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.

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 nondiseased eyes.

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.

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 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 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 iregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eves.

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

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.

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: paflufocon A (FluoroPerm® 92), paflufocon B (FluoroPerm® 60, Paragon HDS®), paflufocon C (FluoroPerm® 30. Paragon Thin™), 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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for various rigid gas permeable (RGP) contact lenses treated with Tangible™ Hydra-PEG. It details the device, its intended use, and a comparison to predicate devices, but it does not include a detailed study with specific acceptance criteria and performance metrics (like sensitivity, specificity, AUC) typically found in AI/ML device studies.

The "Acceptance Criteria" provided in the document refers to the general safety and effectiveness of the contact lenses, focusing on material properties, biocompatibility, and stability, rather than diagnostic performance metrics. The "study" mentioned is primarily non-clinical and previous clinical data from predicate devices.

Therefore, I cannot populate the table and answer the study-specific questions as they would apply to an AI/ML diagnostic or prognostic device study. Instead, I will extract the information that is present regarding the device's characteristics and the evaluations conducted.

Here’s a summary based on the provided text, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for contact lenses with a surface coating, the "acceptance criteria" are related to biocompatibility, material properties, and stability, rather than typical diagnostic performance metrics (e.g., sensitivity, specificity) for AI/ML devices. The key performance metric explicitly reported is wettability.

Criterion	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Not toxic, not irritating	Finished lenses are not toxic and not irritating
Bioburden Levels	<100 cfu/lens initially and after 30 days storage	Bioburden levels are below acceptance criteria
Physical Properties Stability	Stable after 30 disinfection cycles	Physical properties stable after 30 disinfection cycles
Surface Properties Stability	Stable after 30 days of accelerated aging	Surface properties stable after 30 days accelerated aging
Physicochemical/Mechanical Properties	Unchanged after addition of Tangible™ Hydra-PEG (except wettability)	Unchanged after addition of Tangible™ Hydra-PEG (except wettability)
Wettability (Sessile Drop Contact Angle)	Improved significantly compared to uncoated lenses (implied for substantial equivalence)	Coated Lenses: Paflufocon A: 10.5°±2.3° Paflufocon B: 10.3°±1.7° Paflufocon C: 10.2°±0.8° Paflufocon D: 11.3°±3.8°
Wettability (Uncoated Lenses)	Baseline for comparison	Uncoated Lenses: Paflufocon A: 56.4°±6.8° Paflufocon B: 59.4°±5.8° Paflufocon C: 53.6°±4.7° Paflufocon D: 58.8°±4.9°

2. Sample size used for the test set and the data provenance

The document describes non-clinical (in vitro and in vivo toxicology, biocompatibility, stability) and previous clinical testing. It does not specify a "test set" in the context of an AI/ML study (i.e., a dataset used to evaluate a trained algorithm's performance).

Sample Size: Not specified for individual non-clinical tests. General "series of in vitro and in vivo preclinical toxicology and biocompatibility tests" were performed.
Data Provenance: Not explicitly stated, but the studies were "conducted in accordance with the GLP regulation" and "valid scientific protocols." Clinical data was drawn from previous PMA P870024 and its supplements for the underlying materials, and clinical safety and effectiveness for Hydra-PEG treated lenses were "previously demonstrated" (likely referring to the reference predicate K161100). This indicates a blend of new non-clinical testing and leveraging existing clinical data (retrospective from prior approvals).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not an AI/ML diagnostic study that relies on expert interpretation to establish ground truth. The evaluation focused on physical, chemical, and biological properties of contact lenses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This type of adjudication method is relevant for expert-based ground truth in AI/ML diagnostic studies, which is not the case here.

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/ML device, and no MRMC study was conducted.

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

Not applicable. This is a contact lens product, not an algorithm.

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

The "ground truth" here is based on:

Measurement of physical/chemical properties: Such as sessile drop contact angle, bioburden levels using established laboratory methods.
Biocompatibility standards: Evaluated through preclinical toxicology and irritation tests.
Stability testing: Physical properties of the lenses under various conditions.
Previous clinical data: Demonstrating the safety and effectiveness of the base contact lens materials (PMA P870024) and the Hydra-PEG coating (K161100).

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device that requires a training set.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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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.

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

{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.

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.

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

{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.

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."

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)
☑ Prescription Use (Part 21 CFR 801 Subpart D) □ Over-The-Counter Use (21 CFR 801 Subpart C)	☑ Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)
☑ 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."

