CombiDiagnost R90 is a multi-functional general RF 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 lying positions. The CombiDiagnost R90 retrieves images by means of a Cesium Iodide flat panel detector.

Philips fluoroscopy systems (standard configuration) consist of the Basic unit ("geometry" or "table unit"). Workstation Eleva Workspot (with integrated generator control, hand switch, keyboard, mouse, touch screen and PC), dual screen-monitor, Spot film device (digital camera or flat panel detector), Dynamic detector, Fixed detector, X-ray Generator Velara, X-ray tube assembly, Receptor (Flat panel detector). The optional component like 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", are also available.

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. As part of the radiographic system, the Eleva software is intended to acquire, process, store, display and export digital Fluoroscopy and radiographic 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 Front-end Software is intended to acquire images.
The Back-end Software is intended to query patient data from Radiology Information System (RIS), store, display and export digital radiographic images to Picture Archiving and Communication System (PACS)
The Image Processing Software is intended to perform the pre and post processing on the acquired raw images.

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 (K202564) along with functional clusters like Digital Subtraction Imaging and stitching on the table
updates to improve usability and serviceability. -

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a study that directly proves the device meets specific performance metrics in a way that would typically be described for an AI/CADe device. The document is a 510(k) summary for a general radiography/fluoroscopy system (CombiDiagnost R90) and focuses on demonstrating substantial equivalence to a predicate device.

However, based on the information provided, I can infer some aspects related to acceptance and testing.

Here's an attempt to structure the information according to your request, acknowledging the limitations from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of explicit, quantitative acceptance criteria for the new features (like UNIQUE 2 image processing or Bone Suppression) or their specific performance against those criteria. Instead, it relies on demonstrating that these features, which are either identical to or upgrades from previously cleared devices, maintain or improve safety and effectiveness.

The closest to "acceptance criteria" are the standards and guidance documents followed:

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with FDA recognized standards and guidance documents (e.g., ISO, IEC safety and performance standards for X-ray equipment, FDA guidance for solid-state X-ray imaging devices).	Non-clinical verification and validation tests, as well as image quality testing, were performed according to the listed standards and guidance documents. Test results demonstrate that the CombiDiagnost R90 meets the acceptance criteria and is adequate for its intended use. (Page 10)
Maintenance/Improvement of Image Quality (for new imaging features)	- UNIQUE 2 (radiography modality only): Intended to provide improved image processing, reduced noise, and improved contrast compared to UNIQUE for radiography only. It does not alter the clinical workflow, hence there is no change to the safety or effectiveness of the device. (Page 8) - The Eleva software is upgraded to incorporate new features for better imaging, and tests verified no impact on safety or effectiveness. (Page 7) - The Image Acquisition remains the same on a basic level, while incorporating new features. (Page 7)
Mitigation of risks associated with changes (software, optional components)	Safety risk assessment report conducted. Risks associated with changes are considered in the risk management report and activities, showing all risks are sufficiently mitigated and overall residual risks are acceptable. (Page 5, 10)
No negative impact on safety and effectiveness compared to predicate.	Comparisons in Table 1 and Table 2 demonstrate that minor differences in technological characteristics (like the OS upgrade, additional reference monitor, firmware tool) or the inclusion of features from a reference device (UNIQUE 2, Bone Suppression) do not affect the safety or effectiveness of the CombiDiagnost R90 when compared to the predicate device. (Pages 6-9)
Adequate Human Factors and Usability.	Human Factors and Usability Engineering Test performed. (Page 10)

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

The document does not specify a "test set" in terms of patient data or image datasets for the non-clinical performance tests mentioned. The testing refers to conformance to standards and internal verification/validation processes for the device itself. Given it's a 510(k) for an X-ray system, not an AI diagnostic algorithm, the "test set" would typically refer to phantom images, system measurements, and functional tests rather than a patient image dataset.

