(241 days)
Not Found
No.
The device is a high-level disinfectant foam and related wipes. Its function is to chemically disinfect ophthalmic devices, and there is no indication of any computational or intelligent capabilities.
No.
Explanation: This device is a high-level disinfectant for reprocessing ophthalmic devices, not a therapeutic device. It is used to clean and disinfect medical instruments, not to treat a medical condition or provide therapy.
No
This device is a high-level disinfectant, not a diagnostic device. Its purpose is to reprocess ophthalmic devices, not to diagnose medical conditions.
No
The device is a chemical disinfectant foam and wipes used for reprocessing ophthalmic devices. It is a tangible product (chemical and non-woven material) and its effectiveness is measured through non-clinical testing of its bactericidal, fungicidal, virucidal, mycobactericidal, and sporicidal properties, as well as its compatibility and biocompatibility, not through software performance metrics or algorithms.
No.
This device is a high-level disinfectant for reprocessing ophthalmic devices, not a device that is used to perform diagnoses in vitro.
N/A
Intended Use / Indications for Use
Tristel OPH is a high level disinfectant foam for reprocessing ophthalmic devices. It can be used to high level disinfect devices that may contact mucous membranes during use, such as diagnostic and laser lenses, tonometer prisms, pachymeters, retinal imaging probes, A-scan and B-scan biometry probes.
Tristel OPH 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 the Minimum Recommended Concentration (MRC).
Tristel OPH Foam must be applied on the surface of an ophthalmic device using Tristel OPH Wipes. Tristel OPH Wipes are intended for the application of the Tristel OPH Foam on the surface of ophthalmic devices and to remove residue of the foam after high level disinfection.
Each dose of Tristel OPH Foam and each Tristel OPH Wipe are single use.
The semi-critical ophthalmic devices processed by Tristel OPH must first be cleaned according to a validated cleaning protocol or standard and following the device manufacturers' instructions. Tristel OPH Foam bottle is designed in a way that ensures measured dose delivery with each application generating active ingredient above the MRC.
Minimum Recommended Concentration (MRC): ~90% v/v (280ppm) at point of use. MRC of Tristel OPH may be verified using Tristel Test Strips.
Product codes
QWS
Device Description
Tristel OPH is a high level disinfectant foam for reprocessing ophthalmic devices. It can be used to high level disinfect devices that may contact mucous membranes during use, such as diagnostic and laser lenses, tonometer prisms, pachymeters, retinal imaging probes, and A-scan and B-scan probes.
Tristel OPH Foam is packaged in a hand-held dispenser bottle (Figure 1). Tristel OPH Foam is made of two solutions, Tristel OPH Activator solution and Tristel OPH Base solution, which are mixed when dispensed to generate active ingredient chlorine dioxide. In-use concentration of chlorine dioxide (ClO2) is 0.032% (320ppm).
Tristel OPH Foam Activator and Base solutions are contained in a dual compartment bottle with a dispenser pump and are ready to use (Figure 2).
Tristel OPH Foam is supplied with Tristel OPH Wipes. Tristel OPH Wipes are dry wipes made of a non-woven and low-linting material. Tristel OPH Wipes are intended to apply Tristel OPH Foam on the surface of ophthalmic devices and to remove residue of the foam after high level disinfection once the contact time of 2 minutes has elapsed.
Each dose of Tristel OPH Foam and each Tristel OPH Wipe are single-use.
Minimum Recommended Concentration (MRC): ~90% v/v (~280ppm) at point of use. MRC of Tristel OPH may be verified using Tristel Test Strips.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Contact mucous membranes during use, such as diagnostic and laser lenses, tonometer prisms, pachymeters, retinal imaging probes, A-scan and B-scan probes.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Testing
In addition to the non-clinical performance testing carried out on Tristel Duo ULT which are applicable to Tristel OPH, additional non-clinical performance testing for the intended ophthalmic use pattern were performed using the same test methods used to verify the predicate device. The testing demonstrated that the subject device met the acceptance criteria described in the standard/methodology.
Potency
- Bactericidal Efficacy: AOAC 955.15, 964.02 and 955.14 - Bactericidal against Pseudomonas aeruginosa, Staphylococcus aureus and Salmonella enterica in 2.0 minutes exposure at 20°C.
