(604 days)
Peract™ 20 Liquid Sterilant/Disinfectant is intended for sterilization or high level disinfection of medical and surgical instruments that require submersion.
Peract™ 20 Liquid Sterilant/Disinfectant should be used only with heat sensitive medical and surgical instruments that are not compatible with other sterilization or high level disinfection processes that can be biologically monitored.
Peract™ 20 Liquid Sterilant/Disinfectant should be used under the following contact conditions:
| | Time | Temperature | Minimum Effective
Concentration
Peracetic Acid |
|----------------------------|------------|-------------|------------------------------------------------------|
| Sterilization | 8 hours | 68°F (20°C) | 500 ppm |
| High Level
Disinfection | 25 minutes | 68°F (20°C) | 500 ppm |
Peract™ 20 Indicator Test Strips are intended for verifying the minimum effective concentration of peracetic acid in Peract™ 20 Liquid Sterilant/Disinfectant during reuse.
Peract™ 20 Liquid Sterilant/Disinfectant is a single component germicide which does not require mixing or activation. The product is used full strength, without dilution. It is packaged in one gallon polyethylene bottles and has a one year shelf life.
The active ingredient in Peract™ 20 are peracetic acid and hydrogen peroxide. As discussed in Block's' article, the mechanism of microbial action is believed to be oxidizing sulfhydryl and sulfur bonds in proteins and enzymes, particularly in the cell walls.
Peract™ 20 Peracetic Acid Indicator Test Strips are provided to verify that the minimum effective concentration (MEC) (500 ppm peracetic acid) of Peract™ 20 is present. Three test strips are used with cach application.
The acceptance criteria and study details for the PERACT™ 20 LIQUID STERILANT/DISINFECTANT AND PERACT™ 20 INDICATOR TEST STRIPS are as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Device Function / Test Type | Acceptance Criteria (Success Metric/Threshold) | Reported Device Performance |
|---|---|---|
| Liquid Sterilant/Disinfectant | ||
| Sporicidal Efficacy | Sporicidal activity. | Product shown to be sporicidal. |
| Tuberculocidal Efficacy | Tuberculocidal activity. | Product shown to be tuberculocidal. |
| Virucidal Efficacy | Virucidal activity against specified viruses. | Product determined to be virucidal against Poliovirus Type 2, Influenza A2, Human Immunodeficiency Virus Type 1, and Herpes Simplex Virus Type 1. |
| Fungicidal Efficacy | Fungicidal activity against specified fungi. | Product considered fungicidal when tested against Trichophyton mentagrophytes. |
| Bactericidal Efficacy | Bactericidal activity against specified bacteria. | Use dilution testing showed efficacy against Staphylococcus aureus, Salmonella choleraesuis, Pseudomonas aeruginosa. |
| Residuals (On Endoscopes) | No significant residues remaining after sterilization/disinfection and rinsing. | Testing determined residues of Peract™ 20 remaining on endoscopes after sterilization/disinfection and rinsing were not significant. |
| Patient Biocompatibility | Safe for patient use (no significant toxicity, cytotoxicity, hemolysis, irritation). | All biocompatibility testing demonstrated that Peract™ 20 is safe for the patient when used according to instructions for use (evaluated effect of residues, cytotoxicity, hemolysis, acute toxicity, and vaginal (mucosal membrane) irritation). |
| Material Compatibility | Compatible with a wide range of materials and endoscopes. | Material compatibility testing demonstrated that Peract™ 20 is compatible with the materials and devices listed (included soaking and cycling common materials and endoscopes for the estimated lifetime of the items) when used according to the instructions for use. |
| Shelf Life Stability | Chemical and physical stability within specifications at expiration date (1 year). | Stability studies demonstrated that the chemical and physical stability of Peract™ 20 were within specifications at the expiration date, performed according to section (111)(F)(3) of the Liquid Chemical Germicide Document. |
| Indicator Test Strips | ||
| MEC Verification Accuracy | Consistently and accurately test the germicide at its MEC (500 ppm PAA). | Peract™ 20 Indicator Test Strips demonstrated to consistently and accurately test the germicide at its minimum effective concentration of 500 ppm peracetic acid when three test strips were used. Performed appropriately when three strips were used as called out in the directions for use. |
| Strip Efficacy | Efficacy when exposed to Peract™ 20. | Tested through exposure to Peract™ 20. |
| Strip Shelf Life Stability | Stable over the labeled shelf life. | Tested and shown to be stable over the labeled shelf life. |
| Strip In-Use Stability (Opened Bottle) | Stable in the opened bottle for 30 days. | Tested and shown to be stable in the opened bottle for 30 days. |
2. Sample Size Used for the Test Set and Data Provenance
- Sporicidal Testing: Performed on three lots of Peract™ 20. Sporicidal simulated use testing was also performed on endoscopes (specific number not provided).
