(26 days)
The DIGITAL RADIOGRAPHY CXDI-CS01 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-CS01 is a series of solid-state x-ray detectors. 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 digital values are sent to the PC via wired or wireless connection, converted to images with the CXDI Control Software (CCS), then displayed on monitors. The digital value can be communicated to the operator console via wired or wireless connection.
The subject of this Special 510(k) submission is a change to the DIGITAL RADIOGRAPHY CXDI-702C Wireless and CXDI-402C Wireless to make a series of detectors including the DIGITAL RADIOGRAPHY CXDI-702C Wireless (K192632), CXDI-402C Wireless (K192632), CXDI-710C Wireless (K170332), CXDI-810C Wireless (K170332), and CXDI-410C Wireless (K171270), under the proposed device the DIGITAL RADIOGRAPHY CXDI-CS01. This change will change the Multi Box to be a Standard Component from an optional component for the detectors. The Multi Box has the functions of connecting to the X-ray generator to synchronize the X-ray exposure and photographing, supplying power to the FPD (front panel detector), communicating between the FPD and the image capture computer, connecting the status indicator to the Multi Box to turn the FPD on and off and switch to a ready state, connecting to the WLAN access point to communicate to the FPD wirelessly, and connecting to the docking station to charge the FPD and communicate between the FPD and image capture computer. These functions of the Multi Box have not changed since its clearance under the predicate device (K192632). The X-ray I/F (Interface) Unit has been removed as an optional component for the DIGITAL RADIOGRAPHY CXDI-702C Wireless and CXDI-402C Wireless as the Multi Box performs the function of the X-ray I/F Unit (connecting to the X-ray generator to synchronize the x-ray exposure and photographing). In addition, the detectors will all use the version software cleared under the DIGITAL RADIOGRAPHY CXDI-702C Wireless and CXDI-402C Wireless (K192632). Together, these changes make up the DIGITAL RADIOGRAPHY CXDI-CS01.
The provided text describes a Special 510(k) submission (K203849) for a device called "DIGITAL RADIOGRAPHY CXDI-CS01". This submission is for modifications to previously cleared devices rather than a new standalone device. Therefore, the document focuses on demonstrating that the changes do not negatively impact the device's compliance with established standards and do not raise new questions of safety or effectiveness compared to the predicate device.
The acceptance criteria are therefore related to maintaining compliance with existing performance standards and regulations rather than establishing new performance metrics. The study described is a verification/validation activity to confirm that the modifications do not affect compliance.
Here's the information extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not detail specific quantitative acceptance criteria or performance metrics for the device's diagnostic capabilities (e.g., sensitivity, specificity for detecting a disease). Instead, it focuses on demonstrating continued compliance with established standards after modifications. The "performance" section primarily shows that key technical characteristics related to image acquisition are identical to the predicate and reference devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Continued compliance with FDA requirements for Solid State X-ray Imaging Devices (Guidance for 510(k) Submissions) | Documentation was provided demonstrating that the changes to DIGITAL RADIOGRAPHY CXDI-702C Wireless and CXDI-402C Wireless do not impact the device's compliance. |
| Continued conformance with U.S. Performance Standard for radiographic equipment | Evaluation confirmed that the changes did not impact DIGITAL RADIOGRAPHY CXDI-CS01 conformance. |
| Continued conformance with relevant voluntary safety standards (IEC 60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 62366, 60601-2-54, 62220-1, and 62304) | Evaluation confirmed that the changes did not impact DIGITAL RADIOGRAPHY CXDI-CS01 conformance with these standards for Electrical safety and Electromagnetic Compatibility testing. |
| No new questions regarding safety or effectiveness compared to the predicate device | Verification/validation activities successfully demonstrated that the device continues to meet the standards for the areas impacted by the device modifications to the predicate device and raises no new questions regarding either safety or effectiveness when compared to the predicate device. |
| Technological Characteristics (e.g., Scintillator, Pixel Pitch, Spatial Resolution) remain equivalent to predicate | Scintillator: CsI(Tl) [Cesium Iodide doped with Thallium] (Identical to predicate and reference devices) Pixel Pitch: 125μm (Identical to predicate and reference devices) Spatial Resolution: 35% [MTF@2lp/mm] (Identical to predicate and reference devices) Indication for Use: Identical to predicate device Application: General Radiography (Identical to predicate device) Case Material: Magnesium alloy / Carbon Fiber (Identical across various models of proposed and predicate/reference devices) |
| Software functionality (CXDI Control Software V2.19) | CXDI Control Software V2.19 (Identical to predicate device, updated from V2.16 for some reference devices) |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in terms of imaging data or patient cases. The study described is a design verification and validation process focused on the engineering and regulatory impact of changes (making the Multi Box a standard component, removing the X-ray I/F Interface as an option, and updating software). This typically involves testing the modified device against specified technical requirements and standards, not a clinical study with a patient image dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As described above, this was not a clinical study involving image interpretation with expert ground truth.
