IGEL 55UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IGEL 55 UV MULTIFOCAL (METHAFILCON A) SOFT

K020855 · Igel Vision Care Pte , Ltd. · LPL · Jun 4, 2002 · Ophthalmic

Device Facts

• Record ID: K020855
• Device Name: IGEL 55UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IGEL 55 UV MULTIFOCAL (METHAFILCON A) SOFT
• Applicant: Igel Vision Care Pte , Ltd.
• Product Code: LPL · Ophthalmic
• Decision Date: Jun 4, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The Igel 55 UV (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the corrective ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 Diopters that does not interfere with visual acuity. The Iqel 55 UV Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for the correction of presbyopia in myopic and hyperopic eyes in aphakic or not-aphakic persons with non-diseased eves who exhibit no more than 2.00 Diopters of astigmatism and can obtain satisfactory visual acuity, in a power range of +4.00 to -5.00 Diopters and have near add requirements up to 3.00 Diopters. The Igel 55 UV Toric (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 7.00 Diopters. The lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems.

Device Story

Hemispherical flexible soft contact lenses (methafilcon A) covering cornea and sclera; available in single vision, aspherical multifocal, and back surface toric designs. Incorporates UV-absorbing compound and Reactive Blue #19 tint. Prescribed by eyecare practitioners for daily wear or frequent replacement. Patients use chemical or hydrogen peroxide systems for disinfection. Lenses correct refractive errors; improve visual acuity; provide UV protection.

Clinical Evidence

Bench testing only. Pre-clinical testing included systemic injection, primary ocular irritation, and cytotoxicity tests. Results confirmed non-toxic and non-irritating properties. Sterility and stability testing confirmed shelf-life requirements.

Technological Characteristics

Material: methafilcon A (HEMA and methacrylic acid cross-linked with ethyleneglycol dimethacrylate, 55% water). UV-absorbing compound incorporated. Tint: Reactive Blue #19. Dk (35°C): 18.9 x 10^-11. Refractive index: 1.42. Specific gravity: 1.06. Manufacturing: Moulded. Sterilization: Standard process.

Indications for Use

Indicated for daily wear correction of myopia, hyperopia, presbyopia, and astigmatism in aphakic or non-aphakic persons with non-diseased eyes. Power ranges and astigmatism limits vary by lens design (single vision, multifocal, or toric).

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

• Specialty 55 UV (methafilcon A) Soft (Hydrophilic) Contact Lens (K003526)
• Specialty 55 UV Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens (K003526)
• Specialty 55 UV Toric (methafilcon A) Soft (Hydrophilic) Contact Lens (K003526)

Submission Summary (Full Text)

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# ARE PTELTD

JUN 0 4 2002

Image /page/0/Picture/2 description: The image contains a sequence of alphanumeric characters. The sequence starts with the letter 'K', followed by the number '0', then '20', then '8', and ends with '55'. The characters are written in a handwritten style, with varying stroke thicknesses.

## 510(k) Summary

## Submitter Information:

IGEL Visioncare Pte. Ltd. 139 Joo Seng Road, #05-01 ATD Centre Singapore 368362 Registration Number: 9614154

Contact Person: Mr Stephen D Newman, Chief Executive Officer

[phone] Telephone: [phone] Fax:

Date Prepared: March 5, 2002

## Device Name:

| Common Name: | Soft (Hydrophilic) Contact Lens |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade/Proprietary Names: | Igel 55 UV (methafilcon A) Soft<br>(Hydrophilic) Contact Lens for Daily Wear<br><br>Igel 55 UV Multifocal (methafilcon A) Soft (Hydrophilic)<br>Contact Lens for Daily Wear<br><br>Igel 55 UV Toric (methafilcon A) Soft (Hydrophilic)<br>Contact Lens for Daily Wear |
| Classification Name: | Soft (Hydrophilic) Contact Lens |
| Device Classification: | Class II (21 CFR 886.5925) |

## Predicate Devices:

The Specialty 55 UV (methafilcon A) Soft (Hydrophilic) Contact Lens, the Specialty 55 UV Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens and the Specialty 55 UV Toric (methafilcon A) Soft (Hydrophilic) Contact Lens were selected as the predicate devices.

The Igel 55 UV lenses are manufactured in the same facility, under the same quality system, using the same moulding, tinting, packaging and sterilization processes. The Igel 55 UV lenses contain the same UV blocking agent as the Specialty 55 UV lenses, and the manufacturing process for adding the UV blocking agent is the same.

