DX-D 300

{0}------------------------------------------------ ## 510(K) SUMMARY: AGFA DX-D 300 Common/Classification Name: Stationary System, 21 CFR 892.1680 Proprietary Name: DX-D 300 Agfa HealthCare N.V. Septestraat 27 B-2640 Mortsel Belgium Contact: Phil Cuscuna, Prepared: September 24, 2010 Telephone: (416) 240-7317 Facsimile: (416) 240-7359 # QCT 2 9 2010 #### LEGALLY MARKETED PREDICATE DEVICES A. This is a 510(k) for Agfa's DX-D 300, which is a combination of the two predicate devices: Agfa's DX-D Imaging Package (K092669) and Sedecal's X Plus LP Plus x-ray system (K062335). #### DEVICE DESCRIPTION B. The device is a combination of a conventional x-ray system with digital image capture equipment. The new device is a simple combination of the two predicate devices with minor modifications. The DX-D 300 uses Agfa's familiar NX workstation with MUSICA-TM image processing and flat panel detectors of the scintillator-photodetector type (Cesium lodide or Gadolinium Oxysulfide), With the new device, users have the ability to control patient exposure settings from the NX workstation. Principles of operation and technological characteristics of the new and predicate devices are the same. #### C. INTENDED USE Agfa's DX-D 300 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts. Agfa's DX-D 300 is not indicated for use in mammography. #### SUBSTANTIAL EQUIVALENCE SUMMARY D. Agfa's DX-D 300 has an Indications For Use statement nearly identical to the statements for the two predicate devices (Agfa DX-D Imaging Package and the Sedecal X Plus LP Plus). Intended uses are the same. The devices have the same technological characteristics. Descriptive characteristics and performance data are adequate to ensure equivalence. Differences in devices do not alter the intended therapeutic/diagnostic effect. : : :: {1}------------------------------------------------ | PRODUCT COMPARISON TABLE | | | | |-----------------------------------|---------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | AGFA DX-D 300<br>(NEW DEVICE) | AGFA DX-D Imaging<br>Package (PREDICATE-<br>K092669) | Sedecal X-Plus LP Plus<br>(PREDICATE-K062335) | | Communications | Same as predicate | DICOM | N/A | | Detector Material | Same as predicate | Gadolinium Oxysulfide<br>(GOS) or Cesium Iodide<br>(CSI) scintillator | N/A | | Detector Sizes | Same as predicate | 14x17 in. & 17x17 in | N/A | | Active Matrix | Same as predicate | 3056x3056 (17x17 in.)<br>3072x2560 (17x14 in.) | N/A | | Pixel size | Same as predicate | 139 µm | N/A | | Fill factor | Same as predicate | 100% | N/A | | Dynamic Range | Same as predicate | 14 bit DR, 12 bit CR | N/A | | Maximum Image<br>Acquisitions/hr. | Same as predicate | 150 | N/A | | Image processing | Same as predicate | MUSICA2 | N/A | | Operating system | Same as predicate | Windows XP Pro | N/A | | Display System | Same as predicate | Standard PC display or<br>separately cleared medical<br>display (e.g. K051901) | N/A | | Operator<br>Workstation | Agfa NX with Soft<br>Console Software | Agfa NX | N/A | | Power Supply | Same as predicate | 47-63 Hz<br>90-264V auto ranging | U Arm - Single phase,<br>50/60 Hz 230/240v ±10% | | Electrical Safety | Same as predicate | IEC-60601 | IEC-60601 | | Performance<br>Standard | Same as predicate | N/A | 21CFR1020.30 | | Generators | Same as predicate | N/A | Choice of four models, 50-<br>80 KW 400-480v AC, 3<br>phase, 50/60 Hz | | Tubes | Same as predicate | N/A | Choice of three Toshiba<br>models: E7254FX,<br>E7869X and E7884X.<br>Automatic or manual<br>collimation, integrated<br>Dose Area Product (DAP)<br>meter and automatic<br>exposure control. | {2}------------------------------------------------ #### TECHNOLOGICAL CHARACTERISTICS E. Agfa's DX-D 300 includes both a traditional U-Arm x-ray system for patient exposure and digital image capture equipment. The x-ray system includes one of four 50-80 kW generators and one of three Toshiba x-ray tubes. U-arm rotation, height, source-to-image distance and detector rotation are controlled by dual speed motors at the unit or by a remote control. Sensors on the equipment ensure patient safety at all times. An optional rolling patient table is available. A Cesium Iodide or Gadolinium Oxysulfide flat panel detector is used to capture the image. Previews are available to the operator in as little as one second after exposure. MUSICA"1M image processing provides consistent image quality. DICOM connectivity allows images to be directed to the user's PACS system, archive or hard copy printer. The workstation can also be connected other Agfa computed radiography systems at the facility. #### F. TESTING The new device combines proven technology from both predicates which have been combined to create the new device. The new device includes minor modifications that have been fully tested. The device has been tested and shown to conform to electronic medical product safety, radiology, and medical imaging standards including: ### PRODUCT STANDARDS - IEC 60601-1-1: Medical electrical equipment Part 1: General requirements for basic safety and essential . performance, plus collateral standard: Electromagnetic compatibility - requirements and tests. - IEC 60601-1-2: Medical electrical equipment Part 1-2: General Requirements For Safety Collateral . Standard: Electromagnetic Compatibility - Requirements And Tests - ACR/NEMA PS3.1-3.18: Digital Imaging and Communications in Medicine (DICOM) . - IEC 60601-1-3: Medical electrical equipment Part 1: General requirements for safety 3. Collateral standard: � General requirements for radiation protection in diagnostic X-ray equipment - . IEC 60601-1-4 Programmable Electrical Medical Systems - IEC 60601-2-7 (1998-02) Medical electrical equipment Part 2-7: Particular requirements for the safety of . high-voltage generators of diagnostic X-ray generators - IEC 60601-2-28 Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies t for medical diagnosis - IEC 60601-2-32 Particular Requirements For The Safety Of Associated Equipment Of X-Ray Equipment . ### MANAGEMENT STANDARDS - ISO 14971 Application of Risk Management to Medical Devices . - ISO 13485 Medical Devices Quality Management Systems Requirements For Regulatory purposes . Performance of the complete system has been validated. Sample images have been provided. No clinical testing was performed in the development of the DX-D 300. #### G. CONCLUSIONS This 510(k) has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health. > ﺎﺕ : : {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings, rendered in a simple, abstract design. The bird appears to be in flight or soaring, and it is positioned above three wavy lines, which may represent water or movement. # DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002 Agfa HealthCare N.V. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313 Re: K103050 Trade/Device Name: DX-D 300 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: October 14, 2010 Received: October 15, 2010 0CT 2 9 2010 ### Dear Mr. Job: 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 {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. Dan David G. Brown, Ph.D. Acting 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 Form OCT 2 9 2010 KI03050 510(k) Number (if known): Device Name: DX-D 300 Indications for Use: Agfa's DX-D 300 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts. Agfa's DX-D 300 is not indicated for use in mammography. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K103050 Page 1 of _ Page 29