- Tuberculocidal Testing: Performed on three lots of Peract™ 20. Tuberculocidal simulated use testing was also performed on endoscopes (specific number not provided).
- Virucidal/Fungicidal/Bactericidal Testing: Sample size (number of tests/batches) for these specific tests is not explicitly stated beyond the general statement of "Peract™ 20 was determined to be virucidal" and "Peract™ 20 was considered fungicidal" and "Use dilution testing showed the efficacy of Peract™ 20".
- Clinical Testing of Used Scopes: "Clinical testing of used scopes" was performed, but the specific number of scopes or the nature of the clinical study (e.g., number of patients, number of cycles) is not provided.
- Biocompatibility Testing: Performed as "Standard patient toxicity testing" but the sample size of materials, animal models, or human volunteers is not specified.
- Material Compatibility: "Testing included soaking and cycling common materials and endoscopes for the estimated lifetime of the items," but specific numbers of materials or endoscopes are not provided.
- Stability Studies: Performed on Peract™ 20 (number of lots/batches not specified).
- Test Strips: "Performed on a minimum of three lots of strips using Peract™ 20 diluted to various concentrations (including around the MEC)."
- Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. Given the context of a 510(k) submission, it is likely that the efficacy and performance studies were prospectively designed and conducted by the manufacturer (Minntech Corporation), likely in the US, to demonstrate performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish a "ground truth" for the test set in the way one might for diagnostic imaging devices. The efficacy and performance of the liquid sterilant/disinfectant and test strips are determined by standardized laboratory methods (e.g., AOAC sporicidal testing, specific viral, fungal, and bacterial assays, chemical stability tests) and direct physical/chemical measurements.
For clinical testing of used scopes, evaluation of residues would likely be performed by laboratory personnel following established protocols, rather than requiring expert consensus on a 'ground truth' interpretation.
4. Adjudication Method for the Test Set
Not applicable in the context of this type of device and study design. The studies described are primarily laboratory-based efficacy, stability, and compatibility tests with objective endpoints (e.g., microbial kill, chemical concentration, material integrity) rather than subjective interpretations requiring adjudication.
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 the effect of AI assistance on their performance is evaluated. PERACT™ 20 is a liquid sterilant/disinfectant and indicator test strip, not a diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies conducted for the PERACT™ 20 Liquid Sterilant/Disinfectant and Peract™ 20 Indicator Test Strips can be considered standalone performance assessments. The efficacy (sporicidal, tuberculocidal, virucidal, fungicidal, bactericidal), biocompatibility, material compatibility, and stability of the liquid sterilant were evaluated intrinsically, without human intervention in the primary mechanism of action. Similarly, the indicator test strips' ability to accurately detect the MEC was evaluated as a standalone product performance.
7. The Type of Ground Truth Used
The ground truth used for the various studies can be categorized as:
- Microbiological Culture/Assay Results: For sporicidal, tuberculocidal, virucidal, fungicidal, and bactericidal efficacy, the "ground truth" is the verified destruction or inactivation of specific microorganisms as determined by standard microbiological culture techniques or assays.
- Chemical Analysis: For the minimum effective concentration (MEC) verification (test strips) and stability studies, the "ground truth" is the actual chemical concentration of peracetic acid (PAA) as measured by calibrated analytical methods.
- Laboratory Testing/Instrumental Analysis: For residuals and material compatibility, the "ground truth" is determined by objective laboratory measurements and observations (e.g., chemical assays for residues, physical integrity assessments for material compatibility).
- Standardized Biocompatibility Assays: For biocompatibility testing, the "ground truth" is established by the outcomes of validated in vitro and in vivo toxicological tests.
8. The Sample Size for the Training Set
Not applicable. This device is a chemical sterilant/disinfectant and associated test strips, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.