(11 days)
The DIGITAL RADIOGRAPHY CXDI-Elite / E1 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-Elite, also called the DIGITAL RADIOGRAPHY E1, (hereinafter referred to as CXDI-Elite) is a solid-state x-ray imager. The CXDI-Elite is a series of detectors, and in the predicate device consists of the CXDI-720C Wireless detector unit, also called the AR-E3543W 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 CXDI-Elite to add new detectors, the CXDI-420C Wireless (also called AR-E4343W) and the CXDI-420C Fixed (also called AR-E4343S), to the CXDI-Elite series of detectors. In addition, a Detector Stand (DS-01) has also been added as a component to be used with both the CXDI-720C Wireless and CXDI-420C Wireless. Compatibility with the Power Box (PB-01), a CXDI-Pro component that was cleared under K220098 has also been added. The CXDI Control Software has been updated from V3.10.0.4 to V3.10.2.2 to fix some bugs, update the GPU driver, and add several minor functional changes. Together, these changes make up the CXDI-Elite.
Upon review of the provided document, it is important to note that the submission is for an imaging device (Digital Radiography CXDI-Elite / E1), not an AI/Software as a Medical Device (SaMD) that performs diagnostic or assistive functions requiring performance studies with acceptance criteria based on accuracy metrics.
The document primarily addresses a Special 510(k) submission for changes to an existing, cleared device. These changes involve adding new detectors, an optional accessory, and software bug fixes/minor functional changes. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and safety performance, rather than clinical efficacy measured by AI model output and human reader performance.
The provided text does not contain information about:
- A table of acceptance criteria and reported device performance related to diagnostic accuracy.
- Sample sizes for test sets (in the context of clinical performance evaluation).
- Data provenance (country of origin, retrospective/prospective).
- Number of experts for ground truth establishment or their qualifications.
- Adjudication methods.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance studies.
- Types of ground truth (expert consensus, pathology, outcomes data).
- Sample size for training sets.
- How ground truth for training sets was established.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device by confirming that the modifications do not raise new questions of safety or effectiveness. This is primarily achieved through non-clinical/bench testing and adherence to relevant standards.
Here's a summary of what the document does provide regarding acceptance criteria and performance, as it pertains to the hardware and basic software functionality of a digital radiography system:
Acceptance Criteria and Study for Digital Radiography CXDI-Elite / E1 (Hardware/Software Updates)
The acceptance criteria are implicitly met by demonstrating continued compliance with relevant international and FDA standards, and by showing that the changes (new detectors, accessory, software update) do not negatively impact the fundamental performance or safety characteristics of the device.
1. Table of Acceptance Criteria (Implicit) and Reported Device Performance (as stated in the document):
| Acceptance Criteria (Implicit/Standard Compliance) | Reported Device Performance (as per "Summary of Non-Clinical / Test Data") |
|---|---|
| Fundamental Scientific Technology Unchanged | "The fundamental scientific technology of the CXDI-Elite has not been modified." |
| Conformance with U.S. Performance Standard for Radiographic Equipment | "Evaluation of the addition of the new detector and optional accessories confirmed that the changes did not impact CXDI-Elite conformance with the U.S. Performance Standard for radiographic equipment..." |
| Compliance with Voluntary Safety Standards (Electrical Safety, EMC) | "...and with relevant voluntary safety standards for Electrical safety and Electromagnetic Compatibility testing, specifically IEC standards 60601-1, 60601-1-2, 60601-2-54, and 60601-1-6." |
| Device Works as Intended (Functional Performance) | "Adequate detector bench testing should be sufficient to demonstrate that the subject detector CXDI-Elite / E1 works as intended." (This indicates bench testing was done to verify the new components and software perform correctly within the system.) |
| No New Questions Regarding Safety or Effectiveness Compared to Predicate | "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." |
| Pixel Pitch | 125μm (Identical to predicate) |
| Scintillator | CsI(Tl) [Cesium Iodide doped with Thallium] (Identical to predicate) |
| Spatial Resolution | 45% [MTF@2lp/mm] (Identical to predicate) |
| DQE (Detective Quantum Efficiency) | 67% [@0.5 lp/mm, 3.5 uGy] (Identical to predicate) |
| IP Level (Ingress Protection) | CXDI-720C Wireless: IP57, CXDI-420C Wireless: IP57, CXDI-420C Fixed: N/A (Modified from predicate, detailed for each new component) |