## Description of Devices:

The Igel 55 UV, the Igel 55 UV Multifocal, and the Igel 55 UV Toric Daily Wear Contact Lenses (methafilcon A) are hemispherical flexible shells which cover the cornea and a portion of the adjacent sclera. The Igel 55 UV Contact Lens is available in a single vision lens design, the Igel 55 UV Multifocal Contact Lens is available in an aspherical lens design, and the Igel 55 UV Toric Contact Lens is available in a back surface toric design. The lens material (methafilcon A) is a hydrophilic

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polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid cross-linked with ethyleneglycol dimethacrylate (45.0%) and water (55.0%). A UV absorbing compound has been incorporated into the lens polymer. All lenses are tinted using the color additive Reactive Blue #19.

#### Comparison to Predicate Device

| PARAMETER | Igel 55 UV, Igel 55 UV<br>Multifocal, and Igel 55 UV Toric<br>Soft (Hydrophilic) Contact<br>Lenses for Daily Wear | Specialty 55 UV, Specialty 55<br>UV Multifocal and Specialty 55<br>UV Toric Soft (Hydrophilic)<br>Contact Lenses for Daily Wear |
|--------------------|-------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Submission number | | K003526 |
| Material | methafilcon A | methafilcon A |
| Material | Hydrophilic Lens Group 4 | Hydrophilic Lens Group 4 |
| classification | | |
| Indication for use | myopia, hyperopia, presbyopia | myopia, hyperopia, presbyopia |
| | and astigmatism | and astigmatism |
| Water content | 55% | 55% |
| Visible light | 90.3% | 90.3% |
| transmittance | | |
| UV transmittance | < 10% | < 10% |
| Dk (35°C) | $18.9 x 10^{-11}$ | $18.9 x 10^{-11}$ |
| Powers | +20.00 to -20.00 Diopters | +20.00 to -20.00 Diopters |
| Color | blue visibility<br>Reactive Blue #19 | blue visibility,<br>Reactive Blue #19 |
| Refractive index | 1.42 | 1.42 |
| Specific gravity | 1.06 | 1.06 |
| Method of | Moulded | Moulded |
| manufacture | | |

## Indications for Use:

The Igel 55 UV (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic persons with nondiseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 Diopters that does not interfere with visual acuity.

The Igel 55 UV Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for the correction of presbyopia in myopic and hyperopic eves in aphakic or not-aphakic persons with non-diseased eves who exhibit no more than 2.00 Diopters of astigmatism and can obtain satisfactory visual acuity, in a power range of +4.00 to -5.00 Diopters and have near add requirements up to 3.00 Diopters.

The Igel 55 UV Toric (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 7.00 Diopters.

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The lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. Evecare practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems.

## Description of Safety and Substantial Equivalence:

A series of pre-clinical tests were performed to demonstrate the safety and effectiveness of the Igel 55 UV, the Igel UV Multifocal and the Igel 55 UV Toric (methafilcon A) Contact Lenses for Daily Wear. Results of Systemic Injection, Primary Ocular Irritation and Cytotoxicity Tests show the lenses to be non-toxic and non-irritating. Extraction and analysis of the lenses showed no detectables. The Igel 55 UV lenses passed the requirements of sterility and stability testing.

#### Conclusion:

Information submitted in the 510(k) establishes that the Iqel 55 UV, the Igel 55 UV Multifocal and the Igel 55 UV Toric Contact Lenses (methafilcon A) have comparable physicochemical properties to the predicate devices and do not raise questions of safety and effectiveness. Shelf iff testing has shown the lenses remain sterile and that lens properties do not change before the expiration date. Therefore, the devices are substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing right, with three curved lines above them, resembling a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Stephen D. Newman Chief Executive Officer IGEL Visioncare PTE LTD 139 Joo Seng Road #05-01 ATD Centre Singapore 368362

JUN 0 4 2002

Re: K020855

Trade/Device Name: IGEL 55UV (methafilcon A), IGEL 55UV Multifocal (methafilcon A) and IGEL 55UV Toric (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: March 5, 2002 Received: March 15, 2002

Dear Mr. Newman:

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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. Ralph 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

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## INDICATIONS STATEMENT

#### Device Names:

Igel 55 UV (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear

Igel 55 UV Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear

Igel 55 UV Toric (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear

Indications for Use:

The Igel 55 UV (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the corrective ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 Diopters that does not interfere with visual acuity.

The Iqel 55 UV Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for the correction of presbyopia in myopic and hyperopic eyes in aphakic or not-aphakic persons with non-diseased eves who exhibit no more than 2.00 Diopters of astigmatism and can obtain satisfactory visual acuity, in a power range of +4.00 to -5.00 Diopters and have near add requirements up to 3.00 Diopters.

The Igel 55 UV Toric (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 7.00 Diopters.

The lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <span style="text-decoration: overline;">✓</span> | OR | Over-the-Counter Use <span style="text-decoration: overline;"></span> |
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(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

| 510(k) Number | <span style="text-decoration: overline;">K020855</span> |
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