(17 days)
The DIGITAL RADIOGRAPHY CXDI-Pro / D1 provides digital image capture for conventional film/screen radiographic examinations. This device is intended to capture, for display, radiographic images of human anatomy, and to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.
The DIGITAL RADIOGRAPHY CXDI-Pro, also called the DIGITAL RADIOGRAPHY D1, (hereinafter referred to as CXDI-Pro) is a solid-state x-ray imager. The CXDI-Pro is a series of detectors, and in the predicate device (K220098) consists of the CXDI-703C Wireless and CXDI-403C Wireless detectors, also called the AR-D3543W and AR-D4343W detectors respectively. The detectors intercept 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 The digital values are sent to the PC via a wired or wireless connection, converted to images with the CXDI Control Software, and then displayed on the PC/monitors The PC/monitors used with the CXDI-Pro are not a part of this submission.
The subject of this Special 510(k) submission is a change to the predicate device, including compatibility with the Multi Box and Status Indicator, DIGITAL RADIOGRAPHY CXDI-Elite components that were cleared under K213780. The Status Indicator can be used when the proposed device is used in combination with the Multi Box. In addition, the CXDI Control Software has been updated from V3.10.0.8 to V3.10.2.2 to fix some bugs. Together, these changes make up the CXDI-Pro.
Based on the provided text, the device in question, DIGITAL RADIOGRAPHY CXDI-Pro / D1, is a digital radiography system, and the submission (K221876) is a Special 510(k). This means the submission focuses on modifications to an already cleared predicate device (K220098) rather than a completely new device. Therefore, the clinical testing section is deemed "not necessary" due to "minor differences from the predicate device."
This significantly limits the type of performance study and acceptance criteria information available. Special 510(k) submissions typically rely heavily on non-clinical bench testing and verification/validation activities to demonstrate that changes do not adversely affect safety or effectiveness, rather than large-scale clinical trials measuring diagnostic accuracy.
Here's an analysis based on the constraint that "clinical testing is not necessary" for this specific submission:
1. A table of acceptance criteria and the reported device performance:
Since clinical testing was not performed for this submission, there are no acceptance criteria related to diagnostic accuracy or human-in-the-loop performance. The acceptance criteria and performance reported are focused on demonstrating that the modifications (addition of Multi Box and Status Indicator, software update, and firmware update) do not negatively impact the fundamental scientific technology and existing safety/performance standards of the predicate device.
| Acceptance Criteria Category | Specific Acceptance Criteria (from text) | Reported Device Performance / Evaluation (from text) |
|---|---|---|
| Safety & Electrical Performance | Conformance with U.S. Performance Standard for radiographic equipment. | Evaluation confirmed changes did not impact conformance. |
| Conformance with relevant voluntary safety standards for Electrical safety (IEC 60601-1). | Evaluation confirmed changes did not impact conformance. | |
| Electromagnetic Compatibility (EMC) | Conformance with relevant voluntary safety standards for Electromagnetic Compatibility (IEC 60601-1-2). | Evaluation confirmed changes did not impact conformance. |
| Usability / Software Lifecycle | Conformance with IEC 60601-1-6 (Usability). (Implied by software update context) | Verification/validation activities demonstrated the device continues to meet standards. |
| X-ray Imaging Equipment | Conformance with IEC 60601-2-54 (X-ray equipment for radiography and radioscopy). | Evaluation confirmed changes did not impact conformance. |
| Software Functionality | CXDI Control Software V3.10.2.2 fixes previous bugs (from V3.10.0.8). | Verification/validation activities demonstrated the CXDI-Pro works as intended with the updated software. |
| Bio-compatibility | Conformance with ISO 10993-1 for biological evaluation. | Follows applicable elements of ISO 10993-1. |
| Overall Equivalence | No new questions regarding safety or effectiveness compared to the predicate device. | Verification/validation activities support a determination of substantial equivalence. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document explicitly states: "Clinical testing is not necessary for the current submission, based on the minor differences from the predicate device. Adequate verification and validation activities should be sufficient to demonstrate that the CXDI-Pro works as intended."
