(27 days)
Not Found
No
The document describes a contact lens and a manufacturing process modification. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The contact lenses are indicated for the correction of ametropia (myopia and hyperopia) and astigmatism, which are refractive errors, not diseases or therapeutic conditions.
No
The device is a contact lens, indicated for the correction of ametropia, which is a treatment rather than a diagnostic function.
No
The device description clearly states it is a physical contact lens made of silicone hydrogel, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the correction of vision (ametropia, myopia, hyperopia, astigmatism) in non-diseased eyes. This is a therapeutic or corrective function, not a diagnostic one.
- Device Description: The device is a contact lens, which is a physical object placed on the eye to alter light refraction. It does not perform any in vitro testing on biological samples.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a disease, condition, or state of health.
- Clinical Studies: The studies mentioned are physiochemical studies and the lack of required in-vivo clinical studies for this specific change, which aligns with a device that is not performing a diagnostic function.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This contact lens does not fit that description.
N/A
Intended Use / Indications for Use
AVAIRA (enfilcon A) SPHERE Soft (Hydrophilic) 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.
AVAIRA (enfilcon A) TORIC Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
MVN, LPL
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 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 Avaira (enfilcon A) Soft (hydrophilic) contact lenses are a hemispherical shell. This 510(k) submission covers a process modification to add a step to the preparation of the monomer mixture. The physical properties and dimensions of the finished lenses 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
eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
Physiochemical studies were conducted by CooperVision following scientific protocols.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Physiochemical Studies:
In-vitro studies measuring the physical, optical and chemical properties of lenses subjected to the modified manufacturing process were performed. The results show there is no significant change to the physicochemical properties of the lenses.
Tested Characteristics: Refractive Index, Total Extractables, Monomer Residuals, Ionoflux, Contact Angle, UV Transmission, Modulus, Elongation, Tensile Strength, and Power Conformance.
Results: Pass
Clinical Studies:
In-vivo clinical studies were not required for this change, as the dimensions, formulation, lens manufacturing process, and product specifications remain the same.
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
CooperVision, Inc.
K133627
510k Summary AVAIRA (enfilcon A) Sphere and Toric Contact Lenses 12/20/2013
DEC 2 3 2013
| Applicant: | CooperVision, Inc.
6150 Stoneridge Mall Road, Suite 370
Pleasanton, CA 94588 USA |
|------------------------|------------------------------------------------------------------------------------------------------|
| Applicant Contact: | Annette Nelson
Senior Regulatory Affairs Specialist
925-621-2453 (phone)
925-621-2488 (fax) |
| Email: | anelson@coopervision.com |
| Date Prepared: | November 15, 2013 |
| Device Trade Name: | AVAIRA Sphere and Toric Soft Contact Lenses |
| Common/Usual Name: | Enfilcon A Soft (Hydrophilic) Contact Lens |
| Classification Name: | Soft (Hydrophilic) Contact Lens, Daily Wear, Disposable |
| Device Classification: | Class II (21 CFR 886.5925); Product Codes MVN and LPL |
| Predicate Devices: | AVAIRA Sphere and Toric Soft Contact Lenses
(K071736/K113759) |
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 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 Avaira (enfilcon A) Soft (hydrophilic) contact lenses are a hemispherical shell. This 510(k) submission covers a process modification to add a step to the preparation of the monomer mixture. The physical properties and dimensions of the finished lenses are unchanged from predicate 510(k)s.
Intended Use:
SPHERICAL:
Avaira (enfilcon A) SPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The
Cooper Vision, Inc. AVAIRA (enfilcon A) Contact Lens 510(k)
1
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.
Physiochemical Studies
In-vitro studies measuring the physical, optical and chemical properties of lenses subjected to the modified manufacturing process were performed. The results show there is no significant change to the physicochemical properties of the lenses.
| Tested Characteristics | Results |
|---|---|
| Refractive Index, Total Extractables, Monomer | |
| Residuals, Ionoflux, Contact Angle, UV Transmission, | |
| Modulus, Elongation, Tensile Strength, and Power | |
| Conformance | Pass |
Clinical Studies
In-vivo clinical studies were not required for this change, as the dimensions, formulation, lens manufacturing process, and product specifications remain the same.
Conclusion
Validity of Scientific Data
Physiochemical studies were conducted by CooperVision following scientific protocols.
Substantial Equivalence
The information presented in this submission establishes the substantial equivalence of the modified AVAIRA (enfilcon A) SPHERE and TORIC daily wear contact lenses to the predicate devices. The following table summarizes the substantial equivalence comparison information.
2
:
and the comments of the comments of
.
:
. . . .
| Substantial Equivalence Comparison | ||
|---|---|---|
| Characteristic | AVAIRA SPHERE and TORIC | |
| (K071736/K113759) | AVAIRA SPHERE and TORIC | |
| (This Submission) | ||
| Indications for Use | ||
| AVAIRA SPHERE | Correction of ametropia in aphakic | |
| and non-aphakic persons with non- | ||
| diseased eyes and astigmatism | ||
| ≤2.00 diopters | Same | |
| Indications for Use | ||
| AVAIRA TORIC | 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 correction from -0.25 to | ||
| -10.00 diopters | Same | |
| Single Use | Single-use, disposable | Same |
| Replacement | Daily Wear, disinfect using | |
| chemical or hydrogen peroxide | ||
| disinfectant when prescribed for | ||
| planned replacement | Same | |
| Material USAN Name | enfilcon A | Same |
| Principle of Operation | Designed to fit over corneal | |
| surface of eye to provide | ||
| corrective refraction for | ||
| functional conditions of the eye | Same | |
| Refractive Index | 1.40 | Same |
| Oxygen Permeability x 10-11 | 100 (cm²/sec)(ml O₂)/ml*mmHg) | Same |
| Base Curve | 8.2 to 9.2 mm | Same |
| Diameter | 13.5 to 15.0 mm | Same |
| Power Range | -20.00 to +20.00 D | Same |
| Cylinder Power | -0.25 to -10.00 D | Same |
| Water Content (avg, %wt) | 46% | 46% |
| Monomer sonication step | No | Yes |
.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows a partial view of a seal or emblem. The visible text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the edge of the emblem. The central part of the emblem features a stylized design, possibly representing a caduceus or a similar symbol associated with health and medicine. The image is in black and white, with the text and design elements appearing in solid black against a white background.
December 23, 2013
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
CooperVision, Inc. % Ms. Annette Nelson Senior Regulatory Affairs Specialist 6150 Stoneridge Mall Road, Suite 370 Pleasanton, CA 94588
Re: K133627
Trade/Device Name: AVAIRA Sphere and Toric Soft Contact Lenses Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Secondary Product Code: MVN Dated: November 15, 2013 Received: November 26, 2013
Dear Ms. Nelson:
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 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.
4
Page 2 - Ms. Annette Nelson
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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Deborah L. Falls -S
for Malvina B. Eydelman. M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
5
CooperVision, Inc.
Indications for Use
510(k) Number: K133627
Device Name: AVAIRA (enfilcon A) Sphere and Toric Soft Contact Lenses
Indications For Use:
A VAIRA (enfilcon A) SPHERE Soft (Hydrophilic) 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.
AVAIRA (enfilcon A) TORIC Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual 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.
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.
Prescription Use X ______________________________________________________________________________________________________________________________________________________________________________ (part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jeffrey M. Brocious -S 2013.12.20 13:46:29 -05'00'
(Division Sign-Off) Division of Ophthalmic and Ear, Nose, and Throat Devices
510(k) Number: K133627
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Cooper Vision Inc., AVAIRA (enfilcon A) Contact Lens 510(k)