| Wireless Communication | IEEE 802.11a/b/g/n/ac, 2.4GHz/5GHz, Bluetooth Low Energy (only for CXDI-720C Wireless and CXDI-420C Wireless) (Identical to predicate's wireless capabilities) |
| External Dimensions | CXDI-720C Wireless: 384 x 460 x 15.5 mm, CXDI-420C Wireless: 460 x 460 x 15.5 mm, CXDI-420C Fixed: 460 x 460 x 15.3 mm (Modified from predicate, detailed for each new component) |
| Photographing Mode (Functional Modes of Operation) | Standard Synchronization Mode, Standard Synchronization Mode with Built in AEC Assistance, Non Generator Connection Mode, Standalone Mode (only for CXDI-720C Wireless and CXDI-420C Wireless) (Modified from predicate to reflect modes available with new detectors; one mode removed for fixed detector) |
| Compliance with Applicable FDA Guidance Documents | The proposed device follows applicable elements of several FDA guidance documents (e.g., Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, etc.) |
2. Sample Size Used for the Test Set and Data Provenance:
- The document states "Adequate detector bench testing should be sufficient to demonstrate that the subject detector CXDI-Elite / E1 works as intended." This implies physical testing of the devices, but does not specify sample sizes for "test sets" in the clinical performance sense, as this was not a clinical performance study. The testing appears to be primarily engineering verification and validation of hardware and software components.
- Data provenance: Not applicable in the context of clinical images or patient data. The testing is a validation of the device's technical specifications and compliance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
- Not applicable. This was not a study requiring expert readers to establish ground truth on clinical images, as it was not a diagnostic performance study for an AI algorithm.
4. Adjudication Method for the Test Set:
- Not applicable for the reasons stated above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This was not an AI-enabled diagnostic device or a comparative effectiveness study involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is a digital radiography system, not a standalone AI algorithm. Its function is to capture and display radiographic images.
7. The Type of Ground Truth Used:
- Not applicable in the clinical diagnostic sense. The "ground truth" for this submission are the established engineering specifications, safety standards (IEC 60601 series), and FDA guidance documents, against which the device's technical performance (e.g., MTF, DQE, IP level, functional modes) is verified via bench testing.
8. The Sample Size for the Training Set:
- Not applicable. This device does not involve machine learning or AI models with training sets.
9. How the Ground Truth for the Training Set was Established:
- Not applicable for the reasons stated above.
In conclusion, the provided document is a 510(k) summary for a digital radiography hardware system with minor modifications. The "acceptance criteria" and "study" described pertain to engineering validation, safety testing, and demonstration of substantial equivalence by showing that the updated device continues to meet established performance and safety standards, and does not pose new risks. It is not an AI/SaMD performance study seeking to establish diagnostic accuracy against clinical ground truth.
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June 14, 2022
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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: K221620
Trade/Device Name: Digital Radiography CXDI-Elite, Digital Radiography E1 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: June 2, 2022 Received: June 3, 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
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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 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, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT 8B: Division of Radiological Imaging and Electronic Products OHT8: Office of 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) K221620
Device Name DIGITAL RADIOGRAPHY CXDI-Elite DIGITAL RADIOGRAPHY El
Indications for Use (Describe)
The DIGITAL RADIOGRAPHY CXDI-Elite / El 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) |
|---|
| ☑ Research Use Only (21 CFR 201.3 Subject to 501(e)) |
| ☐ Over-The-Counter Use Only (21 CFR 201.3 Subject to 501(e)) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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K221620
Image /page/3/Picture/1 description: The image shows the Canon logo in red, with the text "510(k) SUMMARY" written in black below it. The Canon logo is a stylized version of the company's name. The text "510(k) SUMMARY" is written in a simple, sans-serif font. The image is likely from a document related to the regulatory approval process for a medical device manufactured by Canon.
