(287 days)
ACECIDE-C is a high level disinfectant intended to disinfect reusable clean heatsensitive semi-critical medical devices (such as flexible endoscopes) which contact mucous membranes when used at or above its minimum recommended concentration of 2000 ppm peracetic acid for 7.0 minutes at 20°C.
ACECIDE-C is a sterilant intended to sterilize reusable clean heat-sensitive critical and semi-critical medical devices (such as flexible endoscopes) which contact and potentially penetrate into sterile body areas, for which there is no other practical method of sterilization, when used at or above its minimum recommended concentration of 2000 ppm peracetic acid for 2.0 hours at 20℃.
ACECIDE Test Strips are used with ACECIDE-C High Level Disinfectant and Sterilant use solution to ensure that the level of peracetic acid is above the minimum recommended concentration of 2000 ppm.
ACECIDE-C High-Level Disinfectant and Sterilant is packaged in two separate plastic bottles: ACECIDE-C 6.8% Peracetic Acid Concentrate Solution 1 is a concentrate of acetic acid and hydrogen peroxide, which react with each other in the presence of a catalyst and stabilizer to form 6.2 - 6.8 % w/w peracetic acid at a pH value of
The document describes the acceptance criteria and supporting studies for ACECIDE-C High-Level Disinfectant and Sterilant, which is a liquid chemical high-level disinfectant and sterilant.
Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Minimum Recommended Concentration / Exposure Time / Temperature) | Reported Device Performance |
|---|---|---|
| High-Level Disinfection (HLD) | ||
| Peracetic Acid Concentration | ≥ 2000 ppm | Effective at 2000 ppm |
| Exposure Time | 7.0 minutes | - AOAC Use Dilution Test: All (100%) bacterial-labeled cylinders (Staphylococcus aureus, Salmonella choleraesuis, Pseudomonas aeruginosa) disinfected at 1.0, 3.0, and 5.0 minutes. |
- AOAC Fungicidal Test: All surrogate fungi (Trichophyton mentagrophytes, Aspergillus niger, Candida albicans) killed at 1.0, 2.5, and 5.0 minutes.
- Virucidal Tests: Influenza A Virus, Herpes Simplex Virus type 1, and Adenovirus type 2 killed within 5.0 minutes; Poliovirus type 1 killed within 7.0 minutes (establishing the 7.0 min HLD exposure time).
- Mycobactericidal Tests: 6.0 log10 of M. terrae killed within 4.0 minutes, 8 log10 killed within 5.0 minutes.
- Simulated-use (endoscopes): At least 6 log10 of M. terrae killed within 7.0 minutes. |
| Temperature | 20°C | Effective at 20°C |
| Sterilization | | |
| Peracetic Acid Concentration | ≥ 2000 ppm | Effective at 2000 ppm |
| Exposure Time | 2.0 hours | - Sporicidal Exposure Time Determination: All B. subtilis-labeled carriers sterilized within 15.0 minutes; all C. sporogenes-labeled carriers sterilized within 1.0 hour. A 2.0-hour exposure time was selected for a safety margin. - Full Three Lot AOAC Sporicidal Test: Three lots passed with 2.0 hours exposure.
- Confirmatory Sporicidal Test: One lot passed with 2.0 hours exposure.
- Simulated-use (endoscopes): At least 6 log10 of B. subtilis killed within 2.0 hours. |
| Temperature | 20°C | Effective at 20°C |
| Re-Use Life Maintenance (HLD & Sterilant) | Concentration never decreases below 2000 ppm through 5 days of use | In eight separate five-day EPA Re-Use Tests at 20°C, the concentration of peracetic acid in ACECIDE-C never decreased below 2000 ppm before the conclusion of each study. The initial concentration starts at 3100-3400 ppm peracetic acid. |
| ACECIDE Test Strips | Ensure peracetic acid level is > 2000 ppm | Test strips are based on the same basic chemistry as other peracetic acid test strips (oxidation of iodide to iodine with starch forming a blue-gray/blue-black compound). |
Study Information
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Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- AOAC Use Dilution Test: Stainless steel penicylinders labeled with Staphylococcus aureus, Salmonella choleraesuis, and Pseudomonas aeruginosa. The exact number of cylinders per test is not specified, but the methodology refers to AOAC standards (955.14, 955.15, and 964.02) which dictate specific sample sizes (e.g., 60 carriers per organism per concentration).
- AOAC Fungicidal Test: Cultures of Trichophyton mentagrophytes, Aspergillus niger, and Candida albicans. Again, the exact number of replicates is not specified but would follow AOAC 955.17 standards.
- Virucidal Tests: Influenza A Virus, Herpes Simplex Virus type 1, Adenovirus type 2, and Poliovirus type 1. Sample sizes for viral inactivation studies typically involve multiple replicates, but specific numbers are not given.
- Mycobactericidal Tests: M. terrae. Not specified.
- Sporicidal Exposure Time Determination: 40 of each type of spore-labeled carrier (B. subtilis and C. sporogenes).
- Full Three Lot AOAC Sporicidal Test: Three lots of ACECIDE-C were tested, implying multiple carriers per lot, as per AOAC 966.04.
- Confirmatory Sporicidal Test: One lot of ACECIDE-C.
- Simulated-use tests with flexible endoscopes (M. terrae): Not specified the number of endoscopes or replicates. Endoscopes used included a bronchoscope, gastroscope, and colonoscope.
- Simulated-use tests with flexible endoscopes (B. subtilis): Not specified the number of endoscopes or replicates. Endoscopes used included a bronchoscope, gastroscope, and colonoscope.
- In-use tests with ACECIDE-C: Olympus gastroscopes and colonoscopes (number not specified but implied to be multiple from an endoscopy clinic), and Olympus bronchoscopes (number not specified but implied to be multiple from a hospital).
- Data Provenance: The studies were conducted by MicroChem Laboratory, Inc. in Euless (Dallas), TX, USA. The studies are retrospective from the perspective of the 510(k) submission, confirming product performance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This device is a chemical disinfectant/sterilant, not an imaging or diagnostic device requiring human expert interpretation for ground truth. The "ground truth" is established through standardized microbiological and chemical assays, such as those defined by AOAC and EPA guidelines, which measure microbial kill or chemical concentration. The document mentions Norman Miner, Ph.D., President/Study Director of MicroChem Laboratory, Inc., as the application correspondent and likely oversaw these studies. His qualifications suggest expertise in microbiology and chemistry relevant to disinfectant testing.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. The ground truth relies on objective laboratory assays to determine microbial viability (or lack thereof) post-exposure and chemical concentration, not subjective human assessment requiring adjudication.
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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 an AI-based diagnostic or imaging device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "standalone" performance here refers to the disinfectant's ability to kill microbes and spores without human intervention during the disinfection/sterilization process itself (beyond preparing the solution and operating the device or immersing instruments). All the studies (AOAC, virucidal, mycobactericidal, sporicidal, simulated-use, and in-use tests) demonstrate the standalone efficacy of the ACECIDE-C solution itself under specified conditions.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth is based on microbiological viability testing (showing no colony formation, no viral infectivity, no fungal growth) and chemical concentration measurements. For example, the AOAC Sporicidal Test directly verifies sterilization by determining the absence of viable spores post-treatment. The "in-use" tests directly cultured endoscopes from patient use to confirm the absence of bacteria.
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The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a "training set." The studies performed are direct efficacy tests of a chemical product.
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How the ground truth for the training set was established:
- Not applicable for the same reason as above.
§ 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.