(85 days)
P820021 (S025), K001090
No
The description focuses on the material composition, physical properties, and intended use of contact lenses, with no mention of AI or ML technologies.
No
The device is indicated for the correction of refractive error (myopia or hyperopia) and astigmatism, and for cosmetic purposes (enhancing or altering eye color). These are not considered therapeutic uses.
No
Explanation: The device, a contact lens, is indicated for the correction of refractive error (myopia or hyperopia) and for enhancing or altering eye color. It does not analyze or interpret patient data to make a diagnosis.
No
The device description clearly states it is a physical contact lens made from a hydrophilic copolymer, 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 refractive error in the eye (myopia or hyperopia) and to enhance or alter the apparent color of the eye. This is a therapeutic and cosmetic purpose, not a diagnostic one.
- Device Description: The device is a contact lens, which is a medical device placed on the surface of the eye. It does not analyze biological samples (like blood, urine, or tissue) to provide diagnostic information.
- Lack of Diagnostic Function: The description focuses on the physical properties of the lens and its ability to correct vision and change eye color. There is no mention of it being used to detect, diagnose, or monitor any disease or condition by examining samples from the body.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This contact lens does not fit that definition.
N/A
Intended Use / Indications for Use
The Sofclear Enhance, Colors, and Comfort (methafilcon A) contact lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eves with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Daily wear replacement schedules may vary from patient and should be decided by eye care practitioners in consultation with their patients.
Eye care practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
Eye care practitioners may prescribe any of the above lenses for single use daily disposable wear. When prescribed for daily disposable wear the lens is to be discarded after each removal.
Product codes (comma separated list FDA assigned to the subject device)
LPL, MVN
Device Description
The Sofclear Enhance (methafilcon A) Daily Wear Contact Lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from methafilcon A, which is a hydrophilic copolymer of 2-Hydroxyethyl methacrylate (2-HEMA) and methacrylic acid, cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% methafilcon A and 55% water by weight when immersed in saline solution. The (methafilcon A) name has been adopted by the United States Adopted Names Council (USAN). The Sofclear Enhance (methafilcon A) Daily Wear Contact Lenses are available tinted to enhance or alter the apparent color of the eye. The lenses are tinted with one or a combination of one or more of the following 'listed' color additives: Reactive Blue 21, Reactive Blue 19, Reactive Yellow 86. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. When producing the lenses, the manufacturing process alters and/or changes the specifications to the clear contact lens by binding the reactive color dye(s) into the contact lens material in a location that covers the iris and pupil. The color additives used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the lens.
The Sofclear Colors (methafilcon A) Daily Wear Contact Lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from methafilcon A, which is a hydrophilic copolymer of 2-Hydroxyethyl methacrylate (2-HEMA) and methacrylic acid, cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% methafilcon A and 55% water by weight when immersed in saline solution. The (methafilcon A) name has been adopted by the United States Adopted Names Council (USAN). The Sofclear Colors (methafilcon A) Daily Wear Contact Lenses are available printed to enhance or alter the apparent color of the eye. The lenses are printed with one or a combination of one or more of the following 'listed' color additives: Red Iron Oxide, Violet 23, Titanium Dioxide, Chromium Oxide Green, Blue 36. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. When producing the lenses, the manufacturing process alters and/or changes the specifications to the clear contact lens by pad-printing the color pigment(s)-entrapping them in the interpenetrating network of the contact lens material in a location that corresponds to the iris. The color pigments used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the printing pattern has a minimum clear pupil diameter of 6.5 mm when the lens is hydrated.
The Sofclear Comfort (methafilcon A) Daily Wear Contact Lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from methafilcon A, which is a hydrophilic copolymer of 2-Hydroxyethyl methacrylate (2-HEMA) and methacrylic acid, cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% methafilcon A and 55% water by weight when immersed in saline solution. The (methafilcon A) name has been adopted by the United States Adopted Names Council (USAN). The Sofclear Comfort (methafilcon A) Daily Wear Contact Lenses include a tint (1,4-Bis[4-(2methacryloxyethyl)phenylamino]-9,10-anthraquinone) in the composition of the lens for ease of handling and visibility.
