SkyPlate Detector for Philips Radiography/Fluoroscopy Systems

{0}------------------------------------------------ Image /page/0/Picture/1 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 7, 2017 PHILIPS MEDICAL SYSTEMS DMC GMBH MING XIAO REGULATORY AFFAIRS MANAGER, NORTH AMERICA ROENTGENSTRASSE 24-26 HAMBURG 22335 DE Re: K171461 Trade/Device Name: SkyPlate Detector for Philips Radiography/Fluoroscopy Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: May 18, 2017 Received: May 18, 2017 Dear Mr. Xiao: 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. Please note: CDRH does not evaluate information related to contract 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 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. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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. Robert Oolo Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, which makes the blue letters stand out. # 5. Statement of Indication for Use | DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. | |-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number (if known) | K171461 | | Device Name | SkyPlate Detector for Philips Radiography/Fluoroscopy Systems | | Indications for Use (Describe) | As a part of a radiographic system, the SkyPlate Detector for Philips Radiography/Fluoroscopy Systems is intended to acquire, process, store, display and export digital radiographic images. The SkyPlate Detector for Philips Radiography/ Fluoroscopy Systems is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding mammography. | | Type of Use (Select one or both, as applicable) | <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." SkyPlate Detector for Philips Radiography/Fluoroscopy Systems Premarket Notification – Special 510(k) {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. The background is plain white. # 6. 510(k) Summary ## 510(k) Summary of Safety and Effectiveness This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92. | Date Prepared: | May 16, 2017 (original Submission Date)<br>July 4, 2017 (Revision) | | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------| | Manufacturer: | Philips Medical Systems DMC GmbH<br>Roentgenstrasse 24-26<br>22335 Hamburg<br>GERMANY<br>Establishment registration number: 3003768251 | | | Contact Person: | Ming Xiao<br>Regulatory Affairs Manager North America<br>Phone: +49 40 5078-2306<br>Fax: +49 40 5078-2425<br>E-mail: ming.xiao@philips.com | | | Trade / Device Name: | SkyPlate Detector for Philips Radiography/Fluoroscopy Systems | | | Classification: | (Primary) Regulation Name: Stationary x-ray system | | | | (Primary) Regulation Number: 21CFR 892.1680 | | | | Classification Panel: 90 -- Radiology | | | | Device Regulatory Class: Class II | | | | (Primary) Product Code: MQB | | | | (Secondary) Product Code: LLZ | | | | (Secondary) Regulation Name: Picture archiving and<br>communication system | | | | (Secondary) Regulation Number: 21 CFR 2050 | | | Predicate Device: | Trade / Device Name: Philips Eleva Workspot<br>with SkyPlate Detectors | | | | Manufacturer: Philips Medical Systems<br>DMC GmbH | | | | 510(k) Clearance: K141736 – July 25, 2014 | | | | Regulation Name: Stationary x-ray system,<br>Picture archiving and<br>communications system | | | | Regulation Number: 21CFR 892.1680, 21 CFR 2050 | | | | Classification Panel: | 90 -- Radiology | | | Device Regulatory Class: | Class II | | | Product code: | MOB, LLZ | | Reference Device I: | Trade / Device Name: | Philips CombiDiagnost R90 | | | Manufacturer: | Philips Medical Systems | | | | DMC GmbH | | | 510(k) Clearance: | K163210 - January<br>31.<br>2017 | | | Regulation Name: | Image-intensified | | | | Radiography/Fluoroscopy | | | | x-ray system | | | Regulation Number: | 21 CFR 892.1650 | | | Product Code: | JAA, KPR and MQB | | | Device Regulatory Class: | Class II | | Reference Device II: | Trade / Device Name: | Philips Eleva Workspot<br>with SkyFlow | | | Manufacturer: | Philips Medical<br>Systems<br>DMC GmbH | | | 510(k) Clearance: | K153318 – December 22,<br>2015 | | | Regulation Name: | Stationary X-ray System | | | Regulation Number: | 21 CFR 892.1680 | | | Product Code: | MQB, LLZ | | | Device Regulatory Class: | Class II | | Device Description: | SkyPlate Detector for for Philips Radiography/Fluoroscopy<br>The | | | | Systems is a Solid State X-ray Imaging Device that converts x-ray | | SkyPlate Detector for Philips Radiography/Fluoroscopy Systems Premarket Notification – Special 510(k) 510(k) Summary, revised July 4, 2017 