ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS

K033599 · The Lagado Corp. · HQD · Sep 16, 2004 · Ophthalmic

Device Facts

• Record ID: K033599
• Device Name: ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS
• Applicant: The Lagado Corp.
• Product Code: HQD · Ophthalmic
• Decision Date: Sep 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2

Intended Use

The ONSI™-56 (onsifocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lens is indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic, hyperopic or presbyopic and which may exhibit corneal astigmatism. The lenses may be disinfected only by using chemical disinfection

Device Story

ONSI™-56 is a rigid gas permeable (RGP) contact lens made of onsifocon A polymer. Available in spherical, aspheric, toric, and translating bifocal designs. Used for daily wear to correct visual acuity in myopic, hyperopic, or presbyopic patients. Input is the patient's refractive error; device acts as a corrective optical lens. Operated by the patient for daily wear. Healthcare providers prescribe and fit the lenses based on patient needs. Benefits include improved visual acuity and correction of astigmatism. Lenses are available in various tints and with UV-blocking options.

Clinical Evidence

Clinical trial of 37 subjects (ages 15-58, 73% female) over 3 months of daily wear. Primary endpoints included safety (adverse events, slit lamp findings) and efficacy (visual acuity, wear time). No adverse events reported. Final visual acuity was within 1 line of initial best-corrected acuity. Slit lamp findings showed no significant clinical concerns. Study concluded the device is safe and effective.

Technological Characteristics

Material: onsifocon A (trifluoroethyl methacrylate polymer with siloxane components). Water content <1%. Oxygen permeability: 56.2 (ANSI units). Refractive index: 1.452. Hardness: D/85 (Shore). Wetting angle: 7.25 degrees (sessile drop). Mechanical strength: 2698 psi. Available in spherical, aspheric, toric, and bifocal designs. Chemical disinfection required.

Indications for Use

Indicated for daily wear for correction of visual acuity in non-aphakic persons with non-diseased eyes who are myopic, hyperopic, or presbyopic, and may exhibit corneal astigmatism.

Regulatory Classification

Identification

A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.

Predicate Devices

• Oxycon (wilofocon A) Rigid Gas Permeable Contact Lenses

Submission Summary (Full Text)

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K033599

# SEP 16 2004

## 510(k) SUMMARY FOR FREEDOM OF INFORMATION

### ONSI™-56 (onsifocon A) RIGID GAS PERMEABLE SPHERICAL, ASPHÈRIC, TORIC AND BIFOCAL CONTACT LENS FOR DAILY WEAR

| 1. Submitted by: | The Lagado Corporation<br>2890 South Tejon St<br>Englewood, CO 80110 |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | John M. Szabocsik, Ph.D.<br>Official agent Szabocsik and Associates<br>203 N. Wabash, Ste 1200<br>Chicago, IL 60601<br>[phone] |
| 2. Date prepared: | June 30, 2004 |
| 3. Device:<br>Common Name | ONSI™-56 (onsifocon A) Rigid Gas Permeable Spherical, Aspheric,<br>Toric and Bifocal Contact Lens |
| Trade Name | ONSI™-56 (onsifocon A) Rigid Gas Permeable Spherical, Aspheric,<br>Toric and Bifocal Contact Lens |
| 4. Classification | Class II (Performance Standards)<br>21 CFR 886.5916 (b) (1)<br>Rigid Gas Permeable Contact Lens for Daily Wear |
| 5. Substantial<br>Equivalence | This product is substantially equivalent to other currently marketed rigid lenses, such as Oxycon (wilofocon A) Rigid Gas Permeable Contact Lenses |
| 6. Device<br>Description | The ONSI™-56 (onsifocon A) Rigid Gas Permeable Spherical, Aspheric,<br>Toric and Bifocal Contact Lenses are available in spherical designs in the<br>clear untinted or blue, green, gray, or blue-violet tinted varieties and blue<br>tint with UV-blocker. Each is a shell of the following dimensions. |
| | Spherical Contact Lens:<br>Horizontal Lens Size: 6.5 mm to 11.50mm<br>Base Curve: 6.50mm to 9.50mm<br>Distance Powers: +12.00D to -20.00D<br>Center Thickness:<br>for low minus 0.05mm to 0.30mm<br>for plus 0.10mm to 0.70mm |
| | Aspheric Lens<br>Eccentricity 0 to 1.5<br>Peripheral Curves 0.1 to 1.0mm |
| | Toric Lens<br>Axis 1 to 180 degrees in 1 degree steps |
| | Cylinder power 0.50 to 4.00D |

