(122 days)
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.
The Discovery™ XR656 with VolumeRAD extended claims remains a radiographic X-ray system capable of generating radiographic and tomographic images of human anatomy.
The Discovery XR656 is designed to handle radiographic applications using GE's flat-panel wireless digital detector. The digital detector is comprised of amorphous silicon and cesium iodide scintillator. The resulting digital image can be sent through a DICOM network for applications such as printing, viewing and storage.
The Discovery XR656 Digital Radiographic Imaging system consists of a Wallstand, elevating table, overhead Tube support, X-ray tube, collimator, system controller, X-ray generator, and wireless/tethered digital detector. Various configurations are available to meet radiographic requirements. The Optima XR640 version of this product does not include advanced applications and uses the tethered version of the digital detector.
The Discovery XR656 offers a wide range of advanced clinical applications including GE's VolumeRAD™ (Digital Tomosynthesis), Dual Energy Subtraction, Tissue Equalization and Auto Image Paste.
This 510(k) is to expand our marketing claims for lung nodule detection using the VolumeRAD application. There is no change in design, manufacturing, materials or energy source of the already cleared device. All the abilities required to achieve the results of the extended claims during the clinical trial were available at the initial release of the system.
The provided text describes a 510(k) premarket notification for the GE Healthcare Discovery XR656 with VolumeRAD, seeking to expand its marketing claims for lung nodule detection. The relevant information to address your request is extracted and organized below.
1. Table of Acceptance Criteria and Reported Device Performance
The submission describes the goal of the clinical study, which implicitly sets the acceptance criteria: the device should increase physician accuracy in detecting lung nodules compared to conventional X-ray. The reported performance is that this goal was met.
| Acceptance Criteria (Implicit Goal) | Reported Device Performance |
|---|---|
| Increase physician accuracy in the detection of lung nodules (3-20mm) | "A Multi-centered clinical study was performed to demonstrate that the use of VolumeRAD increases physician accuracy in the detection of lung nodules 3-20mm in diameter, when compared to conventional two-view CxR (posterior-anterior (PA) and left lateral (LAT)), at an average effective dose less than 0.1mSv." "With the extended VolumeRAD claims, the Discovery XR656 with VolumeRAD has demonstrated effectiveness beyond the original limited claims of the VolumeRAD feature." |
| Comparable radiation level | "at a comparable radiation level." |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "A Multi-centered clinical study was performed..." However, it does not specify the sample size used for the test set.
The data provenance is a "Multi-centered clinical study," implying prospective data collection across multiple sites. The document does not explicitly state the country of origin of the data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used to establish ground truth or their qualifications. It only refers to "physician accuracy."
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size
Yes, a comparative effectiveness study was done. The study aimed to demonstrate that "the use of VolumeRAD increases physician accuracy in the detection of lung nodules... when compared to conventional two-view CxR (posterior-anterior (PA) and left lateral (LAT))."
The document explicitly states that the study demonstrated an "increase[d] physician accuracy," implying a positive effect size. However, the exact effect size of how much human readers improve with AI (VolumeRAD) vs. without AI assistance (conventional CxR) is not quantified in the provided text (e.g., as a percentage increase in AUC, sensitivity, or specificity).
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The study described is focused on "physician accuracy," indicating a "human-in-the-loop" scenario where radiologists use the VolumeRAD system. A standalone (algorithm only without human-in-the-loop performance) study is not described in the provided text.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used. Given the focus on "lung nodule detection" and "physician accuracy," it is highly probable that the ground truth involved expert consensus, pathology, and/or follow-up imaging to confirm the presence or absence of lung nodules. However, this is an inference, not explicitly stated.
8. Sample Size for the Training Set
The document does not mention a training set sample size. The submission is for an expanded marketing claim for an existing device ("There is no change in design, manufacturing, materials or energy source of the already cleared device. All the abilities required to achieve the results of the extended claims during the clinical trial were available at the initial release of the system."). This suggests that the VolumeRAD feature was already developed, and this 510(k) is about validating its clinical utility for a specific indication (lung nodule detection), rather than the development of a new AI model requiring a separate training set description in this context.
9. How the Ground Truth for the Training Set Was Established
As no training set is described in the provided text (see point 8), how its ground truth was established is not applicable/described here.
