The DR 800 with DSA system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures:

· Positioning fluoroscopy procedures
· Gastro-intestinal examinations
· Urogenital tract examinations
· Angiography
· Digital Subtraction Angiography

It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for projection radiography of all body parts.

In addition, the system provides the Agfa Tomosynthesis option, which is intended to acquire tomographic slices of human anatomy and to be used with Agfa DR X-ray systems. Digital Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep.

Not intended for cardiovascular and cerebrovascular contrast studies. Not intended for mammography applications.

Device Description

Agfa's DR 800 with DSA medical device is a fluoroscopic x-ray system that includes digital angiography (product code JAA) intended to capture tomographic, static and dynamic images of the human body. The DR 800 is a floor-mounted radiographic, fluoroscopic and tomographic system that consists of a tube and operator console with a motorized tilting patient table. FLFS overlay and bucky with optional wall stand and ceiling suspension. The new device uses Agfa's NX workstation with MUSICA image processing and flat-panel detectors for digital, wide dynamic range and angiographic image capture. It is capable of replacing other direct radiography, tomography, image intensifying tubes and TV cameras, including computed radiography systems with conventional or phosphorous film cassettes.

This submission is to add the newest version of the DR 800 with Digital Subtraction Angiography (DSA) to Agfa's radiography portfolio.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Agfa DR 800 with DSA, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria in a table format for performance metrics. Instead, it describes a more qualitative approach, focusing on equivalence to predicate devices and confirmation through expert evaluation.

Acceptance Criteria (Inferred from text)	Reported Device Performance
Bench Testing (General Performance)	"Technical and acceptance testing was completed on the DR 800 with DSA in order to confirm the medical device functions and performs as intended. All deviations or variances are documented in a defect database and addressed in the CRD documentation and verified. All mitigations have been tested and passed. All design input requirements have been tested and passed. All planned verification activities have been successfully completed."
Functionality and Usability	"Performance functionality and usability evaluations were conducted with qualified experts. The results of these tests fell within the acceptance criteria for the DR 800 with DSA; therefore, the DR 800 supports GenRad, Full Leg/ Full Spine (FLFS), roadmapping and Digital Subtraction Angiography (DSA) workflow."
Clinical Image Quality (DSA)	"Clinical image validation was conducted using anthropomorphic phantoms and evaluated by qualified experts. The radiographers evaluated the DSA image quality on the DR 800 by comparing overall image quality with the primary predicate A device (K190373). Diagnostic confidence for DSA image quality and roadmapping on the DR 800 was between good and excellent." The document also states, "Clinical image quality evaluation is not essential in establishing substantial equivalence for the DR 800 with DSA. Adequate Bench Testing results should be sufficient to determine device safety and effectiveness." This indicates that while performed, it wasn't a strict acceptance criterion in the same vein as quantitative safety/effectiveness thresholds.
Software Verification & Validation (Safety/Risk)	"The complete device has been certified and validated. During the final risk analysis meeting, the risk management team concluded that the medical risk is no greater than with conventional x-ray film previously released to the field." "For the NX 23 (NX Orion) software there are a total of 535 risks in the broadly acceptable region and 37 risks in the ALARP region with only four of these risks identified. Zero risks were identified in the Not Acceptable Region. Therefore, the device is assumed to be safe, the benefits of the device are assumed to outweigh the residual risk."
Electrical Safety and Electromagnetic Compatibility (EMC) Testing	The device is compliant with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, and IEC 60601-2-54. The DR 800 is also compliant with FDA Subchapter J mandated performance standards 21 CFR 1020.30 - 1020.32.
Quality Management, Risk Management, DICOM, Usability Engineering	The company's in-house procedures conform to ISO 13485, ISO 14971, ACR/NEMA PS3.1-3.20 (DICOM), and IEC 62366-1. (This implies compliance with these standards as part of overall acceptance).

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

Test Set Sample Size: Not explicitly stated in terms of number of images or cases. The document mentions "anthropomorphic phantoms" for clinical image validation.
Data Provenance: The study used "anthropomorphic phantoms," which are physical models designed to simulate human anatomy for imaging purposes. This indicates a laboratory/phantom study rather than real patient data. The country of origin for the phantom data is not specified, but the submission is from Agfa N.V. (Belgium). It is a prospective study in the sense that the new device was evaluated with these phantoms.

