Frequency 38 and Silver 07 (polymacon) Soft (hydrophilic) Contact 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 that may exhibit astigmatism up to 2.00 diopters that does not interfere with visual acuity. Eye care practitioners may prescribe Frequency 38 (polymacon) Soft (hydrophilic) Contact Lenses for frequent replacement wear, with cleaning, disinfecting, and scheduled replacement.

Device Description

The Frequency 38 and Silver 07 (polymacon) Hydrophilic Contact Lens for Daily Wear (tinted) is available as a single vision lens. The lens material, polymacon is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) cross-linked with ethyleneglycol dimethacrylate (62%) and water (38%). Frequency 38 and Silver 07 (polymacon) Hydrophilic Contact Lenses for Daily Wear are tinted for visibility purposes from edge to edge using color additive Blue No. 4. Frequency 38 is a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sclera with the following dimensions: Diameter: 14.0 mm to 15.0 mm, Base Curve: 8.4 mm to 9.0 mm, Center Thickness: 0.03 mm to 0.40 mm (varies with power), Powers: -20.00 to +20.00 D. The physical properties of the lens are: Refractive Index: 1.43, Light Transmittance: >97%, Specific Gravity: 1.17, Water Content: 38%, Oxygen Permeability: 8.0 x 10-11 (cm²/sec)(mi 02/ml x mmHg) at 35°C (Fatt method for determination of oxygen permeability).

AI/ML Overview

The CooperVision Frequency 38 and Silver 07 (polymacon) Soft (hydrophilic) Contact Lenses were evaluated for substantial equivalence to a predicate device, the Frequency 38 & Silver 07 Post-Hydration Tint (K971049). The study did not involve a direct assessment of clinical performance against specific acceptance criteria for a new device, but rather a comparison to the established predicate device based on material, physical properties, and toxicology.

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly matching the characteristics and performance of the legally marketed predicate device.

Characteristic	Predicate Device (K971049) Reported Performance	New Device (In-Monomer Tint) Reported Performance	Acceptance Criteria (Implicit)
Material	Polymacon	Polymacon	Match predicate material
Material Classification	Hydrophilic Lens Group 1	Hydrophilic Lens Group 1	Match predicate classification
Indications for Use	Daily wear for correction of refractive ametropia (myopia & hyperopia) in aphakic/non-aphakic persons with non-diseased eyes, exhibiting up to 2.00 diopters astigmatism that doesn't interfere with visual acuity. Frequent replacement wear with cleaning, disinfecting, and scheduled replacement.	Daily wear for correction of refractive ametropia (myopia & hyperopia) in aphakic/non-aphakic persons with non-diseased eyes, exhibiting up to 2.00 diopters astigmatism that doesn't interfere with visual acuity. Frequent replacement wear with cleaning, disinfecting, and scheduled replacement.	Match predicate indications for use
Water Content	38%	38%	Match predicate water content
Light Transmittance	>97%	>97%	Match predicate light transmittance
Dk (35° C) (Oxygen Permeability)	$8.0 \times 10^{-11}$	$8.0 \times 10^{-11}$	Match predicate Dk (oxygen permeability)
Refractive Index	1.43	1.43	Match predicate refractive index
Powers	-20.00 to +20.00 D	-20.00 to +20.00 D	Match predicate power range
Dye	C.I. Reactive Blue #4	C.I. Reactive Blue #4	Match predicate dye
Manufacturing Method	Cast Molded	Cast Molded	Match predicate manufacturing method
Toxicology	Non-toxic (for predicate)	Non-toxic	Demonstrate non-toxicity and equivalence to predicate
Leachable Dye (Color Fastness)	Not explicitly stated for predicate, but implied acceptable.	Below 1 ppm leaching of Blue 4, no significant difference in absorbance pre/post extraction.	Demonstrate acceptable color fastness (matching or better than predicate expectation)

2. Sample Size Used for the Test Set and the Data Provenance

The submission does not detail specific "test set" sample sizes in the way a clinical trial would. For the preclinical studies:

Toxicology testing: The sample size for ocular irritation, cytotoxicity, and systemic toxicity tests is not specified in the provided text. The data provenance is "in-house evaluation."
Physical properties evaluation: The sample size is not specified. The data provenance is "in-house evaluation."
Leachable study: The sample size for the "test lenses" is not specified, but multiple "three extraction solutions" were used to assess the color fastness. The data provenance is "in-house evaluation."

