The CombiDiagnost R90 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 CombiDiagnost R90 is a multi-functional general Radiography/Fluoroscopy (R/F) system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.

The CombiDiagnost R90 is a remote-controlled fluoroscopy system in combination with high-end digital radiography. The system is suitable for routine X-ray examinations and special examinations on patients in standing, seated or laying positions. The CombiDiagnost R90 retrieves images by means of a Cesum Iodide flat panel detector.

Philips fluoroscopy systems consist of the following components (standard configuration):

Basic unit (also called "geometry" or "table unit")
Workstation Eleva Workspot with integrated generator control, hand switch, keyboard, mouse, touch screen and PC
Equipped with a dual screen-monitor as standard
Spot film device (digital camera or flat panel detector)
X-ray Generator Velara
X-ray tube assembly mounted in above table mode to be remote controlled
Receptor: Flat panel detector

Optional components:

Skyplate wireless portable detectors small and large
Ceiling Suspension (CSM3)
Vertical Wall stand (VS2)
Ceiling Suspension for monitors
Monitor trolley
Remote control for RF viewer
Accessories for "Stitching on the Table"

The CombiDiagnost R90 uses the same workflow from the currently marketed and predicate device, CombiDiagnost R90 (K163210) with only the following modifications:

additional optional components (like the reference monitor, remote control),
Eleva Workspot updated to incorporate new imaging features mainly from the previously approved reference device, DigitalDiagnost C90 (K182973) along with functional clusters like Digital Subtraction Imaging and stitching on the table
updates to improve usability and serviceability.

The Eleva software of the proposed CombiDiagnost R90 is based on a workstation i.e., Eleva Workspot (computer, keyboard, display, and mouse) that is used by an operator to preset examination data and to generate, process and handle digital x-ray images. The Eleva Software system is decomposed into software components. These components are clustered in three component collections like the image handling focused Back-end (BE), the acquisition focused Front-end (FE) and Image Processing (IP). The Eleva software is intended to acquire, process, store, display and export digital fluoroscopy and radiographic images.

The proposed CombiDiagnost R90 is same as the predicate device (K203087) with some modifications as described.

The proposed device complies to 'Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices, dated September 1, 2016'. The solid-state imaging components including the detector in the proposed device have the same physical, functional, and operational characteristics as the predicate device (K203087). Also, other image chain components like X-ray tube and generator, which are used for exposure characteristics and clinical performance evaluation remains the same. Hence all the features and characteristics potentially influencing image quality of the proposed are in accordance with FDA guidance document. Additionally, image quality testing has been performed on the proposed device for the changes that are affecting the image quality.

AI/ML Overview

The provided text is a 510(k) Summary for the Philips Medical Systems DMC GmbH CombiDiagnost R90, which is an X-ray system. This document focuses on demonstrating that the proposed device is substantially equivalent to a previously cleared predicate device, rather than proving a new medical diagnosis or treatment effectiveness. Therefore, the traditional acceptance criteria and study designs typically associated with AI/ML diagnostic devices (e.g., sensitivity, specificity, clinical accuracy, MRMC studies) are not directly applicable or reported in this type of submission.

Instead, the acceptance criteria and studies here are aimed at demonstrating that the modified device maintains the safety and effectiveness of the predicate device and complies with relevant standards and regulations.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
System Performance	Conformance to system requirements	Pass (System verification test activities substantiate that the system conforms to the system requirements)
Software Performance	Conformance to software requirements	Pass (Software verification test activities substantiate that the software conforms to the requirements)
Risk Control	System meets defined risk control measures	Pass (System meets the defined risk control measures)
Cybersecurity	System meets defined security risk control measures	Pass (Verification test activities substantiate that the system meets the defined security risk control measures)
Image Quality - MTF	MTF values are similar to or better than the predicate device, with no decrease in performance, and no impact to safety and effectiveness.	Similar: At 1 lp/mm, predicate had 66%, proposed had 63%; at 2 lp/mm, both had 35%; at 3 lp/mm, both had 19%; at 3.4 lp/mm, both had 15%. (See detailed table below; stated "Similar, the MTF remained the same, with on decrease, thus, overall, there is no impact to safety and effectiveness.").
Image Quality - DQE	DQE values are similar to or better than the predicate device, with no negative impact to safety and effectiveness.	Similar: At 0.05 lp/mm, proposed had 69% (predicate not explicitly stated at this point, but context implies comparison); at 1 lp/mm, both had 51%; at 2 lp/mm, both had 41%; at 3 lp/mm, both had 27%; at 3.4 lp/mm, both had 18%. (Stated "Similar, the DQE has remained essentially the same, with one slight increase, thus, overall, there is no impact to safety and effectiveness.").
Substantial Equivalence	Device is substantially equivalent to the predicate device in terms of design features, technological characteristics, indications for use, and safety and effectiveness.	Concluded: The proposed device is substantially equivalent to the predicate device.
Compliance with Standards	Compliance with all relevant FDA recognized consensus standards and guidance documents (e.g., IEC 60601 series, ISO 14971, cybersecurity guidance, solicitation of 510k for solid state x-ray imaging devices).	Pass: The device complies with all referenced standards and guidance documents.

