(27 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 D1, (hereinafter referred to as CXDI-Pro) is a solid-state x-ray imager. The CXDI-Pro is a series of detectors, currently consisting 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 value 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 DIGITAL RADIOGRAPHY CXDI-710C Wireless (hereinafter referred to as CXDI-710C) to make the CXDI-Pro. This change will remove the Docking Station, Multi Box, and Status Indicator as optional components and add the X-ray Interface Box and Power Box as optional components. The software has been updated from CXDI Control Software V2.16 to CXDI Control Software V3.10. The case material has been changed from fiberglass to magnesium alloy. Bluetooth function has been added, and Standalone mode has been removed as a photographing mode. Together, these changes make up the CXDI-Pro.
The provided text is a 510(k) Summary for the Canon DIGITAL RADIOGRAPHY CXDI-Pro D1. This document focuses on demonstrating substantial equivalence to a predicate device based on modifications, rather than establishing de novo performance criteria for an AI/ML device. Therefore, it does not explicitly detail acceptance criteria and a study proving a new device meets these criteria in the context of AI/ML performance metrics (e.g., sensitivity, specificity, AUC).
Instead, the document emphasizes that the fundamental scientific technology of the device has not been modified, and the changes are limited to:
- Software update (from V2.16 to V3.10)
- Changes to optional accessories
- Change in case material (fiberglass to magnesium alloy)
- Addition of Bluetooth
- Removal of Standalone mode as a photographing mode
The "performance" section states: "Evaluation of the changes to the CXDI-710C confirmed that the changes did not impact CXDI-Pro conformance 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, 60601-2-54, 60601-1-6, and IEC 60529."
This indicates that the acceptance criteria are primarily related to safety and effectiveness standards for general radiographic equipment, as well as maintaining the existing performance characteristics (like spatial resolution) of the previous device. The study proving the device meets these criteria involved verification/validation activities demonstrating continued compliance with these standards despite the modifications.
Given this context, I will extract and infer information relevant to your request, acknowledging that it's not a study designed to prove AI performance in the way you might expect for a diagnostic algorithm.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Type) | Reported Device Performance |
|---|---|
| Safety and Electrical Standards | Conformance with U.S. Performance Standard for radiographic equipment and relevant voluntary safety standards for Electrical safety and Electromagnetic Compatibility testing (specifically IEC standards 60601-1, 60601-1-2, 60601-2-54, 60601-1-6, and IEC 60529). |
| Functional Equivalence | The changes (software update, accessories, case material, Bluetooth, removal of Standalone mode) are demonstrated to not negatively impact the fundamental scientific technology or performance characteristics compared to the predicate device. |
| Spatial Resolution | Proposed Device: 35% [MTF@2lp/mm]Predicate Device: 35% [MTF@2lp/mm]This indicates that the spatial resolution performance metric was maintained as identical to the predicate, serving as an implicit acceptance criterion for this characteristic. |
| Indications for Use (Effectiveness) | The "Indication for Use statement is identical to the predicate device." The 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." The modifications did "not change as a result of the modification(s)." This implies the continued ability to effectively perform its stated intended use. |
| Ingress Protection (IP) Level | Proposed Device: IP55Predicate Device: IPX7Reference Devices: IP54While modified from the predicate, the new IP55 rating would have been an acceptance criterion that the modified device met, indicating a specific level of protection against solids and liquids. |
| Pixel Pitch | Proposed Device: 140μmPredicate Device: 125μmReference Devices: 125μmWhile modified from the predicate, the device demonstrably has a pixel pitch of 140μm, implying this new specification was acceptable and likely evaluated not to degrade image quality below an acceptable threshold for its indicated use. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail a "test set" in the context of clinical images for diagnostic AI/ML performance evaluation. The "study" here is a series of "verification/validation activities" focused on engineering, software, and hardware changes. Therefore, there is no mention of a specific sample size of patient data or its provenance (country of origin, retrospective/prospective). The evidence presented focuses on compliance testing with engineering and safety standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable for this type of submission. Ground truth, in the context of medical image interpretation by experts, is not relevant to this submission, which focuses on hardware and software modifications and compliance with engineering standards.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a test set requiring adjudication in the context of diagnostic interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This submission is for a digital radiography system, not an AI-powered diagnostic assistant. Therefore, no MRMC study comparing human readers with and without AI assistance was performed or described.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. While the document mentions "Standalone mode" was removed as a photographing mode for the device itself, this does not refer to an AI algorithm's standalone diagnostic performance. The device is a digital X-ray imager, which functions as a component in the diagnostic workflow, not an autonomous diagnostic algorithm.
