(104 days)
Not Found
No
The summary describes a standard contact lens and its physical, optical, and biocompatibility properties. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is indicated for the correction of ametropia, not for treating a disease or condition.
No
Explanation: This device is a contact lens used for vision correction (ametropia, astigmatism, presbyopia), not for diagnosing medical conditions.
No
The device description clearly states it is a "daily wear silicone hydrogel contact lens," which is a physical medical device, not software.
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 device is for the "correction of ametropia (myopia and hyperopia)" and "correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia". This describes a therapeutic or corrective function, not a diagnostic one.
- Device Description: The description details a contact lens designed to be worn on the eye for vision correction.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, or tissue) or to provide information about a person's health status, disease, or condition.
IVD devices are specifically designed to perform tests on biological samples to diagnose, monitor, or screen for diseases or conditions. This contact lens does not fit that description.
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 soft contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
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 singleuse disposable daily wear.
Product codes (comma separated list FDA assigned to the subject device)
LPL, MVN
Device Description
The AVAIRA (enfilcon A) soft contact lens is a daily wear silicone hydrogel contact lens that is not surface treated and is characterized by 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 lens will be manufactured in spherical, aspherical, toric and multifocal configurations with the following features and properties:
• Chord Diameter • 13.5 mm to 15.0 mm
• Center Thickness • 0.05 mm to 0.60 mm
• Base Curve • 8.2 mm to 9.2 mm
• Power Range • -20.00D to +20.00D in 0.25 steps
• Cylinder Power (TORIC) • -0.25 to -10.00 D
• Add Power (Multifocal) • +0.50 to +4.00 D
• Refractive Index (hydrated) • 1.40
• Water Content • 46% by weight in normal saline
• Oxygen permeability • 100 x 10-11 [(cm2/sec)(ml O2)/ml*mmHg]], 34°C, Polarographic method (corrected)
The lens is supplied sterile in blister packs containing a buffered saline solution. Labeling is printed with appropriate lot numbering, expiration dating and lens parameter identification. Expiration dating is established based on studies of product stability, package integrity, and sterility.
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)
Physical and Optical Studies: The physical and optical properties of the lenses as assessed by various test methods show substantial equivalency with the predicate device. Additional studies were conducted to verify that leachable substances were either low or below measurable levels to mitigate any concerns for its intended use.
Biocompatibility Studies: Biocompatibility studies were conducted and verified that AVAIRA (enfilcon A) lenses were biocompatible for the intended use as assessed using ISO 10993 standards for ocular irritation, cytotoxicity, and systemic toxicity. All results passed with no evidence of adverse clinical effects caused by the modified enfilcon A lens.
Human Clinical Studies: Clinical studies were conducted on the predicate device to demonstrate substantial equivalence of the enfilcon A lens as compared with historical data of the COOPERVISION BIOFINTY lens based on performance and safety. No additional clinical study was required for the modified enfilcon A lens.
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.
COOPERVISION AQUAIR (enfilcon A) Soft Contact Lens [K071736]
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/9 description: The image shows the CooperVision logo. The logo consists of a black circle above the word "CooperVision" in a simple, sans-serif font. A trademark symbol is present to the right of the word "CooperVision".
APR - 3 2012
510(k) SUMMARY
| 1. Applicant Name and Address | CooperVision, Inc.
6150 Stoneridge Mall Road
Suite 370
Pleasanton, CA 94588 USA
(925) 621-2450 | |
|-------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| 2. Contact | Karin Gastineau
Director, Global Regulatory Affairs
CooperVision, Inc.
(925) 621-3732 | |
| Date Prepared | Original: December 20, 2012
Revised: January 19, 2012 | |
| 3. Device Identification | Common Name: | Soft Contact Lens
Trade Name:
AVAIRA (enfilcon A) Soft
Contact Lens |
| | Class Name: | Soft (hydrophilic) Contact Lens
Daily Wear (Disposable) |
| | Classification: | Class II [21 CFR 886.5925] |
4. Device Description
The AVAIRA (enfilcon A) soft contact lens is a daily wear silicone hydrogel contact lens that is not surface treated and is characterized by 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 lens will be manufactured in spherical, aspherical, toric and multifocal configurations with the following features and properties:
Product Code:
LPL. MVN
| • Chord Diameter | • 13.5 mm to 15.0 mm |
|---|---|
| • Center Thickness | • 0.05 mm to 0.60 mm |
| • Base Curve | • 8.2 mm to 9.2 mm |
| • Power Range | • -20.00D to +20.00D in 0.25 steps |
| • Cylinder Power (TORIC) | • -0.25 to -10.00 D |
| • Add Power (Multifocal) | • +0.50 to +4.00 D |
| • Refractive Index (hydrated) | • 1.40 |
| • Water Content | • 46% by weight in normal saline |
| • Oxygen permeability | • 100 x 10-11 [(cm2/sec)(ml O2)/ml*mmHg]], |
| 34°C, Polarographic method (corrected) |
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1
113459
Image /page/1/Picture/1 description: The image shows the CooperVision logo. The logo consists of a stylized globe or sphere above the text "CooperVision". The globe is mostly black with some white spots, and the text is in a simple, sans-serif font.
The lens is supplied sterile in blister packs containing a buffered saline solution. Labeling is printed with appropriate lot numbering, expiration dating and lens parameter identification. Expiration dating is established based on studies of product stability, package integrity, and sterility.
5. 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 soft contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
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 singleuse disposable daily wear.
