CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS

K062541 · Innova Vision, Inc. · LPL · Jun 7, 2007 · Ophthalmic

Device Facts

• Record ID: K062541
• Device Name: CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
• Applicant: Innova Vision, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Jun 7, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens is indicated for daily wear the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic and may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity. The eye care practitioner may prescribe the contact lens for frequent replacement wear, with cleaning, rinsing and disinfection and scheduled replacement as prescribed by the eyecare professional. The contact lens may be disinfected using chemical (not heat) disinfection system.

Device Story

Calaview Colors are soft, hydrophilic contact lenses manufactured via spin-casting. Composed of Etafilcon A (HEMA and methacrylic acid copolymer cross-linked with TMPTMA and EGDMA). Lenses feature pigments in the non-optic area to mask or enhance iris color using FDA-approved additives (iron oxides, titanium dioxide, copper phthalocyanine, etc.). Supplied sterile in blister packs with isotonic phosphate buffered saline. Used by patients for daily wear to correct refractive errors; prescribed by eye care practitioners. Benefits include visual correction and cosmetic iris enhancement. Safety established through biocompatibility, leachability, and sterilization validation.

Clinical Evidence

Clinical study conducted on 65 human eyes over 6 months. Results showed nearly 100% vision correction and high patient satisfaction. No severe complications or significant side effects reported. Data supports safety and effectiveness for daily wear.

Technological Characteristics

Material: Etafilcon A (HEMA/MAA copolymer). Cross-linking agents: TMPTMA, EGDMA. Manufacturing: Spin-casting. Water content: 57-59%. Oxygen permeability: 24x10^-11 (cm2/sec)(ml O2/ml-mmHg). Sterilization: Steam. Pigments: Iron oxides, titanium dioxide, phthalocyaninato copper, phthalocyanine green, vat orange 1.

Indications for Use

Indicated for daily wear correction of visual acuity in non-aphakic, non-diseased eyes with myopia, hyperopia, or refractive astigmatism up to 2.00 diopters. For prescription use only.

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

• ACUVUE 2 colours Brand (Etafilcon A) Contact Lens (K010114)
• Discon (Etafilcon A) Soft (hydrophilic) Contact Lens (K051129)

Submission Summary (Full Text)

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K062541

# SUMMARY OF SAFETY AND EFFECTIVENESS FOR Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear

| | Submitter Information: | |
|-----------------|-----------------------------------------------------------------------------------------------|--------------|
| Company: | INNOVA VISION INC.<br>No. 231-1, Wen-Te Road, Chiung-lin Village,<br>Hsin-Chu County, Taiwan. | JUN - 7 2006 |
| Contact Person: | Mr. Michael w. Hsu,<br>Executive Vice President | |
| Phone: | 886-3-592-7299 | |
| FAX: | 886-3-592-6213 | |
| E-Mail: | [e-mail] | |
| Date Prepared | July. 25, 2006 | |

### ldentification of Device:

| Classification Name: | Soft hydrophilic contact lens, per 21 CFR. 886.5925 |
|-----------------------|---------------------------------------------------------------------------------|
| Trade Name: | Calaview Colors (Etafilcon A) Soft (hydrophilic)<br>Contact Lens for Daily Wear |
| Common or usual Name: | Soft (hydrophilic) Contact lens (daily wear) |
| FDA Classification: | Class II |

### Predicate Device:

| ACUVUE 2 colours Brand<br>(Etafilcon A) Contact Lens cleared<br>via K010114 Johnson & Johnson Co. USA. | Discon (Etafilcon A) Soft (hydrophilic)<br>Contact Lens for Daily Wear cleared<br>via K051129 from Innova Vision Inc., Taiwan. |
|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|

#### Indications for Use

Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens is indicated for daily wear the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic and may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity.

The eye care practitioner may prescribe the contact lens for frequent replacement wear, with cleaning, rinsing and disinfection and scheduled replacement as prescribed by the eyecare professional. The contact lens may be disinfected using chemical (not heat) disinfection system."

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### Description of Device

Calaview Colors Soft (hydrophilic) Contact Lens are available as non-spherical lenses manufactured by spin-casting method. The model illuminated with high water content (58 ± 1%). The hydrogel lens' material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo- polymerization. The Calaview Colors Contact lens contains pigments around the non-optic area that will mask or enhance the color of the natural iris without blocking the light transmittance. The lens is colored with one or more of the FDA-approval color additives: iron oxides, titanium dioxide, phthalocyaninato copper, phtalocyanine green, vat orange 1. The Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens is available in the following opaque colors: Blue, green, violet, gray, hazel, white, yellow, gold, orange red and black. Lenses are supplied sterile in sealed blister packers containing sterile isotonic phosphate buffered saline solution. The compatibility and package integrity of the blister pack packaging system has been demonstrated and successfully used for other marketed lens products:

### Summary of Clinical Study

The Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens were tested in 65 human eyes separately within 6 months. Nearly a hundred percent of the participants' vision was corrected and nearly all were satisfied with the lens wearing and care of lenses. In general, these products are good and safe for customers.

