(111 days)
Image Pasting Application for Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications.
Image pasting allows the operator to generate 2 to 5 sequential radiographic images and electronically join them to create a single electronic mage.
This submission for the GE Medical Systems' Image Pasting application for the Revolution XR/d Digital Radiographic Imaging System (K042602) does not provide explicit acceptance criteria or a detailed study proving the device meets specific performance metrics.
The submission focuses primarily on demonstrating substantial equivalence to a predicate device (Revolution XR/d without image pasting) based on the device's technical specifications, intended use, and adherence to quality standards, rather than direct performance testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Equivalence | The device electronically joins 2 to 5 sequential radiographic images to create a single electronic image. (Implied: The resulting single image is functionally equivalent to an oversized film radiograph made with multiple exposures.) |
| Image Quality | Not explicitly stated in terms of specific metrics (e.g., resolution, contrast, artifact levels). The device facilitates the creation of a "single, longer radiograph" for viewing. |
| Safety (Electrical, Mechanical, Radiation) | Evaluated and conforms with applicable medical device safety standards through independent evaluation. |
| Compliance with Standards | Conforms with 21 CFR 820, ISO 9001, and ISO 13485 quality systems. |
| Substantial Equivalence | "Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. Intended uses and fundamental scientific technology are the same as the legally market Revolution XRd Radiographic Imaging System." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. No dedicated "test set" or clinical study data is described for evaluating the image pasting functionality.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth establishment activity for a test set is described. The submission relies on the established clinical practice for radiography and the predicate device's performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set or adjudication process is described.
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:
- No MRMC study was done. This device is an image processing application, not an AI-assisted diagnostic tool, and the submission explicitly states "Clinical Tests: None required."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The performance described is inherently "standalone" in terms of the image pasting function's ability to combine images. However, this is a technical function, not a diagnostic algorithm where standalone accuracy would be measured against ground truth. The primary evaluation appears to be technical functionality and safety rather than a diagnostic performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No formal ground truth was established for the image pasting functionality, as it's presented as a technical enhancement that mimics existing clinical practice (using oversized film or multiple overlapping exposures). The "ground truth" for the overall system's radiographic image generation would be expert interpretation of the radiographs themselves, but this specific submission focuses on the image manipulation feature.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that would require a "training set" in the conventional sense. The image pasting logic would be based on image processing algorithms.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned.
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JAN 1 3 2005
Special 510(k) Premarket Notification GE Medical Systems - Image Pasting
Attachment B:
Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).
Image /page/0/Picture/5 description: This document appears to be a submission form for GE Medical Systems. It includes the submitter's information, which is GE Medical Systems located in Milwaukee, WI. The contact person is Mark M Stauffer, who works in Safety and Regulatory Engineering, and their phone and fax numbers are listed. The document also mentions the device name, which is an image pasting application for the Revolution XR/d Digital Radiographic Imaging System, and the marketed device, which is the Revolution XR/d Digital Radiographic Imaging System with the 510(k) Number K012389.
Device Description: Image pasting allows the operator to generate 2 to 5 sequential radiographic images and electronically join them to create a single electronic mage.
Indications for Use: The Revolution XRVd is intended for use in generating radiographic Images of human anatomy. It is not intended for mammographic use.
Comparison with Predicate Device: Revolution XR/d and Revolution XR/d with image pasting application are used to generate radiographic invol and revolution XFU with image pasting application date digitally of at the users preference, on film. Each device has one solid state x-ray detector in the cabino x-adiation On occasion a sadiologic in thin. The detectors have a 41 cm by 41 cm surface for capturing x-radiation. On occasion a ratiologist desires a radiograph covering an area larger than that of the delector. Using Revolution XRVd (or any andographic system) and of the of the of
over oversized film Revolution XRVd (or any andiographic system) the techn oversized film cassette, on with either one wide-angle or several smaller overlapping exposures will be made. Using Revolution on the one one the technician will be able to make several digital exposures and electronically join them together for viewing as a single, longer radiograph.
The composition of the two systems is nearly identical. Modifications are made to Revolution XFVd to end of the more of the wo wo works to houly luential. Mounce to Revolune and
Summany of Studies: The device has been evaluated for electrical, mechanical, and radiation safety, and conforms with applicable medical of thecated for thechanical, micrlancal, and radionally Recognized Test Laboratory.
Clinical Tests: None required.
Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. Mended uses and fundamental scientific technology are the same as the legally market Revolution XRd Radiographic Imaging System. The 13485 and development process of the manufacturer conforms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verifled through independent evaluation with factory surveillance. Therefore, it is the opinion of GE Modical Systems that the modified medical device is substantially equivalent with respect to sthe and effectiveness to devices currently cleared for market including Revolution XRVd.
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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
Mr. Mark M. Stauffer Safety and Regulatory Engineer Diagnostic X-ray Engineering GE Medical Systems LLC P.O. Box 414 MILWAUKEE WI 53188
AUG 2 3 2013
Re: K042602
Trade/Device Name: Revolution XR/d Digital Radiographic X-Ray Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: December 16. 2004 Received: December 17. 2004
Dear Mr. Stauffer:
This letter corrects our substantially equivalent letter of January 13, 2005.
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 nredicate 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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Special 510(k) Premarket Notification GE Medical Systems - Image Pasting
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Image Pasting Application for Revolution XR/d Digital Radiographic Imaging System
Indications for Use
Image Pasting Application for Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating radiographic images of human anatomy. 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)
Prescription Use (Per 21 CFR 801-109)
OR Over-The-Counter Use_
Daniel A. Simon
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devic
510(k) Number K042602
§ 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.