(70 days)
The Xaminer (510k submission device) is integrated into the user's stationary radiography system. This typical configuration permits a qualified/trained doctor or technologist to take a range of head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatinc patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions in an integrated system. The Xaminer (510k submission device) is not intended for mammography. These intended uses are identical to the Xplorer 1000 (predicate device).
The Xaminer is the latest version of Xplorer digital radiographic detectors. It includes features and functions that have been developed since the introduction of the original Xplorer in a dicital format will in a digital format without use of film, chemistry, cassettes or expensive imaging plates. With 98 % of fill factor in each pixel, there is a maximum efficiency and lower dose required for image capture. It has single CCD detector with 9 mega pixel digitized at 14 bits per pixels
The provided text is a 510(k) summary for the Xaminer Digital Radiographic Detector. It describes the device and its intended use, and states that it is substantially equivalent to a predicate device (Xplorer 1000 Digital Radiographic x-ray detector). However, it does not contain any information about acceptance criteria or a study proving that the device meets those criteria.
The 510(k) summary primarily focuses on:
- Device Description: The Xaminer is the latest version of Xplorer digital radiographic detectors, offering features like a 98% fill factor, lower dose requirement, single CCD detector, and 9-megapixel resolution digitized at 14 bits per pixel.
- Intended Use: For head-to-toe diagnostic radiographic exposures on adult and pediatric patients for various body parts, not intended for mammography.
- Substantial Equivalence: It claims identical intended uses to the predicate device, Xplorer 1000.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document does not include details on:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study.
- Standalone performance study.
- Type of ground truth used.
- Training set sample size.
- How training set ground truth was established.
This type of information would typically be found in a more detailed technical report or study protocol, not usually summarized in a 510(k) notification's public summary. The 510(k) process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with pre-defined acceptance criteria for new performance endpoints, especially for devices like digital X-ray detectors where image quality is often assessed against established standards or a predicate.
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K0061595
Special 510k Submission Xaminer Digital Radiographic Detector
510 k Summary
AUG 1 7 2006
Submitter:Imaging Dynamics Company Ltd Suite 121, 2340 Pegasus way NE Calgary, AB Canada T2E 8M5
Contact Person: Shirantha Samarappuli - Manager - Regulatory Affairs Tel: 403 251 9939, Fax: 403 251 1771
Date Prepared: Jun 01, 2006
Device Name: Xaminer Digital Radiographic x-ray detector
Marketed Device: Xplorer 1000 Digital Radiographic x-ray detector
Device Description:
The Xaminer is the latest version of Xplorer digital radiographic detectors. It includes features and functions that have been developed since the introduction of the original Xplorer in a dicital format will in a digital format without use of film, chemistry, cassettes or expensive imaging plates. With 98 % of fill factor in each pixel, there is a maximum efficiency and lower dose required for image capture. It has single CCD detector with 9 mega pixel digitized at 14 bits per pixels
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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. Shirantha Samarappuli Manager-Regulatory Affairs Imaging Dynamics Company Ltd. Suite 151, 2340 Pegasus Way NE CALGARY ALBERTA T2E 8M5 CANADA
AUG 2 0 2013
Re: K061595 Trade/Device Name: Xaminer Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MOB Dated: July 21, 2006 Received: July 24. 2006
Dear Mr. Samarappuli:
This letter corrects our substantially equivalent letter of August 17, 2006.
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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Special 510k Submission Xaminer Digital Radiographic Detector
Intended Use:
The Xaminer (510k submission device) is integrated into the user's stationary radiography system. This typical configuration permits a qualified/trained doctor or technologist to take a range of head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatinc patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions in an integrated system.
The Xaminer (510k submission device) is not intended for mammography.
These intended uses are identical to the Xplorer 1000 (predicate device).
AND/OR Over-The-Counter PRESCRIPTION USE (21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY
Concurrence of CDRH, Office of Device Evaluation (ODE)
(DIVISION SIGN-OFF
Yaureyk brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal.
Division of Reproductive, Abdominal,
and Radiological Devices K061595
510(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.