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 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.

Device Description

Clariti 1 Day Multifocal (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker is a hydrophilic co-polymer of silicone containing monomers and hydrophilic monomers which is cross-linked with tetraethyleneglycol dimethacrylate and difunctional 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 Multifocal (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker 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 316-380mm.

The lens has a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sclera.

AI/ML Overview

The provided text is a 510(k) summary for a medical device, specifically a soft contact lens. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. However, it does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device.

Based on the document, here's what can be inferred and what information is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied): The document refers to "performance testing specifications" and states that "non-clinical data presented are adequate to support substantial equivalence." This implies that the device met certain pre-defined performance specifications for physical and optical properties like water content and dimensional/optical parameters, as outlined in BS EN ISO 18369-2:2017 and BS EN ISO 18369-4:2017. However, the specific quantitative acceptance criteria (e.g., precise ranges for water content or diameter tolerance) are not explicitly listed in this summary.
Reported Device Performance:
- Refractive Index: 1.4003
- %Transmittance @ 590nm: 98.13
- %Transmittance @ 280-315nm: 0.71 (less than 5% as per device description)
- %Transmittance @ 316-380nm: 20.62 (less than 50% as per device description)
- Water Content: 56%
- Oxygen Permeability (DK): 60 x 10^-11 (cm^2/sec) (ml O2/ml x mmHg) at 35°C
- Specific Gravity: 1.17

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable / Not Provided: This information is typically relevant for studies validating AI/ML algorithms. The provided document is for a physical medical device (contact lens) and refers to non-clinical performance testing. It does not describe a "test set" in the context of algorithm validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable / Not Provided: This is not relevant for the type of device and testing described in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable / Not Provided: This is not relevant for the type of device and testing described in the document.

5. 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 document describes a physical medical device (contact lens), not an AI/ML-driven diagnostic or assistive device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable: This document describes a physical medical device (contact lens), not an AI/ML algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not Applicable / Implied: For physical and optical properties of a contact lens, the "ground truth" would be established by validated measurement techniques and scientific protocols (e.g., using specialized equipment to measure water content, dimensions, oxygen permeability). The document states, "All tests were conducted in accordance with the GLP regulation (21 CFR Part 58) or according to valid scientific protocols."

8. The sample size for the training set

Not Applicable / Not Provided: This is not relevant for the type of device and testing described. The device doesn't have a "training set" in the AI/ML sense.

9. How the ground truth for the training set was established

Not Applicable / Not Provided: This is not relevant for the type of device and testing described.

In summary, the provided text does not describe an AI/ML device or a study validating an AI/ML algorithm. Instead, it is a regulatory submission for a contact lens, focusing on demonstrating substantial equivalence to a predicate device through non-clinical performance testing of physical and optical properties. The acceptance criteria are implicitly derived from ISO standards, and device performance is reported quantitatively for these physical properties.

Summary

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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 text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 25, 2024

CooperVision, Inc. Sahana Rajashekar Regulatory Affairs Specialist 6101 Bollinger Canyon Road. Suite 500 San Ramon, CA 94583

Re: K234127

Trade/Device Name: Clariti 1 Day Multifocal (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: December 28, 2023 Received: December 28, 2023

Dear Sahana Rajashekar:

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.

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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 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-reportingcombination-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.

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-devicereporting-mdr-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.

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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 -S

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Druq Administration

Indications for Use

510(k) Number (if known) K234127

Device Name

Clariti 1 Day Multifocal (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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K234127

510(k) Summary

Date Prepared: Jan 24, 2024

Submitter: CooperVision, Inc. 6101 Bollinger Canyon Road, Suite 500 San Ramon, CA 94583

Contact Person:

Sahana Rajashekar Regulatory Affairs Specialist 6101 Bollinger Canyon Road, Suite 500 San Ramon, CA 94583 Phone: (925) 366-0300 E-mail: srajashe@coopervision.com

Device Identification:

Trade Name: Clariti 1 Day Multifocal (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker 2. Common Name: Soft (hydrophilic) Contact Lens 3. Classification Name: Lens, Contact, (Disposable)/MVN; Product Code: Lenses, Soft Contact, Daily Wear/LPL 4. Classification Regulation: Class II [21 CFR 886.5925 (b) (1)] 5. Classification Panel: Division of Ophthalmic and Ear, Nose and Throat Devices

Predicate Device: Clariti 1 Day Multifocal (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker (K181920)

Description of Device:

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 316-380mm.

