(102 days)
Not Found
No
The summary describes a standard digital radiography flat panel detector and does not mention any AI or ML capabilities, image processing, or data sets typically associated with AI/ML development.
No
The device is a diagnostic imaging tool (X-ray detector) used to generate images for diagnostic, surgical, and interventional procedures, not to provide therapy.
Yes
The "Intended Use / Indications for Use" section states that the device is "designed to provide fluoroscopic and spot radiographic images of human anatomy during diagnostic, surgical and interventional procedures." This explicitly indicates its use in diagnostic processes.
No
The device description explicitly states it is a "digital radiography flat panel detector" and a "component of an x-ray system," which are hardware components. While it contains software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed to provide images of human anatomy during diagnostic, surgical, and interventional procedures. This involves imaging the body directly.
- Device Description: The device description reinforces this by stating it takes images of any part of the body and converts X-ray images captured by the sensor into digital images.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
This device is an in vivo imaging device, meaning it is used to image the inside of the living body. It does not analyze samples taken from the body.
N/A
Intended Use / Indications for Use
The flat panel detector CSX-30 is designed to provide fluoroscopic and spot radiographic images of human anatomy during diagnostic, surgical and interventional procedures. Examples of clinical application may include angiography, endoscopy, urologic, orthopedic, neurologic, vascular, critical-care and emergency room procedures or other imaging applications at the physician's discretion. The device is intended to replace spot-film device is also intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.
Product codes
MQB, JAA
Device Description
The CSX-30 is a digital radiography flat panel detector that can take fluoroscopic and spot radiographic images of any part of the body. It directly converts the X-ray images captured by the sensor into high-resolution digital images. The instrument is a component of an x-ray system and as such cannot be used outside of such a system. This unit converts the X-rays into digital signals. Not intended for mammography applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy / any part of the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / Diagnostic, surgical and interventional procedures, angiography, endoscopy, urologic, orthopedic, neurologic, vascular, critical-care and emergency room procedures.
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
Tests included verification/validation testing to internal functional specifications (including software) and non-clinical image comparisons involving flat panel display images taken with the new device and the predicate devices.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Tests were performed on the device which demonstrated that the device is safe and effective, performs comparably to and is substantially equivalent to the predicate device.
Non-clinical image comparisons were performed.
Documentation was provided demonstrating compliance of the CSX-30 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.
Documentation was provided demonstrating that the CSX-30 complies with the FDA requirements stated in Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices.
Testing confirmed that the CSX-30 complies 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, 60601-1-9, 60601-2-32, and 60601-2-54. Testing also confirmed compliance to relevant voluntary safety standards IEC 60825-2, IEC 60825-1, and IEC 62220-1-3.
The verification/validation activities successfully demonstrated that the CSX-30 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 devices. Intergration testing was also performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 27, 2017
Canon, Inc. - Medical Equipment Group % Ms. Diane Rutherford Submissions Manager Ken Block Consulting 1201 Richardson Drive, Suite 160 Richardson TX 75080
Re: K162909
Trade/Device Name: CSX-30 Flat Panel Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB, JAA Dated: December 27, 2016 Received: December 28, 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.
1
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 D'Hara
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
For
Enclosure
2
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) K162909
Device Name CSX-30 Flat Panel Detector
Indications for Use (Describe)
The flat panel detector CSX-30 is designed to provide fluoroscopic and spot radiographic images of human anatomy during diagnostic, surgical and interventional procedures. Examples of clinical application may include angiography, endoscopy, urologic, orthopedic, neurologic, vascular, critical-care and emergency room procedures or other imaging applications at the physician's discretion. The device is intended to replace spot-film device is also intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for 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."
3
Image /page/3/Picture/0 description: The image shows the word "Canon" in a bold, red font. The letters are slightly blurred, giving the word a soft appearance. The word is centered and takes up most of the frame.
5. 510(k) SUMMARY
| Submitter: | Canon, Inc. – Medical Equipment Group
9-1, Imaikami-cho, Nakahara-ku
Kawasaki, Kanagawa 211-8501, Japan |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Shinji Mori
Manager
TEL: 81-3-3758-2111
FAX: 81-44-739-6493
shinji.mori@canon.co.jp |
| Date Prepared: | September 27, 2016 |
| Proposed Device | Manufacturer: Canon
Trade Name: CSX-30 Flat Panel Detector
Common Name: Solid State X-ray Imager
Classification Name: Stationary X-ray system
Product Code / Regulatory Standard: MQB, JAA
892.1680 Stationary X-ray System |
| Predicate Device: | Clearance: K111824 dated April 23, 2012
Manufacturer: Canon
Trade Name: CSX-10 Flat Panel Detector
Common Name: Solid State X-ray Imager
Classification Name: Stationary X-ray system
Product Code / Regulatory Standard: MQB
892.1680 Stationary X-ray System |
| Device Description: | The CSX-30 is a digital radiography flat panel detector that can take fluoroscopic
and spot radiographic images of any part of the body. It directly converts the X-ray
images captured by the sensor into high-resolution digital images. The instrument is
a component of an x-ray system and as such cannot be used outside of such a
system. This unit converts the X-rays into digital signals. Not intended for
mammography applications. |
| Indications for Use: | The flat panel detector CSX-30 is designed to provide fluoroscopic and spot
radiographic images of human anatomy during diagnostic, surgical and
interventional procedures. Examples of clinical application may include
angiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac,
critical-care and emergency room procedures or other imaging applications at the
physician's discretion. The device is intended to replace spot-film devices. The
device is also intended to replace fluoroscopic images obtained through image
intensifier technology. Not intended for mammography applications.