Image Quality Details (from document):

Modulation Transfer Function (MTF) (according to IEC 62220-1-3 standard)

lp/mm	Predicate Device (K203087) %	Proposed Device %
1	66	63
2	35	35
3	19	19
3.4	15	15

Detective Quantum Efficiency (DQE) (according to IEC 62220-1-3 standard) at 2 µGy

lp/mm	Predicate Device (K203087) %	Proposed Device %
0.05	N/A (not explicitly listed)	69
1	51	51
2	41	41
3	27	27
3.4	18	18

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of clinical images or patient data for evaluating a diagnostic algorithm. This submission is for an X-ray imaging system, not an AI diagnostic algorithm. The "tests" mentioned are non-clinical engineering and conformity tests.

Test Set Sample Size: Not applicable/not specified in the context of clinical images. The testing refers to verification and validation of the system's hardware and software components.
Data Provenance: Not applicable in the context of clinical images or patient data. The tests are focused on the device's technical specifications and compliance with standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This is not a study requiring expert-established ground truth for diagnostic accuracy, as it's a submission for an imaging device, not an AI diagnostic tool. The "ground truth" for the engineering tests would be the established technical standards and specifications.

4. Adjudication Method for the Test Set

Not applicable. No clinical image test sets requiring adjudication are mentioned. The testing involves compliance with standards and internal system verification.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is not mentioned as it is not relevant for demonstrating substantial equivalence of an X-ray imaging system through non-clinical performance testing.

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

Not applicable. The CombiDiagnost R90 is an X-ray imaging system, not a standalone AI algorithm. While it contains "Eleva software" with imaging features, the submission focuses on the system's overall safety and performance, not a new AI algorithm's standalone diagnostic capability.

7. The Type of Ground Truth Used

The "ground truth" for the evaluations performed in this submission are:

Engineering Specifications: The defined technical parameters and performance metrics for the device components (e.g., MTF, DQE values, electrical safety, EMC).
Regulatory Standards: The requirements outlined in FDA recognized consensus standards (e.g., IEC 60601 series) and FDA guidance documents.
Predicate Device Performance: The established performance and safety characteristics of the legally marketed predicate device (CombiDiagnost R90, K203087), against which the proposed device's performance is compared for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is an X-ray imaging device, not an AI algorithm that requires a training set for machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI algorithm mentioned.

Summary

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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 is in blue and includes the letters "FDA" stacked on top of the words "U.S. FOOD & DRUG ADMINISTRATION".

October 19, 2023

Philips Medical Systems DMC GmbH % Ming Xiao Regulatory Affairs Manager Röntgenstrasse 24 HAMBURG, HAMBURG 22335 GERMANY

Re: K232910

Trade/Device Name: CombiDiagnost R90 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: JAA, KPR Dated: September 19, 2023 Received: September 19, 2023

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerelv.

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known)

K232910

Device Name

CombiDiagnost R90

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness is prepared in accordance with 21 CFR 8807.92