The Sofclear Enhance, Colors, and Comfort (methafilcon A) Daily Wear Contact Lenses incorporate a UV absorbing monomer. The lenses block >88% in the UVB range (280mm - 315nm), and >68% in the UVA range (316nm - 380nm). The Sofclear Enhance, Colors, and Comfort (methafilcon A) Daily Wear Contact Lenses will be manufactured in the spherical design configuration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
Non-clinical Testing: A series of preclinical testing was performed to demonstrate the safety and effectiveness of the Sofclear Enhance, Colors, and Comfort (methafilcon A) finished contact lenses. The results support the claim that the Sofclear Enhance, Colors, and Comfort (methafilcon A) Daily Wear Contact Lenses are substantially equivalent to the currently marketed predicate devices.
Toxicology: In-Vitro Cytotoxicity (ISO 10993-5) results indicated non-toxic. Systemic Toxicity (ISO 10993-11) confirmed non-toxic. Acute Ocular Irritation (ISO 10993-10) produced no ocular irritation.
Shelf Life: Testing demonstrated stability, sterility, and package integrity over labeled expiration date.
Physicochemical & Mechanical Properties: Tests included refractive index, water content, Dk, % transmission (visible & UV), tensile strength, modulus, % elongation to break, specific gravity and polymerization residuals. Results showed consistent material properties with predicate devices.
Clinical Testing: Not required as clinical performance of methafilcon A materials has been previously demonstrated.
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.
P820021 (S025), K001090
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
September 6, 2018
Gelflex Laboratories % Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Ln West Linn, OR 97068
Re: K181558
Trade/Device Name: Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens
Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL, MVN Dated: August 6, 2018 Received: August 9, 2018
Dear Bret Andre:
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.
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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 (21 CFR Part 801 and Part 809); medical device 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely yours,
J. Angelo Green
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
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K181558
Device Name
Sofclear Enhance (methafilcon A) Daily Wear Contact Lens; Sofclear Colors (methafileon A) Daily Wear Contact Lens; Sofelear Comfort (methafilcon A) Daily Wear Contact Lens
Indications for Use (Describe)
The Sofclear Enhance, Colors, and Comfort (methafilcon A) contact lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eves with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Daily wear replacement schedules may vary from patient and should be decided by eye care practitioners in consultation with their patients.
Eye care practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
Eye care practitioners may prescribe any of the above lenses for single use daily disposable wear. When prescribed for daily disposable wear the lens is to be discarded after each removal.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/3/Picture/1 description: The image shows the logo for Gelflex Australian contact lenses. The logo features the word "Gelflex" in blue, with a kangaroo silhouette to the right. Below the logo, it says "Australian contact lenses" in a smaller font. The text "510(k) Premarket Notification" is at the bottom.
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
I. SUBMITTER
| Name: | Gelflex Laboratories |
|---|---|
| Address: | 52 Mulgul Road, Malaga |
| Perth, Western Australia 6090 | |
| Contact Person: | David Masel |
| Managing Director | |
| Phone number: | +61 8 9443 4944 |
| Consultant: | Bret Andre |
| EyeReg Consulting, Inc. | |
| 6119 Canter Ln. | |
| West Linn, OR 97068 | |
| Phone number: | (503) 372-5226 |
II. DEVICE
| Trade Name: | Sofclear Enhance (methafilcon A) Daily Wear Contact Lens
Sofclear Colors (methafilcon A) Daily Wear Contact Lens
Sofclear Comfort (methafilcon A) Daily Wear Contact Lens |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Contact Lens, Daily Wear |
| Classification Name: | Soft (hydrophilic) Contact Lens (21 CFR 886.5925) |
| Regulatory Class: | Class II |
| Product Code: | LPL; MVN |
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Purpose of 510(k) Submission:
~ New Device ~
III. PREDICATE DEVICE
The Sofclear Enhance, Colors, and Comfort (methafilcon A) Daily Wear Contact Lenses are substantially equivalent to the following predicate device(s):
- "55 UV (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear" Optical Connection, Inc. 510(k) number: K051095 Primary Predicate
- 트 "Focus Softcolors (vifilcon A) Soft (Hydrophilic) Contact Lenses" Alcon Laboratories, Inc. PMA number: P820021 (S025) Reference Predicate
- "Frequency Colors (methafilcon A)" o By Coopervision, Inc. 510(k) number: K001090 Reference Predicate
DEVICE DESCRIPTION IV.
