(25 days)
Not Found
No
The document describes contact lenses and their physical properties and intended use for vision correction. There is no mention of any computational or analytical functions that would involve AI/ML.
No.
The device is indicated for the correction of ametropia, which refers to refractive errors like myopia, hyperopia, and astigmatism, not for treating a disease or therapeutic purpose.
No
The device is a contact lens intended for the correction of ametropia, not for diagnosing medical conditions. Its function is to modify light refraction to improve vision.
No
The device described is a physical contact lens, not a software application. The description focuses on the material, design, and physical properties of the lens.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The provided text describes soft contact lenses. Their intended use is for the correction of vision problems (ametropia, astigmatism, presbyopia) by acting as a refracting medium on the cornea.
- Lack of Biological Sample Analysis: The description does not mention the analysis of any biological samples from the patient. The device is placed on the surface of the eye.
Therefore, the function and intended use of these contact lenses do not align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
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.
A VAIRA VITALITY (fanfilcon 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 eves in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.
AVAIRA VITALITY (fanfilcon A) MULTIFOCAL Soft lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with nondiseased 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.
AVAIRA VITALITY (fanfilcon A) MULTIFOCAL TORIC Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes in powers of -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 for 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.
Product codes
LPL, MVN
Device Description
MyDay Contact Lenses are available as 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 lenses have a blue tint which is added to make the lens more visible for handling. The lenses also contain a UV absorbing monomer, benzotriazolyl methacrylate, 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.
Avaira Vitality Contact Lenses are available as Sphere, Asphere, Toric, Multifocal, and Multifocal Toric lens designs. The Avaira Vitality material, fanfilcon A. is primarily a random copolymer of polydimethylsiloxane methacrylate and vinylmethyl acetamide. 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, benzotriazolyl methacrylate, which is used to block UV radiation. When placed on the cornea in its hydrated state, the Avaira Vitality Soft (Hydrophilic) Contact Lens acts as a refracting medium to focus light rays on the retina.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cornea, Eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D), Eye Care Practitioners
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)
Results from non-clinical studies were provided in support of the substantial equivalence determination.
Performance testing was performed in accordance with the Premarket Notification [510(k)] Guidance Document for Daily Wear Contact Lenses, May 12, 1994 amended June 28, 1994. 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
- Water content per BS EN ISO 18369-2:2017 and BS EN ISO 18369-● 4:2017
- Mechanical properties per ANSI Z80.20-2016 and ASTM D1708-02a
- Total extractables per ANSI Z80.20-2016 and BS EN ISO 18369-4:2017 ●
- Dimensional/optical parameters per BS EN ISO 18369-2:2017 and BS EN ● ISO 18369-3:2017
No biocompatibility testing was required as there are no changes to the lens formulation or manufacturing process. Equivalency was demonstrated from an ISO 10993-18:2020 chemical profiling perspective between the modified and unmodified stenfilcon A contact lenses.
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services-USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
February 4, 2022
CooperVision, Inc. Marie Dutton Regulatory Affairs Manager 6101 Bollinger Canyon Road, Suite 500 San Ramon, CA 94583
Re: K220070
Trade/Device Name: MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, 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: January 6, 2022 Received: January 10, 2022
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.
1
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/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-devices/medical-device-safety/medical-devicereporting-mdr-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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220070
Device Name
MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens
Indications for Use (Describe)
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.
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) | ☐ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K220070
Device Name
Avaira Vitality (fanfilcon A) Soft (Hydrophylic) Contact Lens
Indications for Use (Describe)
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.
A VAIRA VITALITY (fanfilcon 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.
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.
AVAIRA VITALITY (fanfilcon A) MULTIFOCAL TORIC Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes in powers of -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 for 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.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
K220070
510(k) Summary
I. SUBMITTER:
CooperVision, Inc. 6101 Bollinger Canyon Road, Suite 500 San Ramon, CA 94583
Contact Person:
Marie Dutton Regulatory Affairs Manager CooperVision, Inc. 6101 Bollinger Canyon Road, Suite 500 San Ramon, CA 94583 Phone: (925) 660-4474 E-mail: MDutton@coopervision.com
Date Prepared:
February 3, 2022
II. DEVICE:
| A. MyDay (stenfilcon A) | |
|---|---|
| Trade Name: | MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact 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 |
B. Avaira Vitality (fanfilcon A)
| Trade Name: | Avaira Vitality (fanfilcon A) Soft (Hydrophilic)
Contact 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:
A. MyDay (stenfilcon A)
The predicate device for MyDay (stenfilcon A) is CooperVision's MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens cleared under 510(k) K190965.
5
B. Avaira Vitality (fanfilcon A)
The predicate device for Avaira Vitality (fanfilcon A) is CooperVision's Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens cleared under 510(k) K213164.
IV. DEVICE DESCRIPTION:
A. MyDay (stenfilcon A)
MyDay Contact Lenses are available as 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 lenses have a blue tint which is added to make the lens more visible for handling. The lenses also contain a UV absorbing monomer, benzotriazolyl methacrylate, 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.
