(210 days)
The DIGITAL RADIOGRAPHY CXDI-401C Wireless provides digital image capture for conventional film/screen radiographic examinations. This device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.
The model of detector included in this submission is a solid state x-ray imager. Model CXDI-401C Wireless has an approximate imaging area of 41.5 x 42.6 cm. For this model, the detector intercepts x-ray photons and the scintillator emits visible spectrum photons that illuminate an array of photo-detectors that create electrical signals. After the electrical signals are generated, the signals are converted to digital values and the images will be displayed on monitors. The digital value can be communicated to the operator console via wiring connection or wireless. The proposed model includes the Non-Generator Connection Mode, allowing this model to detect x-ray irradiation without direct electrical connection to the x-ray generator.
The Canon DIGITAL RADIOGRAPHY CXDI-401C Wireless device is a flat panel digital imager intended to replace conventional film/screen radiographic systems for general diagnostic procedures, excluding mammography. The provided document details its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or specific studies proving device performance against such criteria in the way a clinical performance study would.
Instead, the document focuses on demonstrating substantial equivalence to existing FDA-cleared predicate devices (K131106 MQB DIGITAL RADIOGRAPHY CXDI-701C Wireless and K103591 MQB DIGITAL RADIOGRAPHY CXDI-401C COMPACT). The performance claim is that the device is "safe and effective, performs comparably to the predicate device(s), and is substantially equivalent."
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy, or image quality metrics for specific disease detection) or compare the device's performance against such criteria. The "performance" described is largely comparative to predicate devices for technological characteristics and compliance with safety and established standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness | "device is safe and effective" |
| Comparable performance to predicate devices | "performs comparably to the predicate device(s)" |
| Substantial equivalence to predicate devices | "is substantially equivalent to the predicate device(s)" |
| Compliance with internal functional specifications (including software) | "verification/validation testing to internal functional specifications (including software)" |
| Non-clinical image comparisons | "non-clinical image comparisons involving flat panel display images taken with the new device and the predicate devices" |
| Compliance with FDA Guidance for Software in Medical Devices | "compliance of the CXDI-401C Wireless to all FDA requirements stated in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" |
| Compliance with FDA Guidance for RF Wireless Technology | "CXDI-401C Wireless RF technology is in accordance with the FDA Guidance Radio Frequency Wireless Technology in Medical Devices" |
| Compliance with FDA Guidance for Solid State X-ray Imaging Devices | "CXDI-401C Wireless complies with the FDA requirements stated in Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" |
| Equivalence in image quality to CXDI-701C Wireless | "evaluations of the Non-clinical and Clinical Considerations... including the image quality evaluation, show the CXDI-401C Wireless to be equivalent to the CXDI-701C Wireless" |
| Compliance with U.S. Performance Standard for radiographic equipment | "complies with the U.S. Performance Standard for radiographic equipment" |
| Compliance with relevant voluntary safety standards (IEC) | "complies with... IEC standards 60601-1, 60601-1-2, 60601-1-3, and 60601-2-32" |
| Compliance with FCC test standards (SAR, EMI) | "complies with the FCC test standard for SAR... and for EMI test regulations FCC Part 15 Subpart B:2012 Class A and ICES-003 Issue 5:2012 Class A" |
2. Sample size used for the test set and the data provenance:
The document mentions "non-clinical image comparisons involving flat panel display images taken with the new device and the predicate devices" and "image quality evaluation." However, it does not specify the sample size for any test set (number of images, patients, or types of cases) nor the data provenance (e.g., country of origin, retrospective/prospective). These appear to be internal verification and validation tests rather than a formal clinical trial with a defined test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not provide information on the number or qualifications of experts used to establish ground truth for any image comparisons or evaluations.
4. Adjudication method for the test set:
The document does not specify any adjudication method for a test set.
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 comparative effectiveness study is mentioned. The device described is a digital radiography system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device is a hardware component (flat panel detector) for digital radiography. It is not an algorithm that performs image analysis in a "standalone" fashion as would be discussed for AI. The performance is related to its image capture capabilities, implying a human-in-the-loop for interpretation.
7. The type of ground truth used:
The document implies "image quality evaluation" and "non-clinical image comparisons." The nature of the "ground truth" for these evaluations is not explicitly stated. For "image quality," it could refer to objective metrics, visual assessment against a reference, or comparison to known image characteristics. For "non-clinical image comparisons," it likely refers to direct comparison of images from the new device versus predicate devices. This is not a clinical ground truth derived from pathology or patient outcomes.
8. The sample size for the training set:
The document describes a hardware device. There is no mention of a training set in the context of an algorithm or AI model.
9. How the ground truth for the training set was established:
As there is no training set mentioned for an algorithm, this information is not applicable.
