(351 days)
Sterilox is a high level disinfectant system intended for processing heat-sensitive medical devices when used according to the User Manual with an immersion time of ten (10) minutes at 25°C. Sterilox is a single use product generated on site for use at its MRC of 650-675 ppm (AFC). Sterilox is intended for use with manual or automatic endoscope reprocessing protocols.
Sterilox High Level Disinfectant system is intended for use by qualified health care personnel trained in its use.
The Sterilox Liquid Chemical High Level Disinfectant System is an apparatus that produces a single use High Level Disinfectant by on-site electrochemical activation (electrolysis) of a dilute aqueous solution of sodium chloride (NaCI). The germicide is then circulated through and about reusable heat-sensitive medical devices either in a manual system or within a typical washer-disinfector used in hospitals, clinics and various other health care settings. It is a device intended for use by qualified healthcare personnel trained in its use.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided 510(k) Summary.
Acceptance Criteria and Device Performance for Sterilox Liquid Chemical High Level Disinfectant System
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the efficacy tests performed and the results reported as "Meets (efficacy) requirements" or "Solution is..." (e.g., fungicidal, bactericidal, virucidal, tuberculocidal). For "High Level Disinfectant", the primary criteria relate to the destruction of specific microorganisms within a defined time and temperature.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Microbiological Efficacy: | |
| Spore inactivation (Bacillus subtilis, Clostridium sporogenes) | Meets liquid chemical sterilant efficacy requirements (via AOAC Official Method 966.04) |
| Fungicidal activity (Trichophyton mentagrophytes) | Solution is fungicidal |
| Bactericidal activity (Salmonella choleraesuis, Staphylococcus aureus, Pseudomonas aeruginosa) | Solution is bactericidal |
| Virucidal activity (Herpes Simplex I, Poliovirus II, HIV Type I) | Solution is virucidal |
| Tuberculocidal activity (Mycobacterium bovis) | Solution is tuberculocidal |
| Simulated Use Efficacy (Bacillus subtilis, Clostridium sporogenes) | Meets efficacy requirements (Flexible fiber optic endoscopes contaminated with >10⁶ cfu spores) |
| Simulated Use Efficacy (Mycobacterium terrae) | Meets efficacy requirements (Flexible fiber optic endoscopes contaminated with >10⁶ cfu) |
| Clinical In-Use Efficacy (flexible endoscopes) | No surviving microorganisms on any of the endoscopes tested |
| Residue Data: | |
| Effective removal from complex devices | Effectively removed from a complex device like a flexible endoscope by the rinse cycle after disinfection, posing no additional risk |
| Toxicological Evaluation: | |
| Non-irritating (Skin, Eye) | Non-irritating (Rabbits for Skin, Primary Eye) |
| Non-sensitizing (Skin) | Non-sensitizing (Guinea Pig) |
| Acceptable Dermal Toxicity (LD50) | Dermal LD50 > 2 g/kg body weight (Rabbits) |
| Acceptable Oral Toxicity (LD50) | Dermal LD50 > 5 g/kg body weight (Rats) |
| Non-mutagenic | Non-mutagenic (Bacterial Mutation Assay) |
| Minimal patient/user health risks | Minimal health risks to patient and operator. Unlikely to pose a significant risk. |
| Materials Compatibility: | |
| No corrosion or visible damage to most endoscope components | Does not produce corrosion or visible damage in majority of endoscope components. (Note: Color changes/tack of coating on some, corrosion on anodized aluminum) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a single comprehensive "test set" sample size in terms of the number of unique devices or the overall quantity of tests performed for all criteria. Instead, it lists various studies, each with its own sample considerations, but the exact number of replicates or individual samples within each test is not provided in this summary.
Data Provenance: The document does not specify the country of origin for the data. The studies are described as lab-based efficacy tests (e.g., AOAC methods) and simulated-use/clinical in-use tests. It can be inferred that these are prospective studies conducted specifically for this 510(k) submission, rather than retrospective analyses of pre-existing data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the 510(k) summary. For microbiological efficacy studies, the "ground truth" is typically established by the laboratory performing the tests and adhering to standardized methodologies (e.g., AOAC, EPA). The interpretation of results against pass/fail criteria is inherent in these methods. There's no mention of a separate panel of experts establishing ground truth for individual test outcomes beyond the standard practices of the testing labs.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method in the context of multiple readers or reviewers for the test results. The efficacy tests are primarily quantitative (e.g., log reduction, survival/non-survival) and are typically evaluated against pre-defined acceptance criteria specified by the test method (e.g., AOAC, EPA guidelines).
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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study (MRMC for human readers improving with AI) is relevant for diagnostic imaging AI devices where human interpretation is assisted by AI. The Sterilox Liquid Chemical High Level Disinfectant System is a physical disinfectant system, not a diagnostic AI tool, so an MRMC study is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the primary efficacy testing represents "standalone" performance in the sense that the disinfectant solution's performance was evaluated inherently. While a human initiates the process and follows instructions, the efficacy (microbial kill, toxicological safety, etc.) is an intrinsic property of the chemical system itself when used as directed, independent of ongoing human-in-the-loop decisions during its operation for a specific disinfection cycle. The "Microbiological Efficacy" and "Residue Data" sections specifically detail these standalone performance evaluations.
7. The Type of Ground Truth Used
The ground truth used for the efficacy studies can be categorized as follows:
- Microbiological Culture Results: For all microbial efficacy tests (sporicidal, fungicidal, bactericidal, virucidal, tuberculocidal, simulated use, clinical in-use), the "ground truth" is determined by established laboratory methods that quantify or qualitatively assess the survival or death of target microorganisms. This involves culturing residual organisms after exposure to the disinfectant.
- Analytical Chemistry/Toxicology Assays: For residue data and toxicological assessments, the "ground truth" is derived from quantitative analytical tests for chemical residues and standardized biocompatibility/toxicology assays (e.g., skin irritation, mutation assays).
8. The Sample Size for the Training Set
This device does not utilize a "training set" in the context of machine learning or AI. Therefore, this question is not applicable. The development of chemical disinfectants relies on chemical formulation, microbiology, and toxicology, not statistical models trained on data.
9. How the Ground Truth for the Training Set was Established
As there is no "training set" for this type of device, the concept of establishing ground truth for it is 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.