MyDay (stenfilcon A) ASPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuty.

MyDay (stenfilcon A) TORIC Soft Contact lenses are indicated for the correction of ametropia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.

MyDay (stenfilcon A) MULTIFOCAL Soft Contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuity.

MyDay (stenfilcon A) MULTIFOCAL TORIC Soft Contact lenses are indicated for the optical correction of distance and near vision in presbyopic phakic persons with non-diseased eyes who may have - 10.00 diopters of astigmatism or less.

Device Description

MyDay Contact Lenses are available as an Asphere, Toric, Multifocal, and Multifocal Toric lens designs.

The MyDay material, stenfilcon A, is primarily a random copolymer of polydimethylsiloxane methacrylate and vinylmethyl acetamide. The UV blocker used is a benzotriazolyl methacrylate. The lenses have a blue tint which is added to make the lens more visible for handling. The lenses also contain a UV absorbing monomer which is used to block UV radiation.

When placed on the cornea in its hydrated state, the MyDay Soft (Hydrophilic) Contact Lens acts as a refracting medium to focus light rays on the retina.

AI/ML Overview

The provided text is a 510(k) summary for the MyDay (stenfilcon A) Soft (hydrophilic) Daily Disposable Contact Lens. It outlines testing performed and conclusions regarding its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of AI/ML or diagnostic performance.

The document mainly focuses on:

Device Description: Material, physical parameters, and optical properties of the contact lens.
Performance Testing (Non-clinical): A battery of tests performed according to ANSI, ISO, and ASTM standards to characterize physical/mechanical/optical properties (e.g., contact angle, light transmittance, water content, mechanical properties, refractive index, total extractables, non-polymeric residuals).
Biocompatibility Testing: Extractable residual analysis to compare current and modified stenfilcon A formulations.
Clinical Testing: A statement that clinical performance data was not required because the subject device and predicate device are equivalent in technical characteristics, manufacturing, and sterilization processes, and the non-clinical performance testing demonstrates equivalence.

Therefore, I cannot provide the requested information because the document describes a contact lens and its regulatory submission, not an AI/ML-driven device with diagnostic performance criteria and a study to prove it meets them.

If this were a document about an AI/ML device, the requested information would typically include:

Table of Acceptance Criteria and Reported Device Performance: This would list metrics like sensitivity, specificity, AUC, recall, precision, F1-score, accuracy, or other relevant AI performance indicators, along with the predefined acceptance thresholds and the actual performance achieved by the device in a validation study.
Sample Size for Test Set and Data Provenance: Details on the number of cases/samples in the independent test set used to evaluate the AI, and information about where this data came from (e.g., specific hospitals, countries, whether it was collected retrospectively or prospectively).
Number of Experts and Qualifications: How many human experts reviewed the test data to establish the ground truth, and their professional qualifications (e.g., board-certified radiologists, pathologists, clinical specialists, with specified years of experience).
Adjudication Method: The process used to reconcile disagreements among experts when establishing ground truth (e.g., a "2+1" method where two experts agree, or a third expert resolves disagreements; a "3+1" method; or if no adjudication was used).
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Whether a study was performed to compare human performance with and without AI assistance, and if so, the effect size (e.g., how much the readers' sensitivity or specificity improved, or reduction in reading time).
Standalone Performance: Whether the AI algorithm's performance was evaluated independently without human intervention.
Type of Ground Truth: How the definitive diagnosis or reference standard was established for the test set (e.g., consensus of multiple experts, pathological confirmation, long-term clinical outcome data, surgical findings).
Sample Size for Training Set: The number of cases/samples used to train the AI model.
How Ground Truth for Training Set was Established: The method used to label or annotate the data used for training the AI model (often similar to the test set ground truth establishment but might involve different scales or processes).

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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.

April 29, 2019

CooperVision, Inc. Marie E. Dutton Senior Regulatory Affairs Specialist 5870 Stoneridge Drive. Suite 1 Pleasanton, CA 94588

Re: K190965

Trade/Device Name: MyDay (stenfilcon A) Soft (hydrophilic) Daily Disposable Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: April 11, 2019 Received: April 12, 2019

Dear Ms. 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.

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely yours,

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens

Indications for Use (Describe)

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

I. SUBMITTER:

CooperVision, Inc. 6150 Stoneridge Mall Road, Suite 370 Pleasanton, CA 94588

Contact Person:

Marie Dutton Senior Regulatory Affairs Specialist CooperVision, Inc. 5870 Stoneridge Drive. Suite 1 Pleasanton, CA 94588 Phone: (925) 251-6645 (925) 251-6643 Fax: E-mail: MDutton@coopervision.com

Date Prepared:

April 11, 2019

II. DEVICE:

Trade Name:	MyDay (stenfilcon A) Soft (Hydrophilic) Daily DisposableContact Lens
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 SUS (stenfilcon A) Soft (hydrophilic) Contact Lenses for Single Use Daily Wear, K131378

IV. DEVICE DESCRIPTION:

MyDay Contact Lenses are available as an Asphere, Toric, Multifocal, and Multifocal Toric lens designs.