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

Number of Experts: Not explicitly stated. The document mentions "qualified experts" and "radiographers."
Qualifications of Experts: Described as "qualified experts" and "radiographers." No specific experience levels (e.g., "10 years of experience") are provided.

4. Adjudication Method for the Test Set

Not specified. The document states "evaluated by qualified experts" and "radiographers evaluated...by comparing overall image quality with the primary predicate A device," implying a comparative evaluation rather than a strict adjudication process for ground truth establishment.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted. This is not an AI-assisted diagnostic device; it's a conventional X-ray system with digital image processing and DSA capabilities. The study compared the device's image quality to a predicate device, focusing on equivalence, not human reader improvement with AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in essence, the "Bench Testing" and "Software Verification and Validation Testing" sections describe standalone performance evaluations of the device's functions and image processing algorithms. The "Clinical image validation" with phantoms also focuses on the device's output (image quality) rather than human interaction with the device in a diagnostic workflow where the human acts as the ultimate decision-maker for the study’s performance outcome.

7. The Type of Ground Truth Used

The "ground truth" for the image quality evaluation was based on expert comparison and qualitative assessment of images produced by the device, specifically assessing "diagnostic confidence for DSA image quality and roadmapping" as "between good and excellent" when compared to a predicate device. This is primarily an expert consensus on image quality rather than pathology, clinical outcomes, or a gold standard.

8. The Sample Size for the Training Set

Not applicable. This device is an X-ray imaging system, not a machine learning or AI algorithm that requires a training set of data. The image processing algorithms are described as being "similar to those previously cleared" or "similar to the primary predicate device."

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

Not applicable, as this device does not utilize a machine learning model that would require a ground truth for a training set.

Summary

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August 31, 2021

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box. To the right of the box is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Agfa N.V. % Ms. ShaeAnn Cavanagh Regulatory Affairs Manager, North America Agfa US Corp. 10 South Academy Street GREENVILLE SC 29601

Re: K212145

Trade/Device Name: DR 800 with DSA Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: JAA Dated: July 8, 2021 Received: July 9, 2021

Dear Ms. Cavanagh:

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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) K212145

Device Name DR 800 with DSA

Indications for Use (Describe)

The DR 800 with DSA system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures:

· Positioning fluoroscopy procedures
· Gastro-intestinal examinations
· Urogenital tract examinations
· Angiography
· Digital Subtraction Angiography

It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for projection radiography of all body parts.

Not intended for cardiovascular and cerebrovascular contrast studies. Not intended for mammography applications.

Type of Use (Select one or both, as applicable)

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

K212145

Agfa N.V. DR 800 with DSA

SUBMITTER I.

Agfa N.V. Septestraat 27 B-2640 Mortsel Belgium Contact: Wim Govaerts, Prepared: July 8, 2021 Telephone: + 32 3444 6246

DEVICE II.

Name of Device: DR 800 with DSA Common Name: System, X-Ray, Fluoroscopic Image-Intensified Classification Name: Fluoroscopic Image-Intensified X-Ray System Regulatory Classification: Class II, 21 CFR 892.1650 Product Code: JAA

PREDICATE DEVICE(S) III.

This is a 510(k) for Agfa's DR 800 with DSA which is a fluoroscopic x-ray system, including digital angiography. It is substantially equivalent to Shimadzu Corporation's primary predicate device A. SONIAL VISION G4 (K190373) and Agfa's predicate device B, DR 800 with Tomosynthesis (K183275).

Primary Predicate Device (A): SONIALVISION G4 Common Name: System, X-Ray, Fluoroscopic Image-Intensified Classification Name: Fluoroscopic Image-Intensified X-Ray System Regulatory Classification: Class II, 21 CFR 892.1650 Product Code: JAA

1. Predicate Device (B): DR 800 with Tomosynthesis Name of Device: DR 800 with Tomosynthesis Common Name: System, X-Ray, Tomographic Classification Name: Tomographic X-ray System Regulatory Classification: Class II, 21 CFR 892.1740 Product Code: IZF
  Common Name: System, X-Ray, Fluoroscopic Image-Intensified Classification Name: Fluoroscopic X-ray System Regulatory Classification: Class II, 21 CFR 892.1650 Product Code: JAA

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The SONIALVISION G4 (K190373) primary predicate device has not been subject to a designrelated recall. The DR 800 with Tomosynthesis (K183275) predicate device was part of a Class II recall initiated on February 10, 2020. The recall was related specifically to the tomosynthesis software functionality where an image acquisition sequence did not stop automatically after expected number of exposures. No injuries were reported. Agfa has taken these reported defects into consideration and is mindful of these events while developing the subject device, DR 800 with DSA.

