FluoroPerm® 92 rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerm® 92 rigid gas permicable bifocal, or toric contact lenses are indicated for daily wear only.

FluoroPerm® 92 rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 92 contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes, daily wear application only. FluoroPerm® 92 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 92 bifocal lenses are indicated to treat presbyopia up to +4.00 D ad power.

FluoroPerm® 60 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerm® 60 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.

FluoroPerm® 60 rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 60 contact lenses are indicated for persons requiring. keratoconus management with otherwise non-diseased eyes, daily wear application only. FluoroPerm® 60 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 60 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.

Paragon HDS® rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. Paragon HDS® rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.

Paragon HDS® rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon HDS® contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes, daily wear application only. Paragon HDS® toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon HDS® bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.

FluoroPerm® 30 rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner.

FluoroPerm® 30 rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 30 contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes. FluoroPerm® 30 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 30 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.

Paragon Thin" rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner.

Paragon Thin" rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon Thin" contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes. Paragon Thin" toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon Thin"" bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.

FluoroPerm® 151 rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerm® 151 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.

FluoroPerm® 151 rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 151 contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes, daily wear application only. F FluoroPerm® 151 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 151 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.

Paragon HDS® 100 rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. Paragon HDS® 100 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.

Paragon HDS® 100 rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiscased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon HDS® 100 contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes, daily wear application only. Paragon HDS® 100 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon HDS® 100 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.

Device Description

Keratoconus contact lens designs are available as lath cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from these FDA approved contact lens materials; paflufocon A (FluoroPerm® 92), paflufocon B (FluoroPerm® 60, Paragon HDS®), paflufocon C (FluoroPerm® 30, Paragon Thin""), and paflufocon D (FluoroPerm® 151. Paragon HDS® 100). These materials are thermoset copolymers derived from fluorosilicone acrylate monomers. The lenses may be tinted to offer a handling aid for locating the lens. The tinted lenses contain one or more of the following approved color additives: D&C Green No. 6, Peroxide Yellow No. 9, D&C Violet No. 2 and D&C Red No. 17. These products may be plasma treated. The lenses may be available with an ultraviolet absorber (not in all colors and materials). The ultraviolet absorber. Uvinul D-49, has been integrated as an additive within the polymer matrix, blocking up to 97% of light below 380 nm. The UV absorber is 2,2'-dihydroxy-4,4'dimethoxybenzophenone. The lens designs have a posterior surface consisting of a base curve and a series of four spherical or aspherical curves progressively flatter than the base curve.

AI/ML Overview

This 510(k) summary is for contact lenses, which are medical devices that do not typically involve AI algorithms or software for diagnosis or analysis. The acceptance criteria and study information provided in such documents relate to the physical properties, safety, and efficacy of the lens materials and designs, usually through bench testing, biocompatibility studies, and clinical trials for safety and performance (e.g., visual acuity correction, physiological response of the eye). Therefore, many of the specifics requested in the prompt related to AI/ML device evaluations (like ground truth, expert adjudication, MRMC studies, training/test sets for algorithms) are not applicable here.

However, I can extract the relevant information regarding the acceptance criteria and how the device generally meets them, based on the provided text, and note where other requests are not applicable.

Acceptance Criteria and Device Performance for FluoroPerm® and Paragon HDS® RGP Contact Lenses

This submission is for a traditional medical device (contact lenses) rather than an AI/ML diagnostic or prognostic tool. Therefore, the "acceptance criteria" and "device performance" relate to the physical and chemical properties of the contact lens materials and their demonstrated safety and efficacy through prior regulatory approvals. The "study" proving acceptance criteria is primarily an assertion of substantial equivalence to a predicate device and reliance on previous PMA approvals for the material safety and efficacy.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the properties of the materials and the intended use. Performance is reported through material specifications and the claim of substantial equivalence to a legally marketed predicate device.