FOI Summary, Pg 1

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| Translating Bifocal Contact Lens: | | | |
|-----------------------------------|---------|----|---------|
| Horizontal Lens Size: | 8.00mm | to | 10.50mm |
| Base Curve: | 6.50mm | to | 8.50mm |
| Distance Power: | +12.00D | to | -20.00D |
| Add Power | 1.00 | to | 4.00D |

The lens material, onsifocon A, is trifluoroethyl methacrylate polymer with tris (trimethylsiloxy)methacryloxypropylsilane 3-trimethoxysily|propylmethacrylate methacrylic acid 1,3-bis(3- methacryloxypropyl)tetrakis(trimethylsiloxy)disiloxane ethylene glycol dimethacrylate 2-hydroxyethyl methacrylate N-vinylpyrrolidone. The blue tinted lenses contain D&C Green No. 6; the green lenses contain D&C Green No 6 and CI Solvent Yellow 18; the gray lenses contain D&C Green No 6, D&C Violet No. 2, and CI Solvent Yellow 18; the blue-violet contain D&C Green No. 6 and D&C Violet No. 2; the blue-UV lenses contain D&C Green No 6 and a UV absorber, NORBLOC 7966. The colorants are used in quantities approved for use in contact lenses and proportions required to obtain the desired color.

### 7. Intended use

The ONSI™-56 (onsifocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lens is indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic, hyperopic or presbyopic and which may exhibit corneal astigmatism.

The lenses may be disinfected only by using chemical disinfection

8. Comparison to predicate devices: see following table

### SUBSTANTIAL EQUIVALENCE

| Water Content | OXYCON (wilofocon A) | ONSITM-56 (onsifocon A) |
|-----------------------------------|-----------------------------------|----------------------------------------------|
| | <1% | <1.0% |
| Oxygen Permeability | $26x10^{-11}$<br>Fatt Units(1990) | 56.2<br>ANSI units |
| Refractive Index | 1.44 | 1.452 |
| Hardness | D/89 (Shore) | D/85 (Shore) |
| Specific Gravity | 1.25 | 1.206 |
| Residual Monomers | | no leachable monomers<br>detected |
| Wetting Angle | 23.0\$\nabla\$2<br>(CLMA method) | 7.25E\$\nabla\$1.55<br>(sessile drop method) |
| Mechanical (flexural)<br>Strength | | 2698psi |

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ONSI™-56 (onsifocon A) Rigid Gas Permeable Contact Lenses, FOI

| | Light Transmittance | OXYCON (wilofocon A) | ONSITM-56 (onsifocon A) |
|--|---------------------|----------------------|----------------------------------------|
| | clear | | >95% T |
| | blue | | >70% T |
| | green | 93% | >70% T |
| | gray | 87% | >70% T |
| | blue-violet | | >70% T |
| | blue UV | | >70% T (400-780nm)<br>0% T (200-380nm) |

#### Introduction

The ONSI™-56 (onsifocon A) Rigid Gas Permeable Spherical. Aspheric, Toric and Bifocal Contact Lenses are indicated for daily wear for the correction of visual acuity in notaphakic persons with non-diseased eyes that are myopic, or presbyopic and which may exhibit corneal astigmatism.

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

#### I. Chemistry and Manufacturing

The lens material, onsifocon A, is trifluoroethyl methacrylate polymer with tris (trimethylsiloxy)methacryloxypropylsilane 3-trimethoxysily|propy|methacrylate methacrylic acid 1,3-bis(3- methacryloxypropyl)tetrakis(trimethylsiloxy)disiloxane ethylene glycol dimethacrylate 2-hydroxyethyl methacrylate N-vinylpyrrolidone.

