(138 days)
Not Found
No
The device is a contact lens care solution, and the summary describes chemical and physical properties and performance, with no mention of AI or ML.
No.
A therapeutic device is typically one that treats or prevents a disease or condition. This device is a contact lens care solution, which cleans, disinfects, and stores contact lenses, but does not directly treat or prevent a medical condition of the eye itself. Its function is to maintain the cleanliness and safety of contact lenses, which are then used to correct vision.
No
Explanation: The device is a multi-purpose lens care solution for cleaning, disinfecting, and storing contact lenses. Its intended uses and performance studies focus on lens compatibility, efficacy in disinfection and cleaning, and biocompatibility, not on detecting or diagnosing medical conditions. The "Key Metrics" section explicitly states "Not Applicable (This is a contact lens care solution, not a diagnostic device)".
No
The device is a contact lens care solution, which is a chemical product, not a software-only medical device. The description details its chemical composition and performance studies related to its function as a cleaning and disinfecting solution for contact lenses.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the care and maintenance of contact lenses (cleaning, disinfecting, conditioning, rinsing, and storage). This is a product used on a medical device (contact lenses) to maintain their function and hygiene, not to diagnose a condition or analyze a sample from the human body.
- Device Description: The description lists chemical components of a solution, not reagents or instruments used for in vitro testing.
- Performance Studies: The performance studies focus on the solution's compatibility with lenses, its ability to disinfect and clean, and its safety for use with contact lenses. These are not studies evaluating the accuracy of a diagnostic test.
- Key Metrics: The absence of metrics like sensitivity, specificity, PPV, and NPV further indicates it's not a diagnostic device. These metrics are crucial for evaluating the performance of IVDs.
IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This contact lens care solution does not perform any such function.
N/A
Intended Use / Indications for Use
OTE MPS 045 Multi-Purpose Lens Care Solution is indicated for daily cleaning, chemical (not heat) disinfection, conditioning, rinsing and storage of hydrogel and silicone hydrogel soft (hydrophilic) contact lenses as recommended by your eye care practitioner.
Product codes (comma separated list FDA assigned to the subject device)
LPN
Device Description
OTE MPS 045 Multi-Purpose Lens Care Solution is a sterile, buffered aqueous solution that contains sodium hyaluronate, poloxamer 407, boric acid, sodium borate, propylene glycol, and is preserved with Polyaminopropyl Biguanide Hydrochloride 0.00002%, Polyquaternium-2 0.00043%, and edetate disodium.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home personal use
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)
Non-Clinical Data
A series of tests were performed to demonstrate the substantial equivalence of the OTE MPS 045 Multi-Purpose Lens Care Solution to the predicate device. All tests were conducted in accordance with the Premarket Notification 510(k) Guidance Document for Contact Lens Care Products (1997), ISO Standards or valid scientific protocols.
- Lens Compatibility: Compatibility testing was conducted with six commercially available hydrogel and silicone hydrogel soft contact lenses: Acuvue 2 (etafilcon A), Clarity 56 % 1 Day (somofilcon A), Biofinity Energys (comfilcon A), Air Optix Aqua (lotrafilcon B), Acuvue Vita (senofilcon C) and Pure Vision (balafilcon A). Results demonstrated that the OTE MPS 045 Multi-Purpose Lens Care Solution was compatible with the test contact lenses.
- Disinfecting and Preservative Efficacy: Disinfecting efficacy testing was conducted to evaluate the antimicrobial activity of the OTE MPS 045 Multi-Purpose Lens Care Solution as a contact lens disinfection product. Results demonstrated that harmful microorganisms were effectively reduced to an effective level at 6 and 24 hours. In addition, Preservative Efficacy testing was conducted to support the 3-month open bottle discard date of the OTE MPS 045 Multi-Purpose Lens Care Solution.
- Cleaning Efficacy: Cleaning Efficacy was evaluated in an in-vitro system to determine the Critical Micelle Concentration (CMC) of the OTE MPS 045 Multi-Purpose Lens Care Solution. The concentration of the surfactants is above the CMC of the solution.
