DDRCOMBI TRAUMA

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Swissray, a company that specializes in direct digital X-ray technology. The logo features the word "Swissray" in a bold, sans-serif font, with the tagline "FIRST IN DIRECT DIGITAL X-RAY" printed below it in a smaller font. To the right of the company name is a graphic of four squares arranged in a 2x2 grid. RRG/LLD 1/6/93 Rev. 2/6/96 Dreard premarket Notification 510(k) Screening Checklist 510(k) Number & Device Name: ddRCombi TRAUMA__ Company: Swissray Medical AG | Item | Present | | Needed | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-----------------------------|-----------------------------| | | Yes | No | Y/N ? | | 1. General Information (i.e., trade & classification name, Est. Reg. No. Device class, meets special controls or A performance standards, etc.) | | | | | - Reason for 510(k) – new device or modification | <div align="center">☑</div> | <div align="center">□</div> | <div align="center">☑</div> | | - Identification of legally marketed equivalent device | <div align="center">☑</div> | <div align="center">□</div> | <div align="center">☑</div> | | - Truthful and accurate statement | <div align="center">☑</div> | <div align="center">□</div> | <div align="center">☑</div> | | - SMDA 510(k) summary or statement | <div align="center">☑</div> | <div align="center">□</div> | <div align="center">☑</div> | | 2. Proposed Labeling, Labels, Advertisements | | | | | - Description of new device/modification | <div align="center">☑</div> | <div align="center">□</div> | <div align="center">☑</div> | | - Intended use statement | <div align="center">☑</div> | <div align="center">□</div> | <div align="center">☑</div> | | - Diagrams, Engineering Drawings, Photographs | <div align="center">☑</div> | <div align="center">□</div> | <div align="center">☑</div> | | - Indication for use Statement | <div align="center">☑</div> | <div align="center">□</div> | <div align="center">☑</div> | | 3. Comparison of similarities / differences<br>Legally marketed equivalent device<br>Please provide tabular comparison of specifications and Features to one of your predicate devices utilizing one Comparison chart | <div align="center">☑</div> | <div align="center">□</div> | <div align="center">☑</div> | | - Equivalent Device Labeling, Labels, Advertising | <div align="center">☑</div> | <div align="center">□</div> | <div align="center">☑</div> | | - Intended use of equivalent device | <div align="center">☑</div> | <div align="center">□</div> | <div align="center">☑</div> | | 4. List all patient contracting materials in new device | <div align="center">☑</div> | <div align="center">□</div> | <div align="center">☑</div> | | Comparison of materials to equivalent device | <div align="center">☑</div> | <div align="center">□</div> | <div align="center">☑</div> | | 5. Biocompatibilität information / data for patient<br>Contacting materials, or certification - identical material / formulation | <div align="center">☑</div> | <div align="center">□</div> | <div align="center">☑</div> | | 6. Performance data : bench data<br>Please provide phantom data for resolution, gray scale and Contrast, also provide full MTF curve data, | <div align="center">☑</div> | <div align="center">□</div> | <div align="center">☑</div> | | Animal data | <div align="center">□</div> | <div align="center">☑</div> | <div align="center">☑</div> | | Clinical data | <div align="center">☑</div> | <div align="center">□</div> | <div align="center">☑</div> | | 7. Sterilization information | <div align="center">□</div> | <div align="center">☑</div> | <div align="center">□</div> | | 8. Harware / Software validation & verification | <div align="center">☑</div> | <div align="center">□</div> | <div align="center">☑</div> | | 9. If class III, class III Certification & Summary | <div align="center">□</div> | <div align="center">☑</div> | <div align="center">□</div> | | 10. If kit, kit certification | <div align="center">□</div> | <div align="center">☑</div> | <div align="center">□</div> | | 11. Provide prescription labeling in your User manual | <div align="center">☑</div> | <div align="center">□</div> | <div align="center">☑</div> | | 12. Your device is consider a Tier 1 device and requires MFR statement of SE and DRAERD Checklist | <div align="center">☑</div> | <div align="center">□</div> | <div align="center">☑</div> | {1}------------------------------------------------ # 1. General Information # 1.1 Name and address of manufacturer Swissray Medical AG Turbistrasse 25 ... 27 CH-6280 Hochdorf Switzerland Primary Contact | | Swissray America Inc.