FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG

K180172 · Paragon Vision Sciences · HQD · Mar 16, 2018 · Ophthalmic

Device Facts

• Record ID: K180172
• Device Name: FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG
• Applicant: Paragon Vision Sciences
• Product Code: HQD · Ophthalmic
• Decision Date: Mar 16, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2

Intended Use

FluoroPerm® 92 rigid gas permeable spheric contact lenses with Tangible Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner. FluoroPerm® 92 rigid gas permeable spheric and bifocal contact lenses with Tangible Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with non-diseased 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 toric contact lenses with Tangible Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 92 bifocal lenses with Tangible Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power. In daily wear use only, FluoroPerm® 92 contact lenses with Tangible Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eyes.

Device Story

Lathe-cut rigid gas permeable (RGP) contact lenses; manufactured from fluorosilicone acrylate copolymers (paflufocon A, B, C, D); surface-treated with Tangible Hydra-PEG (polyethylene glycol-based polymer). Hydra-PEG covalently bonds to lens surface; enhances wettability; reduces sessile drop contact angle. Prescribed by eye care practitioners for daily wear. Corrects refractive errors; manages irregular corneal conditions. Patient benefits include improved comfort and visual acuity via enhanced surface properties while maintaining mechanical integrity of underlying RGP material.

Clinical Evidence

No new clinical data provided. Clinical safety and effectiveness of the underlying RGP materials were previously established in PMA P870024 and its supplements. Clinical safety and effectiveness for Hydra-PEG treated contact lenses were previously demonstrated.

Technological Characteristics

Lathe-cut rigid gas permeable contact lenses; materials: paflufocon A, B, C, D (fluorosilicone acrylate thermoset copolymers). Surface modification: covalently bonded Tangible Hydra-PEG (PEG-based polymer). Water content <1%. Wettability: sessile drop contact angle ~10-11°. Sterilization: not specified (vial packaging).

Indications for Use

Indicated for daily wear in not-aphakic persons with non-diseased eyes for correction of myopia, hyperopia, and corneal astigmatism (up to 4.00D spheric/bifocal, up to 6.00D toric). Bifocal lenses treat presbyopia (up to +4.00D add). Also indicated for irregular corneal conditions (keratoconus, pellucid marginal degeneration, post-penetrating keratoplasty, post-radial keratotomy, or post-LASIK).

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 30 & Paragon Thin (paflufocon C) RGP contact lenses (K120996)
• FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses (K120996)
• FluoroPerm 92 (paflufocon A) RGP contact lenses (K120996)
• FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses (K120996)
• Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lenses (K161100)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 16, 2018

Paragon Vision Sciences % Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Lane West Linn, OR 97068

# Re: K180172

Trade/Device Name: FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HOD Dated: January 22, 2018 Received: January 26, 2018

## Dear Bret Andre:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

{1}------------------------------------------------

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" .(21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely. Denise L. Hampton -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K180172

Device Name

FluoroPerm® 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG

Indications for Use (Describe)

FluoroPerm® 92 rigid gas permeable spheric contact lenses with Tangible Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner.

FluoroPerm® 92 rigid gas permeable spheric and bifocal contact lenses with Tangible Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with non-diseased 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 toric contact lenses with Tangible Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 92 bifocal lenses with Tangible Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, FluoroPerm® 92 contact lenses with Tangible Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eyes.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

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

# Indications for Use

510(k) Number (if known)

K180172

Device Name

FluoroPerm® 60 (paflufocon B) RGP contact lenses with Tangible Hydra-PEG

Indications for Use (Describe)

FluoroPerm® 60 rigid gas permeable spheric contact lenses with Tangible Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner.

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

In daily wear use only, FluoroPerm® 60 contact lenses with Tangible Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eyes.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

{4}------------------------------------------------

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K180172

Device Name

Paragon HDS® (paflufocon B) RGP contact lenses with Tangible Hydra-PEG

Indications for Use (Describe)

Paragon HDS® rigid gas permeable spheric contact lenses with Tangible Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner.