§807.92.
Preparation Date:	September 14th, 2023
510(k) Owner:	Philips Medical Systems DMC GmbH
	Röntgenstrasse 24
	22335 Hamburg GERMANY
	Establishment registration number: 3003768251
Primary Contact:	Ming Xiao
	Regulatory Affairs Manager
	Phone: +49(40) 34971-2306
	E-mail: ming.xiao@philips.com
Secondary Contact:	Shalin Dave
	Senior Regulatory Affairs Project Manager
	Phone: +31(6) 42532604
	E-mail: shalin.dave@philips.com
Proposed Device
Device Name	CombiDiagnost R90
Legal Manufacturer	Philips Medical Systems DMC GmbH
	Röntgenstrasse 24
	22335 Hamburg
	GERMANY
Classification Name:	Image-intensified fluoroscopic x-ray System
Classification Regulation:	21 CFR Part 892.1650
Classification Panel:	90 - Radiology
Device Class:	Class II
Product Code:	JAA, KPR
Predicate Device
Device Name	CombiDiagnost R90 (K203087, December 03, 2020)
Legal Manufacturer	Philips Medical Systems DMC GmbH
	Röntgenstrasse 24
	22335 Hamburg
	GERMANY
Classification Name:	Image-intensified fluoroscopic x-ray system
Classification Regulation:	21 CFR Part 892.1650
Classification Panel:	90 - Radiology
Device Class:	Class II
Product Code:	JAA, KPR, MQB
Reference Device # 1
Device Name	ProxiDiagnost N90 (K212837, cleared September 21, 2021)
Legal Manufacturer	Philips Medical Systems DMC GmbH
	Röntgenstrasse 24
	22335 Hamburg
	GERMANY
Classification Name:	Image-intensified fluoroscopic x-ray System
Classification Regulation:	21 CFR Part 892.1650
Classification Panel:	90 - Radiology
Device Class:	Class II

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Device Description:

Philips fluoroscopy systems consist of the following components (standard configuration):

Basic unit (also called "geometry" or "table unit") ●
. Workstation Eleva Workspot with integrated generator control, hand switch, keyboard, mouse, touch screen and PC
Equipped with a dual screen-monitor as standard
Spot film device (digital camera or flat panel detector)
. X-ray Generator Velara
. X-ray tube assembly mounted in above table mode to be remote controlled
Receptor: Flat panel detector Optional components:
. Skyplate wireless portable detectors small and large
Ceiling Suspension (CSM3) ●
. Vertical Wall stand (VS2)
. Ceiling Suspension for monitors
Monitor trolley
. Remote control for RF viewer
Accessories for "Stitching on the Table" ●

The CombiDiagnost R90 uses the same workflow from the currently marketed and predicate device, CombiDiagnost R90 (K163210) with only the following modifications:

additional optional components (like the reference monitor, remote control), -
-Eleva Workspot updated to incorporate new imaging features mainly from the previously approved reference device, DigitalDiagnost C90 (K182973) along with functional clusters like Digital Subtraction Imaging and stitching on the table
undates to improve usability and serviceability. -

The proposed CombiDiagnost R90 is same as the predicate device (K203087) with some modifications as described.

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document. Additionally, image quality testing has been performed on the proposed device for the changes that are affecting the image quality.

Indications for Use:

CombiDiagnost R90 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 proposed CombiDiagnost R90 is substantially equivalent to the manufacturer's legally marketed devices:

. Predicate Device: CombiDiagnost R90, (K203087, SE date December 31, 2020), Philips Medical Systems DMC
A detailed comparison of the proposed and predicate device (K203087) is provided in Table 1.

