ProxiDiagnost N90

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Philips Medical Systems DMC GmbH % Ming Xiao Regulatory Affairs Manager North America Roentgenstrasse 24-26 22335 Hamburg GERMANY February 5, 2018 #### Re: K173433 Trade/Device Name: ProxiDiagnost N90 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA Dated: November 9, 2017 Received: November 13, 2017 Dear Ming 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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}------------------------------------------------ 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. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Michael D. O'Hara For 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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K173433 Device Name ProxiDiagnost N90 #### Indications for Use (Describe) ProxiDiagnost N90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| | <span style="unicode-bidi:isolate; direction:ltr;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="unicode-bidi:isolate; direction:ltr;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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." {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 background is white, providing a strong contrast that makes the word stand out. #### 7. 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. Establishment registration number: 3003768251 - Date Prepared: January 29, 2018 Manufacturer: Philips Medical Systems DMC GmbH Roentgenstrasse 24-26 22335 Hamburg GERMANY - Contact Person: Ming Xiao Regulatory Affairs Manager, North America Phone: +49 40 5078-2306 Fax: +49 40 5078-2425 E-mail: ming.xiao@philips.com - Device Name: ProxiDiagnost N90 - Classification: Classification Name: Image-intensified fluoroscopic x-ray system Classification Regulation: 21CFR 892.1650 Classification Panel: 90 -- Radiology Device Class: Class II OWB Classification Product Code: Secondary Product Codes: JAA Philips EasyDiagnost Eleva Predicate Device: Trade Name: Manufacturer: Philips Medical System DMC 510(k) Clearance: K031535 - June 17, 2003 Classification Name: Image-intensified fluoroscopic x-ray system; Stationary x-ray system; Spot-film device; Tilting Radiographic table Classification Regulation: 21CFR 892.1650 Classification Panel: 90 -- Radiology ProxiDiagnost N90 Premarket Notification – Traditional 510(k) Page 43 of 135 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and fill most of the frame. The background is plain white, which makes the blue letters stand out. | | Device Class: | Class II | |------------------------|-------------------------------------------|---------------------------------------------------------| | | Product code: | JAA | | Reference<br>Device_1: | Trade Name: | CombiDiagnost R90 | | | Manufacturer: | Philips Medical System DMC | | | 510(k) Clearance: | K163210 - Jan 31, 2017 | | | Classification Name: | Image-intensified fluoroscopic x-ray<br>system | | | Classification Regulation: | 21CFR 892.1650 | | | Classification Panel: | 90 -- Radiology | | | Device Class: | Class II | | | Product code:<br>Secondary Product Codes: | JAA<br>KPR, MQB | | Reference<br>Device_2: | Trade Name: | Eleva Workspot with SkyFlow | | | Manufacturer: | Philips Medical System DMC | | | 510(k) Clearance: | K153318 - Dec 22, 2015 | | | Classification Name: | Solid State X-Ray Imager (Flat<br>Panel/Digital Imager) | | | Classification Regulation: | 21CFR 892.1680 | | | Classification Panel: | 90 -- Radiology | | | Device Class: | Class II | | | Product code:<br>Secondary Product Codes: | MQB<br>LLZ | | Reference<br>Device_3: | Trade Name: | Pixium 4343RCE | | | Manufacturer: | Philips Medical System DMC | | | 510(k) Clearance: | K170113 – Feb 9, 2017 | | | Classification Name: | Solid State X-Ray Imager (Flat<br>Panel/Digital Imager) | | | Classification Regulation: | 21CFR 892.1680 | | | Classification Panel: | 90 -- Radiology | | | Device Class: | Class II | | | Product code: | MQB | | Reference | Trade Name: | SkyPlate Detector For Philips | ProxiDiagnost N90 Premarket Notification – Traditional 510(k) Page 44 of 135 {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 Manufacturer: Philips Medical System DMC K171461 – July 7, 2017 510(k) Clearance: Classification Name: Solid State X-Ray Imager (Flat Panel/Digital Imager) Classification Regulation: 21CFR 892.1680 90 -- Radiology Classification Panel: Device Class: Class II Product code: MQB # Device Description: The ProxiDiagnost N90 is a multi-functional nearby controlled fluoroscopy system in combination with a high-end digital radiography system consisting of a floor-mounted tiltadjustable patient support table and a scan unit consisting of a tube and a flat panel dynamic detector, Pixium FE4343F, for the fluoroscopy examinations. The