- Fungicidal Efficacy: AOAC 955.17 - Fungicidal against Trichophyton interdigitale in 1.0 minute exposure at 20°C.
- Virucidal Efficacy: ASTM E1053 - Virucidal against Poliovirus type 1, Herpes simplex virus type 1, Adenovirus type 5 and Feline calicivirus in 30 seconds exposure at 20°C.
- Mycobactericidal Efficacy: Ascenzi et al., 1987 - Mycobactericidal against Mycobacterium terrae in 1.0 minute exposure at 20°C.
- Sporicidal Efficacy: AOAC 966.04 - Sporicidal against Clostridium sporogenes and Bacillus subtilis in 12 hours exposure at 20°C.
- Additional Clinically Relevant Efficacy: Passes AOAC and ASTM1053 against clinically relevant bacteria, fungi and viruses. Candida albicans, Aspergillus brasiliensis, Streptococcus agalacticae, Carbapenem-resistant Klebsiella pneumoniae, Extended Spectrum Beta-Lactamase (ESBL) Escherichia coli, Haemophilus influenza, Vancomycin-Resistant Enterococcus faecalis (VRE), Multi-Drug Resistant Streptococcus pneumoniae, Staphylococcus epidermidis, Human Coronovirus SARS-CoV-2, Human hepatitis B virus surrogate (duck hepatitis B virus), Human immunodeficiency virus type 1, Influenza A Virus. Tristel OPH inactivates Human papillomavirus(HPV) type 16 and type 18.
Simulated-Use Summary: Provides >6 log reduction mycobactericidal efficacy on worst-case inoculated devices in
N/A
FDA 510(k) Clearance Letter - Tristel OPH
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 09, 2025
Tristel Solutions Ltd.
Véronique Li
Unit 1b, Lynx Business Park, Fordham Road
Snailwell
Cambridgeshire, CB8 7NY
United Kingdom
Re: K242732
Trade/Device Name: Tristel OPH
Regulation Number: 21 CFR 880.6886
Regulation Name: Foam Or Gel Chemical Sterilant/High Level Disinfectant
Regulatory Class: Class II
Product Code: QWS
Dated: September 10, 2024
Received: April 8, 2025
Dear Véronique Li:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Page 2
K242732 - Véronique Li
Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
Page 3
K242732 - Véronique Li
Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katharine Segars -S
Katharine Segars, Ph.D.
Assistant Director
DHT4C: Division of Infection Control
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K242732
Device Name
Tristel OPH
Indications for Use (Describe)
Tristel OPH is a high level disinfectant foam for reprocessing ophthalmic devices. It can be used to high level disinfect devices that may contact mucous membranes during use, such as diagnostic and laser lenses, tonometer prisms, pachymeters, retinal imaging probes, A-scan and B-scan probes.
Tristel OPH 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 OPH Foam must be applied on the surface of an ophthalmic device using Tristel OPH Wipes.
Tristel OPH Wipes are intended for application of Tristel OPH Foam on the surface of ophthalmic devices and to remove residue of the foam after high level disinfection.
Each dose of Tristel OPH Foam and each Tristel OPH Wipe are single use.
The semi-critical ophthalmic devices processed by Tristel OPH must first be cleaned according to a validated cleaning protocol or standard and following the device manufacturers' instructions. Tristel OPH Foam bottle is designed in a way that ensures measured dose delivery with each application generating active ingredient above the MRC.
Minimum Recommended Concentration (MRC): ~90% v/v (~280ppm) at point of use. MRC of Tristel OPH may be verified using Tristel Test Strips.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.
Page 5
510(k) Summary K242732
I. SUBMITTER
Tristel Solutions Ltd.