MyDay (stenfilcon A) contact lens parameters are:
| • Chord Diameter: | 13.0 mm to 15.5 mm |
|---|---|
| • Base Curve: | $8.4 \pm 0.5$ mm and $8.7 \pm 0.5$ 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 |
| • | Light Transmittance: | 96% |
| • | Surface Character: | Hydrophilic |
| • | Water Content: | 54% |
| • | Oxygen Permeability: | 80x10-11 [(cm²/sec)x(ml O₂)/(ml x mm Hg)] |
B. Avaira Vitality (fanfilcon A)
Avaira Vitality Contact Lenses are available as Sphere, Asphere, Toric, Multifocal, and Multifocal Toric lens designs.
The Avaira Vitality material, fanfilcon A. is primarily a random copolymer of polydimethylsiloxane methacrylate and vinylmethyl acetamide. The lenses have a blue tint which is added to make the lens more visible for handling.
6
The lenses also contain a UV absorbing monomer, benzotriazolyl methacrylate, which is used to block UV radiation.
When placed on the cornea in its hydrated state, the Avaira Vitality Soft (Hydrophilic) Contact Lens acts as a refracting medium to focus light rays on the retina.
Avaira Vitality (fanfilcon A) contact lens parameters are:
| • Diameter: | 13.5 mm to 15.5 mm |
|---|---|
| • Base Curve: | 8.2 mm and 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 and Multifocal Toric): | -0.25 D to -10.00 D |
| • Axis | |
| (Toric and Multifocal Toric): | 0° to 180° |
| • Add Power Range | |
| (Multifocal and Multifocal Toric): | +0.25 D to +4.00 D |
The physical/optical properties of the lens for the subject device and the predicate device are identical.
The physical/optical properties of the lens 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)] |
v. INDICATIONS FOR USE: A. MyDay (stenfilcon A)
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.
7
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 nondiseased 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.
B. Avaira Vitality (fanfilcon A)
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.
AVAIRA VITALITY (fanfilcon 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 eves in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.
AVAIRA VITALITY (fanfilcon A) MULTIFOCAL Soft lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with nondiseased 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.
AVAIRA VITALITY (fanfilcon A) MULTIFOCAL TORIC Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes in powers of -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 for 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
8
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.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH VI. THE PREDICATE DEVICE:
The technological characteristics of the subject device and the predicate device are compared in the tables below.
| Technology/Material Comparison | ||
|---|---|---|
| Predicate Device | Subject Device | |
| Product Name | CooperVision | |
| MyDay (stenfilcon A) | Same | |
| Material USAN Name | stenfilcon A | Same |
| FDA Category (Group) | Silicone Hydrogel | Same |
| Manufacturing Method | Molded | Same |
| Sterilization | Moist Heat | Same |
| Packaging Materials | Injection molded | |
| polypropylene blisters | ||
| covered by aluminum foil | ||
| laminate; blister strips are | ||
| packed into printed cartons | Same | |
| Packaging Solution | Phosphate Buffered Saline | |
| Solution with Tween | Same | |
| Visibility Tint | RB246 | Same |
| UV Blocker | Norbloc | Same |
- A. MyDay (stenfilcon A)
B. Avaira Vitality (fanfilcon A)
| Technology/Material Comparison | ||||||
|---|---|---|---|---|---|---|
| Predicate Device | Subject Device | |||||
| Product Name | CooperVision | |||||
| Avaira Vitality (fanfilcon A) | Same | |||||
| Material USAN Name | fanfilcon A | Same | ||||
| FDA Category (Group) | Silicone Hydrogel | Same | ||||
| Manufacturing Method | Molded | Same | ||||
| Sterilization | Moist Heat | Same | ||||
| Primary Packaging | ||||||
| Materials | Blister, Foil | Same | ||||
| Packaging Solution | Phosphate buffered saline | |||||
| solution | Same | |||||
| Visibility Tint | RB246 | Same | ||||
| UV Blocker | Norbloc | Same |
9
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
- Water content per BS EN ISO 18369-2:2017 and BS EN ISO 18369-● 4:2017
- Mechanical properties per ANSI Z80.20-2016 and ASTM D1708-02a
- Total extractables per ANSI Z80.20-2016 and BS EN ISO 18369-4:2017 ●
- Dimensional/optical parameters per BS EN ISO 18369-2:2017 and BS EN ● ISO 18369-3:2017
Biocompatibility testing:
No biocompatibility testing was required as there are no changes to the lens formulation or manufacturing process.
Equivalency was demonstrated from an ISO 10993-18:2020 chemical profiling perspective between the modified and unmodified stenfilcon A contact lenses.
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 a manufacturing process change and a change to the purity specification. Because the predicate device lens material characteristics, 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 MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens is considered substantially equivalent to its predicate device, and the subject Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens is considered substantially equivalent to its predicate device.