Sofclear Enhance (methafilcon A) Daily Wear Contact Lens
The Sofclear Enhance (methafilcon A) Daily Wear Contact Lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from methafilcon A, which is a hydrophilic copolymer of 2-Hydroxyethyl methacrylate (2-HEMA) and methacrylic acid, cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% methafilcon A and 55% water by weight when immersed in saline solution. The (methafilcon A) name has been adopted by the United States Adopted Names Council (USAN).
The Sofclear Enhance (methafilcon A) Daily Wear Contact Lenses are available tinted to enhance or alter the apparent color of the eye. The lenses are tinted with one or a combination of one or more of the following 'listed' color additives:
| Color Additive | Listing |
|---|---|
| Reactive Blue 21 | 21 CFR § 73.3127 |
| Reactive Blue 19 | 21 CFR § 73.3127 |
| Reactive Yellow 86 | 21 CFR § 73.3121 |
The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the
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Image /page/5/Picture/1 description: The image contains the word "Gelflex" in a blue, cursive font. To the right of the word is a gray kangaroo silhouette. The kangaroo is facing right and is in a jumping position.
510(k) Premarket Notification
additive needed to accomplish the intended coloring effect. When producing the lenses, the manufacturing process alters and/or changes the specifications to the clear contact lens by binding the reactive color dye(s) into the contact lens material in a location that covers the iris and pupil. The color additives used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the lens.
Sofclear Colors (methafilcon A) Daily Wear Contact Lens
The Sofclear Colors (methafilcon A) Daily Wear Contact Lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from methafilcon A, which is a hydrophilic copolymer of 2-Hydroxyethyl methacrylate (2-HEMA) and methacrylic acid, cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% methafilcon A and 55% water by weight when immersed in saline solution. The (methafilcon A) name has been adopted by the United States Adopted Names Council (USAN).
The Sofclear Colors (methafilcon A) Daily Wear Contact Lenses are available printed to enhance or alter the apparent color of the eye. The lenses are printed with one or a combination of one or more of the following 'listed' color additives:
| Color Additive | Listing |
|---|---|
| Red Iron Oxide | 21 CFR § 73.3125 |
| Violet 23 | 21 CFR § 73.3107 |
| Titanium Dioxide | 21 CFR § 73.3126 |
| Chromium Oxide Green | 21 CFR § 73.3111 |
| Blue 36 | 21 CFR § 73.3110a |
The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. When producing the lenses, the manufacturing process alters and/or changes the specifications to the clear contact lens by pad-printing the color pigment(s)-entrapping them in the interpenetrating network of the contact lens material in a location that corresponds to the iris. The color pigments used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the printing pattern has a minimum clear pupil diameter of 6.5 mm when the lens is hydrated.
Sofclear Comfort (methafilcon A) Daily Wear Contact Lens
The Sofclear Comfort (methafilcon A) Daily Wear Contact Lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from methafilcon A, which is a hydrophilic copolymer of 2-Hydroxyethyl methacrylate (2-HEMA) and methacrylic acid, cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% methafilcon A and 55% water by weight when immersed in saline solution. The (methafilcon A) name has been adopted by the United States Adopted Names Council (USAN).