Tristel Solutions Ltd., Unit 1B, Lynx Business Park,
Fordham Road, Snailwell, Cambridgeshire,
CB8 7NY, United Kingdom Phone:
+44 (0)1638 721500
Contact Person: Julija Shabanova
Tristel Solutions Ltd., Unit 1B, Lynx Business Park,
Fordham Road, Snailwell, Cambridgeshire,
CB8 7NY, United Kingdom
Ph. +44 (0)1638 721500
Em. julijashabanova@tristel.com
Date Prepared: May 9, 2025
II. SUBJECT DEVICE
Brand Name: Tristel OPH
Common Name: High Level Disinfectant
Classification Name: Foam or gel chemical sterilant/high level disinfectant
Regulation Number: 21 CFR 880.6886
Product Code: QWS
Regulatory Class: II
III. PREDICATE DEVICE
Predicate Device: Tristel Duo ULT (DEN220041)
IV. DEVICE DESCRIPTION
Tristel OPH is a high level disinfectant foam for reprocessing ophthalmic devices. It can be used to high level disinfect devices that may contact mucous membranes during use, such as diagnostic and laser lenses, tonometer prisms, pachymeters, retinal imaging probes, and A-scan and B-scan probes.
Page 6
Tristel OPH Foam is packaged in a hand-held dispenser bottle (Figure 1). Tristel OPH Foam is made of two solutions, Tristel OPH Activator solution and Tristel OPH Base solution, which are mixed when dispensed to generate active ingredient chlorine dioxide. In-use concentration of chlorine dioxide (ClO2) is 0.032% (320ppm).
Tristel OPH Foam Activator and Base solutions are contained in a dual compartment bottle with a dispenser pump and are ready to use (Figure 2).
Figure 1. Pictures of the packaged Tristel OPH
Figure 2. Schematic of Tristel OPH Foam bottle
Tristel OPH Foam is supplied with Tristel OPH Wipes. Tristel OPH Wipes are dry wipes made of a non-woven and low-linting material. Tristel OPH Wipes are intended to apply Tristel OPH Foam on the surface of ophthalmic devices and to remove residue of the foam after high level disinfection once the contact time of 2 minutes has elapsed.
Each dose of Tristel OPH Foam and each Tristel OPH Wipe are single-use.
Minimum Recommended Concentration (MRC): ~90% v/v (~280ppm) at point of use. MRC of Tristel OPH may be verified using Tristel Test Strips.
V. INDICATIONS FOR USE
Tristel OPH is a high level disinfectant foam for reprocessing ophthalmic devices. It can be used to high level disinfect devices that may contact mucous membranes during use, such as diagnostic and laser lenses, tonometer prisms, pachymeters, retinal imaging probes, A-scan and B-scan biometry probes.
Tristel OPH 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 the Minimum Recommended Concentration (MRC).
Tristel OPH Foam must be applied on the surface of an ophthalmic device using Tristel OPH Wipes. Tristel OPH Wipes are intended for the application of the Tristel OPH Foam on the surface of ophthalmic devices and to remove residue of the foam after high level disinfection.
Each dose of Tristel OPH Foam and each Tristel OPH Wipe are single use.
Page 7
The semi-critical ophthalmic devices processed by Tristel OPH must first be cleaned according to a validated cleaning protocol or standard and following the device manufacturers' instructions. Tristel OPH Foam bottle is designed in a way that ensures measured dose delivery with each application generating active ingredient above the MRC.
Minimum Recommended Concentration (MRC): ~90% v/v (280ppm) at point of use. MRC of Tristel OPH may be verified using Tristel Test Strips.
Both the subject and the predicate devices have the same intended use for the high level disinfection of semi-critical devices. The Indications for Use differ only in the types of semi-critical devices intended to be disinfected. The differences do not alter the intended.
Table 1 – Predicate Device Tristel Duo ULT and Tristel OPH Indications for Use Comparison Table
| Tristel Duo ULT(DEN220041) | Tristel OPH (K242732) |
|---|---|
| Indications for Use: Tristel Duo ULT is a high level disinfectant 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 Foam must be applied on the surface of an ultrasound probe using Tristel Duo Wipes.
Tristel Duo Wipes are intended for application of 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 Tristel Duo Wipe are single use.
The semi-critical ultrasound probes processed by Tristel Duo ULT must first be cleaned according to a validated cleaning protocol or standard and following the | Tristel OPH is a high level disinfectant foam for reprocessing ophthalmic devices. It can be used to high level disinfect devices that may contact mucous membranes during use, such as diagnostic and laser lenses, tonometer prisms, pachymeters, retinal imaging probes, A-scan and B-scan probes.
Tristel OPH 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 OPH Foam must be applied on the surface of an ophthalmic device using Tristel OPH Wipes.
