SURESMILE SYSTEM

{0}------------------------------------------------ K002620 NOV 1 6 2000 ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (21CFR 807.92) #### I. DATE PREPARED: August 28, 2000 - II. SUBMITTER: OraMetrix, Inc. 12740 Hillcrest Road Suite 100 Dallas, Texas 75230 - III. CONTACT PERSON: Nancy Butcher Director of Quality Assurance & Regulatory Affairs OraMetrix, Inc. (972)-728-5534 - IV. DEVICE NAME: Trade/Proprietary Name: SureSmile™ System Common Name: 3-D Intraoral Camera and Accessories - V. DEVICE CLASSIFICATION Class I under 21 CFR 872.6640. - VI. PREDICATE DEVICE: Spectra Vu 1000 Series Intraoral Camera and Accessories K984332 Class I Decision Date: 04/29/99 #### VII. SUBSTANTIAL EQUIVALENCE CONCLUSIONS: OraMetrix, Inc. concludes that the intended use for the OraMetrix SureSmile™ System is the same as that of the predicate device, and that the technological characteristics demonstrate that they are equivalent to the predicate device. A comparison of the technological characteristics of the predicate and legally marked devices available has been performed. Thus, this premarket notification has demonstrated substantial equivalence. {1}------------------------------------------------ #### DEVICE DESCRIPTION AND INTENDED USE: VIII. The OraMetrix SureSmile System is a complete image management system capable of acquisition, transmission, archive, display and print of patient images and demographic information. Its purpose is to facilitate these operations utilizing shared data to promote the availability of information locally, remotely, and at other facilities other than which it was acquired. The process begins by using the OraScanner to obtain a three-dimensional digital image of the dentition to provide the orthodoniist a 3-D view of the teeth. These images may be integrated with other patient records to establish a three-diment objective. This treatment objective is then used to design a custom appliance system, prescribed by the orthodontist, which is specific to each patient's needs. Follow up scans using the OraScanner allow the orthodontist to precisely monitor patient progress through the entire treatment. Systems are configured to meet the customer's needs. Fully integrated systems could enable orthodontist to utilize speech recognition. #### IX. THE DEVICE The general hardware configuration of the systems may contain the following major components: Connectivity and comparability are evaluated and ensured via the integration test processes internal to OraMetrix, Inc. -SureSmile™ OraScanner -Monitors -Central Processing Units (CPU, memory, disks, microphone, speakers) -Film and Document scanners -Digital camera -CD-ROM writer / reader -Optical Disk Libraries -RAID array -DLT Tape Libraries -9840 Tape Libraries -CD-R writer / reader -DVD-R writer / reader #### X. INDICATION FOR USE The SureSmile™ System is used to provide a total orthodontic care solution to orthodontists with an image acquisition and viewing technology that delivers value throughout the entire care cycle: including record collection, treatment planning, treatment delivery, monitoring of care and patient communication. This treatment objective is then used to design a custom appliance system, prescribed by the orthodontist, which is specific to each patient's needs. The result is a comprehensive care solution that addresses many problems that orthodontists face with patient care. The OraScanner is not intended for use as an operative device and is not manufactured to be sterile. {2}------------------------------------------------ #### SAFETY INFORMATION: XI. The System has limited patient contact and is utilized only by trained professionals. The scanner tips are removable to be sterilized between uses. The hand held unit has been designed to be wiped clean with commercially available disinfectant between uses. Additional trained professionals allowing sufficient review to afford identification and intervention in the event of a malfunction have evaluated the output of the device. Selection of the specific components of the system has been made to allow the system to remain cost effective and consistent with current technology through the substitution of components as technology develops. By retaining criteria for the substitution of components, any concerns about safety or efficacy and substantial equivalence can be satisfactorily met by a determination that the component substitution is not a significant change in the system. This is consistent with the existing Agency guidance. #### CONCLUSION [21 CFR: 807.92(b)(3)] XII. OraMetrix, Inc. believes sufficient information is included to reach a determination of substantial equivalence. We conclude that the subject device is as safe and effective including the component and accessory devices. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image contains the text "Public Health Service". The text is in a bold, sans-serif font. The text is black and the background is white. Image /page/3/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 1 6 2000 Ms. Nancy Butcher MB. Nancy Buccher ORA Metrix, Incorporated 12740 Hillcrest Road, Suite 100 Dallas, Texas 75230 K002620 Re : SureSmile System Trade Name: Regulatory Class: I Product Code: EIA Dated: August 23, 2000 Received: August 23, 2000 ### Dear Ms. Butcher: We have reviewed your Section 510(k) notification of intent to we nave reviewed your benced above and we have determined the market the device ially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate use stated in the chercours, e commerce prior to May 28, 1976, devices marketou in firthe Medical Device Amendments, or to the enactment dace on reclassified in accordance with the devices that have been il Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general The general controls controls provisions of the Act. controis provisions of the Act include requirements for annual listing of devices, good manufacturing practice, registration, 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 be subject to back addroundevice can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਮ rebetantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set the Current System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Chrough periodic go insploverify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: concerning your aremarket notification submission does this response co your promeined not have under sections 531 {4}------------------------------------------------ Page 2 - Ms. Butcher through 542 of the Act for devices under the Electronic cillough 342 or enc 1100 provisions, or other Federal laws or regulations This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Additionally, for questions on Compliance at (301) 594-4692. the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note "Misbranding by reference to the regulation entitled, premarket notification" (21CFR 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/dsma/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # 510(k) Number (if known): KOOQL CQU Device Name: SureSmile™ System Indications for Use: The SureSmile™ System is used to provide a total orthodontic care solution to orthodontists with an image acquisition and viewing technology that delivers value throughout the entire care cycle; including record collection, treatment planning, treatment delivery, monitoring of care and patient communication. This treatment objective is then used to design a custom appliance system, prescribed by the orthodontist, which is specific to each patient's needs. The result is a comprehensive care solution that addresses many problems that orthodontists face with patient care. The OraScanner is not intended for use as an operative device and is not manufactured to be sterile. ## (PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (OBE) Prescription Use (Per 21 CFR 801.109) Over the Counter Use Susan Russer (Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 5 : 04 k) Number .