The blue tinted lenses contain D&C Green No. 6; the green lenses contain D&C Green No 6 and CI Solvent Yellow 18; the gray lenses contain D&C Green No 6, D&C Violet No. 2, and CI Solvent Yellow 18; the blue-violet lenses contain D&C Green No 6 and D&C Violet No 2; the blue-UV lenses contain D&C Green No 6 and a UV absorber, NORBLOC 7966. The colorants are used in quantities approved for use in contact lenses and proportions required to obtain the desired color.

The ONSI™-56 (onsifocon A) Rigid Gas Permeable Spherical. Aspheric, Toric and Bifocal Contact Lenses are available in spherical designs in the clear untinted or blue, green, gray or blue-violet tinted varieties and blue with UV-blocker. Each is a shell of the following dimensions.

| Spherical Contact Lens: | | | |
|-------------------------|---------|----|---------|
| Horizontal Lens Size: | 6.5 mm | to | 11.50mm |
| Base Curve: | 6.50mm | to | 9.50mm |
| Distance Powers: | +12.00D | to | -20.00D |
| Center Thickness: | | | |
| for low minus | 0.05mm | to | 0.30mm |
| for plus | 0.10mm | to | 0.70mm |
| Aspheric Lens | | | |
| Eccentricity | 0 | to | 1.5 |
| Peripheral Curves | 0.1 | to | 1.0mm |

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ONSITM-56 (onsifocon A) Rigid Gas Permeable Contact Lenses. FOI

Toric Lens Axis 1 to 180 degrees in 1 degree steps Cylinder power 0.50 to 4.00D

| Translating Bifocal Contact Lens: | | | |
|-----------------------------------|---------|----|---------|
| Horizontal Lens Size: | 8.00mm | to | 10.50mm |
| Base Curve: | 6.50mm | to | 8.50mm |
| Distance Power: | +12.00D | to | -20.00D |
| Add Power | 1.00 | to | 4.00D |

#### II. Toxicology

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

A. Agar Overlay Cytotoxicity:

The ONSI™-56 (onsifocon A) Rigid Gas Permeable Contact Lens material was tested in a direct contact cytotoxicity assay. The lenses were noncytotoxic.

#### B. Systemic toxicity:

Saline and cottonseed oil extracts of the ONSI™-56 (onsifocon A) Rigid Gas Permeable Contact Lens material were evaluated for systemic toxicity by intraperitoneal (ip) or intravenous (iv) injection in healthy mice, 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 the ONSI™-56 (onsifocon A) Rigid Gas Permeable Contact Lens material were evaluated for ocular irritation by instillation into the inferior ocular cul-de-sac of rabbits. The eyes were examined over a 72 hour period and showed no irritation.

#### III. Microbiology

The material has a water content less than 1%, and is therefore exempt from the microbiological requirements for hydrophobic contact lenses. Bioburden testing will be performed periodically on finished product.

### IV. Clinical Studies

A clinical trial of 3 months usage of the ONSI™-56 (onsifocon A) Rigid Gas Permeable Spherical 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. Comparison was made to historical controls wearing wilofocon A. The clinical summary follows.

The study was conducted over 3 months of wear, subjects being seen initially, and after 1, 2 weeks and 1, 2 and 3 months.

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ONSI™-56 (onsifocon A) Rigid Gas Permeable Contact Lenses, FOI

Three (3) investigators enrolled a total of 37 test subjects. The age range of the test population was from 15 to 58, with 27 (73%) females and 10 (27%) males. Of the 37 subjects, 36 (97%) completed 3 months of wear, and 1 (3%) discontinued.

FINDINGS a. SAFETY:

(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.

(2) Slit Lamp Findings:

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.

The following table shows the incidence of slit lamp findings at the initial and final visits.