4. Adjudication method for the test set
Not applicable.
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 study was performed or described. The device is a digital radiography detector and associated software, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm for autonomous interpretation. It's an imaging capture device.
7. The type of ground truth used
Not applicable in the context of clinical diagnostic accuracy. The "ground truth" for this submission is adherence to existing regulatory requirements and technical standards.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-based device requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
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January 26, 2021
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Canon Inc. % Mr. Gregory Woodard Biomedical Engineer Ken Block Consulting, LLC 800 East Campbell Road, Suite 202 RICHARDSON TX 75081
Re: K203849
Trade/Device Name: Digital Radiography CXDI-CS01 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: December 30, 2020 Received: December 31, 2020
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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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.
For
Thalia T. Mills, Ph.D. Director 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
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Indications for Use
510(k) Number (if known)
Device Name DIGITAL RADIOGRAPHY CXDI-CS01
Indications for Use (Describe)
The DIGITAL RADIOGRAPHY CXDI-CS01 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) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
| K203849 | ||
|---|---|---|
| Submitter: | Canon Inc.30-2 Shimomaruko, 3-chromeOhta-ku, Tokyo 146-8501 Japan | |
| Contact Person: | Mr. Akira HiraiGeneral ManagerTEL: 81-3-3758-2111;FAX: 044-739-6695hirai.akira@mail.canon | |
| Date Prepared: | 12/30/2020 | |
| Submission Type: | Special 510(k) Submission | |
| Proposed Device: | Manufacturer:Trade Name:Common Name:Classification Name:Classification:Product Code: | Canon Inc.DIGITAL RADIOGRAPHY CXDI-CS01Solid State X-Ray Imager (Flat Panel/Digital Imager)Stationary X-ray System892.1680, Stationary X-ray SystemMQB |
| Predicate Device: | 510k Number:Manufacturer:Trade Name:Common Name:Classification Name:Classification:Product Code: | K192632Canon, Inc.DIGITAL RADIOGRAPHY CXDI-702C Wireless,CXDI-402C WirelessSolid State X-Ray Imager (Flat Panel/Digital Imager)Stationary X-ray System892.1680, Stationary X-ray SystemMQB |
| Reference Devices: | 510k Number:Manufacturer:Trade Name:Common Name:Classification Name:Classification:Product Code: | K171270Canon, Inc.DIGITAL RADIOGRAPHY CXDI-410C WirelessSolid State X-Ray Imager (Flat Panel/Digital Imager)Stationary X-ray System892.1680, Stationary X-ray SystemMQB |
| 510k Number:Manufacturer:Trade Name:Common Name:Classification Name:Classification: | K170332Canon, Inc.DIGITAL RADIOGRAPHY CXDI-810C Wireless,CXDI-710C WirelessSolid State X-ray ImagerStationary X-ray System892.1680, Stationary X-ray System |
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Product Code: MQB
Device Description: The DIGITAL RADIOGRAPHY CXDI-CS01 is a series of solid-state x-ray detectors. 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 digital values are sent to the PC via wired or wireless connection, converted to images with the CXDI Control Software (CCS), then displayed on monitors. The digital value can be communicated to the operator console via wired or wireless connection.
