(28 days)
Not Found
No
The document describes a standard contact lens with no mention of AI or ML capabilities in its intended use, device description, or performance studies.
No.
The device is indicated for the correction of ametropia, which is a refractive error, not a disease. While it corrects a vision impairment, it does not treat or cure a disease or medical condition in the therapeutic sense.
No
The Avaira Vitality contact lenses are indicated for the correction of ametropia, astigmatism, and presbyopia, meaning they are used to treat or correct a condition rather than diagnose one. The "Intended Use / Indications for Use" section consistently describes the lenses as correcting these conditions.
No
The device description clearly describes a physical contact lens made of silicone hydrogel material with specific dimensions and physical/optical properties. It is a tangible medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in vitro for the examination of specimens, including blood, tissues, and urine, from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Device Function: The description clearly states that the Avaira Vitality contact lenses are intended for the "correction of ametropia (myopia and hyperopia)" and "correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia". They act as a "refracting medium to focus light rays on the retina."
- Lack of Specimen Examination: The device does not examine any specimens from the human body. It is a physical device placed on the eye to alter the way light is focused.
Therefore, the Avaira Vitality contact lens is a medical device, but it falls under the category of a corrective lens rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Sphere/Asphere: 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.
Product codes
LPL, MVN
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)]
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eyes (cornea, adjacent sclera)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Eye Care Practitioners (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)
Biocompatibility testing was performed on the lens and the packaging solution.
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of a human figure, and the text on the right is in blue. The text is arranged in three lines, with "FDA" on the first line, "U.S. FOOD & DRUG" on the second line, and "ADMINISTRATION" on the third line.
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
1
(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
2
Indications for Use
510(k) Number (if known)
Device Name
Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens
Indications for Use (Describe)
Sphere/Asphere:
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.
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.
3
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4
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.
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.
5
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)] |
6
INDICATIONS FOR USE: V.
| Lens Design | Indication |
|---|---|
| Sphere | 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 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. | |
| 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 and non-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 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.
7
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 saline | |||
| solution | 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 Device | ||
| Avaira Vitality (fanfilcon A) | ||
| K160803 | Subject Device | |
| Avaira 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)
8
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.