SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a logo for Bio Med Sciences, Inc. with the letters "BMS" in a stylized font. The text "Bio Med Sciences, Inc." is printed below the logo. The image also includes the date "DEC 7 1998" and the text "FDA/CDRH/ODE/DMC". K98 No 65 101 Technology Drive . Bethlehem, PA 18015 Phone: (610) 974-8801 FAX: (610) 974-8831 Toll Free: 1-800-25-SILON (257-4566) http://www.silon.com Summary 510 (k) Premarket Notification #### CONTACT PERSON Mark E. Dillon, President, Bio Med Sciences, Inc. ### PRODUCT NAME Silon® Topomat™ Corneal Topography Image Enhancement Device ### PRODUCT DESCRIPTION The Silon Topomat device provides a convenient method of imaging the surface of the cornea with existing corneal topography apparatuses while avoiding the use of dves and wetting agents. The Silon Topomat device consists of a hydrophobic silicone-based membrane. It can accurately contour to irregular surfaces, closely following even minute topographical features. The membrane is fixed within two couplings as to provide a rigid ring structure in the form of a "drum-head" of approximately 13 millimeters in diameter. The ring has a gripping tab on one edge to facilitate handling and serve as an orientation reference. The membrane is applied against the surface of the cornea, and an accurate topographic image is obtained directly from the distal surface of the membrane using videokeratographic or rasterstereographic imaging techniques. #### PRODUCT EQUIV ALENCY Bio Med Sciences claims substantial equivalency for Silon Topomat to the following devices: # 1. Silon® Transparent Wound Dressings (K912032 & K923150) Bio Med Sciences, Inc. 101 Technology Drive Bethlehem, PA 18015 USA Silon interpenetrating polymer network of polydimethylsiloxane and polytetrafluoroethylene in membrane form used on de-epithelialized dermal tissue. # 2. SilSoft® Aphakic Extended-Wear Contact Lens Bausch & Lomb One Bausch & Lomb Place P.O. Box 450 Rochester, NY 14692 ⁶⁰ Registered Trademark, Bio Med Sciences, Inc. {1}------------------------------------------------ 510(k) Premarket Notification Summary Silon® Topomat™ Corneal Topography Image Enhancement Device Bio Med Sciences, Inc., Bethlehem, PA Page 2 of 2 > Soft contact lens made from Elastofilcon A™ polydimethylsiloxane from Dow Corning corporation. Used in direct contact with the human eye. #### 3. Fluorescein Dye Akorn. Inc. 100 Akorn Drive Abita Springs, LA 70420 Used as an image enhancement dye for corneal topographic mapping. #### BIOCOMPATIBILITY SUMMARY The Silon membrane passes the Tripartite Biocompatibility Guidance for Medical Devices as prepared by the Toxicology Sub-group of the Tripartite Sub-Committee on Medical Devices (September 1986) as related to external devices contacting breached surfaces for short durations. The tests were performed by an FDA registered independent testing company (Toxicon Corporation of Woburn, MA). The data can be summarized as follows: | Test | Results | Toxicon Reference | |------------------------------|------------------------------------|-------------------| | Kligman Maximization | Non-sensitizing (0% sensitization) | 91G-0388 | | Primary Dermal Irritation | Non-irritant (PDII = 0) | 91G-0387 | | Hemolysis | Non-hemolytic (2.0 %) | 90G-0670 | | Agarose Overlay Cytotoxicity | No cytopathic effects (grade 0) | 90G-0669 | | MEM Cytotoxicity | Non-cytotoxic (grade 0) | 90G-0668 | Bio Med Sciences has taken the following position relative to the use of the proposed materials: - 1) The Silon membrane material is the corneal contacting surface of the device, and therefore is the material of interest with respect to biocompatibility. - 2) In all biocompatibility tests conducted to date, the Silon membrane has never induced a negative biological response. - 3) The Silon membrane is presently used for woundcare applications wherein it is in direct contact with de-epithelialized tissue for up to 10 days. - 4) The device is only used intermittently for short periods, and therefore is not subject to more rigorous biocompatibility requirements. - 5) Although not in direct contact with the patient, the polyethylene ring and the opacifying agent are known to be generally regarded as safe and are both sterilizable by the EtO method. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 7 1998 DEC Mr. Mark E. Dillon President Bio Med Science, Inc. 101 Technology Drive Bethlehem, PA 18015 Re: K981665 Trade Name: Silcon® Topomat ™ Corneal Topography Image Enhancement Device Regulatory Class: I Product Code: 86 MMQ Dated: November 13, 1998 Received: November 18, 1998 Dear Mr. Dillon: 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 . {3}------------------------------------------------ Page 2 - Mr. Mark E. Dillon, President 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 Roerl Rosenthal A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # INDICATIONS FOR USE 510(k) Number: K981665 Device Name: Silon® Topomat™ Corneal Topography Image Enhancement Device Indications For Use: For the measurement of the topographical surface of the cornea using rasterstereographic imaging techniques. Evelyn Horton Boone 510(k) Number **Prescription Use** (Per 21 CFR 801.109) ^® Registered Trademark, Bio Med Sciences, Inc.