(53 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 using TFT (thin-film transistor) arrays. The CXDI-Elite is a series of detectors, currently consisting of the CXDI-720C Wireless detector unit, also called the AR- E3543W detector. The detector intercepts x-ray photons, and the Cesium-Iodide 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 a digital image, 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 monitors used with the CXDI-Elite are not a part of this submission.
The CXDI Control Software is updated from V2.16 to V3.10 in this submission. The update to the software includes bug fixes, modification to check-in function, modification to communication with X-ray emission devise, calibration support, addition of the Intelligent NR function (previously cleared under K212269), and the addition of Standard Synchronization Mode with Built in AEC Assistance.
The provided document K213780 is a 510(k) Pre-market Notification for a digital radiography device, the Canon DIGITAL RADIOGRAPHY CXDI-Elite / E1. This document establishes substantial equivalence to a predicate device, and as such, does not contain the detailed acceptance criteria for an AI/ML algorithm or the specific study that would prove the device meets such criteria.
The document makes a brief reference to an "Intelligent NR function (previously cleared under K212269)" in the section "Device Description," indicating that this specific function (likely an AI/ML noise reduction feature) has been previously cleared. However, the current 510(k) submission (K213780) is focused on the overall digital radiography system and its hardware/software updates, not specifically on the detailed performance of the "Intelligent NR function."
Therefore, based solely on the provided text, it is not possible to answer the requested questions about acceptance criteria and study details for an AI/ML device/algorithm, as this document does not provide that specific information.
To address the prompt, I will explain why the information cannot be extracted from this document:
- A table of acceptance criteria and the reported device performance: Not present. This document is for a general digital radiography system, not specifically an AI/ML diagnostic or assistive algorithm. The "Intelligent NR function" is briefly mentioned as having been "previously cleared," meaning its performance data and acceptance criteria would be in the K212269 submission, not this one.
- Sample sizes used for the test set and the data provenance: Not present. The document states "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." This indicates that the substantial equivalence was based on bench testing and comparisons with predicate devices, not a clinical test set with human subject data for an AI/ML algorithm.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present, as no clinical test set for an AI/ML algorithm is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not present, as no clinical test set for an AI/ML algorithm is described.
- 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: Not present. The document explicitly states "Clinical testing is not necessary."
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. The focus is on the complete system and its hardware.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present, as no clinical test set for an AI/ML algorithm is described.
- The sample size for the training set: Not present.
- How the ground truth for the training set was established: Not present.
In summary, the provided document (K213780) is a 510(k) Pre-market Notification for a general digital radiography system. It establishes substantial equivalence based on hardware and software updates, and bench testing, not on clinical performance studies of an AI/ML algorithm. While an "Intelligent NR function" (likely an AI/ML feature) is mentioned as previously cleared, the details of its specific acceptance criteria and the study proving it meets those criteria are not included in this particular submission.
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January 24, 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
Canon Inc. % Mr. Gregory Woodard Biomedical Engineer Ken Block Consulting 800 East Campbell Road, Suite 202 RICHARDSON TX 75081
Re: K213780
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: December 2, 2021 Received: December 3, 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@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
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Indications for Use
510(k) Number (if known) K213780
Device Name DIGITAL RADIOGRAPHY CXDI-Elite DIGITAL RADIOGRAPHY E1
Indications for Use (Describe)
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.
| 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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Image /page/3/Picture/0 description: The image shows the word "Canon" in a large, bold, red font. Below the word "Canon" is the text "5. 510(k) SUMMARY" in a smaller, black font. The text is left-aligned and the background is white.
