ENFLU 18 (enflufocon A) Daily Wear Contact Lens

K171575 · Contamac, Ltd. · HQD · Oct 24, 2017 · Ophthalmic

Device Facts

• Record ID: K171575
• Device Name: ENFLU 18 (enflufocon A) Daily Wear Contact Lens
• Applicant: Contamac, Ltd.
• Product Code: HQD · Ophthalmic
• Decision Date: Oct 24, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2

Indications for Use

The ENFLU 18 (enflufocon A) SPHERICAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The ENFLU 18 (enflufocon A) TORIC Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with nondiseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters. The ENFLU 18 (enflufocon A) MULTIFOCAL/BIFOCAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters. The ENFLU 18 (enflufocon A) IRREGULAR CORNEA Daily Wear Contact Lens may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery. Eye care practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Device Story

ENFLU 18 is a lathe-cut, rigid gas permeable (RGP) contact lens made of siloxanyl fluoroitaconate copolymer (enflufocon A). Lenses are tinted for handling and optionally include a benzophenone UV-blocking monomer. Lenses may be optionally treated with Tangible Hydra-PEG, a covalently bonded polyethylene glycol (PEG) polymer layer (~30nm thick) to improve wettability. Lenses are prescribed by eye care practitioners for daily wear to correct refractive errors or manage irregular corneas. Patients clean and disinfect lenses using chemical (non-heat) systems. The device acts as a refractive medium, focusing light on the retina. Benefits include vision correction and management of corneal irregularities; risks are consistent with standard RGP lens use.

Clinical Evidence

No clinical data. Safety and effectiveness established via non-clinical testing, including GLP-compliant toxicology, biocompatibility, microbiology, and shelf-life stability studies. Physicochemical, mechanical, and optical properties were compared to predicates.

Technological Characteristics

Material: siloxanyl fluoroitaconate copolymer (enflufocon A). Manufacturing: lathe-cut. Surface: optional Tangible Hydra-PEG (PEG-based polymer). UV protection: optional benzophenone monomer. Oxygen permeability (Dk): 21.03-23.96 x 10^-11 (cm²/sec)(ml O2/ml x mmHg @ 35°C). Refractive index: 1.44. Specific gravity: 1.221. Sterilization: chemical disinfection (non-heat).

Indications for Use

Indicated for daily wear for correction of refractive error (myopia, hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. Also indicated for refractive astigmatism (up to 10.00D for toric, up to 4.00D for multifocal/bifocal), presbyopia (add power up to +4.00D), and management of irregular corneal conditions (keratoconus, pellucid marginal degeneration, post-penetrating keratoplasty, or post-refractive surgery).

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

• Boston ES (enflufocon A) Daily Wear Contact Lens (K943177)
• 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 shows 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.

October 24, 2017

CONTAMAC Ltd. % Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Ln West Linn, OR 97068

Re: K171575

Trade/Device Name: ENFLU 18 (enflufocon A) Daily Wear Contact Lens Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HOD Dated: September 11, 2017 Received: September 14, 2017

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.

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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue

Silver Spring, MD 20993 www.fda.qov

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

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

## Denise L. Hampton -S

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

Enclosure

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

## Indications for Use

510(k) Number (if known) K171575

Device Name

ENFLU 18 (enflufocon A) Daily Wear Contact Lens

Indications for Use (Describe)

The ENFLU 18 (enflufocon A) SPHERICAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia.

The ENFLU 18 (enflufocon A) TORIC Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters.

The ENFLU 18 (enflufocon A) MULTIFOCAL/BIFOCAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The ENFLU 18 (enflufocon A) IRREGULAR CORNEA Daily Wear Contact Lens may be prescribed in otherwise nondiseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.

Eye care practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

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

| <span style="font-size:100%;"><b></b></span> | <span style="font-size:100%;">Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|----------------------------------------------|-----------------------------------------------------------------------------------|
| <span style="font-size:100%;"><b></b></span> | <span style="font-size:100%;">Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

#### 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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

# 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.

| The assigned 510(k) number is: | K171575 |
|--------------------------------|--------------------------------------------------------------------------------|
| Applicant information: | |
| Date Prepared: | May 22nd, 2017 |
| Name: | Contamac Ltd. |
| Address | Carlton House<br>Shire Hill<br>Saffron Walden<br>Essex CB11 3AU |
| Contact Person: | Robert McGregor<br>Managing Director |
| Phone number: | 44-1799 542 000 |
| Consultant: | Bret Andre<br>EyeReg Consulting, Inc<br>6119 Canter Ln.<br>West Linn, OR 97068 |
| Phone number | [phone] |

