Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens

K142275 · Neo Vision Co., Ltd. · LPL · Oct 7, 2014 · Ophthalmic

Device Facts

• Record ID: K142275
• Device Name: Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens
• Applicant: Neo Vision Co., Ltd.
• Product Code: LPL · Ophthalmic
• Decision Date: Oct 7, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The Neo Cosmo (Polymacon) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or colored and may be used to enhance or alter the apparent color of the eye. Eye care practitioners may prescribe the lens frequent replacement wear with cleaning, disinfecting and schedule replacement. The lens may be disinfected using a chemical (not heat) lens care system only.

Device Story

Neo Cosmo is a hemispherical, flexible, hydrophilic contact lens made of polymacon (HEMA cross-linked with ethyleneglycol dimethacrylate). It covers the cornea and adjacent sclera to correct visual acuity in patients with myopia or hyperopia. The lens is available in clear or colored versions, utilizing FDA-approved color additives (e.g., titanium dioxide, iron oxides). It is prescribed by eye care practitioners for daily wear with a frequent replacement schedule. Patients must use chemical (non-heat) disinfection systems. The device functions as a refractive optical element; it does not involve electronic processing or clinical decision-making software. It provides vision correction and cosmetic enhancement.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including tensile testing, solution compatibility, physical property evaluation, and biocompatibility testing (ocular irritation, skin sensitization, and cytotoxicity).

Technological Characteristics

Material: Polymacon (HEMA 99.3%, ethyleneglycol dimethacrylate 0.7%). Water content: 38%. Refractive index: 1.428. Oxygen permeability: 9.77 x 10^-11 (cm2/s)(ml O2/ml x mmHg) at 35°C. Manufacturing: Lathe-cut (semi-molded). Sterilization: Steam validated autoclave. Packaging: Blister or vial with NaCl solution.

Indications for Use

Indicated for daily wear for correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia; includes patients with refractive astigmatism of 0.50 diopters or less.

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

• Migwang Comfort 38 (K051477)

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

October 7. 2014

Neo Vision Co., Ltd. % Albert Rego Ph.D. Regulatory Consultant Albert Rego, Ph.D., Inc. 27001 La Paz Road, Suite 312 Mission Viejo, CA 92691

Re: K142275

Trade/Device Name: Neo Cosmo (polymacon) Soft (hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: July 31, 2014 Received: August 15, 2014

Dear Dr. Rego:

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 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

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Page 2 -

(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 (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 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 Y. Alexander -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

Enclosure

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## Indications for Use

510(k) Number (if known) K142275

#### Device Name

Neo Cosmo (polymacon) Soft (hydrophilic) Contact Lens

#### Indications for Use (Describe)

The Neo Cosmo (Polymacon) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and non-aphakic persons with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or colored and may be used to enhance or alter the apparent color of the eye. Eye care practitioners may prescribe the lens frequent repacement wear with cleaning, disinfecting and schedule replacement. The lens may be disinfected using a chemical (not heat) lens care system only.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| <span style="unicode-bidi:embed;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="unicode-bidi:embed;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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#### 510(k) SUMMARY

(As required by 21 CFR 807)

| SUBMITTED BY | Neo Vision Co., Ltd.<br>17th Floor, U-Tower, 1029 Yeongdeok-<br>Dong, Giheung-gu, Yongin-si<br>Gyeonggi-do<br>Korea |
|---------------------|---------------------------------------------------------------------------------------------------------------------|
| CONTACT | Kyung Hwa Kim 82-31-889-2040<br>[e-mail] |
| SUBMISSION DATE | April 7, 2014 |
| TRADE NAME | Neo Cosmo (Polymacon) Soft (Hydrophilic<br>Contact Lens - Neo Cosmo |
| COMMON NAME | Lenses, Soft Contact, Daily Wear |
| CLASSIFICATION NAME | Class II (21 CFR 886.5925) |
| PRODUCT CODE | LPL |
| PREDICATE DEVICE | K051477 Migwang<br>Comfort 38<br>Decision Date: 03/10/2006 |

### DEVICE DESCRIPTION

Neo Vision Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens for Daily Wear is available as a single vision lens. The lens material, polymacon is hydrophilic polymer of 2-hydroximethyl methacrylate (HEMA) cross-linked with ethyleneglycol dimethacrylate(62%) and water(38%).

Neo Vision Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens for Daily Wear is colored with one or a combination of one or more of the following color additives: Titanium dioxide (white), C.I Pigment blue 36, Iron oxides, C.I. Pigment green 7, C.I. Pigment violet 23, D&C Yellow No.10.