Sample Size: Not explicitly stated for any specific test. The phrase "non-clinical verification and validation tests as well as image quality testing" suggests a range of internal engineering and performance tests.
Data Provenance: Not applicable in the context of patient data as this summary focuses on device substantial equivalence rather than a new diagnostic AI a diagnostic AI algorithm. The device manufacturer is Philips Medical Systems DMC GmbH, located in Hamburg, Germany.

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

This information is not provided because the submission is not for an AI/CADe device requiring expert ground truth for interpretation of medical images. The "ground truth" for this type of device would be established by engineering specifications, physical measurements, and compliance with recognized standards.

4. Adjudication Method for the Test Set

Not applicable, as this is not an AI/CADe device requiring human interpretation adjudication.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is typically conducted for AI/CADe devices to evaluate their impact on human reader performance, which is not the primary focus of this 510(k) for an X-ray imaging system. The document explicitly states: "The CombiDiagnost R90 did not require a clinical study since substantial equivalence... was demonstrated..." (Page 11).

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

This is not applicable as the device is an X-ray system, not a standalone AI algorithm. It mentions "Image Processing Software" and features like "UNIQUE 2" and "Bone Suppression," but these are integrated functionalities within the imaging system to enhance image quality, not standalone diagnostic algorithms.

7. The Type of Ground Truth Used

For an X-ray imaging system, the "ground truth" for non-clinical testing would typically involve:

Engineering Specifications: Conformance to design parameters and functional requirements.
Physical Measurements: Using phantoms and test equipment to measure parameters like resolution, contrast, dose, noise, and geometric accuracy.
Compliance with Standards: Meeting the requirements outlined in recognized national and international standards (e.g., AAMI ANSI ISO 14971, AAMI ES60601-1, IEC 60601-1-2/3, IEC 60601-2-54, IEC 62220-1-1).

The document mentions "image quality testing" (Page 10) and verifies that upgraded software features (like UNIQUE 2) aim to provide "improved image processing, reduced noise, and improved contrast" (Page 8), suggesting these metrics are part of the testing ground truth.

8. The Sample Size for the Training Set

Not applicable. This device is an X-ray system, not a machine learning model that requires a training set of data. The software components are developed and verified through traditional software engineering processes rather than machine learning training.

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

Not applicable, as there is no machine learning "training set" for this device.

Summary

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Philips Medical Systems DMC GmbH % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114

Re: K203087

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, MOB Dated: November 23, 2020 Received: November 24, 2020

Dear Prithul Bom:

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. 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 located 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.

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) for

December 3, 2020

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devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K203087

Device Name CombiDiagnost R90

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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510(k) Summary of Safety and Effectiveness

510(K) Number : K203087

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.

Issue Date:	July 17th, 2020
Manufacturer:	Philips Medical Systems DMC GmbHRoentgenstrasse 24-2622335 HamburgGERMANYEstablishment registration number: 3003768251
Contact Person:	Dr. Supriya A. DalviRegulatory Operations SpecialistPhone: +91 9825604544 / +918733918445Fax: +49 40 5078-2425E-mail: supriya.dalvi@philips.com
Device TradeName:	CombiDiagnost R90
Classification:	Classification Name:	Image-intensified fluoroscopic x-ray system
	Classification Regulation:	21CFR 892.1650
	Classification Panel:	90 - Radiology
	Device Class:	Class II
	Primary Product Code:	JAA
	Secondary Product Code:	KPR, MQB
PredicateDevice:	Trade Name:	CombiDiagnost R90
	Manufacturer:	Philips Medical Systems DMC
	510(k) Clearance:	K163210 - January 31, 2017
	Classification Name:	Image-intensified fluoroscopic x-ray system
	Classification Regulation:	21CFR 892.1650
	Classification Panel:	Radiology

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Device Class:	Class II
Primary Product Code:	JAA
Secondary Product Codes:	KPR, MQB
Reference Device:
Trade Name:	DigitalDiagnost C90
Manufacturer:	Philips Medical Systems DMC GmbH
510(k) Clearance:	K202564 - September 30, 2020
Classification Name:	Stationary x-ray system
Classification Regulation:	21CFR 892.1680
Classification Panel:	90 -- Radiology
Device Class:	Class II
Product code:	MQB, KPR, LLZ

Device Description:

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The Front-end Software is intended to acquire images.
The Back-end Software is intended to query patient data from Radiology Information System (RIS), store, display and export digital radiographic images to Picture Archiving and Communication System (PACS)
The Image Processing Software is intended to perform the pre and post processing on the acquired raw images.

