IMPERIUM

{0}------------------------------------------------ 510(k) Application IMPERIUM K022114 # ELMSTech INC. 950 JERICHO TURNPIKE WESTBURY, NEW YORK 1 1590, USA TEL: (516) 338 9888 FAX: (516) 338 9889 SEP 1 7 2002 20 JUN 2002 # 510(k) Summary This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. 1. Applicant ELMSTECH, INC. 950 JERICHO TURNPIKE WESTBURY, NEW YORK 11590, USA TEL: (516) 338 9888 FAX: (516) 338 9889 CONTACT PERSON: ROBERT MANNERS PRESIDENT - 2. Device Identification | Proprietary Device Name: | IMPERIUM MOBILE C-ARM X-RAY<br>EQUIPMENT | |-----------------------------|------------------------------------------| | Common/Generic Device Name: | MOBILE C-ARM X-RAY EQUIPMENT | | Classification Name: | SYSTEM, X-RAY, MOBILE | | Product Code: | OWB, JAA & OYO | | Regulatory Class: | Class II | | Regulation Number: | 21 CFR 892.1720 + 892.1650 | {1}------------------------------------------------ ### 3. Substantial Equivalence The IMPERIUM MOBILE C-ARM X-RAY EQUIPMENT is substantially equivalent to the following currently marketed devices: - GE OEC 9800 PLUS (K021049) ● - SIEMENS MEDICAL SIREMOBIL ISO-C (K973598) . ## 4. Description of Device The IMPERIUM is a mobile c-arm x-ray imaging equipment consisting of a carm stand and a monitor trolley. The c-arm stand holds the high-frequency x-ray generator, x-ray tube assembly, x-ray controls, image intensifier and TV camera. Monitor trolley supports the image display monitors, image processing and recording devices. The IMPERIUM is designed to provide the user with smooth lincar and rotational movements around patient without need of further reorientations. The C-arm movements are fully motorized for ease of operation. The IMPERIUM is designed according to such principles as lower dosage, better image quality and manipulation, workflow enhancement, operator and patient comfort and versatility. The IMPERIUM can be operated at Fluoroscopy, Pulsed Fluoroscopy, Digital Radiography, Cassette Radiography, Digital Subtraction Angiography (DSA) and Roadman modes. Image processing and storage capabilities such as last image hold, recursive filtering, real time edge enhancement, real time zooming, image reversal, continuous image rotation, radiation-free collimation and contrast/brightness adjustment are possible under user control. # 5. Intended Use The IMPERIUM is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to digital subtraction angiography (DSA), orthopedic, neurologic, abdominal, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at physician's discretion. #### 6. Technological Characteristics The IMPERIUM employs the same technological characteristics as the predicate devices. This device is intended for the same applications as the currently {2}------------------------------------------------ #### 510(k) Application #### IMPERIUM marketed predicate devices. All systems are image intensified mobile c-arm x-ray imaging systems with fluoroscopic and cassette exposure capabilities. Like the predicate devices. IMPERIUM consists of a c-arm stand, and standard system components: x-ray generator, x-ray tube, Image Intensifier, TV system and a monitor trolley. The IMPERIUM is designed to give the best movement controls to the operator for quick and accurate imaging of the patient in order to save the dose and time. The orbital movement range of c-arm is 190°. The horizontal travel range is 20 cm and vertical travel range is 40 cm. The horizontal swivel range is ±12.5°. A large c-arm depth of 78 cm provides the user with comfortable patient access for the examinations. The image intensifier can be moved in up/down direction independently up to 20 cm to have less source-to-image intensifier distance. With this feature user can concentrate better on a specific region of interest while decreasing the dose applied and getting a better image quality. - Isocentric C-arm ● - Wide Orbital Angle range of 190° - Large x-ray tube to image intensifier distance of 78 cm - Independent source to image intensifier distance adjustment of 20 cm . - . Fully motorized movements ## 7. Standards The IMPERIUM is designed in accordance with the national and international product safety and performance requirements established in the following standards given in Table-1: | 21 CFR 1020.30-32 | FEDERAL PERFORMANCE STANDARD FOR<br>DIAGNOSTIC X-RAY SYSTEMS | |----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------| | ANSI/NFPA 70&99 | NATIONAL ELECTRICAL CODE and STANDARD for<br>HEALTHCARE FACILITIES | | UL 2601 | MEDICAL ELECTRICAL EQUIPMENT | | CSA-C22.2 No.<br>601.1-M90 | MEDICAL ELECTRICAL EQUIPMENT | | IEC 60601-1-1 | Medical Electrical Equipment-Part 1 General Requirements<br>for Safety" with Ammend 1 and 2 | | IEC 60601-1-2 | Medical Electrical Equipment-Part 1 General Requirements<br>for Safety-2. Collateral Standard: Electromagnetic<br>Compatibility-Requirements and Tests | {3}------------------------------------------------ | IEC 60601-1-3 | Medical Electrical Equipment-Part 1 General Requirements<br>for Safety-3. Collateral Standard: General Requirements for<br>radiation protection in diagnostic x-ray equipment | |----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | IEC 60601-2-7 | Medical Electrical Equipment-Part 2 Particular<br>Requirements for the Safety of high-voltage generators of<br>diagnostic x-ray generators | | IEC 60601-2-28 | Medical Electrical Equipment, X-Ray Tubes and X-Ray<br>Source Assemblies | | IEC 60601-2-32 | Medical Electrical Equipment-Part 2 Particular<br>Requirements for the Safety of associated equipment of x-<br>ray equipment | Table-1 Product Performance and Safety Standards Results of performance and compliance testing conducted at manufacturing facility and independent test organizations on IMPERIUM system, indicates conformance to all applicable performance standards promulgated by FDA for these systems. 8. Conclusion Based on the comparison to other devices in technological characteristics and intended usc, the IMPERIUM c-arm mobile x-ray imaging system is substantially equivalent to the predicate devices. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, rendered in a blue color. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 ELMSTech. Inc. % Mr. Tim Mangeruga Legal Assistant Manners & Associates. P.C. 950 Jericho Turnpike, Suite 100 WESTBURY NY 11590-1597 MAY 22 2012 Re: K022114 Trade/Device Name: Imperium Mobile C-arm X-Ray System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA and OXO Dated: June 21, 2002 Received: June 28, 2002 Dear Mr. Mangeruga: This letter corrects our substantially equivalent letter of November 14. 2011. 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809): medical device reporting (reporting of {5}------------------------------------------------ medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html. Sincerely Yours, Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ 510/k) Application IMPERIUM # STATEMENT OF INDICATIONS FOR USE ELMSTECH, INC. Applicant: > 950 JERICHO TURNPIKE WESTBURY, NEW YORK 11590, USA PHONE: (516) 338-9888 FAX: (516) 338-9889 KO22114 510(k) NUMBER: IMPERIUM MOBILE C-ARM X-RAY IMAGING DEVICE NAME: EQUIPMENT # INDICATIONS FOR USE: The IMPERIUM is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to digital subtraction angiography (DSA), orthopedic, neurologic, abdominal, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at physician's discretion. *Prescription Use* David A. Ingram (Division Sign-Off) Division of Reproductive. Ahdominal and Radiological Devicies 510(k) Number _