IGEL 56 UV (HEFILCON C) SOFT (HYDROPHILIC) CONTACT LENS

K984523 · Igel Vision Care Pte , Ltd. · LPL · Feb 16, 1999 · Ophthalmic

Device Facts

• Record ID: K984523
• Device Name: IGEL 56 UV (HEFILCON C) SOFT (HYDROPHILIC) CONTACT LENS
• Applicant: Igel Vision Care Pte , Ltd.
• Product Code: LPL · Ophthalmic
• Decision Date: Feb 16, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The Igel®56 UV (hefilcon C) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism, for the spherical lens up to 1.50 diopters that does not interfere with visual acuity, and for the toric lens up to 7.00 diopters) in not-aphakic persons with non-diseased eyes. The lens may be disinfected using chemical disinfecting systems only.

Device Story

Igel® 56 UV is a hemispherical, flexible, hydrophilic contact lens made of hefilcon C (copolymer of 2-hydroxyethylmethacrylate and N-vinyl-2-pyrrolidone). It functions as a corrective refracting medium placed directly on the human cornea to focus light rays on the retina. The device is used by patients for daily wear to correct refractive ametropia. It is a passive optical device; no electronic or algorithmic processing is involved. The lens includes a UV-absorbing compound to reduce UV transmittance. Clinical benefit is achieved through refractive correction of vision. The device is prescribed by eye care professionals.

Clinical Evidence

Clinical trial of 37 subjects (17-61 years old, 70.3% female) over 4 weeks of daily wear. Primary endpoints included safety (slit lamp findings, adverse events) and efficacy (visual acuity, lens cleanliness). No adverse events reported. Slit lamp findings showed no clinically significant complications (no Grade >2 findings). 91% of lenses were clinically clean (Rudko grades I-II). Visual acuity was maintained. Study concluded the device is safe and effective for its intended use.

Technological Characteristics

Material: hefilcon C (copolymer of 2-hydroxyethylmethacrylate and N-vinyl-2-pyrrolidone). Water content: 56%. Refractive index: 1.41 (hydrated). Oxygen permeability: 21x10^-11 (cm/sec)(ml O2/ml x mmHg). Contains UV-absorbing compound and D&C Green #6 tint. Dimensions: 14.2mm-14.6mm chord diameter, 0.09mm-0.15mm center thickness. Sterilization: Validated manufacturing process. Connectivity: None (passive optical device).

Indications for Use

Indicated for daily wear correction of myopia, hyperopia, and astigmatism (up to 1.50D for spherical, 7.00D for toric) in non-aphakic patients with non-diseased eyes. Contraindicated for patients with diseased eyes or those requiring aphakic correction.

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

• Gold Medalist Toric lenses (K974837)

Submission Summary (Full Text)

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984523 510(k) SUMMARY FOR FREEDOM OF INFORMATION, K984523 IGEL® 56 UV (hefilcon C) SOPT (hydrophilic) CONTACT LENS FOR DAILY WEAR NOTE: This summary is identical to that provided for K974837, except for the name change, the inclusion of the UV absorbing compound in the material description, and the inclusion of the UV transmittance in the physical properties. Labeling changes include the name change and the inclusion of the appropriate UV transmittance graphs and warnings. Igel Vision Care PTE, Ltd l. Submitted by: 139 Joo Seng Road, #06-01 ATD Centre Singapore 368362 John M. Szabocsik, Ph.D. Contact : Official agent Szabocsik and Associates 203 N. Wabash, Ste 1200 Chicago, IL 60601 [phone] February 9, 1999 2. Date prepared: 3. Device: Igel® 56 UV (hefilcon C) Soft (hydrophilic) Common Name Contact Lens Igel® 56 UV (hefilcon C) Soft (hydrophilic) Trade Name Contact Lens Class II (Performance Standards) 4. Classification 21 CFR 886.5925 Soft (hydrophilic) contact lens This product is substantially 5. Substantial equivalent to other currently marketed equivalence hefilcon lenses, such as Gold Medalist Toric lenses 6. Device The Igel® 56 UV (hefilcon C) soft (hydrophilic) contact lens is a description hemispherical, flexible transparent shell of the following dimensions: Chord diameter: 14.2mm Center thickness: 0.09mm (at-3.00 D) Optic Zone: variable optic zone with power Base Curve: 8.60mm Power : -0.50D to -8.00D (in 0.25D steps); -8.50D to
-12.00D (in 0.50D steps); +0.50D to +6.00D (in 0.25D steps)

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The lens material (hefilcon C) is a copolymer of 2 hydroxethylmethacrylate and N-Vinyl pyrrolidone, and contains a UV absorbing compound. The blue tinted lens also contains D&C Green #6. When fully hydrated, the lens is 56% water by weight.