| K213780 | ||
|---|---|---|
| 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: | December 2, 2021 | |
| Proposed Device | Manufacturer: Canon Inc.Trade Name: DIGITAL RADIOGRAPHY CXDI-EliteDIGITAL RADIOGRAPHY E1Common Name: Solid State X-Ray Imager (Flat Panel/Digital Imager)Classification Name: Stationary X-ray SystemProduct Code: MQBRegulation: 892.1680, Stationary X-ray System | |
| Predicate Device: | Clearance: K170332Manufacturer: Canon Inc.Trade Name: DIGITAL RADIOGRAPHY CXDI-710C WirelessCommon Name: Solid State X-ray Imager (Flat Panel/Digital Imager)Classification Name: Stationary X-ray SystemProduct Code: MQBRegulation: 892.1680, Stationary X-ray System | |
| Reference Device: | Clearance: K192632Manufacturer: Canon Inc.Trade Name: DIGITAL RADIOGRAPHY CXDI-702C WirelessCommon Name: Solid State X-ray Imager (Flat Panel/Digital Imager)Classification Name: Stationary X-ray SystemProduct Code: MQBRegulation: 892.1680, Stationary X-ray System | |
| Device Description: | The DIGITAL RADIOGRAPHY CXDI-Elite, also called the DIGITALRADIOGRAPHY E1, (hereinafter referred to as CXDI-Elite) is a solid-state x-rayimager using TFT (thin-film transistor) arrays. The CXDI-Elite is a series of detectors,currently consisting of the CXDI-720C Wireless detector unit, also called the AR-E3543W detector. The detector intercepts x-ray photons, and the Cesium-Iodidescintillator emits visible spectrum photons that illuminate an array of photodetectorsthat create electrical signals. After the electrical signals are generated, the signals areconverted to a digital image, and the images will be displayed on monitors. The digitalimage can be communicated to the operator console via a wired or wireless connection.The monitors used with the CXDI-Elite are not a part of this submission.The CXDI Control Software is updated from V2.16 to V3.10 in this submission. Theupdate to the software includes bug fixes, modification to check-in function, | |
| K213780 | modification to communication with X-ray emission devise, calibration support, addition of the Intelligent NR function (previously cleared under K212269), and the addition of Standard Synchronization Mode with Built in AEC Assistance. | |
| Indications for Use: | 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. | |
| Summary of Technological Characteristics: | Comparison with the predicate device shows the technological characteristics of the CXDI-Elite is substantially equivalent to the predicate device. The flat panel detector units are functionally similar, but the proposed device adds Standard Synchronization Mode with Built in AEC Assistance as a photographing mode. | |
| 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. |
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Image /page/4/Picture/0 description: The image shows the Canon logo in red, followed by the text "5. 510(k) SUMMARY" in black. The Canon logo is a stylized version of the company's name. The text below the logo appears to be a section heading or title, possibly from a document or report. The text is in a bold font and is left-aligned.
| Proposed Device | Predicate Device | Reference Devices | ||
|---|---|---|---|---|
| Trade Name | DIGITAL RADIOGRAPHYCXDI-Elite / E1 | DIGITAL RADIOGRAPHYCXDI-710C Wireless | DIGITAL RADIOGRAPHYCXDI-702C Wireless | |
| 510(k)Submitter[Number] | Canon Inc.[K213780] | Canon Inc.[K170332] | Canon Inc.[K192632] | IDENTICAL |
| Indication forUse | The DIGITAL RADIOGRAPHYCXDI-Elite / E1 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 | 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 | 125μm | 125μm | 125μm | IDENTICAL |
| SpatialResolution | 45% [MTF@2lp/mm] | 35% [MTF@2lp/mm] | 35% [MTF@2lp/mm] | IDENTICAL |
| IP Level | IP57 | IPX7 | IP54 | MODIFIED |
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K213780
| Components | Detector (Sensor) | Detector (Sensor) | Detector (Sensor) | MODIFIED |
|---|---|---|---|---|
| Battery Pack (LB-4A) | Battery Pack (LB-4A) | Battery Pack (LB-4A) | ||