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Image /page/6/Picture/1 description: The image shows the logo for Gelflex Australian contact lenses. The logo features the word "Gelflex" in blue, with a kangaroo silhouette to the right. Below the logo, the text "510(k) Premarket Notification" is displayed.
The Sofclear Comfort (methafilcon A) Daily Wear Contact Lenses include a tint (1,4-Bis[4-(2methacryloxyethyl)phenylamino]-9,10-anthraquinone) in the composition of the lens for ease of handling and visibility.
The Sofclear Enhance, Colors, and Comfort (methafilcon A) Daily Wear Contact Lenses incorporate a UV absorbing monomer. The lenses block >88% in the UVB range (280mm - 315nm), and >68% in the UVA range (316nm - 380nm).
The Sofclear Enhance, Colors, and Comfort (methafilcon A) Daily Wear Contact Lenses will be manufactured in the spherical design configuration. The material properties and available parameters of the finished lenses are as follows:
| Parameter | Range | Tolerance* |
|---|---|---|
| Chord Diameter | 11.00 mm to 15.00 mm | ±0.20 mm |
| Center Thickness | 0.05 mm to 0.210 mm | When ≤ 0.10 mm → ±0.010 mm + 10% |
| When > 0.10 mm → ±0.015 mm + 5% | ||
| Base Curve | 7.00 mm to 10.0 mm | ±0.20 mm |
| Back Vertex Power (F'v) | +20.00D to -20.00D | |
| (in 0.25D steps) | When 0.00 97% | ±5% |
| Ultraviolet Radiation | ||
| Transmittance | 50% H2O, ionic polymer) |
- FDA classification - Soft (hydrophilic) Contact Lens (21 CFR 886.5925)
The Sofclear Enhance, Colors, and Comfort (methafilcon A) Daily Wear Contact Lenses are substantially equivalent to Focus Softcolors (Vifilcon A) Soft (Hydrophilic) Contact Lenses (approved under PMA - P820021 S025) in terms of the following:
-
. Contact lens tinting method - Enhance contact lenses
The Sofclear Enhance, Colors, and Comfort (methafilcon A) Daily Wear Contact Lenses are substantially equivalent to Frequency Colors (methafilcon A) (cleared under K001090) in terms of the following: -
Pad-printing contact lens tinting method
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Pad-Printed Tinting
Enhance Tinting
Image /page/8/Picture/1 description: The image shows the logo for Gelflex Australian contact lenses. The logo features the word "Gelflex" in blue, with the words "Australian contact lenses" in smaller gray font underneath. To the right of the text is a gray silhouette of a kangaroo. Below the logo, the text "510(k) Premarket Notification" is written in a larger font.
The following matrix illustrates the production method, lens function and material characteristics of the Sofclear Enhance, Colors, and Comfort (methafilcon A) Daily Wear Contact Lenses, as well as the predicate devices.