Property/Criteria	Acceptance Criteria (Implied / Predicate Comparison)	Reported Device Performance (Paragon Lenses)
Primary Indication	Similar to Boston® II (itafocon A) RGP contact lens approved in PMA P820065.	FluoroPerm® 30/60/92/151, Paragon Thin™/HDS®/HDS® 100 are indicated for daily wear (some for extended wear 1-7 days). Corrects visual acuity in non-aphakic persons with non-diseased eyes (myopic, hyperopic) with corneal astigmatism up to 4.00 diopters. Crucially, they are indicated for persons requiring keratoconus management with otherwise non-diseased eyes, daily wear application only. (This keratoconus indication is a key difference from the predicate Boston® II for FluoroPerm® 30/Paragon Thin)
Material	itafocon A (for Boston® II predicate)	paflufocon A, B, C, D (fluorosilicone acrylate copolymers)
Specific Gravity	Not explicitly stated for predicate; assumed to be within acceptable biological limits.	Range: 1.10 - 1.16
Refractive Index	Not explicitly stated for predicate; assumed to be within acceptable optical limits.	Range: 1.442 - 1.466
% Light Transmittance	Optimal for vision (e.g., >90%)	Range: 93% - 95% (Blue tinted material)
% Water Content	Low for RGP lenses	< 1%
Oxygen Permeability (Dk)	Adequate for ocular health (as per predicate or recognized standards).	Range: 29 - >145
Biocompatibility & Safety	Demonstrated in prior PMA approvals.	Materials (paflufocon A, B, C, D) have demonstrated safety and efficacy in PMA P870024 and its supplements.
Manufacturing Process	Same as predicate.	Manufactured by the same manufacturing process as the predicate.
Classification	Same as predicate (Class II).	Class II - daily wear contact lens (21 CFR 886.5916).
UV Absorber (if applicable)	Effective blockage; biocompatible.	Uvinul D-49, blocking up to 97% of light below 380 nm. Integrated within the polymer matrix.
Tinted Lenses (if applicable)	Approved color additives.	Contains D&C Green No. 6, Peroxide Yellow No. 9, D&C Violet No. 2 and D&C Red No. 17.

Note: The keratoconus indication for FluoroPerm® 30 and Paragon Thin™ is explicitly stated as a difference from the predicate in the "Substantial Equivalence Summary Table" (Page 3 of 8), but then indicated within the detailed "Indications For Use" section for all FluoroPerm and Paragon HDS lenses (Pages 1-3, and 6-8). This implies the predicate (Boston® II) did not have a specific keratoconus indication, making the addition of this indication for the new devices a non-trivial aspect of their approval.

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

This is not applicable in the context of an AI/ML medical device. For contact lenses, "test sets" would refer to samples used for physical property testing (e.g., Dk measurements), biocompatibility testing, and clinical trials. The document relies on previous PMA approvals (PMA P870024 and supplements) for the materials' safety and efficacy, meaning the data provenance for the foundational studies would be from those prior submissions, not detailed here. No specific "test set" sample sizes are provided for this 510(k) submission as it relies on substantial equivalence and previously approved materials.

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

This is not applicable as there is no "ground truth" to establish in the AI/ML sense. The approval relies on scientific and clinical data from previous PMA submissions, which would have involved ophthalmic practitioners and scientists.

4. Adjudication Method for the Test Set

Not applicable. There is no AI/ML adjudication process described. Clinical trial results (from prior PMAs) would have been reviewed by regulatory bodies and independent experts.

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-assisted diagnostic or prognostic device.

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

Not applicable. This is not an AI algorithm. The device is a physical contact lens.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for contact lenses relates to meeting material specifications, biocompatibility, and clinical performance (e.g., visual acuity, comfort, ocular health parameters) as demonstrated in clinical trials and laboratory testing, often against established standards. The document states that "The safety and efficacy... have been demonstrated in PMA P870024 and various of its supplements." This implies that the 'ground truth' or evidence base is derived from comprehensive preclinical (material science, biocompatibility) and clinical outcomes data from those prior PMA studies.

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML training set.

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

Not applicable.

