(14 days)
The Revolution XR/d Digital Radiographic X-ray System is indicated for use in generating radiographic images of human anatomy. It is intended for use in replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
The Revolution XR/d Digital Radiographic Imaging System is designed to perform radiographic x-ray examinations. The detector is comprised of amorphous silicon with a cesium iodide scintillator. The resulting digital image can be sent through a DICOM network for applications such as printing, viewing, and storage. The Revolution XR/d Digital Radiographic Imaging System consists of an elevating radiographic table with integrated digital detector, x-ray tube, x-ray tube hanger, collimator, system controller, generator, and tilting radiographic wall stand with integrated digital detector. The configuration can consist of digital table and digital wall stand, digital table only, or digital wall stand only.
This document is a 510(k) summary for the GE Medical Systems Revolution XR/d Digital Radiographic Imaging System. It describes the device, its intended use, and its substantial equivalence to a previously cleared device. Due to the nature of this document (a 510(k) summary focused on substantial equivalence), it does not contain the detailed clinical study information typically found in a full clinical trial report or a more extensive submission for novel devices.
Here's the breakdown of the requested information based solely on the provided text, with explicit notes about what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
This document describes the device as being "substantially equivalent" to a previously cleared device (K992066). For devices seeking 510(k) clearance based on substantial equivalence, the primary "acceptance criterion" is often that the new device performs as safely and effectively as the predicate device, or that any differences do not raise new questions of safety or effectiveness. Specific quantitative performance metrics (e.g., sensitivity, specificity, image quality scores) and their associated acceptance thresholds are not provided in this 510(k) summary.
The document states:
- "The Revolution XR/d Digital Radiographic Imaging System is substantially equivalent to the presently marketed Revolution XR/D Digital Radiographic Imaging System (K992066)."
- "The Revolution XR/d Digital Radiographic Imaging System does not include any new indications for use, nor does use of this device result in any new potential hazards."
Therefore, the reported device performance is implicitly considered to be equivalent to the predicate device.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (K992066) | Achieved; device is substantially equivalent to Revolution XR/D Digital Radiographic Imaging System (K992066). |
| No New Indications for Use | Achieved; no new indications for use. |
| No New Potential Hazards | Achieved; no new potential hazards. |
| Conformance to applicable sections of 21CFR 1020.30, 1020.31, and 1020.32 | Stated for the system. |
| Conformance to UL 2601-1, IEC 601-1, IEC 601-1-2, and IEC 601-1-3 | Stated for the system. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary. Given that it's a submission for substantial equivalence to an existing device, it's possible that no new clinical data or a specific "test set" of patient images was explicitly used in the public summary. The focus is on demonstrating that the technical modifications (e.g., new SSXI - presumably a detector technology from the FDA letter) do not alter the fundamental safety and effectiveness of the existing device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the 510(k) summary.
4. Adjudication Method for the Test Set
This information is not provided in the 510(k) summary.
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
An MRMC study is not mentioned in this 510(k) summary. This device is an X-ray imaging system, not an AI-powered diagnostic aid meant to assist human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not discussed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is an imaging system, not a standalone algorithm. Therefore, "standalone" algorithm performance is not applicable and not discussed.
7. The Type of Ground Truth Used
This information is not provided in the 510(k) summary. For a general radiographic system, the "ground truth" would typically refer to the clinical utility of the images produced for diagnostic purposes, which is often inferred from successful use of predicate devices, rather than a specific "ground truth" established for this submission.
8. The Sample Size for the Training Set
This information is not provided in the 510(k) summary. The document does not describe a machine learning algorithm or a "training set" in the context of this device's submission.
9. How the Ground Truth for the Training Set was Established
This information is not provided in the 510(k) summary as there is no mention of a training set or ground truth for such in this document.
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Image /page/0/Picture/0 description: The image shows a logo with the letters 'GE' intertwined inside a circle. The letters are stylized and appear to be handwritten or cursive. The logo is black and white, with the letters and the outline of the circle in black against a white background. The overall design is simple and classic, representing the General Electric brand.
GE Medical Systems P.O. Box 414. W-709 Milwaukee, WI 53201 USA
1012389
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).
| Identification of Submitter: | Larry A. Kroger, Ph.D.Senior Regulatory Programs ManagerGE Medical SystemsTel. (262) 544-3894Summary prepared: 25 June 2001 |
|---|---|
| Identification of Product: | Revolution XR/d Digital Radiographic Imaging System |
| Classification Name: | Stationary X-ray System |
| Manufacturer: | GE Medical Systems3000 N. Grandview Blvd.Waukesha, WI 53188 |
Device Description: The Revolution XR/d Digital Radiographic Imaging System is designed to perform radiographic x-ray examinations. The detector is comprised of amorphous silicon with a cesium iodide scintillator. The resulting digital image can be sent through a DICOM network for applications such as printing, viewing, and The Revolution XR/d Digital Radiographic Imaging storage. System consists of an elevating radiographic table with integrated digital detector, x-ray tube, x-ray tube hanger, collimator, system controller, generator, and tilting radiographic wall stand with integrated digital detector. The configuration can consist of digital table and digital wall stand, digital table only, or digital wall stand only.
- Indications for Use: The Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
- Comparison with: The Revolution XR/d Digital Radiographic Imaging System is an enhanced version of and substantially equivalent to the
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Revolution XR/D Digital Radiographic Imaging System, originally cleared in K992066.
Conformance:
The Revolution XR/d Digital Radiographic Imaging System will conform to applicable sections of 21CFR 1020.30, 1020.31, and 1020.32. The system will also conform to UL 2601-1, IEC 601-1, IEC 601-1-2, and IEC 601-1-3.
Conclusions:
In the opinion of GE Medical Systems, the Revolution XR/d Digital Radiographic Imaging System is substantially equivalent to the presently marketed Revolution XR/D Digital Radiographic Imaging System (K992066). The Revolution XR/d Digital Radiographic Imaging System does not include any new indications for use, nor does use of this device result in any new potential hazards.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
General Electric Medical Systems % Mr. Reiner Krumme Manager, Medical Division TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
AUG 21 2013
Re: K012389
Trade/Device Name: Revolution XR/D Digital Radiographic Imaging System (Radiographic x-ray system with SSXI) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: July 23, 2001 Received: July 27, 2001
Dear Mr. Krumme:
This letter corrects our substantially equivalent letter of August 10, 2001.
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INTENDED USE
510(k) Number (if known):
Device Name: Revolution XR/d Digital Radiographic X-ray System
Indications for Use
The Revolution XR/d Digital Radiographic X-ray System is indicated for use in generating radiographic images of human anatomy. It is intended for use in replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1 Prescription Use (Per 21 CFR 801-109)
OR Over-The-Counter Use_
Nancy C. Langdon
(Division Sign-Off)
(Division Sign-OHY)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012389
§ 892.1680 Stationary x-ray system.
(a)
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.(b)
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.