(173 days)
Not Found
No
The 510(k) summary describes a standard soft contact lens made of polymacon. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the material properties, manufacturing process, and basic optical function of the lens.
No.
The device is a contact lens intended for correcting visual acuity, which is a refractive correction, not a therapeutic treatment for a disease or condition.
No
Explanation: The device is indicated for the correction of visual acuity and enhancing/altering eye color, not for diagnosing a condition or disease. It functions as a refracting medium to focus light rays, which is a treatment rather than a diagnostic function.
No
The device is a physical contact lens made of polymacon material, designed to be placed on the eye. The description details its physical properties, manufacturing process, and how it functions as a refracting medium. There is no mention of software as a component or the primary function of the device.
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 visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia, and for cosmetic purposes (altering eye color). This is a therapeutic and cosmetic purpose, not a diagnostic one.
- Device Description: The device is a contact lens designed to fit over the cornea and act as a refracting medium to focus light. This is a physical device for vision correction and cosmetic alteration.
- 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.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This contact lens does not fit that description.
N/A
Intended Use / Indications for Use
The See Clear Spherical Soft Contact Lenses (polymacon) for Daily Wear are indicated for the correction of visual acuity in aphakic and not aphakic person with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .50 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.
Eye care practitioners may prescribe 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.
Product codes (comma separated list FDA assigned to the subject device)
LPL
Device Description
The See Clear Spherical Soft Contact Lens (polymacon) for Daily Wear (clear. visibility-tinted, and decorative) are hemispherical shells with molded spherical base curves and lathe-cut front surfaces and are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves that conform to the shape of the radius of the cornea and center over the apex of the cornea to provide correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and not-aphakic persons with non-diseased eves.
The non-ionic lens material, polymacon, is a hydrophilic copolymer of 2hydroxyethyl methacrylate (2-HEMA) cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. It consists of consists of 62% polymacon and 38% water by weight when immersed in normal buffered saline solution. The lenses are available clear, or with a visibility-handling tint, or with a decorative tint intended to enhance or alter the apparent color of the eye for dayto-day cosmetic or occasional theatrical purposes. These decorative designs may be distributed under a unique or "private label" trade name such as See Clear, See Clear Color, and Fierce Contact Lenses. Lenses are tinted only with FDAapproved ("listed") listed color additives for which FDA has previously reviewed the toxicology / biocompatibility profiles. Tinted lenses contain only the amount of color additive needed to accomplish the intended decorative effect.
In the dry (unhydrated) state the lens is machined and polished. In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a transparent or colored optical surface. When placed on the cornea, the See Clear Spherical Soft Contact Lens (polymacon) for Daily Wear acts as a refracting medium to focus light rays on the retina.
The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped, however it will return to its proper configuration when completely rehydrated in the proper storage solution.
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 38% water by weight. The physical properties of these polymacon lenses are:
Refractive Index: 1.43 (hydrated)
Light Transmission (clear): greater than 90% T
Light Transmission (tinted): greater than 80% T
Water Content: 38% +/- 2%
Specific Gravity: 1.184 (hydrated)
Oxygen Permeability: 11.92 X 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35 °C), (revised Fatt method).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Corneal surface of the eye
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)
To support the substantial equivalence claim made herein, a combination of nonclinical analysis and testing has been performed as detailed in this Premarket Notification. This includes:
- Chemical composition of finished lenses
- Purity of initial monomers
- Shelf Life
- Leachability of Residual Monomers
- Leachability of Color Additives
- Biocompatibility testing
- Sterilization Validation
- Color and light transmittance
- Refractive index
- Water content
- Oxygen permeability
- Specific gravity
- Mechanical Testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Light Transmittance (Subject Lens): >90%
Oxygen Permeability (Subject Lens): 11.92 X 10^(-11) (cm^2/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fatt method)
Specific Gravity (Subject Lens): 1.184
Tensile Strength @ Break (MPa) (Subject Lens): 0.55
Modulus of Elasticity (MPa) (Subject Lens): 0.78
Elongation @ Break (%) (Subject Lens): 99.9
Breaking Force (Nmm) (Subject Lens): 0.66
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 words "THE SEE CLEAR company" in a stylized format. The words "THE", "S", "e", and "e" are in white letters on a black background. The words "C", "L", "E", "A", and "R" are in black letters on a white background.
See Clear Spherical Soft Contact Lens (polymacon) for Daily Wear (clear, visibility-tinted, and decorative)
I. Submitter Information
| 510(k) Owner: | The See Clear Company, Inc.
4995 Buford HWY Ste 102
Norcross, GA 30071, USA |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ms. DaYoung Kim
719-761-7603 (office)
866-504-8066 (fax) |
| Consultant &
Submission
Correspondent: | Kevin Randall, Principal Consultan
ComplianceAcuity, Inc.
