TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS

K102154 · The Lagado Corp. · HQD · Jan 21, 2011 · Ophthalmic

Device Facts

• Record ID: K102154
• Device Name: TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS
• Applicant: The Lagado Corp.
• Product Code: HQD · Ophthalmic
• Decision Date: Jan 21, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2

Intended Use

The TYRO™-97 (hofocon A) and ONSI™-56 (onsifocon A) Rigid Gas Permeable Contact Lenses are 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. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a gas permeable contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery. The lenses may be disinfected only by using chemical disinfection

Device Story

TYRO-97 (hofocon A) and ONSI-56 (onsifocon A) are rigid gas permeable (RGP) contact lenses for daily wear. Hofocon A is a polymer of trifluoroethyl methacrylate and silicone methacrylate; onsifocon A is a polymer of trifluoroethyl methacrylate, tris(trimethylsiloxy)methacryloxypropylsilane, and other monomers. Lenses are available in spherical, aspheric, toric, and bifocal designs. They are prescribed by eye care professionals to correct refractive errors or manage irregular corneal conditions. Patients wear the lenses daily and must use chemical disinfection. The lenses provide oxygen permeability and refractive correction to improve visual acuity. Benefits include vision correction for patients with irregular corneas where soft lenses may be unsuitable.

Clinical Evidence

Bench testing only. Data provided includes physical property measurements: hardness (Shore D), water content, wetting angle (sessile drop), oxygen permeability (Fatt method), refractive index, specific gravity, and flexural strength. No clinical study data was required or presented for this 510(k) notification.

Technological Characteristics

Materials: Hofocon A (trifluoroethyl methacrylate/silicone methacrylate) and Onsifocon A (trifluoroethyl methacrylate/silicone-based monomers). Properties: Oxygen permeability (97 and 56.2 ANSI units), water content <1%, Shore D hardness (82-85), refractive index (1.440-1.452). Designs: Spherical, aspheric, toric, bifocal. Sterilization: Chemical disinfection required. Connectivity: None.

Indications for Use

Indicated for daily wear in non-aphakic patients with non-diseased eyes (myopic, hyperopic, presbyopic, or with corneal astigmatism) and patients with irregular corneal conditions (keratoconus, pellucid marginal degeneration, post-penetrating keratoplasty, or post-refractive surgery).

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

• BOSTON ES (enflufocon A) (K053124)
• BOSTON EO (enflufocon B) (K053124)
• BOSTON XO (hexafocon A) (K053124)

Submission Summary (Full Text)

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-K 102154.

JAN 2 1 2011

December 14, 2010

# 510(k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS

TYRO™ -97 (hofocon A) and ONSI™ -56 (onsifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear

### 1. SUBMITTER INFORMATION:

The Lagado Corporation 2890 South Tejon St Englewood, CO 80110

Contact:

John M. Szabocsik, Ph.D.

Official agent Szabocsik and Associates 203 N. Wabash, Ste 2208 Chicago, IL 60601 . [phone] .

- 2. December 13, 2010 DATE PREPARED:
### 3. DEVICE NAME:

rigid gas permeable (hydrophilic) contact lenses Classification Name:

TYRO™-97 (hofocon A) Rigid Gas Permeable Spherical, Aspheric, Toric Proprietary Names: and Bifocal Contact Lens

> ONSI™ -56 (onsifocon A) Rigid Gas Permeable Spherical. Aspheric. Toric and Bifocal Contact Lens

### CLASSIFICATION: 4 .

Class II (Performance Standards) Classification: HQD 21 CFR 886.5916 (b) (1) Rigid Gas Permeable Contact Lens for Daily Wear

### 5. DESCRIPTION OF DEVICES:

The TYRO™ 97 (hofocon A) Rigid Gas Permeable lens material, hofocon A, is a polymer of trifluoroethyl methacrylate and silicone methacrylate, with no methyl methacrylate. 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 Cl Solvent Yellow 18; the blue-UV lenses contain D&C Green No 6 and a UV absorber, [ 2-(2'-hydroxy-5'-methacryloxyethylphenyl)-2H-benzotriazole. The colorants are used in quantities approved for use in contact lenses and proportions required to obtain the desired color.

The physical properties of the hofocon A lenses are as follows:

Typical Property

Test Value

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| Hardness | D/82 (Shore HardnessUnits) |
|-----------------------|-----------------------------|
| Water Content | <0.2% |
| Wetting Angle | 23.3E (sessile drop method) |
| Oxygen Permeability | 97 ANSI units |
| Dimensional Stability | · Stable |
| Refractive Index | 1.440 |
| Specific Gravity | 1.087 |
| Flexural Strength | 3952 psi |

The ONSI™-56 (onsifocon A) Rigid Gas Permeable lens material, onsifocon A,is a polymer of trifluoroethyl methacrylate polymer with tris (trimethylsiloxy) methacryloxypropylsilane 3trimethoxysilylpropylmethacrylate methacrylic acid 1,3-bis(3methacryloxypropyl)tetrakis(trimethylsiloxane ethylene glycol dimethacrylate 2-hydroxyethyl methacrylate N-vinylpyrrolidone.

