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.

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.

AI/ML Overview

Based on the provided text, the ProxiDiagnost N90 is evaluated for substantial equivalence to its predicate device, EasyDiagnost Eleva (K031535). The document outlines non-clinical data and makes a case against the need for a clinical study.

Here's an analysis of the requested information:

1. Table of acceptance criteria and the reported device performance:

The document broadly states that "The test results demonstrate that the proposed ProxiDiagnost N90 meets the acceptance criteria and is adequate for its intended use." However, specific numerical acceptance criteria or performance metrics for the ProxiDiagnost N90 are not detailed in a table. The comparison provided focuses on demonstrating technological similarities to the predicate device rather than presenting specific performance thresholds for the new device.

The "Discussion" column in the "Summary of technological characteristics" table implicitly suggests that if a characteristic is "Similar" or "Equivalent" to the predicate, it meets acceptance criteria for substantial equivalence.

Feature	Predicate Device (EasyDiagnost Eleva (K031535))	Proposed Device (ProxiDiagnost N90 (K173433))	Acceptance Criteria (Implicit from Discussion)	Reported Device Performance (Implicit)
Working height (table top center to floorplate)	83cm	83.3cm	Similar to predicate; differences do not affect safety or effectiveness.	Meets criteria
Table tilt movement	-20° to +90° (Optional: -30°, -45°, -85° to +90°)	-90° to +90° movement speed with variable 1 to 6°/s	Similar to predicate; differences do not affect safety or effectiveness.	Meets criteria
Table top suspension	Two sides suspensions	Two sides suspensions	Equivalent to predicate; no impact to safety or effectiveness.	Meets criteria
Table top material	Plastic laminate or carbon fiber	Sandwich of laminate, carbon and foam	Similar to predicate; differences do not affect safety or effectiveness.	Meets criteria
Table top movement	Lateral: -10 cm to + 9 cm, Longitudinal: ± 83 cm	Lateral: -10 cm to + 9 cm, Longitudinal: ± 83.5 cm	Equivalent to predicate; no impact to safety or effectiveness.	Meets criteria
Table top absorption	0.7mm typical (@ 100kV, 2.7mm Al HVL)	0.6mm Al typical @ 100kV	Similar to predicate; minor differences do not affect safety or effectiveness.	Meets criteria
Maximum patient weight	180 kg	static: 300 kg, tilt: 250 kg, all movements: 185 kg	Proposed device holds more weight; does not affect safety or effectiveness.	Meets criteria
Lateral scan distance	22 cm	22 cm	Equivalent to predicate; no impact to safety or effectiveness.	Meets criteria
Lateral scan speed	Manual Movement	Manual Movement	Equivalent to predicate; no impact to safety or effectiveness.	Meets criteria
Longitudinal scan distance	75 cm mechanical range	75 cm mechanical range	Equivalent to predicate; no impact to safety or effectiveness.	Meets criteria
Table column angulation	-85° to +90°	-85° to +90°	Equivalent to predicate; no impact to safety or effectiveness.	Meets criteria
Source image distance	73 cm – 103 cm, 88 cm – 118 cm with Geomat in extended position	81 cm – 130 cm	Similar to predicate; differences do not affect safety or effectiveness.	Meets criteria
Collimator	Square / rectangular plus Iris	rectangular collimation	No impact on safety or effectiveness. Same as reference device (CombiDiagnost R90).	Meets criteria
Grid	Parkable	Parkable	Equivalent to predicate; no impact to safety or effectiveness.	Meets criteria
Picture archiving and communication system	Yes	Yes	Equivalent to predicate; no impact to safety or effectiveness.	Meets criteria
Image chain (fluoroscopy)	Philips Image Intensifier / CCD TV / Digital Imaging	Philips Dynamic Eleva Image Chain	No impact on safety or effectiveness. Same as reference device (Eleva Workspot with SkyFlow, CombiDiagnost R90).	Meets criteria
Detector	Image Intensifier 23 cm, 31 cm or 38 cm	Pixium FE 4343F	No impact on safety or effectiveness. Same as reference device (CombiDiagnost R90).	Meets criteria
Modulation Transfer Function (MTF) (according to IEC 62220-1-3 standard)	Not available	1 lp/mm 66%, 2 lp/mm 35%, 3 lp/mm 19%, 3.4 lp/mm 15%	No impact on safety or effectiveness. Same as reference device (CombiDiagnost R90).	Meets criteria (implicitly, as it aligns with a cleared component)
Detective Quantum Efficiency (DQE) (according to IEC 62220-1-3 standard)	Not available	DQE at 1 µGy: 0.05 lp/mm 65%, 1 lp/mm 51%, 2 lp/mm 41%, 3 lp/mm 27%, 3.4 lp/mm 18%	No impact on safety or effectiveness. Same as reference device (CombiDiagnost R90).	Meets criteria (implicitly, as it aligns with a cleared component)
Wireless Static Detector for Radiographic Exams	Wireless Portable Detector Pixium4600 (previous version of SkyPlate Detector)	SkyPlate Detector	No impact on safety or effectiveness. Same as reference device (SkyPlate Detectors for R/F Systems).	Meets criteria
Wireless Static Detector for Radiographic Exams	N/A	Pixium RCE	No impact on safety or effectiveness. Same as reference device (Pixium RCE).	Meets criteria
Generator	Philips Velara GCF/RF, 50kW, 65kW or 80kW	Philips Velara GCF/RF, 65 kW, optional 80 kW	Equivalent to predicate; no impact to safety or effectiveness.	Meets criteria
Tube	Philips SRO 2550 or SRM 2250 GS	Philips SRM 2250 ROT-GS 504 or SRO 2550 ROT380 or SRO 33100 ROT380 (optional in CSM)	Equivalent to predicate; no impact to safety or effectiveness.	Meets criteria
System Control	Near by	Nearby	Equivalent to predicate; no impact to safety or effectiveness.	Meets criteria
Indications for Use	Multi-functional/universal system, general R/F, Fluoroscopy, Radiography and Angiography, pediatric examinations and some more specialized interventional applications.	Multi-functional general R/F system, all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.	Equivalent to predicate; similar to reference device (CombiDiagnost R90).	Meets criteria

