DX-D IMAGING PACKAGE

K142184 · Agfa Healthcare N.V. · MQB · Oct 16, 2014 · Radiology

Device Facts

• Record ID: K142184
• Device Name: DX-D IMAGING PACKAGE
• Applicant: Agfa Healthcare N.V.
• Product Code: MQB · Radiology
• Decision Date: Oct 16, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

Agfa's DX-D Imaging Package is indicated for use in general projection radiographic applications to capture for display diagnostic quality radiographic images of human anatomy. The DX-D Imaging Package may be used wherever conventional screen-film systems may be be used. Agfa's DX-D Imaging Package is not indicated for use in mammography.

Device Story

DX-D Imaging Package is a solid-state direct radiography (DR) system capturing diagnostic quality X-ray images of human anatomy. System comprises Agfa NX workstation and flat-panel detectors (DX-D40C/G). Detectors use scintillator-photodetector technology to capture and digitize X-ray signals. Used in clinical settings where conventional screen-film systems are utilized. Operated by radiology staff. Workstation processes images for display; output allows clinicians to perform diagnostic evaluations. Benefits include transition from film to digital imaging, improved workflow, and diagnostic utility. System links to X-ray generators (e.g., Siemens, Sedecal) to receive exposure parameters.

Clinical Evidence

No clinical studies or animal testing performed. Evidence consists of bench testing, including laboratory image quality measurements (DQE), standard GenRad workflow performance tests, and usability evaluations. In-hospital image quality comparisons were conducted with independent radiologists to confirm performance equivalence to predicates.

Technological Characteristics

Solid-state flat panel DR system. Detectors use Gadolinium Oxysulfide (GOS) or Cesium Iodide (CsI) scintillators. 14-bit dynamic range. Connectivity via DICOM. Standards: ACR/NEMA PS3.1-3.20 (DICOM), IEC 60601-1 (Safety), IEC 60601-1-2 (EMC). Software level of concern: moderate.

Indications for Use

Indicated for general projection radiographic applications for human anatomy. Not indicated for mammography.

Regulatory Classification

Identification

A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.

Predicate Devices

• Agfa DX-D Imaging Package (K121095)
• Viework ViVIX-S Wireless Panel (K122865)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 16, 2014

AGFA HealthCare N.V. % Ms. Shaeann Cavanagh Regulatory Affairs Specialist NA 10 South Academy Street GREENVILLE SC 29601

Re: K142184

Trade/Device Name: DX-D Imaging Package Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: August 8, 2014 Received: August 8, 2014

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Sm. 7)

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

## 510(k) Number (if known)

K142184

Device Name

### DX-D Imaging Package

Indications for Use (Describe)

Agfa's DX-D Imaging Package is indicated for use in general projection radiographic applications to capture for display diagnostic quality radiographic images of human anatomy. The DX-D Imaging Package may be used wherever conventional screen-film systems may be be used.

Agfa's DX-D Imaging Package is not indicated for use in mammography.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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FORM FDA 3881 (1/14)

Page 1 of 1

PSC Publishing Services [phone] EF

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# 510(K) SUMMARY Agfa's DX-D Imaging Package - DX-D40C/G Detectors

Common Name: Solid State X-Ray Imager (Flat Panel/Digital Imager) Classification Name: Stationary X-Ray System Regulatory Classification: 21 CFR 892.1680 Product Code: MQB Proprietary Name: DX-D Imaging Package Agfa HealthCare N.V. Septestraat 27 B-2640 Mortsel Belgium Contact: Koen Vervoort, Prepared: August 8, 2014 Telephone: [phone]

#### LEGALLY MARKETED PREDICATE DEVICES A.

This is a 510(k) for Agfa's DX-D Imaging Package, a solid state, flat panel x-ray imaging device. It is substantially equivalent to systems with Agfa's DX-D Imaging Package (K121095) and Viework's ViVIX-S Wireless Panel (K122865).

#### DEVICE DESCRIPTION B.

Agfa's DX-D Imaging Package is a solid state flat panel x-ray system, a direct radiography (DR) system (product code MQB) intended to capture images of the human body. It is a combination of Agfa's NX workstation and one or more flat-panel detectors.

This submission is to add the DX-D40C/G Flat Panel Detector to Agfa's DX-D Imaging Package portfolio. Agfa's DX-D40C/G is currently marketed by Vieworks as the ViVIX-S Wireless Panel (K122865), which is one of predicates for this submission.

