K Number
K991781
Device Name
FLUOREX ULTRA (FLUSILFOCON E) RIGID GAS PERMEABLE CONTACT LENS
Date Cleared
1999-06-29

(35 days)

Product Code
Regulation Number
886.5916
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Fluorex® Ultra (flusilfocon E) 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 astigmatism of 1.50 diopters or less that does not interfere with visual acuity. The Fluorex® Ultra (flusilfocon E) 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 Fluorex® Ultra (flusilfocon E) is a fluoro-silicate-acrylic-copolymer. The Fluorex® Ultra (flusilfocon E) Rigid Gas Permeable Contact Lens when placed on a cornea acts as a refracting medium to focus light rays onto the retina.
More Information

P880001

P880001

No
The summary describes a physical contact lens and its intended use, with no mention of software, algorithms, or any technology related to AI or ML.

No
Explanation: This device is indicated for the correction of visual acuity by acting as a refracting medium on the cornea, which is a corrective function, not a therapeutic one. It does not treat or cure a disease or condition.

No
The text indicates the device is a contact lens used for correcting visual acuity, not for diagnosing conditions.

No

The device description clearly states it is a physical contact lens made of a fluoro-silicate-acrylic-copolymer, which is a hardware component.

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 by acting as a refracting medium on the cornea. This is a physical correction of vision, not a diagnostic test performed on biological samples outside the body.
  • Device Description: The description focuses on the material composition and how the lens physically interacts with the eye to focus light.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions through laboratory tests, or providing information for diagnosis or treatment decisions based on such analysis.

IVD devices are specifically designed to be used in vitro (outside the living body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This contact lens does not fit that description.

N/A

Intended Use / Indications for Use

The Fluorex® Ultra (flusilfocon E) 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 astigmatism of 1.50 diopters or less that does not interfere with visual acuity.

The Fluorex® Ultra (flusilfocon E) 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.

Product codes

86 HQD

Device Description

The Fluorex® Ultra (flusilfocon E) material is a fluoro-silicate-acrylic-copolymer. The Fluorex® Ultra (flusilfocon E) Rigid Gas Permeable Contact Lens when placed on a cornea acts as a refracting medium to focus light rays onto the retina.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

human cornea, eyes

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

P880001

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

510 (K) SUMMARY FOR FREEDOM OF INFORMATION

JUN 2 9 1999 Fluorex® Ultra (flusilfocon E) Material for Rigid Permeable Contact Lenses

  • G. T. Laboratories, Inc 1. Submitted by: 2007 Johns Drive Glenview, IL 60025-1616
    Contact Person:

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

  1. Date Prepared
  • Contact Lens 3. Common/Usual
  • Fluorex® Ultra (flusilfocon E) 4. Proprietary Name Rigid Gas Permeable Contact Lenses

May 17, 1999

  • The lens material (flusilfocon E), 5. Device Description is a fluoro-silicate-acrylic-The Fluorex® Ultra copolymer. (flusilfocon E) Rigid Gas Permeable Contact Lens when placed on a cornea acts as a refracting medium to focus light rays onto the retina.
  • The spherical lens is intended to 6. Intended Use be used in the correction of visual acuity in eyes that are myopic or Bifocal and trifocal hyperopic. designs are available for the correction of visual acuity in eyes that are also presbyopic.
  • The sponsor considers these lenses 7. Equivalence: 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 material to the predicate device.

1

Fluorex® Ultra, 510(k) FOI, Pg 2

Fluorex® Ultra compared to Fluorex® 700

ﻟﻢ ﺗﻢ ﻳﺘﻢ ﺗﻌﻠﻴﻘﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ

Material TypeFluorex® 700Fluorex® Ultra
Material DescriptionFluoro-silicate-acrylic-copolymers. Tinted lenses contain one or more of the following dyes: D&C Green dye #6, D&C Yellow dye #10. D&C Violet #2, D&C Red dye #17, CI Solvent Yellow 18.
Gas permeability (D k) (polarographic method)70.060.0
Hardness (Shore D hardness ANZI/ASTM)85.586.0
Wetting Angle (Wilhelmy plate method)15.3°13.9°
Water absorption (ANZI Z80.6; 5.6.1)70% (aqua)
ActionsWhen placed on the human cornea, the hydrated lens acts as a corrective refracting medium to focus light rays on the retina.
Chord Diameter*7.00 to 10.50 mm
Center thickness0.10 to 1.00 mm
Base Curve6.00 to 9.00 mm
Powers-20.00 to +12.00 D

*Parameters for spherical lenses

2

Fluorex® Ultra, 510(k) FOI, Pg 3

CHEMISTRY

The Fluorex® Ultra (flusilfocon E) material is a rigid gas permeable material for making contact lenses, consisting of a fluorine-containing polyacrylate-silicone blend, identical to the already approved Fluorex® 700 (flusilfocon A) material in component monomers, with differences only in the relative proportion of each component, which results in the difference in gas permeability (Dx). No monomers were found to be extracted from the material.

TOXICOLOGY

The Fluorex® Ultra (flusilfocon E) 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

3

Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 1999

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

Re: K991781 Trade Name: Fluorex® Ultra (flusilfocon E) Rigid Gas Permeable Contact Lens Regulatory Class: II Product Code: 86 HQD Dated: May 17, 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 (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 .

4

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. Rosenthal

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

Enclosure

5

Page 1 of 1

510(k) NUMBER (IF KNOWN)

Fluorex® Ultra (flusilfocon E) Rigid Gas DEVICE NAME Permeable Contact Lens

INDICATIONS FOR USE

The Fluorex® Ultra (flusilfocon E) 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 astigmatism of 1.50 diopters or less that does not interfere with visual acuity.

The Fluorex® Ultra (flusilfocon E) 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.

(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)

J. W. C. Brown, Ph.D.

(Division Sign-Off) Division of Ophthalmic Devices K991781 510(k) Number.