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 (K202564) along with functional clusters like Digital Subtraction Imaging and stitching on the table
updates to improve usability and serviceability. -

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 CombiDiagnost R90 employs the same basic construction and fundamental scientific technology as the currently marketed and predicate device. CombiDiagnost R90 (K163210), with regards to the functionality of all its components with the same high voltage generator, X-ray tube, Collimator, Wireless portable detectors, workstation (ELEVA) for images post-processing, storage and viewing. Many of the modifications to the CombiDiagnost R90 are already FDA cleared in reference device, DigitalDiagnost C90 (K202564). All features characteristics that potentially have an influence on image quality are assessed and verified according to FDA Guidance for Industry and Food and Drug Administration Staff: Guidance for the Submission of 510/k)'s for Solid State X-ray Imaging Devices; issued on September 1, 2016. Further the Non-clinical information sufficiently supports the substantial equivalence as per chapter VII- Non clinical Considerations of FDA Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices.

These modifications have been evaluated in safety risk assessment report. The risks associated with these changes are considered in the risk management report and risk management activities show that all risks are sufficiently mitigated and that the overall residual risks are acceptable.

The outcome of this technological characteristics comparison between the CombiDiagnost R90 and currently marketed and predicate device, CombiDiagnost R90 (K163210) also demonstrate that the minor differences in the technological characteristics do not affect the safety or effectiveness of the CombiDiagnost R90 when compared to the currently marketed predicate.

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Summary of technological characteristics:

The CombiDiagnost R90 has the same indications for use and technological characteristics as the currently marketed and predicate device, CombiDiagnost R90 (K163210) demonstrating its substantial equivalence to the predicate device. Refer Table 1 below for comparisons of the technological characteristics of CombiDiagnost R90 and the predicate device and Table 2 for comparison between CombiDiagnost R90 and the reference device, DigitalDiagnost C90 (K202564)

Table 1: Comparison of the Technological Characteristics and Indications for use of the CombiDiagnost R90 and the Currently Marketed and Predicate device, CombiDiagnost R90