16576 W. 53rd Way
Golden, CO 80403
(303) 828-0844 (direct)
(303) 828-0835 (fax)
Email: info@complianceacuity.com |
| Date Summary
Prepared: | October 25, 2011 |
II. Name of Device
- Trade Name: See Clear Spherical Soft Contact Lens (polymacon) for Daily * Wear (clear, visibility-tinted, decorative). Clear and decorative designs may be distributed under unique or "private label" trade names such as See Clear, See Clear Color, and Fierce Contact Lenses.
-
- Common Name: Daily Wear Soft Contact Lens
-
- Classification Name: Lenses, Soft Contact, Daily Wear
- મ USAN (generic name): Polymacon
III. Predicate Devices
In conformance with Section 510(k) of the Food, Drug and Cosmetic Act, The See Clear Company hereby submits this notification of our intent to manufacture and place into interstate commerce the See Clear Spherical Soft Contact Lens (polymacon) for Daily Wear. The predicate device to which substantial equivalence is being claimed is identified in the matrix below:
1
Image /page/1/Figure/1 description: The image shows the words "THE See CLEAR company". The words "THE", "S", "e", and "e" are in white letters on a black background. The words "C", "L", "E", "A", and "R" are in black letters on a white background.
See Clear Spherical Soft Contact Lens (polymacon) for Daily Wear (clear, visibility-tinted, and decorative)
| Subject Device | Predicate Device(s) |
|---|---|
| See Clear Spherical Soft Contact Lens | |
| (polymacon) for Daily Wear (clear, | |
| visibility-tinted, and decorative) | MiGwang Comfort 38 (polymacon) |
| Spherical Soft Contact Lens for Daily | |
| Wear (clear, tinted, and cosmetic) | |
| (K051477) |
A comparison of similarities and differences between the See Clear Spherical Soft Contact Lens (polymacon) for Daily Wear, and the legally marketed predicate lens has been tabulated in the Substantial Equivalence Comparison Matrix exhibited below:
| Comparison Element | Subject Lens: | Predicate: |
|---|---|---|
| Identification | See Clear Spherical Soft | |
| Contact Lens (polymacon) | ||
| for Daily Wear | ||
| (clear, visibility-tinted, | ||
| decorative) | MiGwang Comfort 38 | |
| (polymacon) Spherical Soft | ||
| Contact Lens for Daily | ||
| Wear (clear, tinted, and | ||
| cosmetic) | ||
| Manufacturer | The See Clear Company | MiGwang Contact Lens Co. |
| Ltd. | ||
| 510(k) Number | K111345 | K051477 |
| Intended Use | Daily wear correction of | |
| refractive ametropia (myopia, | ||
| hyperopia, and astigmatism) in | ||
| aphakic and not-aphakic | ||
| persons with non-diseased | ||
| eyes. The lenses are available | ||
| clear, or with a visibility- | ||
| handling tint, or with a | ||
| decorative tint intended to | ||
| enhance or alter the apparent | ||
| color of the eye for day-to-day | ||
| cosmetic or occasional | ||
| decorative purposes. | Daily wear correction of | |
| visual acuity in aphakic or not | ||
| aphakic person with non- | ||
| diseased eyes with myopia or | ||
| hyperopia. The lens may be | ||
| worn by persons who exhibit | ||
| refractive astigmatism of .50 | ||
| 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. | ||
| Production Method | Molded Base Curve | |
| Surfaces with Lathe-Cut | ||
| Front Curve Surfaces | Molded Base Curve | |
| Surfaces with Lathe-Cut | ||
| Front Curve Surfaces | ||
| Hydrophilic Material / USAN | polymacon | polymacon |
| Water Content | $38 % +/- 2%$ | $38 % +/- 2%$ |
| Index of Refraction | $1.43$ | $1.43$ |
2
Image /page/2/Picture/1 description: The image shows the words "THE SEE CLEAR company" in a stylized format. The words "THE" and "SEE" are in white letters on a black background, while the word "CLEAR" is in black letters on a white background. The word "company" is in black letters on a white background and is smaller than the other words.
See Clear Spherical Soft Contact Lens (polymacon) for Daily Wear (clear, visibility-tinted, and decorative)
| Comparison Element | Subject Lens: | Predicate: |
|---|---|---|
| Light Transmittance | >90% | >90% |
| Oxygen Permeability | $11.92 X 10^{-11} (cm^2/sec) (ml O_2/ml x mm Hg @ 35°C),$ | |
| (revised Fatt method) | $9.77 X 10^{-11} (cm^2/sec) (ml O_2/ml x mm Hg @ 35°C),$ | |
| (revised Fatt method) | ||
| Specific Gravity | 1.184 | 1.165 |
| Tensile Strength @ Break | ||
| (MPa) | 0.55 | 0.559 |
| Modulus of Elasticity | ||
| (MPa) | 0.78 | 0.728 |
| Elongation @ Break (%) | 99.9 | 127.36 |
| Breaking Force (Nmm) | 0.66 | 0.66 |
The See Clear Spherical Soft Contact Lens (polymacon) for Daily Wear is substantially equivalent to the predicate device in terms of the following key areas:
- Same Indications for Use .
- Same Contraindications .
- Same Design concepts .
