SCLERAL SHELL

{0} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Xavier A. Guerra, Ocularist 4640 Centerview Drive San Antonio, TX 78228 JUL - 7 1997 Re: K970320 Trade Name: Scleral Shell Regulatory Class: II Product Code: 86 HQT Dated: April 15, 1997 Received: April 21, 1997 Dear Mr. Guerra: 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. {1} Page 2 - Mr. Xavier A. Guerra, Ocularist 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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours,  A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2} Page 1 of 1 510(k) Number (if known): K970320 Device Name: SCLERAL SHELL Indications For Use: The Custom Scleral Cover Shell, is an ocular prosthesis, (artificial eye), fitted over a deformed, or disfigured blind eye, or over an eviscerated globe, for a specific patient. Scleral Cover Shells are also indicated for patients with Microphthalmia, Phthisis Bulbi, or other types of eye deformities. In cases of infants and children with microphthalmia, and /or anophthalmia, the orbital fascia, bony orbit, and palpebral fissures, will be provided with the volume and surface area necessary to develop more normally, thus avoiding the complication of future deformities and possible corrective surgery. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CORH, Office of Device Evaluation (ODE) Prescription Use ☑ (Per 21 CFR 801.109) Over-the-Counter Use ☐ (Optional Format 1-2-96) Donna Vechner (Division Sign-Off) Division of Ophthalmic Devices 510(k) Number K970320