(23 days)
The DIGITAL RADIOGRAPHY CXDI-Pro / D1 provides digital image capture for conventional film/screen radiographic examinations. This device is intended to capture, for display, radiographic images of human anatomy, and to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.
The DIGITAL RADIOGRAPHY CXDI-Pro, also called the DIGITAL RADIOGRAPHY D1, (hereinafter referred to as CXDI-Pro) is a solid-state x-ray imager. The CXDI-Pro is a series of detectors, and in the predicate device consists of the CXDI-703C Wireless detector unit, also called the AR-D3543W detector. The detector intercepts x-ray photons, and the scintillator emits visible spectrum photons that illuminate an array of photodetectors 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 image can be communicated to the operator console via a wired or wireless connection.
The subject of this Special 510(k) submission is a change to the CXDI-Pro add a detector, the CXDI-403C Wireless (also called AR-D4343W) to the CXDI-Pro series of detectors. In addition, a Detector Stand (DS-01) and a new Battery Charger (BC-01) have been added as optional components to be used with the proposed CXDI-Pro detectors (CXDI-703C Wireless and CXDI-403C Wireless), the sleep to ready cycle time for the proposed CXDI-Pro detectors has been decreased, and the CXDI Contro Software has been updated from V3.10.0.3 to V3.10.0.8 to add the Intelligent NR function (cleared under K212269) and apply some bug fixes. Together, these changes make up the CXDI-Pro.
Here's a breakdown of the acceptance criteria and study information for the Canon Inc. Digital Radiography CXDI-Pro / D1, based on the provided FDA 510(k) summary:
This submission (K220098) is a Special 510(k) submission, which indicates that the changes made to the device (new detector, accessories, reduced cycle time, software update) did not fundamentally alter its intended use or fundamental scientific technology. Therefore, the primary focus of the performance evaluation is to ensure that these changes do not negatively impact the device's conformance with relevant standards and do not raise new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a Special 510(k) for modifications to an already cleared device, the "acceptance criteria" are primarily related to maintaining conformance with existing performance and safety standards, rather than establishing new clinical performance targets. The reported device performance confirms that these standards are still met.
| Acceptance Criteria (related to modified aspects) | Reported Device Performance |
|---|---|
| Maintain conformance with U.S. Performance Standard for radiographic equipment. | Evaluation of the addition of the new detector (CXDI-403C Wireless) and optional accessories (Detector Stand, Battery Charger) confirmed that the changes did not impact CXDI-Pro conformance with this standard. |
| Maintain conformance with relevant voluntary safety standards for Electrical safety and Electromagnetic Compatibility (EMC), specifically IEC 60601-1, 60601-1-2, 60601-2-54, 60601-1-6, and IEC 60529. | Verification/validation activities successfully demonstrated that the device continues to meet these standards. |
| Ensure the reduction in "Sleep to Ready Cycle Time" (from 7 sec to less than 5 sec) does not compromise safety or effectiveness. | Implied: The successful verification/validation activities encompass this change, indicating it does not raise new questions of safety or effectiveness. (Specific performance data for this change beyond the stated time is not detailed, but its successful integration into the system meeting overall standards implies acceptance.) |
| Ensure the software update (V3.10.0.3 to V3.10.0.8, including Intelligent NR function K212269) and firmware update (01.00.00.03 to 01.00.02.00) do not compromise safety or effectiveness. | Implied: The software update to incorporate an already cleared feature (Intelligent NR, K212269) and bug fixes, along with the firmware update, were part of the verification/validation activities that demonstrated the device continues to meet standards and raises no new questions regarding safety or effectiveness. (Specific performance data for the software/firmware changes beyond their successful integration and bug fixes are not detailed in this summary.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set sample size" in terms of patient images or clinical cases. The performance evaluation is described as "Verification/validation activities" which focused on technical performance and safety standards. This suggests that the testing involved:
- Engineering tests on the physical components (new detector, accessories).
- Software testing for the updated control software and firmware.
- Electromagnetic compatibility (EMC) testing.
- Electrical safety testing.
The data provenance is industrial and engineering testing, rather than clinical data from specific countries or retrospective/prospective studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable in the context of this Special 510(k). Ground truth for clinical diagnostic performance (e.g., presence/absence of disease) is not the focus of this submission. The "ground truth" here is adherence to engineering specifications and safety standards, which would be assessed by engineers and quality control personnel.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring reader adjudication of clinical findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed to demonstrate the clinical performance of a diagnostic aid, which is not the scope of this Special 510(k) submission focused on hardware/software modifications and maintaining safety/performance standards.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The document primarily describes the performance of the overall digital radiography system, which includes the detector and control software. While the software update includes an "Intelligent NR function" (cleared under K212269), this submission's performance evaluation focuses on the integrated system's safety and continued conformance, not a standalone algorithm's diagnostic performance. Its effectiveness would have been established in the K212269 submission.
