(559 days)
CIDEX® OPA Concentrate is a high level disinfectant (HLD) at the minimum IN USE concentration of 0.055% with a contact time of 5 minutes at 50°C for reprocessing heat sensitive (
CIDEX® OPA Concentrate is formulated to contain 5.75% w/v of ortho-phthalaldehyde. The resultant solution contains a corrosion inhibitor, a chelating agent, 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.
Here's a breakdown of the acceptance criteria and study information for the CIDEX® OPA Concentrate, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by High-Level Disinfectant Claims) | Reported Device Performance (CIDEX® OPA Concentrate) |
|---|---|
| Microbiological Efficacy: | |
| * Sporicidal activity | Demonstrated sporicidal efficacy. |
| * Bactericidal activity | Demonstrated bactericidal efficacy. |
| * Fungicidal activity | Demonstrated fungicidal efficacy. |
| * Tuberculocidal activity (against Mycobacterium terrae) | Demonstrated tuberculocidal efficacy. Specifically, simulated use testing resulted in a >6 Log10 reduction of Mycobacterium terrae when flexible endoscopes were contaminated with cells and artificial soil. The diluted CIDEX® OPA Concentrate at an MEC of 0.055% concentration at 50°C was effective against Mycobacterium terrae in artificial soil. |
| * Virucidal activity | Demonstrated virucidal efficacy. |
| Clinical Efficacy (In-Use conditions): | In-Use Testing: Endoscopes used in a clinical setting were subjected to high-level disinfection without cleaning. Sterility testing showed no growth on all endoscope surfaces and channels after reprocessing in CIDEX® OPA Concentrate In Use solution. |
| Biocompatibility: | The active ingredient and formulated product were subjected to a panel of toxicological tests (acute oral/dermal toxicity, skin sensitization, genetic toxicity, subchronic oral toxicity, developmental toxicity). All animal toxicity data indicate the product is at least as safe for human use as the predicate device. Product residues absorbed onto materials were at levels well below those causing toxic effects in animals. |
| Material Compatibility: | Evaluated for effects on materials commonly used in washer/disinfectors and medical devices. Results showed minimal effect on test articles, similar to the predicate device. |
| Stability: | Stable for 15 months at 15-30°C. In-machine use life is 80 days. |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set:
- Microbiology Tests: Not explicitly stated as a number, but refers to "standard array of microbiology tests."
- Simulated Use Testing: Not explicitly stated as a number of endoscopes, but mentions "flexible endoscopes."
- In-Use Testing: Not explicitly stated as a number of endoscopes, but refers to "Endoscopes used in a clinical setting."
- Biocompatibility: Not explicitly stated for human subjects; refers to "animal toxicity data."
- Material Compatibility: Not explicitly stated, but refers to "test articles" representative of commonly used materials.
- Data Provenance: The document does not specify the country of origin for the data. "In-Use Testing" implies prospective clinical data in a real-world setting. "Simulated Use" implies laboratory-controlled prospective data. Microbiology tests are typically laboratory-based.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The studies described are laboratory and clinical efficacy tests against known microbial targets or using standard toxicological/materials testing methods, rather than expert-driven diagnostic interpretations.
4. Adjudication Method for the Test Set
This information is not applicable as the studies are focused on direct measurement of antimicrobial efficacy, toxicity, and material compatibility, not on human interpretation or diagnostic agreement.
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. This device is a liquid chemical germicide, not an AI-powered diagnostic tool, so MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in essence. The performance data presented for CIDEX® OPA Concentrate, particularly the efficacy testing (sporicidal, bactericidal, fungicidal, tuberculocidal, virucidal) and simulated use testing, represents the standalone performance of the chemical disinfectant itself, without human intervention affecting its germicidal action beyond following the directions for use. Its effectiveness is based on its chemical properties, not an algorithm.
7. The Type of Ground Truth Used
- Microbiological Efficacy: Ground truth is established by standard microbiological methods that quantify the reduction or elimination of specific microorganisms (e.g., bacteria, fungi, spores, viruses, mycobacteria). This involves culturing and enumeration techniques.
- Simulated Use/In-Use Testing: The ground truth for effectiveness is validated through sterility testing (absence of microbial growth) on the reprocessed endoscopes.
- Biocompatibility: Ground truth is established by toxicological endpoints measured in animal models and in vitro systems, as well as comparison to established safety profiles of predicate devices and known toxic thresholds.
- Material Compatibility: Ground truth is established by direct observation and measurement of material degradation or changes after exposure, often compared against manufacturer specifications or predicate device effects.
8. The Sample Size for the Training Set
Not Applicable. This is a chemical disinfectant, not an AI model, so there is no "training set." Its effectiveness is based on its chemical formulation and validated through laboratory and clinical testing, not machine learning.
9. How the Ground Truth for the Training Set was Established
Not Applicable. As there is no training set for an AI model, this question does not apply.
§ 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.