PVS BASICS

K984436 · Paragon Vision Sciences · HQD · Apr 21, 1999 · Ophthalmic

Device Facts

• Record ID: K984436
• Device Name: PVS BASICS
• Applicant: Paragon Vision Sciences
• Product Code: HQD · Ophthalmic
• Decision Date: Apr 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2

Indications for Use

The PVS BASICS ™ (paflufocon E) rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. The PVS BASICS ™ (paflufocon E) rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes who are nearsighted (myopic), farsighted (hyperopic) and who may exhibit corneal astigmatism up to 4.00 diopters or less that does not interfere with visual acuity. PVS BASICS ™ (paflufocon E) toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. PVS BASICS ™ Bifocal lenses are indicated for presbyopic persons (far or near sighted) including astigmatic corrections up to +4.00 D requiring add power of up to + 4.00 D.

Device Story

PVS BASICS are rigid gas permeable (RGP) contact lenses manufactured from paflufocon E polymer. Lenses are prescribed by eye care practitioners for daily wear to correct refractive errors including myopia, hyperopia, astigmatism, and presbyopia. The device functions as a corrective optical lens placed directly on the cornea. Clinical benefit is achieved through the physical correction of visual acuity. The device is available in spherical, aspheric, toric, and bifocal configurations, with optional violet tinting (D&C Violet #2 and D&C Red #17).

Clinical Evidence

Randomized, double-masked clinical trial comparing paflufocon E (PVS Basics) to predicate paflufocon A (FluoroPerm 92). Study enrolled 70 eyes for PVS Basics and 22 for control. Primary endpoints included visual acuity, comfort, lens-eye relationship, movement, slit lamp findings, and functional wetting. Results showed no adverse reactions, corneal ulcers, iritis, or significant staining/edema/neovascularization in either group. Biocompatibility testing included ISO 10993 ocular irritation (rabbits), cytotoxicity (L-929 mouse fibroblasts), and delayed dermal sensitization (guinea pigs), all showing no evidence of toxicity or irritation.

Technological Characteristics

Material: Paflufocon E polymer. Water content: <1%. Dk: 67. Refractive index: 1.454. Specific gravity: 1.10. Hardness: 81.7. Dimensions: 7.0-10.5 mm chord diameter, 0.05-0.70 mm center thickness. Powers: -20.00 to +12.00 Diopters. Bifocal add: +0.25 to +4.00 Diopters. Tint: Violet (D&C Violet #2, D&C Red #17).

Indications for Use

Indicated for daily wear in non-aphakic, non-diseased patients (myopic, hyperopic, or presbyopic) to correct visual acuity. Corrects corneal astigmatism up to 4.00D (spherical/aspheric/bifocal) or up to 6.00D (toric). Bifocal lenses indicated for presbyopia with add power up to +4.00D.

Regulatory Classification

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.

Predicate Devices

• FluoroPerm 92 (P820063)

Submission Summary (Full Text)

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4/21/99

K 9 8 4 4 3 6

# APPENDIX H 510(k) Summary

Company Name: Paragon Vision Sciences Submitter. Address: 945 East Impala Ave. Phone: [phone] Fax: [phone] Registration: Owner Operator # 9024618

Manufacturer:

Company Name: Paragon Vision Sciences Address: 945 East Impala Ave. Mesa AZ 85204 Phone: [phone] Fax: [phone]: Registration. Site Registration #2020433

Official Correspondent: William E. Meyers, Ph.D. % Paragon Vision Sciences Address: 945 East Impala Ave. Mesa AZ 85204 Phone: [phone] Fax: [phone] Reason for 510(k) Submission: Material change

Date of submission 12/10/98

Device Identification:

Trade Name: PVS BASICS ™ Common Name: contact lens Classification Name: rigid gas permeable contact lens for daily wear Reference: 21 CFR 886.5916;rigid gas permeable contact lens, Class II- daily wear

Indications For Use:

The PVS BASICS ™ (paflufocon E) rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. The PVS BASICS ™ (paflufocon E) rigid gas perical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes who are nearsighted (myopic), farsighted (hyperopic) and who may exhibit corneal astigmatism up to 4.00 diopters or less that does not interfere with visual acuity. PVS BASICS ™ (paflufocon E) toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. PVS BASICS ™ Bifocal lenses are indicated for presbyopic persons (far or near sighted) including astigmatic corrections up to +4.00 D requiring add power of up to + 4.00 D.