7. Type of Ground Truth Used
The "ground truth" here is the adherence to established engineering, safety, and performance standards (e.g., IEC 60601 series, MTF measurements, IP ratings). It's not clinical ground truth derived from expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set
Not applicable. This document describes hardware and software changes to an established medical device, not the training of a new AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no AI/ML training set is discussed. The "ground truth" for the device's functional integrity is presumably established through rigorous engineering testing, quality control, and adherence to manufacturing specifications, rather than through labeled datasets for machine learning.
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September 30, 2021
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Canon Inc. % Mr. Gregory Woodard Biomedical Engineer Ken Block Consulting 800 East Campbell Road, Suite 202 RICHARDSON TX 75081
Re: K212553
Trade/Device Name: DIGITAL RADIOGRAPHY CXDI-Pro D1 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MOB
Dear Gregory Woodard:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated September 9, 2021. Specifically, FDA is updating this SE Letter (Typo in the Trade Name) as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Laurel Burk, OHT7: Office of In Vitro Diagnostics and Radiological Health, 301-796-5933, laurel.burk(@fda.hhs.gov.
Sincerely, Laurel M Burk -S
Digitally signed by Laurel M. Burk -S
Date: 2021.09.30 14:31:00 -04'00'
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
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September 9, 2021
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Canon Inc. % Mr. Gregory Woodard Biomedical Engineer Ken Block Consulting 800 East Campbell Road. Suite 202 RICHARDSON TX 75081
Re: K212553
Trade/Device Name: DIGITAL RADIOGRAPHY CXDI-Pro, D1 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: August 12, 2021 Received: August 13, 2021
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
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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 medical devices and radiation-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(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/2/Picture/5 description: The image shows a digital signature. The signature is from Laurel M. Burk -S. The date of the signature is 2021.09.09, and the time is 10:30:16 -04'00'.
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) K212553
Device Name DIGITAL RADIOGRAPHY CXDI-Pro 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) |
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5. 510(k) SUMMARY
| Applicant/Sponsor: | 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: | August 12, 2021 |
| Submission Type: | Special 510(k) Submission |
| Proposed Device: | Manufacturer: Canon Inc.Trade Name: DIGITAL RADIOGRAPHY CXDI-ProD1Common 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: K170332Manufacturer: Canon Inc.Trade Name: DIGITAL RADIOGRAPHY CXDI-710CCommon Name: Solid State X-ray ImagerClassification Name: Stationary X-ray SystemClassification: 892.1680, Stationary X-ray SystemProduct Code: MQB |
| Reference Devices: | 510k Number: K192632Manufacturer: Canon Inc.Trade Name: DIGITAL RADIOGRAPHY CXDI-702CCommon 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 D1, (hereinafter referredto as CXDI-Pro) is a solid-state x-ray imager. The CXDI-Pro is a series of detectors,currently consisting of the CXDI-703C Wireless detector unit, also called the AR-D3543W detector. The detector intercepts x-ray photons, and the scintillator emitsvisible spectrum photons that illuminate an array of photodetectors 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 a wired or wireless connection. |
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| The subject of this Special 510(k) submission is a change to the DIGITALRADIOGRAPHY CXDI-710C Wireless (hereinafter referred to as CXDI-710C) tomake the CXDI-Pro. This change will remove the Docking Station, Multi Box, andStatus Indicator as optional components and add the X-ray Interface Box and PowerBox as optional components. The software has been updated from CXDI ControlSoftware V2.16 to CXDI Control Software V3.10. The case material has beenchanged from fiberglass to magnesium alloy. Bluetooth function has been added, andStandalone mode has been removed as a photographing mode. Together, thesechanges make up the CXDI-Pro. | |
|---|---|
| Indication for Use: | The Indication for Use statement is identical to the predicate device. The intended useof the modified device, as described in the labeling, has not changed as a result of themodification(s).The DIGITAL RADIOGRAPHY CXDI-Pro / D1 provides digital image capture forconventional film/screen radiographic examinations. This device is intended tocapture, for display, radiographic images of human anatomy, and to replaceradiographic film/screen systems in all general purpose diagnostic procedures. Thisdevice is not intended for mammography applications. |