Therefore, there is no human patient "test set" or related sample size or data provenance information. The "test set" here refers to the bench tests and engineering validations performed on the device and its components to ensure compliance with the mentioned technical standards and functionality.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as human clinical evaluation or ground truth adjudication by experts (e.g., radiologists) for diagnostic performance was not part of this "Special 510(k)" submission. The "ground truth" for the non-clinical tests would be established through engineering specifications, calibration standards, and regulatory requirements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as there was no test set requiring human expert adjudication for diagnostic performance.
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 done. This device is a digital radiography system; the submission focuses on hardware and software updates to the imaging system itself, not an AI feature that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No standalone performance evaluation of a diagnostic algorithm was done. This is a review of a general-purpose digital X-ray system, not an AI diagnostic algorithm. The software update mentioned is for the CXDI Control Software, which governs the imaging process and display, not for an AI interpretation algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this submission's evaluation is based on engineering specifications, regulatory standards (e.g., IEC 60601 series, U.S. Performance Standard for radiographic equipment), and the performance characteristics of the predicate device. It's not clinical ground truth (like pathology or patient outcomes) because clinical testing was not required.
8. The sample size for the training set:
Not applicable. This submission is for modifications to a general radiography system, not for an AI algorithm. There is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for an AI algorithm.
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July 15, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
Canon Inc. % Saori Sawaki Business Manager, Regulatory Consultant Ken Block Consulting 800 E. Campbell Road, Suite 202 RICHARDSON TX 75081
Re: K221876
Trade/Device Name: Digital Radiography CXDI-Pro, Digital Radiography D1 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: June 27, 2022 Received: June 28, 2022
Dear Saori Sawaki:
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
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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 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 (OS) 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 OHT 8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K221876
Device Name DIGITAL RADIOGRAPHY CXDI-Pro DIGITAL RADIOGRAPHY D1
Indications for Use (Describe)
The DIGITAL RADIOGRAPHY CXDI-Pro / D1 provides digital image capture for conventional film/screen radiographic examinations. This device is intended to capture, for display, radiographic images of human anatomy, and to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X 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/1 description: The image shows the word "Canon" in a bold, red font. The word is slightly blurred, giving it a sense of depth. Below the word "Canon" is the text "510(-) SUMMARY", which is smaller and in a different font.
| STU(K) SUMMAK Y | |
|---|---|
| Applicant/ Sponsor: | Canon Inc.9-1 Imaikami-choNakahara-ku, Kanagawa 211-8501 JAPAN |
|---|---|
| Contact Person: | Mr. Akira Hirai |
General Manager TEL: 81-3-3758-2111 FAX: 044-739-6695 hirai.akira@mail.canon
Date Prepared: June 27, 2022
Submission Type: Special 510(k) Submission
| Proposed Device | Manufacturer: | Canon Inc.DIGITAL RADIOGRAPHY CXDI-ProDIGITAL RADIOGRAPHY D1 | ||
|---|---|---|---|---|
| Common Name: | Solid State X-Ray Imager (Flat Panel/Digital Imager) | |||
| Classification Name: | Stationary X-ray System | |||
| Product Code: | MQB | |||
| Regulation: | 892.1680, Stationary X-ray System | |||
| Predicate Device: | Clearance: | K220098 | ||
| Manufacturer: | Canon Inc. | |||
| Trade Name: | DIGITAL RADIOGRAPHY CXDI-ProDIGITAL RADIOGRAPHY D1 | |||