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The lenses have the following dimensions and characteristics:

| Parameters | PVS BASICS TM |
|--------------------------------|---------------|
| Material | Paflufocon E |
| Indication | Daily wear |
| Water content | < 1% |
| Dk (35)° | 67* |
| Light transmittance Violet**** | 92% |
| Wetting Angle*** | 16 |
| Hardness | 81.7 |
| refractive index | 1.454 |
| Specific gravity | 1.10 |
| color | violet |

*Oxygen Permeability 67 x10-11Dk** at 35'C

** (cm2/sec)(mL 02/mL x mm Hg) Method of Irving Fatt, Ph.D.

*** after soaking in conditioning solution

*** +12 D, 7mm OZ, 7.8 BC, .45mm CT, harmonic mean thickness over 7mm = 0.329 mm.

#### Lens Parameters:

| Chord Diameter | 7.0 to 10.5 mm |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Center Thickness | 0.05 to 0.70 mm |
| Base Curve | 6.50 to 9.00 mm |
| Powers | 20.00 to +12.00 Diopters |
| | 11:0 -- 1 4 1 1 D ------------------------------------------------------------------------------------------------------------------------------------------------------------ |

Bifocal Add Powers ... +0.25to +4.00 Diopters Concentric Bifocal Add Diameter ................................................................................................................................................................. Monocentric Bifocal Add Diameter ................................................................................................................................................................. Monocentric Bifocal Prism ..................... 1.0 to 2.5 Diopters

The PVS BASICS 714 (paflufocon E) rigid gas permeable contact lenses are available in violet color. The violet tinted lenses contain D & C Violet # 2 and D & C Red #17.

The PVS BASICS 714 parturocon E) Dk 65 contact lens is substantially equivalent to the FluoroPerin 92 Dk 92 Rigid Gas Permeable Contact Lens marketed by Paragon Vision Sciences which is presently approved for daily wear under PMA (P820063). The physical, optical and chemical properties of the PVS BASICS ™ (paffufocon E) contact lens are substantially equivalent to the FluoroPerm 92 (paflufocon A).

In addition to the physicochemical comparison, toxicity and human clinical studies were conducted.

The test article, PVS Basics (AKA patlufocon E), Batch 234880-6, was extracted in 0.9% sodium chloride USP solution (SC) and cottonseed oil, NF (CSO). These extracts were evaluated for ocular irritation base on the International Organization for Standardization 10993: Biological Evaluation of Medical Devices, Part 10: Tests for Irritation and Sensitization.

A 0.2 ml dose of the appropriate test article extract was instilled in the right eye of three test rabbits. Similarly, the corresponding reagent control was instilled into the left eye of each rabbit to serve as the control conditions were evaluated at 1, 24, 48, and 72 hours after the single exposure.

Under the conditions of this study, there was no evidence of irritation in the test eye or any rabbit.

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The SC and CSO test article extracts would not be considered irritants to the ocular tissue of the rabbit.

An in vitro biocompatibility test, based on the International Organization (ISO 10993-5) guidelines, was conducted on the test article. PVS Basics (AKA patlufocon E). Lot HS401710-8, in order to determine the potential for in vitro cytotoxicity. A single lens was placed on triplicate agarose surfaces directly overlaying confluent monolayers of L-929 mouse fibroblast cells. Similarly, triplicate negative and positive control wells were presared. After incubating at 37°C in 5% or for 24-26 hours, the cell cultures were examined macroscopically for cell decolorization around the test article and controls to determine the zone of cell lysis (if any). The cultures were then examined microscopically (100X) to verify any decolorized zones and to determine cell morphology in proximity to and beneath the test article.