IV. DEVICE DESCRIPTION

This submission is to add the newest version of the DR 800 with Digital Subtraction Angiography (DSA) to Agfa's radiography portfolio.

The image processing algorithms in the new device are similar to those previously cleared in the DR 800 with Tomosynthesis (K183275) and other devices in Agfa's radiography portfolio today which includes DR 600 with Tomosynthesis (K193262) and DR 400 (K141192). The addition of the angiographic image processing is similar to the primary predicate device (K190373).

Principles of operation and technological characteristics of the new and predicate devices are the same. The new device is virtually identical to Agfa's DR 800 with Tomosynthesis (K183275) with the exception that it has additional DSA software for processing digital angiographic studies. The SONIALVISION G4 (primary predicate A. K190373) contains similar software algorithms for processing angiographic studies of the human body. The DR 800 with Tomosynthesis (predicate B. K183275) uses the same flat panel detectors to capture and digitize the image. Differences in devices do not alter the intended diagnostic effect. Laboratory data and image quality evaluations conducted with independent radiologists confirm that performance is equivalent to the predicates.

Configuration information for the flat-panel detectors can be found in the DR 14s (K161368) user manuals. The DR 14s and RF FL 4343 flat-panel detectors can be integrated in an X-ray system that communicates to a workstation. The Service Manual details the possible configurations and integrations with the NX workstation and X-ray generator. All of Agfa's DR X-ray systems (i.e. DX-D 100-K103597, DX-D 300-K103050, DX-D 600-K112670, DR 400-K141192, DR 600-K152639, DR 800 with MUSICA Dynamic -K180589, DR 800 with Tomosynthesis - K 183275, DR 100s – K191884 & DR 600 with Tomosynthesis – K193262) will integrate with the detectors. The NX4.x.23 Service Manual, Chapter 4 and associated appendices addresses the installation and configuration with other system components.

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V. INDICATIONS FOR USE

The DR 800 with DSA system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures:

Positioning fluoroscopy procedures
· Gastro-intestinal examinations
Urogenital tract examinations
Angiography
Digital Subtraction Angiography

It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for projection radiography of all body parts.

In addition, the system provides the Agfa Tomosynthesis option, which is intended to acquire tomographic slices of human anatomy and to be used with Agfa DR X-rav systems. Digital Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep.

Not intended for cardiovascular and cerebrovascular contrast studies. Not intended for mammography applications.

NOTE: The mammography applications embedded in the MUSICA software are for previously cleared CR imaging applications (K081963) and not intended for direct radiography (DR) imaging. Furthermore, the additional mammography software is only available through additional license keys that must be purchased. These license keys are only available outside of the USA.

PEDIATRIC USE SUMMARY

The DR 800 with DSA medical device is intended for general populations, including adult and pediatric patients. Specific design features of the DR 800 with DSA for pediatric use include but not limited to using the FLFS application without the grid, specific AEC values and NX protocol settings per pediatric age range. The following specific design features and instructions enable safer use of the device with pediatric patients:

Pediatric Imaging Design Features	Standard or Optional
Protocols or exposure indices	Standard - make own exam treeoptional - make use of age groups
Filter and removable grid	Standard
Collimator alignment	Standard
Variable focal spot size	Standard
Post-processing application	Standard/ no specific pediatric post processingfor tomosynthesis
Reconstruction algorithm	no specific pediatric reconstruction algorithm

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICES

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Agfa's DR 800 with DSA, Shimadzu Corporation's SONIALVISION G4 primary predicate device (K190373) and Agfa's DR 800 with Tomosynthesis predicate device (K183275) are all fluoroscopic x-ray imaging devices, Product Code JAA. Agfa's DR 800 with DSA is substantially equivalent to the primary predicate device (K190373) in that it uses similar technology to capture and transmit angiographic images. The DR 800 is a floor-mounted radiographic, fluoroscopic and tomographic system that consists of a tube and operator console with a motorized tilting patient table, FLFS overlay and bucky with optional wall stand and ceiling suspension. The new device uses Agfa's NX workstation with MUSICA image processing and flat-panel detectors for digital, wide dynamic range and angiographic image capture. It is capable of replacing other direct radiography, tomography, image intensifying tubes and TV cameras, including computed radiography systems with conventional or phosphorous film cassettes.