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, providing a strong contrast that makes the word stand out. Systems is a Solid State X-ray Imaging Device that converts x-ray patterns into electrical signals. The signals are converted into visible images for use in medical diagnosis. A cesium iodide scintillator absorbs the input x-ray photons in the detector. The cesium iodide scintillator in turn emits visible spectrum photons that illuminate an array of photodetectors that create an electrical charge representation of the x-ray input. A matrix scan of the array converts the integrated charges into a modulated electrical signal. > The SkyPlate Detector for Philips Radiography/Fluoroscopy Systems is optionally installed and is intended to be integrated into an x-ray system, where it constitutes an x-ray receptor for direct radiography x-ray imaging. It is electrically powered by and connected with the x-ray system. The SkyPlate Detector for Philips SkyPlate Detector for Philips Radiography/Fluoroscopy Systems Premarket Notification - Special 510(k) 510(k) Summary, revised July 4, 2017 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, which makes the blue letters stand out. The word is horizontally oriented and centered. Radiography/Fluoroscopy Systems is connected to the Philips Eleva Workspot with SkyFlow (cleared via K153318) to create a complete x-ray imaging chain, and is intended to be used for radiography in Philips Radiography/Fluoroscopy systems, such as the CombiDiagnost R90 (cleared via K163210). The SkyPlate Detector for Philips Radiography/Fluoroscopy Systems, is used to acquire diagnostic radiographic images during radiographic procedures. Key features for the SkyPlate Detector for Philips Radiography/Fluoroscopy Systems are provided below: - Detector Size: ● SkyPlate Large (also called Pixium 3543EZ): 384.5mm x 460.5mm x 16mm SkyPlate Small (also called Pixium 2430EZ): 268.5mm x 328.5mm x 16mm - Image Size: . SkyPlate Large (also called Pixium 3543EZ): 2400 x 2880 pixels SkyPlate Small (also called Pixium 2430EZ): 1560 x 1920 pixels - Pixel Size: 148um ● - Image Resolution up to 3.38 LP/mm ● The identical Skyplate detector was previously cleared under K141736 (July 25, 2014) for use with currently marketed Philips radiography systems, such as the Philips DigitalDiagnost and the Philips ProGrade. The SkyPlate Detector for Philips Radiography/Fluoroscopy Systems is integrated for use with Philips radiography/fluoroscopy systems, such as the CombiDiagnost R90 (K163210). The modifications included mechanical integration of the SkyPlate detector and the radiography/fluoroscopy system and integration of the SkyPlate Detector for Philips Radiography/Fluoroscopy Systems software interface with the Philips Eleva Workspot with SkyFlow software (K153318) to facilitate communication. ### Indications for Use: The Indication for Use for the SkyPlate Detector for Philips Radiography/Fluoroscopy Systems is as follows: As a part of a radiographic system, the SkyPlate Detector for Philips Radiography/Fluoroscopy Systems is intended to acquire, process, store, display and export digital radiographic images. The SkyPlate Detector for Philips Radiography/Fluoroscopy Systems is suitable for all routine radiography exams, including SkyPlate Detector for Philips Radiography/Fluoroscopy Systems Premarket Notification - Special 510(k) 510(k) Summary, revised July 4, 2017 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, providing a strong contrast that makes the word stand out. specialist areas like intensive care, trauma, or pediatric work, excluding mammography. | Fundamental<br>Scientific Technology: | The fundamental scientific technology of the SkyPlate Detector for<br>Philips Radiography/Fluoroscopy Systems is that it converts x-ray<br>patterns into electrical signals, which are then converted into<br>visible images for use in medical diagnosis.