## Device Information:

| Device Classification: | Class II |
|------------------------|------------------------------------------------------------------|
| Product Code: | HQD |
| Classification Name: | Daily Wear Rigid Gas Permeable Contact Lens<br>(21 CFR 886.5916) |
| Common Name: | Rigid Gas Permeable Contact Lens |
| Trade Name: | ENFLU 18 (enflufocon A) Daily Wear Contact Lens |

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

Purpose of 510(k) Submission: ~ New Device ~

## Predicate Devices:

The ENFLU 18 (enflufocon A) Daily Wear Contact Lenses are substantially equivalent to the following predicate devices:

"Boston ES (enflufocon A) Daily Wear Contact Lens" By Bausch & Lomb, Inc. 510(k) number; K943177 -primary predicate

"Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lenses" by Contamac Ltd. 510(k) number; K161100 -reference predicate

## Device Description:

The ENFLU 18 (enflufocon A) Daily Wear Contact Lens is manufactured from a machine latheable rigid gas permeable material composed of siloxanyl fluoroitaconate copolymer that is tinted for visibility and available with or without an ultraviolet (UV) light absorber.

In the ENFLU 18 (enflufocon A) Daily Wear Contact Lens with UV Blocker, a Benzophenone UV blocking monomer is used to block UV radiation. The UV blocking for ENFLU 18 averages > 98% in the UVB range of 280nm - 315nm and >83% in the UVA range of 316 - 380mm.

The ENFLU 18 (enflufocon A) Daily Wear Contact Lens incorporates a visibility tint to make the lens more visible for handling. The tinted lenses contain one or more of the following color additives: D&C Green No. 6, C.I. Solvent Yellow No. 18, D&C Violet No. 2 and D&C red No. 17.

The ENFLU 18 (enflufocon A) Daily Wear Contact Lens may be optionally treated to incorporate Tangible "M 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 (enflufocon A) is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses. The resulting layer is hydrophilic and approximately 30nm in thickness. The following table depicts the contact angle of the coated vs. uncoated ENFLU 18 (enflufocon A) Daily Wear Contact Lens:

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

| | ENFLU 18 - Enflufocon A | |
|------------------------------------------------------|-------------------------|-------------------------------|
| | Uncoated* | Tangible TM Hydra-PEG Coated* |
| Average Sessile Drop Contact Angle<br>(degrees) n=30 | 86.5 | 48.0 |
| Standard Deviation | 2.85 | 4.20 |
| % Standard Deviation | 3.30 | 8.75 |

*lenses were manufactured and soaked in borate buffered saline for 24 hours prior to contact angle measurement

The ENFLU 18 (enflufocon A) Daily Wear Contact Lens may be packaged and shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the ENFLU 18 (enflufocon A) Daily Wear Contact Lenses is the PolyVial Contact Lens Case. When shipped "wet", the ENFLU 18 (enflufocon A) Daily Wear Contact Lenses may be packaged and shipped in the Unique pH contact lens care system by Menicon Co., Ltd. The active ingredients in Unique pH solution are Edetate Disodium 0.01% and Polyquaternium 10.0011%.

The physical properties of the ENFLU 18 (enflufocon A) Daily Wear Contact Lens are as follows:

| | ENFLU 18 (enflufocon A) | ENFLU 18 (enflufocon A) with<br>Tangible HydraPEG |
|-----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Refractive Index (dry) | 1.4436 | 1.4432 |
| Light Transmission (@380-<br>780nm) | >90% | >90% |
| UVA Transmission (@316-<br>380nm) | <17% | <14% |
| UVB Transmission (@280-<br>315nm) | <2% | <1% |
| Specific Gravity (g/cm³) | 1.221 | 1.221 |
| Oxygen Permeability<br>(Dk)<br>ISO/FATT Method | $21.03 \times 10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @ 35 °C) | $23.96 \times 10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @ 35 °C) |
| Visitint lenses contain one or<br>more of the following color<br>additives conforming to:<br>21 CFR Part 73 & 74, Subpart D | D&C Green No. 6, C.I. Solvent Yellow<br>No. 18, D&C Violet No. 2 and D&C red<br>No. 17 | D&C Green No. 6, C.I. Solvent Yellow<br>No. 18, D&C Violet No. 2 and D&C red<br>No. 17 |

The ENFLU 18 (enflufocon A) Daily Wear Contact Lens is available in the Spherical, Toric, Multifocal/Bifocal, Irregular Cornea (Scleral) design configurations, within the following lens parameters:

- Chord Diameter: 7.0mm to 22.0mm ●
- Center Thickness: Varies
- Base Curve:

●

- Spherical Powers:
- -20.00 Diopters to +20.00 Diopters up to -10.00 Diopters

5.0mm to 8.0mm

- o Toric Powers: Add Powers: up to +4.00 Diopters ●

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

## Intended Use:

The ENFLU 18 (enflufocon A) SPHERICAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia.

The ENFLU 18 (enflufocon A) TORIC Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with nondiseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters.