Paragon HDS® rigid gas permeable spheric and bifocal contact lenses with Tangible Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with non-diseased 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® toric contact lenses with Tangible Hvdra-PEG are indicated to correct astigmatism of up to 6.00 diopters. Paragon HDS® bifocal lenses with Tangible Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, Paragon HDS® contact lenses with Tangible Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eyes.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 20px;">☑</span> |
|----------------------------------------------|-----------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | □ |

CONTINUE ON A SEPARATE PAGE IF NEEDED.This section applies only to requirements of the Paperwork Reduction Act of 1995.

## "DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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

## Indications for Use

510(k) Number (if known)

K180172

Device Name

FluoroPerm® 30 (paflufocon C) RGP contact lenses with Tangible Hydra-PEG

Indications for Use (Describe)

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

FluoroPerm® 30 rigid gas permeable spheric and bifocal contact lenses with Tangible Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with non-diseased 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 toric contact lenses with Tangible Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 30 bifocal lenses with Tangible Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, FluoroPerm® 30 contact lenses with Tangible Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eyes.

| Type of Use (Select one or both, as applicable) | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| <table style="border:none"><tr><td><span style="padding-right: 10px;"> <b> <span style="font-size: 14px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </b> </span></td><td><b> <span style="font-size: 14px;">□</span> Over-The-Counter Use (21 CFR 801 Subpart C) </b></td></tr></table> | <span style="padding-right: 10px;"> <b> <span style="font-size: 14px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </b> </span> | <b> <span style="font-size: 14px;">□</span> Over-The-Counter Use (21 CFR 801 Subpart C) </b> |
| <span style="padding-right: 10px;"> <b> <span style="font-size: 14px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </b> </span> | <b> <span style="font-size: 14px;">□</span> Over-The-Counter Use (21 CFR 801 Subpart C) </b> | |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## "DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{6}------------------------------------------------

# Indications for Use

510(k) Number (if known)

K180172

Device Name

Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG

Indications for Use (Describe)

Paragon Thin rigid gas permeable contact lenses with Tangible Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner.

Paragon Thin rigid gas permeable spherical, aspheric and bifocal contact lenses with Tangible Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with non-diseased 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 toric contact lenses with Tangible Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. Paragon Thin bifocal lenses with Tangible Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, Paragon Thin contact lenses with Tangible Hydra-PEG are indicated for management of iregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eyes.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K180172

Device Name

FluoroPerm® 151 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG

Indications for Use (Describe)

FluoroPerm® 151 rigid gas permeable spheric contact lenses with Tangible Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner.

FluoroPerm® 151 rigid gas permeable spherical, aspheric and bifocal contact lenses with Tangible Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with non-diseased 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 toric contact lenses with Tangible Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 151 bifocal lenses with Tangible Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, FluoroPerm® 151 contact lenses with Tangible Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eyes.

Type of Use (Select one or both, as applicable)

| <div> <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

CONTINUE ON A SEPARATE PAGE IF NEEDED.This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

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

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K180172

Device Name

Paragon HDS® 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG

Indications for Use (Describe)

Paragon HDS® 100 rigid gas permeable spheric contact lenses with Tangible Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner.

Paragon HDS® 100 rigid gas permeable spheric and bifocal contact lenses with Tangible Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with non-diseased 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 toric contact lenses with Tangible Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. Paragon HDS® 100 bifocal lenses with Tangible Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, Paragon HDS® 100 contact lenses with Tangible Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eyes.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{9}------------------------------------------------

# 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

K180172 The assigned 510(k) number is:

### SUBMITTER I.

| Date Prepared: | January 17th, 2018 |
|----------------------------------|---------------------------------------------------------------------------------------------------|
| Name:<br>Address: | Paragon Vision Sciences<br>947 E Impala Ave<br>Mesa, AZ 85204<br>United States |
| Contact Person:<br>Phone number: | Rich Jefferies<br>President<br>[phone] |
| Consultant:<br>Phone number: | Bret Andre<br>EyeReg Consulting, Inc.<br>6119 Canter Ln.<br>West Linn, OR 97068<br>[phone] |

