(21 days)
Revolution XR/d Digital Radiographic Imaging System with Image Pasting and Autopositioning is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications.
The Revolution XR/d with Image Pasting and Autopositioning is the latest version of the Revolution XR/d digital radiographic x-ray system. It includes features and functions that have been developed since the introduction of the original XRd in 2001. Auto image pasting enables the operator to electronically join several sequentially acquired radiographs into a single image (such as spine images). Autopositioning offers improved end user workflow by minimizing the number of steps needed to set up and initiate imaging.
The provided documentation for the Revolution XR/d Digital Radiographic Imaging System with Image Pasting and Autopositioning (K050704) does not contain information about acceptance criteria or a study proving that the device meets such criteria.
Instead, the document primarily focuses on establishing substantial equivalence to a predicate device based on its intended use and fundamental scientific technology.
Here's why the requested information cannot be extracted from the provided text:
- No mention of specific performance metrics: The document does not define any quantitative or qualitative metrics that would serve as acceptance criteria (e.g., image quality scores, diagnostic accuracy, efficiency improvements, specific error rates).
- No detailed study report: The "Summary of Studies" section only states that the device was evaluated for electrical and radiation safety and conforms to applicable medical device safety standards. It does not describe any performance-based study methodology, results, or statistical analysis.
- "Clinical Tests: None required.": This explicit statement indicates that no clinical performance study was conducted or deemed necessary for this 510(k) submission.
Therefore, I cannot populate the requested table or provide details on the study design elements (sample size, data provenance, expert qualifications, adjudication, MRMC, standalone performance, ground truth types and establishment methods) as this information is absent from the provided text.
The key takeaway from the document regarding acceptance criteria and performance is that the device was considered substantially equivalent to a predicate device (Revolution XR/d with image pasting application, K042602) because its new features (Image Pasting and Autopositioning) primarily offered improved workflow and ease-of-use without altering the intended use or fundamental scientific technology of the device.
If acceptance criteria and a corresponding study were conducted, they would typically be detailed in a separate, more comprehensive study report submitted as part of the 510(k) application, or summarized with specific performance metrics within the "Summary of Safety and Effectiveness" document. This particular document serves as a high-level summary that doesn't delve into that level of detail.
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2005 APR 8
Attachment B:
Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).
KOSOTOU
GE Medical Systems
General Electric Company P.O. Box 414, Milwaukee, WI 53201
| Submitter: | GE Medical SystemsPO Box 414Milwaukee, WI 53201 |
|---|---|
| Contact Person: | John L. SchmidtSafety and Regulatory EngineeringTelephone: 262-548-4964; Fax: 262-544-3863 |
| Date Prepared: | March 15, 2005 |
| Device Name: | Revolution XR/d Digital Radiographic Imaging System with Image Pasting andAutopositioning21 CFR 892.1680 and 892.1650; 90 KPR and 90 MQB |
| Marketed Device: | Revolution XR/d Digital Radiographic Imaging System, 510(k) Number K012389Image Pasting Application, K042602, currently in commercial distribution. |
Device Description: The Revolution XR/d with Image Pasting and Autopositioning is the latest version of the Revolution XR/d digital radiographic x-ray system. It includes features and functions that have been developed since the introduction of the original XRd in 2001. Auto image pasting enables the operator to electronically join several sequentially acquired radiographs into a single image (such as spine images). Autopositioning offers improved end user workflow by minimizing the number of steps needed to set up
and initiate imaging.
Indications for Use: The Revolution XR/d 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 with image pasting and autopositioning is substantially equivalent to the predicate Revolution XR/d, with image pasting application option. The features and functions available on the new version XR/d offer improved workflow and ease-of-use to the operator, but do not alter the intended use of the device.
Summary of Studies: The device has been evaluated for electrical, and radiation safety, and conforms to applicable medical device safety standards, as conlirmed by a Nationally 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. Intended uses and fundamental scientific technology are the same as the legally marketed Revolution XR/d Radiographic Imaging System with Image Pasting Application. The design and development process of the manufacturer conforms to 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with factory surveillance. Therefore, it is the opinion of GE Medical Systems that the modified medical device is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market including Revolution XR/d.
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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of two parts: a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol is a stylized representation of a human figure, and the text is written in a clear, sans-serif font. The color of the logo is a light blue.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. John L. Schmidt Safety and Regulatory Engineer General Electric Co. GE Medical Systems LLC PO Box 414 MILWAUKEE WI 53201
AUG - 9 2013
Re: K050704
Trade/Device Name: Revolution XR/D Digital Radiographic Imaging System With Image Pasting Autopositioning
Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MOB Dated: March 16, 2005 Received: March 18. 2005
Dear Mr. Schmidt:
This letter corrects our substantially equivalent letter of April 8, 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. Drue, 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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Special 510(k) Premarket Notification GE Medical Systems - XR/d with Image Pasting and Autopositioning
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): __ Ko 50704_________________________________________________________________________________________________________________________________________
Device Name: Revolution XR/d Digital Radiographic Imaging System with Image Pasting and Autopositioning
Indications for Use
Revolution XR/d Digital Radiographic Imaging System with Image Pasting and Autopositioning 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_
Nancy C. Croston
(Division Sign-Off)
Division of Reproductive. Abde area Carloning al Devices ் ! O(K) Number
§ 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.