| Summary ofTechnologicalCharacteristics: | Comparison with the predicate devices shows the characteristics of the proposedmodifications (changes to the optional accessories, software change from V2.16 toV3.10, change in case material from fiberglass to magnesium alloy, addition ofBluetooth, and removal of Standalone mode) to the CXDI-Pro to be substantially |
| Proposed Device | Predicate Device | Reference Devices | ||
|---|---|---|---|---|
| Trade Name | DIGITAL RADIOGRAPHYCXDI-Pro / D1 | DIGITAL RADIOGRAPHYCXDI-710C | DIGITAL RADIOGRAPHYCXDI-702C | |
| 510(k)Submitter[Number] | Canon Inc.[TBD] | Canon Inc.[K170332] | Canon, Inc.[K192632] | IDENTICAL |
| Indication forUse | The DIGITAL RADIOGRAPHYCXDI-Pro / D1 provides digitalimage capture for conventionalfilm/screen radiographicexaminations. This device isintended to capture, for display,radiographic images of humananatomy, and to replaceradiographic film/screen systemsin all general purpose diagnosticprocedures. This device is notintended for mammographyapplications. | The DIGITAL RADIOGRAPHYCXDI-710C Wireless providesdigital image capture forconventional film/screenradiographic examinations. Thisdevice is intended to capture, fordisplay, radiographic images ofhuman anatomy, and to replaceradiographic film/screen systemsin all general purpose diagnosticprocedures. This device is notintended for mammographyapplications. | The DIGITAL RADIOGRAPHYCXDI-702C Wireless providesdigital image capture forconventional film/screenradiographic examinations. Thisdevice is intended to capture, fordisplay, radiographic images of humananatomy, and to replaceradiographic film/screen systemsin all general purpose diagnosticprocedures. This device is notintended for mammographyapplications. | IDENTICAL |
| Application | General Radiography | General Radiography | General Radiography | IDENTICAL |
| Case Material | Magnesium alloy | Fiberglass | Magnesium Alloy | MODIFIED |
| Scintillator | CsI(TI)[Cesium Iodide doped withThallium] | CsI(TI)[Cesium Iodide doped withThallium] | CsI(TI)[Cesium Iodide doped withThallium] | IDENTICAL |
| Pixel Pitch | 140μm | 125μm | 125μm | MODIFIED |
| SpatialResolution | 35% [MTF@2lp/mm] | 35% [MTF@2lp/mm] | 35% [MTF@2lp/mm] | IDENTICAL |
| IP Level | IP55 | IPX7 | IP54 | MODIFIED |
equivalent to the predicate device.
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| StandardComponents | Detector (Sensor), Battery Pack(LB-4A), Documentation(Manuals) | Detector (Sensor), Battery Pack(LB-4A), Documentation(Manuals) | Detector (Sensor), Battery Pack(LB-4A), Documentation(Manuals) | IDENTICAL |
|---|---|---|---|---|
| OptionalComponents | Battery Charger (BC-1A), BatteryPack (LB-4A), X-ray InterfaceBox (XB-1A), Power Box (PB-01),Wiring Cable (WC-01), PCConnection Cable (CP-01), ReadyIndicator (RI-3A) | Docking Station (DS-4A), BatteryCharger (BC-1A), Battery Pack(LB-4A), Multi Box (MB-4A),Status Indicator (SI-4A), WiringCable (WC-4A), PC ConnectionCable (CP-4A), Ready Indicator(RI-3A) | Docking Station (DS-4A), BatteryCharger (BC-1A), Battery Pack(LB-4A), Multi Box (MB-4A),Status Indicator (SI-4A), WiringCable (WC-4A), PC ConnectionCable (CP-4A), Ready Indicator(RI-3A), X-ray Interface Box(XB-1A) | MODIFIED |
| Software | CXDI Control Software V3.10 | CXDI Control Software V2.16 | CXDI Control Software V2.19 | MODIFIED |
| PhotographingMode | Standard Synchronization Mode,Non Generator Connection Mode | Standard Synchronization Mode,Non Generator Connection Mode,Standalone Mode | Standard Synchronization Mode,Non Generator Connection Mode | MODIFIED |
| WirelessCommunication | IEEE 802.11n/ac/a/g/b2.4GHz/5GHzBluetooth Low Energy | IEEE 802.11n2.4GHz/5GHz | IEEE 802.11n/a/g/b2.4GHz/5GHz | MODIFIED |
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.
Performance: The fundamental scientific technology of the CXDI-Pro has not been modified. The changes are an update to the software in the CXDI-710C, changes to the optional accessories, change in case material from fiberglass to magnesium alloy, addition of Bluetooth, and removal of Standalone mode.
Evaluation of the changes to the CXDI-710C confirmed that the changes did not impact CXDI-Pro conformance 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, 60601-2-54, 60601-1-6, and IEC 60529.
These verification/validation activities successfully demonstrated that the device continues to meet the standards for the areas impacted by the modifications to the predicate device and raises no new questions regarding either safety or effectiveness when compared to the predicate device. Therefore, the verification/validation activities conducted support a determination of substantial equivalence for the CXDI-Pro.
Canon Inc. considers the CXDI-Pro to be substantially equivalent to the predicate Conclusion: device listed above. This conclusion is based on the similarities in primary intended use, 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.