<br>Submission correspondent | |----------|---------------------------------------------------| | Resp. | Mr. John Monahan | | Date | 2005-03-15 | | Address | 1180 Mclesterstreet Unit #2 | | City | Elizabeth | | ZIP Code | NJ 07201 | | Country | USA | | Phone | 001 908 35 30 971 | | FAX | 001 908 35 31 237 | | E-mail | JMonahan@swissray.com | #### 1.2 Establishment registration number 8043768 #### 1.3 Classification, common and proprietary names of the device Classification Name: Stationary X-ray system, 21 CFR 892.1680 Stationary X-ray system Common names: Proprietary Names: ddRCombi TRAUMA ddRCombi TRAUMA components - X-ray detector AddOn-bucky - Collimator - X-ray tube - X-ray Generator and eXpert 4000 control desk + application selection - Movable Stand - Ceiling suspension - Height adjustable fix table IGS TRAUMA - Workstation (Image processing) 1.4 Class Class II {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for Swissray. The logo consists of the word "Swissray" in a bold, sans-serif font, with a stylized graphic to the right. The graphic is made up of four squares arranged in a 2x2 grid. Below the word "Swissray" is the text "FIRST IN DIRECT DIGITAL X-RAY" in a smaller font. # 1.5 Applicable Standards Code of Federal Regulations Title 21 subchapter J - Radiological Health, Part 888 Parts 1020.10, 1020.30, 1020.30, 1020.31 and 1020.40 Note: Swissray is not a manufacture of video monitors and film printers IEC / EN 60601-1 Electrical Safety UL 60601-1 and CSA 22.2 No. M601.1 IEC / EN 60601-2-32 Mechanical safety IEC / EN 60601-1-2 EMC IEC / EN 60601-1-3 X-ray Protection IEC / EN 60601-2-7 X-ray Generator IEC / EN 60601-1-4 Risk analysis for programmable medical electrical systems IEC / EN 60601-2-28 SAFETY OF X-RAY SOURCE ASSEMBLIES AND X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS DICOM 3.0 HL-7 Data Exchange Standard IHE ARC / NEMA Data Exchange Standard Quality System ISO EN 9001:2000 and ISO EN 13485:2000 (CAN + ECC) {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a blue emblem on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in blue on the right. The emblem features a stylized human figure with outstretched arms, representing the department's mission to protect the health of all Americans. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002 Swissray Medical AG % Mr. John Monahan QA Manager Swissray Int., Inc. 1180 Mclester Street, unit #2 ELIZABETH NJ 07201 AUG 2 3 2013 Re: K050718 Trade/Device Name: ddRCombi Trauma Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: March 16, 2005 Received: April 6, 2005 Dear Mr. Monahan: This letter corrects our substantially equivalent letter of May 26, 2005. 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, listing 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 {4}------------------------------------------------ medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) 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 {5}------------------------------------------------ 510 (K) Number: K050718 Device name : ddRCombi Trauma Indication for Use The Swissray Medical AG Direct Digital X-ray Radiography diagnostic system class II (stationary) ddRCombi Trauma is a further development of the AddOn Multi System. This system can be used in a standard X-ray room and suitable for emergency / Trauma X-ray rooms. The ddRCombi Trauma is intend for applying general radiography on a patient in a supine, seated or standing position. With the fix height adjustable patient table and the new flexible detector positioning, the patient must be no more repositioned for the most X-ray applications. The ddRCombi Trauma allows the operator a full control of the Patient data, positioning, X-ray parameter (automatic by organ selection or manual settings), exposure control and image quality. The operator can use the following image control functions without losing the original exposure: Brightness, contrast, shape, rotate, zoom, inverse, cut off etc. l Storage function (PACS, HL 7) included all X-ray parameter and patient information . The ddRCombi Trauma allows the operator to print images (DICOM format) in background on a laser printer (the most printer suppliers are available) or CD-ROM. The major system components are: fix height adjustable patient table, X-ray generator, X-ray tube, Collimator, stand, ceiling suspension, digital AddOn bucky (4 CCD cameras), Image processing software and monitors. (Please do not write below this line- continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (DOE) Prescription Use or Over-The Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96) Yancy C. Bringham (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices K050718 510(k) Number