I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2

K033136 · Innova Vision, Inc. · LPL · Mar 5, 2004 · Ophthalmic

Device Facts

• Record ID: K033136
• Device Name: I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2
• Applicant: Innova Vision, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Mar 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SuperView (polymacon) soft (hydrophilic) contact lens for daily wear is indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are myopia (nearsighted) and may exhibits 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. The contact lens may be disinfected using heat (not chemical), hydrogen peroxide, or chemical (not heat) disinfection system.

Device Story

SuperView is a soft hydrophilic contact lens made of polymacon (HEMA crosslinked with EGDMA). It features a 38.5% water content and a blue visibility tint (Reactive blue 19). Produced via spin-casting to create a non-spherical flexible surface, the lens covers the cornea to correct refractive errors. Lenses are supplied sterile in blister packs with phosphate-buffered saline. Used by patients for daily wear, the lens is prescribed by eye care practitioners who determine the replacement schedule and appropriate cleaning/disinfection regimen (heat, hydrogen peroxide, or chemical). The device improves patient vision by compensating for myopia and astigmatism.

Clinical Evidence

Clinical study conducted on 60 human eyes over 6 months. Primary endpoints included vision correction efficacy and patient satisfaction. Results showed nearly 100% vision correction and high patient satisfaction. No severe complications reported. Additional evidence includes historical usage data from international markets (Taiwan, China, Japan, Europe) showing stable performance.

Technological Characteristics

Material: Polymacon (HEMA crosslinked with EGDMA). Water content: 38.5%. Refractive index: 1.437. Light transmittance: >93%. Oxygen permeability: 8.6x10^-11 (cm²/sec)(ml O2/ml-mmHg) @ 35°C. Diameter: 13.7-14.1 mm. Power: Plano to -12.00D. Sterilization: Steam autoclave (SAL 10^-6).

Indications for Use

Indicated for correction of visual acuity in non-aphakic, non-diseased eyes with myopia and refractive astigmatism up to 2.00 diopters. For daily wear, frequent replacement, and prescribed by eye care practitioners.

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

• Optima FW™ (polymacon) Visibility Tinted Contact Lenses (NDA number N16895/S087)
• SeeQuence (polymacon) Contact Lens for Daily Wear

Submission Summary (Full Text)

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# Ko33136

### 510 (K) Summary

## SUMMARY OF SAFETY AND EFFECTIVENESS

#### FOR

SuperView (polymacon) 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. James Chang |
| | General manager |
| Phone: | 886-3-592-7299 |
| FAX: | 886-3-592-6213 |
| E-Mail: | [e-mail] |
| Date Prepared | 10 Sep, 2003 |
| Identification of Device: | |

#### Classification Name: Soft hydrophilic contact lens, per 21 CFR. 886,5925 Trade Name: SuperView (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear Common or usual Soft Contact lens Name: FDA Classification: Class II

#### Predicated Device:

Optima FW™ (polymacon) Visibility Tinted Contact Lenses (NDA number N16895/S087) & SeeQuence (polymacon) Contact Lens for Daily Wear made from Bausch & Lomb Inc.

#### Indications for Use:

SuperView (polymacon) soft (hydrophilic) contact lens for daily wear is indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are myopia (nearsighted) and may exhibits | 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. The contact lens may be disinfected using heat (not chemical), hydrogen peroxide, or chemical (not heat) disinfection system.

#### Description of Device:

SuperView (polymacon) soft (hydrophilic) contact lens for daily wear with water content (38.5%) when immersed in a sterile saline solution. lt

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consists of a polymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with Ethylene Glycol Dimethacrylate (EGDMA) served as crosslinker. The lenses are produced by spin-casting method to form non-spherical flexible surface, which covers the cornea. The SuperView Contact lens with visible tint is tinted blue using C.) Reactive blue 19 to make the lens more visible for handling. Lenses are supplied sterile in sealed blister PP cup containing isotonic phosphate buffered saline solution. The compatibility and package integrity of the blister cup packaging system has been demonstrated and successfully used for other marketed lens products, and packaged lenses are effectively steam sterilized in a validated autoclave.

#### Summary of Clinical Study:

The SuperView lenses were test in 60 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. The ophthalmologists concludes, based on the specified clinical protocol, that the achieved report demonstrates the SuperView Lenses are safe and effective means of daily wear vision correction and make sure they are a good fit for the human eyes.

Furthermore, SuperView lenses have been wide-used around the world, including Taiwan, China, Europe, Japan, etc. Among the users being daily worn the Super\/iew lenses, all the procedure was in generally stable condition without severe complication to be observed.

