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510(k) Data Aggregation
(338 days)
Tristel Duo ULT is a high level disinfect foam for reprocessing ultrasound probes. It can be used to high level disinfect endocavity transvaginal and transrectal probes, and skin surface transducers that may contact non-intact skin during use.
Tristel Duo ULT is a high level disinfectant when used in accordance with the directions for use, including a disinfection contact time of 2 minutes, at room temperature and a concentration at or above Minimum Recommended Concentration (MRC).
Tristel Duo ULT must be applied on the surface of an ultrasound probe using Duo Wipes.
Duo Wipes are intended to apply Tristel Duo ULT foam on the surface of ultrasound probes and to remove residue of the foam after high level disinfection.
Each dose of Tristel Duo ULT foam and each Duo Wipe are single use.
The semi-critical ultrasound probes reprocessed by Tristel Duo ULT must first be cleaned according to a validated cleaning protocol or standard and following the device manufacturers' instructions.
Tristel Duo ULT foam bottle is designed in a way that ensures measured dose delivery with each application generating active ingredient above the MRC.
MRC: ~90% v/v (~280ppm) at point of use. MRC of Tristel Duo ULT may be verified using Duo Test Strips.
Tristel Duo ULT is intended to be marketed for prescription use.
Tristel Duo ULT is a high level disinfectant foam intended to disinfect cleaned, reusable, nonlumened ultrasound probes. Tristel Duo ULT is intended to be used by qualified healthcare personnel. Tristel Duo ULT does not sterilize.
Tristel Duo ULT generates chlorine dioxide foam from two "precursor" solutions (Base Solution and Activator Solution), which are packaged separately within two individual containers and secured together within a single dispenser apparatus known as the "pump" shown in Figure 2. When depressed, the pump dispenses these solutions at equal volumes.
The components of the Base and Activator solutions chemically react. This reaction generates chlorine dioxide in liquid solution, which is the active germicidal ingredient. A mesher present in the applicator pump causes the formulation to be dispensed as a ready-to-use foam.
The active ingredient in Tristel Duo ULT high level disinfectant is chlorine dioxide, which is generated in situ from the Activator and Base solutions. Tristel Duo ULT also contains other (D) CI (b) 49 ingredients, such as sodium chlorite, citric acid monohydrate. (0) 49)
The Duo bottle configuration consists of the two bottles (containers), a single pump head with two thread neck closures and a cap. Each Duo bottle contains 125 milliliters (mL)/4.40 fl oz of Base Solution and 125 mL/4.40 fl oz of Activator Solution. The left and right containers are made to the same specification, with the difference in the orientation of the neck thread. The bottle is handheld. Shown in Figures 3 and 4.
An 80% V/V dilution of Duo was determined as the Minimum Effective Concentration (MEC) for Duo.
Duo Wipes are dry, non-woven, low-linting wipes. They are specifically designed to apply the Tristel Duo ULT foam onto the surface of a medical device. A user lays the Duo Wipe in one hand and applies 4 doses of the Tristel Duo ULT foam before closing their hand around the wipe and waiting for 10 seconds. The wipe can then be used to spread the foam in a massaging motion from one end of the device to the other 4 times. After the device is wiped, it is left undisturbed for 2 minutes.
The Duo Test Strips are semi-quantitative chemical indicators used to determine whether the concentration of the Tristel Duo ULT high level disinfectant foam is above or below the minimum recommended concentration (MRC) (~90% v/v /~280 ppm).
Tristel Duo ULT foam bottle is designed in a way that ensures measured dose delivery with each application generating active ingredient above the MRC.
The Duo Test Strips, when used in accordance with directions for use detect the MRC and above giving a color indication of a "PASS" and if the concentration is below the MRC a color indication of a "FAIL".
This document describes the regulatory acceptance of a medical device, a high-level disinfectant, not an AI/ML-driven diagnostic device. Therefore, many of the requested criteria related to AI/ML study design (e.g., sample size for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, etc.) are not applicable to the Tristel Duo ULT disinfectant.
However, I can extract and present the acceptance criteria and the study performance for the disinfectant, re-framing the questions where relevant to fit the context of a chemical disinfectant.
Device Name: Tristel Duo ULT high level disinfectant
Device Type: Foam or gel chemical sterilant/high level disinfectant
Regulatory Class: Class II
Acceptance Criteria and Reported Device Performance
The acceptance criteria for a chemical high-level disinfectant are primarily demonstrated through a series of performance efficacy tests, biocompatibility, and human factors evaluations. The "performance" in this context refers to the device's ability to effectively disinfect, maintain stability, and be safely used.
