(224 days)
No
The summary describes a scatter correction algorithm for image processing, which is a traditional image processing technique and does not inherently imply the use of AI or ML. There is no mention of AI, ML, or related concepts like training data or models.
No
The device is described as a component of a radiography system intended for digital image capture, processing, and display for diagnostic procedures, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that "This device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures."
No
The device is described as "CXDI Control Software when used with a compatible CXDI detector". This indicates that the software is a component of a larger system that includes hardware (the CXDI detector). The submission is for a change to the software, but the device as a whole is not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "digital image capture, and display for conventional film/screen radiographic examinations." This is related to medical imaging, not the examination of specimens derived from the human body.
- Device Description: The description focuses on image processing (scatter correction) to enhance radiographic images. This is a function related to the imaging process itself, not the analysis of biological samples.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on sample analysis
- Using reagents or assays
The device is a component of a radiography system used for capturing and processing medical images. This falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
As a part of the CXDI series radiography system, the CXDI Control Software when used with a compatible CXDI detector is intended to provide digital image capture, and display for conventional film/screen radiographic examinations. This device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures including specialist areas like intensive care, trauma, and pediatric work. This device is not intended for fluoroscopic, angiographic, or mammography applications.
Product codes
MQB
Device Description
The subject of this submission is a change to the CXDI Control Software to incorporate a scatter correction algorithm. By incorporating the scatter correction algorithm into the CXDI Control Software, the image contrast is enhanced and the images produced have similar detail contrast as images acquired with an anti-scatter grid.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Tests were performed on the proposed CXDI Control Software which demonstrates that the device is safe and effective, performs comparably to the predicate device(s), and is substantially equivalent to the predicate device(s). Tests included verification/validation testing to internal software specifications and image comparisons involving flat panel display images taken without a grid. Additional evaluations were conducted with clinical images to demonstrate and evaluate the performance of the software feature. Documentation was provided demonstrating compliance of the CXDI Control Software to all FDA requirements stated in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, including results of verification/ validation plus traceability of verification/validation tests to software requirements and software risk hazards. Together, these verification/validation activities successfully demonstrated that the Scatter Correction for CXDI Series correctly performs as designed, has been validated for its intended use, and raises no new questions regarding either safety or effectiveness when compared to the predicate device(s).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K102012, K103591, K111682, K112309, K131106, K133693
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 28, 2016
Canon, Inc % Ms. Diane Rutherford Submissions Manager Ken Block Consulting 1201 Richardson Drive, Suite 160 RICHARDSON TX 75080
Re: K153312
Trade/Device Name: Scatter Correction for CXDI Series Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: May 25, 2016 Received: May 26, 2016
Dear Ms. Rutherford:
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 II (Special Controls) or class III (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 (21 CFR Part 807); labeling (21 CFR Part 801); 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), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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.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 Industry and Consumer Education 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.
Sincerely yours.
Michael O'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name Scatter Correction for CXDI Series
Indications for Use (Describe)
As a part of the CXDI series radiography system, the CXDI Control Software when used with a compatible CXDI detector is intended to provide digital image capture, and display for conventional film/screen radiographic examinations. This device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures including specialist areas like intensive care, trauma, and pediatric work. This device is not intended for fluoroscopic, angiographic, or mammography applications.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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5. 510(k) SUMMARY
| Submitter: | Canon, Inc. - Medical Equipment Group
30-2 Shimomaruko, 3-chrome
Ohta-ku, Tokyo 146-8501 Japan | |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Shinji Mori
Manager
TEL: 81-3-3758-2111;
FAX: 81-3-5482-3960
mori.shinji@canon.co.jp | |
| Date Prepared: | November 6, 2015 [revised May 23, 2016] | |
| Trade Name: | Scatter Correction for CXDI Series | |
| Common Name: | Control Software for Flat Panel Digital Imager | |
| Classification
Name: | MQB (Solid State X-Ray Imager, Flat Panel/Digital Imager)
892.1680
(Stationary X-Ray System) | |
| Predicate Devices: | | |
| Predicate 1: | MQB
510(k) #
K102012
K103591
K111682
K112309
K131106
K133693 | Canon DIGITAL RADIOGRAPHY CXDI Series Detectors
Models
CXDI-70C Wireless
CXDI-401C, CXDI-401G, CXDI-401C Compact, CXDI-401G Compact
CXDI-501C, CXDI-501G
CXDI-80C Wireless, CXDI-80G Wireless
CXDI-701C Wireless, CXDI-701G Wireless, CXDI-801C Wireless,
CXDI-801G Wireless
CXDI-401C Wireless |
| Predicate 2: | MQB / LLZ
K140771 | Philips Elva Workspot with Skyflow |
| Device Description: | The subject of this submission is a change to the CXDI Control Software to
incorporate a scatter correction algorithm. By incorporating the scatter
correction algorithm into the CXDI Control Software, the image contrast is
enhanced and the images produced have similar detail contrast as images
acquired with an anti-scatter grid. | |
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5. 510(k) SUMMARY (continued)
Statement of As a part of the CXDI series radiography system, the CXDI Control Intended Use: Software when used with a compatible CXDI detector is intended to provide [Indications for digital image capture, processing, and display for conventional film/screen Use Statement] radiographic examinations. This device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures including specialist areas like intensive care, trauma, and pediatric work. This device is not intended for fluoroscopic, angiographic, or mammography applications. Summary of Comparisons with the predicate device(s) show the characteristics of the proposed Scatter Correction for CXDI Series to be substantially equivalent to the predicate Technological device(s). Characteristics: The Canon CXDI Control NE software with scatter correction can only be used with compatible Canon CXDI detectors: CXDI-70C Wireless. CXDI-80C Wireless. CXDI-80G Wireless, CXDI-401C, CXDI-401C Wireless CXDI-401G, CXDI-401C Compact, CXDI-401G Compact, CXDI-501C, CXDI-501G, CXDI-701C Wireless, CXDI-701G Wireless, CXDI-801C Wireless, CXDI-801G Wireless. Summary of Tests were performed on the proposed CXDI Control Software which Non-Clinical / demonstrates that the device is safe and effective, performs comparably to the Test Data: predicate device(s), and is substantially equivalent to the predicate device(s). Tests included verification/validation testing to internal software specifications and image comparisons involving flat panel display images taken without a grid. Additional evaluations were conducted with clinical images to demonstrate and evaluate the performance of the software feature. Documentation was provided demonstrating compliance of the CXDI Control Software to all FDA requirements stated in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, including results of verification/ validation plus traceability of verification/validation tests to software requirements and software risk hazards. Together, these verification/validation activities successfully demonstrated that the Scatter Correction for CXDI Series correctly performs as designed, has been validated for its intended use, and raises no new questions regarding either safety or effectiveness when compared to the predicate device(s). Therefore, the verification/validation testing conducted supports a determination of substantial equivalence for the Scatter Correction for CXDI Series. As reported in prior submissions to FDA, the compatible detectors comply with the U.S. Performance Standard for radiographic equipment and with relevant voluntary safety standards for Electrical Safety and Electromagnetic Compatibility testing, specifically IEC standards 60601-1, 60601-1-2, 60601-1-3, and 60601-2-32. The wireless detectors also comply with the FCC test standard for SAR, specifically 47CFR 2.1093 and for EMI test regulations FCC Part 15 Subpart B:2012 Class A and ICES-003 Issue 5:2012 Class A. Conclusion: Canon, Inc. - Medical Equipment Group considers the Scatter Correction for CXDI Series to be substantially equivalent to the predicate devices listed above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use.