ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color)

K161098 · Joowon Innovation Co., Ltd. · LPL · Aug 22, 2016 · Ophthalmic

Device Facts

• Record ID: K161098
• Device Name: ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color)
• Applicant: Joowon Innovation Co., Ltd.
• Product Code: LPL · Ophthalmic
• Decision Date: Aug 22, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The ChicView (polymacon) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye. Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients. Frequent/Planned Replacement Wear: Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system. Disposable Wear: Eyecare practitioners may prescribe any of the above lenses for Daily Disposable Wear. When Prescribed for Daily Disposable Wear the lenses are not to be used with disinfecting systems as they are to be discarded after a single use.

Device Story

ChicView soft contact lenses are hemispherical polymacon shells; molded spherical base curves and front surfaces. Material: 62% polymacon, 38% water. Available clear or tinted (gray, green, violet, brown, blue, black) using FDA-listed color additives entrapped within lens layers. Function: refractive medium focusing light on retina; covers cornea and extends beyond limbus. Used by patients for vision correction; prescribed by eyecare practitioners. Replacement schedules: frequent/planned (with cleaning/disinfection) or daily disposable (discard after single use). Benefits: vision correction and cosmetic eye color alteration.

Clinical Evidence

No clinical data. Safety and effectiveness established via non-clinical bench testing, including in vitro and in vivo toxicology, biocompatibility, microbiology, chemistry, and shelf-life stability studies conducted under GLP.

Technological Characteristics

Material: polymacon (2-HEMA cross-linked with EGDMA). Water content: 38±2%. Oxygen permeability: 11.15 x 10^-11 (cm²/sec)(mlO₂)/(ml x mmHg @ 35°C). Refractive index: 1.435. Specific gravity: 1.17. Dimensions: 12.00-15.50 mm diameter, 0.07-0.13 mm center thickness, 7.0-9.0 mm base curve. Power range: -20.00D to +20.00D. Sterilization: sterile saline solution in blister packs.

Indications for Use

Indicated for daily wear correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia; includes patients with refractive astigmatism ≤ 0.75 diopters.

Regulatory Classification

Identification

A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.

Predicate Devices

• Comfort 38 (K051477)
• Neo Cosmo (K142275)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 22, 2016

Joowon Innovation Co., Ltd. % Mr. Bret Andre Consultant/ Official Correspondent EyeReg Consulting, Inc. 6119 Canter Ln West Linn, OR 97068

Re: K161098

Trade/Device Name: ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hvdrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: July 7, 2016 Received: July 11, 2016

Dear Mr. 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.

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

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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.

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 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 at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

Kesia Alexander

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

Enclosure

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## Indications for Use

510(k) Number (if known) K161098

#### Device Name

ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color)

#### Indications for Use (Describe)

The Chic View (polymacon) Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.

Frequent/Planned Replacement Wear:

Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

Disposable Wear:

Eyecare practitioners may prescribe any of the above lenses for Daily Disposable Wear. When Prescribed for Daily Disposable Wear the lenses are not to be used with disinfecting systems as they are to be discarded after a single use.

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

| <span></span> | Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|----------------------------------------------|
| <span></span> | Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 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: | K161098 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------|
| Applicant information: | |
| Date Prepared: | April 6th, 2016 |
| Name: | Joowon Innovation Co., Ltd.<br>44, Sureteo 1-gil, Cheonan-si, Seobuk-gu<br>Chung Cheong Nam-do<br>South Korea |
| Contact Person: | Lee Hae-Hang<br>President |
| Phone number: | [phone] |
| Consultant: | Bret J Andre<br>EyeReg Consulting, Inc.<br>6119 Canter Ln<br>West Linn, OR 97068<br>United States |
| Phone number: | [phone] |
| Device Information: | |
| Device Classification: | Class II |
| Product Code: | LPL; MVN |
| Classification Name: | Soft (hydrophilic) Contact Lens (21 CFR 886.5925) |
| Trade Name: | ChicView (polymacon) Daily Wear Soft (hydrophilic)<br>Contact Lenses (Tinted/Color) |

