DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS)

K132261 · Ge Medical Systems, LLC · IZF · Nov 18, 2013 · Radiology

Device Facts

• Record ID: K132261
• Device Name: DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS)
• Applicant: Ge Medical Systems, LLC
• Product Code: IZF · Radiology
• Decision Date: Nov 18, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1740
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Discovery XR656 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position and is intended for use in all routine radiography exams. When the VolumeRAD option is included on the system, the system can generate tomographic images of human anatomy including the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages. When the VolumeRAD option is used for patients undergoing thoracic imaging, it is indicated for the detection of lung nodules. VolumeRAD generates diagnostic images of the chest that aid the radiologist in achieving superior detectability of lung nodules versus posterior-anterior and left lateral views of posterior. the chest, at a comparable radiation level. The device is not intended for mammographic applications.

Device Story

Discovery XR656 is a stationary digital radiographic/tomographic X-ray system; utilizes flat-panel wireless digital detector (amorphous silicon/cesium iodide scintillator). System components: wallstand, elevating table, overhead tube support, X-ray tube, collimator, system controller, generator. VolumeRAD feature performs digital tomosynthesis to generate tomographic images. Used in clinical settings by healthcare professionals. Radiologist reviews images via DICOM network for diagnostic assessment; VolumeRAD aids in lung nodule detection by providing superior detectability compared to standard 2D PA/lateral chest X-rays. Benefits include improved diagnostic accuracy for lung nodules at comparable radiation doses.

Clinical Evidence

Multi-centered clinical study compared VolumeRAD to conventional two-view (PA and LAT) chest X-rays for detection of 3-20mm lung nodules. Results demonstrated increased physician accuracy with VolumeRAD at an average effective dose < 0.1 mSv.

Technological Characteristics

Stationary X-ray system; flat-panel wireless digital detector (amorphous silicon, cesium iodide scintillator). Complies with 21 CFR X-ray requirements, IEC 60601-1 safety standards. Connectivity via DICOM network. No changes to design, materials, or energy source from predicate.

Indications for Use

Indicated for digital radiographic and tomographic imaging of skull, spine, chest, abdomen, and extremities in patients of all ages. Specifically indicated for detection of lung nodules in thoracic imaging. Contraindicated for mammography.

Regulatory Classification

Identification

A tomographic x-ray system is an x-ray device intended to be used to produce radiologic images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Discovery XR656 with VolumeRAD (K051967)

Submission Summary (Full Text)

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## GE Healthcare 510(k) Premarket Notification Submission

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## 510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