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document explicitly states: "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."

Therefore, there is no test set sample size from a clinical study for the ProxiDiagnost N90 itself. The evaluation relied on non-clinical verification and validation tests against recognized consensus standards and a comparison to the predicate and reference devices.

No information on data provenance for a clinical test set is available, as no clinical study was conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Since no clinical study was performed and no test set with clinical data was used for evaluation, there were no experts used to establish ground truth for a test set in this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

As no clinical test set was used for evaluation of the ProxiDiagnost N90, no adjudication method was applied for a test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study being conducted for the ProxiDiagnost N90. The device is a general R/F system, not an AI-assisted diagnostic tool, so such a study would not be relevant in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device is an imaging system, not an algorithm in the AI sense. Its "performance" would relate to image quality and system functionality, which was assessed through non-clinical performance testing (verification and validation tests according to standards like IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54, IEC 62220-1). These tests are typically "standalone" in that they evaluate the device's technical specifications and functionality independent of direct human interpretation studies.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the non-clinical performance and validation tests, the "ground truth" would be established by the specified engineering tolerances, recognized international standards (e.g., IEC standards for image quality, safety, and performance), and the performance characteristics of the predicate and reference devices. For instance, the MTF and DQE values for the detector are reported and implicitly "compared" to cleared components, meaning the "ground truth" for the acceptance of these values is their alignment with previously cleared and accepted digital imagers.

8. The sample size for the training set:

As no clinical study was performed and the device is an imaging system (not an AI model requiring a training set), there is no training set sample size.

9. How the ground truth for the training set was established:

Since no training set was used, ground truth for a training set was not established.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K173433

Device Name

ProxiDiagnost N90

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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

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	Device Class:	Class II
	Product code:	JAA
ReferenceDevice_1:	Trade Name:	CombiDiagnost R90
	Manufacturer:	Philips Medical System DMC
	510(k) Clearance:	K163210 - Jan 31, 2017
	Classification Name:	Image-intensified fluoroscopic x-raysystem
	Classification Regulation:	21CFR 892.1650
	Classification Panel:	90 -- Radiology
	Device Class:	Class II
	Product code:Secondary Product Codes:	JAAKPR, MQB
ReferenceDevice_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 (FlatPanel/Digital Imager)
	Classification Regulation:	21CFR 892.1680
	Classification Panel:	90 -- Radiology
	Device Class:	Class II
	Product code:Secondary Product Codes:	MQBLLZ
ReferenceDevice_3:	Trade Name:	Pixium 4343RCE
	Manufacturer:	Philips Medical System DMC
	510(k) Clearance:	K170113 – Feb 9, 2017
	Classification Name:	Solid State X-Ray Imager (FlatPanel/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

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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 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(Eleva Workspot)	Eleva Workspot with SkyFlow (K153318, December 22, 2015)
Dynamic flat detector, PixiumFE4343F andmotorized collimator (in ceiling suspensions)	CombiDiagnost R90 (K163210, January 31, 2017)
Wireless portable detector	SkyPlate Detector for Radiography/FluoroscopySystems (K171461, July 7, 2017)
Fixed static detector	Pixium 4343 RCE (K170113, February 9, 2017)

Device 4:

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Indications for Use:

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:EasyDiagnost Eleva( K031535 )	Proposed Device:ProxiDiagnost R90( K173433 )	Discussion
Table Features
Working height(table top centerto floorplate)	83cm	83.3cm	Similar; the range of workingheight does not affect thesafety or effectiveness of thedevice.
Table tiltmovement	-20° to +90°Optional:-30° to +90°-45° to +90°-85° to +90°	-90° to +90°movement speed withvariable 1 to 6°/s	Similar: The table tiltmovement does not affect thesafety or effectiveness of thedevice.
Table topsuspension	Two sides suspensions	Two sides suspensions	Equivalent; No impact tosafety or effectiveness of thedevice.
Table top	Plastic laminate or carbon	Sandwich of laminate,	Similar: The table top
	Primary Predicate Device:EasyDiagnost Eleva(K031535)	Proposed Device:ProxiDiagnost R90(K173433)	Discussion
material	fiber	carbon and foam	material movement does not affect the safety or effectiveness of the device.
Table topmovement	Lateral: -10 cm to + 9 cmLongitudinal: ± 83 cm	Lateral: -10 cm to + 9 cmLongitudinal: ± 83.5 cm	Equivalent; No impact to safety or effectiveness of the device.
Table topabsorption	0.7mm typical (@ 100kV,2.7mm Al HVL)	0.6mm Al typical @100kV	Similar: Minor differences in the table top absorption does not affect the safety or effectiveness of the device.
Maximumpatient weight	180 kg	static: 300 kgtilt: 250 kgall 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 scandistance	22 cm	22 cm	Equivalent; No impact to safety or effectiveness of the device.
Lateral scanspeed	Manual Movement	Manual Movement	Equivalent; No impact to safety or effectiveness of the device.
Longitudinalscan distance	75 cm mechanical range	75 cm mechanical range	Equivalent; No impact to safety or effectiveness of the device.
Table columnangulation	-85° to +90°	-85° to +90°	Equivalent; No impact to safety or effectiveness of the device.
Source imagedistance	73 cm – 103 cm,88 cm – 118 cm withGeomat in extendedposition	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 plusIris	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 archivingandcommunicationsystem	Yes	Yes	Equivalent; No impact to safety or effectiveness of the device.
Image chain(fluoroscopy)	Philips Image Intensifier /CCD TV / Digital Imaging	Philips Dynamic ElevaImage Chain	The proposed ProxiDiagnost N90 includes the currently marketed and reference
	Primary Predicate Device:EasyDiagnost Eleva(K031535)	Proposed Device:ProxiDiagnost R90(K173433)	Discussion
Detector	Image Intensifier 23 cm, 31cm or 38 cm	Pixium FE 4343F	(K153318) as part of theimage chain. In addition, thissame image chain is used inthe currently marketed andreference device,CombiDiagnost R90(K163210). Therefore, thereis no impact on the safety oreffectiveness of the device.The proposed ProxiDiagnostN90 includes the fixeddetector Pixium FE 4343Fused in the currentlymarketed and referencedevice, CombiDiagnost R90(K163210). Therefore, thereis no impact on the safety oreffectiveness of the device.
ModulationTransferFunction (MTF)(according to IEC62220-1-3 standard)	Not available	lp/mm%1 662 353 193.4 15	The proposed ProxiDiagnostN90 includes the fixeddetector Pixium FE 4343Fused in the currentlymarketed and referencedevice, CombiDiagnost R90(K163210). Therefore, thereis no impact on the safety oreffectiveness of the device.
DetectiveQuantumEfficiency(DQE)(according to IEC62220-1-3 standard)	Not available	DQE at 1 µGylp/mm %0.05 651 512 413 273.4 18	The proposed ProxiDiagnostN90 includes the fixeddetector Pixium FE 4343Fused in the currentlymarketed and referencedevice, CombiDiagnost R90(K163210). Therefore, thereis no impact on the safety oreffectiveness of the device.
Wireless StaticDetector forRadiographicExams	Wireless Portable DetectorPixium4600 (previousversion of SkyPlateDetector)	SkyPlate Detector	The proposed ProxiDiagnostN90 includes the currentlymarketed and referencedevice, SkyPlate Detectorsfor R/F Systems (K171461).Therefore, there is no impacton the safety or effectivenessof the device.
Wireless StaticDetector forRadiographicExams	N/A	Pixium RCE	The proposed ProxiDiagnostN90 includes the currentlymarketed and referencedevice, Pixium RCE(K170113). Therefore, thereis no impact on the safety oreffectiveness 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:EasyDiagnost Eleva(K031535)	Proposed Device:ProxiDiagnost R90(K173433)	Discussion
			device.
Tube	Philips SRO 2550 or SRM2250 GS	Philips SRM 2250 ROT-GS 504 orSRO 2550 ROT380 orSRO 33100 ROT380(optional in CSM)	Equivalent; No impact tosafety or effectiveness of thedevice.
System Control	Near by	Nearby	Equivalent; No impact tosafety or effectiveness of thedevice.
Indications forUse	The Philips EasyDiagnostEleva intended use is for thefollowing applications: As amulti-functional/ universalsystem, general R/F, Fluoro-scopy, Radiography andAngiography can beperformed along withpediatric examinations andsome more specializedinterventional applications.	ProxiDiagnost N90 is amulti-functional generalR/F system. It is suitablefor all routine radiographyand fluoroscopy exams,including specialist areaslike angiography orpediatric work, excludingmammography.	Equivalent; The Indicationsfor Use for the proposedProxiDiagnost N90 is moregeneral in nature and exactlythe same as the currentlymarketed and referencedevice, CombiDiagnost R90(K163210).

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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

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. 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.

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.