The blue tinted onsifocon A 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 Cl Solvent Yellow 18; the blue-UV lenses contain D&C Green No 6 and a UV absorber, { 2-(2'-hydroxy-5'methacryloxyethylphenyl)-2H-benzotriazole. The colorants are used in quantities approved for use in contact lenses and proportions required to obtain the desired color.

The physical properties of onsifocon A lenses are as follows:

| Typical Property | Test Value |
|-----------------------|-----------------------------------|
| Hardness | D/85 (Shore HardnessUnits) |
| Water Content | <1.0% |
| Wetting Angle | 7.25° ±1.55 (sessile drop method) |
| Oxygen Permeability | 56.2 ANSI units |
| Dimensional Stability | Stable |
| Refractive Index | 1.452 |
| Specific Gravity | 1.206 |
| Flexural Strength | 3952 psi |

### INDICATIONS FOR USE: 6.

The TYRO™-97 (hofocon A) and ONSI™-56 (onsifocon A) Rigid Gas Permeable Contact Lenses are 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 comeal astigmatism. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a gas permeable contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery.

The lenses may be disinfected only by using chemical disinfection

### SAFETY AND SUBSTANTIAL EQUIVALENCE: 7.

The safety and efficacy of the TYRO™ -97 (hofocon A) and ONSI™ -56 (onsifocon A) Rigid Gas Permeable Contact Lenses were demonstrated in 510(k) Premarket Notifications as follows: K052507 - SE Decision Date 02-NOV-05 and K033599 - SE Decision Date 16-SEP-04, respectively.

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December 14, 2010

The TYRO™-97 (hofocon A) and ONSI™-56 (onsifocon A) Rigid Gas Permeable Contact Lenses
are substantially equivalent to the BOSTON ES (enflufocon A), BOSTON EO (enflufocon B) XO (hexafocon A) Rigid Gas Permeable Contact Lenses indicated for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery K053124 - SE Decision Date 30-JAN-06.

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December 14, 2010

# SUBSTANTIAL EQUIVALENCE

| | Hofocon A | Onsifocon A | Hexafocon B (Boston XO) | Enflufocon A (Boston ES) | Enflufocon B (Boston EO) |
|--------------------------------|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|
| Water Content | <0.2% | <1.0% | <1% | <1% | <1% |
| O₂ Permeability | Fatt Method: D units=97 x 10-11 (cm³O₂)(cm)/[(sec)(cm²)(mmHg)] @ 35°C | Fatt Method: D units=56.5 x 10-11 (cm³O₂)(cm)/[(sec)(cm²)(mmHg)] @ 35°C | Fatt Method: D units=141 x 10-11 (cm³O₂)(cm)/[(sec)(cm²)(mmHg)] @ 35°C | Fatt Method: D units= 18 x 10-11 (cm³O₂)(cm)/[(sec)(cm²)(mmHg)] @ 35°C | Fatt Method: D units= 58 x 10-11 (cm³O₂)(cm)/[(sec)(cm²)(mmHg)] @ 35°C |
| Refractive Index | 1.440 | 1.452 | 1.415 | 1.443 | 1.420 |
| Hardness | D/82 (Shore) | D/85 (Shore) | | | |
| Specific Gravity | 1.087 | 1.206 | 1.27 | 1.22 | 1.23 |
| Wetting Angle | estimate <25° | 7.25 ± 1.55° | 49° | 52° | 49° |
| Mechanical (flexural) Strength | 3952 psi | 2698 psi | | | |
| Light Transmittance | Clear >95%T<br>Blue >70% T<br>Green>70% T | Clear>95% T<br>Blue>70% T<br>Green>70% T<br>Grey>70% T<br>Blue-violet>70% T<br>Blue-UV>70%T(400-780nm) | >92% | >85% | >85% |
| | | | | | 0%T |

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Image /page/4/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings and body. The text "DEPARTMENT OF HEALTH &" is vertically oriented on the left side of the logo.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Szabocsik and Associates c/o Dr. John M. Szabocsik 203 North Wabash Avenue Suite 2208 Chicago, Illinois 60601

JAN 2 1 201

Re: K102154

Trade/Device Name: TYRO-97 (hofocon A), ONSI™ - 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 for Daily Wear Regulatory Class: Class II Product Code: HQD Dated: December 20, 2010 Received: December 23, 2010

Dear Dr. Szabocsik:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 - Dr. John M. Szabocsik

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 liasting (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements set forth in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11178001,1 profox the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFF), Paul 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Alexander

Image /page/5/Picture/7 description: The image shows the handwritten word "for" in cursive. The letter "f" has a large, elongated loop extending below the baseline, and the "o" and "r" are connected with a smooth, flowing line. The writing appears to be done with a pen or marker, and the ink is black. The background is plain white.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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December 14, 2010

Page 1 of 1

# 510(k) NUMBER (IF KNOWN)

# DEVICE NAME TYRO™-97 (hofocon A) and ONSI™-56 (onsifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear

# INDICATIONS FOR USE

The TYRO™-97 (hofocon A) and ONSI™-56 (onsifocon A) Rigid Gas Permeable Contact Lenses are 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. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a gas permeable contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery.

The lenses may be disinfected only by using chemical disinfection

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ X Over-The-Counter-Use (Per 21 CFR 801.109) OR (Optional Format 1-2-96)

Page 1 of 1

Jana Postell

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K102154