(200 days)
Resert™ XL HLD is a ready to use liquid chemical germicide. The product is a 2.0% nominal hydrogen peroxide solution. The minimum recommended concentration (MRC) is 1.5%. Resert XL HLD is intended to be used by health care practitioners in clinical settings as a ready to use liquid chemical disinfectant for the high level disinfection of semi-critical medical devices for which alternative methods of terminal reprocessing are not suitable or available.
High Level Disinfectant: Resert™ XL HLD High Level Disinfectant is a high level disinfectant when used or reused undiluted for a maximum of 21 days at a minimum temperature of 20℃ (68°F) for a minimum immersion time of 8 minutes.
Resert XL HLD High Level Disinfectant is a nominal 2.0% hydrogen peroxide solution, buffered with furoic acid and phosphorous acids. Hydrogen peroxide is the active ingredient in Resert XL HLD, which exerts its germicidal action via a strong oxidation reaction of cellular components.
Here's a breakdown of the acceptance criteria and study information for the Resert™ XL HLD High Level Disinfectant, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Criterion | Acceptance Criteria (Implied by equivalence) | Reported Device Performance (Resert XL HLD) |
|---|---|---|
| Microbiological Efficacy | ||
| AOAC Sporicidal Test (B. subtilis, C. sporogenes) | Meets sporicidal efficacy requirements (as demonstrated by predicate) | Meets sporicidal efficacy requirements |
| AOAC Use-Dilution Test (P. aeruginosa, S. aureus, S. enterica) | Bactericidal (as demonstrated by predicate) | Stressed solution is bactericidal |
| AOAC Fungicidal Test (T. mentagrophytes) | Fungicidal (as demonstrated by predicate) | Stressed solution is fungicidal |
| EPA Virucidal Test (Poliovirus Type I, Herpes Simplex Type 1, Adenovirus Type 5) | Virucidal (as demonstrated by predicate) | Stressed Solution is virucidal |
| Tuberculocidal Activity Test (M. terrae) | Tuberculocidal (as demonstrated by predicate - M. bovis) | Stressed solution is tuberculocidal |
| Simulated Use Test (M. terrae) | Meets efficacy requirements (as demonstrated by predicate) | Meets efficacy requirements (≥ 6 log10 reduction of test organism for endoscope sets after 8 minutes contact with stressed solution) |
| Toxicological Evaluation | ||
| Primary dermal Irritation | Comparable to predicate (SPOROX: Moderate irritant) | Slight irritant |
| Acute Dermal Toxicity | Dermal LD50 >5000 mg/kg body weight (as demonstrated by predicate) | Dermal LD50 >5000 mg/kg body weight |
| Ocular Irritation | Comparable to predicate (SPOROX: Severe irritant) | Mild irritant |
| Acute Oral Toxicity | Oral LD50 >5000 mg/kg body weight (as demonstrated by predicate) | Oral LD50 >5000 mg/kg body weight |
| Skin sensitization | Non-sensitizing (as demonstrated by predicate) | Non-sensitizing |
| Bacterial Reverse Mutation Assay (Ames Test) | Non-mutagenic (as demonstrated by predicate) | Non-mutagenic |
| Material Compatibility | No significant cosmetic changes or functional alteration after exposure | Validated through testing on various plastics, metals, and elastomers for up to 134 hours (1005 disinfectant cycles) at 25±2°C. No significant cosmetic changes or functional alteration observed on flexible endoscopes after 134 hours immersion. |
| Stability/Shelf-Life | At least 1 year shelf-life (unopened), and 21 days reuse life (opened) | At least 1 year shelf-life (unopened); reused for up to 21 days at minimum 20°C (68°F) |
| In-Use Efficacy (Clinical Endoscopes) | Effectively high level disinfected | Effectively high level disinfected (pre-cleaned, representative patient soiled endoscopes manually reprocessed for 8 minutes at ≥ 20°C) |
Study Details:
2. Sample Size Used for the Test Set and Data Provenance:
- Microbiological Efficacy Testing: Not explicitly stated for each individual test, but the methods (AOAC, EPA) generally involve specific numbers of replicates for bacterial/fungal/viral challenges.
- Toxicological Evaluation: Not explicitly stated. Standard toxicology tests involve specific numbers of animal subjects per group as per regulatory guidelines.
- Material Compatibility:
- Generic Materials: "A number of different plastic, metals, and elastomers" were evaluated. No specific count is given.
- Actual Devices: Two Fujinon and Olympus flexible colonoscope sets (including procedural and cleaning/reprocessing accessories) were tested.
- Simulated Use Testing: Five clinical endoscope sets (comprised of flexible endoscopes, procedural endoscope accessories, and cleaning accessories) were tested.
- In Use Testing: Not explicitly stated, but refers to "Pre-cleaned, representative patient soiled endoscopes".
- Data Provenance: The document does not specify the country of origin for the data. The testing appears to be prospective bench testing and simulated/in-use testing conducted by STERIS Corporation to demonstrate the device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided in the document. The studies are primarily lab-based performance tests (microbiological, toxicological, material compatibility) rather than studies requiring expert human interpretation of results in a clinical setting. The "ground truth" for these tests is established by published regulatory standards (e.g., AOAC, EPA methods) for determining efficacy.
4. Adjudication Method for the Test Set:
- Not Applicable. The studies described are laboratory and simulated/in-use performance tests, not clinical studies requiring human reader adjudication to establish ground truth.
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:
- No. This device is a high-level disinfectant, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. All the reported performance tests (microbiological, toxicological, material compatibility, simulated use) are "standalone" in the sense that they evaluate the disinfectant's efficacy directly against established standards without human intervention in the disinfection process or its immediate outcome assessment. The "device" (the chemical disinfectant) functions independently of human interpretation for its primary action.
7. The Type of Ground Truth Used:
- Regulatory/Standardized Test Methods and Measurable Outcomes:
- Microbiological Efficacy: Ground truth is established by the ability to achieve specific log reductions of test organisms (e.g., ≥ 6 log10 reduction for Mycobacterium terrae), as defined by standardized test methods like AOAC and EPA.
- Toxicological Evaluation: Ground truth is defined by specific quantitative thresholds (e.g., LD50 values) and qualitative observations (e.g., "slight irritant," "non-sensitizing") as determined by standardized toxicology protocols.
- Material Compatibility: Ground truth is determined by the absence of "significant cosmetic changes" and the maintenance of "functional" integrity, evaluated against visual and functional criteria after exposure.
- Stability: Ground truth is the ability to maintain efficacy (e.g., retain minimum recommended concentration) and physical properties over time as per shelf-life and reuse claims.
8. The Sample Size for the Training Set:
- Not Applicable. This is a chemical disinfectant, not a machine learning or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As no training set is involved, there is no ground truth to be established for it.
§ 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.