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."

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)

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.

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

{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.

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:Address:	Paragon Vision Sciences947 E Impala AveMesa, AZ 85204United States
Contact Person:Phone number:	Rich JefferiesPresident(480) 892-7602
Consultant:Phone number:	Bret AndreEyeReg Consulting, Inc.6119 Canter Ln.West Linn, OR 97068(503) 372-5226

II. DEVICE

Trade Name:	FluoroPerm® 30 & Paragon ThinTM (paflufocon C) RGP contact lenses withTangibleTM Hydra-PEG; FluoroPerm® 60 & Paragon HDS® (paflufocon B)RGP contact lenses with TangibleTM Hydra-PEG; FluoroPerm® 92(paflufocon A) RGP contact lenses with TangibleTM Hydra-PEG;FluoroPerm® 151 & Paragon HDS® 100 (paflufocon D) RGP contact lenseswith 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

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)

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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 ContactAngle ± StandardDeviation	Coated: 10.5°±2.3°Uncoated: 56.4°±6.8°	Coated: 10.3°±1.7°Uncoated: 59.4°±5.8°	Coated: 10.2°±0.8°Uncoated: 53.6°±4.7°	Coated: 11.3°±3.8°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.

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,FluoroPerm® 60, ParagonHDS®, FluoroPerm ® 30,Paragon Thin TM,FluoroPerm® 151, andParagon HDS® 100 lenseswith Tangible™ Hydra-PEG	FluoroPerm® 92,FluoroPerm® 60, ParagonHDS®, FluoroPerm ® 30,Paragon Thin TM,FluoroPerm® 151, andParagon HDS® 100 lenses	Optimum GP withTangible™ Hydra-PEG(roflufocon C, D, E)
	New Device	Predicate Device	Predicate Device
Functionality	The contact lenses act as arefractive medium that focuslight rays from near and distantobjects on the retina	The contact lenses act as arefractive medium that focus lightrays from near and distant objectson the retina	The contact lenses act as arefractive medium that focuslight rays from near and distantobjects on the retina
Intended Use	Daily Wear	Daily Wear	Daily Wear
Indication for Use	Indicated for daily wear for thecorrection of visual acuity innot-aphakic persons with non-diseased eyes that arenearsighted (myopic), farsighted(hyperopic), and may exhibitcorneal astigmatism up to 4.00diopters that does not interferewith visual acuity. The contactlenses are indicated to correctastigmatism of up to 6.00diopters, and bifocal lenses areindicated to treat presbyopia upto +4.00 D add power. Thelenses are also indicated formanagement of irregular cornealconditions such as keratoconus,pellucid marginal degeneration,or following penetratingkeratoplasty, radial keratotomy,or LASIK surgery in otherwisenon-diseased eyes.	Indicated for daily wear for thecorrection of visual acuity in not-aphakic persons with non-diseased eyes that are nearsighted(myopic), farsighted (hyperopic),and may exhibit cornealastigmatism up to 4.00 dioptersthat does not interfere with visualacuity. The contact lenses areindicated to correct astigmatismof up to 6.00 diopters, and bifocallenses are indicated to treatpresbyopia up to +4.00 D addpower. The lenses are alsoindicated for management ofirregular corneal conditions suchas keratoconus, pellucid marginaldegeneration, or followingpenetrating keratoplasty, radialkeratotomy, or LASIK surgery inotherwise non-diseased eyes.	Indicated for daily wear for thecorrection of visual acuity inaphakic and not aphakic personswith non-diseased eyes withmyopia or hyperopia and/orpresbyopia. The lens may also beprescribed for management ofirregular corneal conditions such askeratoconus and post graft fitting.
Production Method	Lathe-Cut, custommanufactured	Lathe-Cut, custommanufactured	Lathe-Cut, custommanufactured
USAN name	paflufocon A, B, C, D	paflufocon A, B, C, D	roflufocon C, D, E
Water Content (%)	<1%	<1%	<1%
Wettability(sessile dropadvancing contactangle)	Paflufocon A: 10.5°Paflufocon B: 10.3°Paflufocon C: 10.2°Paflufocon D: 11.3°	Paflufocon A: 56.4°Paflufocon B: 59.4°Paflufocon C: 53.6°Paflufocon D: 58.8°
Includes Hydra-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.

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.