	Predicate Device, CombiDiagnostR90 (K203087)	Proposed Device, CombiDiagnostR90
LegalManufacturer	Philips Medical Systems DMC GmbH	Identical
Classification	Class II per 21 CFR Part 892.1650, Primary Productcode: JAASecondary Product code: KPR, MQB	Identical
Regulation Name	Stationary x-ray system	Identical
Class	II	Identical
Review Panel	Radiology	Identical
Indications for Use	CombiDiagnost R90 is a multi-functional general R/Fsystem. It is suitable for all routine radiography andfluoroscopy exams, including specialist areas likeangiography or pediatric work, excludingmammography.	Identical
Energy Source	X-ray	Identical
Principle ofOperation	CombiDiagnost R90 is intended for the medicalapplication procedures radiography and fluoroscopy.Depending on the specific indication, X-ray proceduresvary in patient positioning and the modification ofradiographic parameters. The system is suitable forroutine X-ray examinations and special examinationson patients in standing, seated or laying positions,depending on the specific indication.	Identical
Table Features
Working height(table top center tofloorplate)	65 cm – 133 cm	Identical
Table tiltmovement	-90° to +90°	Identical
Table topsuspension	Two sides suspensions	Identical
	Predicate Device, CombiDiagnostR90 (K203087)	Proposed Device, CombiDiagnostR90
Table top material	Plastic laminate or carbon fiber	Identical
Table topmovement	Lateral: 32 cm (12.6") (± 16 cm (6.3"))Longitudinal: Only detector movements toimprove patient comfort	Identical
Table topabsorption	Plastic, with Carbon fiber: 0.6mm Al @ 100kV,HVL = 3.6mm Al	Identical
Maximum patientweight	284 kg (626 lbs)	Identical
Lateral scandistance	32 cm ± 16 cm	Identical
Lateral scan speed	5 cm/s, soft start and stop Auto centering	Identical
Longitudinal scandistance	148 cm (58.3") longitudinal, motorized	Identical
Longitudinal scanspeed / Detectormovement	3 cm - 20 cm / sec	Identical
Table columnangulation	-40° to +40°	Identical
Source imagedistance	113cm - 183cm	Identical
Other Components
Generator	Philips Velara GCF/RF, 65 kW, optional80 kWSPDU initial version (4512-202-03291)	Philips Velara GCF/RF, 65 kWoptional 80 kWSPDU upgrade version (4512-202-03293)This functionality has beenverified to have no impact on theproduct safety and effectivenessof the proposed device. It issubstantial equivalent to referencedevice ProxiDiagnost N90(Κ212837).
Tube	Philips SRO 33100 ROT 380 or SRM 0608 ROT GS505	Identical
Fixed Detector(Fluoroscopy)	Pixium FE 4343 F	Identical
Fixed Detector(Optional forRadiography)	Pixium 4343RCE	Pixium 4343RCE2Substantial equivalent, Thischange has no impact onproduct Intended Use, safety,functionality, performanceand effectiveness.

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lp/mm	%	lp/mm	%
1	66	1	63
2	35	2	35
3	19	3	19
3.4	15	3.4	15 hasSimilar, the MTF remainedthe same, with ondecrease, thus, ov

	Predicate Device, CombiDiagnostR90 (K203087)	Proposed Device, CombiDiagnostR90
		there is no impact to safety andeffectiveness.
Detective QuantumEfficiency (DQE)(according to IEC62220-1-3standard)	DQE at 2 µGylp/mm % 0.051 512 413 273.4 18	DQE at 2 µGylp/mm % 0.051 69512 413 273.4 18Similar, the DQE has remainedessentially the same, with oneslight increase, thus, overall, thereis no impact to safety andeffectiveness.
System Control	Remote, optional nearby with nearby control trolley	Identical
Collimator(Fluoroscopy)	Motorized automatic collimation	Identical
Grid	Parkable	Identical
Image Acquisition	Eleva WorkSpot	Identical
Operating System	Microsoft Windows 10	Identical
Image Processing	UNIQUE 2	Identical
Image processing
Image processing functionality
DSA (DigitalSubtractionAngiography)(Optional)	Digital Subtraction Angiography functionality isavailable. It is used for angiography and providesinteractive viewing operations on a vascular run, sothat the vascular anatomy becomes visible.	Identical
Predefinedannotationsintegrated into thedynamic viewer	Predefined annotations are available which enablesthe user to assign annotation to the image with thehelp of a set of predefined annotations. This speedsthe user workflow.	Identical
Image processing functionality
Bone Suppression(Optional)	Bone Suppression post-processing application isavailable. It is intended to generate secondary digitalradiographic image of the chest by suppressing bonesfrom the original image.	Identical

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Intuitive UserInterface forProcessingParameters	An intuitive way of modifying the availableparameters is introduced (e.g., contrast, brightness,noise limit, detail enhancement etc.) on the Eleva userinterface.	Identical
Deviation andTarget ExposureIndices	Deviation Index (DI) function is available to quantifythe deviation of the Exposure Index (EI s) from theTarget Exposure Index (EI T). This feature is used bythe clinical user only to identify whether a certainimage has been correctly exposed.	Identical
SkyFlow(Optional)	Skyflow is extended to imaging of other anatomies(e.g., Leg, hand etc.) including the chest AP/PAimaging, with Skyplate detector.	Identical

