The Fluorex® 700-UV (flusilfocon A), Fluorex® 500-UV (flusilfocon B) and Fluorex® 300-UV (flusilfocon C) Spherical Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic, hyperopic and which may exhibit astiqmatism of 1.50 diopters or less that does not interfere with visual acuity.

The Fluorex® 700-UV (flusilfocon A), Fluorex® 500-UV (flusilfocon B) and Fluorex® 300-UV (flusilfocon C) Translating Bifocal and Trifocal Contact Lenses are indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased presbyopic eyes that are myopic or hyperopic and which may exhibit astigmatism of 3.50 diopters or less that does not interfere with visual acuity.

Device Description

The UV blocking materials contain a UV-absorbing compound incorporated into the fluoro-silicate-acryliccopolymers (flusilfocon A, B, C). The Fluorex® UV (flusilfocon) Rigid Gas Permeable Contact Lens when placed on a cornea acts as a refracting medium to focus light rays onto the retina.

AI/ML Overview

This is a 510(k) summary for a contact lens material, not an AI device. As such, the requested information regarding AI device acceptance criteria and study details (sample size, experts, ground truth, MRMC study, standalone performance, training set) is not applicable or available in the provided text.

The document describes the addition of a UV blocker to existing Fluorex® contact lens materials and seeks substantial equivalence to already approved predicate devices. The "study" here refers to the comparison of material properties between the new UV-blocking versions and the predicate devices.

Here's the relevant information that can be extracted, framed within the context of a medical device submission rather than an AI study:

1. Table of Acceptance Criteria and Reported Device Performance

The device is considered substantially equivalent if its properties are comparable to the predicate device. The acceptance criteria are implicit in the "Substantial Equivalence" table, where the new materials' properties are presented alongside the predicate's for direct comparison. Deviations are noted, but typically the values are expected to be very similar for substantial equivalence.

Acceptance Criteria (Predicate Device Property)	Reported Device Performance (Fluorex® 700-UV)	Reported Device Performance (Fluorex® 500-UV)	Reported Device Performance (Fluorex® 300-UV)
Material Type: Fluoro-silicate-acrylic-copolymers, tinted with specific dyes.	Fluoro-silicate-acrylic-copolymers, tinted with specific dyes, plus Cyasorb UV-416	Fluoro-silicate-acrylic-copolymers, tinted with specific dyes, plus Cyasorb UV-416	Fluoro-silicate-acrylic-copolymers, tinted with specific dyes, plus Cyasorb UV-416
Actions: Corrective refracting medium on human cornea.	Same	Same	Same
Chord Diameter*: 7.00 to 10.50 mm	-> (Implies same range)	-> (Implies same range)	-> (Implies same range)
Center thickness*: 0.10mm to 1.00mm	-> (Implies same range)	-> (Implies same range)	-> (Implies same range)
Base Curve*: 6.00 to 9.00 mm	-> (Implies same range)	-> (Implies same range)	-> (Implies same range)
Powers*: -20.00 to +12.00 D	-> (Implies same range)	-> (Implies same range)	-> (Implies same range)
Gas permeability (Dk): 70.0	70.0	51.5 (Predicate: 50.0)	29.3 (Predicate: 30.0)
Hardness (Shore D hardness): 85.5	85.5	86.5	87.0
Wetting Angle (Wilhelmy plate method): 14.8°	14.8°	13.8°	12.9°
Water content: All materials <1.0%	All materials <1.0%	All materials <1.0%	All materials <1.0%
Refractive Index: 1.457	1.457	1.460 (Predicate: 1.460)	1.464 (Predicate: 1.465)
Specific Gravity: 1.097	1.085	1.110	1.119 (Predicate: 1.118)
Light Transmission, Visible (380-780nm): All materials >90%	All materials >90%	All materials >90%	All materials >90%
Light Transmission, UV (250-350nm): Not specified (for predicate)	0.0% (for UV absorbing materials)	0.0% (for UV absorbing materials)	0.0% (for UV absorbing materials)

Note: The "->" in the table for Chord Diameter, Center thickness, Base Curve, and Powers implies that the values are the same as the predicate since the "Substantial Equivalence" column header covers all materials.