- Same "Listed" Color Additives .
- . Same Production Method used in the fabrication of the lens
- Same Lens Function t
- Same Warnings .
- Same Precautions .
- Same polymer (polymacon) .
- Similar Parameters being offered .
It is the conviction of The See Clear Company that the information and data submitted in this 510(k) substantiate our ability to manufacture a contact lens with a safety and effectiveness profile that is substantially equivalent to the predicate device, and does not raise different questions of safety and effectiveness. When placed on the human eye the See Clear Spherical Soft Contact Lens (polymacon) for Daily Wear performs the same function as the legally marketed predicate device identified herein.
3
Image /page/3/Picture/0 description: The image shows a logo for "The See Clear company". The words "The", "See", and "Clear" are arranged in a grid-like fashion, with each letter occupying a square. The word "company" is written in a smaller font size to the right of the grid.
See Clear Spherical Soft Contact Lens (polymacon) for Daily Wear (clear, visibility-tinted, and decorative)
IV. Device Description & Technological Characteristics
The See Clear Spherical Soft Contact Lens (polymacon) for Daily Wear (clear. visibility-tinted, and decorative) are hemispherical shells with molded spherical base curves and lathe-cut front surfaces and are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves that conform to the shape of the radius of the cornea and center over the apex of the cornea to provide correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and not-aphakic persons with non-diseased eves.
The non-ionic lens material, polymacon, is a hydrophilic copolymer of 2hydroxyethyl methacrylate (2-HEMA) cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. It consists of consists of 62% polymacon and 38% water by weight when immersed in normal buffered saline solution. The lenses are available clear, or with a visibility-handling tint, or with a decorative tint intended to enhance or alter the apparent color of the eye for dayto-day cosmetic or occasional theatrical purposes. These decorative designs may be distributed under a unique or "private label" trade name such as See Clear, See Clear Color, and Fierce Contact Lenses. Lenses are tinted only with FDAapproved ("listed") listed color additives for which FDA has previously reviewed the toxicology / biocompatibility profiles. Tinted lenses contain only the amount of color additive needed to accomplish the intended decorative effect.
In the dry (unhydrated) state the lens is machined and polished. In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a transparent or colored optical surface. When placed on the cornea, the See Clear Spherical Soft Contact Lens (polymacon) for Daily Wear acts as a refracting medium to focus light rays on the retina.
The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped, however it will return to its proper configuration when completely rehydrated in the proper storage solution.
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 38% water by weight. The physical properties of these polymacon lenses are:
4
Image /page/4/Picture/0 description: The image shows a logo for "The See Clear company". The words "The", "See", and "Clear" are arranged in a 3x3 grid, with each word occupying a cell. The word "company" is written to the right of the grid.
111345
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS K11345
See Clear Spherical Soft Contact Lens (polymacon) for Daily Wear (clear, visibility-tinted, and decorative)
| Refractive Index | 1.43 (hydrated) |
|---|---|
| Light Transmission (clear) | greater than 90% T |
| Light Transmission (tinted) | greater than 80% T |
| Water Content | 38% +/- 2% |
| Specific Gravity | 1.184 (hydrated) |
| Oxygen Permeability | 11.92 X 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35 °C), (revised Fatt method). |
V. Intended Use
The See Clear Spherical Soft Contact Lenses (polymacon) for Daily Wear are indicated for the correction of visual acuity in aphakic and not aphakic person with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .50 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.
Eye care practitioners may prescribe 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.
VI. Non-Clinical Performance Data
To support the substantial equivalence claim made herein, a combination of nonclinical analysis and testing has been performed as detailed in this Premarket Notification. This includes:
| • Chemical composition of finished lenses | • Color and light transmittance |
|---|---|
| • Purity of initial monomers | • Refractive index |
| • Shelf Life | • Water content |
| • Leachability of Residual Monomers | • Oxygen permeability |
| • Leachability of Color Additives | • Specific gravity |
| • Biocompatibility testing | • Mechanical Testing |
| • Sterilization Validation |
END OF 510(k) SUMMARY
5
Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV - 2 2011
The See Clear Company c/o Mr. Kevin Randall Official Correspondent Compliance Acuity 16576 W. 531d Way Golden, CO 80403
Re: K111345
Trade/Device Name: See Clear Spherical Soft Contact Lens (polymacon) for Daily Wear (clear, visibility-tinted, and decorative) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: September 30, 2011 Received: October 4, 2011
Dear Mr. Randall:
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.
6
Page 2 - Mr. Kevin Randall
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.
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
Enclosure
7
Indications for Use
510(k) Number (if known): K111345
Device Name:
See Clear Spherical Soft Contact Lens (polymacon) for Daily Wear (clear, visibility-tinted, and decorative)
Indications For Use:
The See Clear Spherical Soft Contact Lenses (polymacon) for Daily Wear are indicated for the correction of visual acuity in aphakic and not aphakic person with nondiseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .50 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.
Eye care practitioners may prescribe 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.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 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)
Marc Rollog
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K111345