| Applicant/Sponsor: | Canon Inc.9-1 Imaikami-choNakahara-ku, Kanagawa 211-8501 JAPAN | |
|---|---|---|
| Contact Person: | Mr. Akira HiraiGeneral ManagerTEL: 81-3-3758-2111FAX: 044-739-6695hirai.akira@mail.canon | |
| Date Prepared: | June 10, 2022 | |
| Proposed Device | Manufacturer:Trade Name: | Canon Inc.DIGITAL RADIOGRAPHY CXDI-EliteDIGITAL RADIOGRAPHY E1 |
| Common Name:Classification Name:Product Code:Regulation: | Solid State X-Ray Imager (Flat Panel/Digital Imager)Stationary X-ray SystemMQB892.1680, Stationary X-ray System | |
| Predicate Device: | Clearance:Manufacturer:Trade Name: | K213780Canon Inc.DIGITAL RADIOGRAPHY CXDI-EliteDIGITAL RADIOGRAPHY E1 |
| Common Name:Classification Name:Product Code:Regulation: | Solid State X-ray Imager (Flat Panel/Digital Imager)Stationary X-ray SystemMQB892.1680, Stationary X-ray System | |
| DeviceDescription: | The DIGITAL RADIOGRAPHY CXDI-Elite, also called the DIGITALRADIOGRAPHY E1, (hereinafter referred to as CXDI-Elite) is a solid-state x-rayimager. The CXDI-Elite is a series of detectors, and in the predicate device consists ofthe CXDI-720C Wireless detector unit, also called the AR-E3543W 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 value 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-Elite to add newdetectors, the CXDI-420C Wireless (also called AR-E4343W) and the CXDI-420CFixed (also called AR-E4343S), to the CXDI-Elite series of detectors. In addition, aDetector Stand (DS-01) has also been added as a component to be used with both theCXDI-720C Wireless and CXDI-420C Wireless. Compatibility with the Power Box(PB-01), a CXDI-Pro component that was cleared under K220098 has also been added.The CXDI Control Software has been updated from V3.10.0.4 to V3.10.2.2 to fix somebugs, update the GPU driver, and add several minor functional changes. Together, thesechanges make up the CXDI-Elite. | ||
| Indications forUse: | The DIGITAL RADIOGRAPHY CXDI-Elite / E1 provides digital image capture forconventional film/screen radiographic examinations. This device is intended to capture,for display, radiographic images of human anatomy, and to replace radiographicfilm/screen systems in all general purpose diagnostic procedures. This device is notintended for mammography applications. | |
| Summary ofTechnologicalCharacteristics: | Comparison with the predicate device shows the technological characteristics of theCXDI-Elite is substantially equivalent to the predicate device. The flat panel detectorunits are functionally similar, but one of the proposed detectors, CXDI-420C Fixed,removes Standalone Mode as a photographing mode. |
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Image /page/4/Picture/0 description: The image shows the word "Canon" in a stylized, red font. Below the word "Canon" is the text "510(k) SUMMARY" in a bold, black font. The text is centered below the Canon logo. The image appears to be a document header or title page.
The major differences between the CXDI-Elite and the predicate are differences in standard and optional components, newer version of CXDI control software, difference in case material, and a photographing mode not available in the predicate device. The proposed indications for use statement is identical to the predicate device.
| Proposed Device | Predicate Device | ||
|---|---|---|---|
| Trade Name | DIGITAL RADIOGRAPHY CXDI-Elite / E1 | DIGITAL RADIOGRAPHY CXDI-Elite / E1 | |
| 510(k) Submitter[Number] | Canon Inc.[TBD] | Canon Inc.[K213780] | IDENTICAL |
| Indication for Use | The DIGITAL RADIOGRAPHY CXDI-Elite / E1provides digital image capture for conventionalfilm/screen radiographic examinations. This device isintended to capture, for display, radiographic images ofhuman anatomy, and to replace radiographicfilm/screen systems in all general purpose diagnosticprocedures. This device is not intended formammography applications. | The DIGITAL RADIOGRAPHY CXDI-Elite / E1 provides digital image capturefor conventional film/screen radiographicexaminations. This device is intended tocapture, for display, radiographic imagesof human anatomy, and to replaceradiographic film/screen systems in allgeneral purpose diagnostic procedures.This device is not intended formammography applications. | IDENTICAL |
| Application | General Radiography | General Radiography | IDENTICAL |
| Components | CXDI-720C Wireless and CXDI-420C Wireless:Detector (Sensor)Battery Pack (LB-4A)Battery Charger (BC-01/BC-1A)Multi Box (MB-02)Status Indicator (SI-01/SI-4A)Wiring Cable (WC-01)PC Connection Cable (CP-01)Ready Indicator (RI-3A)X-ray Interface Box (XB-1A)Detector Stand (DS-01)CXDI-420C Fixed:Detector (Sensor)Multi Box (MB-02)Status Indicator (SI-01/SI-4A)Ready Indicator (RI-3A)X-ray Interface Box (XB-1A) | Detector (Sensor)Battery Pack (LB-4A)Battery Charger (BC-01/BC-1A)Multi Box (MB-02)Status Indicator (SI-01/SI-4A)Wiring Cable (WC-01)PC Connection Cable (CP-01)Ready Indicator (RI-3A)X-ray Interface Box (XB-1A) | MODIFIED |
| Other CompatibleComponents | Power Box (PB-01) | N/A | MODIFIED |
| Software | CXDI Control Software V3.10 | CXDI Control Software V3.10 | MODIFIED |
| Detector | CXDI-720C Wireless (AR-E3543W)CXDI-420C Wireless (AR-E4343W)CXDI-420C Fixed (AR-E4343S) | CXDI-720C Wireless(AR-E3543W) | MODIFIED |
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Image /page/5/Picture/0 description: The image contains the word "Canon" in a large, bold, red font. Below the word "Canon" is the text "510(k) SUMMARY" in a smaller, bold, black font. The text is centered below the word "Canon".
