(307 days)
Cetylcide-G is intended for use as a liquid chemical sterilant and/or a high level disinfectant to sterilize and disinfect medical devices and instruments in hospitals, medical, dental, and other healthcare facilities when used according to the directions for use in the package insert.
Sterilant: Cetylcide-G is a sterilant when mixed and used in accordance with its directions for use for a maximum of 28 days at 20°C with an immersion time of at least 10 hours at its minimum effective concentration (MEC) of 2.1% glutaraldehyde.
High Level Disinfectant: Cetylcide-G is a high level disinfectant when mixed and used according to its directions for use for a maximum of 28 days at 20°C with an immersion time of at least 40 minutes at its minimum effective concentration (MEC) of 2.1% glutaraldehyde.
Concentrated glutaraldehyde solution for sterilization and high level disinfection (used with diluent solution)
The provided text describes Cetylcide-G, a liquid chemical sterilant and high-level disinfectant. The document focuses on demonstrating its substantial equivalence to predicate devices (Cidex Plus 28-day Solution and MetriCide 28-day Long-Life Activated Dialdehyde Solution) based on shared intended use, active ingredient (glutaraldehyde), and demonstrated efficacy.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for Cetylcide-G are primarily based on its performance in various efficacy tests and its ability to maintain its minimum effective concentration (MEC) over a 28-day reuse period. The device's performance is compared against these criteria.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy | Achieve sterilization when used in accordance with directions, specifically: 10 hours immersion at 20°C at an MEC of 2.1% glutaraldehyde. | Sporicidal Tests: |
- Passed AOAC Sporicidal Test against B. subtilis spores and C. sporogenes spores on silk suture loops and porcelain penicylinders in 10 hours at 20°C.
- Sporicidal at 20°C with exposure times ranging from 9 hours to 10 hours and 30 minutes for B. subtilis on silk suture carriers.
- D-value of 6-8 minutes for C. sporogenes and 90 minutes for B. subtilis at 20°C. |
| High-Level Disinfection Efficacy | Achieve high-level disinfection when used in accordance with directions, specifically: 40 minutes immersion at 20°C at an MEC of 2.1% glutaraldehyde. | Tuberculocidal Tests: Stressed Cetylcide-G achieved a six log reduction in Mycobacterium bovis in 40 minutes at 20°C.
Fungicidal Test: Stressed Cetylcide-G killed Trichophyton mentagrophytes within 5 minutes at 20°C.
Simulated In-Use Test: Effectively disinfected flexible fiber optic endoscopes with no microorganisms recovered after 20 minutes exposure at 20°C.
Viricidal Efficacy Test: Stressed Cetylcide-G was effective against Polio Type II virus and Herpes simplex Type I virus in ten minutes at 20°C. |
| Reuse Period & MEC Maintenance | Reusable for a maximum of 28 days, provided glutaraldehyde concentration, pH, and temperature exist, and MEC (2.1%) is verified using DisIntek™ reagent test strips. | Testing of Indicator Strip: Cetylcide-G use dilution was manually stressed for 28 days. DisIntek test strip produced "high" glutaraldehyde readings only when the glutaraldehyde concentration was above the MEC (2.1%), indicating a comfortable safety margin between MEC and test strip readings. |
| Material Compatibility | Compatible with common medical device materials. | Found compatible with: Metals (Chrome Plated, Nickel Plated, Carbon Steel, Stainless Steel, Aluminum), Elastomers (Black rubber, red rubber, silicone rubber, polyurethane), Plastics (ABS, PVC, polystyrene, polyethylene, polypropylene, polysulfone, polymethylmethacrylate, polyethylene terephthalate). (Note: Not recommended for unanodized aluminum or certain polycarbonate equipment due to stress cracking risk). |
| Residue Levels | Acceptable levels of glutaraldehyde residue after processing. | Glutaraldehyde concentration in final soak/rinse water was undetectable or in the low mg/L range. Endoscopes had, on average, 2.5 mg of glutaraldehyde remaining on surfaces after 10 hours immersion and single-rinse residue reduction step. Other, less toxic soluble ingredients were not specifically tested for residue given their low concentration and expected easy rinsing. |
2. Sample Size Used for the Test Set and Data Provenance
The text does not explicitly state the overall "sample size" of medical devices or microbial tests as a single number. However, it indicates the types of tests performed and some specifics:
- Sporicidal Tests: B. subtilis spores and C. sporogenes spores carried on "silk suture loops and porcelain penicylinders." One sporicidal test involved "an end-point analysis of silk suture carriers inoculated with B. subtilis."
- Tuberculocidal Test: Tested against "Mycobacterium bovis."
- Fungicidal Test: Tested against "Trichophyton mentagrophytes."
- Simulated In-Use Test: Performed on "flexible fiber optic endoscopes."
- Viricidal Efficacy Test: Tested against "Polio Type II virus and Herpes simplex Type I virus."
- Residue Study: Measured residues on "three Olympus endoscopes."
- Indicator Strip Testing: "Two lots" of Cetylcide-G use dilution were stressed, and readings were taken on days 1, 8, 15, 19, 21, 23, 25, and 27.
The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, the tests are laboratory-based efficacy studies performed under controlled conditions (e.g., AOAC protocols, specified temperatures and times). The "Simulated In-Use Test" is a prospective simulation of real-world use. The indicator strip testing involved "manual stressing to simulate worst-case conditions encountered during its reuse," suggesting a prospective, simulated environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of human experts to establish "ground truth" for the performance efficacy of the sterilant itself. The ground truth for microbial efficacy (e.g., sporicidal, bactericidal, fungicidal, virucidal) is established through standardized laboratory protocols (e.g., AOAC tests) which quantify microbial reduction or kill. For material compatibility and residue studies, the "ground truth" is based on observable physical changes or chemical analytical measurements, respectively.
4. Adjudication Method for the Test Set
Not applicable. The performance tests are quantitative laboratory assessments based on established protocols for microbial viability, chemical concentration, or physical observation, rather than subjective interpretation requiring adjudication among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data, and AI assistance is evaluated for its impact on their performance. Cetylcide-G is a chemical sterilant/disinfectant, and its effectiveness is measured through direct laboratory microbial assays and chemical analysis.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance tests described (sporicidal, bactericidal, fungicidal, tuberculocidal, virucidal assays, simulated in-use test, material compatibility, residue study, and indicator strip testing) represent standalone performance of the product (Cetylcide-G). Since this is a chemical product rather than an AI algorithm, the concept of "algorithm only" doesn't directly apply. However, the efficacy studies are designed to demonstrate the inherent capabilities of the chemical solution itself.
7. The Type of Ground Truth Used
The ground truth used for evaluating Cetylcide-G's performance is primarily quantitative laboratory measurements based on established scientific and regulatory protocols:
- Microbial Assays: Direct measurement of microbial kill or reduction (e.g., "six log reduction in Mycobacterium bovis," effective against specific fungi, bacteria, and viruses).
- Chemical Analysis: Measurement of glutaraldehyde concentration (e.g., titration for indicator strip accuracy, residue measurements in mg/L).
- Physical Observation: Assessment of material integrity after exposure ("without corrosive or other apparent damaging effects," "possible stress cracking after repeated treatments").
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here as Cetylcide-G is a chemical product, not an AI algorithm that undergoes training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
§ 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.