	Predicate device:CombiDiagnost R90(K163210)	CombiDiagnost R90	Discussion
Regulationnumber	21CFR 892.1650	Identical	-
ClassificationPanel	90 - Radiology	Identical	-
Device Class	Class II	Identical	-
Product codes	JAA, KPR, MQB	Identical	-
Table Features
Working height(table top centerto floorplate)	65 cm - 133 cm	Identical	Substantially Equivalent; Noimpact to safety andeffectiveness of the device.
Table tiltmovement	-90° to +90°	Identical	Substantially Equivalent; Noimpact to safety andeffectiveness of the device.
Table topsuspension	Two sides suspensions	Identical	Substantially Equivalent; Noimpact to safety andeffectiveness of the device.
Table topmaterial	Plastic laminate or carbonfiber	Identical	Substantially Equivalent; Noimpact to safety andeffectiveness of the device.
Table topmovement	Lateral: 32 cm (12.6") (± 16cm (6.3"))Longitudinal: Only detectormovements toimprove patient comfort	Identical	Substantially Equivalent; Noimpact to safety andeffectiveness of the device.
Table topabsorption	Plastic, with Carbon fiber:0.6mm Al @ 100kV,HVL = 3.6mm Al	Identical	Substantially Equivalent; Noimpact to safety andeffectiveness of the device.
Maximumpatient weight	284 kg (626 lbs)	Identical	Substantially Equivalent; Noimpact to safety andeffectiveness of the device.
Lateral scandistance	32 cm ± 16 cm	Identical	Substantially Equivalent; Noimpact to safety andeffectiveness of the device.
Lateral scanspeed	5 cm/s, soft start and stopAuto centering	Identical	Substantially Equivalent; Noimpact to safety andeffectiveness of the device.
Longitudinalscan distance	148 cm (58.3") longitudinal, motorized	Identical	Substantially Equivalent; Noimpact to safety andeffectiveness of the device.
Longitudinalscan speed /Detectormovement	3 cm – 20 cm / sec	Identical	Substantially Equivalent; Noimpact to safety andeffectiveness of the device.
Table columnangulation	-40° to +40°	Identical	Substantially Equivalent; Noimpact to safety andeffectiveness of the device.
Source imagedistance	113cm – 183cm	Identical	Substantially Equivalent; Noimpact to safety andeffectiveness of the device.
Collimator	Motorized automaticcollimation	Identical	Substantially Equivalent; Noimpact to safety andeffectiveness of the device.
Preparation timefor exposure	1 sec (approximately)	Identical	Substantially Equivalent; Noimpact to safety andeffectiveness of the device.
Grid	Parkable	Identical	Substantially Equivalent; Noimpact to safety andeffectiveness of the device.
Auto GridSelection	Yes	Identical	Substantially Equivalent; Noimpact to safety andeffectiveness of the device.
Automatic pre-position of thetable	Yes	Identical	Substantially Equivalent; Noimpact to safety andeffectiveness of the device.
Picture archivingandcommunicationsystem	Yes	Identical	Substantially Equivalent; Noimpact to safety andeffectiveness of the device.
Image chain(fluoroscopy)	Philips dynamic ElevaImage Chain	Identical	Substantially Equivalent; Noimpact to safety andeffectiveness of the device.
Detector	Pixium FE 4343F (clearedvia K080859 – Villa SistemiMedicali S.p.A.)	Identical	Substantially Equivalent; Noimpact to safety andeffectiveness of the device.
Generator	Philips Velara 65kW,optional 80 kW	Identical	Substantially Equivalent; Noimpact to safety andeffectiveness of the device.
Tube	Philips SRO 33100 ROT380 or SRM 0608 ROT GS505	Identical	Substantially Equivalent; Noimpact to safety andeffectiveness of the device.
System Control	Remote, optional nearbywith nearby control trolley	Identical	Substantially Equivalent; Noimpact to safety andeffectiveness of the device
ImageAcquisition	Eleva WorkSpot	Updated Eleva WorkSpotto include new imagingfeatures UNIQUE 2 andBone Suppression from thereference device,DigitalDiagnost C90(K202564) along with	The basis and functionality ofthe Image acquisition remainssame. The Eleva software isupgraded to incorporate thenew features for betterimaging was tested andverified to have no impact on

