(29 days)
Amerse 2 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 with a 10 minute contact time at 20°C by housekeeping, nurses, and emergency medical personnel.
Amerse 2 is a general purpose disinfectant used to reprocess noncritical devices and medical equipment surfaces and to preclean or decontaminate critical or semi-critical medical devices prior to sterilization or high-level disinfection with a 10 minute contact time at 20°C.
Amerse 2 is a liquid chemical germicide concentrate utilizing phenolic compounds as active ingredients.
The provided text describes the 510(k) summary for "Amerse 2", a liquid chemical germicide. It details the product's description, intended use, and substantial equivalence to existing products, along with safety and effectiveness data. However, the document does not contain information about a study that would include elements like test set sample size, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for AI/ML device evaluation. This document is a regulatory submission for a disinfectant, not an AI/ML medical device. Therefore, I cannot extract the requested information from the provided text.
Specifically, the document focuses on:
- Product: Amerse 2, a general purpose disinfectant.
- Intended Use: Inactivating bacteria, fungi, and viruses on hard inanimate surfaces and non-critical medical devices.
- Effectiveness Data: Passes standard tests (AOAC Germicidal Use-Dilution Test, AOAC Tuberculocidal Test, AOAC Fungicidal Test, Virucidal Qualification Test, EPA approved Dilution Method against HIV-1). These tests are laboratory-based and establish the disinfectant's ability to kill specific microorganisms under controlled conditions.
The questions you've asked are typically relevant to the evaluation of AI/ML-driven medical devices, which rely on extensive datasets, ground truth established by experts, and detailed performance metrics to assess their diagnostic or analytical capabilities. The provided text does not describe such a device or study.
§ 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.