Principles of operation and technological characteristics of the new and predicate devices are the same. The new device is virtually identical to Agfa's DR 800 with Tomosynthesis (K183275) with the exception that it has additional DSA software for processing digital angiographic studies. The SONIALVISION G4 (primary predicate A, K190373) contains similar software algorithms for processing angiographic studies of the human body. The DR 800 with Tomosynthesis (predicate B, K183275) uses the same flat panel detectors to capture and digitize the image. Differences in devices do not alter the intended diagnostic effect.

The image processing algorithms in the new device are similar to those previously cleared in the DR 800 with Tomosynthesis (K183275) and other devices in Agfa's radiography portfolio today which includes DR 600 with Tomosynthesis (K193262) and DR 400 (K141192). The addition of the digital angiographic image processing is similar to the primary predicate device (K190373).

Agfa's DR 800 with DSA has an Indications For Use statement virtually identical to the predicate B device (K183275) except it includes the addition of Digital Subtraction Angiography and the contraindication for cardiovascular and cerebrovascular contrast studies. The DR 800 with DSA new device has a similar Indications For Use statement as the primary predicate A device (K190373). Intended uses are the same. The devices have technological characteristics.

The DR 800 indications for use is equivalent to both the predicate devices (K190373 & K183275) because both include fluoroscopic, radiographic and tomographic image processing and all are indicated for use in general and pediatric patient populations. The DR 800 with DSA and both predicate devices (K190373 & K183275) include the statement that the device is not indicated for mammography. The DR 800 with DSA and both predicates (K190373 & K183275) use DICOM for sending and receiving images and none of the devices are indicated for interventional procedures.

There is a difference between the new device and primary predicate device (K190373) Indication for Use statement regarding a general reference to the human body; however, standard practice dictates that diagnostic procedures for general human anatomy include chest and extremities. Another difference between the new device and primary predicate device (K190373) is that the new device Indications For Use statement lists out examples of imaging procedures; it is logical to conclude these same imaging procedures are also indicated with the predicate device based on standard medical practice. The differences between the subject device, DR 800 with DSA, and predicate devices (K190373 & K183275) do not seem to impact safety or effectiveness.

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Performance data, image quality clinical evaluations, and usability/functionality data are adequate to ensure equivalence. Descriptive characteristics and performance data including image quality evaluations by qualified experts are adequate to ensure equivalence. Differences in devices do not alter the intended therapeutic/diagnostic effect.

