(342 days)
Rapicide™ High Level Disinfectant and Sterilant is intended to be used for the automated sterilization of clean, heat sensitive, critical medical equipment for which alternative methods of sterilization are not suitable. Critical medical devices are those that contact normally sterile areas of the body. Critical medical devices must be sterilized.
Rapicide™ High Level Disinfectant and Sterilant is a sterilant when used or reused, in a legally marketed Automated Endoscope Reprocessor according to Directions for Use, at a minimum recommended Concentration (MRC) of 1.5% glutaraldehyde at 35℃ (95°F), not to exceed 28 days, with a minimum contact or immersion time of at least 7 hours and 40 minutes.
Rapicide™ High Level Disinfectant and Sterilant is intended to be used for the automated high level disinfection of clean, heat sensitive, semi-critical medical devices for which sterlization is not practical. Semi-critical medical devices may be sterilized or high-level disinfected. Semi-critical medical devices are those that contact mucous membranes or other body surfaces not normally considered sterile.
Rapicide™ High Level Disinfectant and Sterilant is a high-level disinfectant when used or reused, in a legally marketed Automated Endoscope Reprocessor according to Directions for Use, at a minimum recommended concentration (MRC) of 1.5% glutaraldehyde at 35°C (95°F), not to exceed 28 days, with a minimum contact or immersion time of at least 5 minutes.
Rapicide™ High Level Disinfectant and Sterilant is a ready-to-use solution with an active ingredient of 2.5 ± 0.1% w/v qlutaraidehyde, with a slightly acidic pH value of 6.3 to 6.7. The patented formulation (U.S. Pat. Reg. No. 4,748,279) includes a non-ionic detergent for improved wetting of surfaces. The glutaraldehyde concentration is stabilized by means of a buffer to pH 6.3 to 6.7. Other formula ingredients include a corrosion inhibitor, silicone antifoam chemical, and dyes. The formula is about 90% purified water. The ingredients of Rapicide™ High Level Disinfectant and Sterilant are similar to those in the predicate, Wavicide-01 Solution.
Here's an analysis of the provided text regarding the acceptance criteria and study for Rapicide™ High Level Disinfectant and Sterilant:
This document is a 510(k) summary for a sterilant/disinfectant, not a diagnostic device using AI. Therefore, many of the requested categories like "Number of experts used to establish the ground truth," "Adjudication method," "MRMC study," "Standalone performance," "Training set sample size," and "How the ground truth for the training set was established" are not applicable to this type of product and study. The studies focus on microbiological efficacy rather than diagnostic accuracy.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for Rapicide™ High Level Disinfectant and Sterilant are based on achieving specific antimicrobial efficacy under defined conditions. The reported device performance demonstrates successful fulfillment of these criteria.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Sterilization Efficacy (Spores) | |
| Exposure Time - Sterilization Response Curve: | |
| All (100%) of 60 spore-labeled carriers (C. sporogenes or B. subtilis) sterilized within 4.0 hrs at 35°C by "worst case" (stressed and diluted to 1.5% glutaraldehyde) Rapicide™. | The sterilization label claim was set at 7 hours 40 minutes at 35°C (at ≥1.5% glutaraldehyde MRC) to provide a margin of safety beyond the observed 4.0 hr complete kill time. This was based on B. subtilis-labeled silk loops, which were the most resistant. |
| Full AOAC Sporicidal Activity of Disinfectants Test 966.04: | |