- Toxicology: A series of in-vitro and in-vivo biocompatibility tests were conducted in accordance with the GLP regulation (21 CFR Part 58) and ISO biocompatibility standards to ensure the safety of the OTE MPS 045 Multi-Purpose Lens Care Solution and the packaging components. Results of all biocompatibility testing demonstrated that the solution and packaging components are non-toxic, non-irritating and non-sensitizing.
Clinical Data
- Study Design: A clinical study was conducted comparing OTE MPS 045 Multi-Purpose Lens Care Solution to Bausch & Lomb Biotrue Multi-Purpose solution when used daily for cleaning, disinfecting and conditioning hydrogel and silicone hydrogel soft contact lenses. This study was a doublemasked (Investigator and Subject), multi-center, randomized, concurrent control study with a duration of 30 days (1 month) and 199 subjects.
- Study End Points:
- Primary Safety Endpoints: Non Inferiority of slit lamp findings, limbal hyperemia, bulbar hyperemia and corneal staining. The safety endpoint was supported by the study findings.
- Primary Effectiveness Endpoints: Non Inferiority of comfort, visual acuity, surface wettability, lens deposits. At each visit, OTE MPS 045 Multi-Purpose Lens Care Solution was non-inferior to BioTrue with respect to wettability and film deposits. The efficacy endpoint was supported by the study findings.
- Safety (Adverse Events): Adverse events were reported in ten subjects. Six subjects had symptoms that were mild/non-significant, one subject had symptoms that were moderate and significant, and three subjects had non-device related adverse events. All adverse events had resolved before the end of the study.
- Clinical Summary: The purpose of the study was to evaluate the clinical performance of the contact lens care solution OTE MPS 045 in comparison with BioTrue® (Bausch & Lomb) Multi-purpose contact lens care solution in a representative population of soft contact lens wearers. The Primary Safety and Effectiveness endpoints were supported by the study data. Therefore, the OTE MPS 045 Lens Care Solution is substantially equivalent to the predicate, BioTrue® (Bausch & Lomb) Multi-purpose contact lens care solution.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 886.5928 Soft (hydrophilic) contact lens care products.
(a)
Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 26, 2021
OTE North America LLC % Ellen M. Beucler Vice President Foresight Regulatory Strategies, Inc. 1820 Turnpike Street, Suite 201 North Andover, MA 01845
Re: K210051
Trade/Device Name: OTE MPS 045 Multi-purpose Lens Care Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (Hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LPN Dated: April 19, 2021 Received: April 21, 2021
Dear Ellen M. Beucler:
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 (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 located 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.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,
J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210051
Device Name
OTE MPS 045 Multi-Purpose Lens Care Solution
Indications for Use (Describe)
OTE MPS 045 Multi-Purpose Lens Care Solution is indicated for daily cleaning, chemical (not heat) disinfection, conditioning, rinsing and storage of hydrogel and silicone hydrogel soft (hydrophilic) contact lenses as recommended by your eye care practitioner.
| 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) |
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510(k) Summary
OTE MPS 045 Multi-Purpose Lens Care Solution
1. Applicant Information
OTE NORTH AMERICA LLC 40 Bayview Ave. Inwood, New York, USA 11096
| Contact Person: | Nathan Rosenberg |
|---|---|
| Telephone No.: | 516-371-0225 |
| Email: | nathan@oteamerica.com |
| Date Prepared: | May 23, 2021 |
2. Device Information
| Device classification: | Class II |
|---|---|
| Classification name: | 21 CFR 886.5928 |
| Soft (hydrophilic) Contact Lens Care Product | |
| Proprietary name: | OTE MPS 045 Multi-Purpose Lens Care Solution |
| Product code: | LPN |
3. Predicate Device
OTE North America claims substantial equivalence to K083757 Bausch & Lomb® BPZ02, commercially distributed as Biotrue® Multi-Purpose Solution.