tabletop can be moved by a motor in the lateral and longitudinal direction and can be tilted -85° to +90° degrees. The scan unit tilts with the table and can be moved in the longitudinal and lateral direction, relative to the table and to the patient. The fully integrated system is provided with a x-ray tube(s) with collimator and high resolution displays. The ProxiDiagnost N90 is configured with a Philips x-ray generator and a flat panel dynamic detector, Pixium FE4343F, components of the Philips radiography/fluoroscopy Image Chain. As additional options, the ProxiDiagnost N90 can be used as a digital radiography system consisting of a mounted tube in a ceiling suspension together with the portable or fixed detector in the vertical stand. The ProxiDiagnost N90 uses the same workflow as the currently marketed and predicate device, Philips EasyDiagnost Eleva (K031535, cleared June 17, 2003). The ProxiDiagnost N90 incorporates the following features, previously cleared by FDA in the following reference devices: | Design Feature/ Attribute | Currently Marketed and Reference Device | |-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | | Philips Medical Systems | | Image Chain acquisition-station and workflow<br>(Eleva Workspot) | Eleva Workspot with SkyFlow (K153318, December 22, 2015) | | Dynamic flat detector, PixiumFE4343F and<br>motorized collimator (in ceiling suspensions) | CombiDiagnost R90 (K163210, January 31, 2017) | | Wireless portable detector | SkyPlate Detector for Radiography/Fluoroscopy<br>Systems (K171461, July 7, 2017) | | Fixed static detector | Pixium 4343 RCE (K170113, February 9, 2017) | #### Device 4: {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 word is centered and takes up most of the frame. # Indications for Use: ProxiDiagnost N90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography. # Fundamental Scientific Technology: The ProxiDiagnost N90 employs the same basic construction and fundamental scientific technology as the currently marketed and predicate EasyDiagnost Eleva (K031533), with regards to the functionality of the following components: table, system-control, X-Ray tube, and generator (see the comparison table comparing the ProxiDiagnost N90 to the currently marketed and predicate EasyDiagnost Eleva provided below). The ProxiDiagnost N90 employs the following cleared features: fixed detector (Pixium FE 4343F K163210), wireless detectors (Pixium 4343RCE, K170113, February 9, 2017; SkyPlate Detector for R/F Systems, K171461, July 7, 2017) and the image chain acquisitionstation and workflow (fluoroscopy) (Eleva Workspot with SkyFlow, K153318, Dec 22, 2015). The fixed detector, wireless portable detectors, and the image chain and workstation of the ProxiDiagnost N90 are identical to the fixed detector, wireless portable detectors, and the image chain and workstation of the currently marketed and reference devices. Therefore, the fixed detector, wireless portable detectors, and the image chain and workstation employ identical fundamental scientific technology. The outcome of this comparison demonstrates that the minor differences in the technological characteristics do not affect the safety or effectiveness of the ProxiDiagnost N90 when compared to the currently marketed and predicate EasyDiagnost Eleva. # Summary of technological characteristics: The ProxiDiagnost N90 has similar indications for use and technological characteristics as the predicate device, EasyDiagnost Eleva. Comparisons of the technological characteristics demonstrate the substantial equivalence to the predicate device. | | Primary Predicate Device:<br><i>EasyDiagnost Eleva</i><br>( <i>K031535</i> ) | Proposed Device:<br><i>ProxiDiagnost R90</i><br>( <i>K173433</i> ) | Discussion | |-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Table Features | | | | | Working height<br>(table top center<br>to floorplate) | 83cm | 83.3cm | Similar; the range of working<br>height does not affect the<br>safety or effectiveness of the<br>device. | | Table tilt<br>movement | -20° to +90°<br>Optional:<br>-30° to +90°<br>-45° to +90°<br>-85° to +90° | -90° to +90°<br>movement speed with<br>variable 1 to 6°/s | Similar: The table tilt<br>movement does not affect the<br>safety or effectiveness of the<br>device. | | Table top<br>suspension | Two sides suspensions | Two sides suspensions | Equivalent; No impact to<br>safety or effectiveness of the<br>device. | | Table top | Plastic laminate or carbon | Sandwich of laminate, | Similar: The table top | | | Primary Predicate Device:<br>EasyDiagnost Eleva<br>(K031535) | Proposed Device:<br>ProxiDiagnost R90<br>(K173433) | Discussion | | material | fiber | carbon and foam | material movement does not affect the safety or effectiveness of the device. | | Table top<br>movement | Lateral: -10 cm to + 9 cm<br>Longitudinal: ± 83 cm | Lateral: -10 cm to + 9 cm<br>Longitudinal: ± 83.5 cm | Equivalent; No impact to safety or effectiveness of the device. | | Table top<br>absorption | 0.7mm typical (@ 100kV,<br>2.7mm Al HVL) | 0.6mm Al typical @<br>100kV | Similar: Minor differences in the table top absorption does not affect the safety or effectiveness of the device. | | Maximum<br>patient weight | 180 kg | static: 300 kg<br>tilt: 250 kg<br>all movements: 185 kg | The proposed ProxiDiagnost N90 is able to hold more patient weight; this does not affect the safety or effectiveness of the device. | | Lateral scan<br>distance | 22 cm | 22 cm | Equivalent; No impact to safety or effectiveness of the device. | | Lateral scan<br>speed | Manual Movement | Manual Movement | Equivalent; No impact to safety or effectiveness of the device. | | Longitudinal<br>scan distance | 75 cm mechanical range | 75 cm mechanical range | Equivalent; No impact to safety or effectiveness of the device. | | Table column<br>angulation | -85° to +90° | -85° to +90° | Equivalent; No impact to safety or effectiveness of the device. | | Source image<br>distance | 73 cm – 103 cm,<br>88 cm – 118 cm with<br>Geomat in extended<br>position | 81 cm – 130 cm | Similar: The source image distance provided with the proposed ProxiDiagnost N90 does not affect the safety or effectiveness of the device. | | Collimator | Square / rectangular plus<br>Iris | rectangular collimation | The rectangular collimator provided with the proposed ProxiDiagnost N90 does not affect the safety or effectiveness of the device. It is the same collimator used in the currently marketed and reference device, CombiDiagnost R90 (K163210) | | Grid | Parkable | Parkable | Equivalent; No impact to safety or effectiveness of the device. | | Picture archiving<br>and<br>communication<br>system | Yes | Yes | Equivalent; No impact to safety or effectiveness of the device. | | Image chain<br>(fluoroscopy) | Philips Image Intensifier /<br>CCD TV / Digital Imaging | Philips Dynamic Eleva<br>Image Chain | The proposed ProxiDiagnost N90 includes the currently marketed and reference | | | Primary Predicate Device:<br>EasyDiagnost Eleva<br>(K031535) | Proposed Device:<br>ProxiDiagnost R90<br>(K173433) | Discussion | | Detector | Image Intensifier 23 cm, 31<br>cm or 38 cm | Pixium FE 4343F | (K153318) as part of the<br>image chain. In addition, this<br>same image chain is used in<br>the currently marketed and<br>reference device,<br>CombiDiagnost R90<br>(K163210). Therefore, there<br>is no impact on the safety or<br>effectiveness of the device.<br>The proposed ProxiDiagnost<br>N90 includes the fixed<br>detector Pixium FE 4343F<br>used in the currently<br>marketed and reference<br>device, CombiDiagnost R90<br>(K163210). Therefore, there<br>is no impact on the safety or<br>effectiveness of the device. | | Modulation<br>Transfer<br>Function (MTF)<br>(according to IEC<br>62220-1-3 standard) | Not available | lp/mm<br>%<br>1 66<br>2 35<br>3 19<br>3.4 15 | The proposed ProxiDiagnost<br>N90 includes the fixed<br>detector Pixium FE 4343F<br>used in the currently<br>marketed and reference<br>device, CombiDiagnost R90<br>(K163210). Therefore, there<br>is no impact on the safety or<br>effectiveness of the device. | | Detective<br>Quantum<br>Efficiency<br>(DQE)<br>(according to IEC<br>62220-1-3 standard) | Not available | DQE at 1 µGy<br>lp/mm %<br>0.05 65<br>1 51<br>2 41<br>3 27<br>3.4 18 | The proposed ProxiDiagnost<br>N90 includes the fixed<br>detector Pixium FE 4343F<br>used in the currently<br>marketed and reference<br>device, CombiDiagnost R90<br>(K163210). Therefore, there<br>is no impact on the safety or<br>effectiveness of the device. | | Wireless Static<br>Detector for<br>Radiographic<br>Exams | Wireless Portable Detector<br>Pixium4600 (previous<br>version of SkyPlate<br>Detector) | SkyPlate Detector | The proposed ProxiDiagnost<br>N90 includes the currently<br>marketed and reference<br>device, SkyPlate Detectors<br>for R/F Systems (K171461).<br>Therefore, there is no impact<br>on the safety or effectiveness<br>of the device. | | Wireless Static<br>Detector for<br>Radiographic<br>Exams | N/A | Pixium RCE | The proposed ProxiDiagnost<br>N90 includes the currently<br>marketed and reference<br>device, Pixium RCE<br>(K170113). Therefore, there<br>is no impact on the safety or<br>effectiveness of the device. | | Generator | Philips Velara GCF/RF, | Philips Velara GCF/RF, | Equivalent; No impact to | | | 50kW.65kW or 80kW | 65 kW, optional 80 kW | safety or effectiveness of the | | | Primary Predicate Device:<br>EasyDiagnost Eleva<br>(K031535) | Proposed Device:<br>ProxiDiagnost R90<br>(K173433) | Discussion | | | | | device. | | Tube | Philips SRO 2550 or SRM<br>2250 GS | Philips SRM 2250 ROT-<br>GS 504 or<br>SRO 2550 ROT380 or<br>SRO 