Summary

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FEB 1 0 2006

K052983

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

FluoroPerm® 30 and Paragon Thin" (paflufocon C); FluoroPerm® 60 and Paragon HDS® (paflufocon B); FluoroPerm® 92 (patufocon A); and, FluoroPerm® 151 and Paragon HDS® 100 (paflufocon D) RGP Contact Lenses for Daily Wear Keratoconus Indication

Date of Submission

January 31, 2006

Submitter

Company Name: Address: Phone: Fax:

Paragon Vision Sciences 945 East Impala Ave., Mesa, AZ 85204 480-892-7602 480-892-3226

Manufacturer Information

Company Name: Address: Phone: Fax:

Paragon Vision Sciences 945 East Impala Ave., Mesa, AZ 85204 480-892-7602 480-892-3226

Official Correspondent

Name: Address: Address: Phone: Fax:

William E. Meyers, Ph.D. % Paragon Vision Sciences 945 East Impala Ave., Mesa, AZ 85204 480-507-7606 480-892-3226

Device Identification

Common Name: Trade Name:

Classification:

Predicate Device

Contact lens FluoroPerm® 30, FluoroPerm® 60, FluoroPerm® 92, FluoroPerm® 151, Paragon Thin", Paragon HDS and Paragon HDS 100 21 CFR 886.5916; rigid gas permeable contact lens, Class II - daily wear contact lens

A claim of substantial equivalence to the Boston® II (itafocon A) rigid gas permeable contact lens in keratoconus lens designs approved in PMA P820065. on 11/17/1983

Device Description

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The lenses may be tinted to offer a handling aid for locating the lens. The tinted lenses contain one or more of the following approved color additives: D&C Green No. 6, Peroxide Yellow No. 9, D&C Violet No. 2 and D&C Red No. 17. These products may be plasma treated.

The lenses may be available with an ultraviolet absorber (not in all colors and materials). The ultraviolet absorber. Uvinul D-49, has been integrated as an additive within the polymer matrix, blocking up to 97% of light below 380 nm. The UV absorber is 2,2'-dihydroxy-4,4'dimethoxybenzophenone.

The lens designs have a posterior surface consisting of a base curve and a series of four spherical or aspherical curves progressively flatter than the base curve.

Properties of the Contact Lenses

	FluoroPerm					Paragon
Property	30	60	92	151	Thin	HDS	HDS 100
Specific Gravity	1.14	1.15	1.10	1.10	1.145	1.16	1.10
Refractive Index	1.466	1.453	1.453	1.442	1.463	1.449	1.442
% LightTransmittance*	94	95	93	93	94	95	93
% Water Content	< 1	< 1	< 1	< 1	< 1	< 1	< 1
OxygenPermeability(Dk)**	30	60	92	151	29	58	>145

*Blue tinted material

**Revised Method of I. Fatt

Safety and Efficacy

The safety and efficacy of paflufocon A (FluoroPerm® 92), paflufocon B (FluoroPerm® 60 and Paragon HDS®), paflufocon C (FluoroPerm® 30 and Paragon Thin") and paflufocon D (FluoroPerm® 151 and Paragon HDS® 100) materials as rigid gas permeable contact lenses have been demonstrated in PMA P870024 and various of its supplements.

Intended Use

Device Name: FluoroPerm® 30 (paflufocon C) rigid gas permeable contact lenses

FluoroPerm® 30 rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner.

FluoroPerm® 30 rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 30 contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eves. FluoroPerm® 30 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 30 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.

Paragon Thin (paflufocon C) rigid gas permeable contact lenses Device Name:

Paragon Thin" rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner.

Paragon Thin" rigid gas permeable spheric and bifocal contact tenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eves that are nearsighted (myopic),

{2}------------------------------------------------

farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon Thin" contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes. Paragon Thin" toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon Thin" bifocal lenses are indicated to treat presbvopia up to +4.00 D add power.

FluoroPerm® 60 (paflufocon B) rigid gas permeable contact lenses Device Name:

FluoroPerm® 60 rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 60 contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes, daily wear application only. FluoroPerm® 60 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 60 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.

Paragon HDS (paflufocon B) rigid gas permeable contact lenses Device Name:

Paragon HDS® rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. Paragon HDS® rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.

Paragon HDS® rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon HDS® contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes, daily wear application only. Paragon HDS toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon HDS® bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.

Device Name:

FluoroPerm® 92 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerm® 92 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.

FluoroPerm® 92 rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 92 contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes, daily wear application only. FluoroPerm® 92 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 92 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.

FluoroPerm® 151 (paflufocon D) rigid gas permeable contact lenses Device Name:

FluoroPerm® 151 rigid gas permeable spheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended

{3}------------------------------------------------

by the eye care practitioner. FluoroPerm® 151 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.