Neo Vision Neo Cosmo is a hemispherical flexible shell which covers the cornea and a portion of the adjacent sclera with the following dimensions:

- Diameter: 13.8mm to 14.5mm
- Base Curve: 8.0mm to 9.0mm ●
- Center Thickness: 0.05mm to 0.135 (varies with power) ●
- Powers: 0.00D to -10.00D ●

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The physical properties of the lens are:

- I Refractive Index: 1.43
- I Light Transmittance: >95% .
- I Water Contents: 38% .
- I Oxygen Permeability: 9.5 X 10-11(cm2/s) [ml X mmHg) at 35°C .

Neo Vision Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact lens consists of:

| No. | Part<br>Name | Raw Material | Composition<br>(%) | Remark | Function |
|-----|-------------------|-----------------------------------|--------------------|------------------|------------------|
| 1 | Base | 2-hydroxyethylmethacrylate | 99.3 | CAS No. 868-77-9 | Main<br>Element |
| | | Ethylene glycol<br>dimethacrylate | 0.7 | CAS No. 97-90-5 | Cross-<br>linker |
| 2 | Color<br>Additive | Titanium dioxide (white) | $\leq$ 0.04 | CFR No. 73.3126 | Color |
| | | Iron oxides | | CFR No. 73.3125 | Color |
| | | C.I. Pigment violet -23 | | CFR No. 73.3107 | Color |
| | | D & C Yellow No. 10 | | CFR No. 73.3110a | Color |
| | | C.I. Pigment green -7 | | CFR No. 73.3124 | Color |

Neo Vision Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact lens is packaged in either in a vial package or a blister package.

The vial package is a 5mL Borosilicate glass vial filled with NaCI 0.85 ~0.95 w/v% solution. The cap is aluminum with a locking rubber (Chlorobutyl rubber for medical use).

The blister package consists of 3mL Polypropylene filled with NaCI 0.85 ~0.95 w/v% solution with an aluminum sealing film sheet.

### INDICATIONS FOR USE

The Neo Cosmo (Polymacon) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or colored and may be used to enhance or alter the apparent color of the eye. Eye care practitioners may prescribe the lens frequent replacement wear with cleaning, disinfecting and schedule replacement. The lens may be disinfected using a chemical (not heat) lens care system only.

# SUMMARY OF SUBSTANTIAL EQUIVALENCE

This device is substantially equivalent to the predicate devices in its intended use and technological characteristics, manufacturing process specified in following table;