Principles of operation and technological characteristics of the new and predicate devices are the same. The new device is physically and electronically identical to both predicates, K121095 and K122865. It uses the same workstation as predicate K121095 and the same scintillatorphotodetector flat panel detectors to capture and digitize the images as predicate K122865.

Laboratory data and image quality evaluations conducted with independent radiologists confirm that performance is equivalent to the predicates.

#### C. INTENDED USE

Agfa's DX-D Imaging Package is indicated for use in general projection radiographic applications to capture for display diagnostic quality radiographic images of human anatomy. The DX-D Imaging Package may be used wherever conventional screen-film systems may be used.

Agfa's DX-D Imaging Package is not indicated for use in mammography.

Intended use has not changed as a result of any labeling modification(s).

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#### SUBSTANTIAL EQUIVALENCE SUMMARY D.

Agfa's DX-D Imaging Package has an Indications For Use statement identical to the predicate device (K121095) and similar to predicate device (K122865). Intended uses are the same. The devices have the same technological characteristics.

The DX-D Imaging Package indications for use is substantially equivalent to both predicate devices (K121095& K122865). The DX-D Imaging Package and both predicate devices (K121095 & K122865) include the statement that the device is not indicated for mammography. The DX-D Imaging Package and both predicate devices (K121095 & K122865) describe the imaging applications may be used utilized where screen-film systems exist. Differences in devices do not alter the intended diagnostic effect.

The new device and the both predicate devices (K122865) are solid state imaging devices, Product Code MQB. Agfa's DX-D Imaging Package is substantially equivalent to both predicate devices (K121095 and K122865) in that it uses precisely the same technology to capture and transmit images.

Principles of operation and technological characteristics of the new and predicate devices are the same. The new device is physically and electronically identical to both predicates. K121095 and K122865. It uses the same workstation as predicate K121095 and the same scintillatorphotodetector flat panel detectors to capture and digitize the images as predicate K122865.

Agfa's DX-D40C/G is currently marketed by Vieworks as the ViVIX-S Wireless Panel (K122865), which is one of the predicates for this submission.

Performance data including laboratory image quality measurements (DOE), image quality clinical evaluations, standard GenRad workflow tests, and a usability evaluation are adequate to ensure equivalence.

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| PRODUCT COMPARISON TABLE | | | |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | DX-D Img Pkg<br>(New Device) | AGFA DX-D Imaging Package<br>(PREDICATE-K121095) | Vieworks ViVIX-S<br>(PREDICATE-K122865) |
| Communications | Same as predicates | DICOM | DICOM |
| Flat Panel | Same as predicates | Flat Panel Detector | Flat Panel Detector |
| Detector Material | Same as predicates | Gadolinium Oxysulfide (GOS) or<br>Cesium Iodide (CsI) scintillator | Gadolinium Oxysulfide<br>(GOS) or Cesium Iodide<br>(CsI) scintillator |
| Detector Sizes | Same as predicates | 17x17 in.<br>14x17 in. | 17x17 in.<br>14x17 in. |
| Active Matrix (14x17 in.) | Same as predicates | 2560 x 3072 | 2560 x 3072 |
| Pixel size | Same as K122865 | 139 µm | 140 µm |
| Dynamic Range | Same as predicates | 14 bit | 14 bit |
| Maximum Image<br>Acquisitions/hr. | Same as predicates | 150 | 150 |
| Power Supply | Same as predicates | 50-60 Hz<br>100-240V auto ranging | 50-60 Hz<br>100-240V auto ranging |
| Operator Workstation | Same as K121095 | Agfa NX | Intel PRO 1000 Series |
| Image processing | Same as K121095 | MUSICA | VXvue |
| Operating system | Same as predicates | Windows 7 | Windows 7 |
| Display System | Same as K121095 | Separately cleared medical<br>display (K051901) | Standard PC display or<br>separately cleared medical<br>display |
| Indications for Use | Agfa's DX-D Imaging<br>Package is indicated<br>for use in general<br>projection<br>radiographic<br>applications to capture<br>for display diagnostic<br>quality radiographic<br>images of human<br>anatomy. The DX-D<br>Imaging Package may<br>be used wherever<br>conventional screen-<br>film systems may be<br>be used.<br>Agfa's DX-D Imaging<br>Package is not<br>indicated for use in<br>mammography. | Agfa's DX-D Imaging Package is<br>indicated for use in general<br>projection radiographic<br>applications to capture for display<br>diagnostic quality radiographic<br>images of human anatomy. The<br>DX-D Imaging Package may be<br>used wherever conventional<br>screen-film systems may be used.<br>Agfa's DX-D Imaging Package is<br>not indicated for use in<br>mammography. | The ViVIX-S Wireless is<br>indicated for digital imaging<br>solution designed as a<br>general<br>radiographic system for<br>human anatomy. It is<br>intended to replace film or<br>screen based radiographic<br>systems in all general<br>purposes of diagnostic<br>procedures. It is not to be<br>used for mammography. |

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#### E. TECHNOLOGICAL CHARACTERISTICS

Agfa's DX-D Imaging Package is a solid state flat panel x-ray system, a direct radiography (DR) system (product code MQB) intended to capture images of the human body. It is a combination of Agfa's NX workstation and one or more flat-panel detectors.