The ENFLU 18 (enflufocon A) MULTIFOCAL/BIFOCAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The ENFLU 18 (enflufocon A) IRREGULAR CORNEA Daily Wear Contact Lens may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.

Eye care practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

## Testing:

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 the ENFLU 18 (enflufocon A) Daily Wear Contact Lens. 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 nonclinical testing on the ENFLU 18 (enflufocon A) Daily Wear Contact Lens demonstrate that:

- The finished lenses are not toxic and not irritating, ●
- The physicochemical, mechanical, and optical properties of the lenses are ● substantially equivalent to the predicate device.
- . Bioburden levels are below the acceptance criteria (<100 cfu/lens) initially (dry) and following 30 days of storage in Unique pH at ambient temperatures.
- . Physical parameters are stable following 30 days of storage in Menicon Unique pH at ambient temperatures,
- . The surface properties of the lens are stable following 24 days of accelerated aging in Menicon Unique pH.

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

Clinical Testing The clinical safety and effectiveness has been previously established for contact lenses manufactured from (enflufocon A) and contact lenses treated with Tangible 114 Hydra-PEG.

## Conclusions Drawn from Studies

## 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 ENFLU 18 (enflufocon A) Daily Wear Contact Lens is 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.

#### Substantial Equivalence:

Comparison to Predicate Device(s):

The ENFLU 18 (enflufocon A) Daily Wear Contact Lens is substantially equivalent to the Boston ES (enflufocon A) Daily Wear Contact Lens (cleared under K943177) in terms of the following:

- contact lens material (enflufocon A)
- production method: lathe cut manufacturing process
- functionality
- indications for use (sphere, toric, multifocal, irregular cornea) o

The ENFLU 18 (enflufocon A) Daily Wear Contact Lens is substantially equivalent to the Optimum GP with HPT (roflufocon C, D. and E) Daily Wear Contact Lens (cleared under K161100) in terms of the following:

- may optionally incorporate the Tangible™ Hydra-PEG surface coating ●
The following matrix illustrates the production method, lens function and material characteristics of the ENFLU 18 (enflufocon A) Daily Wear Contact Lens as well as the predicate devices.

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

# Substantial Equivalence Matrix

| | ENFLU 18<br>(enflufocon A)<br>New Device | Boston ES (enflufocon A)<br>Predicate Device | Optimum GP with HPT<br>(roflufocon C, D, E)<br>Predicate Device |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Indicated for daily wear for the<br>correction of visual acuity in aphakic<br>and not aphakic persons with non-<br>diseased eyes with myopia or<br>hyperopia and/or presbyopia. The<br>lens may also be prescribed for<br>management of irregular corneal<br>conditions such as keratoconus and<br>post graft fitting. | Indicated for daily wear for the<br>correction of visual acuity in<br>aphakic and not aphakic persons<br>with non-diseased eyes with myopia<br>or hyperopia and/or presbyopia.<br>The lens may also be prescribed for<br>management of irregular corneal<br>conditions such as keratoconus and<br>post graft fitting. | 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<br>as keratoconus and post graft<br>fitting. |
| Functionality | The contact lenses act as a<br>refractive medium that focus<br>light rays from near and<br>distant objects on the retina | The contact lenses act as a<br>refractive medium that focus<br>light rays from near and<br>distant objects on the retina | The contact lenses act as a<br>refractive medium that<br>focus light rays from near<br>and distant objects on the<br>retina |
| Indications | Daily Wear | Daily Wear | Daily Wear |
| Production Method | Lathe-Cut, custom<br>manufactured | Lathe-Cut, custom<br>manufactured | Lathe-Cut, custom<br>manufactured |
| USAN name | enflufocon A | enflufocon A | roflufocon C, D, E |
| Water Content (%) | <1% | <1% | <1% |
| Specific Gravity | 1.221 | 1.220 | Roflufocon C: 1.178<br>Roflufocon D: 1.166<br>Roflufocon E: 1.155 |
| Oxygen Permeability<br>(cm2/sec) (ml O2/ml x mm Hg @<br>35°C) | Uncoated: 21 x 10-11<br>Coated: 24 x 10-11 | 22 x 10-11 | Roflufocon C: 65x10-11<br>Roflufocon D: 100x10-11<br>Roflufocon E: 125x10-11 |
| Wettability<br>(sessile drop contact<br>angle) | Uncoated: 86.5°<br>Coated: 48.0° | 87.5° | Roflufocon C: 40.28°<br>Roflufocon D: 40.40°<br>Roflufocon E: 36.90°<br>(measured by captive bubble<br>advancing contact angle) |
| UV Absorber/Blocker<br>Available | Yes, Optional | Yes | Yes, Optional |
| Includes Hydra-PEG<br>Surface Coating | Yes, Optional | No | Yes |