4. Description of Device
OTE MPS 045 Multi-Purpose Lens Care Solution is a sterile, buffered aqueous solution that contains sodium hyaluronate, poloxamer 407, boric acid, sodium borate, propylene glycol, and is preserved with Polyaminopropyl Biguanide Hydrochloride 0.00002%, Polyquaternium-2 0.00043%, and edetate disodium.
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5. Indications for Use
OTE MPS 045 Multi-Purpose Lens Care Solution is indicated for daily cleaning, chemical (not heat) disinfection, conditioning, rinsing and storage of hydrogel and silicone hydrogel soft (hydrophilic) contact lenses, as recommended by your eye care practitioner.
6. Performance Data
Non-Clinical Data
A series of tests were performed to demonstrate the substantial equivalence of the OTE MPS 045 Multi-Purpose Lens Care Solution to the predicate device. All tests were conducted in accordance with the Premarket Notification 510(k) Guidance Document for Contact Lens Care Products (1997), ISO Standards or valid scientific protocols.
-
Lens Compatibility
Compatibility testing was conducted with six commercially available hydrogel and silicone hydrogel soft contact lenses: Acuvue 2 (etafilcon A), Clarity 56 % 1 Day (somofilcon A), Biofinity Energys (comfilcon A), Air Optix Aqua (lotrafilcon B), Acuvue Vita (senofilcon C) and Pure Vision (balafilcon A). Results demonstrated that the OTE MPS 045 Multi-Purpose Lens Care Solution was compatible with the test contact lenses. -
. Disinfecting and Preservative Efficacy Disinfecting efficacy testing was conducted to evaluate the antimicrobial activity of the OTE MPS 045 Multi-Purpose Lens Care Solution as a contact lens disinfection product. Results demonstrated that harmful microorganisms were effectively reduced to an effective level at 6 and 24 hours. In addition, Preservative Efficacy testing was conducted to support the 3-month open bottle discard date of the OTE MPS 045 Multi-Purpose Lens Care Solution.
-
Cleaning Efficacy
Cleaning Efficacy was evaluated in an in-vitro system to determine the Critical Micelle Concentration (CMC) of the OTE MPS 045 Multi-Purpose Lens Care Solution. The concentration of the surfactants is above the CMC of the solution.
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- Toxicology
A series of in-vitro and in-vivo biocompatibility tests were conducted in accordance with the GLP regulation (21 CFR Part 58) and ISO biocompatibility standards to ensure the safety of the OTE MPS 045 Multi-Purpose Lens Care Solution and the packaging components.
Biocompatibility testing for the container components was conducted in compliance with the following standards.
- 21 CFR, Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies ●
- ISO10993-5, 2009 Biological Evaluation of Medical Devices Part 5: . Tests for In Vitro Cytotoxicity
- ISO10993-10, 2010 Biological Evaluation of Medical Devices Part 10: . Tests for Irritation and Skin Sensitization
- ISO10993-11, 2017 Biological Evaluation of Medical Devices Part 11: . Tests for Systemic Toxicity
Biocompatibility testing for the OTE MPS 045 Multi-Purpose Lens Care Solution was conducted in compliance with the following standards.
- 21 CFR, Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies ●
- . ISO10993-5, 2009 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity
- ISO10993-10, 2010 Biological Evaluation of Medical Devices Part 10: . Tests for Irritation and Skin Sensitization
- ISO10993-11, 2017 Biological Evaluation of Medical Devices Part 11: ● Tests for Systemic Toxicity
- ISO18189, 2016(E), Ophthalmic optics Contact Lens and Contact Lens Care . Products - Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interaction.
- ISO9394, 2012, Ophthalmic optics Contact lenses and contact lens care products -● Determination of biocompatibility by ocular study with rabbit eyes
Results of all biocompatibility testing demonstrated that the solution and packaging components are non-toxic, non-irritating and non-sensitizing.