#### II. DEVICE

| Trade Name: | FluoroPerm® 30 & Paragon ThinTM (paflufocon C) RGP contact lenses with<br>TangibleTM Hydra-PEG; FluoroPerm® 60 & Paragon HDS® (paflufocon B)<br>RGP contact lenses with TangibleTM Hydra-PEG; FluoroPerm® 92<br>(paflufocon A) RGP contact lenses with TangibleTM Hydra-PEG;<br>FluoroPerm® 151 & Paragon HDS® 100 (paflufocon D) RGP contact lenses<br>with TangibleTM Hydra-PEG |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Daily wear rigid gas permeable contact lens |
| Classification Name: | Rigid gas permeable contact lens. (21 CFR 886.5916) |
| Regulatory Class: | Class II |
| Product Code: | HQD |

{10}------------------------------------------------

# Purpose of 510(k) Submission:

~ New Technology ~

The FluoroPerm® 30, Paragon Thin™, FluoroPerm® 60, Paragon HDS®, FluoroPerm® 92, FluoroPerm® 151 & Paragon HDS® 100 Daily Wear Rigid Gas Permeable Contact Lenses-cleared under 510(k) K120996-are modified to include the Tangible™ Hydra-PEG surface coating-which is a thin, polyethylene glycol (PEG)-based polymer designed to improve the wettability of the contact lenses. Specifically, Tangible Hydra-PEG treated contact lenses demonstrate a measurable improvement in the contact angle compared to untreated lenses.

### PREDICATE DEVICE III.

The FluoroPerm® 30, Paragon Thin™, FluoroPerm® 60, Paragon HDS®, FluoroPerm® 92, FluoroPerm® 151 & Paragon HDS® 100 Daily Wear Rigid Gas Permeable Contact Lenses with Tangible™ Hydra-PEG are substantially equivalent to the following predicate devices:

- . "FluoroPerm® 30 & Paragon Thin™ (paflufocon C) RGP contact lenses" "FluoroPerm® 60 & Paragon HDS® (paflufocon B) RGP contact lenses" "FluoroPerm® 92 (paflufocon A) RGP contact lenses" "FluoroPerm® 151 & Paragon HDS® 100 (paflufocon D) RGP contact lenses" By Paragon Vision Sciences 510(k) number: K120996 -primary predicate
- "Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lenses" By Contamac Ltd. 510(k) number; K161100 -reference predicate

### IV. DEVICE DESCRIPTION

FluoroPerm® 30, Paragon Thin™, FluoroPerm® 60, Paragon HDS®, FluoroPerm® 92, FluoroPerm® 151 & Paragon HDS® 100 lenses with Tangible™ Hydra-PEG are available as lathe cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from the following currently marketed contact lens materials:

- I paflufocon A (FluoroPerm® 92)
- paflufocon B (FluoroPerm® 60, Paragon HDS®)
- 트 paflufocon C (FluoroPerm® 30. Paragon Thin™)
- I paflufocon D (FluoroPerm® 151, Paragon HDS® 100)

{11}------------------------------------------------

Non-proprietary names paflufocon A, B, C, and D were assigned by the United States Adopted Names Council (USAN). These materials are thermoset copolymers derived from fluorosilicone acrylate monomers. The lenses may be tinted to offer a handling aid for locating the lenses may be available with an ultraviolet absorber (not in all colors and materials). The lens designs have a posterior surface consisting of a base curve and a series of up to four annular spherical or aspheric curves peripheral to the base curve.

The FluoroPerm® 92, FluoroPerm® 60, Paragon HDS®, FluoroPerm ® 30, Paragon Thin™ FluoroPerm®151, and Paragon HDS® 100 lenses are treated to incorporate Tangible™ Hydra-PEG-which is a thin polyethylene glycol (PEG)-based polymer that is covalently bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with Tangible™ Hydra-PEG, the underlying material is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses.