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K132261
Page 1 of 3
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)3000 N. Grandview Blvd. W-709[Waukesha, WI. 53188] |
| Primary Contact Person: | John L. SchmidtRegulatory Affairs Leader - X-RayGE Healthcare, (GE Medical Systems, LLC)Office: 262-548-4964eFax: 262-997-1080Email: John.L.Schmidt@ge.com |
| Secondary Contact Person: | Steven J. KachelmeyerRegulatory Affairs Director -X-RayGE Healthcare, (GE Medical Systems, LLC)262-548-2432Email: Steven.Kachelmeyer@ge.com |
| Device Trade Name: | Discovery XR656 with VolumeRAD |
| Common/Usual Name: | Digital Radiographic X-Ray System |
| Classification Names:Product Code: | Stationary X-Ray System (21CFR § 892.1680), solid state x-rayimager (21CFR § 892.1650) and Tomographic x-ray system (892.1740)KPR, MQB and IZF |
| Predicate Device(s): | Stationary X-Ray System, MODEL: Discovery XR656 withVolumeRAD (K051967) (aka Revolution XR/d withTomosynthesis) |
| Marketed Devices: | Previous name changes included Definium 8000 and OptimaXR640/Discovery 650 where the XR640 is a de-featured versionof the system without advanced features like VolumeRAD.VolumeRAD is the GE name for the Digital Tomosynthesisfeature. |
| Device Description: | The Discovery™ XR656 with VolumeRAD extended claimsremains a radiographic X-ray system capable of generating |
| radiographic and tomographic images of human anatomy. | |
| The Discovery XR656 is designed to handle radiographicapplications using GE's flat-panel wireless digital detector. Thedigital detector is comprised of amorphous silicon and cesiumiodide scintillator. The resulting digital image can be sentthrough a DICOM network for applications such as printing,viewing and storage. | |
| The Discovery XR656 Digital Radiographic Imaging systemconsists of a Wallstand, elevating table, overhead Tube support,X-ray tube, collimator, system controller, X-ray generator, andwireless/tethered digital detector. Various configurations areavailable to meet radiographic requirements. The OptimaXR640 version of this product does not include advancedapplications and uses the tethered version of the digitaldetector. | |
| The Discovery XR656 offers a wide range of advanced clinicalapplications including GE's VolumeRAD™ (DigitalTomosynthesis), Dual Energy Subtraction, Tissue Equalizationand Auto Image Paste. | |
| This 510(k) is to expand our marketing claims for lung noduledetection using the VolumeRAD application. There is no changein design, manufacturing, materials or energy source of thealready cleared device. All the abilities required to achieve theresults of the extended claims during the clinical trial wereavailable 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 digitalradiographic images of the skull, spinal column, chest,abdomen, extremities, and other body parts in patients of allages. Applications can be performed with the patient sitting,standing, or lying in the prone or supine position and is intendedfor use in all routine radiography exams. |
| When the VolumeRAD option is included on the system, thesystem can generate tomographic images of human anatomyincluding the skull, spinal column, chest, abdomen, extremities,and other body parts in patients of all ages.When the VolumeRAD option is used for patients undergoingthoracic imaging, it is indicated for the detection of lungnodules. VolumeRAD generates diagnostic images of the chestthat aid the radiologist in achieving superior detectability oflung 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 ofSubstantial Equivalence: | Summary of Clinical Tests:A Multi-centered clinical study was performed to demonstratethat the use of VolumeRAD increases physician accuracy in thedetection of lung nodules 3-20mm in diameter, when comparedto conventional two-view CxR (posterior-anterior (PA) and leftlateral (LAT)), at an average effective dose less than 0.1mSv. |
| Summary of Non-Clinical Tests:The Discovery XR656 with extended claims employs the samedesign, manufacturing, materials or energy source of thealready cleared device and complies with voluntary standards.It is certified to comply with the X-ray requirements of 21 CFR,as well as safety requirements of IEC 60601-1 and associatedcollateral and particular standards. In addition, verification andvalidation testing is done as required by GE Healthcare' qualitysystem. | |
| Conclusion: | The Discovery XR656 with its Extended Claims for VolumeRADdoes not result in any new potential safety risks and performsas well as the currently marketed Discovery XR656. With theextended VolumeRAD claims, the Discovery XR656 withVolumeRAD has demonstrated effectiveness beyond theoriginal 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 (800) 638-2041 or (301) 796-7100 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 (800) 638 2041 or (301) 796-7100 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
Image /page/5/Picture/1 description: The image shows a logo with the letters 'GE' intertwined within a circular border. The letters 'GE' are stylized and appear to be hand-drawn. The border surrounding the letters is also ornate and decorative. The logo is black and white.
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)
§ 892.1740 Tomographic x-ray system.
(a)
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.(b)
Classification. Class II.