2. Sample size used for the test set and the data provenance: Not applicable. This is a material characterization rather than a data-driven AI test. Material properties are measured according to established standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Material properties are determined by standardized physical and chemical tests, not expert consensus.

4. Adjudication method for the test set: Not applicable.

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 not an AI device.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable. This is not an AI device.

7. The type of ground truth used: Material properties are established through direct measurement and testing according to industry standards (e.g., ANZI, ASTM). For example:
* Gas permeability (Dk) by polarographic method.
* Hardness by Shore D hardness (ANZI/ASTM).
* Wetting Angle by Wilhelmy plate method.
* Water content by ANZI Z80.6; 5.6.1.
* Refractive Index by ANZI/ASTM D542-20.
* Light Transmission by ANZI/ASTM 280.6.4.5.
* Toxicology was assessed via an agar overlay cytotoxicity test.

The "ground truth" for the new materials is their experimentally determined physical and chemical characteristics.

8. The sample size for the training set: Not applicable. This is not an AI device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI device.

Summary of the study that proves the device meets the acceptance criteria:

The study demonstrating the device meets acceptance criteria is a material characterization and comparison study. G. T. Laboratories, Inc. performed various physical, chemical, and biological tests on the new UV-blocking Fluorex® materials (Fluorex® 700-UV, 500-UV, 300-UV) to show their properties are substantially equivalent to the previously approved Fluorex® materials (Fluorex® 700, 500, 300).

The key findings indicating the "proof" are:

Chemistry: The UV-blocking materials are described as "identical to the already approved Fluorex® (flusilfocon) materials in component monomers, with the only difference being the addition of the UV blocker." No monomers were found to be extracted.
Toxicology: The UV-blocking material was found to be "noncytotoxic in an agar overlay cytotoxicity test."
Microbiology and Clinical: No testing was required due to the similarity to the predicate device, indicating that the addition of the UV blocker was not expected to significantly alter these aspects based on existing data for the predicate.
Material Property Comparison (Table): The provided table directly compares multiple physical properties (Gas permeability, Hardness, Wetting Angle, Water content, Refractive Index, Specific Gravity, Light Transmission) between the new UV-blocking materials and their non-UV predicate counterparts. The results show very similar values, with the primary difference being the intended 0.0% UV light transmission in the new UV-absorbing materials, which is the desired feature. The minor differences in Dk, Refractive Index, and Specific Gravity are deemed acceptable for substantial equivalence.

Summary

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JUN 2 9 1999_510(K) SUMMARY FOR PREEDOM OF INFORMATION

510(K) SUMMARY FOR FREEDOM OF INFORMATION

Addition of UV blocker to Fluorex® 700, 500, 300 (flusilfocon A, B, C) Material for Rigid Permeable Contact Lenses

1. Submitted by:	G. T. Laboratories, Inc2007 Johns DriveGlenview, IL 60025-1616
------------------	------------------------------------------------------------------------

John M. Szabocsik, Ph.D. Contact Person: Szabocsik and Associates 203 N. Wabash, Ste 1200 Chicago, IL 60601 TEL: 312-553-0828

May 18, 1999 2. Date Prepared

Contact Lens 3. Common/Usual

Fluorex® 700-UV (flusilfocon A), 4. Proprietary Name Fluorex® 500-UV (flusilfocon B), Fluorex® 300-UV (flusilfocon C), Rigid Gas Permeable Contact Lenses
1. Device Description The UV blocking materials contain a UV-absorbing compound incorporated into the fluoro-silicate-acryliccopolymers (flusilfocon A, B, C). The Fluorex® UV (flusilfocon) Rigid Gas Permeable Contact Lens when placed on a cornea acts as a refracting medium to focus light rays onto the retina.
1. Intended Use The spherical lens is intended to be used in the correction of visual acuity in eyes that are myopic or hyperopic. Bifocal and trifocal designs are available for the correction of visual acuity in eyes that are also presbyopic.
1. Equivalence: The sponsor considers these lenses to be substantially equivalent to Fluorex® 700 (flusilfocon A) Rigid Gas Permeable Contact Lenses, approved under PMA #P880001. The attached table summarizes the comparison of the new materials to the predicate device.