- The Igel® 56 UV (hefilcon C) Soft 7. Intended use (hydrophilic) Contact Lens for Daily Wear is available as a spherical lens for the correction of near-sightedness (myopia) and farsightedness (hyperopia). A toric version of the same lens is able to correct for astiqmatism from 0.50D to 7.00D.
- 8. Comparison to predicate devices: see following table

SUBSTANTIAL EQUIVALENCE

| Material | Igel® 56 UV<br>hefilcon C | Gold Medalist™ Toric<br>hefilcon C |
|-------------------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Description | random copolymer of<br>2-hydroxyethyl<br>methacrylate and N-<br>vinyl-2-pyrrolidone | random copolymer of<br>2-hydroxyethyl<br>methacrylate and N-<br>vinyl-pyrrolidone |
| Water Content | 56% in buffered<br>saline | 57% in normal saline |
| Specific<br>Gravity | 1.16 | 1.1 |
| Refractive<br>Index | 1.41 (hydrated) | 1.41 |
| Light<br>Transmittance<br>(visible) | 94.5% (clear)<br>90.3% (blue handling<br>tint) | at least 90% |
| UV<br>Transmittance | <10% (-7.00D,<br>thinnest lens) | not applicable |
| Oxygen<br>permeability | 21x10-11(cm/sec)(ml<br>O2/mlxmm Hg)<br>Measured at 35°C<br>(revised Fatt<br>method). | 17x10-11(cm/sec)(ml<br>O2/mlxmm Hg) Measured<br>at 35°C (revised Fatt<br>method). |

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SUBSTANTIAL EQUIVALENCE (continued)

| Material | Igel® 56 UV<br>hefilcon C | Gold Medalist™ Toric<br>hefilcon C |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Actions | When placed on the<br>human cornea, the<br>hydrated Igel® 56 UV<br>(hefilcon C) Soft<br>(hydrophilic)<br>Contact Lens acts as<br>a corrective<br>refracting medium to<br>focus light rays on<br>the retina. | In its hydrated<br>state, the Bausch &<br>Lomb Gold Medalist™<br>Toric (hefilcon C)<br>Visibility Tinted<br>Contact Lens when<br>placed on the cornea<br>acts as a corrective<br>refracting medium to<br>focus light rays on<br>the retina. |
| Chord Diameter* | 14.2mm | 12.0 to 18.0mm |
| Center<br>thickness* | 0.09mm (at -3.00D) | 0.02mm to 1.0mm |
| Base Curve* | 8.6mm | 8.3mm to 9.2mm |
| Powers<br>(Spherical)<br>(Cylinder) | -12.00 to +6.00D<br>up to 7.00D | +20.00 to -20.00D<br>up to 5.00D |
| Optical Zone | vary with power | |

* Igel® 56 UV parameters for spheres only provided in this table

Introduction

The Igel® 56 UV (hefilcon C) Soft (hydrophilic) Contact Lens is a spherical lens for the correction of nearsightedness (myopia) and farsightedness (hyperopia). A toric version of the same lens is able to correct for astigmatism from 0.50D to 7.00D.

Contained in the submission are comparisons of the product to the predicate device, information on the chemistry and manufacturing, results of toxicological and microbiological tests, and the report of a clinical trial of 37 subjects, who have used the product over a period of four weeks .

I. Chemistry and Manufacturing

The lens material (hefilcon C) is a copolymer of 2 hydroxethylmethacrylate and N-Vinyl pyrrolidinone and contains a UV absorbing compound. The blue tinted lens also contains D&C Green #6. When fully hydrated, the lens is 56% water by weight.