| Pixel Pitch | 125μm | 125µm | IDENTICAL |
|---|---|---|---|
| Scintillator | CsI(Tl)[Cesium Iodide doped with Thallium] | CsI(Tl)[Cesium Iodide doped with Thallium] | IDENTICAL |
| SpatialResolution | 45% [MTF@2lp/mm] | 45% [MTF@2lp/mm] | IDENTICAL |
| DQE | 67% [@0.5 lp/mm, 3.5 uGy] | 67% [@0.5 lp/mm, 3.5 uGy] | IDENTICAL |
| IP Level | CXDI-720C Wireless: IP57CXDI-420C Wireless: IP57CXDI-420C Fixed: N/A | IP57 | MODIFIED |
| WirelessCommunication | IEEE 802.11a/b/g/n/ac2.4GHz/5GHzBluetooth Low Energy(only for CXDI-720C Wireless and CXDI-420CWireless) | IEEE 802.11a/b/g/n/ac2.4GHz/5GHzBluetooth Low Energy | IDENTICAL |
| ExternalDimensions | CXDI-720C Wireless: 384 x 460 x 15.5 mmCXDI-420C Wireless: 460 x 460 x 15.5 mmCXDI-420C Fixed: 460 x 460 x 15.3 mm | 384 x 460 x 15.5 mm | MODIFIED |
| PhotographingMode | Standard Synchronization Mode,Standard Synchronization Mode with Built in AECAssistance,Non Generator Connection Mode,Standalone Mode (only for CXDI-720C Wireless andCXDI-420C Wireless) | Standard Synchronization Mode,Standard Synchronization Mode withBuilt in AEC Assistance,Non Generator Connection Mode,Standalone Mode | MODIFIED |
Summary of Non-Clinical / Test Data:
The fundamental scientific technology of the CXDI-Elite has not been modified. The changes are the addition of new detectors CXDI-420C Wireless (AR-E4343W) and CXDI-420C Fixed (AR-E4343S); the addition of an optional accessory, the Detector Stand (DS-01); the update to the CXDI Control Software from 3.10.0.4 to 3.10.2.2; and the update to the detector firmware from 02.00.00.03 to F2.00.03.00.
Evaluation of the addition of the new detector and optional accessories confirmed that the changes did not impact CXDI-Elite 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, and 60601-1-6.
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. Clinical testing is not necessary for the current submission, based on the minor differences from the predicate device. Adequate detector bench testing should be sufficient to demonstrate that the subject detector CXDI-Elite / E1 works as intended. Therefore, the verification/validation activities conducted support a determination of substantial equivalence for the CXDI-Elite.
The proposed device follows the applicable elements of the following FDA guidance documents: Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices, Guidance for the Content of Premarket Submissions for Software contained in Medical Devices, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", Radio Frequency Wireless Technology in Medical Devices, and Pediatric Information for X-ray Imaging Device Premarket Notifications.
Canon Inc. considers the DIGITAL RADIOGRAPHY CXDI-Elite / E1 device to be Conclusion: substantially equivalent to the predicate device listed above. This conclusion is based on
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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.