Optical Sofclear Alcon Coopervision Connection Inc. Enhance, Colors, & 55 UV Focus Softcolors Frequency Colors Comfort (K051095) (P820021 S025) (K001090) (Subject Device) Indicated for daily Indicated for daily wear Indicated for daily wear Indicated for daily wear for the correction for the correction of for the correction of wear for the correction of refractive error in refractive error in refractive error in of refractive error in aphakic and not Indications for Use aphakic and not aphakic aphakic and not aphakic aphakic and not aphakic persons with persons with nonpersons with nonaphakic persons with non-diseased eyes diseased eyes with diseased eyes with non-diseased eyes with with myopia or myopia or hyperopia. myopia or hyperopia. myopia or hyperopia. hyperopia. The contact lenses act as The contact lenses act The contact lenses act The contact lenses act as a refractive medium a refractive medium that as a refractive medium as a refractive medium Actions focus light rays from that focus light rays that focus light rays that focus light rays near and distant objects from near and distant from near and distant from near and distant on the retina objects on the retina objects on the retina objects on the retina Soft (hydrophilic) Soft (hydrophilic) Soft (hydrophilic) Soft (hydrophilic) FDA Classification Contact Lens (21 CFR Contact Lens (21 CFR Contact Lens (21 CFR Contact Lens (21 CFR 886.5925) 886.5925) 886.5925) 886.5925) FDA Group 4 FDA Group 4 FDA Group 4 FDA Group 4 (>50% H2O, ionic (>50% H2O, ionic (>50% H2O. ionic FDA Group (>50% H2O, ionic polymer) polymer) polymer) polymer) Production Method Fully molded Fully molded Fully molded Fully molded methafilcon A methafilcon A methafilcon A USAN name vifilcon A Water Content (%) 55+2% 55±2% 55±2% 55+2% Oxygen Permeability x 10-11 (cm²/sec)(mlO₂)/(ml 20.4 20.7 16.0 19.7 x mmHg @ 35°C)) (revised Fatt method) Refractive Index 1.405 1.406 1.415 1.410 (hydrated) UV Blocker Yes Yes Yes Yes
No
No
No
Yes
Substantial Equivalence Matrix
Yes
Yes
Yes
No
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Image /page/9/Picture/1 description: The image shows the Gelflex logo with a kangaroo above the words "Australian contact lenses". Below this is the text "510(k) Premarket Notification". The Gelflex logo is in blue, and the kangaroo is in gray. The text is in black.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Non-clinical Testing
A series of preclinical testing was performed to demonstrate the safety and effectiveness of the Sofclear Enhance, Colors, and Comfort (methafilcon A) finished contact lenses. The results support the claim that the Sofclear Enhance, Colors, and Comfort (methafilcon A) Daily Wear Contact Lenses are substantially equivalent to the currently marketed predicate devices. A summary of the results from the preclinical studies is presented below.
Toxicology:
All non-clinical toxicology tests were conducted in accordance with the GLP regulation.
- · In-Vitro Cytotoxicity: Cytotoxicity testing was performed in accordance with ISO 10993-5 with results indicating that the finished lenses and packaging materials are non-toxic.
- · Systemic Toxicity: The finished lenses and packaging materials meet the requirements of the systemic injection test in accordance with ISO 10993-11 and are considered nontoxic.
- · Acute Ocular Irritation: Acute ocular irritation test was performed in accordance with ISO 10993-10 and produced no ocular irritation for the finished lenses and packaging materials.
Shelf Life:
Testing was performed to evaluate the stability, sterility, and package integrity of the Sofclear Enhance, Colors, and Comfort (methafilcon A) finished contact lenses over the duration of the labeled expiration date. The data presented supports substantial equivalence of the contact lenses to the already marketed predicate devices.
Physicochemical & Mechanical Properties:
The following tests were completed to verify substantial equivalence: refractive index, water content, Dk, % transmission (visible & UV), tensile strength, modulus, % elongation to break, specific gravity and polymerization residuals. Results of physicochemical and mechanical property testing demonstrate consistent material properties between the Sofclear Enhance, Colors, and Comfort (methafilcon A) contact lenses and the predicate devices.
Clinical Testing
Clinical testing is not required. The clinical performance of soft (hydrophilic) contact lenses manufactured from methafilcon A materials has been demonstrated previously.
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510(k) Premarket Notifica
VIII. CONCLUSIONS
Validity of Scientific Data
Laboratories under Good Laboratory Practice regulations conducted toxicology, microbiology, and shelf-life stability studies following scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7.
Substantial Equivalence
Information presented in this Premarket Notification establishes that the Sofclear Enhance, Colors, and Comfort (methafilcon A) Daily Wear Contact Lenses are as safe and effective as the predicate device when used in accordance with the labeled directions for the proposed indication.
Risks and Benefits
The risks of the subject device are the same as those normally attributed to the wearing of soft (hydrophilic) daily wear contact lenses. The benefits to the patient are the same as those for other soft (hydrophilic) daily wear contact lenses.