(79 days)
Not Found
No
The device description focuses on the physical properties and materials of contact lenses, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is indicated for the correction of refractive ametropia (myopia and hyperopia) and astigmatism, which are not considered diseases requiring therapeutic intervention. While it helps protect against harmful UV radiation, its primary function is vision correction.
No
The provided text describes contact lenses used for correcting refractive errors, which is a treatment or corrective function, not a diagnostic one.
No
The device description clearly describes physical contact lenses made of a specific material with defined dimensions and physical/optical properties. There is no mention of software as the primary component or 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 refractive ametropia (myopia, hyperopia, and astigmatism) and protection against UV radiation. This is a therapeutic and protective function, not a diagnostic one.
- Device Description: The device is a contact lens, which is a medical device used to correct vision and protect the eye. It does not perform any in vitro testing on biological samples to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This contact lens does not fit that description.
N/A
Intended Use / Indications for Use
-
- Frequency 55 UV and Frequency 55 UV Aspheric lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-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.
-
- Frequency 55 UV Toric lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and not-aphakic persons with nondiseased eyes. The lenses may be worn by persons who have astigmatism of 12.00 diopters or less.
FREQUENCY 55 LENSES WITH UV ABSORBING MONOMER HELPS PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND THE EYE.
Note: Only chemical (not heat) and hydrogen peroxide disinfection systems may be used with Frequency 55 UV lenses.
Product codes
LPL
Device Description
Frequency 55 UV and Frequency 55 UV Aspheric (methafilcon A) soft (hydrophilic) contact lenses are available as spherical lenses. Frequency 55 UV Toric (methafilcon A) soft (hydrophilic) contact lenses are available as astigmatic (toric) lenses. The lens material, methafilcon A, is a random copolymer of hydroxyethylmethacrylate and methacrylic acid. A benzophenone UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 10% in the UVB range of 280 to 315 nm and less than 40% in the UVA range of 315 to 380 nm. The lenses are tinted aqua from edge to edge for visibility purposes with the color additives, C.I. Reactive Blue No. 4 and C.I. Reactive Yellow 86.
Frequency 55 UV. Frequency 55 UV Aspheric and Frequency 55 UV Toric contact lenses are hemispherical shells with the following dimensions:
- Diameter: 14.0mm to 15.0mm
- Base Curve: 8.0mm to 9.5mm
- Center Thickness: 0.03mm to 0.60mm (varies with power)
- Spherical Powers: -20.00 to +20.00D
- Cylindrical Powers: plano to -12.00
- Axis: 1° to 180°
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cornea and the Eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
eye care practitioner
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)
Toxicology tests performed:
- Cytotoxicity Study Using the ISO Agarose Overlay Method: Test article showed no evidence of causing cell lysis.
- ISO Ocular Irritation Study in the Rabbit: Test article extracts would not be considered irritants to the ocular tissue of the rabbit.
- ISO Acute Systemic Toxicity Study in the Mouse: No mortality or evidence of systemic toxicity from the extracts. Each test article extract met the test requirements.
Additional Non-Clinical Testing:
- Leachability Study: Demonstrated colorfastness; undetectable levels of dye (below 1ppm) were observed in extraction solutions after two weeks at 37°C in saline.
- Determination of Extractables using High Pressure Liquid Chromatography: Test extracts did not contain residual monomers within the detection limits of the analysis.
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
Image /page/0/Picture/0 description: The image shows the logo for CooperVision. The logo consists of the company name in a stylized font, with the "C" in "Cooper" being a double circle. To the right of the name is a square containing a stylized eye.
APR 2 6 2002 Frequency 55 UV Methafilcon A
Premarket Notification
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Submitter Information: | CooperVision, Inc.