7. The Type of Ground Truth Used
The ground truth used for these verification and validation activities is based on:
- Engineering specifications (for the new detector, cycle time, accessories).
- International standards (IEC 60601-1, 60601-1-2, 60601-2-54, 60601-1-6, IEC 60529).
- U.S. Performance Standard for radiographic equipment.
- Software testing protocols to verify bug fixes and the integration of the Intelligent NR function without introducing new issues.
8. The Sample Size for the Training Set
Not applicable. This submission does not describe a machine learning model being developed or trained on a dataset. The software update includes an "Intelligent NR function" which would have involved a training set in its original K212269 submission, but that information is not provided here.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set described in this submission.
{0}------------------------------------------------
February 4, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Canon Inc. % Mr. Gregory Woodard Biomedical Engineer Ken Block Consulting 800 East Campbell Road, Suite 202 RICHARDSON TX 75081
Re: K220098
Trade/Device Name: Digital Radiography CXDI-Pro, Digital Radiography D1 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: January 11, 2022 Received: January 12, 2022
Dear Mr. Woodard:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
{1}------------------------------------------------
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurel Burk Assistant Director Diagnostic X-ray Systems Team Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K220098
Device Name DIGITAL RADIOGRAPHY CXDI-Pro DIGITAL RADIOGRAPHY D1
Indications for Use (Describe)
The DIGITAL RADIOGRAPHY CXDI-Pro / D1 provides digital image capture for conventional film/screen radiographic examinations. This device is intended to capture, for display, radiographic images of human anatomy, and 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) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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 red font at the top. Below that, the words "510(k) SUMMARY" are written in a bold, black font. The text is centered on the page.
| Applicant/Sponsor: | Canon Inc.9-1 Imaikami-choNakahara-ku, Kanagawa 211-8501 Japan |
|---|---|
| Contact Person: | Mr. Akira HiraiGeneral ManagerTEL: 81-3-3758-2111;FAX: 044-739-6695hirai.akira@mail.canon |
| Date Prepared: | January 28, 2022 |
| Submission Type: | Special 510(k) Submission |
| Proposed Device: | Manufacturer: Canon Inc.Trade Name: DIGITAL RADIOGRAPHY CXDI-ProDIGITAL RADIOGRAPHY D1Common Name: Solid State X-Ray Imager (Flat Panel/Digital Imager)Classification Name: Stationary X-ray SystemClassification: 892.1680, Stationary X-ray SystemProduct Code: MQB |
| Predicate Device: | 510k Number: K212553Manufacturer: Canon Inc.Trade Name: DIGITAL RADIOGRAPHY CXDI-ProDIGITAL RADIOGRAPHY D1Common Name: Solid State X-Ray Imager (Flat Panel/Digital Imager)Classification Name: Stationary X-ray SystemClassification: 892.1680, Stationary X-ray SystemProduct Code: MQB |
| Device Description: | The DIGITAL RADIOGRAPHY CXDI-Pro, also called the DIGITALRADIOGRAPHY D1, (hereinafter referred to as CXDI-Pro) is a solid-state x-rayimager. The CXDI-Pro is a series of detectors, and in the predicate device consists ofthe CXDI-703C Wireless detector unit, also called the AR-D3543W detector. Thedetector intercepts x-ray photons, and the scintillator emits visible spectrum photonsthat illuminate an array of photodetectors that create electrical signals. After theelectrical signals are generated, the signals are converted to digital values, and theimages will be displayed on monitors. The digital image can be communicated to theoperator console via a wired or wireless connection.The subject of this Special 510(k) submission is a change to the CXDI-Pro add adetector, the CXDI-403C Wireless (also called AR-D4343W) to the CXDI-Pro seriesof detectors. In addition, a Detector Stand (DS-01) and a new Battery Charger (BC-01) have been added as optional components to be used with the proposed CXDI-Prodetectors (CXDI-703C Wireless and CXDI-403C Wireless), the sleep to ready cycletime for the proposed CXDI-Pro detectors has been decreased, and the CXDI ControSoftware has been updated from V3.10.0.3 to V3.10.0.8 to add the Intelligent NRfunction (cleared under K212269) and apply some bug fixes. Together, thesechanges make up the CXDI-Pro. |
{4}------------------------------------------------
K220098
Indication for Use: The Indication for Use statement is identical to the predicate device. The intended use of the proposed device, as described in the labeling, has not changed as a result of the modification(s).
The DIGITAL RADIOGRAPHY CXDI-Pro / DIGITAL RADIOGRAPHY D1 provides digital image capture for conventional film/screen radiographic examinations. This device is intended to capture, for display, radiographic images of human anatomy, and to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.
