(338 days)
QWS, OWS
Not Found
No
The device is a chemical disinfectant and associated application/testing components. There is no mention of any computational or analytical capabilities that would involve AI or ML.
No.
This device is a high-level disinfectant for medical equipment (ultrasound probes), not a therapeutic device that treats or prevents diseases in patients.
No.
The device is a high-level disinfectant foam and related accessories intended for reprocessing ultrasound probes, not for diagnostic purposes.
No
The device is a chemical high-level disinfectant and associated physical components (bottles, pump, wipes, test strips). It does not involve any software.
Based on the provided text, Tristel Duo ULT is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The primary intended use of Tristel Duo ULT is to disinfect ultrasound probes. This is a process applied to medical devices to reduce the risk of infection transmission, not to diagnose a condition or provide information about a patient's health status.
- Mechanism of Action: Tristel Duo ULT works by generating chlorine dioxide, a chemical germicide, to kill microorganisms on the surface of the probes. This is a disinfection process, not a diagnostic test.
- Device Description: The description focuses on the chemical composition and delivery mechanism of the disinfectant foam and the associated wipes and test strips used to ensure proper concentration. It does not describe a device that analyzes biological samples or provides diagnostic information.
- Performance Studies: The performance studies described evaluate the efficacy of the disinfectant (sporicidal, mycobactericidal, etc.) and its compatibility with ultrasound probes. These are relevant to a disinfectant, not an IVD.
- Lack of Diagnostic Elements: There is no mention of analyzing patient samples, detecting biomarkers, or providing any information related to a patient's diagnosis, treatment, or health status.
While the Duo Test Strips are mentioned, their purpose is to verify the concentration of the disinfectant, not to diagnose a condition in a patient. They are a quality control tool for the disinfection process.
Therefore, Tristel Duo ULT falls under the category of a high-level disinfectant for medical devices, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Tristel Duo ULT high level disinfectant is indicated as follows:
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.
Product codes
QWS, OWS
Device Description
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".
Tristel Duo ULT, according to the directions of use, 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.
Tristel Duo ULT has been tested on a large number of materials and found to be compatible after a total of 120 hours immersion. Tristel Duo ULT is labeled for use on ultrasound probes only and is not intended for disinfection of other semi-critical medical devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
transvaginal, transrectal (for endocavity probes)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Tristel Duo ULT is intended for use by qualified healthcare professionals (HCP) and reprocessing technicians. The HCP's intended use environments include a procedure room and exam room. The reprocessing technicians' intended use environment includes a central processing unit. Each environment should include a designation between contaminated and clean work surfaces, a sink, a clock or another device to track time, and personal protective equipment such as gloves, masks with eye protection, and gowns.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
- Potency tests were provided, including sporicidal efficacy, mycobactericidal efficacy, fungicidal efficacy, bactericidal efficacy, virucidal efficacy, to qualify the Tristel Duo ULT as a high level disinfectant, which has been confirmed by an independent laboratory.
- 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.
- 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.
- The material compatibility testing with ultrasound device manufacturers was conducted and supportive of compatibility on various ultrasound probes and equipment. Manufacturers of ultrasound svstems have evaluated compatibility of Tristel Duo ULT with their ultrasound devices assessing the impact Duo high level disinfectant has on the materials and functionality.
- 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.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
DE NOVO CLASSIFICATION REQUEST FOR TRISTEL DUO ULT HIGH LEVEL DISINFECTANT
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Foam or gel chemical sterilant/high level disinfectant. A foam or gel chemical sterilant/high level disinfectant is a germicide in the form of a foam or gel that is intended for use as the terminal step in high level disinfection of medical devices prior to patient use.
NEW REGULATION NUMBER: 21 CFR 880.6886
CLASSIFICATION: Class II
PRODUCT CODE: OWS
BACKGROUND
DEVICE NAME: TRISTEL DUO ULT
SUBMISSION NUMBER: DEN220041
DATE DE NOVO RECEIVED: July 13, 2022
SPONSOR INFORMATION:
Hyman, Phelps, & McNamara, P.C. 700 13th St NW. Suite 1200. Washington, DC 20005 USA On behalf of: Tristel Solutions Limited, Lynx Business Park, Fordham Road, Snailwell, CB8 7NY, United Kingdom
INDICATIONS FOR USE
The Tristel Duo ULT high level disinfectant is indicated as follows:
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.
1
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.
LIMITATIONS
Tristel Duo ULT is intended to be marketed for prescription use.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
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.
Image /page/1/Figure/11 description: The image shows two bottles connected at the top. The bottle on the left is labeled "Duo Activator", and the bottle on the right is labeled "Duo Base". Both bottles appear to be empty and have a pump mechanism at the top.
Figure 2 - Schematic Representation of Duo Bottle
2
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)
(b)(4) (b)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4)(4
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.
Image /page/2/Picture/4 description: The image shows a bottle of "TriGel Duo ULT" hand sanitizer. The bottle is white with a pink and purple label. The label has the words "TriGel Duo ULT" in large, bold letters. Below the name is the phrase "Proper Patient Decontamination System for today's clinical environment."
Figure 3 - Tristel Duo Handheld Dispenser
Figure 4 - Tristel Duo in Use
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.
3
Image /page/3/Picture/0 description: The image shows a container of Duo Wipes. The container is white and has the words "Duo Wipes" printed on it in a bold, sans-serif font. Below the words, there is a colorful graphic of swirling lines in shades of blue, pink, and yellow. The container appears to be made of plastic and has a label on the side with additional information.
Image /page/3/Picture/1 description: The image shows a package of Duo Wipes. The package has a white background with colorful streaks of blue, pink, yellow, and green. The words "Duo Wipes" are printed in a white oval in the center of the package.
Figure 7 - Duo Wipes in Tub and Flow Wrap Commercial Packaging
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".
Image /page/3/Picture/6 description: The image shows a container of Duo Test Strips next to three individual test strips. The container is white and has the words "Duo Test Strips" printed on it. The test strips are thin and white with a small square at the end. The background is white.
Figure 8 - The Duo Test Strips
Tristel Duo ULT, according to the directions of use, 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.
Tristel Duo ULT has been tested on a large number of materials and found to be compatible after a total of 120 hours immersion. Tristel Duo ULT is labeled for use on ultrasound probes only and is not intended for disinfection of other semi-critical medical devices.
Tristel Duo ULT is intended for use by qualified healthcare professionals (HCP) and reprocessing technicians. The HCP's intended use environments include a procedure room and
4
exam room. The reprocessing technicians' intended use environment includes a central processing unit. Each environment should include a designation between contaminated and clean work surfaces, a sink, a clock or another device to track time, and personal protective equipment such as gloves, masks with eye protection, and gowns.
SUMMARY OF BENCH STUDIES
REPROCESSING, STERILITY AND SHELF-LIFE
The Tristel Duo ULT high level disinfectant foam is not intended for either cleaning or sterilization, it is intended to disinfect cleaned, reusable, non-lumened ultrasound probes. Performance related to the high level disinfection was reviewed as a part of the performance testing. The device includes instructions for reprocessing ultrasound probes. Specifically, the sponsor has included reprocessing instructions that they have validated according to the FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling".
The storage stability study is provided to support: (i) a two-year shelf life of the product from the date of manufacture of the unopened product; and (ii) 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).
The transport stability study is provided to support the 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).
BIOCOMPATIBILITY
The Tristel Duo ULT is categorized as a surface disinfectant, with contact to mucosal membranes, A-limited (