(30 days)
Not Found
No
The summary describes a contact lens with specific material properties and configurations, but there is no mention of AI or ML technology in the intended use, device description, or performance studies.
No
This device is a contact lens used for vision correction (ametropia), not for treating or curing a disease.
No
The "Intended Use / Indications for Use" section clearly states that the device is a soft contact lens indicated for the correction of ametropia, not for diagnosing any condition.
No
The device description clearly states it is a physical contact lens made of enfilcon A, a silicone hydrogel material. It describes the physical properties and configurations of the lens, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the contact lenses are for the correction of ametropia (myopia, hyperopia, astigmatism, presbyopia) in aphakic and non-aphakic persons with non-diseased eyes. This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The description details the physical properties and material composition of a contact lens, which is a medical device used for vision correction.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a disease, condition, or state of health. It does not analyze samples from the human body (like blood, urine, or tissue) to provide diagnostic information.
- Anatomical Site: The anatomical site is the eyes, and the device is placed on the surface of the eye for vision correction. IVDs typically interact with biological samples.
In summary, the Avaira (enfilcon A) Soft Contact Lens is a medical device for vision correction, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
SPHERICAL AND ASPHERICAL:
Avaira (enfilcon A) SPHERE and ASPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) 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.
TORIC:
Avaira (enfilcon 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 (enfilcon A) MULTIFOCAL 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.
The Avaira (enfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear. When prescribed for planned replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting systems. The lens may also be prescribed for single-use disposable daily wear.
Product codes (comma separated list FDA assigned to the subject device)
MVN, LPL
Device Description
The Avaira (enfilcon A) soft contact lens is a Group I, daily wear silicone hydrogel contact lens that is not surface treated and is characterized by a high oxygen permeability (Dk). The lens material, enfilcon A, is composed of silicone macromers cross linked with other monomers, incorporating phthalocyanine blue as an integrated, handling tint. A UV blocker is added to reduce the amount of ultraviolet light transmitted into the eye. The lenses are manufactured in spherical, aspherical, toric and multifocal configurations. The Avaira (enfilcon A) Soft (hydrophilic) contact lenses are a hemispherical shell. The physical properties and available dimensions are unchanged from predicate 510(k)s.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
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
K113245 DEC - 2 2011
510(k) Summary
-
- Applicant Name and Address
CooperVision, Inc. 6150 Stoneridge Mall Drive Suite 370 Pleasanton CA 94588
- Applicant Name and Address
- Contact
Gwen Sharp Regulatory Affairs (925) 621-2457 gsharp@coopervision.com
- Date Prepared
November 1, 2011
4. Device Identification
| Trade Name: | Avaira (enfilcon A) Soft (Hydrophilic)
Contact Lens |
|---------------------------|-------------------------------------------------------------|
| Common Name: | Soft Contact Lens |
| Classification
Name: | Soft (hydrophilic) Contact Lens -
Daily Wear; Disposable |
| Device
Classification: | Class II (21 CFR 886.5925) |
| FDA Material
Class: | FDA Group I, Low Water, Nonionic
Soft Contact |
| Product Code: | MVN, LPL |
1
5. Device Description
The Avaira (enfilcon A) soft contact lens is a Group I, daily wear silicone hydrogel contact lens that is not surface treated and is characterized by a high oxygen permeability (Dk). The lens material, enfilcon A, is composed of silicone macromers cross linked with other monomers, incorporating phthalocyanine blue as an integrated, handling tint. A UV blocker is added to reduce the amount of ultraviolet light transmitted into the eye. The lenses are manufactured in spherical, aspherical, toric and multifocal configurations. The Avaira (enfilcon A) Soft (hydrophilic) contact lenses are a hemispherical shell. The physical properties and available dimensions are unchanged from predicate 510(k)s.
6. Intended Use
SPHERICAL AND ASPHERICAL:
Avaira (enfilcon A) SPHERE and ASPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) 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.
TORIC:
Avaira (enfilcon 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 (enfilcon A) MULTIFOCAL 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.
The Avaira (enfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear. When prescribed for planned replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting systems. The lens may also be prescribed for single-use disposable daily wear.
2
7. Predicate Device(s)
Avaira (enfilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear (K071736) cleared January 4. 2008.
8. Characteristics of Substantial Equivalence
The soft contact lenses have the following similarities to the predicate lens that previously received 510(k) clearance:
- . have the same indicated use,
- incorporate the same design, .
- incorporate the same materials, .
- . have the same shelf life, and
- are packaged and sterilized using the same materials and processes. .
The modifications to the stability/shelf life protocol include an alternate test method for package integrity and adjusted storage temperatures for the packaged products that will be tested using alternate package integrity test method.
In summary, the enfilcon A soft contact lenses described in this submission are substantially equivalent to the predicate device.
9. Physiochemical Studies
Results from physical, optical and chemical properties were not required as support for this modification to shelf life protocol. Change will not affect physicochemical properties of the lenses.
10. Toxicology Studies
Results from in-vivo and in-vitro studies were not required as support for this modification to shelf life protocol. Change will not affect lenses ability to remain non-toxic and biocompatible with the ocular environment.
3
K113245
11. Conclusions of Non-Clinical Tests Performed:
-
트 Physiochemical:
The physical, optical and chemical properties of this lens remain unchanged from the unmodified device, and are within established specifications for the lenses. -
. Toxicology:
Results from in-vivo and in-vitro studies originally conducted remain valid and verify that the lenses remain non-toxic and are biocompatible with the ocular environment.
12. Clinical Studies
The technical characteristics, formulation, manufacturing, and sterilization processes of this lens are not changing and therefore are equivalent to enfilcon A soft contact lenses currently marketed by CooperVision, therefore no clinical data is required.
13. Conclusions
Based on no change to material, no change to manufacturing methods, no change to lens parameters and no change to indicated use, the enfilcon A soft contact lens described in this document are substantially equivalent to the predicate devices.
4
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, symbolizing freedom and protection. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The overall design is simple and professional, reflecting the department's role in public health and welfare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
CooperVision, Inc. c/o Ms. Gwen Sharp Global Regulatory Affairs 6150 Stoneridge Mall Road Suite 370 Pleasanton, CA 94588
DEC - 2 2011
Re: K113245
Trade/Device Name: Avaira (enfilcon A) Soft (Hydrophilic) Contact Lenses: Avaira (enfilcon A) Spherical and Aspherical Soft (Hydrophilic) Contact Lenses for Daily Wear Avaira (enfilcon A) Toric Soft (Hydrophilic) Contact Lenses for Daily Wear Avaira (enfilcon A) Multifocal Soft (Hydrophilic) Contact Lenses for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lenses Regulatory Class: Class II Product Code: LPL and MVN Dated: November 01, 2011 Received: November 02, 2011
Dear Ms. Sharp:
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. 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.
5
Page 2 – Ms. Gwen Sharp
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Kevia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): _(1) 3245
Device Name: Avaira (enfilcon A) Soft (hydrophilic) Contact Lenses
Indications for Use:
SPHERICAL AND ASPHERICAL:
A VAIRA (enfilcon A) SPHERE and ASPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) 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.
TORIC:
A VAIRA (enfilcon 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 (enfilcon A) MULTIFOCAL 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.
DAILY DISPOSABLE:
The Avaira (enfilcon A) Soft (hydrophilic) Contact Lenses are indicated for single-use disposable wear.
FREQUENT REPLACEMENT:
The Avaira (enfilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear. When prescribed for planned replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting system.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
Page 1 of 1
510(k) Number K113245