	Predicate Device, CombiDiagnostR90 (K203087)	Proposed Device, CombiDiagnostR90
Access to andExport of OriginalImage Data	Access to and Export of Original Image Data featureenables the access to an export of original image data(clean raw images without any modification) on thesystem.	Identical
One Button StoresAll (OBSA):Content andperformanceImprovement	System can additionally use OBSA for sending logfile(Alert files) to central database (RSN, e.g., RADARor M2M server) frequently by single button click.	Identical
View Selection forChanged X-RayGeneration DataSets	Users can change a data set only for currentexamination or the examinations that are using thisdata set.In addition to the current examinations, the user canselect to apply the changes to subset of allexaminations too that are using this data set.	Identical
Avoid Ghosting inVerificationImages of PortableDetectors	The feature to avoid ghosting in verification images ofportable detectors is available. It enables the system todisplay verification images on wireless (SkyPlate)detector without ghosting artifacts	Identical
Software
Operating System	Windows 10	Identical
Image Chain(fluoroscopy)	Philips Dynamic Eleva Image Chain	Identical
Image acquisition	Eleva Workspot (Increment 42)	Identical
Ceiling Suspension (optional) for Radiography examinations only
Type	Four-part aluminum telescopic column with springcounter balanced holder for X-ray tube assembly;adaptable to individual room heights	Identical
Movement	3440 mm to 6140 mm	Identical
Transverse travel	1500 mm to 3220 mm	Identical
Vertical travel	1650mm to 1705mm	Identical
	Predicate Device, CombiDiagnostR90 (K203087)	Proposed Device, CombiDiagnostR90
	Live Camera (optional) on tube head for patient positioning support With 2 Lasers (inside the collimator) Detector Calibration with a Filter integrated into the Collimator
Fixed vertical stand(Optional)	Hardware-Counterbalanced rugged column for motorized and manual vertical movement of the detector, Vertical travel - 30 cm to 180 cm Installation-Floor and wall attachment or floor only	Identical
Wireless detector(Optional) invertical stand andtable bucky(Radiography)	SkyPlate Large (pixium 3543EZ) SkyPlate Small (pixium 2430EZ)	Identical
SkyPlate DetectorSharing	Yes	Identical
Tube	High power X-ray Tube,Philips SRO 33100 ROT 380 or SRM 0608 ROT GS 505	Identical
Automatic ImageStitching(Optional)	Yes	Identical
X-ray tubeassembly rotation	around vertical axis: ±180°, lock-in position every 45° around horizontal axis: ±115°, lock-in position at 0°, ±90°	Identical
Tube Head control	Tube head operation user interface: The User interface on Eleva tube head is touch control. Display: 12" color graphics display with touch control functionality for tube head operation. Eleva screen display in the examination room enables the user to use all the control room parameters from examination room as well. Control Handle: Control handle with flat capacitive sensor for releasing brakes for the ceiling suspension movement.	Identical
Collimator	Ralco P 225 ACS DHHS Motorized automatic collimation Manual overrule possible With light field indicator	Identical

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The outcome of this technological characteristics comparison and risk assessment demonstrate that the minor differences in the technological characteristics do not affect the safety or effectiveness of the proposed CombiDiagnost R90, when compared to the legally marketed predicate device (K203087). This thus demonstrates the substantial equivalence of the proposed device with the predicate device (K203087).

Summary of Non-Clinical and Clinical Performance Data:

This 510(K) premarket notification includes non-clinical performance testing.

Tests were performed on the proposed ProxiDiagnost N90 according to the following FDA recognized standards and guidance documents: The verification and validation methods and acceptance criteria) used to evaluate the proposed CombiDiagnost R90 are the same as those used for the predicate device (K203087) and follow FDA recognized consensus standards and guidance documents applicable to this device type:

. ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (Recognition #19-4)
IEC 60601-1-2 Edition 4.0 2014-02, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests (Recognition #19-8)
. IEC 60601-1-3 Edition 2.1 2013-04, Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment (Recognition # 12-269)
. IEC 60601-1-6 Edition 3.1 2013-10, Medical Electrical Equipment - Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability (Recognition # 5-89)
. IEC 60601-2-54 Edition 1.1 2015-04, Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (Recognition # 12-296)
. IEC 62304 Edition 1.1 2015-06, Medical device software - Software life cycle processes (Recognition # 13-79)
. ANSI AAMI ISO 14971: 2007/(R)2010, Medical devices-Application of risk management to medical devices (Recognition # 5-40)
ISO 10993-1, Fifth edition 2018-08, Biological evaluation of medical devices Part 1: Evaluation and . testing within a risk management process (Recognition # 2-258)
. Guidance for the Submission of 510(k)s for Solid State X-Ray Imaging Devices, issued September 1, 2016
. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 11, 2005
. Guidance for Pediatric Information for X-ray Imaging Device Premarket Notifications, issued November 2017
. 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 proposed device complies with the Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices. The solid-state imaging components including the detector in the proposed device have the same physical, functional, and operational characteristics as the predicate device (K203087). Also, other image chain components like X-ray tube and generator, which are used for exposure characteristics and clinical performance evaluation remain the same. Hence, all the features and characteristics potentially influencing image quality of the proposed are in accordance with FDA guidance document 'Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices, dated September 1, 2016'. Additionally,

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Image quality testing has been performed on the proposed device for the changes that are affecting the image quality.