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P.05/15

The Igel® 56 UV (hefilcon C) Soft (hydrophilic) Spherical Contact Lens is a hemispherical, flexible transparent shell of the following dimensions: Chord diameter: 14.2mm 0.09mm (at-3.00 D) Center thickness: variable optic zone with Optic Zone: power 8.60mm Base Curve: -0.50D to -8.00D (in 0.25D Power: steps) -8.50D to -12.00D (in 0.50D steps) +0.50D to +6.00D (in 0.25D steps) The Igel® 56 UV (hefilcon C) Soft (hydrophilic) Toric Contact Lens has the following characteristics: 14.6mm Chord diameter: 0.15mm Center thickness: 8 - 4 5mm Optic Zone: 8.70mm Base Curve: Plano to -8.00 D (in 0.25 D steps) Sphere: Plano to +6.00 D (in 0.25 D steps) up to 7.00 D Cylinder: 80, 90, 100, 160, 170, 180, 10 & 20 Axis : Dynamic Stabilizing Stabilizing Mechanism: Sectors The physical properties of the lens (sphere or toric) are as follows: Specific Gravity: 1.16 1.41 (hydrated)
94.5% (clear) Refractive index: Light transmission: 90.3% (blue handling tint) <10%(-7.00D, thinnest UV transmittance lens hydrophilic Surface character: 56% weight in normal Water content: buffered saline 2.85 kg/cm² Tensile strength: Elongation: 728 5.20 kg/cm² Modulus of Elasticity: Dx: 21x10-11 ( cm/sec ) { ml Oxygen permeability: O2/mlxmm Kg) Measured at 35°C (revised Patt method). A. Extractables

Samples of lenses were extracted in saline, and the extracts analyzed by high performance liquid chromatography to determine if any monomers were extracted from the material. There were no extractables detected.

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## B. Process validation

The manufacturing process for this cast-moulded lens was shown to be valid both for lens quality and sterility.

### II. Toxicology

The toxicological testing is summarized below. The lens material was shown to be non-toxic in all tests.

#### A -Agar Overlay Cytotoxicity:

Igel® 56 UV (hefilcon C) Soft (hydrophilic) Contact Lenses were tested in a direct contact cytotoxicity assay. The lenses were noncytotoxic.

### Systemic toxicity: B.

Saline and cottonseed oil extracts of Igel® 56 UV (hefilcon C) Soft (hydrophilic) Contact Lenses were evaluated for systemic toxicity by intravenous (iv, saline) and intraperitoneal (ip, cottonseed oil) injection in healthy mice, both at 50ml/kg body weight. The animals were observed over a 72 hour period, and showed no difference from control animals. The lenses passed the test requirements, that there be no difference between the response of test and control animals.

C. Acute Ocular irritation:

Saline and cottonseed oil extracts of Igel® 56 UV (hefilcon C) Soft (hydrophilic) Contact Lenses were evaluated for ocular irritation by instillation into The eyes the inferior ocular cul-de-sac of rabbits. were examined over a 72 hour period and showed no irritation.

## III. Microbiology

A. Sterility

The Igel® 56 UV (hefilcon C) Soft (hydrophilic) Contact Lenses passed the requirements of sterility testing.

#### B. Stability

Stability data, including package integrity, lens parameters (diameter, base curve, power, optics, appearance), stability of tint and UV transmittance, and sterility will be collected according to protocol. Product will not be marketed until data supporting the expiration dating are available.

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IV. Clinical Studies

A clinical trial of 4 weeks usage of the Igel® 56 UV (hefilcon C) Soft (hydrophilic) Contact Lenses by 37 subjects, wearing lenses on a daily wear schedule, showed that the product is substantially equivalent to other lenses available on the market. The clinical summary follows.

The study was conducted over 1 month of wear, subjects being seen initially, and after 1, 2 and 4 The study was initiated July 11, 1997 and weeks. completed August 19, 1997.

Two (2) investigators enrolled a total of 37 test subjects. The age range of the test population was from 17 to 61, with 26 (70.3%) females and 11 (29.7%) males.

Of the 37 subjects, 35 (94.6%) completed 1 month of wear, and 2 (5.4%) discontinued.

FINDINGS

SAFETY : a.

(1) Adverse Reactions

The FDA regulations for medical devices (21 CFR 812.3) define an unanticipated adverse device effect as :

"any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem or death was not previously identified in nature, severity or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that related to the rights, safety or welfare of the subject"

There were no adverse events during this study.

Slit Lamp Findings: (2)

A positive slit lamp finding is a routinely occurring complication that can be expected with or without the presence of contact lenses. The degree of severity may range from very slight, representing no medical concern, to serious, requiring medical treatment.

Table B shows the incidence of slit lamp findings in the investigational group at the initial and final visits.

The slit lamp finding listed as "Other" at the initial visit was an old healed neovascularization.