| Pass test with an exposure of 5.0 hrs at 35°C using worst case Rapicide™ at MRC. | Three lots of "worst case" Rapicide™ passed the test with an exposure of 5.0 hrs at 35°C. |
| Confirmative AOAC Sporicidal Activity of Disinfectants Test 966.04: | |
| Pass test with an exposure of 5.0 hrs at 35°C using worst case Rapicide™ at MRC, with 30 carriers per combination. | Two lots of "worst case" Rapicide™ passed the test at 5.0 hrs at 35°C. |
| Simulated Use - Sterilization Mode: | |
| Kill ≥ 6 log$_{10}$ of B. subtilis in endoscope channels. | More than six log$_{10}$ of B. subtilis were killed by "worst case" Rapicide™ (1.5% glutaraldehyde) exposed for 5.0 hrs at 35±1°C in endoscope channels. This supports the 7 hrs 40 min sterilization claim. |
| High-Level Disinfection Efficacy (M. bovis var. BCG) | |
| Quantitative Tuberculocidal Activity: Kill M. bovis var. BCG within a defined time. | "Worst case" Rapicide™ at 35°C killed 3.5 x 10⁷ Colony Forming Units (CFU) of M. bovis var. BCG within 2.0 min. |
| Simulated Use - High-Level Disinfection Mode: | |
| Kill ≥ 10⁶ CFU of M. bovis var. BCG in endoscope channels within 5 min. | No surviving CFU of M. bovis var. BCG in five of six endoscopes tested, and four CFU recovered from one endoscope with an unusually high challenge of 1.3 x 10⁹ CFU. This supports killing ≥ 10⁶ CFU within 5.0 min at 35±1°C. |
| Clinical In-Use Tests: | |
| Kill wild type aerobic bacteria in endoscope channels after patient use within 5 min. | Three gastroscopes and three colonoscopes contaminated with 3.6 x 10³ to 1.0 x 10⁷ CFU of bacteria showed No (zero) bacteria recovered after 5.0 min exposure to Rapicide™ at 35±1°C. |
| High-Level Disinfection Efficacy (Vegetative Bacteria) | |
| AOAC Use Dilution Tests (S. aureus, P. aeruginosa, S. choleraesuis): | |
| Pass test with 5 min exposure at 35±1°C using "worst case" Rapicide™ at 1.5% glutaraldehyde. | All (100%) cylinders were disinfected of all three test bacterial species for all three lots of "worst case" Rapicide™ within 5 min at 35±1°C. |
| AOAC Use Dilution Tests (Function of Exposure Time & Glutaraldehyde Concentration): | |
| Kill S. aureus or P. aeruginosa within 2.5 min at 35±1°C at 1.5% glutaraldehyde. | "Worst case" Rapicide™ at 1.5% or 1.0% glutaraldehyde disinfected all of these cylinders within 2.5 min at 35±1°C. This indicates a margin of safety for the 5 min claim. |
| High-Level Disinfection Efficacy (Fungi) | |
| AOAC Fungicidal Activity of Disinfectants Test 955.17: | |
| Kill T. mentagrophytes, C. albicans, or A. niger. | "Worst case" Rapicide™ at 1.5% or 1.0% glutaraldehyde killed all three species of fungi within 2.5 min at 35±1°C. This indicates a margin of safety for the 5 min claim. |
| High-Level Disinfection Efficacy (Viruses) | |
| Kill ≥ 99.9% of specified viruses within 5.0 min. | Both 1.5% and 1.0% glutaraldehyde concentrations killed ≥ 99.9% of Poliovirus type 1, Adenovirus type 2, Influenza virus type A2, Herpes simplex virus type 1 and type 2, and HIV type 1 within 5.0 min at 35±1°C. This indicates a margin of safety for the 5 min claim. |
| Glutaraldehyde Concentration Monitoring | |
| Monitor capable of accurately indicating when glutaraldehyde concentration falls below 1.5%. | The 3M Comply™, SteriLog™ 1.5%, Glutaraldehyde Monitor (Cat. No. 3983 MM) accurately indicated discard solution at 1.5% glutaraldehyde. |
Study Details
Below are the details of the studies, where applicable:
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Sample sizes used for the test set and the data provenance:
- Exposure time-sterilization response curve: 60 unglazed porcelain cylinders or silk suture loops per test, labeled with C. sporogenes or B. subtilis spores. The data provenance is non-clinical laboratory testing.
