(167 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 30°C. Sterilox is a single use product generated on site by the Maxigen II (E200) generator for use at its MRC of 400-450 ppm (AFC). The Sterilox high level disinfectant is intended for processing only in an automated endoscope reprocessor or washer disinfector with FDA-cleared capability to maintain the solution temperature at 30°C.
The device 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 (NaCl). The disinfectant is then circulated on the internal and external surfaces of re-usable heat-sensitive medical devices within a washer-disinfector AER with FDA-cleared capability to maintain the solution temperature at 30°C 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 provided text regarding the Sterilox™ High Level Disinfectant System, structured to answer your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Method) | Reported Device Performance |
|---|---|
| Sporicidal Activity of Disinfectants; AOAC Official Method 966.04 | Meets liquid chemical High level disinfectant efficacy requirements |
| Confirmatory Sporicidal Activity of Disinfectants; AOAC Official Method 966.04 | Meets liquid chemical High level disinfectant efficacy requirements |
| Fungicidal Activity of Disinfectants (AOAC 6.3.02:1995, Official Method 955.17) | Solution is fungicidal |
| Use-Dilution Method (AOAC 6.2.01:1995, Official Methods 955.14, 955.15, 964.02) | Solution is bactericidal |
| EPA Virucidal Testing (DIS/TSS-7, Nov. 1981) | Solution is virucidal |
| Quantitative Tuberculocidal Test | Solution is tuberculocidal |
| Simulated Use Test | Meets efficacy requirements |
| Clinical In-Use (Organisms remaining on flexible endoscopes after clinical use) | No surviving microorganisms on any of the endoscopes tested |
| Residue Testing (after disinfection and rinsing) | Sterilox components effectively removed, no additional risk to patient/user |
| Skin Irritation (Rabbits) | Non-irritating |
| Skin Sensitization (Guinea Pig) | Non-sensitizing |
| Acute Dermal Toxicity (Rabbits) | Dermal LD50 > 2 g/kg body weight |
| Acute Oral Toxicity (Rats) | Dermal LD50 > 5 g/kg body weight |
| Primary Eye Irritation (Rabbits) | Non-irritating |
| Bacterial Mutation Assay | Non-mutagenic |
| Cytotoxicity | Non-cytotoxic |
| Materials Compatibility (corrosion, damage, appearance) | No corrosion or visible damage in majority of endoscope components; some color changes/tack on sheaths; corrosion on anodized aluminum. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific numerical sample sizes for each microbiological or toxicity test test set, other than:
- "Clinical In-Use": "No surviving microorganisms on any of the endoscopes tested" implies a sample size of multiple endoscopes, but the exact number isn't given.
- "Simulated Use Test": "inoculated scopes were processed in Sterilox and AER for 10 minutes at 30° C." implies multiple scopes, but quantity not specified.
- General Microbiological Tests (AOAC, EPA methods): These methods typically have defined sample sizes, but the report summarizes the results rather than detailing the experimental setup for each test performed on this specific device.
Data Provenance: The information provided generally describes laboratory testing (e.g., AOAC methods for efficacy, animal studies for toxicity). There is no explicit mention of data origin (e.g., country) for these studies. The "Clinical In-Use" implies real-world usage, making it prospective in nature for that specific part of the study. The remaining tests are laboratory studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no information in the provided text about the use of "experts" to establish ground truth in the way one might for diagnostic AI. The ground truth for the microbiological efficacy tests and toxicological tests is established by standardized laboratory methods (e.g., AOAC, EPA protocols) which inherently define what constitutes a positive or negative result. For instance, for sporicidal activity, the ground truth is whether spores are killed as per the method's criteria, not an expert's interpretation of an image.
4. Adjudication Method for the Test Set
Not applicable. This device is a high-level disinfectant, not an AI or diagnostic tool where expert adjudication of results would typically be employed. The tests are laboratory-based and use objective endpoints.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is a chemical disinfectant, not a diagnostic imaging device or AI algorithm for human interpretation enhancement. Therefore, an MRMC study is not relevant or included in this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in the sense that all efficacy and safety studies were conducted on the device itself (the Sterilox Liquid Chemical High Level Disinfectant System and its germicide solution), demonstrating its performance independently without a human interpretation component that would require "human-in-the-loop" considerations.
7. The Type of Ground Truth Used
The ground truth used for this device's evaluation is primarily:
- Laboratory outcomes/direct measurements: For microbiological efficacy, it's the destruction or inactivation of specific microorganisms (e.g., spores, bacteria, fungi, viruses, mycobacteria) under specified conditions, measured by standard laboratory culture techniques.
- Physiological/toxicological responses: For toxicity, the ground truth is the observable response (or lack thereof) in animal models (e.g., irritation, sensitization, LD50 values, mutagenicity) against established biological endpoints.
- Chemical analysis: For residue data, the ground truth is the quantifiable level of Sterilox components remaining after rinsing.
- Physical observation: For material compatibility, the ground truth is visible changes, damage, or corrosion.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device. There is no "training set" in the context of supervised learning. The testing described is empirical validation against pre-defined performance standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device submission.
§ 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.