The negative controls and the positive controls performed. Under the conditions of this study, the test article showed no evidence of causing cell lysis or toxicity. The test article was not cytotoxic and passed this ISO study.

A guinea pig maximization test of PVS Basics (AKA paffuroon E), Batch 234880-6, was conducted to evaluate the potential for delaved dermal contact sensitization. This study was conducted based on the international Organization for Standardization 10993; Biological Evaluation of Medical Devices, Part 10: Tests for Irritation and Sensitization.

The test article was extracted in 0.9% sodium chloride USP (SC) and contonsed oil. NF (CSO). Each extract was intradermally injected and occlusively patched to test guinea pies (per extract) in an attempt to induce sensitization. The vehicle was similarly injected and occlusively patched to five control guinea pigs (per vehicle). Following a recovery period, the test and control animals received a challenge patch of the appopriate test and the reagent control. All sites were scored at 24, 48 and 72 hours after patch removal.

Under the conditions of this study, the SC and CSO test article extracts showed no evidence of causing delayed demall contact sensitization in the guinea pig.

A clinical evaluation of the safety and effectiveness of the paflufocon E (PVS Basic™) polymer lens was reefformed. This randomized double-masked controlled trial evaluated the clinical performance of lenses produced using the new pathutocon E material in comparison to control lenses made with FDA approved prodicate material, paflufoon A (FluoroPerm 92TN).

Decision criteria were established for the equivalence of the materials these variables were: Visual Acuity, Comfort, Lens-Eye Relationship, Movement, Slit lamp Findings, Functional Wetting,

This clinical trial established Patlufocon E as safe and effective when compared to the currently marketed predicate control material, Paflufocon A (FluoroPerm 92™). The tables below summarize the results of the study.

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#### EYES ENROLLED IN THE STUDY AND DISTRIBUTION AND STATUS

| Status | | Number of Eyes | |
|------------------------|-----------------|------------------------|----------------------|
| | | Paflufocon A<br>TOTALS | PVS Basics<br>TOTALS |
| Enrolled Dispensed | | | |
| Completed | | 22 | 68 |
| Active | | | |
| | Dispensing | 22 | 70 |
| | First Follow Up | 22 | 68 |
| | Final Visit | 22 | 68 |
| Total Active | | 22 | 68 |
| Discontinued | | 0 | 2 |
| Incomplete | | 0 | 0 |
| Total Dispensed | | 22 | 70 |
| Enrolled Not Dispensed | | 0 | 0 |
| Total Enrolled | | 22 | 70 |

## SUMMARY OF FINDINGS RELATED TO SAFETY

| | Paflufocon A<br>TOTALS | PVS Basics<br>TOTALS | |
|----------------------------|------------------------|----------------------|-----|
| NUMBER OF EYES | 22 | 68 | |
| DISCONTINUED EYES | 0 | 2 | |
| AVERAGE WEARING TIME | $14.09$ | $13.58$ | TMC |
| ALL ADVERSE REACTIONS | 0 | 0 | |
| ALL CORNEAL ULCERS | 0 | 0 | |
| ALL IRITIS | 0 | 0 | |
| STAINING REPORTS > GRADE 2 | 0 | 0 | |
| EDEMA REPORTS >GRADE 2 | 0 | 0 | |
| INJECTION REPORTS >GRADE 2 | 0 | 0 | |
| NEOVASC. REPORTS >GRADE 2 | 0 | 0 | |
| VISITS | 44 | 136 | |
| MISSED VISITS | 0 | 0 | |

