CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

K073060 · Innova Vision, Inc. · MVN · Nov 29, 2007 · Ophthalmic

Device Facts

• Record ID: K073060
• Device Name: CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
• Applicant: Innova Vision, Inc.
• Product Code: MVN · Ophthalmic
• Decision Date: Nov 29, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

Calaview (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. Eye care practitioners may prescribe the lenses for either single-use daily disposable wear or frequent/planned replacement wear with cleaning, rinsing , disinfection and scheduled replacement as prescribed by the eyecare professional.. When prescribed for .requent/planned replacement wear , The contact lens may be disinfected using chemical (not heat) disinfection system.

Device Story

Soft (hydrophilic) contact lens; manufactured via spin-casting; composed of Etafilcon A (HEMA and MAA copolymer cross-linked with TMPTMA and EGDMA). Features pigments in non-optic area for iris color enhancement/masking. Supplied sterile in blister packs with isotonic phosphate buffered saline. Prescribed by eye care practitioners for daily wear; single-use or frequent/planned replacement. Patient self-applies lens to eye to correct refractive errors. Benefits include improved visual acuity and cosmetic iris coloration.

Clinical Evidence

No new clinical data provided. Relies on clinical data previously submitted for predicate K062541. Non-clinical evidence includes biocompatibility (rabbit eye irritation, systemic toxicity, cytotoxicity), leachability studies showing no residues, and validated steam sterilization (SAL 10^-6).

Technological Characteristics

Material: Etafilcon A (HEMA/MAA copolymer); cross-linked with TMPTMA/EGDMA. Water content: 58%. Refractive index: 1.407. Oxygen permeability: 24x10^-11 (cm2/sec)(ml O2/ml-mmHg). Manufacturing: Spin-casting. Sterilization: Steam. Pigments: Iron oxides, titanium dioxide, phthalocyaninato copper, phtalocyanine green, vat orange 1.

Indications for Use

Indicated for daily wear correction of visual acuity in non-aphakic, non-diseased eyes; myopic or hyperopic patients with refractive astigmatism up to 2.00 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

• Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens (K062541)
• ACUVUE 2 colours Brand (Etafilcon A) Contact Lens (K010114)

Reference Devices

• Discon Lens (K051129)

Submission Summary (Full Text)

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**510 (K) Summary**

K073

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

### Submitter Information:

| Company: | INNOVA VISION INC. | |
|-----------------|--------------------------------------------------------------|--------------|
| | No. 231-1, Wen-Te Road, Chiung-lin Village, Hsin-Chu County, | |
| | Taiwan. | |
| Contact Person: | Mr. Michael w. Hsu, | |
| | Executive Vice President | |
| Phone: | 886-3-592-7299 | |
| FAX: | 886-3-592-6213 | |
| E-Mail: | [e-mail] | NOV 2 9 2007 |
| Date Prepared | July. 25, 2006 | |

### Identification of Device:

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

### Predicate Device:

Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear cleared via K062541 INNOVA VISION INC.

ACUVUE 2 colours Brand (Etafilcon A) Contact Lens cleared via K010114 Johnson & Johnson Co. USA.

### Indications for Use

Calaview (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.

Eye care practitioners may prescribe the lenses for either single-use daily disposable wear or frequent/planned replacement wear with cleaning, rinsing , disinfection and scheduled replacement as prescribed by the eyecare professional.. When prescribed for .requent/planned replacement wear , The contact lens may be disinfected using chemical (not heat) disinfection system.

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## Description of Device

Calaview (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is available as non-spherical lenses manufactured by spin-casting method. The model illuminated with high water content (58 %). 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 (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear 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 (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear 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.

## Summary of Clinical Study

This special 510(k) application describes a labeling modification to the predicate device --Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear cleared via K062541 INNOVA VISION INC. There is no change in lens material, the manufacturing process, nor the parameter and properties. therefore, the clinical data previously submitted in K062541 supports the clinical safety of the subject device.

## Nonclinical Studies

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.

This special 510(k) application describes a labeling modification to the predicate device --Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear cleared via K062541 INNOVA VISION INC.. There is no change in lens material, the manufacturing process, nor the parameter and properties. Therefore, the non-clinical data previously submitted in K062541 supports the clinical safety of the subject device. The non-clinical performance tests had been 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).The evidence of substantial equivalent to the predicate lens described as follow:

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- a) Technological characteristics studies
There characterizations of Calaview (Etafilcon A) Soft (hydrophilic) Contact Lens are equivalent and comparable to those of predicate lenses.

| Characteristic | Calaview | Acuvue 2 Colors |
|----------------------------------------------|-----------------------------------------------|-------------------------------------------------|
| %Water content | 57 to 59 | 58 |
| Refractive index | 1.407 | 1.40 |
| Specific Gravity | 1.05 | 1.05 |
| Oxygen permeability (edged corrected) @ 35°C | $24\times10^{-11}$ [(cm2/sec)(ml 02/ml-mmHg)] | $21.4\times10^{-11}$ [(cm2/sec)(ml 02/ml-mmHg)] |
| %Light Transmission | >93 | >85 |
| Base Curve Radius, mm | 8.00~9.00 | 7.85~10.00 |
| Diameter, mm | 13.8~14.2 | 12.0~15.0 |
| Center Thickness, mm | 0.08~0.12 | 0.06~1.00 |
| Power, Diopters | +6.0D~-12.0D | +20.0D~-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 (Etafilcon 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 irritated. The Cytotoxicity testing demonstrates the lens is not cytotoxic under the 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 Soft (hydrophilic) Contact Lens for Daily Wear indicated that it can support the safety and effectiveness as well as the predicate devices- Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear (K062541) & ACUVUE 2 colours Brand (Etafilcon A) Contact Lens (K010114), when used in accordance with the instructions for use.

Moreover , The Calaview (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear has identical lens material, manufacturing process, parameters and properties as the predicate device -- Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear cleared via K062541 INNOVA VISION INC..

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 Soft (hydrophilic) Contact Lens, with the same established safety profile and effectiveness as the predicate device-- Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear (K062541) & 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 features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

NOV 2 9 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Innova Vision Inc. c/o Jennifer Reich Harvest Consulting Corp. 2904 N. Boldt Drive Flaggstaff, AZ 86001

Re: K073060

Trade/Device Name: Calaview (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact lens Regulatory Class: II Product Code: MVN, LPL Dated: October 17, 2007 Received: October 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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#### Page 2 - Ms. Jennifer Reich

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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. Egleber, MD

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: _ _ K 073060

Device Name: Calaview (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear _

Indications for Use:

Calaview (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.

Eye care practitioners may prescribe the lenses for either single-use daily disposable wear or frequent/planned replacement wear with cleaning, rinsing , disinfection and scheduled replacement as prescribed by the eyecare professional.. When prescribed for frequent/planned replacement wear , The contact lens may be disinfected using chemical (not heat) disinfection system.

| Concurrence of CDRH, Office of Device Evaluation (ODE) | | | |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|----|----------------------------------------------------------------------------------------------------------------------------------------|
| Chandnamallika Ghosh | | | |
| (Division Sign-Off) | | | |
| Division of Ophthalmic Ear, | | | |
| Nose and Throat Devices | | | |
| 510(k) Number | K073060 | | |
| Prescription Use: | <div style="display:inline-block;"> <span> ☑ </span> </div> | or | Over the Counter Use <div style="display:inline-block;"> <span> ☐ </span> </div> |