(310 days)
MedSCI 3% glutaraldehyde may be used to sterilize or high-level disinfect reusable medical devices that are heat labile or otherwise incompatible with other biologically monitored methods of sterilization. MedSCI 3% glutaraldehyde is intended to be used by healthcare practitioners, e.g., doctors, nurses and dentists in various healthcare facilities, e.g., hospitals, doctors offices and dentist offices.
Germicidal Level of Activity of MedSCI 3% glutaraldehyde as a:
Sterilant. MedSCI 3% glutaraldehyde is a sterilant when reusable medical devices are immersed for 10 hours at 25°C. It may be used or reused for a maximum of 28 days if the glutaraldehyde concentration is above the Minimum Effective Concentration (MEC) of 1.8% as determined by the 3M Cold Sterilog® 2.1% Glutaraldehyde Monitor.
High-Level Disinfectant. MedSCI 3% glutaraldehyde is a high-level disinfectant when reusable medical devices are immersed for 25 minutes at 25° C. It may be used or reused for a maximum of 28 days if the glutaraldehyde concentration is above the Minimum Effective Concentration (MEC) of 1.8% as determined by the 3M Cold Sterilog® 2.1% Glutaraldehyde Monitor.
MedSCI 3% glutaraldehyde is an activated glutaraldehyde liquid chemical sterilant and high-level disinfectant when used according to the Directions for Use. The active ingredient in MedSCI 3% glutaraldehyde is glutaraldehyde in a nominal concentration of 3.0%. In addition, the activated solution contains buffers, wetting agent, rust inhibitor, fragrance and a dye that changes the solution green upon activation thereby indicating readiness for use.
This document describes the acceptance criteria and study proving the efficacy of MedSCI 3% glutaraldehyde as a sterilant and high-level disinfectant.
1. Table of Acceptance Criteria and Reported Device Performance
| Claim | Acceptance Criteria (Contact Time, Temp, MEC) | Reported Device Performance (Study/Test) |
|---|---|---|
| Sterilant | 10 hours at 25°C, MEC > 1.8% glutaraldehyde | All spores eliminated in AOAC Sporicidal Test for 3 lots of stressed product. Confirmatory AOAC Sporicidal Test performed on 2 lots. |
| High-Level Disinfectant | 25 minutes at 25°C, MEC > 1.8% glutaraldehyde | Satisfactory results in Quantitative Tuberculocidal Test. Effectiveness against M. Terrae demonstrated in Simulated Use Test for endoscopes. |
| Product Reuse/Shelf Life | Up to 28 days reuse if MEC > 1.8% | Stressed Test with 3 lots for 28 days demonstrated maintained glutaraldehyde concentration at or below MEC for other tests. |
| Effectiveness against Vegetative Bacteria, Fungi, Viruses | Not explicitly stated as a specific acceptance criterion, but required for general disinfectant claims inherent in high-level disinfection. | Satisfactory results at 1.8% MEC. |
2. Sample Size Used for the Test Set and Data Provenance
- Sterilant Claim (AOAC Sporicidal Test): Three lots of MedSCI 3% glutaraldehyde for the primary test, and two lots for the confirmatory test.
- High-Level Disinfection Claim (Quantitative Tuberculocidal Test, Simulated Use Test): Not explicitly stated, but implies sufficient samples for these standardized tests.
- Other Efficacy Tests (Vegetative Bacteria, Fungi, Viruses): Not explicitly stated.
- Stressed Test: Three lots of MedSCI 3% glutaraldehyde.
- 3M Cold Sterilog® Monitor Performance Test: Not explicitly stated, but data analysis included comparative sensitivity and specificity.
The data provenance is not explicitly stated in terms of country of origin. The studies are described as retrospective laboratory performance assessments conducted to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This document describes performance testing for a chemical germicide, not an AI/ML medical device. Therefore, the concept of "experts used to establish ground truth" in the context of clinical interpretation or image annotation is not applicable here. The ground truth is intrinsically defined by standardized microbiological assays (e.g., elimination of spores, killing of specific microorganisms) performed by trained laboratory personnel following established protocols (e.g., AOAC methods).
4. Adjudication Method for the Test Set
Not applicable, as this is laboratory performance testing of a chemical product, not an AI/ML device requiring human adjudication of classifications or interpretations. The results are based on direct observation of microbial growth/eradication.
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
Not applicable. This is a submission for a chemical sterilant/disinfectant, not an AI/ML device that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This is a chemical product, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for the efficacy claims is based on microbiological assay results (e.g., absence of viable microorganisms after treatment, reduction in colony-forming units) following established, standardized test protocols (e.g., AOAC Sporicidal Test, Quantitative Tuberculocidal test, AOAC Use Dilution Test, AOAC Fungicidal Effectiveness Test, Virucidal Effectiveness Test, HIV Effectiveness Test). For the monitor performance, the ground truth is the actual glutaraldehyde concentration as measured by analytical chemistry.
8. The Sample Size for the Training Set
Not applicable. This document pertains to the performance testing of a chemical product, not the development or training of an AI/ML model.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for a chemical product.
§ 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.