- Full AOAC Sporicidal Activity of Disinfectants Test 966.04: Specific sample sizes are not explicitly stated beyond "three lots" in the summary, but the AOAC method implies a certain number of carriers per lot (typically 60 carriers). Data provenance is non-clinical laboratory testing.
- Confirmative AOAC Sporicidal Activity of Disinfectants Test 966.04: 30 spore-labeled carriers per spore and carrier combination. Data provenance is non-clinical laboratory testing conducted at ViroMed Biosafety Laboratories and MicroBioTest Inc.
- Quantitative Tuberculocidal Activity: Not directly stated, but implicit for a quantitative rate of kill test (multiple samples across three test dates). Data provenance is non-clinical laboratory testing.
- AOAC Use Dilution Tests (Function of Exposure Time & Glutaraldehyde Concentration): 60 stainless steel penicylinders per test (labeled with S. aureus or P. aeruginosa) at each exposure time and concentration. Data provenance is non-clinical laboratory testing.
- AOAC Use Dilution Tests: 60 stainless steel cylinders per bacterial species (S. aureus, P. aeruginosa, S. choleraesuis) per lot. Data provenance is non-clinical laboratory testing.
- Fungicidal Activity: Not explicitly stated, but tests were performed on T. mentagrophytes, C. albicans, or A. niger. Data provenance is non-clinical laboratory testing.
- Virucidal Activity: Not explicitly stated, but viruses tested included Pollovirus type 1, Adenovirus type 2, Influenza virus type A2, Herpes simplex virus type 1 and type 2, and HIV type 1. Data provenance is non-clinical laboratory testing.
- Simulated Use - Sterilization Mode: Three Olympus brand flexible endoscopes (gastroscope, colonoscope, sigmoidoscope). Each endoscope was repeated several times. Data provenance is non-clinical simulated use testing.
- Simulated Use - High-Level Disinfection Mode: Three different types of Olympus-brand flexible endoscopes (gastroscope, colonoscope, sigmoidoscope). Each endoscope was tested twice. Data provenance is non-clinical simulated use testing.
- Clinical In-Use Tests: Three Pentax-brand gastroscopes and three Pentax-brand colonoscopes. Data provenance is prospective clinical testing at an endoscopy clinic in Fort Worth, TX.
- Glutaraldehyde Reduction Tests: Three Olympus-brand flexible endoscopes (gastroscope, colonoscope, sigmoidoscope). Data provenance is non-clinical laboratory testing.
- Glutaraldehyde Monitor Studies: Not explicitly stated but mentions testing a "stressed lot" of Rapicide™ against the monitor at various concentrations. Data provenance is non-clinical laboratory testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for this device's performance (antimicrobial efficacy) is established through standardized microbiological and chemical testing methods, not by expert consensus in the same way a diagnostic image would be. Live/dead microbes are objectively detected.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. As the studies are microbiological tests, the results (e.g., presence or absence of growth, log reduction) are objectively measured, not adjudicated by human interpretation in this manner.
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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 is not a diagnostic device involving human readers or AI.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a chemical disinfectant, not an algorithm. Its performance is inherently "standalone" in terms of its chemical action.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for these studies is based on quantifiable microbiological end-points (e.g., absence of microbial growth, log reduction in CFU/spores, time to kill) as defined by established regulatory and industry-standard test methods (e.g., EPA Re-Use Test Protocol, AOAC Sporicidal Activity Test 966.04, Quantitative Tuberculocidal Activity tests, AOAC Use Dilution Tests, AOAC Fungicidal Activity Test 955.17, virucidal efficacy tests). For simulated and clinical use tests, the ground truth is the presence or absence of viable microorganisms after exposure to the disinfectant. Chemical concentration measurements also serve as ground truth for stability and monitoring.
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The sample size for the training set: Not applicable. This is a chemical disinfectant, and its efficacy is tested, not "trained" like a machine learning model.
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How the ground truth for the training set was established: Not applicable.
§ 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.