33100 ROT380<br>(optional in CSM) | Equivalent; No impact to<br>safety or effectiveness of the<br>device. | | System Control | Near by | Nearby | Equivalent; No impact to<br>safety or effectiveness of the<br>device. | | Indications for<br>Use | The Philips EasyDiagnost<br>Eleva intended use is for the<br>following applications: As a<br>multi-functional/ universal<br>system, general R/F, Fluoro-<br>scopy, Radiography and<br>Angiography can be<br>performed along with<br>pediatric examinations and<br>some more specialized<br>interventional applications. | ProxiDiagnost N90 is a<br>multi-functional general<br>R/F system. It is suitable<br>for all routine radiography<br>and fluoroscopy exams,<br>including specialist areas<br>like angiography or<br>pediatric work, excluding<br>mammography. | Equivalent; The Indications<br>for Use for the proposed<br>ProxiDiagnost N90 is more<br>general in nature and exactly<br>the same as the currently<br>marketed and reference<br>device, CombiDiagnost R90<br>(K163210). | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and fill most of the frame. The background is plain white, which makes the blue letters stand out. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and appear to be a sans-serif font. The background is plain white, which makes the blue letters stand out. {9}------------------------------------------------ Image /page/9/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. Based on the information provided above, the ProxiDiagnost N90 is considered substantially equivalent to the currently marketed and predicate device, EasyDiagnost Eleva (K031535, June 17, 2003) in terms of fundamental scientific technology. # Summary of Non-Clinical Data: This 510(k) premarket notification contains technical documentation which includes nonclinical verification and validation tests as well as image quality tests were performed on the proposed ProxiDiagnost N90 according to the following international and FDA-recognized consensus standards: - ISO 14971, Medical devices. Application of risk management to medical devices - IEC 60601-1, Medical electrical equipment. General requirements for safety. . Collateral standard. Safety requirements for medical electrical systems - IEC 60601-1-2, Medical electrical equipment. General requirements for basic safety ● and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests - IEC 60601-1-3. Medical electrical equipment. General requirements for basic safety . and essential performance. Collateral Standard: Radiation protection in diagnostic Xray equipment - . IEC 60601-2-54. Medical electrical equipment. Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy - IEC 6220-1, Medical electrical equipment. Characteristics of digital X-ray imaging devices. Determination of the detective quantum efficiency - IEC 62304, Medical device software. Software life-cycle processes ● - Guidance for the Submission of 510(k)s for Solid State X-Ray Imaging Devices, issued September 1, 2016 ProxiDiagnost N90 Premarket Notification – Traditional 510(k) Page 49 of 135 {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters against a white background. The font is sans-serif and the letters are evenly spaced. The word is horizontally oriented and centered in the image. - . Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 11, 2005 - Pediatric Information for X-ray Imaging Device Premarket Notifications, Draft, issued May 10, 2012 - Guidance for the Submission of Premarket Notifications for Medical Image ● Management Device, issued July 27, 2000 - Guidance for Radio Frequency Wireless Technology in Medical Devices, issued August 14, 2013 - . Guidance for Management of Cybersecurity in Medical Devices, issued October 2, 2014 The test results demonstrate that the proposed ProxiDiagnost N90 meets the acceptance criteria and is adequate for its intended use. Based upon the same intended use, similar technology, software functionalities, same product configuration and administration, and similarity of materials, it can be concluded the proposed ProxiDiagnost N90 is substantially equivalent to the predicate device, Philips EasyDiagnost Eleva, in terms of intended use, design characteristics, and safety and effectiveness. #### Summary of Clinical Data: The proposed ProxiDiagnost N90 did not require a clinical study since substantial 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 Equivalence Conclusion: The comparison of technological characteristics, non-clinical performance data, safety testing, software validation, and clinical image concurrence data demonstrates that the device is as safe and effective as the predicate device. Philips Medical Systems concludes that the proposed ProxiDiagnost N90 is substantially equivalent to the legally marketed predicate device, EasyDiagnost Eleva.