When placed on the cornea in its hydrated state, the MyDay Soft (Hydrophilic) Contact Lens acts as a refracting medium to focus light rays on the retina.

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MyDay (stenfilcon A) contact lens parameters are:

• Chord Diameter:	13.0 mm to 15.5mm
• Base Curve:	8.4 ± 0.5 mm and 8.7 ± 0.5 mm
• Center Thickness:	0.08 mm to 0.218 mm (varies with power
• Powers:	-20.00D to +20.00D
• Cylinder Powers:	-0.25D to -10.00D
• Axis:	0° to 180° in 10° increments
• Add Power Range:	+0.50 to +4.00

The physical/optical properties of the lens are:

Specific Gravity: 1.033 Refractive Index: 1.401 ● 96%
Light Transmittance:

Surface Character:

Hydrophilic
Water Content: 54%
Oxygen Permeability: 80x10-11 [(cm2/sec)x(ml O2)/(ml x mm Hg)]

V. INDICATIONS FOR USE:

●

MyDay (stenfilcon A) ASPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuity.

MyDay (stenfilcon A) TORIC Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.

MyDay (stenfilcon A) MULTIFOCAL Soft Contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuity.

MyDay (stenfilcon A) MULTIFOCAL TORIC Soft Contact lenses are indicated for the optical correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes who may have -10.00 diopters of astigmatism or less.

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VI. 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	CooperVisionSUS (stenfilcon A)	CooperVisionMyDay (stenfilcon A)
Material USAN Name	stenfilcon A	Same
510(k) Number	K131378	TBD – Current Submission
FDA Category (Group)	Silicone Hydrogel	Same
Manufacturing Method	Molded	Same
Sterilization	Moist Heat	Same
Packaging Materials	Injection moldedpolypropylene blisterscovered by aluminum foillaminate; blister strips arepacked into printed cartons	Same
Packaging Solution	Phosphate Buffered SalineSolution with Tween	Same
Visibility Tint	Reactive Blue #246 (RB246)	Same
UV Blocker	Norbloc	Same

VII. 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, May 12, 1994 amended June 28, 1994, the following battery of testing was performed. All tests were conducted in accordance with the GLP regulation (21 CFR Part 58) or according to valid scientific protocols. Each test was conducted according to the ANSI, ISO, and/or ASTM standard indicated:

Contact angle per ANSI Z80.20-2016 ●
Light transmittance per ISO 18369-2:2017 and ISO 18369-3:2017 ●
Water content per ISO18369-2:2017 and ISO 18369-4:2017
Mechanical properties per ANSI Z80.20-2016 and ASTM D1708-18 ●
Refractive index per ISO 18369-2:2017 and ISO 16369-4:2017
Total extractables per ANSI Z80.20-2016 and ISO 18369-4:2017 ●
Non-polymeric residuals in lens and packaging solution, solvents chosen o per EN ISO 18369-4:2017

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Biocompatibility testing:

An extractable residual analysis, in accordance with EN ISO 10993-18:2009, Annex C. was performed on both the current stenfilcon A and the modified stenfilcon A formulations. Based on the comparison of the extractable residual profiles, the residual concentration is maintained. Therefore, the similarity in the extractable residual levels is established, and additional biocompatibility testing was not required to complete the substantial equivalent determination.

Clinical testing:

Test results provided in this 510(k) are sufficient to adequately characterize the subject device in terms of its physical/mechanical/optical characteristics when compared to the predicate. The results are equivalent, determining that additional clinical performance data was not required to complete the substantial equivalent determination. Additionally, the technical characteristics and manufacturing and sterilization processes of the subject lens are equivalent to stenfilcon A contact lens currently marketed by Cooper Vision; therefore, it was confirmed that no clinical data is required.

VIII. CONCLUSIONS:

Conclusive evidence was provided to demonstrate that the subject device lens material is equivalent to the currently marketed predicate device lens material through the statistical analysis of the physical/mechanical/optical properties of the lens. Based on the performance testing and the fact that the subject device has the same manufacturing process as the marketed predicate device lens, clinical performance data was not required to be submitted in this 510(k). The performance testing demonstrates that the subject device is as safe, as effective, and performs as well 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.