AVAIRA VITALITY SPHERE and ASPHERE (fanfilcon A) 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.

Toric:

AVAIRA VITALITY (fanfilcon A) TORIC Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aplakic 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.

Multifocal:

AVAIRA VITALITY (fanfilcon A) MULTIFOCAL Soft lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Multifocal Toric:

AVAIRA VITALITY (fanfilcon A) MULTIFOCAL TORIC Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -10.00 diopters.

Eye Care Practitioners may prescribe the Avaira Vitality (fanfilcon A) Soft Contact lenses fo frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement or for single-use disposable wear.

When prescribed for frequent/planned replacement, the Avaira Vitality (fanfilcon A) Soft Contact lens is to be cleaned, rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection only.

When prescribed for single-use disposable wear, the Avaira Vitality (fanfilcon A) Soft Contact lens is to be discarded after each removal.

Device Description

The Avaira Vitality (fanfilcon A) Contact Lens visibility tinted with UV blocker is available as sphere/asphere lens, toric lens, multifocal lens, and multifocal toric lens.

The lenses are made of a silicone hydrogel material which is not surface treated and is characterized by high oxygen permeability (Dk). The Avaira Vitality (fanfilcon A) Contact Lens is tinted blue using Reactive Blue #246 to make the lens more visible for handling. A Norbloc UV blocker is used to reduce the amount of ultraviolet light transmitted into the eye. The Avaira Vitality (fanfilcon A) lens is supplied sterile, packaged in a phosphate buffered saline solution. The composition of the lens is 45% fanfilcon A and 55% water by weight when hydrated and stored in buffered saline solution.

In its hydrated state, the Avaira Vitality (fanfilcon A) Contact Lens visibility tinted, with UV blocker, when placed on the cornea, acts as a refracting medium to focus light rays on the retina.

The lens has a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sclera, with the following dimensions:

• Diameter: 13.5 mm to 15.0 mm
• Base Curve: 8.2 mm to 9.2 mm
• Center Thickness: 0.06 mm to 0.6 mm (varies with power)
• Powers: -20.00 D to +20.00 D
• Cylinder Powers (Toric): -0.25 D to -10.00 D
• Axis (Toric): 0° to 180°
• Add Power Range (Multifocal) +0.25 D to +4.00 D

The physical/optical properties of the lenses are:

• Specific Gravity: 1.026
• Refractive Index: 1.398 ± 0.005
• Light Transmittance: 98% +2/-5%
• Surface Character: Hydrophilic
• Water Content: 55% ± 2%
• Oxygen Permeability: 90x10-11 [(cm²/sec) x (ml O2)/ (ml x mm Hg)]

AI/ML Overview

This document is a 510(k) Premarket Notification from CooperVision, Inc. to the FDA regarding their Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens (K213164).

Based on the provided text, the device in question is a contact lens, not an AI/ML powered device, therefore, many of the requested criteria are not applicable (N/A) or cannot be extracted from this document, as they pertain to the evaluation of AI/ML software performance.

Here's an analysis of the acceptance criteria and study information that can be extracted, and where the information is N/A:

Acceptance Criteria and Reported Device Performance

The document describes the device, its properties, and compares it to a legally marketed predicate device (K160803). The "performance data" section focuses on physical and optical properties rather than diagnostic performance metrics typically seen with AI/ML devices.

Acceptance Criteria	Reported Device Performance (Subject Device K213164)	Predicate Device (K160803)
Water Content %	55%	55%
Refractive Index @ 20°C	1.40	1.40
Specific Gravity g/mL	1.026	1.026
Oxygen Permeability (Dk)	90	90
Base Curve, mm	8.4	8.4
Diameter, mm	14.2	14.2
Diameter Range (Lens Description)	13.5 mm to 15.0 mm	Not explicitly listed in comparison table, but implied by "Same" for specific diameter.
Base Curve Range (Lens Description)	8.2 mm to 9.2 mm	Not explicitly listed in comparison table, but implied by "Same" for specific base curve.
Center Thickness (Lens Description)	0.06 mm to 0.6 mm (varies with power)	Not explicitly listed in comparison table.
Powers	-20.00 D to +20.00 D	Not explicitly listed in comparison table.
Cylinder Powers (Toric)	-0.25 D to -10.00 D	Not explicitly listed in comparison table.
Axis (Toric)	0° to 180°	Not explicitly listed in comparison table.
Add Power Range (Multifocal)	+0.25 D to +4.00 D	Not explicitly listed in comparison table.
Specific Gravity	1.026	1.026
Refractive Index	1.398 ± 0.005	1.40
Light Transmittance	98% +2/-5%	Not explicitly listed in comparison table.
Surface Character	Hydrophilic	Not explicitly listed in comparison table.
Visibility Tint	Reactive Blue #246	Reactive Blue #246
UV Blocker	Norbloc UV blocker	Present (implied by "Same" for product name)
Material USAN Name	fanfilcon A	fanfilcon A
Manufacturing Method	Molded	Molded
Sterilization	Moist Heat	Moist Heat
Primary Packaging	Blister, Foil	Blister, Foil
Packaging Solution	Phosphate buffered saline solution	Phosphate buffered saline solution
Biocompatibility Testing: Cytotoxicity	Performed (ISO 10993-5:2009)	N/A (Comparison is to predicate, not specific testing results are provided)
Biocompatibility Testing: Irritation & Sensitization	Performed (ISO 10993-10:2010)	N/A (Comparison is to predicate, not specific testing results are provided)

