(35 days)
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.
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.
This 510(k) summary for the Fluorex® Ultra (flusilfocon E) Rigid Permeable Contact Lenses indicates that the device's acceptance criteria are based on achieving substantial equivalence to a predicate device, Fluorex® 700 (flusilfocon A) Rigid Gas Permeable Contact Lenses (PMA #P880001). The "study" proving the device met the acceptance criteria was primarily a comparison of material properties, with no clinical or traditional standalone studies performed for the Fluorex® Ultra itself.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for Fluorex® Ultra were implicitly defined by demonstrating that its material properties were comparable to or acceptably different from the predicate device, Fluorex® 700.
| Material Property | Predicate Device (Fluorex® 700) Performance | Acceptance Criteria (Implied) | Reported Device Performance (Fluorex® Ultra) |
|---|---|---|---|
| Material Description | Fluoro-silicate-acrylic-copolymers | Similar formulation | Fluoro-silicate-acrylic-copolymer (similar to predicate in component monomers, differing in proportions) |
| Gas Permeability (Dk) | 70.0 | Acceptable Dk for RGP lenses | 60.0 |
| Hardness (Shore D) | 85.5 | Comparable | 86.0 |
| Wetting Angle (Wilhelmy plate method) | 15.3° | Comparable | 13.9° |
| Water absorption | <1.0% | Comparable | <1.0% |
| Refractive Index | 1.457 | Comparable | 1.458 |
| Specific Gravity | 1.097 | Comparable | 1.103 |
| Light Transmission | 88.1% (clear), 75.0% (gray), 74.9% (blue), 72.6% (green) | >70% (aqua) color variant | >70% (aqua) |
| Cytotoxicity | (Implied safe from predicate) | Non-cytotoxic | Non-cytotoxic (agar overlay test) |
Note: The physical dimensions (Chord Diameter, Center thickness, Base Curve, Powers) listed for Fluorex® 700 are provided as context for the type of lens, but Fluorex® Ultra is not explicitly stated to meet these exact dimensions; rather, it is presumed to be available in a similar range. The "Actions" are also a functional description that applies to both.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of a traditional test set for performance evaluation. The "test" here refers to the material characterization of Fluorex® Ultra. The report does not specify the number of material samples used for each physical property measurement.
- Data Provenance: The data appears to be from internal laboratory testing of the Fluorex® Ultra material itself, likely performed by G.T. Laboratories, Inc. or a contracted lab. The document does not specify a country of origin for the data beyond the applicant's location in Illinois, USA. It is retrospective in the sense that the material was manufactured and then tested.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device classification relies on substantial equivalence based on material properties, not on expert-adjudicated ground truth data for a diagnostic or imaging device.
4. Adjudication Method for the Test Set
Not applicable. No expert adjudication was performed for the material property tests.
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 relevant for diagnostic devices involving human interpretation of results, which is not the case for a contact lens material.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. A "standalone" performance study in the context of AI or diagnostic algorithms is not applicable here. The performance evaluation was based on laboratory testing of the material properties of the contact lens itself (e.g., Dk, hardness, wetting angle), and toxicology/cytotoxicity.
7. The Type of Ground Truth Used
The "ground truth" for the Fluorex® Ultra material was established through laboratory measured physical and chemical properties and cytotoxicity testing. For example, the gas permeability (Dk) was determined by the polarographic method, hardness by Shore D hardness ANZI/ASTM, and so on. The "ground truth" for demonstrating substantial equivalence was the known properties of the predicate device, Fluorex® 700.
8. The Sample Size for the Training Set
Not applicable. There was no "training set" in the context of an AI/machine learning model. The device is a material, not a data-driven algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there was no training set, there was no ground truth for it. The comparison was against the established characteristics of the predicate device.
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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
- 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.
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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 Type | Fluorex® 700 | Fluorex® Ultra |
|---|---|---|
| Material Description | Fluoro-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) | 70.0 | 60.0 |
| Hardness (Shore D hardness ANZI/ASTM) | 85.5 | 86.0 |
| Wetting Angle (Wilhelmy plate method) | 15.3° | 13.9° |
| Water absorption (ANZI Z80.6; 5.6.1) | <1.0% | <1.0% |
| Refractive Index (ANZI/ASTM D542-20) | 1.457 | 1.458 |
| Specific Gravity | 1.097 | 1.103 |
| Light Transmission, (ANZI/ASTM 280.6.4.5) | 88.1% (clear)75.0% (gray)74.9% (blue)72.6% (green) | >70% (aqua) |
| Actions | When 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 thickness | 0.10 to 1.00 mm | |
| Base Curve | 6.00 to 9.00 mm | |
| Powers | -20.00 to +12.00 D |
*Parameters for spherical lenses
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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
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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 .
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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. Rosenthal
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
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.
§ 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.