<br><br>The fundamental scientific technology of the SkyPlate Detector<br>for Philips Radiography/Fluoroscopy Systems remains unchanged<br>from the currently marketed and predicate Philips Eleva Workspot<br>with SkyPlate Detectors (K141736, July 25, 2014) thus<br>demonstrating substantial equivalence. | |-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Summary of<br>Non-clinical<br>Performance Data: | The SkyPlate Detector for Philips Radiography/Fluoroscopy<br>Systems complies with the following international and FDA-<br>recognized consensus standards:<br>International and FDA-recognized consensus standards: ISO 14971: Medical Devices - Application of risk<br>management to medical devices NEMA PS 3.1-3.20 Digital Imaging and Communication<br>in Medicine (DICOM) Set AAMI ANSI IEC 62304:2006 Medical Device Software<br>- Software lifecycle processes IEC 62220-1: Medical electrical equipment, Characteristics<br>of digital x-ray imaging devices IEC 62220-1-1:2015: Medical electrical equipment,<br>Characteristics of digital x-ray imaging devices – Part 1-<br>1: Determination of the detective quantum efficiency –<br>Detectors used in radiographic imaging IEC 60601-1: Medical electrical equipment – Part 1:<br>General requirements for basic safety and essential<br>performance (IEC 60601-1:2005 + A1:2012, MOD) IEC 60601-1-2: Medical electrical equipment. General<br>requirements for basic safety and essential performance.<br>Collateral standard: Electromagnetic compatibility<br>requirements and tests IEC 60601-1-3: Medical electrical equipment. General<br>requirements for basic safety and essential performance.<br>Collateral standard: Radiation in diagnostic X-ray<br>equipment IEC 60601-2-54: Medical electrical equipment. Particular<br>requirements for basic safety and essential performance of | SkyPlate Detector for Philips Radiography/Fluoroscopy Systems Premarket Notification – Special 510(k) 510(k) Summary, revised July 4, 2017 {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. The background is white. X-ray equipment for radiography and radioscopy - Device specific guidance document: ● - "Guidance for the Submission of 510(k)s for Solid State C X-ray Imaging Device", issued September 1, 2016 - "Guidance for the Content of Premarket Submissions for O software contained in Medical Device", issued May 11, 2005 - Pediatric information for X-Ray Imaging Device o Premarket Notifications, Draft, issued May 10, 2012 Non-clinical verification and validation tests have been performed with regards to the intended use, technical claims, requirement specifications, and risk management results. The software information was provided according to a moderate level of concern. Non-clinical verification and validation test results demonstrate that the SkyPlate Detector for Philips Radiography/Fluoroscopy Systems: - Complies with the aforementioned international and FDArecognized consensus standards and device specific guidance documents. - Meets the acceptance criteria and is adequate for its ● intended use. Therefore, the SkyPlate Detector for Philips Radiography/Fluoroscopy Systems is substantially equivalent to the currently marketed and predicate Philips Eleva Workspot with SkyPlate Detectors (K141736. July 25, 2014) thus demonstrating substantial equivalence. The SkyPlate Detector for Philips Radiography/Fluoroscopy Summary of Clinical Systems did not require a clinical study since substantial Data: equivalence to the currently marketed and predicate device was demonstrated with the following attributes: - Design features; ● - Indication for use; - Fundamental scientific technology; ● - Non-clinical performance testing including validation; and - . Safety and effectiveness. Substantial The comparison of technological characteristics, non-clinical Equivalence performance data, safety testing, software validation, and clinical image concurrence data demonstrates that the device is as safe, as SkyPlate Detector for Philips Radiography/Fluoroscopy Systems Premarket Notification - Special 510(k) 510(k) Summary, revised July 4, 2017 {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. The background is plain white. #### effective, and performs as well or better than the predicate device. Conclusion: The SkyPlate Detector for Philips Radiography/Fluoroscopy Systems has the same indications for use and intended use, has identical or equivalent technological characteristics, provides images of equivalent diagnostic capability, and does not introduce new potential hazards or safety risks. The SkyPlate Detector for Philips Radiography/Fluoroscopy Systems is substantially equivalent to the currently legally marketed predicate device (K141736, July 25, 2014) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness. Additionally, substantial equivalence was demonstrated with non-clinical performance (verification and validation) tests, which complied with the requirements specified in the international and FDA-recognized consensus standards: IEC 62304 and ISO 14971. The results of these tests demonstrate that the SkyPlate Detector for Philips Radiography/Fluoroscopy Systems met the acceptance criteria and is adequate for its intended use.