Study Details (Focusing on AI/ML Criteria - Mostly N/A for this device)

Sample size used for the test set and the data provenance:
- Not applicable (N/A). This document is for a physical medical device (contact lens), not an AI/ML software device that would require a "test set" of data in the context of algorithm evaluation. The document states, "The modification does not warrant performance testing to support substantial equivalence." This implies a lack of new clinical performance studies on the finished device in general.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable (N/A). No "ground truth" establishment in the context of diagnostic agreement is described for this physical device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable (N/A). No adjudication method is necessary for a physical contact lens.
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 (N/A). This is a contact lens, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable (N/A). This is a physical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable (N/A). The evaluation for this device focuses on physical properties, material composition, manufacturing, and biocompatibility, not diagnostic 'ground truth.' The basis for substantial equivalence is primarily the identical material and manufacturing process to the predicate device, along with limited biocompatibility testing.
The sample size for the training set:
- Not applicable (N/A). No AI/ML model for which a "training set" would be used is described.
How the ground truth for the training set was established:
- Not applicable (N/A). No AI/ML model or training set is described.

Summary of the Study Proving Substantial Equivalence for the Contact Lens:

The submission for K213164 (Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens) is a 510(k) application for substantial equivalence to a predicate device (K160803), which is an earlier version of the same product.

The core of the "study" proving the device meets acceptance criteria for substantial equivalence relies on:

Demonstrating Technological Characteristics are Identical: The subject device shares the exact same material (fanfilcon A), manufacturing method (Molded), sterilization method (Moist Heat), primary packaging, packaging solution, and visibility tint with the predicate device.
Demonstrating Performance Specifications are Identical: Key physical and optical properties like water content, refractive index, specific gravity, oxygen permeability (Dk), base curve, and diameter are listed as "Same" as the predicate device.
Limited Biocompatibility Testing: In accordance with GLP regulation (21 CFR Part 58), biocompatibility testing was performed on the lens and packaging solution, specifically:
- ISO 10993-5:2009 (Tests for in vitro cytotoxicity)
- ISO 10993-10:2010 (Tests for irritation and skin sensitization)
  The document states that "limited biocompatibility testing is adequate to support substantial equivalence" because the predicate device's lens material characteristics, primary packaging materials, and packaging solution are identical.
Regulatory Basis: The 510(k) is submitted in accordance with the May 12, 1994 Premarket Notification [510(k)] Guidance Document for Daily Wear Contact Lenses. The modification (a "lens extract non-polymeric residuals specification change") was deemed by the submitter to not warrant performance testing to support substantial equivalence due to the fundamental similarities with the predicate.

In conclusion, for this specific medical device, the "acceptance criteria" revolve around demonstrating the device is fundamentally the same as a previously cleared device, supported by the specific physical and chemical properties and basic biocompatibility testing, rather than a clinical performance study with AI-specific metrics.

Summary

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October 26, 2021

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

Re: K213164

Trade/Device Name: Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: September 27, 2021 Received: September 28, 2021

Dear Ahanitha Ashok:

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

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(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/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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

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Indications for Use

510(k) Number (if known)

Device Name

Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens

Indications for Use (Describe)

Sphere/Asphere:

Toric:

Multifocal:

When prescribed for single-use disposable wear, the Avaira Vitality (fanfilcon A) Soft Contact lens is to be discarded after each removal.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

I. SUBMITTER:

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

Contact Person:

Ahanitha Ashok Regulatory Affairs Specialist 6101 Bollinger Canyon Road, Suite 500 San Ramon, CA 94583 (925) 660-4482 Phone: -E-mail: aashok(@coopervision.com

Date Prepared:

October 22, 2021

II. DEVICE:

Trade Name:	Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens
Common Name:	Soft (Hydrophilic) Contact Lens
Classification Name:	Lens, Soft Contact, (Daily Wear) [21 CFR 886.5925 (b)(1)]
Regulatory Class:	II
Product Code:	LPL, MVN
Classification Panel:	Ophthalmic

III. PREDICATE DEVICE:

CooperVision's Avaira Vitality (fanfilcon A) Soft ● (Hydrophilic) Contact Lens, K160803

IV. DEVICE DESCRIPTION:

The Avaira Vitality (fanfilcon A) Contact Lens visibility tinted with UV blocker is available as sphere/asphere lens, toric lens, multifocal lens, and multifocal toric lens.

hydrated and stored in buffered saline solution.