711 North Road
Scottsville, NY 14546 |
|---------------------------|-----------------------------------------------------------------------------------|
| Contact Person: | Bonnie Tsymbal
Manager, Regulatory Affairs |
| Telephone: | (585) 264-3210 |
| Fax: | (585) 889-5688 |
| Date Prepared: | February 5 th , 2002 |
| 2. Device Name: | |
| Common Name: | Soft (hydrophilic) Contact Lens |
| Trade/Proprietary Name: | Frequency 55 UV (methafilcon A) Soft (hydrophilic)
Contact Lens for Daily Wear |
| Device Classification: | Class II |
3. Predicate Device:
The predicate devices are the Sauflon 55 UV (methafilcon A) Soft (hydrophilic) Visibility Tinted Contact Lens marketed by Sauflon Pharmaceuticals Ltd. and Frequency 55 with UVAM (methafilcon A) (Sphere, Asphere and Toric) Soft (hydrophilic) contact lenses for daily wear manufactured by Aspect Vision. The predicate devices were cleared under K013649 and K982997 respectively. The devices were selected as the predicate devices based on the material, intended use and design.
4. Device Description:
Frequency 55 UV and Frequency 55 UV Aspheric (methafilcon A) soft (hydrophilic) contact lenses are available as spherical lenses. Frequency 55 UV Toric (methafilcon A) soft (hydrophilic) contact lenses are available as astigmatic (toric) lenses. The lens material, methafilcon A, is a random copolymer of hydroxyethylmethacrylate and methacrylic acid. A benzophenone UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 10% in the UVB range of 280 to 315 nm and less than 40% in the UVA range of 315 to 380 nm. The lenses are tinted aqua from edge to edge for visibility purposes with the color additives, C.I. Reactive Blue No. 4 and C.I. Reactive Yellow 86.
Frequency 55 UV. Frequency 55 UV Aspheric and Frequency 55 UV Toric contact lenses are hemispherical shells with the following dimensions:
14.0mm to 15.0mm
0.03mm to 0.60mm (varies with power)
8.0mm to 9.5mm
-
Diameter: .
-
Base Curve: ●
-
Center Thickness: .
-
Spherical Powers: .
-
. Cylindrical Powers:
-
Axis: .
-
-20.00 to +20.00D plano to -12.00 1° to 180°
1
The physical/optical properties of the Frequency 55 UV and Frequency 55 UV Aspheric and Frequency 55 UV Toric contact lenses are:
| • Refractive Index: | 1.40 |
|---|---|
| • % Transmittance @ 590nm: | >90% |
- % Transmittance @ 590nm: .
- % Transmittance @ 280-315nm: 50% ionic
polymer | Equivalent | Equivalent |
| Indication | Myopia, hyperopia
and astigmatism | Myopia and
Hyperopia | Myopia, hyperopia
and astigmatism |
| Water Content | 55% | 55% | 55% |
| Light Transmittance (%)
At 590nm | 94.61 | 94.61 | 93.58 |
| UVA region (316-380nm) | 36.00 | 36.00 | 4.09 |
| UVB region (280-315nm) | 9.41 | 9.41 | 6.00 |
| Dk (35° C) | $15.8 x 10^{-11}$ | $15.8 x 10^{-11}$ | $14.0 x 10^{-11}$ |
| Powers | +20.00 to -20.00 D | +20.00 to -20.00 D | +20.00 to -20.00 D |
| Tint | Clear or Aquamarine | Aquamarine | Clear or Aquamarine |
| Manufacturing Method | Fully Molded | Fully Molded | Fully Molded |
| Lens Design | Spherical
Aspheric
Back Surface Toric | Sphere | Spherical
Aspheric
Back Surface Toric |
| Packaging | Blister Pack | Blister Pack | Blister Pack |
3
7. Toxicology
The following toxicological tests were performed on Frequency 55 UV lenses:
-
Cytotoxicity Study Using the ISO Agarose Overlay Method a)
Under the conditions of this study, the test article showed no evidence of causing oell Iysis of Onder the conditions of this Stary, the test antists of the negative and positive controls performed as anticipated. -
b) ISO Ocular Irritation Study in the Rabbit
Under the conditions of this study, the test article extracts would not be considered irritants to the ocular tissue of the rabbit. -
ISO Acute Systemic Toxicity Study in the Mouse ে
Under the conditions of this study, there was no mortality or evidence of systemic toxicity from the extracts. Each test article extract met the test requirements.