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| Substantial Equivalency | Soft (hydrophilic) contact lens | | |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Manufacture | MiGwang Contact Lens Co., Ltd. | Neo Vision | |
| Article name | Migwang Comfort 38 | Neo Cosmo | |
| Material<br>USAN name | Polymacon | Polymacon | |
| Type | Spherical, Toric | Spherical, Toric | |
| FDA Classification | Lenses, Soft Contact, Daily Wear<br>(Class II) | Lenses, Soft Contact, Daily<br>Wear (Class II) | |
| Water Content | 38±2% | 38±2% | |
| Light Transmittance | >90% | >90% | |
| Index of Refraction | 1.43 | 1.428 | |
| Oxygen permeability | 9.77 * 10-11 (cm²/sec)(ml O2/ml *<br>mm Hg @ 35℃) | 9.77 * 10-11 (cm²/sec)(ml<br>02/ml * mm Hq @ 35℃) | |
| Manufacturing Method | Lathe-cut<br>(semi molded) | Lathe-cut<br>(semi molded) | |
| Sterilization | Steam Validated Autoclave | Steam Validated Autoclave | |
| Packaging | Blister Pack & vial | Blister Pack & vial | |
| Visibility tint | Titanium Dioxide;<br>21CFR 73.3126 | Titanium Dioxide(White);<br>21CFR 73.3126 | |
| Visibility tint | Iron Oxides;<br>21CFR 73.3125 | Iron Oxides(Red);<br>21CFR 73.3125 | |
| Visibility tint | C.I Pigment Green 7;<br>21CFR 73.3124 | C.I Pigment Green 7;<br>21CFR 73.3124 | |
| Visibility tint | (Phthalocyaninato(2-)) Copper;<br>21CFR 74.3045 | (Phthalocyaninato(2-))<br>Copper;<br>21CFR 74.3045 | |
| Visibility tint | C.I. Reactive Black 5<br>21CFR 73.3121 | Reactive Black 5<br>21CFR 73.3121 | |
| Tint Process | Entrapment | Entrapment | |
| Indication | Soft Contact Lenses for daily<br>wear are indicated for the<br>correction of visual in aphakic and Contact Lens is indicated for<br>non-aphakic persons with non-<br>diseased eyes with myopia or<br>hyperopia and/or possesses<br>refractive astigmatism not<br>exceeding 5.00 diopter, and/or<br>are presbyopia.<br>NOTE: Refractive astigmatism<br>and presbyopia N/A for spherical | The Neo Vision Neo Cosmo<br>(Polymacon) Soft (hydrophilic)<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 | |
| | lenses. | does not interfere with visual | |
| | | acuity. | |
| | | The lens is available clear or<br>colored and may be sued to<br>enhance or alter the apparent<br>color of the eye. | |
| | | Eye care practitioners may<br>prescribe the lens frequent<br>replacement wear with<br>cleaning, disinfecting and<br>schedule replacement. not<br>exceeding 5.00 diopter,<br>and/or are presbyopia. | |
| Powers | +25.00 ~ -25.00 Diopter | +25.00 ~ -25.00 Diopter | |
| Total diameter | 12.8 ~ 14.8 | 13.5 ~ 14.5 | |
| Geometrical center<br>thickness | 0.03 ~ 0.30 | 0.03 ~ 0.50 | |
| Curvature | 8.0 ~ 9.5 | 8.3 ~ 9.0 | |
| Optic zone | 6.0 ~ 12.5 | 6.0 ~ 12.5 | |
| Radial edge thickness | 0.03 ~ 0.12 | 0.03 ~ 0.05 | |
| Color | brown, gray, aqua, blue, violet,<br>green | brown, gray, aqua, blue | |
| Toxicity(Safety) | Non-Toxic | Non-Toxic | |
| Tensile Strength (MPa) | 0.427 | 0.425 | |
| % Elongation to Break | 128% | 127% | |
| Module of Elasticity<br>(MPa) | 0.338 | 0.350 | |
| Breaking Force (N) | 0.449 | 0.439 | |

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## SUMMARY NON-CLINICAL TESTING

The Neo Vision Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens has been subjected to property evaluation, moist heat (steam) sterilization evaluation and biocompatibility evaluation, and has successfully passed all testing.

### PERFORMANCE TESTING

| TEST TITLE | FINAL REPORT<br>NUMBER | TEST<br>RESULT |
|----------------------------------------------------|------------------------------------------------------------|----------------|
| Tensile Testing | TP-001/TR-001 | Pass |
| Solution Compatibility (Cleaning Cycle<br>Testing) | Protocol per FDA<br>Guidance – Attached/<br>Report 13-0400 | Pass |
| Physical Properties of the Neo Cosmo | MTK-6310 | Pass |
| Physical Properties of the Neo Vision Neo<br>Cosmo | MSK-1241 | Pass |
| Physical Properties of the NEO Toric | MSK-1242 | Pass |

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| Physical Properties of the NEXT | MSK-1243 | Pass |
|--------------------------------------|----------|------|
| Physical Properties of the NEW GREEN | MSK-1244 | Pass |
| Physical Properties of the NEO CLEAN | MSK-1245 | Pass |

#### BIOCOMPATIBILITY TESTING

| TEST TITLE | FINAL REPORT<br>NUMBER | TEST<br>RESULT |
|---------------------------------------------------------------------------------------------------------|---------------------------|----------------|
| Ocular Irritation Test | MTK-6310 | Pass |
| Skin Sensitization Test | MTK-6310 | Pass |
| Cytotoxicity Test<br>(Proliferation Inhabition Test) | MTK-6310 | Pass |
| Cytotoxicity Test<br>(Agar Diffusion Test) | MTK-6310 | Pass |
| Ocular Irritation Study of Neo Cosmo Soft<br>Contact Lens in NZW Rabbits | TBH-0375<br>(KG-2013-121) | Pass |
| Skin Sensitization Study of Neo Cosmo soft<br>contact lens using Guinea-Pig Maximization<br>Test (GPMT) | TBH-0376<br>(KG-2013-122) | Pass |

## SUMMARY CLINICAL TESTING

The Neo Vision Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens was not evaluated with clinical testing.

# CONCLUSION

Based on analyzing the device characteristics, bench performance and sterilization testing, and biocompatibility testing, it is the conclusion of Neo Vision Co., Ltd., that the Neo Vision Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact lens is safe and effective for its intended use.