Summary of Comparison with the predicate device shows the characteristics of the proposed Technological modifications (addition of a new detector and additional optional accessories) to the Characteristics: CXDI-Pro to be substantially equivalent to the predicate device.
| Proposed Device | Predicate Device | ||
|---|---|---|---|
| Trade Name | DIGITAL RADIOGRAPHY CXDI-Pro /DIGITAL RADIOGRAPHY D1 | ||
| 510(k) Submitter[Number] | Canon Inc.[K220098] | Canon Inc.[K212553] | IDENTICAL |
| Indication for Use | The DIGITAL RADIOGRAPHY CXDI-Pro /DIGITAL RADIOGRAPHY D1 providesdigital image capture for conventionalfilm/screen radiographic examinations. Thisdevice is intended to capture, for display,radiographic images of human anatomy, andto replace radiographic film/screen systems inall general purpose diagnostic procedures.This device is not intended for mammographyapplications. | The DIGITAL RADIOGRAPHY CXDI-Pro /DIGITAL RADIOGRAPHY D1 providesdigital image capture for conventionalfilm/screen radiographic examinations. Thisdevice is intended to capture, for display,radiographic images of human anatomy, andto replace radiographic film/screen systems inall general purpose diagnostic procedures.This device is not intended for mammographyapplications. | IDENTICAL |
| Application | General Radiography | General Radiography | IDENTICAL |
| Case Material | Magnesium alloy | Magnesium alloy | IDENTICAL |
| Scintillator | CsI(Tl)[Cesium Iodide doped with Thallium] | CsI(Tl)[Cesium Iodide doped with Thallium] | IDENTICAL |
| Pixel Pitch | 140μm | 140μm | IDENTICAL |
| SpatialResolution | 35% [MTF@2lp/mm] | 35% [MTF@2lp/mm] | IDENTICAL |
| IP Level | IP55 | IP55 | IDENTICAL |
| Detector(s) | CXDI-703C Wireless (AR-D3543W)CXDI-403C Wireless (AR-D4343W) | CXDI-703C Wireless (AR-D3543W) | MODIFIED |
| Components | Detector (Sensor)Battery Charger (BC-1A)Battery Pack (LB-4A)X-ray Interface Box (XB-1A)Power Box (PB-01)Wiring Cable (WC-01)PC Connection Cable (CP-01)Ready Indicator (RI-3A)Detector Stand (DS-01)Battery Charger (BC-01) | Detector (Sensor)Battery Charger (BC-1A)Battery Pack (LB-4A)X-ray Interface Box (XB-1A)Power Box (PB-01)Wiring Cable (WC-01)PC Connection Cable (CP-01)Ready Indicator (RI-3A)Battery Charger (BC-01) | MODIFIED |
| Software | CXDI Control Software V3.10.0.8 | CXDI Control Software V3.10.0.3 | MODIFIED |
| PhotographingMode | Standard Synchronization Mode, NonGenerator Connection Mode | Standard Synchronization Mode, NonGenerator Connection Mode | IDENTICAL |
| WirelessCommunication | IEEE 802.11n/ac/a/g/b 2.4GHz/5GHzBluetooth Low Energy | IEEE 802.11n/ac/a/g/b 2.4GHz/5GHzBluetooth Low Energy | IDENTICAL |
| Cycle Time: Sleepto Ready Time | Cycle Time is less than 5 sec when thestorage time is set to 100ms | Cycle Time is 7 sec when the storage time isset to 100ms | MODIFIED |
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the word "Canon" in a stylized red font at the top. Below the word "Canon" is the text "510(k) SUMMARY" in a bold, black font. The text is centered below the Canon logo. The background of the image is white.
K220098
| The User's and Installation Manuals provide detailed instructions and informationfor safe and effective use of the device, and users are expected to adhere to theinstructions and other information. The User's Manual explains how to use thedetector and other equipment. Connected medical equipment, such as x-raygenerators, must comply with IEC 60601-1. | |
|---|---|
| Performance: | The fundamental scientific technology of the CXDI-Pro has not been modified. Thechanges are the addition of a new detector, CXDI-403C Wireless (AR-D4343W); theaddition of optional accessories, a Detector Stand (DS-01) and a different BatteryCharger (BC-01); a decrease in the sleep to ready cycle time; the update to the CXDIControl Software from 3.10.0.3 to 3.10.0.8; and the update to the detector firmwarefrom 01.00.00.03 to 01.00.02.00.Evaluation of the addition of the new detector and optional accessories confirmedthat the changes did not impact CXDI-Pro conformance with the U.S. PerformanceStandard for radiographic equipment and with relevant voluntary safety standards forElectrical safety and Electromagnetic Compatibility testing, specifically IECstandards 60601-1, 60601-1-2, 60601-2-54, 60601-1-6, and IEC 60529.These verification/validation activities successfully demonstrated that the devicecontinues to meet the standards for the areas impacted by the modifications to thepredicate device and raises no new questions regarding either safety or effectivenesswhen compared to the predicate device. Therefore, the verification/validationactivities conducted support a determination of substantial equivalence for theCXDI-Pro. |
| Conclusion: | Canon Inc. considers the CXDI-Pro to be substantially equivalent to the predicatedevice listed above. This conclusion is based on the similarities in primary intendeduse, principles of operation, functional design, and established medical use. |
§ 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.