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## Predicate Devices:

ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color) are substantially equivalent to the following predicate devices:

- "Comfort 38" . By Migwang Contact Lens Co., Ltd. 510(k) number; K051477
- . "Neo Cosmo" By Neo Vision Co., Ltd. 510(k) number: K142275

### Device Description:

The ChicView soft contact lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The ChicView soft contact lenses are fabricated from polymacon, which has been adopted by the United States Adopted Names Council (USAN). The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The nonionic lens material. (polymacon) is a hydrophilic polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 62% polymacon and 38% water by weight when immersed in saline solution.

ChicView lenses are available clear, tinted for visibility/handling, and tinted to enhance or alter the apparent color of the eye. Tinted or color lens designs may be distributed under unique or "private label" trade names. ChicView lenses are available in gray, green, violet, brown, blue or blackwhich are tinted with one or a combination of one or more of the following "listed" color additives:

| Name of Colorant | Listing |
|-----------------------|------------------|
| D&C Yellow 10 | 21 CFR § 74.3710 |
| Titanium Dioxide | 21 CFR § 73.3126 |
| Iron Oxide (Red) | 21 CFR § 73.3125 |
| D&C Green No. 6 | 21 CFR § 74.3206 |
| Reactive Blue 19 | 21 CFR § 73.3127 |
| C.I. Reactive black 5 | 21 CFR § 73.3127 |

Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives, and contain only the amount of color additive needed to accomplish the intended coloring effect. When producing the tinted or color lenses, the manufacturing process alters and/or changes the specifications to the clear version of a contact lens by entrapment of the listed color additives in the center of the contact lens (surrounded by layers of contact lens material) in a location that corresponds to the iris. The color additives used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens. The color lens tinting pattern has a minimum Clear Pupil diameter of 6.0 mm.

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a transparent or colored optical surface. The (polymacon) soft

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hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped; it will return to its proper configuration when completely rehydrated in the proper storage solution.

The physical properties of the lens are:

| Refractive Index | 1.435 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Light Transmission (clear) | greater than 98% |
| Light Transmission (tinted/color) | greater than 98% (at clear region corresponding to pupil, minimum 6.0 mm diameter);<br>Opaque or 0-10% (at tinted region corresponding to iris) |
| Surface Character | hydrophilic |
| Water Content | 38±2% |
| Specific Gravity | 1.17 (hydrated) |
| Oxygen Permeability | 11.15 x 10-11 (cm²/sec)(mlO₂)/(ml x mmHg @ 35°C)) (revised Fatt method) |

The hydrophilic characteristics allow aqueous solution to enter the lens, and in its fully hydrated state the lens is approximately 38% water by weight. The lenses will be manufactured in the spherical configuration with the following features and properties:

| Chord Diameter: | 12.00 mm to 15.50 mm |
|-------------------|-----------------------------------|
| Center Thickness: | 0.07 mm to 0.13 mm |
| Base Curve: | 7.0 mm to 9.0 mm |
| Power Range | -20.00D to +20.00D in 0.25D steps |

ChicView lenses are supplied sterile in saline solution containing blister packages with a base made from polypropylene and a laminated foil seal on top. Blister package labeling is printed with the appropriate lot numbering, expiration dating, and lens parameter identification. Expiration dating has been established based on studies of product stability, package integrity, and validation of the sterilization process.

## Intended Use:

The ChicView (polymacon) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.

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#### Frequent/Planned Replacement Wear:

Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

### Disposable Wear:

Eyecare practitioners may prescribe any of the above lenses for Daily Disposable Wear. When Prescribed for Daily Disposable Wear the lenses are not to be used with disinfecting systems as they are to be discarded after a single use.

### 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 ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses. 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 ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses demonstrate that: ● Lenses supplied in blister packages are sterile for the indicated shelflife, The packaging material and extracts are not toxic and not irritating, ● and

- Lens physical and material properties are consistent with currently marketed lenses.
Clinical Data The clinical performance of the (polymacon) lens material has been previously established, and therefore was not required for this 510(k).