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	PRODUCT COMPARISON TABLE
	DR 800 with DSA(New Device)	SONIALVISION G4(PREDICATE A- K190373)	DR 800 w/ Tomo(PREDICATE B - K183275)	Explanation ofDifferences
Communication	Same as both Predicates	DICOM	DICOM	N/A
Flat PanelDetectors	Same as both Predicates	Flat Panel Detector	Flat Panel Detector	N/A
DetectorMaterial	Gadolinium Oxysulfide (GOS) orCesium Iodide (CsI) scintillator	Cesium Iodide (CsI) scintillator	Gadolinium Oxysulfide (GOS)or Cesium Iodide (CsI)scintillator	Includes GOS
Detector Sizes	17x17 in.14 x 17 in10 x 10 in	17x17 in.	17x17 in.14 x 17 in10 x 10 in	Includes 14x17 in &10x10 in as well
Pixel size	Same as Predicate K183275	139 µm	148 $μ$ m	Comparable
DynamicRange	Same as both Predicates	16 bit	16 bit	N/A
Power Supply	Same as Predicate K183275	--	50-60 Hz100-240V auto ranging	Unable to find info forpredicate K190373
OperatorWorkstation	Same as Predicate K183275	Diagnostic Workstation	Agfa NX using Microsoft 7/10
Imageprocessing	Same as Predicate K183275	SUREengine-Advance	MUSICA 3MUSICA 4	Agfa's imageprocessing software
Radiography	Fluoroscopic, Tomographic, GenRadradiography & DSA	SPOT, division & serial radiography,DSA	Fluoroscopic, Tomographic,GenRad radiography	Includes DSA likepredicate K190373
Display System	Same as both Predicates	Separately cleared medical display	Separately cleared medicaldisplay (K051901)	N/A
TabletopFeatures	Tilt +/- 90°, 240 x 80 cm265 kg maximum weight	Tilt +/- 90°, 240 x 89 cm318 kg maximum weight	Tilt +/- 90°, 240 x 80 cm265 kg maximum weight	Slight difference inheight & weightdoesn't affect S&E
Generators	Choice of three models:50, 65KW, 80 KW	80 KW	Choice of three models:50, 65KW, 80 KW	Same choice of 80KWas predicate K190373
Indications forUse	The DR 800 with DSA system isindicated for performing dynamicimaging examinations (fluoroscopyand/or rapid sequence) of the followinganatomies/procedures:• Positioning fluoroscopyprocedures• Gastro-intestinal examinations• Urogenital tract examinations• Angiography• Digital Subtraction AngiographyIt is intended to replace fluoroscopicimages obtained through imageintensifier technology.In addition, the system is intended forprojection radiography of all bodyparts. In addition, the system providesthe Agfa Tomosynthesis option, whichis intended to acquire tomographicslices of human anatomy and to beused with Agfa DR X-ray systems.Digital Tomosynthesis is used tosynthesize tomographic slices from asingle tomographic sweep.Not intended for cardiovascular andcerebrovascular contrast studies.Not intended for mammographyapplications.	The equipment is intended to be usedfor the fluoroscopy/radiographydiagnosis in hospital. The equipmentmust only be operated by qualifiedpersonnel, such as radiographytechnicians or those with equivalentqualifications. The equipment is usedfor total patient population.The equipment is NOT intended to beused for Mammography screening.The equipment is NOT intended to beused for interventional procedure.The equipment is used for radiographic,fluoroscopic, angiographic andpediatric examinations. Stored imagesin the equipment can be used for re-monitoring, image processing, storingto optical media (CD/DVD), andsending to DICOM server. TheTomosynthesis option for theSONIALVISION G4 is intended togenerate tomographic images of humananatomy including chest or extremities.Tomosynthesis technique is used toproduce a specific cross-sectional planeof the body by reconstruction oftomographic acquisition. The device isnot intended for mammographicapplications	The DR 800 system isindicated for performingdynamic imagingexaminations (fluoroscopyand/or rapid sequence) of thefollowing anatomies/procedures: • Positioningfluoroscopy procedures• Gastro-intestinalexaminations• Urogenital tract examinations• AngiographyIt is intended to replacefluoroscopic images obtainedthrough image intensifiertechnology. In addition, thesystem is intended for projectradiography of all body parts.In addition, the systemprovides the AgfaTomosynthesis option, whichis intended to acquiretomographic slices ofhuman anatomy and to be usedwith Agfa DR X-Ray systems.Tomosynthesis is used tosynthesize tomographic slicesfrom a single tomographicsweep. The DR 800 is notintended for mammographyapplications.	1. General reference tothe human body versusdelineation of bodyparts - standardpractice includes chestand extremities ingeneral2. List of imagingprocedures instead of ageneral statement -same imagingprocedures can becompleted on theprimary predicatedevice

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VII. PERFORMANCE DATA

Laboratory testing and software testing (for a moderate level of concern device) using equivalent test protocols were evaluated by qualified individuals to demonstrate that adequate design controls (according to 21 CFR 820.30) were in place.

Verification and validation testing confirmed the device meets performance, safety, usability and security requirements. Pediatric indications were also taken into account. Results were verified and validated.

No clinical trials were performed in the device. No animal or clinical studies were performed in the development of the new device. No patient treatment was provided or withheld.

Bench Testing

Image quality evaluations, performance/functionality and usability data has been provided.

. Technical and acceptance testing was completed on the DR 800 with DSA in order to confirm the medical device functions and performs as intended. All deviations or variances are documented in a defect database and addressed in the CRD documentation and verified. All mitigations have been tested and passed. All design input requirements have been tested and passed. All planned verification activities have been successfully completed.
. Performance functionality and usability evaluations were conducted with qualified experts. The results of these tests fell within the acceptance criteria for the DR 800 with DSA; therefore, the DR 800 supports GenRad, Full Leg/ Full Spine (FLFS), roadmapping and Digital Subtraction Angiography (DSA) workflow.
. Clinical image validation was conducted using anthropomorphic phantoms and evaluated by qualified experts. The radiographers evaluated the DSA image quality on the DR 800 by comparing overall image quality with the primary predicate A device (K190373). Diagnostic confidence for DSA image quality and roadmapping on the DR 800 was between good and excellent.