The subject of this Special 510(k) submission is a change to the DIGITAL RADIOGRAPHY CXDI-702C Wireless and CXDI-402C Wireless to make a series of detectors including the DIGITAL RADIOGRAPHY CXDI-702C Wireless (K192632), CXDI-402C Wireless (K192632), CXDI-710C Wireless (K170332), CXDI-810C Wireless (K170332), and CXDI-410C Wireless (K171270), under the proposed device the DIGITAL RADIOGRAPHY CXDI-CS01. This change will change the Multi Box to be a Standard Component from an optional component for the detectors. The Multi Box has the functions of connecting to the X-ray generator to synchronize the X-ray exposure and photographing, supplying power to the FPD (front panel detector), communicating between the FPD and the image capture computer, connecting the status indicator to the Multi Box to turn the FPD on and off and switch to a ready state, connecting to the WLAN access point to communicate to the FPD wirelessly, and connecting to the docking station to charge the FPD and communicate between the FPD and image capture computer. These functions of the Multi Box have not changed since its clearance under the predicate device (K192632). The X-ray I/F (Interface) Unit has been removed as an optional component for the DIGITAL RADIOGRAPHY CXDI-702C Wireless and CXDI-402C Wireless as the Multi Box performs the function of the X-ray I/F Unit (connecting to the X-ray generator to synchronize the x-ray exposure and photographing). In addition, the detectors will all use the version software cleared under the DIGITAL RADIOGRAPHY CXDI-702C Wireless and CXDI-402C Wireless (K192632). Together, these changes make up the DIGITAL RADIOGRAPHY CXDI-CS01.
Indication for Use: The Indication for Use statement is identical to the predicate device. The intended use of the modified device, as described in the labeling, has not changed as a result of the modification(s).
The DIGITAL RADIOGRAPHY CXDI-CS01 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.
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Summary of Technological Characteristics: Comparisons with the predicate devices show the characteristics of the proposed modifications (making the Multi Box a standard component, removing the X-ray I/F Interface as an option, and updating the CXDI Control Software to version 2.19) to the DIGITAL RADIOGRAPHY CXDI-CS01 to be substantially equivalent to the predicate device.
| Proposed Device | Predicate Device | Reference Devices | ||
|---|---|---|---|---|
| Trade Name | CXDI-CS01 | CXDI-702C Wireless /CXDI-402C Wireless | CXDI-710C Wireless / CXDI-810C Wireless / CXDI-410CWireless | |
| 510(k)Submitter[Number] | Canon, Inc.[TBD] | Canon, Inc.[K192632] | Canon, Inc.[K170332][K171270] | IDENTICAL |
| Indication forUse | The DIGITALRADIOGRAPHY CXDI-CS01 provides digital imagecapture for conventionalfilm/screen radiographicexaminations. This device isintended to capture, fordisplay, radiographic imagesof human anatomy, and toreplace radiographicfilm/screen systems in allgeneral purpose diagnosticprocedures. This device isnot intended formammography applications. | The DIGITALRADIOGRAPHY CXDI-402C Wireless andDIGITAL RADIOGRAPHYCXDI-702C Wirelessprovides digital imagecapture for conventionalfilm/screen radiographicexaminations. This device isintended to capture, fordisplay, radiographic imagesof human anatomy, and toreplace radiographicfilm/screen systems in allgeneral purpose diagnosticprocedures. This device isnot intended formammography applications. | The DIGITALRADIOGRAPHY CXDI-710CWireless, DIGITALRADIOGRAPHY CXDI-810CWireless, and DIGITALRADIOGRAPHY CXDI-410CWireless provides digital imagecapture for conventionalfilm/screen radiographicexaminations. This device isintended to capture, for display,radiographic images of humananatomy, and to replaceradiographic film/screensystems in all general purposediagnostic procedures. Thisdevice is not intended formammography applications. | IDENTICAL |
| Application | General Radiography | General Radiography | General Radiography | IDENTICAL |
| Case Material | [Detector of CXDI-702CWireless and CXDI-402CWireless]Magnesium alloy[Detector of CXDI-710CWireless. CXDI-810CWireless and CXDI-410CWireless]Carbon Fiber | Magnesium alloy | Carbon Fiber | IDENTICAL |