6. Predicate Device(s)
- ♦ COOPERVISION AQUAIR (enfilcon A) Soft Contact Lens [K071736]
7. Characteristics of Substantial Equivalence
The AVAIRA (enfilcon A) Soft Contact Lens is substantially equivalent to the COOPERVISION AQUAIR (enfilcon A) Soft Contact Lenses. The lenses are low water, nonionic, silicone hydrogel lenses. The lenses are Class II and have indications for daily wear per premarket notification. The following Table summarizes the primary features for this comparison, illustrating the similarities and differences.
2
Image /page/2/Picture/1 description: The image shows the CooperVision logo. The logo consists of a circular shape at the top, which appears to be a stylized representation of an eye or a lens. Below the circular shape, the text "CooperVision" is displayed, with the trademark symbol (™) next to it. The text is in a simple, sans-serif font.
| Attributes | CooperVision
AVAIRA
[Current Submission] | CooperVision
AQUAIR
[K071736] |
|-----------------------------------------------------------------------|------------------------------------------------|-------------------------------------|
| Material | enfilcon A
silicone hydrogel | enfilcon A
silicone hydrogel |
| Category (Group) | N/A
(low water, nonionic) | N/A
(low water, nonionic) |
| Manufacturing Method | Cast Molded | Cast Molded |
| Indication | Daily Wear | Daily Wear |
| Water Content (%) | 46 | 46 |
| Oxygen Permeability - Dk @ 35°C
[(cm²/sec) x (ml O2)/(ml x mm Hg)] | $100 x 10^{-11} †$ | $100 x 10^{-11} †$ |
| Refractive Index | 1.40 | 1.40 |
| Light Transmittance (%) | > 97 | > 97 |
| Chord Diameter Range(mm) | 13.5 to 15.0 | 13.5 to 15.0 |
| Base Curve Range (mm) | 8.2 to 9.2 | 8.2 to 9.2 |
| Center Thickness (mm) | 0.08 @ -3.00D | 0.08 @ -3.00D |
| Powers | -20.00D to +20.00D
in 0.25 steps | -20.00D to +20.00D
in 0.25 steps |
- polarographic method (corrected) $ coulometric method
8. Physical and Optical Studies
The physical and optical properties of the lenses as assessed by various test methods show substantial equivalency with the predicate device as illustrated in the preceding table. Additional studies were conducted to verify that leachable substances were either low or below measurable levels to mitigate any concerns for its intended use.
9. Biocompatibility Studies
Biocompatibility studies were conducted and verified that AVAIRA (enfilcon A) lenses were biocompatible for the intended use as assessed using ISO 10993 standards for ocular irritation, cytotoxicity, and systemic toxicity. All results passed with no evidence of adverse clinical effects caused by the modified enfilcon A lens.
10. Human Clinical Studies
Clinical studies were conducted on the predicate device to demonstrate substantial equivalence of the enfilcon A lens as compared with historical data of the COOPERVISION BIOFINTY iens based on performance and safety. No additional clinical study was required for the modified enfilcon A lens.
~ 3 ~
3
KIJ 3759
Image /page/3/Picture/1 description: The image shows the logo for CooperVision. The logo consists of a black circle with some white shading at the top. Below the circle, the word "CooperVision" is written in a simple, sans-serif font, with a trademark symbol after the word.
11. Conclusions
The enfilcon A soft contact lens with the modified process has the same intended use and substantially similar indications, technological characteristics, and principles of operation as the cleared enfilcon A soft contact lens ("predicate device"). The minor differences between the device and the predicate device do not raise any new questions of safety or effectiveness. The testing conducted demonstrates that the device meets design inputs and is substantially equivalent to the predicate. Thus, the modified enfilcon A soft contact lens is substantially equivalent to its predicate device.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is simple and iconic, representing the department's mission to protect the health of all Americans and provide essential human services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Karin J. Gastineau Director, Global Regulatory Affairs CooperVision, Inc. 6150 Stoneridge Mall Road, Suite 370 Pleasanton, CA 94588
2012
Re: K113759 ·
Trade/Device Name: AVAIRA (enfilcon A) Soft Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: March 2, 2012 Received: March 5, 2012
Dear Ms. Gastineau:
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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r 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 or any I vaturer station of strequirements, 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
5
Page 2 - Ms. Karin J. Gastineau
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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 If you desire specific advice to: your covities soffices/CDRH/CDRHOffices/ucm115809.html for go to mig.//www.loa.gov/rtRodiological Health's (CDRH's) Office of Compliance. Also, please mote the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regulation onlined. Thisolarians 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 Tou may other 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,
Kesia 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
6
Kii3759
Indications for Use
510(k) Number (if known):
Device Name: AVAIRA (enfilcon A) Soft (Hydrophilic) Contact Lens
Indications for Use:
SPHERICAL AND ASPHERICAL:
AVAIRA (enfilcon A) Sphere and Asphere Soft Contact lenses are indicated for AVAII (Chilloon // / Optia (myopia and hyperopia) in aphakic and non-aphakic the concount of aniot opia (ves. The lenses may be worn by persons who persons with non alsoused 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 ametropia (firyopia or and eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.
MULTIFOCAL:
OCAL.
AVAIRA (enfilcon A) Multifocal lenses are indicated for the correction of refractive AVAIIVA (enmoon A) Multiroourish) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by and non-aphakic persons with hon diocuse of on the submit of the summer of with visual acuity.
The AVAIRA (enfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear. The AVAIRA (emilion A) Ook (Hyurophills) Ookus may be disinfected using a chemical vvillen prescribed for planned replademic the lens may also be prescribed for singleuse disposable daily wear.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
OR × Prescription Use __
Signature
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
Over-The-Counter Use
(Optional Format 1-2-96)
510(k) Number K113759