Clinical image quality evaluation is not essential in establishing substantial equivalence for the DR 800 with DSA. Adequate Bench Testing results should be sufficient to determine device safety and effectiveness.

Software Verification and Validation Testing

Verification and validation plans comprise of test protocols. The complete device has been certified and validated. During the final risk analysis meeting, the risk management team concluded that the medical risk is no greater than with conventional x-ray film previously released to the field.

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DSA software verification testing for NX 23 was completed in scope of the DR 800 with DSA X-Software testing of MUSICA image processing included digital subtraction Ray System. angiography (DSA). HERDE defects were identified; however, they were solved between test execution and the completion of the final report and will be part of the next maintenance software release.

Additional validation testing for NX 23 was completed and data provided in the premarket 510(k) notification for the DX-D Imaging Package - XD Detectors which is currently pending 510(k) clearance (K211790). Refer to this submission for all verification and validation documentation for NX 23 GenRad software applications and the XD Detector workflow.

For the NX 23 (NX Orion) software there are a total of 535 risks in the broadly acceptable region and 37 risks in the ALARP region with only four of these risks identified. Zero risks were identified in the Not Acceptable Region. Therefore, the device is assumed to be safe, the benefits of the device are assumed to outweigh the residual risk. The software risk assessed on solution level for the DR 800 with DSA.

The term "Level of Concern" means the level of risk that the software device is determined to be if the software were to fail. The Level of Concern for the DR 800 with DSA and NX 23 has been determined to be moderate.

Electrical Safety and Electromagnetic Compatibility (EMC) Testing:

IEC 60601-1: 2005 Medical Electrical Equipment: General Requirements for Safety and . Essential Performance.
IEC 60601-1-2: 2014 Medical Electrical Equipment Part 1-2: General Requirements for ● Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests.
IEC 60601-1-3: 2013 Medical Electrical Equipment Part 1-3: General Requirements for ● the Basic Safety and Essential Performance - Collateral Standard Radiation Protection in Diagnostic X-Ray Equipment
IEC 60601-2-54:2019 Medical Electrical Equipment Part 2-54: Particular Requirements ● for the Basic Safety and Essential Performance of X-Ray Equipment for Radiography and Radioscopy.

The DR 800 is compliant to FDA Subchapter J mandated performance standards 21 CFR 1020.30 - 1020.32

Agfa's in-house standard operating procedures were also used for the development of the device and software; these procedures conform to the following standards:

ISO 13485:2015 Medical Devices Quality Management Systems ●
ISO 14971:2012 Application of Risk Management to Medical Devices ●
ACR/NEMA PS3.1-3.20: 2011 Digital Imaging and Communications in Medicine (DICOM) ●
IEC 62366-1:2015 Medical Devices – Part 1: Application of Usability Engineering to Medical Devices

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IEC 62304:2006 Medical Device Software Software Lifecycle Processes [Including . Amendment 1 (2016)]

Guidance Documents

Agfa utilized the following guidance documents in the development of the DR 800 with DSA:

Guidance for the Content of Premarket Submissions for Software Contained in Medical ● Devices (May 2005)
Cybersecurity for Networked Medical Devices Containing Off-The-Shelf (OTS) Software (Jan 2005)
Off-the-Shelf Software Use in Medical Devices (September 2019)
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices . (Oct 2018)
Guidance for Pediatric Information for X-ray Imaging Device Premarket Notifications (Nov 2017)

Summarv

Based on the performance data as documented in the above testing, the DR 800 with DSA is found to have a safety and effectiveness profile that is similar to both of the predicate devices.

VIII. CONCLUSIONS

Agfa's DR 800 with DSA has indications for use that is consistent with that of the legally marketed predicate devices (K190373 & K183275). Intended uses are the same. Laboratory tests conclude that the device is substantially equivalent to the predicate. Differences in devices do not alter the intended diagnostic effect nor do they impact the safety and effectiveness of the device.

The new device and the SONIAL VISION G4 primary predicate device A (K190373) and predicate device B, DR 800 with Tomosynthesis (K183275) are fluoroscopic x-ray systems, Product Code JAA. Agfa's DR 800 with DSA device is substantially equivalent to both the primary predicate device A (K190373) and predicate device B (K183275) in that it uses the same basic technology to capture and transmit images.

This 510(k) has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

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.