The Intended Use of the CSX-30 is the same as for the predicate device, CSX-10. |
| Summary of
Technological
Characteristics: | Comparison with the predicate shows the technological characteristics of the
CSX-30 are substantially equivalent to the predicate device. The flat panel detector
units are functionally identical.
The CSX-30 is the next model in the CSX family of detectors. The differences
between the CSX-30 and the predicate CSX-10 are primarily increased size and
increased performance. Increased size results in larger dimensions, larger image |
4
Image /page/4/Picture/0 description: The image shows the word "Canon" in red font. The font is bold and slightly italicized. The background is white.
area, more pixels, and increased weight over the predicate. Performance has been increased resulting in increased DOE, dynamic range, and frame rates. These modifications have been incorporated into the CSX-30 in an effort to improve the product performance.
| | New Device: CSX-30
K162909 | Predicate Device: CSX-10
K111824 | |
|------------------------------------|-------------------------------------------------------------------------|------------------------------------------------------------------|-----------|
| Application | Fluoroscopy and Spot Radiology | Fluoroscopy and Spot Radiology | Identical |
| Technology | Flat panel detector:
Scintillator and CSX
sensing unit | Flat panel detector:
Scintillator and CSX
sensing unit | Identical |
| Scintillator | CsI(TI)
[Cesium lodide doped
with Thallium] | CsI(TI)
[Cesium lodide doped
with Thallium] | Identical |
| Pixel Pitch | 160 x 160 μm | 160 x 160 μm | Identical |
| Pixels | 2,496 x 1,856
(approx 4.6 million) | 1,792 x 1,632
(approx 2.9 million) | Modified |
| Image Size | 399 x 297 mm | 287 x 261 mm | Modified |
| Overall Dimensions | 470 x 363 x 82.5 mm
(Except flexible tubes and minor
protrusions) | 360 x 346 x 65.5 mm | Modified |
| Weight | 19.0 kg | 6.7 kg | Modified |
| Acquisition Mode
(Binning mode) | Up to 60 fps (1x1)
Up to 230 fps (2x2)
Up to 300 fps (4x4) | Up to 30 fps (1x1)
Up to 100 fps (2x2)
Up to 200 fps (4x4) | Modified |
| A/D Conversion | 16-bit | 14-bit | Modified |
Summary of Non-Clinical /Test Data:
Tests were performed on the device which demonstrated that the device is safe and effective, performs comparably to and is substantially equivalent to the predicate device.
Tests included verification/validation testing to internal functional specifications (including software) and non-clinical image comparisons involving flat panel display images taken with the new device and the predicate devices. Documentation was provided demonstrating compliance of the CSX-30 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.
Documentation was provided demonstrating that the CSX-30 complies with the FDA requirements stated in Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices. The evaluations of the CSX-30 compared to the CSX-10, show the CSX-30 to be equivalent to the CSX-10.
Testing confirmed that the CSX-30 complies 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, 60601-1-9, 60601-2-32, and 60601-2-54. Testing also confirmed compliance to relevant voluntary safety standards IEC 60825-2, IEC 60825-1, and IEC 62220-1-3.
Together, these verification/validation activities successfully demonstrated that the CSX-30 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 devices. Therefore, the verification testing conducted supports a determination of substantial equivalence for the CSX-30 device.
5
Image /page/5/Picture/0 description: The image shows the word "Canon" in red font. The font is bold and slightly italicized. The background is white.
Integration: The CSX-30 is a hardware only FPD for integration into x-ray systems. The CSX-30 connects to an x-ray imager control PC and does not connect directly to an x-ray generator. The Instruction Manual provides detailed instructions and information for safe and effective system integration including: system configuration; electrical, mechanical, and cooling requirements; installation conditions; interfaces (image, command and service, and power input). Integrators are expected to adhere to the instructions and other information in the published Installation Manual. Conclusion:
Canon, Inc. – Medical Equipment Group considers the CSX-30 to be substantially equivalent to the predicate device listed above. This conclusion is based on the same intended use and similar principles of operation, functional design, and established medical use for the flat panel detector.