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Clinical Data
Study Design
A clinical study was conducted comparing OTE MPS 045 Multi-Purpose Lens Care Solution to Bausch & Lomb Biotrue Multi-Purpose solution when used daily for cleaning, disinfecting and conditioning hydrogel and silicone hydrogel soft contact lenses. This study was a doublemasked (Investigator and Subject), multi-center, randomized, concurrent control study with a duration of 30 days (1 month) and 199 subjects.
Study End Points
Primary Safety Endpoints: Non Inferiority of slit lamp findings, limbal hyperemia, bulbar hyperemia and corneal staining. The safety endpoint was supported by the study findings.
Primary Effectiveness Endpoints: Non Inferiority of comfort, visual acuity, surface wettability, lens deposits. At each visit, OTE MPS 045 Multi-Purpose Lens Care Solution was non-inferior to BioTrue with respect to wettability and film deposits. The efficacy endpoint was supported by the study findings.
Safety (Adverse Events)
Adverse events were reported in ten subjects. Six subjects had symptoms that were mild/non-significant, one subject had symptoms that were moderate and significant, and three subjects had non-device related adverse events. All adverse events had resolved before the end of the study.
Clinical Summary
The purpose of the study was to evaluate the clinical performance of the contact lens care solution OTE MPS 045 in comparison with BioTrue® (Bausch & Lomb) Multi-purpose contact lens care solution in a representative population of soft contact lens wearers. The Primary Safety and Effectiveness endpoints were supported by the study data. Therefore, the OTE MPS 045 Lens Care Solution is substantially equivalent to the predicate, BioTrue® (Bausch & Lomb) Multi-purpose contact lens care solution.
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Conclusion
Based upon the data presented, the OTE MPS 045 Multi-Purpose Lens Care Solution is as safe, as effective and performs as well as the predicate device.
7. Substantial Equivalence
The claim of substantial equivalence to the previously cleared device is supported by the non-clinical data, clinical data and the Comparison of Characteristics in Table 1.
| Product Name | OTE MPS 045 Multi-Purpose Solution | BioTrue Solution Multi-Purpose Solution |
|---|---|---|
| 510(k) # | - | K083757 |
| FDA Product Code | LPN | LYL |
| Classification | Class II (21 CFR 886.5928) | Class II (21 CFR 886.5928) |
| Intended Use | OTE MPS 045 Multi-Purpose Lens Care | |
| Solution is indicated for daily cleaning, | ||
| chemical (not heat) disinfection, | ||
| conditioning, rinsing and storage of hydrogel | ||
| and silicone hydrogel soft (hydrophilic) | ||
| contact lenses as recommended by your eye | ||
| care practitioner. | Bausch & Lomb® BPZ02 Multi-Purpose | |
| Solution is indicated for use in the daily | ||
| conditioning, cleaning, removal of protein | ||
| deposits, rinsing, chemical (not heat) | ||
| disinfection, and storage of soft (hydrophilic | ||
| contact lenses, including silicone hydrogel | ||
| contact lenses, as recommended by your eye | ||
| care practitioner. | ||
| For Use With | Hydrogel and Silicone Hydrogel Soft | |
| (hydrophilic) Contact Lenses | Hydrogel and Silicone Hydrogel Soft | |
| (hydrophilic) Contact Lenses | ||
| Dual Preservatives | Polyaminopropyl Biguanide Hydrochloride, | |
| Polyquaternium-2 | Polyaminopropyl Biguanide Hydrochloride, | |
| Polyquaternium-1 | ||
| Buffer System | Sodium Borate, Boric Acid | Sodium Borate, Boric Acid |
| Disinfection Cycle | At least 6 hours | At least 4 hours |
| Lubricating Agent | Sodium Hyaluronate | Sodium Hyaluronate |
| Target Population | Home personal use | Home personal use |
| Sterile | Yes | Yes |
| CE Mark | Yes | Yes |
| Appearance | Clear, Colorless Solution free of particles | Clear, Colorless Solution free of particles |
| pH | 7.2 - 7.4 | 7.5 |
| Osmolarity | 300-330 mOsm/kg | - |
Table 1 Comparison of Characteristics