8. Additional Non-Clinical Testing
-
a) Leachability Study
Leaching studies were undertaken to demonstrate colorfastness of assessing the acceptability of tinting the Frequency 55 UV lens with CI Reactive Blue and Reactive Yellow 86. This study demonstrates how, after two weeks of extraction at 37°c in saline, undetectable levels of dye (below 1ppm) were observed in the extraction solutions. -
b) Determination of Extractables using High Pressure Liquid Chromatography
Under the conditions of this study, the test extracts did no contain residual monomers within the detection limits of the analysis.
9. Conclusions
The Frequency 55 UV (methafilcon A) Soft (hydrophilic) Contact Lens will be manufactured according to specified process controls and an ISO 9001/EN46001 and CGMP quality assurance program currently in place. The established safety profile (preclinical, toxicological, chemical/optical) of the Frequency 55 UV is equivalent to Sauflon 55 UV and Frequency 55 with UVAM.
Being similar with respect to indications for use, materials and comparable physiochemical properties to the predicate devices, this meets the requirements per section 510(k) of the act regarding substantial equivalence and does not raise questions of safety and effectiveness than the predicate devices.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 6 2002
CooperVision, Inc. c/o Ms. Bonnie Tsymbal Manager, Regulatory Affairs 711 North Road Scottsville, NY 14546
Re: K020392
. K020592
Trade/Device Name: Frequency 55 UV (methafilcon A) Soft (hydrophilic) Regulation Number: 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: February 5, 2002 Received: February 6, 2002
Dear Ms. Tsymbal:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications felerenced above and nave develommed and marketed predicate devices marketed in interstate for use stated in the encrosure) to regars and the Medical Device Amendments, or to comments provision to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, devices that have occh recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM allu Cosmette Act (11ct) that to hevice, subject to the general controls provisions of the Act. The You may, ulciclore, market the act include requirements for annual registration, listing of general controls provisions of ractice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (600 a00 rols. Existing major regulations affecting your device can may oc subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may oublish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of advisou that I Dr over device complies with other requirements of the Act that I Dr Hab Intactions and regulations administered by other Federal agencies. You must or any I cutili statutes and regirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Pat 007); mooning (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
Page 2- Ms. Bonnie Tsymbal
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
6
CooperVision
Indication for Use Statement
711 North Roz Scottsville, New York 1454 (716) 385-68 x (716) 889-569
510(k) Number: K020392
Device Name:
Frequency 55 UV Frequency 55 UV Aspheric Frequency 55 UV Toric
Indication for Use:
-
- Frequency 55 UV and Frequency 55 UV Aspheric lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-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.
-
- Frequency 55 UV Toric lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and not-aphakic persons with nondiseased eyes. The lenses may be worn by persons who have astigmatism of 12.00 diopters or less.
FREQUENCY 55 LENSES WITH UV ABSORBING MONOMER HELPS PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND THE EYE.
Note: Only chemical (not heat) and hydrogen peroxide disinfection systems may be used with Frequency 55 UV lenses.
Frequent/Planned Replacement Wear
When prescribed for Frequent/Planned Replacement Wear, the Frequency 55 UV and Frequency 55 UV Toric lenses are to be cleaned, rinsed and disinfected each time they are removed from the eye and discarded after the recommended wearing period prescribed by the eye care practitioner.
Disposable Wear
When prescribed for Disposable Wear, the wearing time prescribed by the eye care practitioner is for daily wear (single use). Patients should be instructed to discard the lenses at each removal.
PLEASE DO NO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel W.L. Brown, Ph.D.
Nose and Throat Devises
310(k) Number_K020392
Prescription Use
(Per 21 CFR 801.109) x
Over-The-Counter