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#### SUMMARY OF SYMPTOMS PROBLEMS AND COMPLAINTS

#### Completed Control Eyes

| | Initial Dispensing<br>Visit | | Intermediate Visits | | | |
|------------------------|-----------------------------|---------|---------------------|---------|--------|---------|
| | 1 | | 2 | | | |
| Total Eyes at Visit | 22 | | 22 | | 22 | |
| | Number | Percent | Number | Percent | Number | Percent |
| None | 19 | 86.4 | 16 | 72.7 | 14 | 63.6 |
| Discomfort | 3 | 13.6 | 4 | 18.2 | 6 | 27.3 |
| Excess Tearing * | 0 | 0 | 0 | 0 | 0 | 0 |
| Photophobia | 0 | 0 | 0 | 0 | 0 | 0 |
| Halos | 0 | 0 | 0 | 0 | 0 | 0 |
| Itching/Burning | 0 | 0 | 1 | 4.5 | 4 | 18.2 |
| Spectacle Blur* | 0 | 0 | 0 | 0 | 0 | 0 |
| Variable Vision | 0 | 0 | 0 | 0 | 4 | 18.2 |
| Blurred Vision | 2 | 9.1 | 3 | 13.6 | 8 | 36.4 |
| Lens Needs Cleaning | 2 | 9.1 | 3 | 13.6 | 2 | 9.1 |
| Other | | | | | | |
| Dryness | 2 | 9.1 | 3 | 13.6 | 6 | 27.3 |
| Total Positive Reports | 9 | | 14 | | 24 | |

### Completed Trial Eyes

| | Initial Dispensing<br>Visit | | Intermediate Visits | | | |
|------------------------|-----------------------------|---------|---------------------|---------|--------|---------|
| | | | 1 | | 2 | |
| Total Eyes at Visit | 70 | | 68 | | 68 | |
| | Number | Percent | Number | Percent | Number | Percent |
| None | 55 | 78.6 | 52 | 76.5 | 45 | 66.2 |
| Discomfort | 6 | 8.6 | 4 | 5.9 | 8 | 11.8 |
| Excess Tearing | 0 | 0 | 0 | 0 | 0 | 0 |
| Photophobia | 0 | 0 | 0 | 0 | 0 | 0 |
| Halos | 2 | 2.9 | 0 | 0 | 2 | 2.9 |
| Itching/Burning | 1 | 1.4 | 2 | 2.9 | 2 | 2.9 |
| Spectacle Blur | 0 | 0 | 0 | 0 | 0 | 0 |
| Variable Vision | 0 | 0 | 6 | 8.8 | 5 | 7.4 |
| Blurred Vision | 4 | 5.7 | 4 | 5.9 | 2 | 2.9 |
| Lens Needs Cleaning | 0 | 0 | 6 | 8.8 | 4 | 5.9 |
| Other | Dryness | | | | | |
| Dryness | 5 | 7.1 | 5 | 7.4 | 6 | 8.8 |
| Total Positive Reports | 18 | | 27 | | 29 | |

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 1 1993

William E. Meyers, Ph.D. Vice President, Science & Technology PARAGON VISION SCIENCES 947 East Impala Mesa, AZ 85204

Re: K984436 Trade Name: PVS BASICS ™ (paflufocon E) Rigid Gas Permeable Contact Lenses For Daily Wear (Spherical, Aspheric, Toric and Bifocal) Clear and Violet Tinted (with D&C Violet # 2 and D & C Red # 17) Regulatory Class: II Product Code: 86 HQD Dated: March 2, 1999 Received: March 3, 1999

Dear Dr. Meyers:

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

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Page 2 - William E. Meyers, 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A Ralph 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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#### Indications Statement

510(k) Number (if known):

Device Name: PVS BASICS TM (paflufocon E)Contact Lens

Indications For Use:

The PVS BASICS "M (paflufocon E) rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. The PVS BASICS ™ (paflufocon E) rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes who are nearsighted (myopic), farsighted (hyperopic) and who may exhibit corneal astigmatism up to 4.00 diopters or less that does not interfere with visual acuity. PVS BASICS ™ (paflufocon E) toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. PVS BASICS ™ Bifocal lenses are indicated for presbyopic persons (far or near sighted) including astigmatic corrections up to +4.00 D requiring add power of up to + 4.00 D.

> PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR

Over-The Counter Use

(Optional Format 1-2-96)

Erica

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K 984436