DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)

K161368 · Agfa Healthcare N.V. · MQB · Sep 22, 2016 · Radiology

Device Facts

• Record ID: K161368
• Device Name: DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)
• Applicant: Agfa Healthcare N.V.
• Product Code: MQB · Radiology
• Decision Date: Sep 22, 2016
• 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 used. Agfa's DX-D Imaging Package is not indicated for use in mammography.

Device Story

DX-D Imaging Package is a direct radiography (DR) system consisting of Agfa NX workstation and flat-panel detectors (DR 10s/DR 14s, also labeled Pixium 2430EZ/3543EZ). System captures X-ray signals using scintillator-photodetector panels; digitizes images for display. Used in clinical settings by radiographers/technicians for general projection radiography. NX workstation processes images via MUSICA software; output displayed for physician review to support clinical decision-making. Benefits include digital image capture replacing conventional screen-film systems, enabling efficient workflow and diagnostic imaging.

Clinical Evidence

No clinical or animal studies performed. Bench testing only. Evidence includes laboratory image quality measurements (DQE), spatial frequency (MTF) evaluations, grid performance, and usability/functionality testing. Image quality validated using anthropomorphic phantoms evaluated by independent radiographers, confirming performance equivalent or superior to predicate devices.

Technological Characteristics

Solid-state flat-panel X-ray system. Detectors use CsI or GOS scintillators. Pixel size 148 µm; 16-bit A/D conversion. Connectivity via wireless interface to NX workstation. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ISO 14971 (risk management), ISO 13485 (quality). Software includes NX8900 and XRDi17.

Indications for Use

Indicated for general projection radiographic applications to capture diagnostic quality images of 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's DX-D Imaging Package (K142184)

Reference Devices

• DX-D 100 (K103597)
• DX-D 300 (K103050)
• DX-D 600 (K112670)
• DR 400 (K141192)
• DR 600 (K152639)
• CR 10-X (K121948)
• CR 12-X (K131408)
• Separately cleared medical display (K051901)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: a circular text element and a symbolic graphic. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The graphic element features a stylized representation of human profiles, stacked one behind the other, creating a sense of depth and unity.

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

September 22, 2016

Agfa HealthCare N.V. % ShaeAnn Cavanagh, RAC Regulatory Affairs Manager NA AGFA Healthcare 10 South Academy Street GREENVILLE SC 29601

Re: K161368

Trade/Device Name: DX-D Imaging Package Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: August 26, 2016 Received: August 29, 2016

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.

Michael D'Hara

For

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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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) | K161368 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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) | |
|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| <label><input checked="true" type="checkbox"/>Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/>Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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

FOR FDA USE ONLY

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|----------------------|-------------|----------------------------------------|
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# 510(K) SUMMARY

## Agfa's DX-D Imaging Package - DR 10s & DR 14s Detectors

#### I. SUBMITTER

Agfa HealthCare N.V. Septestraat 27 B-2640 Mortsel Belgium

Contact: Koen Vervoort, Prepared: May 16, 2016 Telephone: [phone]

#### II. DEVICE

Name of Device: DX-D Imaging Package Classification Name: Stationary X-Ray System Regulatory Classification: Class II, 21 CFR 892.1680 Product Code: MQB

#### IJII. PREDICATE DEVICES

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 Agfa's DX-D Imaging Package (K142184).

#### DEVICE DESCRIPTION IV.

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 DR10s and DR14s Flat Panel Detectors to Agfa's DX-D Imaging Package portfolio. The DX-D Imaging Package with the DR 10s and DR 14s wireless panels will be labeled as the Pixium 2430EZ and Pixium 3543EZ. DR 10s and DR 14s are commercial trade names used by Agfa HealthCare for marketing purposes only.

Principles of operation and technological characteristics of the new and predicate device are the same. There are no changes to the intended use/indications of the new device is physically and electronically identical to the predicate, K142184. It uses the same workstation and the similatorphotodetector flat panel detectors to capture and digitize the images as predicate K142184.

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

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| Agfa HealthCare NV |
|----------------------------------------------------------------------------|
| Premarket Notification: DX-D Imaging Package – DR 10s and DR 14s Detectors |