The surface properties of paflufocon A, paflufocon C, and paflufocon C, and paflufocon D materials uncoated and coated with Tangible Hydra-PEG are depicted in the following table:

| | Paflufocon A | Paflufocon B | Paflufocon C | Paflufocon D |
|-------------------------------------------------------|--------------------------------------------|--------------------------------------------|--------------------------------------------|--------------------------------------------|
| Sessile Drop Contact<br>Angle ± Standard<br>Deviation | Coated: 10.5°±2.3°<br>Uncoated: 56.4°±6.8° | Coated: 10.3°±1.7°<br>Uncoated: 59.4°±5.8° | Coated: 10.2°±0.8°<br>Uncoated: 53.6°±4.7° | Coated: 11.3°±3.8°<br>Uncoated: 58.8°±4.9° |

The FluoroPerm® 30, Paragon Thin™, FluoroPerm® 60, Paragon HDS®, FluoroPerm® 92, FluoroPerm® 151 & Paragon HDS® 100 lenses with Tangible™ Hydra-PEG are available in the same design configurations and available parameters as the predicate device, cleared under K120996.

### INDICATIONS FOR USE V.

# FluoroPerm® 92

FluoroPerm® 92 rigid gas permeable spherical or aspheric contact lenses with Tangible™ Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner.

FluoroPerm® 92 rigid gas permeable spheric and bifocal contact lenses with Tangible™ Hydra-PEG 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. FluoroPerm® 92 toric contact lenses with Tangible™ Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 92 bifocal lenses with Tangible™ Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only. FluoroPerm® 92 contact lenses with Tangible™ Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration,

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or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.

# FluoroPerm® 60

FluoroPerm® 60 rigid gas permeable spherical or aspheric contact lenses with Tangible™ Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner.

FluoroPerm® 60 rigid gas permeable spheric and bifocal contact lenses with Tangible™ Hydra-PEG 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 toric contact lenses with Tangible™ Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 60 bifocal lenses with Tangible™ Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, FluoroPerm® 60 contact lenses with Tangible™ Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.

# Paragon HDS®

Paragon HDS® rigid gas permeable spheric contact lenses with Tangible™ Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner.

Paragon HDS® rigid gas permeable spheric and bifocal contact lenses with Tangible™ Hydra-PEG 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® toric contact lenses with Tangible™ Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. Paragon HDS® bifocal lenses with Tangible™ Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, Paragon HDS® contact lenses with Tangible™ Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eyes.

## FluoroPerm® 30

FluoroPerm® 30 rigid gas permeable contact lenses with Tangible™ Hydra-PEG are indicated for daily wear as recommended by the eve care practitioner.

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FluoroPerm® 30 rigid gas permeable spheric and bifocal contact lenses with Tanzible™ Hydra-PEG 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 toric contact lenses with Tangible™ Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 30 bifocal lenses with Tangible™ Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, FluoroPerm® 30 contact lenses with Tangible™ Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration. or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.

# Paragon Thin™

Paragon Thin™ rigid gas permeable contact lenses with Tangible™ Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner.

Paragon Thin™ rigid gas permeable spherical, aspheric and bifocal contact lenses with Tangible™ Hydra-PEG 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'm toric contact lenses with Tangible™ Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. Paragon Thin™ bifocal lenses with Tangible™ Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, Paragon Thin™ contact lenses with Tangible™ Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eves.

# FluoroPerm® 151

FluoroPerm® 151 rigid gas permeable spheric contact lenses with Tangible™ Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner.

FluoroPerm® 151 rigid gas permeable spherical, aspheric and bifocal contact lenses with Tangible™ Hydra-PEG 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 toric contact lenses with Tangible™ Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 151 bifocal lenses with Tangible™ Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, FluoroPerm® 151 contact lenses with Tangible™ Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration.

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or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.

# Paragon HDS® 100

Paragon HDS® 100 rigid gas permeable spherical or aspheric contact lenses with Tangible™ Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner.