| Scintillator | CsI(Tl)[Cesium Iodide doped withThallium] | CsI(TI)[Cesium Iodide doped withThallium] | CsI(Tl)[Cesium Iodide doped withThallium] | IDENTICAL |
| Pixel Pitch | 125μm | 125μm | 125μm | IDENTICAL |
| SpatialResolution | 35% [MTF@2lp/mm] | 35% [MTF@2lp/mm] | 35% [MTF@2lp/mm] | IDENTICAL |
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Performance:
| Proposed Device | Predicate Device | Reference Devices | ||
|---|---|---|---|---|
| Trade Name | CXDI-CS01 | CXDI-702C Wireless /CXDI-402C Wireless | CXDI-710C Wireless / CXDI-810C Wireless / CXDI-410CWireless | |
| IP Level | [Detector of CXDI-702CWireless and CXDI-402CWireless]IP54[Detector of CXDI-710CWireless, CXDI-810CWireless and CXDI-410CWireless]IPX7 | IP54 | IPX7 | IDENTICAL |
| StandardComponents | Detectors (Sensors), BatteryPack,Documentation (Manuals),Multi Box | Detector (Sensor), BatteryPack,Documentation (Manuals) | Detector (Sensor), Battery Pack,Documentation (Manuals) | MODIFIED |
| Options | Docking Station, BatteryCharger, Battery Pack,Status Indicator, WiringCable, PC ConnectionCable, Ready Indicator | Docking Station, BatteryCharger, Battery Pack,Multi Box, Status Indicator,Wiring Cable, PCConnection Cable, ReadyIndicator, X-ray I/F unit | Docking Station, BatteryCharger, Battery Pack, MultiBox, Status Indicator, WiringCable, PC Connection Cable,Ready Indicator | MODIFIED |
| Software | CXDI Control SoftwareV2.19 | CXDI Control SoftwareV2.19 | CXDI Control Software V2.16 | MODIFIED |
| PhotographingMode | [Detector of CXDI-702CWireless and CXDI-402CWireless]Standard SynchronizationMode, Non GeneratorConnection Mode[Detector of CXDI-710CWireless, CXDI-810CWireless and CXDI-410CWireless]Standard SynchronizationMode, Non GeneratorConnection Mode,Standalone Mode | Standard SynchronizationMode, Non GeneratorConnection Mode | Standard Synchronization Mode,Non Generator ConnectionMode, Standalone Mode | IDENTICAL |
The User's and Installation Manuals provide detailed instructions and information for safe and effective use of the device and users are expected to adhere to the instructions and other information. The User's Manual explains how to use the detector and other equipment. Connected medical equipment, such as X-ray generators, must comply with IEC 60601-1. Before using the product, be sure to read the manual thoroughly in order to utilize it more effectively. The fundamental scientific technology of the detectors under DIGITAL RADIOGRAPHY CXDI-CS01 have not been modified. The detector units of the DIGITAL RADIOGRAPHY CXDI-CS01 has not been modified, and the change is to update the software in the DIGITAL RADIOGRAPHY CXDI-710C Wireless, CXDI-810C Wireless, and CXDI-410C Wireless; make the Multi Box a standard component; and remove the X-ray I/F Unit as an optional component.
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| Documentation was provided demonstrating that the changes to DIGITALRADIOGRAPHY CXDI-702C Wireless and CXDI-402C Wireless do not impactthe device's compliance with FDA requirements stated in “Guidance for theSubmission of 510(k)'s for Solid State X-ray Imaging Devices”. |
|---|
| Evaluation of the changes to the DIGITAL RADIOGRAPHY CXDI-CS01 confirmedthat the changes did not impact DIGITAL RADIOGRAPHY CXDI-CS01conformance with the U.S. Performance Standard for radiographic equipment andwith relevant voluntary safety standards for Electrical safety and ElectromagneticCompatibility testing, specifically IEC standards 60601-1, 60601-1-2, 60601-1-3,60601-1-6, 62366, 60601-2-54, 62220-1, and 62304. |
| These verification/validation activities successfully demonstrated that the devicecontinues to meet the standards for the areas impacted by the device modificationsto the predicate device and raises no new questions regarding either safety oreffectiveness when compared to the predicate device. Therefore, theverification/validation conducted supports a determination of substantialequivalence for the DIGITAL RADIOGRAPHY CXDI-CS01 device. |
| Conclusion: |
| Canon Inc. considers the DIGITAL RADIOGRAPHY CXDI-CS01 to be substantiallyequivalent to the predicate device listed above. This conclusion is based on thesimilarities in primary intended use, principles of operation, functional design, andestablished 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.