| Battery Charger (BC-01/BC-1A) | Battery Charger (BC-1A) | Battery Charger (BC-1A) | ||
| Multi Box (MB-02) | Multi Box (MB-4A) | Multi Box (MB-4A) | ||
| Status Indicator (SI-01/SI-4A) | Status Indicator (SI-4A) | Status Indicator (SI-4A) | ||
| Wiring Cable (WC-01) | Wiring Cable (WC-4A) | Wiring Cable (WC-4A) | ||
| PC Connection Cable (CP-01) | PC Connection Cable (CP-4A) | PC Connection Cable (CP-4A) | ||
| Ready Indicator (RI-3A) | Ready Indicator (RI-3A) | Ready Indicator (RI-3A) | ||
| X-ray Interface Box (XB-1A) | Docking Station (DS-4A) | X-ray Interface Box (XB-1A)Docking Station (DS-4A) | ||
| Software | CXDI Control Software V3.10 | CXDI Control Software V2.16 | CXDI Control Software V2.19 | MODIFIED |
| ExternalDimensions | 384 x 460 x 15.5 mm | 384 x 460 x 15.7 mm | 384 x 460 x 15.7 mm | MODIFIED |
| DQE | A typical DQE value at 3.5uGy in0.5 lp/mm is 0.67, withmeasurement error of less than±10%. | A typical DQE value at 4 $\mu$ Gy in 0lp/mm is 0.6. The level ofuncertainty is estimated as lessthan ±10%. | A typical DQE value at 1 mR in0.5 lp/mm is 0.58. The level ofuncertainty is estimated as lessthan ±10%. | MODIFIED |
| DetectorTechnology | TFT | TFT | TFT | IDENTICAL |
| PhotographingMode | Standard Synchronization Mode,Standard Synchronization Modewith Built in AEC Assistance,Non Generator Connection Mode,Standalone Mode | Standard Synchronization Mode,Non Generator Connection Mode,Standalone Mode | Standard Synchronization Mode,Non Generator Connection Mode | MODIFIED |
| WirelessCommunication | IEEE 802.11a/b/g/n/ac2.4GHz/5GHzBluetooth Low Energy | IEEE 802.11n2.4GHz/5GHz | IEEE 802.11n/a/g/b2.4GHz/5GHz | MODIFIED |
Summary of Non-Clinical / Test Data:
Tests were performed on the device which demonstrated that the device is safe and effective, performs comparably to and is substantially equivalent to the predicate device. Tests included verification/validation testing to internal functional specifications (including software) and non-clinical image comparisons. Documentation was provided demonstrating compliance of the CXDI-Elite to all FDA requirements stated in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, including results of verification/validation plus traceability of verification/validation tests to software requirements and software risk hazards. Other FDA guidance documents used in development include Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
Documentation was provided demonstrating that the device complies with the FDA requirements stated in Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices. The evaluations of the device, compared to the predicate, show the device to be equivalent to the predicate.
Testing confirmed that the device complies with the U.S. Performance Standard for radiographic equipment and with relevant voluntary safety standards for Electrical Safety and Electromagnetic Compatibility testing, specifically IEC standards 60601-1, 60601-1-2, 60601-1-3, 60601-1-6, and 60601-2-54. An IP Code of IP57 has been established for the CXDI-Elite per IEC 60529.
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.
Together, these verification/validation activities successfully demonstrated that the device correctly performs as designed, has been validated for its intended use, and raises no new questions regarding either safety or effectiveness when compared to the
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Image /page/6/Picture/0 description: The image shows the word "Canon" in a large, red, bold font at the top. Below the word "Canon" is the text "5. 510(k) SUMMARY" in a smaller, black, bold font. The text is aligned to the left and appears to be part of a document or report. The image is simple and contains only text.
K213780
predicate device. Therefore, the verification/validation testing conducted supports a determination of substantial equivalence for the device.
- Company considers the DIGITAL RADIOGRAPHY CXDI-Elite / E1 device to be Conclusion: substantially equivalent to the predicate devices 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.