Paragon HDS® 100 rigid gas permeable spherical, aspheric and bifocal contact lenses with Tangible™ Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with non-diseased 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 toric contact lenses with Tangible™ Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. Paragon HDS® 100 bifocal lenses with Tangible™ Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, Paragon HDS® 100 contact lenses with Tangible™ Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.

### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE

The FluoroPerm® 92, FluoroPerm® 60, Paragon HDS®, FluoroPerm ® 30, Paragon Thin ™ FluoroPerm® 151, and Paragon HDS® 100 lenses with Tanzible™ Hydra-PEG surface technology are substantially equivalent to the FluoroPerm® 92, FluoroPerm® 60, Paragon HDS®, FluoroPerm® 30, Paragon Thin™, FluoroPerm®151, and Paragon HDS® 100 rigid gas permeable contact lenses (cleared under K120996) in terms of the following:

- 트 Proprietary contact lens material formulation and USAN
- Intended use – daily wear contact lenses
- 트 Indications for use
- I Lens designs and available parameters

The FluoroPerm® 92, FluoroPerm® 60, Paragon HDS®, FluoroPerm ® 30, Paragon Thin ™ FluoroPerm® 151, and Paragon HDS® 100 lenses with Tanzible™ Hydra-PEG surface technology are substantially equivalent to the Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lenses (cleared under K161100) in terms of the following:

- I Thermoset copolymers derived from fluorosilicone acrylate monomers
- 트 Tangible™ Hydra-PEG surface coating

The following matrix illustrates the production method. Iens function and material characteristics of the FluoroPerm® 92, FluoroPerm® 60, Paragon HDS®, FluoroPerm ® 30, Paragon Thin TM

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FluoroPerm® 151, and Paragon HDS® 100 lenses with Tangible™ Hydra-PEG surface technology, as well as the predicate devices.

| | FluoroPerm® 92,<br>FluoroPerm® 60, Paragon<br>HDS®, FluoroPerm ® 30,<br>Paragon Thin TM,<br>FluoroPerm® 151, and<br>Paragon HDS® 100 lenses<br>with Tangible™ Hydra-<br>PEG | FluoroPerm® 92,<br>FluoroPerm® 60, Paragon<br>HDS®, FluoroPerm ® 30,<br>Paragon Thin TM,<br>FluoroPerm® 151, and<br>Paragon HDS® 100 lenses | Optimum GP with<br>Tangible™ Hydra-PEG<br>(roflufocon C, D, E) |
|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | New Device | Predicate Device | Predicate Device |
| Functionality | The contact lenses act as a<br>refractive medium that focus<br>light rays from near and distant<br>objects on the retina | The contact lenses act as a<br>refractive medium that focus light<br>rays from near and distant objects<br>on the retina | The contact lenses act as a<br>refractive medium that focus<br>light rays from near and distant<br>objects on the retina |
| Intended Use | Daily Wear | Daily Wear | Daily Wear |
| Indication for Use | Indicated for daily wear for the<br>correction of visual acuity in<br>not-aphakic persons with non-<br>diseased eyes that are<br>nearsighted (myopic), farsighted<br>(hyperopic), and may exhibit<br>corneal astigmatism up to 4.00<br>diopters that does not interfere<br>with visual acuity. The contact<br>lenses are indicated to correct<br>astigmatism of up to 6.00<br>diopters, and bifocal lenses are<br>indicated to treat presbyopia up<br>to +4.00 D add power. The<br>lenses are also indicated for<br>management of irregular corneal<br>conditions such as keratoconus,<br>pellucid marginal degeneration,<br>or following penetrating<br>keratoplasty, radial keratotomy,<br>or LASIK surgery in otherwise<br>non-diseased eyes. | Indicated for daily wear for the<br>correction of visual acuity in not-<br>aphakic persons with non-<br>diseased eyes that are nearsighted<br>(myopic), farsighted (hyperopic),<br>and may exhibit corneal<br>astigmatism up to 4.00 diopters<br>that does not interfere with visual<br>acuity. The contact lenses are<br>indicated to correct astigmatism<br>of up to 6.00 diopters, and bifocal<br>lenses are indicated to treat<br>presbyopia up to +4.00 D add<br>power. The lenses are also<br>indicated for management of<br>irregular corneal conditions such<br>as keratoconus, pellucid marginal<br>degeneration, or following<br>penetrating keratoplasty, radial<br>keratotomy, or LASIK surgery in<br>otherwise non-diseased eyes. | Indicated for daily wear for the<br>correction of visual acuity in<br>aphakic and not aphakic persons<br>with non-diseased eyes with<br>myopia or hyperopia and/or<br>presbyopia. The lens may also be<br>prescribed for management of<br>irregular corneal conditions such as<br>keratoconus and post graft fitting. |
| Production Method | Lathe-Cut, custom<br>manufactured | Lathe-Cut, custom<br>manufactured | Lathe-Cut, custom<br>manufactured |
| USAN name | paflufocon A, B, C, D | paflufocon A, B, C, D | roflufocon C, D, E |
| Water Content (%) | <1% | <1% | <1% |
| Wettability<br>(sessile drop<br>advancing contact<br>angle) | Paflufocon A: 10.5°<br>Paflufocon B: 10.3°<br>Paflufocon C: 10.2°<br>Paflufocon D: 11.3° | Paflufocon A: 56.4°<br>Paflufocon B: 59.4°<br>Paflufocon C: 53.6°<br>Paflufocon D: 58.8° | |
| Includes Hydra-<br>PEG | Yes | No | Yes |

