(29 days)
None
No
The document describes a contact lens and its physical properties and intended use. There is no mention of any computational or analytical capabilities, let alone AI or ML.
No.
The device is indicated for the correction of refractive ametropia (myopia and hyperopia) and/or presbyopia, which are refractive errors, not diseases or conditions that require therapy.
No
The device is a contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) and/or presbyopia, which are optical corrections, not diagnostic purposes. It acts as a refracting medium to focus light rays on the retina.
No
The device is a physical contact lens made of specific materials with defined physical and optical properties, not a software program.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "correction of refractive ametropia (myopia and hyperopia)" and "optical correction of refractive ametropia (myopia)" and "optical corrective ametropia (myopia and hyperopia) and/or presbyopia". These are all related to correcting vision problems, not diagnosing a disease or condition.
- Device Description: The description focuses on the physical and optical properties of the contact lens and how it functions as a "refracting media to focus light rays on the retina." This is consistent with a vision correction device.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide information for the diagnosis of a disease or condition.
IVD devices are used to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This contact lens does not fit that description.
N/A
Intended Use / Indications for Use
The CLARITI 1 DAY (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eves that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuty.
The CLARITI 1 DAY TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters.
The CLARITI 1 DAY MULTIFOCAL (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the optical corrective ametropia (myopia and hyperopia) and/or presbyopia in phakic persons with non-diseased eyes that may require a reading addition of +3.00 Diopters or less and may exhibit astigmatism up to 1.50 Diopters or less.
The CLARITI 1 DAY MULTIFOCAL TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the optical corrective ametropia (myopia and hyperopia) and/or presbyopia in phakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters and require a reading addition of +3.00 Diopters or less.
Product codes
LPL, MVN
Device Description
The Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker is available as sphere lens, toric lens, multifocal lens, and multifocal toric lens.
In its hydrated state, Clariti 1 day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker when placed on the cornea acts as a refracting media to focus light rays on the retina.
Clariti 1 day (somofilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear Single Use are a hydrophilic co-polymer of silicone containing monomers and hydrophilic monomers which is cross-linked with tetraethyleneglycol dimethacrylate and di-functional methacryloxypropyl-terminated poly(dimethylsiloxane).
When hydrated the lens consists of 44.0% somofilcon A and 56.0% water by weight of saline immersed in normal saline. A benzophenone UV absorbing monomer is used in the contact lens to help protect against transmission of harmful UV radiation and Clariti 1 day (somofilcon A) Soft contact lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The average transmittance characteristics are less than 5% in the UVB range of 280 to 315nm and less than 50% in the UVA range of 316-380nm.
The lens has a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sclera, with the following dimensions:
• Chord Diameter: 13.0mm to 15.5mm
• Centre Thickness: 0.03mm to 0.50mm
• Base Curve: 7.5mm to 9.30mm
• Powers: -20.00 DS to +20.00 DS
• Toric Cylinder options: -0.75, -1.25, -1.75 and -2.25
• Toric Axis options: 10° to 180° (10° steps)
• Multifocal Add:
Lens "LOW" = "low" for spectacle near ADD lens (Max +2.25 ADD)
Lens "HIGH" = "high" for spectacle near ADD lens (+2.50 ADD or greater)
The physical/optical properties of the lenses are:
• Refractive Index: 1.4003
• %Transmittance @ 590nm: 98.13
• %Transmittance @ 280-315nm: 0.71
• %Transmittance @ 316-380nm: 20.62
• Surface Character: Hydrophilic
• Water Content: 56%
• Oxygen Permeability (DK): 60 x 10-11 (cm²/sec)(ml O2/ml x mmHg) at 35°C (Fatt Method for determination of oxygen permeability)
• Specific Gravity: 1.17
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 20, 2020
CooperVision, Inc. Marie Dutton Senior Regulatory Affairs Specialist 6101 Bollinger Canyon Road, Suite 500 San Ramon, CA 94583
Re: K202756
Trade/Device Name: Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: September 18, 2020 Received: September 21, 2020
Dear Marie Dutton:
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 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
1
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 medical devices and radiation-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
2
Indications for Use
510(k) Number (if known) K202756
Device Name
Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker
Indications for Use (Describe)
The CLARITI 1 DAY (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eves that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuty.
