The FANTASY, NATURAL, BRILLIANCE, GLAMOUR AND CRAZY™ (methafilcon A ) Hydrophilic Contact Lens (clear and tinted ) is 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. These lenses may be used to enhance or alter the apparent color of the eye.

Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.

Device Description

Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA crosslinked with EGDMA which yield the appearance of lenses which are designed to fit over the corneal surface of the eye. The lenses are made by modifying the uncolored methafilcon A cast molded lens by affixing a colored pigment on that the unoolorod from hamsee that corresponds to the iris. The colored pigments consist of portion on the from oxide green, dihydrodinaphto brown, dihydrodioxo yellow, phthalocyanine green, iron oxide red, iron oxide brown, iron oxide black, phthalocyanine phinalobyanino groom, we . These lenses are designed with varying base curves which conform to the shape of the radius of the cornea and center over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (multiple foci). Each lens provides corrective power that is to correspond to the refractive power of the eye to which it is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens which is generally of a diameter greater than 6mm. Secondary and tertiary curves as well as beveled edge configurations are built into the lens for the purpose of aiding in lens centration and comfort.

AI/ML Overview

This 510(k) submission describes the FANTASY, NATURAL, BRILLIANCE, GLAMOUR AND CRAZY™ (methafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted). The submission relies on demonstrating substantial equivalence to a predicate device, rather than providing extensive de novo performance studies with separate acceptance criteria.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission primarily demonstrating substantial equivalence to an existing predicate device, explicit acceptance criteria in terms of specific performance metrics (like accuracy, sensitivity, specificity for a diagnostic device) are not presented in the same way they would be for a novel device. Instead, the "acceptance criteria" are implicitly met by demonstrating that the new device's properties are equivalent to the predicate device, which is presumed to have already met necessary safety and effectiveness standards.

Acceptance Criteria Category	Reported Device Performance (FANTASY, NATURAL, BRILLIANCE, GLAMOUR AND CRAZY™)
Material Composition	Made of polymerized HEMA crosslinked with EGDMA; methafilcon A. Equivalent to predicate.
Physical Properties	Equivalent to Aspect Vision Care, Ltd.'s FREQUENCY 55 (methafilcon A) Soft Contact Lens for Daily Wear.
Optical Properties	Equivalent to Aspect Vision Care, Ltd.'s FREQUENCY 55 (methafilcon A) Soft Contact Lens for Daily Wear.
Chemical Properties	Equivalent to Aspect Vision Care, Ltd.'s FREQUENCY 55 (methafilcon A) Soft Contact Lens for Daily Wear.
Toxicology	Non-toxic (demonstrated by cytotoxicity, acute systemic toxicity, acute ocular irritation tests).
Leachability	Respective extracts did not contain leachable color or significant levels of residual monomers.
Indications for Use	Same indications for use as the predicate (K971164): correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes, up to 2.00 Diopters astigmatism that does not interfere with visual acuity. May enhance or alter eye color. Daily wear in a Frequent Replacement Program. Disinfection using chemical or hydrogen peroxide systems.
Parameters Available	+8.00 to -8.00D Powers, 0.12 mm Center Thickness, 14.2 mm Diameter, 8.8 mm Base Curve. (These are reported as descriptive parameters, not explicit acceptance criteria with thresholds, but they fall within expected ranges for contact lenses).
FDA Classification	Group 4, Ionic, high water content polymers, as established by FDA (Guidance Document for Daily Wear Contact Lenses, Revised Edition May 1994).

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

The document describes performance testing related to toxicology and leachability, but it doesn't specify a "test set sample size" in the context of comparative clinical performance against human readers or standalone diagnostic accuracy.

Toxicology and Color Leachability: Lenses were loaded with eleven specified pigments and tested for cytotoxicity, acute systemic toxicity, acute ocular irritation, residual monomer, and color leachability.
- Sample Size: Not explicitly stated in terms of number of lenses or subjects. The phrasing "The results of toxicology testing...have demonstrated" and "the results of residual monomer and color leachability testing demonstrate" implies a study was conducted, but the specifics of the sample size are absent.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

For the claim of substantial equivalence regarding physical, optical, and chemical properties, the "sample" is essentially the design and manufacturing specifications of the new device being compared to the predicate. The document states: "The physical, optical, and chemical properties of the FANTASY, NATURAL, BRILLIANCE, GLAMOUR AND CRAZY (methafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted)) are equivalent to those of the FREQUENCY 55 (methafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted) from Aspect Vision Care, Ltd. since this lens is provided to CL-TINTERS by Aspect Vision Care, Ltd." This suggests an inherent equivalence due to shared manufacturing/supplier, rather than a separate, large-scale comparative study.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of information is not applicable to this 510(k) submission. The device is a contact lens, not an AI diagnostic tool requiring expert interpretation for ground truth establishment. The "ground truth" for contact lens performance typically involves engineering specifications, material science testing, and clinical safety/tolerance studies.

