(274 days)
Extended Use Aldahol High Level Disinfectant is intended for the high level disinfection of reusable, clean, heat-sensitive, semi-critical medical devices which contact intact mucous membranes when the disinfectant is used at or above its minimum recommended concentration of 1.8% glutaraldehyde for 5.0 min at 25℃ in an automated endoscope reprocessor with FDA-cleared capability to maintain the exposure of 5.0 min at 25°C.
Extended Use Aldahol High Level Disinfectant is intended for the sterilization of reusable, clean, heat-sensitive critical and semi-critical medical devices which contact and potentially penetrate into sterile body areas, for which there is no other practical method of sterilization, when the disinfectant is used at or above its minimum recommended concentration of 1.8% glutaraldehyde for 6.0 hrs at 25℃.
Extended Use Aldahol High Level Disinfectant (HLD) is an aqueous solution that requires the combination of two parts, the unactivated Extended Use Aldahol HLD solution, packaged in gallon-sized containers, and a red Activator Buffer Salt Solution packaged in a smaller container included with the unactivated Extended Use Aldahol HLD solution container.
Once activated, the red/red-orange Extended Use Aldahol HLD as manufactured contains 3.4% w/w of glutaraldehyde and 20.1% w/w of isopropanol in a buffered salt solution of a surfactant, and potassium acetate intended to enhance the antimicrobial activity of the glutaraldehyde.
The microbial mode of action of glutaraldehyde has been extensively studied and reviewed since glutaraldehyde was introduced as a disinfectant in the late 1960's. All of these reviews indicate that glutaraldehyde cross-links proteins and lipoproteins of microbes to denature the proteins and lipoproteins, thus killing the cells.
The provided text describes the safety and effectiveness testing for the Extended Use Aldahol High Level Disinfectant. While it outlines the efficacy of the disinfectant against various microorganisms and its performance in simulated-use and clinical-use studies, it does not provide information on an AI-powered device or an algorithm. The document is a 510(k) summary for a liquid chemical disinfectant, which is a chemical product, not a medical device in the context of an "algorithm" or "AI assistance" as implied by the request's structure.
Therefore, the requested information pertaining to acceptance criteria of an AI device, sample sizes for test/training sets, expert consensus, MRMC studies, or standalone algorithm performance, cannot be extracted from this document.
The document details the performance of the disinfectant based on meeting regulatory standards for various antimicrobial activities, material compatibility, and stability.
Here's a breakdown of what can be extracted, framed to the best of my ability given the constraint of the request:
1. Table of Acceptance Criteria and Reported Device Performance (as a disinfectant):
| Test/Criteria | Acceptance Criteria (Implied by passing tests) | Reported Device Performance (Extended Use Aldahol HLD) |
|---|---|---|
| High-Level Disinfection | Eliminate specified bacteria, fungi, and viruses | Kills Staphylococcus aureus, Salmonella choleraesuis, Pseudomonas aeruginosa, Trichophyton mentagrophytes, Aspergillus niger, Candida albicans, Mycobacterium terrae (>6 log10 reduction), Adenovirus Type 2, Herpes Simplex Virus Type 1, Human Influenza Virus A, and Poliovirus Type 1 within 5 minutes at 25°C at 1.8% w/w glutaraldehyde. |
| Sterilization | Eliminate specified spores | Sterilizes Bacillus subtilis and Clostridium sporogenes inoculated items within 6.0 hours at 25°C at 1.8% w/w glutaraldehyde. |
| Simulated Use (M. terrae) | >6 log10 reduction of M. terrae on device surfaces/channels after 5 min. | >6 log10 reduction of M. terrae on bronchoscope, gastroscope, and colonoscope surfaces/channels after 5.0 minutes at 25°C with worst-case Aldahol HLD. |
| Simulated Use (B. subtilis) | >6 log10 reduction of B. subtilis on device surfaces/channels after 6 hrs. | >6 log10 reduction of B. subtilis on bronchoscope, gastroscope, and colonoscope surfaces/channels after 6.0 hours at 25°C with Extended Use Aldahol HLD. |
| Clinical Efficacy | No bacteria recovered from patient-used, cleaned endoscopes after HLD exposure. | No (zero) bacteria recovered from patient-used, cleaned bronchoscopes, gastroscopes, and colonoscopes after 5.0 minutes exposure to worst-case Extended Use Aldahol HLD (1.8% w/w glutaraldehyde) at 25°C. |
| Biocompatibility | Residues of glutaraldehyde and isopropanol after rinsing are below toxic limits. | Residues of Extended Use Aldahol HLD remaining on endoscopes after sterilization/HLD and rinsing were well below toxic limits. |
| Material Compatibility | No significant changes or incompatibility with commonly used medical device materials. | Compatible with endoscopes and a variety of materials common in medical facilities at 25°C, with the exception of brass and copper showing changes after 7 hours. |
| Stability (product & activator) | Maintain effectiveness at labeled expiration date. | Both Extended Use Aldahol HLD and the Activator Buffer Salt Solution were found to be stable at the labeled expiration date. |
| Test Strip Accuracy | Accurately test 1.8% w/w glutaraldehyde MRC. | 3M Comply 1.8% Glutaraldehyde Monitor Strips Catalog No. 3987 demonstrated the ability to accurately test Extended Use Aldahol HLD at its MRC of 1.8% w/w glutaraldehyde when used according to Directions for Use. |
| Reuse Period | Maintain effectiveness for up to 14 days or until glutaraldehyde concentration declines below 1.8% w/w. (The tests were performed on "aged and stressed" samples to represent this). | Efficacy testing was performed on aged and stressed product to the end of the 14-day reuse period, still demonstrating required sporicidal, virucidal, fungicidal, and bactericidal activity. Clinical efficacy was shown with product from a 14-day EPA Reuse Test. |
Since the request is about an AI device and the document describes a chemical disinfectant, the following points are not applicable and cannot be answered:
- Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective) - This applies to imaging/diagnostic devices, not chemical disinfectants. The "sample" for this device refers to microorganisms and medical devices, not patient data.
- 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 to a chemical disinfectant.
- 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 as this is not an AI device.
- If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done - Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) - For antimicrobial tests, the "ground truth" is typically the absence or presence and quantity of viable microorganisms after exposure, determined by standard microbiological culturing and counting methods, not expert consensus or pathology in the AI sense.
- The sample size for the training set - Not applicable as there is no AI algorithm being trained.
- How the ground truth for the training set was established - 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.