TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSES FOR DAILY WEAR

{0}------------------------------------------------ ## 510(k) SUMMARY FOR FREEDOM OF INFORMATION K052507 NOV - 2 2005 . . #### . · TYRO™-97 (hofocon A) RIGID GAS PERMEABLE . SPHERICAL, ASPHERIC, TORÍC 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<br>Szabocsik and Associates<br>203 N. Wabash, Ste 1200<br>Chicago, IL 60601<br>(312) 553-0828 | | 2. Date prepared: | September 8, 2005 | | 3. Device:<br>Common Name | TYRO ^TM -97 (hofocon A) Rigid Gas Permeable Spherical,<br>Aspheric, Toric and Bifocal Contact Lenses for Daily Wear | | Trade Name | TYRO ^TM -97 (hofocon A) Rigid Gas Permeable Spherical,<br>Aspheric, Toric and Bifocal Contact Lenses for Daily Wear | | 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<br>rigid lenses, such as Oxycon (wilofocon A) Rigid Gas Permeable<br>Contact Lenses | | 6. Device<br>Description | The TYRO ^TM -97 (hofocon A) Rigid Gas Permeable Spherical, Aspheric,<br>Toric and Bifocal Contact Lenses for Daily Wear are available in<br>spherical, aspherical and toric designs in the clear untinted or blue, green<br>and gray tinted varieties with and without UV-blocker. Each is a shell of<br>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 | {1}------------------------------------------------ | Aspheric Lens | | |-----------------------------------|-----------------------------------| | Eccentricity | -1.5 to 1.5<br>Oblate to prolate | | Peripheral Curves | 0.1 to 1.0mm | | Toric Lens | | | Axis | 1 to 180 degrees in 1 degree step | | 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 | The 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 CI Solvent Yellow 18; 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. +12.00D 1.00D -20.00D 4.00D to to 7. Intended use: The TYROTM-97 (hofocon 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 Distance Power: Add Power {2}------------------------------------------------ : 上海 ## 8. Comparison to predicate devices: see following table # SUBSTANTIAL EQUIVALENCE | | OXYCON (wilofocon<br>A) | TYROTM-97 (hofocon<br>A) | |-----------------------------------------------|------------------------------|----------------------------------------| | Water Content | <1% | <0.2% | | Oxygen Permeability | 26x10-11<br>Fatt Units(1990) | 97.98<br>ANSI units | | Refractive Index | 1.44 | 1.440 | | Hardness | D/89 (Shore) | D/82 (Shore) | | Specific Gravity | 1.25 | 1.087 | | Residual Monomers | | no leachable monomers<br>detected | | Wetting Angle | 23.0±2<br>(CLMA method) | 23.3°<br>(sessile drop technique) | | Mechanical (flexural)<br>Strength | | 3952psi | | Light Transmittance<br>clear<br>blue<br>green | 93%<br>87% | >95% T<br>>70% T<br>>70% T | | Blue-UV | | >70% T (400-780nm)<br>0% T (200-380nm) | #### Introduction : The TYRO™-97 (hofocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal 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. 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 clinical trials. Chemistry and Manufacturing I. > The 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, 7 {3}------------------------------------------------ and CI Solvent Yellow 18; 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. Material and lenses are manufactured in the same manner as the predicate device, and details are contained in K990895. - II. Toxicology The toxicological testing is summarized below. - Agar Overlay Cytotoxicity: A. - B. Systemic toxicity: - C. Acute Ocular irritation: The lens material was shown to be non-toxic in all tests. - III. Microbiology The material has a water content less than 1%, and is therefore exempt from the microbiological requirements for hydrophobic contact lenses. #### IV. Clinical Studies The safety of the TYRO™-97 (hofocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lenses has been confirmed through a clivical, trial for daily wear contact lens materials according to the Premarket Notification [510(k)] Guidance Document for Daily Wear Contact Lenses (May 1994). ## OVERALL CONCLUSION OF THE CLINICAL STUDY: The data of the clinical trials demonstrate the safety of the TYRO™-97 (hofocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lenses. {4}------------------------------------------------ Public Health Service Image /page/4/Picture/2 description: The image is a black and white emblem for the Department of Health & Human Services - USA. The emblem features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol consisting of three overlapping profiles, which are meant to represent the health and well-being of individuals. ## NOV - 2 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 The Lagado Corporation c/o John M. Szabocsik, PhD Szabocsik and Associates 203 North Wabash Avenue Suite 1200 Chicago, IL 60601 Re: K052507 Trade/Device Name: TYRO-97 (hofocon A) Rigid Gas Permeable Contact Lens Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: September 8, 2005 Received: September 13, 2005 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. Insting 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. {5}------------------------------------------------ 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, permitts varied 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 (301) 827-8910. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. David M. Whipple Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ September 8, 2005 : ## 510(k) NUMBER (IF KNOWN) KO 5 2 5 0 7 DEVICE NAME TYRO™-97 (hofocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lens for Daily Wear #### INDICATIONS FOR USE The TYRO™-97 (hofocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal 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 presbyoptic and which may exhibit corneal astigmatism. The lenses may be disinfected only by using chemical disinfection Prescription Use X (Part 21CFR 801 Subpart D) OR Over-The-Counter-Use (Part 21CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)_ Concurrence of CDRH, Office of Device Evaluation (ODE) Myrabnith 10-1-44 Page 1 of 1 516 Number K052507 K.