# Substantial Equivalence Matrix

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### VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

# Non-clinical Testing

A series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of FluoroPerm® 30, Paragon Thin™, FluoroPerm® 60, Paragon HDS®, FluoroPerm® 92, FluoroPerm® 151 & Paragon HDS® 100 rigid gas permeable contact lenses with Tangible™ Hydra-PEG packaged in vials. All non-clinical toxicology tests were conducted in accordance with the GLP regulation. All other testing was conducted according to valid scientific protocols. Test results of the non-clinical testing on the device demonstrate that:

- 트 The finished lenses are not toxic and not irritating,
- 트 Bioburden levels are below the acceptance criteria (<100 cfu/lens) initially and following 30 days of storage in solution (Boston Simplus) at ambient temperatures,
- 트 The physical properties of the lenses are stable following 30 disinfection cycles in Clear Care & Boston Simplus at ambient temperatures, and
- 트 The surface properties of the lens are stable following 30 days of accelerated aging.
- I The physicochemical and mechanical properties are unchanged after the addition of Tangible™ Hydra-PEG, with the exception of wettability (contact angle).

# Clinical Testing

The clinical safety and effectiveness of finished rigid gas permeable contact lenses manufactured from FluoroPerm® 30, Paragon Thin™, FluoroPerm® 60, Paragon HDS®, FluoroPerm® 92, FluoroPerm® 151 & Paragon HDS® 100 materials have been demonstrated in PMA P870024 and several of its supplements. The clinical safety and effectiveness for contact lenses treated with Hydra-PEG has been previously demonstrated.

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# VIII. CONCLUSIONS

# Validity of Scientific Data

Laboratories under Good Laboratory Practice regulations conducted toxicology, microbiology, and shelf-life stability studies following scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7.

# Substantial Equivalence

Information presented in this Premarket Notification establishes that the FluoroPerm® 30, Paragon Thin™, FluoroPerm® 60, Paragon HDS®, FluoroPerm® 92, FluoroPerm® 151 & Paragon HDS® 100 rigid gas permeable contact lenses with Tangible™ Hydra-PEG are as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the proposed indication.

## Risks and Benefits

The risks of the subject device are the same as those normally attributed to the wearing of rigid gas permeable (RGP) daily wear contact lenses. The benefits to the patient are the same as those for other RGP contact lenses.