(17 days)
Coverage HBV is used to inactivate specific bacteria, fungi and viruses on hard inanimate surfaces including reusable non-critical medical devices and environmental surfaces in healthcare facilities.
Coverage HBV is a liquid chemical germicide utilizing quatinary ammonium chloride compounds as active ingredients.
The provided text describes a disinfectant product, Coverage HBV, and its effectiveness against various microorganisms. It is not a medical device in the context of AI/ML or image analysis, so the requested information categories regarding acceptance criteria, study methodologies, expert involvement, and ground truth establishment (which are typical for AI/ML-based medical devices) are not applicable.
However, I can extract the information that is present and indicate where the requested categories are not relevant for this type of product.
Description of Coverage HBV and its Effectiveness:
This document is a 510(k) Summary for a General Purpose Disinfectant named Coverage HBV.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category (Relevant for AI/ML devices, described for disinfectant effectiveness here) | Reported Performance (Disinfectant Effectiveness) |
|---|---|
| Germicidal Efficacy | Approved by EPA as effective against: * S. aureus * S. choleraesuis * Ps. aeruginosa * Other bacteria |
| Fungicidal Efficacy | Approved by EPA as effective against: * T. mentagrophytes * Aspergillus candidus * Aspergillus niger * Candida albicans * Penicillium chermesinum * Penicillin oxalicum * Penicillium spinulosum * Ulocladium sp. |
| Virucidal Efficacy | Approved by EPA as effective against: * Avian Influenza/Turkey/Wisconsin Virus * Cytomegalovirus * Hepatitis B Virus * Herpes Simplex type 2 Virus * Influenza A Virus * Influenza B Virus * Influenza C Virus * Measles Virus * Newcastle Disease Virus * Parainfluenza type 1 Virus * Poliovirus type 1 * Porcine Parovirus * Pseudorabies Virus * T1 bacteriophage * T4 bacteriophage * Vaccinia |
| Safety Data | Acute Oral LD50 (Rats) = 5,000 mg/kg |
| Acute Dermal LD50 (Rabbits) = 2,000 mg/kg | |
| Dermal Irritation (Rabbit) neat = Corrosive | |
| Eye Irritation (Rabbit) neat = Severe nonreversible irritation | |
| Eye Irritation (Rabbit) 1:64 aqueous dilution = No irritation | |
| Dermal Sensitization (Guinea Pig) = Negative as sensitizer |
Explanation of Non-Applicability for AI/ML-specific questions:
The following requested points are specific to the study and validation of AI/ML-based medical devices, which Coverage HBV (a chemical disinfectant) is not. Therefore, this information is not available or relevant in the provided text.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a chemical disinfectant. The "test set" here refers to the microorganisms and toxicology models used in laboratory effectiveness and safety studies, not a digital dataset.
- 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): Not applicable. Ground truth for a disinfectant is established through standardized microbiological and toxicological laboratory assays, not expert clinical review.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 for AI-assisted human reading tasks.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithm performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a disinfectant, the "ground truth" is determined by the results of standardized laboratory tests demonstrating microbial inactivation and safety, as regulated by bodies like the EPA.
- The sample size for the training set: Not applicable. This refers to AI model training data.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document details the effectiveness and safety profiles of a chemical disinfectant according to regulatory approvals (EPA) rather than the performance metrics and study designs typically associated with AI/ML medical devices.
§ 880.6890 General purpose disinfectants.
(a)
Identification. A general purpose disinfectant is a germicide intended to process noncritical medical devices and equipment surfaces. A general purpose disinfectant can be used to preclean or decontaminate critical or semicritical medical devices prior to terminal sterilization or high level disinfection. Noncritical medical devices make only topical contact with intact skin.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.