocompatibility: The product (active ingredient and formulated product) must be safe for human use and product residues on reprocessed devices must not cause toxic effects. | * Biocompatibility (product itself): Evaluated through a panel of toxicologic tests: acute oral and dermal toxicity, skin sensitization, genetic toxicity (in vitro and in vivo), subchronic oral toxicity, and developmental toxicity tests. "All animal toxicity data indicate that the product is at least as safe for human use as the predicate device." |
| * Biocompatibility (residues): "Biocompatibility of product residues testing was conducted." Results indicated "levels well below those, which cause toxic effects in animals." | |
| Material Compatibility: The solution should not significantly damage medical device materials after multiple disinfection cycles. | "Evaluated for its effect on materials commonly used to fabricate medical devices." "Multiple disinfection soaks over extended periods of time resulted in minimal effect on the test articles." Effects were "similar to those seen with the predicate device." |
| Stability: The product must remain stable for its claimed shelf life. | "Tested and found stable for 24 months at 15-30℃." |
2. Sample Size Used for the Test Set and Data Provenance
- Simulated Use (Tuberculocidal): Specific sample size for this test is not explicitly stated, but it involved efficacy against Mycobacterium terrae in artificial soil.
- In Use Testing: One hundred endoscopes were studied.
- Data Provenance: The document does not specify the country of origin of the data. The studies appear to be prospective in nature, designed to test the performance of the CIDEX® OPA Solution under controlled and simulated-use conditions.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- The document describes laboratory efficacy tests and clinical "in use" testing. For these types of studies involving disinfection and sterilization, "ground truth" is typically established by standardized laboratory protocols and microbiological cultures, rather than expert medical consensus in the diagnostic sense.
- The "In Use Testing" on 100 endoscopes would have involved microbiologists or laboratory personnel responsible for culturing and determining the presence/absence of microorganisms, and potentially clinicians handling the endoscopes. No specific number or qualifications for "experts" establishing ground truth are provided in the context of consensus interpretation, as this is not an image-based or qualitative diagnostic assessment. The "ground truth" is typically objective microbiological growth or lack thereof.
4. Adjudication Method for the Test Set
- Adjudication methods like "2+1" or "3+1" are relevant for subjective assessments (e.g., interpreting medical images).
- For the types of tests described (microbiological efficacy, biocompatibility, material compatibility), adjudication by consensus of multiple human readers is not typically involved. Results are usually objective measurements (e.g., colony counts, toxicity levels, material degradation) performed according to established protocols. Therefore, the adjudication method would effectively be none in the traditional sense, relying instead on the established scientific reproducibility of the tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done.
- MRMC studies are typically used to evaluate the diagnostic performance of human readers, with and without the assistance of AI, usually in the context of medical imaging or pathology. This submission is for a chemical disinfectant, which is evaluated based on objective laboratory and in-use efficacy against microorganisms, not human diagnostic interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- This question is not applicable to this device. CIDEX® OPA Solution is a chemical disinfectant, not an algorithm or an AI software device. Its performance is inherent to its chemical properties and formulation.
7. The Type of Ground Truth Used
The "ground truth" for the studies described is primarily:
- Microbiological Culture Results: For efficacy testing (sporicidal, bactericidal, fungicidal, tuberculocidal, virucidal, and in-use testing), the ground truth is the presence or absence of viable microorganisms after exposure to the disinfectant, as determined by standard microbiological culture and enumeration techniques.
- Toxicological Endpoints: For biocompatibility, the ground truth is based on observed biological responses in in vitro and in vivo animal models (e.g., acute toxicity, sensitization, genetic toxicity, developmental toxicity).
- Material Integrity Assessments: For material compatibility, the ground truth is based on visual inspection, mechanical property testing, or other methods to assess degradation or changes to medical device materials.
8. The Sample Size for the Training Set
- This question is not applicable as CIDEX® OPA Solution is a chemical disinfectant, not a machine learning or AI-based device that requires a "training set" in the computational sense. The formulation of the disinfectant is based on chemical principles and experimental optimization, not on a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable for the same reasons as point 8.
§ 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.