#### Conclusions Drawn from Studies

#### Validity of Scientific Data

Several laboratories under Good Laboratory Practice regulations conducted toxicology studies, microbiology, chemistry, shelf-life stability studies and followed 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 ChicView. (polymacon) Soft Contact Lenses for Daily Wear is as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the requested indication.

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#### Risks and Benefits

The risks of the subject device are the same as those normally attributed to the wearing of daily wear soft contact lenses. The benefits to the patient are the same as those for other daily wear soft contact lenses.

#### Substantial Equivalence:

The ChicView Soft Contact Lens will be manufactured according to specified process controls and a cGMP quality assurance program currently in place. The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the ChicView contact lens material is equivalent to the predicate devices identified previously. Being similar with respect to indications for use, materials, physical construction and safety & effectiveness to the predicate devices, this meets the requirements per section 510(k) of the act regarding substantial equivalence and does not raise different questions of safety and effectiveness than the predicate device identified above.

The following matrix illustrates the equivalencies of the ChicView Soft (hydrophilic) Contact Lens, as well as the substantial equivalent predicate devices.

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## Substantial Equivalence Matrix

| | Joowon Innovation Co., Ltd.<br>“ChicView”<br>(polymacon)<br>New Device | Migwang Co., Ltd.<br>“Comfort 38”<br>(polymacon)<br>Predicate Device | Neo Vision Co., Ltd.<br>“Neo Cosmo”<br>(polymacon)<br>Predicate Device |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | 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 possesses refractive<br>astigmatism not exceeding 0.75<br>diopters. The lens is available clear or<br>colored and may be used to<br>enhance or alter the apparent<br>color of the eye. | Indicated for daily wear for the<br>correction of visual acuity in aphakic and<br>not aphakic persons with non-diseased<br>eyes with myopia or hyperopia and/or<br>possesses refractive astigmatism not<br>exceeding 4.00 diopters. NOTE:<br>refractive astigmatism N/A for spherical<br>lenses. The lens is available clear or<br>colored and may be used to<br>enhance or alter the apparent<br>color of the eye. | Indicated for<br>daily wear for the correction of<br>visual acuity in aphakic and<br>non-aphakic persons with<br>non-diseased eyes with<br>myopia or hyperopia. The<br>lens may be worn by persons<br>who exhibit refractive<br>astigmatism of 0.50 diopters<br>or less where the astigmatism<br>does not interfere with visual acuity.<br>The lens is available clear or<br>colored and may be used to<br>enhance or alter the apparent<br>color of the eye. |
| Functionality | Same as predicate device | The contact lenses act as a refractive<br>medium that focus light rays from near<br>and distant objects on the retina | The contact lenses act as a refractive<br>medium that focus light rays from near and<br>distant objects on the retina |
| Classification | Daily Wear, Soft (hydrophilic)<br>Contact Lens (Class II) | Daily Wear, Soft (hydrophilic)<br>Contact Lens (Class II) | Daily Wear, Soft (hydrophilic)<br>Contact Lens (Class II) |
| Production<br>Method | Fully-molded | Fully-molded | Fully-molded |
| USAN name | polymacon | polymacon | polymacon |
| Water Content<br>(%) | 38±2% | 38±2% | 38±2% |
| Oxygen<br>Permeability | 11.15 x $10^{-11}$ (cm²/sec)(mlO₂)/(ml<br>x mmHg @ 35°C)) (revised Fatt<br>method) | 9.89 x $10^{-11}$ (cm²/sec)(mlO₂)/(ml x<br>mmHg @ 35°C)) (revised Fatt method) | 9.77 x $10^{-11}$ (cm²/sec)(mlO₂)/(ml x<br>mmHg @ 35°C)) (revised Fatt method) |
| Specific Gravity | 1.17 (hydrated) | 1.18 (hydrated) | - |