| Date: | July 18, 2013 |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Healthcare, (GE Medical Systems, LLC)<br>3000 N. Grandview Blvd. W-709<br>[Waukesha, WI. 53188] |
| Primary Contact Person: | John L. Schmidt<br>Regulatory Affairs Leader - X-Ray<br>GE Healthcare, (GE Medical Systems, LLC)<br>Office: 262-548-4964<br>eFax: 262-997-1080<br>Email: [e-mail] |
| Secondary Contact Person: | Steven J. Kachelmeyer<br>Regulatory Affairs Director -X-Ray<br>GE Healthcare, (GE Medical Systems, LLC)<br>262-548-2432<br>Email: [e-mail] |
| Device Trade Name: | Discovery XR656 with VolumeRAD |
| Common/Usual Name: | Digital Radiographic X-Ray System |
| Classification Names:<br>Product Code: | Stationary X-Ray System (21CFR § 892.1680), solid state x-ray<br>imager (21CFR § 892.1650) and Tomographic x-ray system (892.1740)<br>KPR, MQB and IZF |
| Predicate Device(s): | Stationary X-Ray System, MODEL: Discovery XR656 with<br>VolumeRAD (K051967) (aka Revolution XR/d with<br>Tomosynthesis) |
| Marketed Devices: | Previous name changes included Definium 8000 and Optima<br>XR640/Discovery 650 where the XR640 is a de-featured version<br>of the system without advanced features like VolumeRAD.<br>VolumeRAD is the GE name for the Digital Tomosynthesis<br>feature. |
| Device Description: | The Discovery™ XR656 with VolumeRAD extended claims<br>remains a radiographic X-ray system capable of generating |
| | radiographic and tomographic images of human anatomy. |
| | The Discovery XR656 is designed to handle radiographic<br>applications using GE's flat-panel wireless digital detector. The<br>digital detector is comprised of amorphous silicon and cesium<br>iodide scintillator. The resulting digital image can be sent<br>through a DICOM network for applications such as printing,<br>viewing and storage. |
| | The Discovery XR656 Digital Radiographic Imaging system<br>consists of a Wallstand, elevating table, overhead Tube support,<br>X-ray tube, collimator, system controller, X-ray generator, and<br>wireless/tethered digital detector. Various configurations are<br>available to meet radiographic requirements. The Optima<br>XR640 version of this product does not include advanced<br>applications and uses the tethered version of the digital<br>detector. |
| | The Discovery XR656 offers a wide range of advanced clinical<br>applications including GE's VolumeRAD™ (Digital<br>Tomosynthesis), Dual Energy Subtraction, Tissue Equalization<br>and Auto Image Paste. |
| | This 510(k) is to expand our marketing claims for lung nodule<br>detection using the VolumeRAD application. There is no change<br>in design, manufacturing, materials or energy source of the<br>already cleared device. All the abilities required to achieve the<br>results of the extended claims during the clinical trial were<br>available at the initial release of the system. |
| Intended Use: | General Purpose Digital Radiographic Imaging System |
| Indication for Use: | The Discovery XR656 is intended to generate digital<br>radiographic images of the skull, spinal column, chest,<br>abdomen, extremities, and other body parts in patients of all<br>ages. Applications can be performed with the patient sitting,<br>standing, or lying in the prone or supine position and is intended<br>for use in all routine radiography exams. |
| | When the VolumeRAD option is included on the system, the<br>system can generate tomographic images of human anatomy<br>including the skull, spinal column, chest, abdomen, extremities,<br>and other body parts in patients of all ages.<br>When the VolumeRAD option is used for patients undergoing<br>thoracic imaging, it is indicated for the detection of lung<br>nodules. VolumeRAD generates diagnostic images of the chest<br>that aid the radiologist in achieving superior detectability of<br>lung nodules versus posterior-anterior and left lateral views of posterior. |
| | the chest, at a comparable radiation level. |
| | The device is not intended for mammographic applications. |
| Determination of<br>Substantial Equivalence: | Summary of Clinical Tests:<br>A Multi-centered clinical study was performed to demonstrate<br>that the use of VolumeRAD increases physician accuracy in the<br>detection of lung nodules 3-20mm in diameter, when compared<br>to conventional two-view CxR (posterior-anterior (PA) and left<br>lateral (LAT)), at an average effective dose less than 0.1mSv. |
| | Summary of Non-Clinical Tests:<br>The Discovery XR656 with extended claims employs the same<br>design, manufacturing, materials or energy source of the<br>already cleared device and complies with voluntary standards.<br>It is certified to comply with the X-ray requirements of 21 CFR,<br>as well as safety requirements of IEC 60601-1 and associated<br>collateral and particular standards. In addition, verification and<br>validation testing is done as required by GE Healthcare' quality<br>system. |
| Conclusion: | The Discovery XR656 with its Extended Claims for VolumeRAD<br>does not result in any new potential safety risks and performs<br>as well as the currently marketed Discovery XR656. With the<br>extended VolumeRAD claims, the Discovery XR656 with<br>VolumeRAD has demonstrated effectiveness beyond the<br>original limited claims of the VolumeRAD feature. |

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## GE Healthcare 510(k) Premarket Notification Submission

:

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Public Health Service

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

November 18, 2013

GE Medical Systems, LLC % Mr. John Schmidt Regulatory Affairs Leader - X-Ray 3000 N. Grandview Blvd. WAUKESHA WI 53188

Re: K132261

Trade/Device Name: Discovery XR656 with VolumeRAD (digital tomosynthesis) Regulation Number: 21 CFR 892.1740 Regulation Name: Tomographic x-ray system Regulatory Class: II Product Code: 1ZF, KPR and MOB Dated: August 28, 2013 Received: August 30, 2013

Dear Mr Schmidt:

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 11 (Special Controls) or class 111 (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 (2 l CFR Part 807); labeling (21 CFR Part 801 and Part 809); 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 and Part 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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.lda.gov/McdicalDevices/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/dcfault.htm.

Sincerely yours,

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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GE Healthcare 510(k) Premarket Notification Submission

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## Indications for Use

510(k) Number (if known): K132261

Device Name: Discovery XR656 with VolumeRAD

Indications for Use:

The Discovery XR656 is intended to generate digital radiographic imoges of the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages. Applications con be performed with the patient sitting, standing, or lying in the prone or supine position and is intended for use in all routine radiography exams.

When the VolumeRAD option is included on the system, the system can generate tomographic images of human anatomy including the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages.

When the VolumeRAD option is used for potients undergoing thorocic imaging, it is indicated for the detection of lung nodules. VolumeRad generates diagnostic images of the chest that aid the radiologist in achieving superior detectability of lung nodules versus posterior-anterior and left lateral views of the chest, at o comparable radiation level.

The device is not intended for mammographic applications.

Prescription Use ਮ lPart 21 CFR 801 Subport Di AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart Cl

IPLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)