Calaview Colors lenses have been wide-used around the world, including Taiwan. China, Europe, etc. Among the users being daily worn the Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens, all the procedures were in generally stable condition without severe complication. There are no significant side effects and complaints to be observed.

#### Nonclinical Studies

A series of non-clinical performance tests were performed to demonstrate the safety and effectiveness of the Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens, and establish substantial equivalence to predicate lenses-Discon Lens (K051129); ACUVUE 2 colours Brand (Etafilcon A) Contact Lens (K010114). All testing was conducted in accordance with the May 1994 FDA guideline titled Premarket Notification 510(K) Guidance Document for Class IV Contact lenses, and in conformance to applicable device regulations. The evidence of substantial equivalent to the predicate lens described as follow:

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### a) Technological characteristics studies

There characterizations of Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens are equivalent and comparable to those of predicate lenses.

| Characteristic | Calaview Colors | Acuvue<br>Colors | Discon |
|-------------------------------------------------|-----------------------------------------------------|-------------------------------------------------------|-----------------------------------------------------|
| %Water content | 57 to 59 | 58 | 57 to 59 |
| Refractive index | 1.407 | 1.40 | 1.407 |
| Specific Gravity | 1.05 | 1.05 | 1.05 |
| Oxygen permeability (edged<br>corrected) @ 35°C | $24\times10^{-11}$<br>[(cm2/sec)(ml<br>O2/ml-mmHg)] | $22.4\times10^{-11}$<br>[(cm2/sec)(ml<br>O2/ml-mmHg)] | $24\times10^{-11}$<br>[(cm2/sec)(ml<br>O2/ml-mmHg)] |
| %Light Transmission | >93 | >85 | >93 |
| Base Curve Radius, mm | 8.00~9.00 | 7.85~10.00 | 8.00~9.00 |
| Diameter, mm | 13.8~14.2 | 12.0~15.0 | 13.8~14.2 |
| Center Thickness, mm | 0.08~0.20 | 0.06~1.00 | 0.08~0.20 |
| Power, Diopters | +6.0D~-20.0D | +20.0D~-20.0D | +6.0D~-20.0D |

### b) Biocompatibility

In accordance with the May 1994 Guidance Document for daily wear contact lenses, toxicity studies have been conducted on the model: Calaview Colors (Efafilcon A) Soft (hydrophilic) Contact Lens. The Irritation test in the rabbit eye and Systemic toxicity studies indicate the extracts would be considered as non-toxic and nor The Cytotoxicity testing demonstrates the lens is not cytotoxic under the irritated. conditions of the study.

#### c) Microbiology

Steam sterilization process has been validated to deliver a minimum SAL of 10°, thereby complying with the requirement of FDA Group IV. There is shelf-life stability data supporting that the lens remains sterile through the expiration date claimed for the product.

#### d) Leachability

Studies were conducted to determine the leachable materials from the finished lens. The results show that, at the levels of the detection reported, there are no leachable monomers and addictive residues.

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### Substantial equivalence Statement

Testing performed on the Calaview Colors Soft (hydrophilic) Contact Lens for Daily Wear indicated that it can support the efficiency and security use as well as the predicate devices-Discon (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear (K051129) & ACUVUE 2 colours Brand (Etafilcon A) Contact Lens (K010114), when used in accordance with the instructions for use. It is due to the facts that the risks and benefits of the subject device are the same as soft contact lenses for to the daily wear.

In conclusion, it is Innova's conviction that data submitted in this 510(k) to validate the claim of substantial equivalency, substantiates our ability to manufacture a soft contact lens, the Calaview Colors Soft (hydrophilic) Contact Lens, with the same established safety profile and effectiveness as the predicate device-- Discon (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear (K051129) & ACUVUE 2 colours Brand (Etafilcon A) Contact Lens (K010114).

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a series of human profiles, rendered in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Innova Vision, Inc. c/o Ms. Jennifer Reich Harvest Consulting Corp. 2904 N. Boldt Dr. Flagstaff AZ 86001

JUN - 7 2007

Re: K062541

Trade/Device Name: Calaview Colors (etafilcon A) Soft Hydrophilic Contact Lens for Daily Wear

Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: May 25, 2007 Received: May 30, 2007

Dear Ms. Reich:

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.

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

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M.B. Eichelman S.M.D

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 STATEMENT

510(k) Number:

Device Name: Calaview Colors Soft (hydrophilic) Contact Lens for Daily Wear

Indications for Use:

Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens is indicated for daily wear the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic and may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity.

The eye care practitioner may prescribe the contact lens for frequent replacement wear, with cleaning, rinsing and disinfection and scheduled replacement as prescribed by the eyecare professional. The contact lens may be disinfected using chemical (not heat) disinfection system."

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of Ophthalmic Ear, | |
| Nose and Throat Devices | |
| 510(k) Number | K062541 |

Prescription Use:
or Over the Counter Use