The proposed device complies with the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 11, 2005. The changes to the proposed device the intended use or the fundamental scientific technology when compared to the predicate device (K203087). The software for the proposed device has the same 'Level of concern (Moderate)' as that of the predicate device (K203087). The software verification testing has been conducted as per the level of concern.

The proposed device complies with the Guidance for Pediatric Information for X-ray Imaging Device Premarket Notifications, issued November 2017. The changes made to the proposed device do not affect the pediatric application. The indication for use of the proposed device is the same as the predicate device (K203087).

The proposed device complies with Guidance for Radio Frequency Wireless Technology in Medical Devices, issued August 14, 2013. All the radiofrequency components of the predicate device (K203087) and proposed device are the same except for the replacement of Bluetooth remote control in the predicate device by infrared remote control in the proposed device. The verification testing has been conducted for the safety and efficacy of the remote control.

The proposed device complies with the Guidance for Management of Cybersecurity in Medical Devices, issued October 2, 2014. A set of cybersecurity controls to assure proposed device's cybersecurity and maintain medical device functionality and safety are in place. Cybersecurity plan and risk document are prepared to assess the proposed device for the following: o Identification of assets, threats, and vulnerabilities:

Assessment of the impact of threats and vulnerabilities on device functionality and end o users/patients;

O Assessment of the likelihood of a threat and of a vulnerability being exploited;
Determination of risk levels and suitable mitigation strategies; 0
Assessment of residual risk. O

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Refer Table 2 for the non-clinical testing that were performed on the proposed device with respect to the changes. Test results demonstrate that the proposed CombiDiagnost R90 meets acceptance criteria and is adequate for its intended use. Risk assessment activities show that the risks are sufficiently mitigated.

Tests	Document number	Test results
SystemVerification testing	• D000710352: System Verification ReportCombiDiagnost R90 Rel. 1.1.1 & 1.1.2• D000906247, System Verification ReportCombiDiagnost R90_R1.1.4• D001021873: SVR_CombiDiagnost R90_R1.1.5	PassSystem verification testactivities substantiate that thesystem conforms to thesystem requirements
Softwareverification testing	• D000693721: Verification report SubSystem ElevaInc.42.1• D000457609: Subsystem Verification Report R1.1.4• D001012699: Subsystem Verification Report 42.0Combi R1.1.5• D000185012: Configuration Management Plan Eleva• D000560160: TEST Report IEC 62304 Medical devicesoftware – Software life-cycle processes includingsoftware maintenance plan	PassSoftware verification testactivities substantiate that thesoftware conforms to therequirements
Risk control	• D000234134: Risk Matrix Status Report forCombiDiagnost R90• D000188652: RMSR for subsystem Eleva	PassSystem meets the defined riskcontrol measures
Cyber Security	• D000584899: Cyber Security Plan CombiDiagnost R90• D000256905: Cyber Security Risk Management MatrixCombiDiagnsot R90• D000585130: Cyber Security Risk StatementCombiDiangost R90• D000513810: Manufacturer Disclosure Statement forMedical Device Security for CombiDiagnost R90• D001393076: SBOM	PassVerification test activitiessubstantiate that the systemmeets the defined securityrisk control measures

			Table 2 Testing Summary for the changes on the proposed device

There is no clinical data submitted in this 510(k) premarket notification.

Substantial Equivalence Conclusion:

The proposed device, CombiDiagnost R90 is substantially equivalent to the currently marketed and predicate device, (K203087) in terms of the of design features, technological characteristics, indications for use, and safety and effectiveness.

Additionally, substantial equivalence was demonstrated with non-clinical performance tests and testing as per FDA-recognized consensus standards. The test results demonstrates that the device conforms to its specifications and is safe and effective for its intended use.

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.