EPIVISION SL SYSTEM

{0}------------------------------------------------ # 02 # Gebauer EpiVision™ SL SYSTEM JAN 1 6 2009 # 510(k) PREMARKET NOTIFICATION SUMMARY · Device Trade or Proprietary Name: Ep1Vision™ SL System •Common/Classification Name: Keratome, AC Powered ·Class: Class I ·Classification Panel: કર્ણ •Product Code HNO # ·Labeling: Federal (United States) Law restricts this device to sale by or on the order of a physician # · Predicate Devices for Substantial Equivalence Comparison: The EpIVision™ SL System is claimed to be substantially equivalent to the following currently marketed Predicate Devices | Manufacturer | Device Name | 510-K<br>number | Decision<br>Date | |-----------------------------------|------------------------------------------------------------------------------------------|-------------------------|------------------------------| | Gebauer<br>Medizintechnik<br>GmbH | EpiTome<br>System and Lasitome<br>System Keratome<br>AC powered<br>*Now EpiVision System | K041206 | 09/15/2004 | | BioVision | Visitome 20-10<br>Microkeratome | K014000<br>&<br>K042083 | 3/11/2002<br>&<br>11/16/2004 | * The name was changed from EpiTome to EpiVision System and LasiTome System on 06/10/2005 {1}------------------------------------------------ #### · Device Description: The EpiVision™ SL System is a fully automated, AC powered ophthalmic keratome system. The EpiVision™ SL System is used to produce a lamellar corneal flap in an Epithelial Separation or LASIK procedure. With these methods, the refraction of the comea is changed using a laser treatment, a comeal flap is created. However, this flap is not completely separated (except when an epithelial free flap is desired), but remains connected by a small segment of the flap to the eyeball. This segment is called the hinge. The hinge size, the advancing speed during cutting, and the oscillation frequency of the cutter are fixed parameters. The user cannot change these parameters. The EpiVision™ SL System's function is to remove an eye's upper corneal layer (epithelium) using an Epithelial Separation method or to create a cut in the epithelium of the cornea for using a LASIK operation method, after which the contour of the cornea is treated with a vision-correcting laser is not manufactured by Gebauer Medizintechik GmbH. The oscillating Separator/Blade, with fixed parameters creates a separation between the epithelium and Bowman's layers, or a cut in the epithelium. The EpiVision™ SL System is a motor driven Microkeratome which is composed of a Console with power-cable, a Handpiece with a removable Handpiece-cable, a Footswitch, with different colored Foot-pedals, a Single-Use-Set/Single-Use LASIK Set for EpiVision™ SL and a Disposable Tubing System for Epi Vision™ SL System. The Single-Use Set/Single-Use LASIK Set for EpiVision™ SL consists of a Head, a Suction-Ring and a Separator. The components should be assembled per the assembly description in Section 7 of the Users Manual. The EpiVision™ SL System is operated exclusively {2}------------------------------------------------ by the Footswitch. On top of the Console are LEDs which provide optical signals for "on" and "off" of the console, activated vacuum, vacuum level and run cycle. In addition to LEDs there are acoustical signals which sound when 0.75 bar vacuum is achieved, when the vacuum is deactivated, when the vacuum level drops below 0.6 bar during a run cycle, and when the Handpiece has reached the forward stop and the reverse stop. The EpiVision™ SL Control Console is comprised of a Vacuum. The EpiVision™ SL System includes a choice of sterile Single-Use Sets/Single-Use LASIK Sets to allow the System User to select the appropriate ring size and head on an individual patient basis. The EpiVision™ SL system is designed for use with disposable tubing that is readily available/commercially approved within the United States for other approved microkeratome systems. # •Indications for Use Statement: The EpiVision™ SL System is indicated for the following uses: The EpiVision™ SL System is indicated for the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea and for use in the making of a corneal flap in patients undergoing LASIK treatment. #### ·Clinical Performance Data No clinical performance data has been submitted. # · Non-Clinical Performance Data In-Vitro non-clinical performance data is provided in the submission. {3}------------------------------------------------ ## ·Rationale for