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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
Multifocal ADD:

Multifocal 3 ADD (Binocular Progressive System) Power Range: LOW = (+0.75D to +1.25D) MED = (+1.50D to +1.75D) HIGH = (+2.00D to +2.50D)

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

Indications for use:

The indications for use statement for the subject device and predicate device is identical.

Lens Design	Indication
Multifocal	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.

Lens Design

Indication

Multifocal

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.

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Comparison of technological characteristics with the predicate device:

The technological characteristics of the subject device and the predicate device are compared in the table below.

Technology/Material Comparison
	Predicate Device	Subject Device
Product Name	Clariti 1 Day Multifocal(somofilcon A) Soft(Hydrophilic) DailyDisposable Contact Lenswith UV Blocker	Same
Material USAN Name	somofilcon A	Same
510(k) Number	K181920	K234127
FDA Category (Group)	Materials having a Dkgreater than 40 Dk units(using mmHg) and havinga Dk greater than thatexpected based on thematerials' water contentalone (Group V)	Same
Indications for Use	Clariti 1 Day Multifocal(somofilcon A) Soft(Hydrophilic) DailyDisposable Contact Lenswith UV Blocker isindicated for daily wearsingle use only for theoptical correction ofrefractive ametropia(myopia and hyperopia)and/or presbyopia inphakic or aphakic personswith non-diseased eyes thatmay require a readingAddition of +3.00 Dioptersor less and may exhibitastigmatism up to 1.50Diopters or less.	Same
Manufacturing Method	Cast Molding	Same
Wearing andReplacement Schedule	Daily Wear Single Use	Same
Sterilization Method	Moist Heat	Same
Technology/Material Comparison
	Predicate Device	Subject Device
Packaging Materials	Injection moldedpolypropylene blisterscovered by aluminum foillaminate and blister stripsare packed into printedcartons	Same
Packaging Solution	Phosphate Buffered SalineSolution containing0.005% w/v Poloxamer407	Same
Blue Visibility Tint	No	Same
Tint	None	Same
UV Blocker	UV416	Same
Design	2ADD (Low and High)	3ADD (Low, Medium, andHigh)

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Performance data:

Results from non-clinical studies were provided in support of the substantial equivalence determination.

Performance testing:

In accordance with the Premarket Notification [510(k)] Guidance Document for Daily Wear Contact Lenses, issued June 27, 1994, the following performance tests were conducted according to BS EN ISO 18369-2:2017 and BS EN ISO 18369-4:2017:

Water content 0
Dimensional/optical parameters ●

All tests were conducted in accordance with the GLP regulation (21 CFR Part 58) or according to valid scientific protocols.

Biocompatibility testing:

No biocompatibility testing was required as there are no changes to the lens formulation or manufacturing method.

Conclusion

This 510(k) is submitted in accordance with the Premarket Notification [510(k)] Guidance Document for Daily Wear Contact Lenses, issued June 27, 1994, for a change in the lens design. Because the predicate device lens material, performance testing specifications, primary packaging materials and packaging solution are identical to the subject device, non-clinical data presented are adequate to support substantial equivalence. Therefore, the subject Clariti 1 Day Multifocal (somofilcon A) Soft

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(Hydrophilic) Daily Disposable Contact Lens with UV Blocker is considered as safe and as effective as the predicate device.

Regulation Number and Section

§ 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.