| Performance | DX-D 10 Flat- | DX-D 20 Flat- | DX-D 40 Flat- | DR 10s | DR 14s Wireless |
|-----------------|--------------------------------|--------------------------------|--------------------------------|-------------------|--------------------------------|
| Characteristics | Panel Detector | Panel Detector | Panel Instant | Wireless | Detector |
| | | (Handle) | Detector | Detector | |
| Scintillator | CsI, GOS | CsI, GOS | CsI, GOS | CsI | CsI, GOS |
| Cassette size | 35x43cm/14x17in | 35x43cm/14x17in | 35x43cm/14x17in | 24x30cm | 35x43cm/14x17in |
| Pixel Size | 139 µm | 139 µm | 140 µm | 148 µm | 148 µm |
| A/D Conversion | 14 bits | 14 bits | 14 bits | 16 bits | 16 bits |
| Interface to | Ethernet | Ethernet | AED & | AED & | AED & |
| Generator | | | Synchronized | Synchronized | Synchronized |
| Communication | Tethered | Tethered | Wireless | Wireless | Wireless |
| Power | I/O Interface Box: | I/O Interface Box: | Battery: | Battery: | Battery: |
| | 100-240 VAC, | 100-240 VAC, 47- | replaceable & | replaceable & | replaceable & |
| | 47-63 Hz | 63 Hz | rechargeable | rechargeable | rechargeable |
| Weight | 3.9 kg (8.6 lbs) | 4.9 kg (10.8 lbs) | 3.4 kg (7.5 lbs) | 1.6 kg (3.53 lbs) | 2.8 kg (6.17 lbs) |
| DQE | 1lp/mm - 0.530/0.608; | 1lp/mm - 0.530/0.608; | 1lp/mm - 0.38/0.40; | 1lp/mm - 0.523; | 1lp/mm - 0.521/0.292; |
| | 2lp/mm - 0.219/0.298; | 2lp/mm - 0.219/0.298; | 2lp/mm - 0.23/0.24; | 2lp/mm - 0.476; | 2lp/mm - 0.449/0.189; |
| | 3lp/mm - 0.092/0.147 | 3lp/mm - 0.092/0.147 | 3lp/mm - 0.13/0.11 | 3lp/mm - 0.295 | 3lp/mm - 0.296/0.071 |
| MTF | 1lp/mm - 0.205/0.456; | 1lp/mm - 0.205/0.456; | 1lp/mm - 0.570/0.578; | 1lp/mm - 0.637: | 1lp/mm - 0.638/0.526; |
| | 2lp/mm - 0.106/0.304; | 2lp/mm - 0.106/0.304; | 2lp/mm - 0.269/0.279; | 2lp/mm - 0.360: | 2lp/mm - 0.363/0.208; |
| | 3lp/mm - 0.092/0.147 | 3lp/mm - 0.092/0.147 | 3lp/mm - 0.142/0.150 | 3lp/mm - 0.199 | 3lp/mm - 0.198/0.081 |

Configuration information can be found in the DR 10s and DR 14s User Manuals. The DR 10s and DR 14s detectors can be integrated in an X-ray system that communicates to a workstation. The DR 10s and DR 14s Service Manual details the possible configurations and integrations with the NX workstation and X-ray generator. All of Agfa HealthCare's DR and CR x-ray systems (i.e. DX-D 100-K103597, DX-D 300-K103050, DX-D 600-K112670, DR 400-K141192, DR 600-K152639, CR 10-X-K121948, and CR 12-X-K131408) will integrate with the new device. The NX8900 Service Manual, Chapter 4 and associated appendices addresses the installation and configuration with other system components.

#### INDICATIONS FOR USE v.

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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### VI. COMPARISON OF TEDCHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICES

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 device are the same. There are no changes to the intended use/indications of the device. The new device is physically and electronically identical to the predicate, K142184. It uses the same workstation and the similar scintillator-photodetector flat panel detectors to capture and digitize the images as predicate K142184. There are no differences between the device and predicates K142184 that impact safety and effectiveness.

Performance data including laboratory image quality measurements (DQE), image quality clinical evaluations, and spatial frequency (MTF), grid test, and performance/functionality and usability data are adequate to ensure equivalence.

Agfa's DX-D Imaging Package has an Indications For Use statement identical to the predicate device (K142184). Intended uses are the same. The devices have the same technological characteristics.

The DX-D Imaging Package indications for use statement is substantially equivalent to the predicate device (K142184). The DX-D Imaging Package and predicate device (K142184) include the statement that the device is not indicated for mammography. The DX-D Imaging Package and predicate device (K142184) describe the imaging applications may be used utilized where screen-film systems exist. Differences in devices do not alter the intended diagnostic effect.

The table on the next page compares these technological characteristics.

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| PRODUCT COMPARISON TABLE | | | | | |
|-----------------------------------|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| | DX-D Img Pkg<br>(New Device) | AGFA DX-D Imaging Package<br>(PREDICATE-K142184) | | | |
| Communications | Wireless | DICOM | | | |
| Flat Panel | Same as Predicate | Flat Panel Detector | | | |
| Detector Material | Same as Predicate | Gadolinium Oxysulfide (GOS) or<br>Cesium Iodide (CsI) scintillator | | | |
| Detector Sizes | 10x12 in<br>14x17in | 17x17 in.<br>14x17 in. | | | |
| Active Matrix (14x17 in.) | 2400 x 2880 | 2560 x 3072 | | | |
| Pixel size | 148 µm | 140 µm | | | |
| Dynamic Range | 16 bits | 14 bit | | | |
| Maximum Image<br>Acquisitions/hr. | 240 | 150 | | | |
| Power Supply | +12V 1A DC Battery | 50-60 Hz<br>100-240V auto ranging | | | |
| Operator Workstation | Same as Predicate | Agfa NX | | | |
| Image processing | Same as Predicate | MUSICA | | | |
| Operating system | Same as Predicate | Windows 7 | | | |
| Display System | Same as Predicate | Separately cleared medical display<br>(K051901) | | | |
| Indications for Use | Same as Predicate | Agfa's DX-D Imaging Package is indicated<br>for use in general projection radiographic<br>applications to capture for display diagnostic<br>quality radiographic images of human<br>anatomy. The DX-D Imaging Package may<br>be used wherever conventional screen-film<br>systems may be used.<br>Agfa's DX-D Imaging Package is not<br>indicated for use in mammography. | | | |