The CLARITI 1 DAY TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters.
The CLARITI 1 DAY MULTIFOCAL (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the optical corrective ametropia (myopia and hyperopia) and/or presbyopia in phakic persons with non-diseased eyes that may require a reading addition of +3.00 Diopters or less and may exhibit astigmatism up to 1.50 Diopters or less.
The CLARITI 1 DAY MULTIFOCAL TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the optical corrective ametropia (myopia and hyperopia) and/or presbyopia in phakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters and require a reading addition of +3.00 Diopters or less.
| 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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3
510(k) Summary
I. SUBMITTER:
CooperVision, Inc. 6101 Bollinger Canyon Road, Suite 500 San Ramon, CA 94583
Contact Person:
Marie Dutton Senior Regulatory Affairs Specialist 6101 Bollinger Canyon Road, Suite 500 San Ramon, CA 94583 Phone: (925) 660-4474 E-mail: MDutton@coopervision.com
Date Prepared:
September 18, 2020
II. DEVICE:
Trade Name: Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker Common Name: Soft (hydrophilic) Contact Lens Classification Name: Lens, Contact, (Disposable) [21 CFR 886.5925 (b) (1)] Regulatory Class: II Product Code: LPL, MVN Classification Panel: Ophthalmic
III. PREDICATE DEVICE:
CooperVision's Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker, K130331
IV. DEVICE DESCRIPTION:
The device description for the subject device and predicate device is identical. The Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker is available as sphere lens, toric lens, multifocal lens, and multifocal toric lens.
In its hydrated state, Clariti 1 day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker when placed on the cornea acts as a refracting media to focus light rays on the retina.
Clariti 1 day (somofilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear Single Use are a hydrophilic co-polymer of silicone containing monomers and hydrophilic monomers which is cross-linked with tetraethyleneglycol dimethacrylate and di-functional methacryloxypropyl-terminated poly(dimethylsiloxane).
4
When hydrated the lens consists of 44.0% somofilcon A and 56.0% water by weight of saline immersed in normal saline. A benzophenone UV absorbing monomer is used in the contact lens to help protect against transmission of harmful UV radiation and Clariti 1 day (somofilcon A) Soft contact lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The average transmittance characteristics are less than 5% in the UVB range of 280 to 315nm and less than 50% in the UVA range of 316-380nm.
The lens has a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sclera, with the following dimensions:
| • Chord Diameter: | 13.0mm to 15.5mm |
|---|---|
| • Centre Thickness: | 0.03mm to 0.50mm |
| • Base Curve: | 7.5mm to 9.30mm |
| • Powers: | -20.00 DS to +20.00 DS |
| • Toric Cylinder options: | -0.75, -1.25, -1.75 and -2.25 |
| • Toric Axis options: | 10° to 180° (10° steps) |
| • Multifocal Add: |
Lens "LOW" = "low" for spectacle near ADD lens (Max +2.25 ADD) Lens "HIGH" = "high" for spectacle near ADD lens (+2.50 ADD or greater)
The physical/optical properties of the lenses are:
| • Refractive Index: | 1.4003 |
|---|---|
| • %Transmittance @ 590nm: | 98.13 |
| • %Transmittance @ 280-315nm: | 0.71 |
| • %Transmittance @ 316-380nm: | 20.62 |
| • Surface Character: | Hydrophilic |
| • Water Content: | 56% |
| • Oxygen Permeability (DK): | 60 x 10-11 (cm²/sec) |
| (ml O2/ml x mmHg) at 35°C (Fatt | |
| Method for determination of oxygen | |
| permeability) | |
| • Specific Gravity: | 1.17 |
5
V. INDICATIONS FOR USE:
The indications for use statement for the subject device and predicate device is identical.