Here's a table summarizing the acceptance criteria (often stated as special controls and performance tests required) and the reported device performance for Tristel Duo ULT:
| Acceptance Criteria (Special Controls / Required Performance) | Reported Device Performance / Study Finding |
|---|---|
| 1. Non-clinical performance testing demonstrates intended performance under anticipated conditions of use. | "The device has been appropriately evaluated for performance on the bench." |
| 1. (i) Storage stability testing: Demonstrate real-time stability and dynamics within expiration date (shelf life) of unopened product and use period of opened container. | Supported: "A two-year shelf life of the product from the date of manufacture of the unopened product" and "a use period of six months of the opened container from the date of opening under the prescribed storage conditions of room temperature (15-25°C)." |
| 1. (ii) Transport stability testing: Demonstrate resilience to transport conditions (temperature, pressure, humidity, freeze/thaw, mechanical impacts). | Supported: "Resilience to transport conditions (such as temperature, pressure, and humidity), environmental factors (such as freeze and thaw), and mechanical impact (such as drop effect on package integrity) and the capability of maintaining its composition (physical and chemical integrity)." |
| 1. (iii) Potency testing: Demonstrate sporicidal, mycobactericidal, fungicidal, bactericidal, and virucidal activities. | Confirmed: Has "passed the AOAC Sporicidal Activity Test in 12 hours and additional potency tests against mycobacteria, fungi, bacteria and viruses in 2 minutes at 20°C at a worst case concentration below the MRC at 80% v/v of the nominal concentration of Duo." "The test results qualify Tristel Duo ULT as a high level disinfectant." "Confirmed by an independent laboratory." |
| 1. (iv) Simulated use testing: Use mycobacterium species most resistant to germicide on inoculated instruments to demonstrate >= 10^6 kill under labeled contact time. | Demonstrated: "Simulated-use tests were provided, with a total of six skin surface ultrasound probes and a total of seven endocavity ultrasound probes were tested in triplicate. It demonstrated the penetrating capability of this high-level disinfectant along with other factors that may prevent or limit contact and effectiveness of the germicide." (Note: The prompt implies specific quantitative kill was achieved, though not explicitly stated with the number 10^6 in this section). |
| 1. (v) In-use testing: Test clinical-relevant microorganisms on clinically used instruments to confirm simulated use testing results. | Confirmed: "In-use tests were conducted under clinical condition with wild type bacteria and fungi from patient contaminated BK Medical endocavity ultrasound probes. It confirmed the results of simulated-use testing and high level disinfectant performance in clinical use conditions." |
| 1. (vi) Compatibility testing: With labeled devices and materials. | Supportive: "Material compatibility testing with ultrasound device manufacturers was conducted and supportive of compatibility on various ultrasound probes and equipment." "Evaluated compatibility of Tristel Duo ULT with their ultrasound devices assessing the impact Duo high level disinfectant has on the materials and functionality." |
| 1. (vii) Chemical indicator validation: Demonstrate characteristic chemical reaction to concentration of active ingredients (relevant for Duo Test Strips). | Adequate: "A chemical indicator validation test was provided, with adequate performance testing and shelf life/stability testing, to support that the Duo test strip is appropriately designed to respond with a characteristic chemical reaction to the concentration of the germicide active ingredients of Tristel Duo ULT." |
| 2. Biocompatibility: Device must be demonstrated to be biocompatible (for user and patient exposure to residues). | Acceptable: Various studies were provided for "Duo Working Solution," "Duo with Duo Wipes," and "Duo Residues" (e.g., Genotoxic tests, Skin Irritation/Sensitization, Acute Eye/Oral, Cytotoxicity, Mucosa Irritation, exhaustive extractable and leachable, inhalation toxicity) and "The results of these tests are deemed acceptable." |
| 3. Usability/Human Factors Validation Testing: Demonstrate correct use based solely on directions for use. | Safe and Effective: "A simulated-use human factors (HF) study was provided... It included participants representative of the intended healthcare professionals and reprocessing technicians... 27 assessments... found that users understood." "The provided human factors validation testing results, analyses and conclusions established that Tristel Duo ULT is safe and effective for the intended users, its intended uses, and use environments." |
| 4. Labeling requirements: Includes detailed instructions, warnings, use-life, storage, training, disposal, classification, compatibility, mode of action, toxicology. | Comprehensive: "The labeling consists of Instructions for Use... and packaging labels... includes the indications for use; a description of the device, contraindications, warnings, precautions; information on use-life; instructions for the safe use of the device... storage condition and stability information, user training, emergency and/or additional information, disposal; germicide classification scheme... general information on selection and use of germicides... material and device compatibility; mode of action... precleaning agent compatibility; toxicology and adverse reactions." |
Given that this is a chemical disinfectant and not an AI/ML diagnostic device, the following points are generally not applicable or are addressed in a different manner than for an AI/ML system:
- Sample size used for the test set and the data provenance: Not applicable in the context of an AI test set. Performance is based on standardized microbiological and chemical tests and human factors studies. For simulated use, "six skin surface ultrasound probes and a total of seven endocavity ultrasound probes were tested in triplicate." For in-use testing, "wild type bacteria and fungi from patient contaminated BK Medical endocavity ultrasound probes" were used. Data provenance is implied to be from laboratory testing and clinical settings relevant to the device's use.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" for a disinfectant is established by validated microbiological methods (e.g., AOAC standards) and chemical analyses, not expert consensus on medical images. Expertise lies in microbiology, chemistry, and regulatory science.
- Adjudication method for the test set: Not applicable. Performance is measured objectively by laboratory assays (e.g., log reduction of microorganisms).
- 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 not an AI-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. Not an algorithm. Its performance is inherent to its chemical properties and use protocol (human-in-the-loop for proper application).
- The type of ground truth used:
- Microbiological Efficacy: Ground truth established via validated culture methods demonstrating log reduction of specified microorganisms (spores, mycobacteria, fungi, bacteria, viruses) under controlled laboratory conditions.
- Chemical Stability/Concentration: Ground truth established via analytical chemistry methods to determine active ingredient concentration over time and under various conditions.
- Biocompatibility: Ground truth established via ISO 10993 series of biological evaluation tests.
- Human Factors: Ground truth established through observation of user performance on critical tasks during simulated use scenarios, assessing task completion and identification of use errors.
- The sample size for the training set: Not applicable. This is not an AI/ML device; there is no "training set" in the computational sense. Development involves formulation and iterative testing.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided text robustly details the experimental evidence required for a chemical high-level disinfectant, emphasizing its efficacy against various microbes, its stability, material compatibility, user safety (biocompatibility and human factors), and appropriate labeling. The "acceptance criteria" are the special controls and performance testing elements outlined, and the "proof" is the successful completion and positive results of all the specified studies.
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