Tristel OPH Wipes are intended for application of Tristel OPH Foam on the surface of ophthalmic devices and to remove residue of the foam after high level disinfection.
Each dose of Tristel OPH Foam and each Tristel OPH Wipe are single use.
The semi-critical ophthalmic devices processed by Tristel OPH must first be cleaned according to a validated cleaning protocol or standard and following the |
Page 8
| Tristel Duo ULT(DEN220041) | Tristel OPH (K242732) |
|---|---|
| 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. |
Minimum Recommended Concentration (MRC): ~90% v/v (~280ppm) at point of use. MRC of Tristel Duo ULT may be verified using Tristel Test Strips. | device manufacturers' instructions. Tristel OPH Foam bottle is designed in a way that ensures measured dose delivery with each application generating active ingredient above the MRC.
Minimum Recommended Concentration (MRC): ~90% v/v (~280ppm) at point of use. MRC of Tristel OPH may be verified using Tristel Test Strips. |
VI. TECHNOLOGICAL CHARACTERISTIC COMPARISON
A side-by-side comparison of the technological characteristics of the predicate device and Tristel OPH is shown in Table 2.
Table 2 – Predicate Device Tristel Duo ULT and Tristel OPH Technological Characteristics Comparison Table
| Tristel Duo ULT (DEN220041) | Tristel OPH (K242732) | Comparison | |
|---|---|---|---|
| General | |||
| Active Chemistry: | Chlorine dioxide | Chlorine dioxide | Same |
| Active Concentration: | ~320ppm | ~320ppm | Same |
| Purpose: | To achieve high level disinfection by destroying viable forms of microbial life, when used according to labeling | To achieve high level disinfection by destroying viable forms of microbial life, when used according to labeling | Same |
| Labeling: | High Level Disinfectant Foam | High Level Disinfectant Foam | Same |
| No. of Foam Doses Required for Each Use: | 4 | 2 | Smaller ophthalmic devices require less volume of foam |
| Prescription Device: | Yes | Yes | Same |
| Human Factors: | Dispensed ready-to-use foam and applied by a wipe | Dispensed ready-to-use foam and applied by a wipe | Same |
| Design, Construction, Components: | Aqueous solutions contained in two separate reservoirs within a single dispenser apparatus and mixed together when dosed onto a Tristel Wipe | Aqueous solutions contained in two separate reservoirs within a single dispenser apparatus and mixed together when dosed onto a Tristel Wipe | Same |
| Reuse Characteristics: | Each dose of Tristel Duo ULT Foam and each Tristel Duo Wipe are single use. | Each dose of Tristel OPH Foam and each Tristel OPH Wipe are single use. | Same |
| Chemical Indicator: | Tristel Test Strips | Tristel Test Strips | Same |
Page 9
| Tristel Duo ULT (DEN220041) | Tristel OPH (K242732) | Comparison | |
|---|---|---|---|
| Contact Time for HLD: | 2 minutes at room temperature | 2 minutes at room temperature | Same |
| Mode of Action: | Chemical oxidation of biomolecules, including the cell membrane and nucleic acids. | Chemical oxidation of biomolecules, including the cell membrane and nucleic acids. | Same |
| Packaging: | Tristel Duo ULT Foam Activator and Base solutions are contained in a dual compartment bottle with a dispenser pump and are ready to use. | Tristel OPH Foam Activator and Base solutions are contained in a dual compartment bottle with a dispenser pump and are ready to use. | Same |
| Stability | |||
| Shelf Life: | 2 years unopened Shelf life | ||
| 6 month opened Shelf life | 2 years unopened Shelf life | ||
| 6 month opened Shelf life | Same | ||
| Transport Stability: | Conditions encountered for global road, sea, and air freight have no effect on product performance. | Conditions encountered for global road, sea, and air freight have no effect on product performance. | Same |
| Wipes | |||
| Physical Characteristics: | Dry, non-woven, and low-linting | Dry, non-woven, and low-linting | Same |
| No. of Wipes Supplied: | Pack variant specific (e.g. 200) | Pack variant specific (e.g.310) | Pack variant specific |
| Linting Tests: | 6 log reduction mycobactericidal efficacy on worst-case inoculated devices in 6 log reduction mycobactericidal efficacy on worst-case inoculated devices in |