Substantial Equivalence - The INTENDED USES and the OPERATING and CUTTING 1 PRINCIPLES (1e. Effectiveness) of the Gebauer Ep1Vision™ SL System are the SAME as the predicate devices - The OPERATIONAL FEATURES of the Gebauer Ep1V1s10n™ SL 2 System are the same/comparable to those offered to the predicate devices - The SAFETY FEATURES of the Ep1Vision™ SL System are the ಗ same, very similar or better to those offered on one or more of the predicate devices Therefore, in summary, the Ep1Vision™ SL System is substantially equivalent to the two identified predicate devices that have previously been allowed for commercial distribution in the United States, in terms of ALL key aspects of the device _ device effectiveness/operation, device intended usage, device features/surgical parameters and safety features #### ·Safety and Effectiveness 1 - 2 The EpIVision™ SL System is designed to comply with the electrical standards of the Underwriters Laboratories UL 2601-1 and has passed an unspection to these standards by an independent testing house Furthermore, the EpiVision, a sister device to the EpiVision™ SL System (devices are identical in terms of electrical and EMI issues) underwent independent scrutiny and testing by UL-Germany to assess the overall electrical safety and EMI safety UL-Germany after extensive evaluation determined that the Ep1Vision System met all electrical and electromagnetic compatibility (EMI) safety requirements set forth in the International Electro-technical Commissions (IEC) 60601-1 1988 +A1 +A2 (EN 60601-1-1990 + A1 +A2) International Electro-technical Commissions IEC 601-1-1 and IEC 601-1-2 which reasonably assures the device is safe when used as directed for its prescribed intended use {4}------------------------------------------------ Additionally several operational safety features are designed into the Ep1Vision™ SL (vacuum level gauge, a low suction LED and "audible tone" indicators, automatic cutting stop if vacuum level drops and forward and reverse foot pedal controls) The effectiveness of the device was confirmed during bench testing which was designed to evaluate the functional ability of the Gebauer EpiVision™ SL System to create highly precise epithelial incisions with constant cut thickness The Gebauer Epi Vision™ SL System does not raise any new issues of safety, effectiveness or performance of the device when compared to the existing predicate devices #### ·Conclusions The data submitted in this 510(k) Premarket Notification, for the Gebauer EpiVision™ SL System demonstrates that this product is substantially equivalent with respect to the indications for use, operating principles, operational features, and safety features to another legally marketed predicate device. With the information provided, the safety and effectiveness of the product can be reasonably assured, and we believe that this device clearly meets the requirement for a "Substantial Equivalence" decision in accordance with the 510(k) guidelines. {5}------------------------------------------------ Image /page/5/Picture/14 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Gebauer Medizintechnik GMBH c/o Kımberley Doney 54 Forest Street Lexington, Massachusetts 02421 JAN 1 6 2009 Re K072102 Trade/Device Name Ep1Vision™ SL System Regulation Number 21 CFR 886 4370 Regulation Name AC Powered Keratome Regulatory Class I Product Code HNO Dated January 12, 2009 Received January 13, 2009 Dear Ms Doney 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 {6}------------------------------------------------ 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, 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464 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 (240) 276-3150 or at its Internet address http //www fda gov/cdrh/industry/support/index html Sincerely yours, Malvina B. Eystad, ud Malvina B. Eydelman, MI Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ # Indications for Use 510(k) Number (if known): Original Premarket Notification Device Name: EpiVision™ SL System Indications for Use: The EpiVision™ SL System is indicated for the separation of the epithelium from the comea in preparation for subsequent surgical procedures on the denuded comea and for use in the making of a corneal flap in patients undergoing LASIK treatment. Prescription Use X (Part 21 CFR 801 Subpart D) Page _1_ of__1_ 6 Daryl L. Kaufman (Division Sign-Off) Division of Or: Thairms . . . . . . Nose and Throal Davices 510(k) Number_