Paragon HDS® 100 (paflufocon D) rigid gas permeable contact lenses Device Name:

Paragon HDS® 100 rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eves that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon HDS® 100 contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eves, daily wear application only. Paragon HDS 100 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon HDS® 100 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.

Substantial Equivalence

The FluoroPerm® 30 and Paragon Thin" (paflufocon C); FluoroPerm® 60 and Paragon HDS® (paflufocon B); FluoroPerm® 92 (paflufocon A); and, FluoroPerm® 151 and Paragon HDS® 100 (paflufocon D) Rigid Gas Permeable Contact Lenses are similar to the currently marketed Boston® II (itafocon A) Rigid Gas Permeable Contact Lens, in that all fall into the same FDA contact lens classification (Class II) and all are manufactured by the same manufacturing process. The following Substantial Equivalence Summary Table lists the similarities and differences among the devices.

Similarities		FluoroPerm®				ParagonThin™	ParagonHDS®	ParagonHDS® 100
	Boston® II	30	60	92	151	Daily Wear	Daily Wear	Daily Wear
Indicationsfor Use	DailyWear	DailyWear	DailyWear	DailyWear	DailyWear
Differences		paflufocon
Material	itafocon	C	B	A	D	C	B	D
IndicationforKeratoconus	YES	NO	NO	NO	NO	NO	NO	NO

Substantial Equivalence Summary Table

As the comparison table shows there are virtually no differences between the products offered by Paragon Vision Sciences and the Boston® II product, except material and the indication for keratoconus.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 0 2006

Paragon Vision Sciences c/o William E. Meyers, PhD Vice President, Science and Technology 947 East Impala Ave. Mesa, AZ 85204-6619

Re: K052983

Trade/Device Name: FluoroPerm® 92 (paflufocon A) Rigid Gas Permeable Contact Lenses FluoroPerm® 60 (paflufocon B) Rigid Gas Permeable Contact Lenses Paragon HDS® (paflufocon B) Rigid Gas Permeable Contact Lenses FluoroPerm® 30 (paflufocon C) Rigid Gas Permeable Contact Lenses Paragon Thin™ (paflufocon C) Rigid Gas Permeable Contact I enses FluoroPerm® 151 (paflufocon D) Rigid Gas Permeable Contact ' enses Paragon HDS® 100 (paflufocon D) Rigid Gas Permeable Contact Lenses Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HOD Dated: January 13, 2006 Received: January 17, 2006

Dear Dr. Meyers:

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.

{5}------------------------------------------------

Page 2 - William Meyers, PhD

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. 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 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), please contact the Office of Compliance at (301) 827-8910. 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/industry/support/index.html.

Sincerely yours.

M B Eycholtz, mD

Malvina B. Eydelman, M.D. Acting Division 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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Indications For Use

510(k) Number (if known): K052983

Device Name:

FluoroPerm® 92 (paflufocon A) rigid gas permeable contact lenses FluoroPerm® 60 (paflufocon B) rigid gas permeable contact lenses Paragon HDS® (paflufocon B) rigid gas permeable contact lenses FluoroPerm® 30 (paflufocon C) rigid gas permeable contact lenses Paragon Thin" (paflufocon C) rigid gas permeable contact lenses FluoroPerm® 151 (paflufocon D) rigid gas permeable contact lenses Paragon HDS® 100 (paflufocon D) rigid gas permeable contact lenses

Indications For Use:

FluoroPerm® 92

FluoroPerm® 60

J. Savita

vision of Ophthalmic Ea Nose and Throat Devises

510(k) Number

Page 1 of 3

{7}------------------------------------------------

Paragon HDS®

FluoroPerm® 30

FluoroPerm® 30 rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner.

Paragon Thin™

Paragon Thin" rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner.

FluoroPerm® 151

Savirata

510(k) Number

Page 2 of 3

{8}------------------------------------------------

FluoroPerm® 151 (continued)

FluoroPerm® 151 rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 151 contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes, daily wear application only. FluoroPerm® 151 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 151 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.

Paragon HDS® 100

Prescription Use X
(Part 21 CFR 801 Subpart D)

AND/OR

Over – the – Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IS NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODF)
--------------------------------------------------------	--

Myna Smith

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devices

Page 3 of 3

510(k) Number K052453

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.