The data provenance is presented as "in-house evaluation" by CooperVision. The country of origin is not explicitly stated for individual study data, but CooperVision Manufacturing, Ltd. is located in Southampton, UK. The studies appear to be retrospective analyses and comparisons to the predicate device's established properties.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This submission is for substantial equivalence and relies on material and chemical characterization, as well as comparison to an existing device, rather than expert-derived ground truth from a clinical test set. The determination of "non-toxic" would be based on standard toxicological protocols and expert interpretation within CooperVision and potentially by regulatory bodies.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication in the context of this submission. The determination of substantial equivalence was based on a comparison of device characteristics and preclinical data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a contact lens submission, not an AI-assisted diagnostic device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a contact lens submission, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this substantial equivalence claim is effectively the established and accepted characteristics and performance of the predicate device (Frequency 38 & Silver 07 Post-Hydration Tint, K971049).

For toxicology, the ground truth is the established safety profiles for contact lens materials and dyes.
For physical and chemical properties, the ground truth is the measured values of the predicate device and accepted industry standards for those properties.
For the leachable study, the ground truth is the acceptable level of leached dye, which was interpreted as "below 1 ppm" and "no significant difference" in absorbance.

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set was Established

Not applicable.

Summary

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CooperVision

NOV 1 6 2004

Premarket Notification

In-Monomer Tint Polymacon

510(k) Summary

K042824

1. SUBMITTER:

Submitted on Behalf of:

以 Company Name:
피 Address:
로 Phone:
트 Fax:

2. CONTACT PERSON:

트 Company Name:
트 Address:
取 Phone:
를 Fax:

비

3. DATE SUMMARY PREPARED:

Common Name:

Device Classification:

Classification

4. DEVICE IDENTIFICATION:

i Trade Name:
CooperVision Manufacturing, Ltd. Unit 2, South Point Hamble SO3 4RF Southampton UK 011 44 2380 605200 011 44 2380 605299

Bonnie Tsymbal

CooperVision, Inc. 711 North Road Scottsville, NY 14546 (585) 264-3210 (585) 889-5688

September 21st, 2004

Frequency 38 and Silver 07 (polymacon) Soft (hydrophilic) Contact Lens

Hydrophilic Soft Contact Lens Lenses, Soft Contact, Daily Wear 86LPL Class II (21 CFR 886.5925)

5. DEVICE DESCRIPTION:

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●

Frequency 38 is a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sclera with the following dimensions:

. Diameter: 14.0 mm to 15.0 mm
. Base Curve: 8.4 mm to 9.0 mm . Center Thickness:

0.03 mm to 0.40 mm (varies with power)

Powers: -20.00 to +20.00 D
The physical properties of the lens are:
. Refractive Index: 1.43
. Light Transmittance: >97%
. Specific Gravity: 1.17
Water Content: . 38%
8.0 x 10-11 (cm²/sec)(mi 02/ml x mmHg) at 35°C . Oxygen Permeability: (Fatt method for determination of oxygen permeability)

6. INTENDED USE:

Eye care practitioners may prescribe Frequency 38 (polymacon) Soft (hydrophilic) Contact Lenses for frequent replacement wear, with cleaning, disinfecting, and scheduled replacement.

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Image /page/2/Picture/0 description: The image shows the logo for CooperVision. The logo consists of the word "CooperVision" in a stylized font. To the right of the word is a black square with a white spiral inside. The logo is simple and modern.