In its hydrated state, the Avaira Vitality (fanfilcon A) Contact Lens visibility tinted, with UV blocker, when placed on the cornea, acts as a refracting medium to focus light rays on the retina.

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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:

• Diameter:	13.5 mm to 15.0 mm
• Base Curve:	8.2 mm to 9.2 mm
• Center Thickness:	0.06 mm to 0.6 mm (varies with power)
• Powers:	-20.00 D to +20.00 D
• Cylinder Powers (Toric):	-0.25 D to -10.00 D
• Axis (Toric):	0° to 180°
• Add Power Range (Multifocal)	+0.25 D to +4.00 D

The physical/optical properties of the lenses are:

• Specific Gravity:	1.026
• Refractive Index:	1.398 ± 0.005
• Light Transmittance:	98% +2/-5%
• Surface Character:	Hydrophilic
• Water Content:	55% ± 2%
• Oxygen Permeability:	90x10-11 [(cm²/sec) x (ml O2)/ (ml x mm Hg)]

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INDICATIONS FOR USE: V.

Lens Design	Indication
Sphere	AVAIRA VITALITY SPHERE and ASPHERE (fanfilcon A) SoftContact lenses are indicated for the correction of ametropia (myopia andhyperopia) in aphakic and non-aphakic persons with non-diseased eyes inpowers from -20.00 to +20.00 diopters. The lenses may be worn bypersons who exhibit astigmatism of 2.00 diopters or less that does notinterfere with visual acuity.
Toric	AVAIRA VITALITY (fanfilcon A) TORIC Soft Contact lenses areindicated for the correction of ametropia (myopia or hyperopia withastigmatism) in aphakic and non-aphakic persons with non-diseased eyesin powers from -20.00 to +20.00 diopters and astigmatic corrections from-0.25 to -10.00 diopters.
Multifocal	AVAIRA VITALITY (fanfilcon A) MULTIFOCAL Soft lenses areindicated for the correction of refractive ametropia (myopia andhyperopia) and emmetropia with presbyopia in aphakic and non-aphakicpersons with non-diseased eyes in powers from -20.00 to +20.00 dioptersand with add powers from +0.25 to +4.00 diopters. The lenses may beworn by persons who exhibit astigmatism of 2.00 diopters or less thatdoes not interfere with visual acuity.
MultifocalToric	AVAIRA VITALITY (fanfilcon A) MULTIFOCAL TORIC SoftContact lenses are indicated for the optic correction of distance andnear vision in presbyopic phakic or aphakic persons with non-diseasedeyes in powers of -20.00 to +20.00 diopters with add powers from +0.25to +4.00 diopters and astigmatism corrections from -0.25 to -10.00diopters.

Eye Care Practitioners may prescribe the Avaira Vitality (fanfilcon A) Soft Contact lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement or for single-use disposable wear.

When prescribed for single-use disposable wear, the Avaira Vitality (fanfilcon A) Soft Contact lens is to be discarded after each removal.

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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	Avaira Vitality (fanfilcon A) Soft(Hydrophilic) Contact Lens	Same
Material USAN Name	fanfilcon A	Same
510(k) number	K160803	K213164
FDA Category (Group)	Silicone Hydrogel	Same
Manufacturing Method	Molded	Same
Sterilization	Moist Heat	Same
Primary Packaging	Blister, Foil	Same
Packaging Solution	Phosphate buffered salinesolution	Same
Visibility Tint	Reactive Blue # 246	Same

VII PERFORMANCE DATA:

The performance specifications/parameters of the subject device and the predicate device are compared in the table below.

Performance Specifications/Parameters Comparison
	Predicate DeviceAvaira Vitality (fanfilcon A)K160803	Subject DeviceAvaira Vitality (fanfilcon A)K213164
Water Content %	55%	Same
Refractive Index@20°C	1.40	Same
Specific Gravity g/mL	1.026	Same
Oxygen Permeability(Dk)*	90	Same
Base Curve, mm	8.4	Same
Diameter, mm	14.2	Same

*Dk units: x 10-11 (cm²/sec) x (ml O2)/ml x mmHg)

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VIII. BIOCOMPATIBILITY TESTING:

In accordance with the GLP regulation (21 CFR Part 58), the following battery of biocompatibility testing was performed on the lens and the packaging solution in support of the substantial equivalence determination:

. ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
. ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

IX. 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 a lens extract non-polymeric residuals specification change. The modification does not warrant performance testing to support substantial equivalence. Because the predicate device lens material characteristics, primary packaging materials and packaging solution are identical to the subject device, limited biocompatibility testing is adequate to support substantial equivalence. Therefore, the subject device is considered substantially equivalent to 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.