4. Adjudication Method for the Test Set

This information is not applicable. There is no "test set" in the context of human interpretation or diagnostic decision-making to require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating observer performance, particularly in diagnostic imaging, which is not relevant to a contact lens.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone performance study in the context of an "algorithm" is not applicable. This device is a physical medical device (contact lens), not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

Material Science and Engineering Specifications: The chemical composition (methafilcon A, HEMA, EGDMA), physical dimensions, optical power, water content, and other parameters that define the lens.
Predicate Device Equivalence: The primary "ground truth" for regulatory clearance is that the new device's properties (physical, optical, chemical) and indications for use are "substantially equivalent" to a legally marketed predicate device (Aspect Vision Care, Ltd.'s FREQUENCY 55).
Toxicology and Leachability Testing: Lab-based tests demonstrating non-toxicity and non-leachability of color additives/monomers.
FDA Guidance: Compliance with established FDA guidance for daily wear contact lenses (e.g., being a Group 4, ionic, high water content polymer).

8. The Sample Size for the Training Set

This information is not applicable. Contact lenses do not utilize "training sets" in the context of AI or machine learning algorithms.

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

This information is not applicable for the same reason as point 8.

Summary

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982774

2 1998 SEP

510 (k) Summary

SUBMITTER:

Submitted on behalf of:

Manufacturer:

CL-TINTERS

Address:

Hoylaamotie 7 Fin-00380 Helsinki Finland

Phone:

358 9340 5066

CONTACT PERSON:

Martin S. Knopf

DATE SUMMARY PREPARED: August 1, 1998

TRADE NAME:

ﻤﺴﺎ

)

ﻨﺔ .

FANTASY, NATURAL, BRILLIANCE, GLAMOUR AND CRAZY™ (methafilcon A ) Hydrophilic AND CRAZ I - (motile) Wear (clear and tinted)

contact lens COMMON NAME:

SUBSTANTIALLY EQUIVALENT TO:

FANTASY, NATURAL, BRILLIANCE, GLAMOUR AND CRAZY™ (methall.con A )
Creating Children for Drile)Wass (alsos and tipted) are equivalent to Aspect FANTASY, NATURAL, BRILLIANCE, SOLAMOON NAD Of See equivalent to Aspect
Hydrophilic Contact Lens for Daily Wear (clear and tinted) are equivalent Lens for I Hydrophilic Contact Lens for Daily Wear (clear and timed) are ogeneral (1984)
Vision Care, Ltd.'s FREQUENCY 55 (methafilcon A) Hydrophilic Contact Lens for Daily
1991 - Std. Vision Care, Ltd. 3 FREQUENCY 35 (REQUENT) . Wear (clear and tinted) .

FANTASY, NATURAL, BRILLIANCE, GLAMOUR AND CRAZY (methafilcon A)
Claimed Children (cu Deile:W/gor (cloar and tipted) are substantially equili FANTASY, NATURAL, BRILLIANCE, GLAMOUN Alined) are substantially equivalent to
Hydrophilic Contact Lens for Daily Wear (clear and tinted) are substantially equivality of A Hydrophilic Contact Lens for Daily Weal (clear and times) UENCY 55 (methafilcon A)
the indications for use of Aspect Vision Care, Ltd.'s FREQUENCY 55 (methant to K971164. In the indications for use of Aspect Vision Cale, Ltd. 3 intedburns and to K971164. In
Hydrophilic Contact Lens for Daily Wear (clear and tinted) pursuant to K971164. In Hydrophilic Contact Lens for Daily villa (cuea and intod) parsual lenses at the same
addition, Aspect Vision Care, Ltd. will produce the dry cast molded lenses are subsequent addition, Aspect Vision Care, Ltd. Will produce the are subsequently manufacturing location as the predicate devices. "Those tones" is a listed color additives) to produce their unique tinting patterns.

This lens is in Group 4, lonic, high water content polymers as established by the FDA and This lens is in Group 4, lonic, high water content Lenses, Revised Edition May
located in the Guidance Document for Daily Wear Contact Lenses, Revised Edition May located in the Guidance Document for bally virosties of the FANTASY, NATURAL.
1994. The physical, optical, and chemical properties of the FANTASY, NATURAL 1994. The physical, optical, and chemican propriated A) Hydrophilic Contact Lens for Daily
BRILLIANCE, GLAMOUR AND CRAZY (methafilicon A) Hydrophilic Care, Ud BRILLIANCE, GLAMOOK AND OF OLE I Those of the Aspect Vision Care, Ltd.
Wear (clear and tinted) are equivalent to those of the Aspect Vision and Wear (clear and tinted) are equivalent to those of the Abpoor Holly Wear (clear and tinted).
FREQUENCY 55 (methafilcon A) Soft Contact Lens for Daily Wear (clear and tinted).