#### Nonclinical Studies:

A series of non-clinical performance tests were performed to demonstrate the safety and effectiveness of the SuperView Soft Contact lens, and establish substantial equivalence to currently marketed predicate lenses-Optima FW™ (polymacon) Visibility Tinted Contact Lenses (NDA number N16895/S087) & SeeQuence (polymacon) Contact Lens for Daily Wear made from Bausch & Lomb Inc. The evidence of substantial equivalent to the predicate lens described as follow:

- a) Technological characteristics studies
SuperView lenses designs in the following parameter ranges:

Diameter range; 13.7 to 14.1 mm

Power range: Plano to -12.00D

Center thickness: varies with power (0.08 to 0.12 mm for -3.00D) Lenses have the following properties:

REV (B)

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Refractive index: 1.437 (hydrated) Light transmittance: >93% Water content: 38.5 % Oxygen permeability (edged corrected) : 8.6x 10-11 [(cm²/sec)(ml O3/ml-mmHg)] @ 35°C

These characteristics of SuperView Contact lenses are equivalent and comparable to that of predicate lenses.

- b) Biocompatibility
In accordance with the May 1994 Guidance Document for daily wear contact lenses, toxicity studies have been conducted on the model: SuperView Contact lens. The Irritation test in the rabbit eye and Systemic toxicity studies in the mouse indicate the extracts would be considered as non-toxic, nor irritated. The Cytotoxicity inspect demonstrates the lens is not cytotoxic under the conditions of the study.

- c) Microbiology
The lens sterilization process, steam sterilization, has been validated to deliver a minimum SAL of 10*, thereby meeting the requirement of FDA Group I. There is shelf-life stability data supporting that the lens remains sterile through the three years of 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.

#### Substantial equivalence Statement:

Testing performed on the SuperView (polymacon) soft (hydrophilic) contact lens for daily wear indicated that it can support the efficiency and safety use as well as the predicate devices- Optima FW™ (polymacon) Visibility Tinted Contact Lenses (NDA number N16895/S087) & SeeQuence (polymacon) Contact Lens for Daily Wear made from Bausch & Lomb Inc., when used in accordance with the instructions for use. It is due to the facts that both fall into the same FDA material classification grouping (Group 1), USAN name (Polymacon), intended use, and efficiency & safety. In conclusion, it is Innova's conviction that data submitted in this 510(k) to validate the claim of substantial equivalency, the SuperView soft contact lens with the same established safety profile and effectiveness as the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with flowing lines, representing the department's mission related to health and human welfare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 5 2004

INNOVA VISION, Inc. c/o Ms. Jennifer Reich 3892 South America West Trail Flagstaff, AZ 86001

Re: K033136

K033150
Trade/Device Name: SuperView (polymacon) 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: December 11, 2003 Received: January 29, 2004

Dear Ms. Reich:

Wc have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your Bection 910(x) production is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the encrosure) thanksett promoted in Medical Device Amendments, or to devices that probl to May 26, i 770, the onections and the provisions of the Federal Food, Drug, and Cosmetic have been reclassified in accordance with and proval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, market the device, subject to an as for annual registration, listing of devices, good controls provibitions of allabeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (600 a00 70) . Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation Fran may be subject to sam additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of I cannouncements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I that FDA has made a determination that your device complies with other requirements of the Act that I D7X has made a decembalized administered by other Federal agencies. You must comply or any I coclar statutes and regalaries and regulation and listing and listing - (21 CFR with an the Act 3 requirements) meets); good manufacturing practice requirements as set forth in I all 807), labeling (21 CFR Part 821), grFR Part 820); and if applicable, the elcctronic product the quality by home (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 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/dsma/dsmamain.html

Sincerely yours,

A Kalph Rosenthal

A. Ralph Rosenthal, 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

K033136 510(k) Number:

Device Name: SuperView (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear Innova Vision, Inc.

Indications for Use:

The SuperView (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is The Ouper visw (polyments)
indicated for the correction of visual acuity in not-aphakic persons with nonindouted for the corre myopia (nearsighted) and may exhibit . refractive discussu byou that are mypters that does not interfere with visual acuity.

The eye care practitioner may prescribe the contact lens for frequent replacement The Cyc ours practitions way |
wear, with cleaning, rinsing and disinfection and scheduled replacement. The weat, with cleaning, mising and and themical), hydrogen peroxide, or chemical (not heat) disinfection system.

Concurrence of CDRH, Office of Device Evaluation (ODE)

T. is G
(Division Sign Off)

(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devices

Ko33136 510(k) Number _

AND/OR Prescription Use (Per 21 CFR 801.109)

Over-The-Counter