| INCIDENCE OF SLIT LAMP FINDINGS | | |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| FINDING FINDING | INITIAL ---------------------------------------------------------------------------------------------------------------------------------------------------------------------- | FINAL |
| | | |
| NO FINDINGSª | 90.5 | વેરે '8 |
| EDEMA® | 0.0 | 0.0 |
| NEOVASCUL. | 1.4 | 0.0 |
| STAINING | 5.4 | 3.2 |
| HYPEREMIA | 1.4 | 0.0 |
| PALPEBRAL | | |
| ABNORM. | 1.4 | 0.0 |
| OTHER | 0.0 | 0.0 |
| | | |

a Percent of eyes examined with no findings, initial or final scheduled follow-up visits only

b Percent of eyes with finding, initial or final scheduled follow-up visits only

#### (3) Symptoms, Problems and Complaints:

Symptoms, problems and complaints were reported by the investigators at each visit. "No symptoms" were reported at 76% of the scheduled follow up visits, and at all interim visits. The most frequent symptoms were of lens awareness and reading problems, followed by need for cleaning and dryness. The "other" symptoms in the population were: tired or fatigue (4 reports, 4 eyes of 2 subjects); cloudy or fogging (8 reports, 4 eyes of 2 subjects); scratchy sensation or itch (4 reports, 4 eyes of 2 subjects); difficult to remove (6 reports, 2 eyes of 1 subject).

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#### SELECTED SYMPTOMS, PROBLEMS AND COMPLAINTS

| SYMPTOM | INCIDENCE |
|-------------------|-----------|
| NONEa | 75.7% |
| LENS AWARENESSb | 5.7% |
| READING PROBLEMS | 5.5% |
| NEED FOR CLEANING | 5.2% |
| DRYNESS | 4.6% |

- a Percent of eyes examined with no findings, regularly scheduled visits only b Percent of eyes with finding, regularly scheduled visits only
#### (4) Discontinuations:

Throughout the study, 1 subject (3%) was discontinued.

#### b. EFFICACY:

#### (1) Visual Acuity:

All eyes had a final visual acuity within 1 line of the initial best corrected acuity.

#### (2) Wear Time:

Wear time remained essentially unchanged over the three months of the study, indicating continuing comfort and cleanliness with the investigational lenses.

#### (3) Lens Replacements:

A total of 10 lenses were replaced during the study, 6 for visual acuity, 5 of the 6 within the first month. These results indicate that the lenses are effective in the correction of myopia.

#### Gender Comparisons:

The overall population was 73% female, 27% male. No further gender analysis was warranted.

### OVERALL CONCLUSION OF THE CLINICAL STUDY:

The data of the clinical trial demonstrate the safety and efficacy of the ONSI™-56 (onsifocon A) Rigid Gas Permeable Spherical Contact Lenses.

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Image /page/6/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the upper half of the circle. Inside the circle is an abstract symbol of an eagle with three lines representing the wings and a stylized body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 6 2004

The Lagado Corporation c/o John M. Szabocsik, Ph.D. Szabocsik and Associates 203 North Wabash Avenue Suite 1200 Chicago, IL 60601

Re: K033599

KUSSJ77
Trade/Device Name: ONST™ – 56 (onsifocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lenses Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid gas permeable contact lens Regulatory Class: Class II Product Code: HQD Dated: July 7, 2004 Received: July 8, 2004

Dear Dr. Szabocsik:

We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conniner of Price 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). and Oosmeter for (10) and the device, subject to the general controls provisions of the Act. The I ou may, therefore, mains of the Act include requirements for annual registration, listing of general conable pro resuring 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 If your device is elassinos (tional controls. Existing major regulations affecting your device can may oe subject to back acceral 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 I Tease of advised that I Driseanter sever device complies with other requirements of the Act that 1 Dri has made a assoc regulations administered by other Federal agencies. You must of any I ederal statutes uncrements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 607), laborning (21 CFR Part 820); and if applicable, the electronic forth in the quality of events (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w you to organization of substantial equivalence of your device to a legally promance houried.com "consification 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 If you active 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 other general 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. Kalipi 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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## 510(k) NUMBER (IF KNOWN) K033599

ONSI™-56 (onsifocon A) Rigid Gas Permeable Spherical, DEVICE NAME Aspheric, Toric and Bifocal Contact Lens

#### INDICATIONS FOR USE

The ONSIJ-56 (onsifocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lens is indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic, hyperopic or presbyopic and which may exhibit corneal astigmatism.

The lenses may be disinfected only by using chemical disinfection

Prescription Use
(Part 21CFR 801 Subpart D)

Over-The-Counter-Use OR (Part 21CFR 801 Subpart C)

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

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Division of Ophthal
Nose and Throat Devises
510(k) Number K033599

510(k) Number