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		Subtraction Imaging andstitching on the table	the device. Thusdemonstrating SubstantialEquivalence
OperatingSystem	Microsoft Windows 7	Microsoft Windows 10	The upgrade to Window 10 isa part of routine softwareupgrade done by Microsoft.Further verification testsdemonstrates no impact on thesafety and effectiveness of thedevice. Thus demonstratingSubstantial Equivalence
ImageProcessing	UNIQUE (fluoroscopy +radiography modality)	UNIQUE (fluoroscopymodality only)UNIQUE 2 (radiographymodality only)	UNIQUE 2 is only used forradiography workflows forthe subject device. It isintended to provide improvedimage processing, reducednoise, and improved contrastcompared to UNIQUE forradiography only.UNIQUE 2 does not replaceUNIQUE for fluoroscopy oralter the clinical workflow,hence there is no change tothe safety or effectiveness ofthe device. Both UNIQUEand UNIQUE 2 are embeddedin their respective workflowsand cannot be used cross-modality.
Referencemonitor	No	Yes	The additional referencemonitor is made available forthe display a reference imagein the Control Room and theExamination Room. This doesnot impact safety andeffectiveness of the device.Thus, demonstratingSubstantial Equivalence
Firmware for thedynamic detector	No	Yes	This is a service tool toprovide functionality toperform firmware updates ofthe detector. It doesn'timpact safety andeffectiveness of the device.Thus, demonstratingSubstantial Equivalence
Indications forUse	CombiDiagnost R90 is amulti-functional general R/Fsystem. It is suitable for allroutine radiography andfluoroscopy exams,including specialist areaslike angiography orpediatric work, excludingmammography.	Identical	Substantially Equivalent; Noimpact to safety andeffectiveness of the device.
	CombiDiagnost R90	Reference DeviceDigitalDiagnost C90(K202564)	Discussion
ImageAcquisition	Updated Eleva WorkSpot toinclude new imagingfeatures UNIQUE 2 andBone Suppression from thereference device,DigitalDiagnost C90(K202564) along withfunctional clusters, DigitalSubtraction Imaging andstitching on the table	Eleva WorkSpot	The basis and functionality ofthe Image acquisition remainssame. The Eleva software isupgraded to incorporate thenew features for betterimaging was tested andverified to have no impact onthe safety or effectiveness ofthe device.
OperatingSystem	Microsoft Windows 10	Identical	No impact on safety andeffectiveness of the device.Further testing has beencarried to confirm the safetyand effectiveness
ImageProcessing	UNIQUE 2 (radiographymodality only)	UNIQUE 2 (radiographymodality only)	No impact on safety andeffectiveness of the device asthe feature is included only inthe radiography workflow ofthe subject device, which issame as the reference deviceFurther testing has beencarried to confirm the safetyand effectiveness
Post-processingapplication	Bone Suppression	Identical	No impact on safety andeffectiveness of the device.Further testing has beencarried to confirm the safetyand effectiveness
Scattercorrection	Skyflow Plus	Identical	No impact on safety andeffectiveness of the device.Further testing has beencarried to confirm the safetyand effectiveness
Tube Head	Eleva Tube head withoptional live camerapackage	Identical	No impact on safety andeffectiveness of the device.Further testing has beencarried to confirm the safetyand effectiveness

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Table 2: Comparison of the Technological Characteristics of the CombiDiagnost R90 and the reference device, DigitalDiagnost C90

Summary of Non-Clinical Data:

This 510(k) premarket notification contains technical documentation which includes non-clinical verification and validation tests as well as image quality testing. Tests were performed on the CombiDiagnost R90 according to the following FDA recognized standards and guidance documents as well as additional non-standard performance tests:

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. AAMI ANSI ISO 14971:2007/ (R) 2010, Medical devices. Application of risk management to medical devices
AAMI ES60601-1:2005/(R)2012 and . C1:2009/(R)2012 ANSI and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
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
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
. IEC 60601-2-54 Edition 1.1 2015-04 CONSOLIDATED VERSION Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
. IEC 6220-1-1 Edition 1.0 2015-03 Medical electrical equipment-Characteristics of digital X-ray imaging devices Part 1-1: Determination of the detective quantum efficiency Detectors used in radiographic imaging
IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software -● Software life cvcle processes
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

Additional non-standard performance tests have been performed to demonstrate the safety and effectiveness as follows:

. System Verification Test
. Image Quality Test
Human Factors and Usability Engineering Test

The test results of Non-Clinical testing demonstrate that the CombiDiagnost R90 meets the acceptance criteria and is adequate for its intended use. Additionally, the risk management activities show that all risks are sufficiently mitigated and overall residual risks are acceptable.

Based on the supporting data provided in this 510(k) premarket notification, the CombiDiagnost R90 is substantially equivalent to the currently marketed and predicate device, CombiDiagnost R90 (K163210) in terms of safety and effectiveness.

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Summary of Clinical Data:

The CombiDiagnost R90 did not require a clinical study since substantial equivalence to the currently marketed and predicate device, CombiDiagnost R90 (K163210) was demonstrated with the following attributes:

Design features;
Indication for use;
Fundamental scientific technology; ●
Non-clinical performance testing and
Safety and effectiveness. ●

Substantial Equivalence Conclusion:

The comparison of technological characteristics, non-clinical performance data, safety testing demonstrates that CombiDiagnost R90 is substantially equivalent to the currently marketed and predicate device, CombiDiagnost R90 (K163210) and is safe and effective.

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.