MINI 6800 DIGITAL MOBILE C-ARM

{0}------------------------------------------------ AUG 19 1999 K992506 Image /page/0/Picture/2 description: The image shows the logo for OEC Medical Systems, Inc. The logo consists of the letters "OEC" stacked on top of each other. The "O" and "C" are curved, and the "E" is made up of three horizontal lines. Below the letters, the words "OEC MEDICAL SYSTEMS, INC" are printed in a smaller font. 384 WRIGHT BROTHERS DRIVE SALI LAKE CITY. UTAH 84116 80L−328−9300 「AX 801−328−4300 # 510(k) SUMMARY This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. #### Date: July 23, 1999 #### Name of Submitter: OEC Medical Systems, Inc. 384 Wright Brothers Drive Salt Lake City, UT 84116 801-328-9300 #### Corresponding Official: Ted L. Parrot, Vice President, Quality Assurance & Regulatory Affairs. #### Device Proprietary Name: MINI 6800 Digital Mobile C-arm ### Classification Name: Mobile X-ray System ## Common/Usual Names: Mini C-arm Mobile C-arm {1}------------------------------------------------ #### Substantial Equivalence: The MINI 6800 Digital Mobile C-arm is substantially equivalent to the following devices that are currently marketed: - MINI 6600 Digital Mobile C-arm . - FluoroScan Premier - ORCA Orthopedic C-arm . All of these devices are mobile C-arm type diagnostic x-ray systems intended for fluoroscopic imaging, particularly during orthopedic procedures and extremity examinations. All systems include a high-voltage x-ray generator, stationary anode x-ray tube, image intensifier, video image display, digital image processing and image storage capability. #### Device Description: Indications for Use The MINI 6800 Digital Mobile C-arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric imaging. #### User Characteristics The device is used by health care professionals such as medical doctors, surgeons, radiologists and technologists in a hospital or clinical environment. In addition to being qualified within their respective medical fields, users must be trained in the use of medical x-ray equipment. OEC applications specialists train the user in the proper use of this product. The device labeling stipulates that only properly trained persons operate this equipment. #### General Description The OEC mobile workstation, which supports image display monitors, image processing and recording devices, is combined with a miniature C-arm to create the MINI 6800 Digital Mobile C-arm. Interfaces are provided for optional peripheral devices such as thermal or laser printers and VCRs. Video outputs are compatible with RS-170 format for North American markets, CCIR format for international markets, and DICOM 3.0. The MINI 6800 has the following physical characteristics: - . All components are contained in one mobile workstation. - . An articulating arm is attached to the workstation and extends out from the main cabinet to position the x-ray imaging components. - . All mechanical positioning of the workstation and articulating arm is manual (nonmotorized). - . The system is powered by a non-detachable power cord. - Power ratings between 100-240 VAC, 4-6 Amps at 50/60 Hz. . - . Internal system power is insulated from input power by an isolation transformer. - Fluoroscopic operation: . {2}------------------------------------------------ AUG 19 333 - -- 40 to 80 kVp - -- 20 to 160 µA (0.020 to 0.160 mA) - Automatic Exposure Rate Control Major components of the system include: - Dual video monitors . - Input isolation transformer . - Digital image processing and x-ray control . - Monoblock X-ray tube and high-voltage power supply . - lmage intensifier ● ### Standards: The MINI 6800 Digital Mobile C-arm is designed in accordance with product safety requirements established in the following standards: | 21 CFR 1020.30-32 | Federal Performance Standard for Diagnostic X-ray Systems | |-------------------------|------------------------------------------------------------------------| | ANSI/NFPA 70 & 99 | National Electrical Code and Standard for Health Care Facilities | | UL 2601 | Medical Electrical Equipment | | CSA-C22.2 No. 601.1-M90 | Medical Electrical Equipment | | IEC 60601-1 | Medical Electrical Equipment, General Requirements for Safety | | IEC 60601-1-2 | Medical Electrical Equipment, Electromagnetic Compatibility | | IEC 60601-1-3 | Medical Electrical Equipment, Radiation Protection in Diagnostic X-ray | | IEC 60601-1-4 | Medical Electrical Equipment, Programmable Electrical Medical Systems | | IEC 60601-2-7 | Medical Electrical Equipment, Safety of HV/X-ray Generators | | IEC 60601-2-28 | Medical Electrical Equipment, X-ray Tubes and X-ray Source Assemblies | | IEC 60601-2-32 | Medical Electrical Equipment, Safety of Associated X-ray Equipment | | 93/42/EEC - Annex 1 | Essential Requirements of the Medical Devices Directive | This concludes this 510(k) Summary. Aano Ted L. Parrot, Vice President, Quality Assurance & Regulatory Affairs OEC Medical Systems, Inc. K992526 {3}------------------------------------------------ Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, surrounded by a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is written around the border of the circle. The eagle is composed of several curved lines, giving it a modern and abstract appearance. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Mr. Ted L. Parrot Vice President, Quality Assurance & Regulatory Affairs OEC Medical Systems, Inc. 384 Wright Brothers Drive SALT LAKE CITY UT 84116 NOV 1 7 2011 Re: K992506 Trade/Device Name: Mini 6800 Digital Mobile C-Arm Regulation Number: 21 CFR 892.1650 Regulation Name: Image intensified fluoroscopic x-ray system, mobile Regulatory Class: II Product Code: OXO Dated: July 23, 1999 Received: July 27, 1999 Dear Mr. Parrot: This letter corrects our substantially equivalent letter of August 19, 1999. 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 (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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please Note: CDRH does not evaluate information related to contact liability warranties. We remind you: however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 {4}------------------------------------------------ comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely Yours. Michael D'Antoni to_ Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Indications For Use Statement OEC Medical Systems, Inc. Applicant: 510(k) No. (if known): MINI 6800 Digital Mobile C-arm Device name: The MINI 6800 Digital Mobile C-arm is designed to provide the Indications for use: The Mini 0000 Digital Mobile copic visualization of the patient physician with general habrosoopal orthopedic and extremity imaging. ificiding but not limited to fargit or whole-body pediatric imaging. .. . # (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE) **Prescription Use** √ OR Over-The-Counter (Per 21 CFR 801.109) Thirl le beym (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K992506 (Optional Format 1-2-96)