| Lens Design | Indication |
|---|---|
| Sphere | The CLARITI 1 DAY (somofilcon A) Soft (hydrophilic) Daily |
| Disposable Contact Lens with UV blocker is indicated for daily wear | |
| single use only for the correction of refractive ametropia (myopia and | |
| hyperopia) in phakic or aphakic persons with non-diseased eyes that | |
| may exhibit astigmatism up to 2.00 Diopters that does not interfere | |
| with visual acuity. | |
| Toric | The CLARITI 1 DAY TORIC (somofilcon A) Soft (hydrophilic) |
| Daily Disposable Contact Lens with UV blocker is indicated for daily | |
| wear single use only for the optical correction of refractive ametropia | |
| (myopia and hyperopia) in phakic or aphakic persons with non- | |
| diseased eyes that may exhibit astigmatism up to 10.00 Diopters. | |
| Multifocal | The CLARITI 1 DAY MULTIFOCAL (somofilcon A) Soft |
| (hydrophilic) Daily Disposable Contact Lens with UV blocker is | |
| indicated for daily wear single use only for the optical correction of | |
| refractive ametropia (myopia and hyperopia) and/or presbyopia in | |
| phakic or aphakic persons with non-diseased eyes that may require a | |
| reading addition of +3.00 Diopters or less and may exhibit astigmatism | |
| up to 1.50 Diopters or less. | |
| Multifocal | |
| Toric | The CLARITI 1 DAY MULTIFOCAL TORIC (somofilcon A) Soft |
| (hydrophilic) Daily Disposable Contact Lens with UV blocker is | |
| indicated for daily wear single use only for the optical correction of | |
| refractive ametropia (myopia and hyperopia) and/or presbyopia in | |
| phakic or aphakic persons with non-diseased eyes that may exhibit | |
| astigmatism up to 10.00 Diopters and require a reading addition of | |
| +3.00 Diopters or less. |
6
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:
The technological principle for both the subject and predicate device is identical.
| Technology/Material Comparison | ||
|---|---|---|
| Predicate Device | Subject Device | |
| Product Name | Clariti 1 day (somofilcon | |
| A) Soft (Hydrophilic) | ||
| Daily Disposable Contact | ||
| Lens with UV Blocker | Same | |
| Material USAN Name | somofilcon A | Same |
| 510(k) Number | K130331 | Current Submission |
| FDA Category (Group) | Materials having a Dk | |
| greater than 40 Dk units | ||
| (using mmHg) and having | ||
| a Dk greater than that | ||
| expected based on the | ||
| materials' water content | ||
| alone (Group V) | Same | |
| Manufacturing Method | Cast Molding | Same |
| Wearing and | ||
| Replacement Schedule | Daily Wear Single Use | Same |
| Sterilization Method | Moist Heat | Same |
| Packaging Materials | Injection molded | |
| polypropylene blisters | ||
| covered by aluminum foil | ||
| laminate and blister strips | ||
| are packed into printed | ||
| cartons | Same | |
| Packaging Solution | Borate Buffered Saline | |
| Solution containing | ||
| 0.005% w/v Poloxamer | ||
| 407 | Same | |
| Blue Visibility Tint | No | Same |
| Tint | None | Same |
| UV Blocker | UV416 | Same |
7
VII. PERFORMANCE DATA:
The performance specifications/parameters for both the subject and predicate device are identical.
| Performance Specifications/Parameters Comparison | ||
|---|---|---|
| Predicate Device | ||
| Clariti 1 day | ||
| (somofilcon A) | ||
| K130331 | Subject Device | |
| Clariti 1 day | ||
| (somofilcon A) | ||
| Current Submission | ||
| Water Content (%) | 56 | Same |
| Refractive Index | 1.401 | Same |
| Oxygen Permeability | ||
| (Dk @ 35°C) | $60 x 10^{-11} [(cm^2/sec) x (ml O_2)/(ml x mm Hg)]$ | Same |
| Base Curve (mm) | 8.6 | Same |
| Diameter (mm) | 14.0 | Same |
| Light Transmittance (%) | >95 | Same |
| Modulus (MPa) | ≥0.3 | Same |
| Tensile Strength (MPa) | ≥0.4 | Same |
| Elongation to Break (%) | ≥100 | Same |
| Surface Treatment | No | Same |
| Center Thickness (mm) | Varies with power | Same |
| Power Range (D) | -20.00 to + 20.00 | Same |
VIII. CONCLUSIONS:
This 510(k) is submitted in accordance with the May 12, 1994 Premarket Notification [510(k)] Guidance Document for Daily Wear Contact Lenses, amended June 28, 1994, for the change from a biological release to parametric release of finished product. The modification does not warrant performance testing to support substantial equivalence. Therefore, the subject device is considered substantially equivalent to the predicate device.