{0}------------------------------------------------
Canon
5. 510(k) SUMMARY
JUL 01 2014
Page 1 of 2
| Submitter: | Canon, Inc. - Medical Equipment Group30-2 Shimomaruko, 3-chromeOhta-ku, Tokyo 146-8501 Japan |
|---|---|
| Contact Person: | Applicant:Mr. Shinji MoriManagerTEL: 81-3-3758-2111FAX: 81-3-5482-3960mori.shinji@canon.co.jp |
| Date Prepared: | November 22, 2013 (revised Jan 9, 2014) |
| Trade Name: | DIGITAL RADIOGRAPHY CXDI-401C Wireless |
| Common Name: | Flat Panel Digital Imager |
| ClassificationName: | MQB (Solid State X-Ray Imager, Flat Panel/Digital Imager)892.1680 (Stationary X-Ray System) |
| Predicate Devices: | K131106 MQB DIGITAL RADIOGRAPHY CXDI-701C Wireless, Canon, Inc.K103591 MQB DIGITAL RADIOGRAPHY CXDI-401C COMPACT, Canon, Inc. |
| Device Description: | The model of detector included in this submission is a solid state x-ray imager.Model CXDI-401C Wireless has an approximate imaging area of 41.5 x 42.6 cm.For this model, the detector intercepts x-ray photons and the scintillator emitsvisible spectrum photons that illuminate an array of photo-detectors that createelectrical signals. After the electrical signals are generated, the signals are convertedto digital values and the images will be displayed on monitors. The digital value canbe communicated to the operator console via wiring connection or wireless.The proposed model includes the Non-Generator Connection Mode, allowing thismodel to detect x-ray irradiation without direct electrical connection to the x-raygenerator. |
| Statement ofIntended Use: | The DIGITAL RADIOGRAPHY CXDI-401C Wireless provides digital imagecapture for conventional film/screen radiographic examinations. This device isintended to replace radiographic film/screen systems in all general purposediagnostic procedures. This device is not intended for mammography applications. |
| Summary ofTechnologicalCharacteristics: | Comparisons with the predicate devices show the technological characteristics ofthe proposed DIGITAL RADIOGRAPHY CXDI-401C Wireless device to besubstantially equivalent to the predicate devices. The proposed device isfunctionally identical to the predicate devices.The CXDI-401C Wireless is a modification of the CXDI-401C COMPACT clearedunder K103591. The differences between the CXDI-401C Wireless and the CXDI-401C COMPACT are dynamic range, wireless capability, power supply, andexternal dimensions. However, for each of these features where the CXDI-401CWireless differs from the CXDI-401C COMPACT, the CXDI-401C Wireless isidentical to the CXDI-701C Wireless. |
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image contains the word "Canon" in a bold, sans-serif font. The letters are closely spaced together, creating a compact and recognizable logo. The word is presented in a simple, monochromatic color scheme, with the letters appearing in black against a white background.
K133693
Page 2
Tests
included
5. 510(k) SUMMARY (continued)
risk hazards.
Summary of Technological Characteristics: (continued)
Summary of
Test Data:
Non-Clinical /
The CXDI-401C Wireless utilizes a flat panel detector (Scintillator [Cs]] and amorphous silicon [a-Si]) [identical to both K131106 and K103591] with a pixel pitch of 125x125um [identical to both K131106 and K103591]. 3.320 x 3,408 pixels [identical to K103591], external dimensions of 460 x 15.4mm [equivalent to K103591]. a 16bit dynamic range [identical to K131106], wireless capability fidentical to K131106], an approximate weight of 3.8kg fequivalent to K131106], and has both AC and DC power supply [identical to K131106]. The CXDI-401C Wireless can only be used with systems running Canon CXDI Control NE software.
Tests were performed on the proposed model which demonstrated that the device is safe and effective, performs comparably to the predicate device(s), and is substantially equivalent to to the predicate device(s). 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 CXDI-401C Wireless 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
Documentation was provided demonstrating that the CXDI-401C Wireless RF technology is in accordance with the FDA Guidance Radio Frequency Wireless Technology in Medical Devices.
traceability of verification/validation tests to software requirements and software
Documentation was provided demonstrating that the CXDI-401C Wireless 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 Non-clinical and Clinical Considerations of the CXD1-701C Wireless compared to the CXD1-401C Wireless, including the image quality evaluation, show the CXDI-401C Wireless to be equivalent to the CXDI-701C Wireless.
Testing confirmed that the CXDI-401C Wireless 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, and 60601-2-32,
Testing confirmed that the CXDI-401C Wireless complies 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.
Together, these verification/validation activities successfully demonstrated that the CXDI-401C Wireless 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 CXDI-401C Wireless device.
Conclusion:
Canon. Inc. - Medical Equipment Group considers the DIGITAL RADIOGRAPHY CXDI-401C Wireless device to be substantially equivalent to the predicate devices CXDI-401C COMPACT and CXDI-701C Wireless. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use.
{2}------------------------------------------------
Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract eagle or bird-like figure with three curved lines representing wings or feathers.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 1, 2014
Canon. Inc. % Ms. Diane Rutherford Submissions Manager Ken Block Consulting 1201 Richardson Drive, Suite 280 RICHARDSON TX 75080
Re: K133693
Trade/Device Name: Digital Radiography CXDI-401C Wireless Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: May 23, 2014 Received: May 29, 2014
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 10 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: CDRFI docs 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 or any I vith 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.
{3}------------------------------------------------
Page 2 - Ms. Diane Rutherford
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/ResourcesforYou/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 vours.
Sammy H. Menge
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
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) K133693
Device Name
Digital Radiography CXDI-401C Wireless
Indications for Use (Describe)
The Digital Radiography CXD1-401C Wireless provides digital image capture for conventional film/screen radiographic examinations. This device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is 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)
Stenngh. Menge
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 The burden time for this onloolion of maintains to uces, gather and maintain the data needed and complete time to review that dolled 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."
FORM FDA 3881 (1/14)
§ 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.