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DESCRIPTION of the DEVICE:

INDICATIONS FOR USE:

Device Name: FANTASY, NATURAL, BRILLIANCE, GLAMOUR AND CRAZY (methafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted)

Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.

Performance Testing of Contact Lens

Lenses were loaded with the following eleven pigments (i.e., listed color additives):

Carbazole violet, chromium oxide green, dihydrodinaphto brown, dihydrodioxo yellow, phthalocyanine green, iron oxide red, iron oxide black, phthalocyanine blue and titanium dioxide.

The results of toxicology testing (cytotoxicity, acute systemic toxicity and acute ocular irritation) have demonstrated that the subject lens is non toxic. Furthermore, the results of residual monomer and color leachability testing demonstrate that the respective extracts did not contain leachable color or significant levels of residual monomers.

The physical optical, and chemical properties of the FANTASY, NATURAL, BRILLIANCE, GLAMOUR AND CRAZY (methafilcon A) Hydrophilic Contact Lens for

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Daily Wear (clear and tinted)) are equivalent to those of the FREQUENCY 55
Cally Wear Air Hotel webilia Centret Lens for Daily Wear (clear and tinted) from th Daily Wear (clear and tinted) are equivalent to those or the Prezent inted) from Aspect
(methafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted) from Aspect (methafilcon A) Hydrophilic Contact Lens for Daily Vveal (cical under) (and the mail.
Vision Care, Ltd. since this lens is provided to CL-TINTERS by Aspect Vision Care, Ltd.

PARAMETERS AVAILABLE:

The FANTASY, NATURAL, BRILLIANCE, GLAMOUR AND CRAZY™ (methafilcon A )
Creative Collection of Jacand tipted) Hydrophilic Contact Lens (clear and tinted) +8.00 to -8.00D Powers: Center Thickness: 0.12 mm 14.2 mm Diameter: 8.8 mm Base Curve:

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 1998 SEP

CL- TINTERS c/o Martin S. Knopf President and CEO Knopf Associates, Inc. 84 West Main Street Freehold, New Jersey 07728

Re: K982774

Trade Name: FANTASY, NATURAL, BRILLANCE, GLAMOUR AND CRAZY (methalfilcon A) Hydrophilic Contact Lens for Daily Wear (clear, tinted and cast molded) Regulatory Class: II Product Code: 86 LPL Dated: August 1, 1998 Received: August 7, 1998

Dear Mr. Knopf:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for used stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set for childling the Current Good
Medical Devices: Concept on the in (91 GETT in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

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Page 2 - Martin S. Knopf

This letter will allow you to begin marketing your device as described in your 510(k) I mis letter will anow you to begin indine of substantial equivalence of your device to a premarket notification. The I Dri midnig of vasitication 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 OFF Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and Compliance at (001) 591 1815 - 12011-11-27) - 11-11-2017 - 11-11-2017 - 11-21-2017 - 11-21-2017 - 11-21-2017 - 11-21-2017 please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be (2) Cr (6) ... ). Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Ralph Rosenthal

Rosenthal, M.D. A. Ralph Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS STATEMENT

Device Name: FANTASY, NATURAL, BRILLIANCE, GLAMOUR AND CRAZY

Clear and Children Child Contact Lean for Daily Wear (clear and tighted) Device Name: FANTAST, NATORAL, BRIZEMTOD, Septact Clear and tinted)

The FANTASY, NATURAL, BRILLIANCE, GLAMOUR AND CRAZY (methalitoon A) The FANTASY, NATURAL, BRICLIANCE, SEAMOUNT for Casily wear for the comection Hydrophilic Contact Lens (clear and thile) is included for and nor-aphakic persons with
of refractive ametropia (myopia and hyperopia) in aphakic and not and of refractive ametropia (myopla and nyporopian up to 2.00 Diopters that does not
non-diseased eyes that may exhibit astigment on used to replance or alter the app non-diseased eyes that may exhibit asigniatism up to 2.05 bigpler that the apparent color of the eye.

Eyecare practitioners may proscribe the lens for daily waar in a Frequent Replacement Eyecare practilioners may prescribe the fens for using would in the reach as a conside disinfection systems.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF

NEEDED)

Over the Counter Use

Concurrence of CDRH, Office of Device Evaluation (ODE)

Proscription Use______________________________________________________________________________________________________________________________________________________________

Samuel W.C. Brown, Ph.D

K982774

Division of Ophthalmic Devices

(Division Sign-Off)

510(k) Number

(Optional Format 1-2-86)

178

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.