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6.08/15

### TABLE B

| FINDINGS | | INCIDENCE OF SLIT LAMP FINDINGS |
|--------------|---------|---------------------------------|
| FINDING | INITIAL | FINAL |
| NO FINDINGSa | 51.4 | 58.6 |
| EDEMAb | 0.0 | 0.0 |
| NEOVASCULAR | 18.9 | 11.4 |
| STAINING | 5.4 | 1.4 |
| INJECTION | 0.0 | 0.0 |
| TARSAL | 48.6 | 40.0 |
| OTHER | 1.4 | 0.0 |

a Percent of eyes examined with no findings, regularly scheduled visits only

D Percent of eyes with finding, regularly scheduled visits only

The Trend Analysis Profile showed no reports of positive slit lamp findings greater than Grade 2.

# (3) Symptoms, Problems and Complaints:

Symptoms, problems and complaints were reported by the investigators at each visit. Lens awareness, handling problems and reading problems were the most frequently reported symptoms among all subjects. Table C shows the overall incidence of these selected symptoms .

The "other" symptoms were dryness (reported by 2 subjects); torn lenses reported by 1 subject.

### TABLE C

SELECTED SYMPTOMS, PROBLEMS AND COMPLAINTS

| SYMPTOM | Incidence |
|-------------------|-----------|
| NONEa | 62.6% |
| LENS AWARENESSb | 14.5% |
| HANDLING PROBLEMS | 8.4% |
| READING PROBLEMS | 7.9% |

scheduled visits only

A Percent of eyes examined with no findings, regularly scheduled visits only D Percent of eyes with finding, reqularly

#### Discontinuations: ( 4 )

READING PROBLEMS

Throughout the study, 2 subjects (5.4%) were discontinued.

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#### EFFICACY : b.

#### Visual Acuity: (1)

All but 2 eyes had a final visual acuity within 1 line of the initial best corrected acuity. The appropriate acuity was achieved by all eyes, since those two eyes were in subjects fit for monovision.

#### Wear Time: (2)

Wear time remained essentially unchanged over the one month of the study, indicating continuing comfort and cleanliness with the investigational solution.

#### Lens Cleanliness: (3)

Lenses were evaluated at each visit, according to a modified Rudko classification. Overall, the reports of the Rudko evaluation showed that 91% of test lenses were clinically clean during the study. (Rudko grades I and II are considered clinically clean.)

These results confirm that the Igel® 56 UV (hefilcon C) Soft (hydrophilic) Contact Lenses are effective in the correction of myopia and hyperopia.

### Gender Comparisons:

The overall test population was 70.3% female, 29.7% male, and the visit distribution over the study was 69% female, 31% male. Overall, there were no slit lamp findings at 58% of the visits; among females, at There were no 63%, among males at 47% of the visits. symptoms reported at 61% of the visits; among females, no symptoms were reported at 64%, among males, at 56%. There is no significant difference in the findings, and no further analysis was warranted. Because of the small sample size, the gender analysis may be statistically irrelevant.

### OVERALL CONCLUSION OF THE CLINICAL STUDY:

The data of the clinical trial confirm that the Igel® 56 UV (hefilcon C) Soft (hydrophilic) Contact Lenses are substantially equivalent to currently marketed lenses in safety and efficacy.

### LABELING

The name of the lens has been changed from the Igel® 56 (hefilcon C) Soft (hydrophilic) Contact Lens to the Igel® 56 UV (hefilcon C) Soft (hydrophilic) The appropriate UV transmittance graphs, Contact Lens. warnings, and note have been included in the labeling.

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Image /page/8/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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 6 1999

Igel Vision Care PTE, Ltd. c/o John M. Szabocsik, Ph.D. Szabocsik and Associates 203 N. Wabash Avenue, Suite 1200 Chicago, IL 60601

Re: K984523

Trade Name: IGEL ® 56 UV (hefilcon C) soft (hydrophilic) Contact Lens for Daily Wear (clear or visitint. Spherical and Toric, cast molded) Regulatory Class: II

Product Code: 86 LPL Dated: December 14, 1998 Received: December 21, 1998

Dear Dr. Szabocsik:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

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Page 2 - Dr. John M. Szabocsik, Ph.D.

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Roerl forentthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) NUMBER (IF KNOWN)

DEVICE NAME Igel®56 UV (hefilcon C) Soft (hydrophilic) Contact Lens

INDICATIONS FOR USE

The Igel®56 UV (hefilcon C) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism, for the spherical lens up to 1.50 diopters that does not interfere with visual acuity, and for the toric lens up to 7.00 diopters) in not-aphakic persons with non-diseased The lens may be disinfected using chemical eyes. disinfecting systems only.

ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Over-The-Counter-Use Prescription Use _ V (Per

21 CFR 801.109)

(Optional Format 1-2-96)

Division Sign-Off

Division of Ophthalmic Devices
S10(k) Number K984523