Principles of operation and technological characteristics of the new and predicate devices are the same. The new device is physically and electronically identical to the predicates K121095 and K122865. It uses the same workstation as predicate K121095 and the same scintillatorphotodetector flat panel detectors to capture and digitize the images as predicate K122865. There are no differences between the device and the predicates (K121095 & K122865) that impact safety and effectiveness.

The DX-D 40C/G DR Panel can be used with each modality that has not been equipped with a separate DR panel. It is a non-integrated system including the generator and tube. When using Siemens or Sedecal generators (integrated system), there is a link between the NX workstation and the generator to send exposure parameters. This link is validated by Agfa Service Technicians. However, for every installation Agfa Service Technicians perform an acceptance test to guarantee the system is working as intended without integration issues.

#### F. TESTING

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

Laboratory image quality measurements (DQE), image quality clinical evaluations, standard GenRad workflow tests, and a usability evaluation data has been provided.

In-hospital image quality comparisons have been conducted with qualified independent radiologists as well.

Standard GenRad workflow performance and Usability of the complete system have been validated.

Where patient images were utilized, they were first anonymized to remove all identifying patient information. No animal or clinical studies were performed in the development of the new device. No patient treatment was provided or withheld.

The product, manufacturing and development processes conform to product safety and medical imaging standards including:

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#### G. PRODUCT STANDARDS

- . ACR/NEMA PS3.1-3.20: 2011 Digital Imaging and Communications in Medicine (DICOM).
- IEC 60601-1: 2012 Medical Electrical Equipment: General Requirements for Safety and ● Essential Performance.
- IEC 60601-1-2: 2007 Medical Electrical Equipment Part 1-2: General Requirements for ● Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests.

## QUALITY MANAGEMENT STANDARDS

- . ISO 14971:2007 Application of Risk Management to Medical Devices
- ISO 13485:2003 Medical Devices Quality Management Systems Requirements For . Regulatory purposes

## H. RISK ASSESSMENT AND MANAGEMENT SUMMARY

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 DX-D40C/G (XRDi15 software) there are a total of 41 risks in the broadly acceptable region and two risks in the ALARP region. 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.

There are no residual risks for the released NX software versions NX8800 (NX Ikonos) in the ALARP region after mitigation. Only two risks were identified in the Broadly Acceptable Region. Therefore, the device is assumed to be safe, the benefits of the device are assumed to outweigh the residual risk.

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 device has been determined to be moderate.

#### I. CONCLUSIONS

Agfa's DX-D Imaging Package has an Indications For Use statement identical to the predicate device (K121095) and similar to predicate device (K122865). Intended uses are the same. The devices have the same technological characteristics.

The DX-D Imaging Package indications for use is substantially equivalent to both predicate devices (K121095& K122865). The DX-D Imaging Package and both predicate devices (K121095 & K122865) include the statement that the device is not indicated for mammography. The DX-D Imaging Package and both predicate devices (K121095 & K122865) describe the imaging applications may be used utilized where screen-film systems exist. Differences in devices do not alter the intended diagnostic effect.

The new device and the both predicate devices (K122865) are solid state imaging

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devices, Product Code MQB. Agfa's DX-D Imaging Package is substantially equivalent to both predicate devices (K121095 and K122865) in that it uses precisely the same technology to capture and transmit images.

Principles of operation and technological characteristics of the new and predicate devices are the same. The new device is physically and electronically identical to both predicates. K121095 and K122865. It uses the same workstation as predicate K121095 and the same scintillatorphotodetector flat panel detectors to capture and digitize the images as predicate K122865.

Agfa's DX-D40C/G is currently marketed by Vieworks as the ViVIX-S Wireless Panel (K122865), which is one of the predicates for this submission.

Performance data including laboratory image quality measurements (DQE), image quality clinical evaluations, standard GenRad workflow tests, and a usability evaluation are adequate to ensure equivalence.

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.