#### VII. PERFORMANCE DATA

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 employed 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, and spatial frequency (MTF), performance/functionality and usability data, and grid evaluation data have been provided.

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

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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.

### Bench Testing

Image quality measurement data (DQE), spatial frequency (MTF) data, performance/functionality data, usability data, and grid evaluation have been provided. No patient treatment was provided or withheld. No clinical or animal testing was performed in the development of the DX-D Imaging Package.

- Laboratory image quality (DOE) comparison and spatial frequency (MTF) evaluation of ● the DR 10sC. DR14sC. and DR14sG with other Agfa HealthCare flat-panel detectors currently on the market including the predicate (K142184). The test results confirmed that the DX-D Imaging Package with DR 10sC, DR14sC, and DR14sG flat-panel detectors was equivalent to other flat-panel detectors Agfa currently markets including the predicate (K142184).
- Usability and functionality evaluations were conducted with qualified independent ● radiographers. The results of these tests fell within the acceptance criteria for all of the flat-panel detectors; the DX-D Imaging Package supports a radiographic workflow including calibration, compatibility, linear dose and dynamic ranges, and sensitivity.
- Grid Evaluation was conducted with a qualified internal radiographer. The results of the grid evaluation of the chest, skull, and pelvis remained consistent with other Agfa HealthCare flat-panel detectors currently on the market including the predicate (K142184).. The intended use is fulfilled using different flat-panel detectors.
- Image Quality Validation testing was conducted using anthropomorphic phantoms and ● evaluated by qualified independent radiographers. The test results indicated that the DR 10sC, DR14sC, and DR14sG flat-panel detectors have at least the same if not better image quality than other flat-panel detectors currently on the market.

### Software Validation Testing

Verification and validation plans comprise of test protocols. The software components of the device have 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 DR 10s and DR 14s (XRDi17 software) there is only one risk identified in the Broadly Acceptable Region and no identified residual risks in the ALARP region after mitigation. 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 identified residual risks for the released NX software versions NX8900 (NX Juno) in the ALARP region after mitigation. Only one risk was identified in the Broadly Acceptable Region after mitigation. Therefore, the device is assumed to be safe, the device are assumed to outweigh the residual risk.

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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 NX 8900 device has been determined to be moderate and the Level of Concern for the XRDi17 software has been determined to be minor.

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

### PRODUCT STANDARDS

- IEC 60601-1: 2012 Medical Electrical Equipment: General Requirements for Safety and Essential Performance.
- IEC 60601-1-2: 2014-4 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

### Summary

Based on the performance data as documented in the above testing. DX-D Imaging Package is found to have a safety and effectiveness profile that is similar to the predicate devices.

#### GUIDANCE DOCUMENTS VIII.

The applicant is aware of the following guidance documents that apply to products of this type:

- Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices (August ● 1999).
- o Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005).
- Off-the-Shelf Software Use in Medical Devices (September 1999). ●
- Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software ● (January 2005)
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (October 2014)

#### IX. CONCLUSIONS

Agfa's DX-D Imaging Package has an Indications For Use statement identical to the predicate device (K142184). Intended uses are the same. The devices have the same technological characteristics.

The DX-D Imaging Package indication for use is substantially equivalent to the predicate device

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(K142184). The DX-D Imaging Package and predicate device (K142184) include the statement that the device is not indicated for mammography. The DX-D Imaging Package and predicate device (K142184) 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 predicate device (K142184) are solid state imaging devices, Product Code MQB. Agfa's DX-D Imaging Package is substantially equivalent to the predicate device (K142184) in that it uses the same technology to capture and transmit images.

Principles of operation and technological characteristics of the new and predicate device are the same. There are no changes to the intended use/indications of the device. The new device is physically and electronically identical to the predicate, K142184. It uses the same workstation and the similar scintillator-photodetector flat panel detectors to capture and digitize the images as predicate K142184.

The DX-D Imaging Package with the DR 10s and DR 14s wireless panels will be labeled as the Pixium 2430EZ and Pixium 3543EZ. The DR 10s and DR 14s are commercial trade names used by Agfa HealthCare for marketing purposes only.

Performance data including laboratory image quality measurements (DQE), image quality clinical evaluations, and spatial frequency (MTF), grid test, and performance/functionality and usability data 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.