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	SUBSTANTIAL EQUIVALENCE
Material Type	Fluorex® 700	Fluorex® 700-UV	Fluorex® 500	Fluorex® 500-UV	Fluorex® 300	Fluorex® 300-UV
MaterialDescription	Fluoro-silicate-acrylic-copolymers. Tinted lenses contain one or more of thefollowing dyes: D&C Green dye #6, D&C Yellow dye #10. D&C Violet #2, D&C Red dye#17, CI Solvent Yellow 18. The UV absorbing lenses also contain Cyasorb UV-416
Actions	When placed on the human cornea, the hydrated lens acts as a corrective refractingmedium to focus light rays on the retina.
Chord Diameter*	<	7.00 to 10.50 mm	->
Center thickness*	<	0.10mm to 1.00mm	->
Base Curve*	<	6.00 to 9.00 mm	->
Powers*	<	-20.00 to +12.00 D	->
Gas permeability(Dk) (polarographicmethod )	70.0	70.0	50.0	51.5	30.0	29.3
Hardness(Shore D hardnessANZI / ASTM )	85.5	85.5	86.5	86.5	87.0	87.0
Wetting Angle(Wilhelmy platemethod )	14.8°	14.8°	13.8°	13.8°	12.9°	12.9°
Water content(ANZI Z80.6; 5.6.1)			All materials <1.0%
Refractive Index(ANZI/ASTM D542-20)	1.457	1.457	1.460	1.460	1.465	1.464
Specific Gravity	1.097	1.085	1.110	1.110	1.118	1.119
Light Transmission,Visible (380-780nm)Clear lens (ANZI/ASTM 280.6.4.5)			All materials >90%
Light Transmission,UV (250-350nm)			All UV absorbing materials 0.0%

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*Parameters for spherical lenses

CHEMISTRY

The Fluorex® -UV (flusilfocon) materials are rigid gas permeable materials for making contact lenses, consisting of a fluorine-containing polyacrylate-silicone blend, and identical to the already approved Fluorex® (flusilfocon ) materials in component monomers, with the only difference being the addition of the UV blocker. No monomers were found to be extracted from the material.

TOXICOLOGY

The Fluorex® UV (flusilfocon) material was found to be noncytotoxic in an agar overlay cytotoxicity test.

MICROBIOLOGY

No testing was required, based on the similarity to the predicate device

CLINICAL

No testing was required, based on the similarity to the predicate device

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Public Health Service

JUN 2 9 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

G.T. Laboratories, Inc. C/O John M. Szabocsik, Ph.D. 203 North Wabash Avenue Suite 1200 Chicago, IL 60601

Re: K991780

Trade Name: Fluorex® 700-UV (flusilfocon A), Fluorex® 500-UV (flusilfocon B) and Fluorex® 300-UV (flusilfocon C) Rigid Gas Permeable Contact Lenses

Regulatory Class: II Product Code: 86 HQD Dated: May 21, 1999 Received: May 25, 1999

Dear Dr. Szabocsik:

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 use 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 forth in the Quality System Regulation (OS) 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 - John M. Szabocsik, Ph.D.

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the 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 Roerl lorentbal

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

Enclosure

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Page 1 of 1

K991780 510 (k) NUMBER (IF KNOWN)

Fluorex® 700-UV (flusilfocon A), DEVICE NAME Fluorex® 500-UV (flusilfocon B) and Fluorex® 300-UV (flusilfocon C) Rigid Gas Permeable Contact Lenses

INDICATIONS FOR USE

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

X Prescription Use (Per 21 CFR 801.109)

Over-The-Counter-Use OR (Optional Format 1-2-96)

Lionel V. C. Brown, Ph.D.

Division of Ophthalmic Devices 510(k) Number --K991780

Regulation Number and Section

§ 886.5916 Rigid gas permeable contact lens.

(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract 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.