In-Monomer Tint Polymacon

7. SUBSTANTIAL EQUIVALENCE:

Characteristic	PolymaconIn-Monomer Tint(New Device)	Frequency 38 & Silver 07Post-Hydration TintK971049
Material	Polymacon	Polymacon
MaterialClassification	Hydrophilic LensGroup 1	Hydrophilic LensGroup 1
Indications for Use	Daily WearFrequency 38 and Silver 07(polymacon) Soft (hydrophilic)Contact Lenses are indicated fordaily wear for the correction ofrefractive ametropia (myopia andhyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibitastigmatism up to 2.00 dioptersthat does not interfere with visualacuity.Eye care practitioners mayprescribe Frequency 38(polymacon) Soft (hydrophilic)Contact Lenses for frequentreplacement wear, with cleaning,disinfecting, and scheduledreplacement.	Daily WearFrequency 38 and Silver 07(polymacon) Soft (hydrophilic)Contact Lenses are indicated fordaily wear for the correction ofrefractive ametropia (myopia andhyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibitastigmatism up to 2.00 dioptersthat does not interfere with visualacuity.Eye care practitioners mayprescribe Frequency 38(polymacon) Soft (hydrophilic)Contact Lenses for frequentreplacement wear, with cleaning,disinfecting, and scheduledreplacement.
Water Content	38%	38%
Light Transmittance	>97%	>97%
Dk (35° C)	$8.0 x 10^{-11}$	$8.0 x 10^{-11}$
Refractive Index	1.43	1.43
Powers	-20.00 to +20.00 D	-20.00 to +20.00 D
Dye	C.I. Reactive Blue #4	C.I. Reactive Blue #4
Manufacturing Method	Cast Molded	Cast Molded

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8. PRECLINICAL INFORMATION:

The results of toxicology testing, including Ocular Irritation, Cytoxicity and Systemic Toxicity have demonstrated that the subject lens is non-toxic.

Our in-house evaluation of the physical properties of the in-monomer tinted polymacon showed the values to be consistent with the post-hydration tinted polymacon. No significant differences were noted.

A leachable study was conducted to assess the color fastness of C.I. Reactive Blue 4 when used for in-monomer tinting of the Frequency 38 and Silver 07 (polymacon) Soft (hydrophilic) Contact Lens.

From the absorbance values obtained from the three extraction solutions it is possible to show that the concentration of:

1. Reactive dye Blue 4 that leached out of the test lenses, if present, was below 1 ppm.
1. The mean absorbance values of the contact lenses prior to and following extraction were not significantly different and suggested that no leaching of the dye had occurred.

As a consequence to this, it is possible to conclude that despite utilizing an inmonomer tint option for the C.I. Reactive Blue 4 dye in Frequency 38 and Silver 07 (polymacon) soft contact lenses, an acceptable level of color fastness is still obtained.

9. CLINICAL DATA:

It was determined that Clinical Studies were not necessary to establish the safety and efficacy of the Frequency 38 and Silver 07 (polymacon) Soft (hydrophill in Contact Lens. This determination was based on the following:

The in-monomer tinted polymacon soft (hydrophilic) contact lens has demonstrated to be substantially equivalent to the predicate post-hydration tinted polymations soft (hydrophilic) contact lens (K971049).

10. CONCLUSION:

The information provided in this 510(k) establishes that the Frequency 38 and Silver 07 (polymacon) Soft (hydrophilic) Contact Lenses are equivalent in optical, chemical and physical properties of the predicate device and does not raise any questions of safety and effectiveness. Therefore, the device is substantially equivalent to the predicate device.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes extending from its back, representing the department's commitment to health and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.

NOV 1 6 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CooperVision c/o Ms. Bonnie Tsymbal Manager, Regulatory Affairs 711 North Road Scottsville, NY 14546

Re: K042824

Trade/Device Name: Frequency 38 and Silver 07 (polymacon) Soft (hydrophilic) Contact Lenses Regulation Number: 21CFR886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: II Product Code: LPL Dated: October 6, 2004 Received: October 13, 2004

Dear Ms. Tsymbal:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Ms. 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 legal|y 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A haligi korenthal

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

Enclosure

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Image /page/6/Picture/0 description: The image shows the word "CooperVision" in a stylized font. The "C" in Cooper is stylized with a line underneath it. To the right of the word "Vision" is a black square with a white swirl inside.

Regulatory Affairs 711 North Road Scottsville, NY 14546 (585) 385-6810 Fax: (585) 889-5688

Indication for Use Statement

510(k) Number:

Device Name: Frequency 38 and Silver 07 (polymacon) Soft (hydrophilic) Contact Lenses

Indication for Use:

Eye care practitioners may prescribe Ereguency 38 (polymacon) Soft (hydrophilic) Contact Lenses for frequent replacement wear, with cleaning, disinfecting, and scheduled replacement.

Prescription Use X
(Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter (Per 21 CFR 801 Subpart C)

PLEASE DO NO WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

T.i.G
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K042824

Regulation Number and Section

§ 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.