| Common Name: | Solid State X-ray Imager (Flat Panel/Digital Imager) | |||
| Classification Name: | Stationary X-ray System | |||
| Product Code: | MQB | |||
| Regulation: | 892.1680, Stationary X-ray System | |||
| DeviceDescription: | The DIGITAL RADIOGRAPHY CXDI-Pro, also called the DIGITALRADIOGRAPHY D1, (hereinafter referred to as CXDI-Pro) is a solid-state x-rayimager. The CXDI-Pro is a series of detectors, and in the predicate device(K220098) consists of the CXDI-703C Wireless and CXDI-403C Wirelessdetectors, also called the AR-D3543W and AR-D4343W detectors respectively.The detectors intercept x-ray photons, and the scintillator emits visible spectrumphotons that illuminate an array of photodetectors that create electrical signals.After the electrical signals are generated, the signals are converted to digital valuesThe digital values are sent to the PC via a wired or wireless connection, convertedto images with the CXDI Control Software, and then displayed on the PC/monitorsThe PC/monitors used with the CXDI-Pro are not a part of this submission. | |||
| The subject of this Special 510(k) submission is a change to the predicate device,including compatibility with the Multi Box and Status Indicator, DIGITALRADIOGRAPHY CXDI-Elite components that were cleared under K213780. TheStatus Indicator can be used when the proposed device is used in combination withthe Multi Box. In addition, the CXDI Control Software has been updated fromV3.10.0.8 to V3.10.2.2 to fix some bugs. Together, these changes make up theCXDI-Pro. |
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Image /page/4/Picture/0 description: The image shows the word "Canon" in a large, red, bold font. Below the word "Canon" is the text "510(k) SUMMARY" in a smaller, black, bold font. The text is centered below the word "Canon".
| Indications forUse: | The DIGITAL RADIOGRAPHY CXDI-Pro / DIGITAL RADIOGRAPHY D1provides digital image capture for conventional film/screen radiographicexaminations. This device is intended to capture, for display, radiographicimages of human anatomy, and to replace radiographic film/screen systems inall general purpose diagnostic procedures. This device is not intended formammography applications. |
|---|---|
| Summary ofTechnologicalCharacteristics: | Comparison with the predicate device shows the technological characteristics ofthe CXDI-Pro is substantially equivalent to the predicate device. |
| The major differences between the CXDI-Pro and the predicate are differences inthe components and a newer version of the CXDI control software. The proposedindications for use statement is identical to the indications for use statement of the |
predicate device.
| Proposed Device | Predicate Device | ||||
|---|---|---|---|---|---|
| Trade Name | DIGITAL RADIOGRAPHY CXDI-Pro / D1 | DIGITAL RADIOGRAPHY CXDI-Pro / D1 | |||
| 510(k) Submitter[Number] | Canon Inc.[TBD] | Canon Inc.[K220098] | IDENTICAL | ||
| Indication for Use | The DIGITAL RADIOGRAPHY CXDI-Pro /DIGITAL RADIOGRAPHY D1 providesdigital image capture for conventionalfilm/screen radiographic examinations. Thisdevice is intended to capture, for display,radiographic images of human anatomy, and toreplace radiographic film/screen systems in allgeneral purpose diagnostic procedures. Thisdevice is not intended for mammographyapplications. | The DIGITAL RADIOGRAPHY CXDI-Pro /DIGITAL RADIOGRAPHY D1 providesdigital image capture for conventionalfilm/screen radiographic examinations. Thisdevice is intended to capture, for display,radiographic images of human anatomy, and toreplace radiographic film/screen systems in allgeneral purpose diagnostic procedures. Thisdevice is not intended for mammographyapplications. | IDENTICAL | ||
| Application | General Radiography | General Radiography | |||
| Components | Detector (Sensor)Documentation (Manuals)Battery Charger (BC-1A/BC-01)Battery Pack (LB-4A)X-ray Interface Box (XB-1A)Power Box (PB-01)Wiring Cable (WC-01)PC Connection Cable (CP-01)Ready Indicator (RI-3A)Detector Stand (DS-01) | Detector (Sensor)Documentation (Manuals)Battery Charger (BC-1A/BC-01)Battery Pack (LB-4A)X-ray Interface Box (XB-1A)Power Box (PB-01)Wiring Cable (WC-01)PC Connection Cable (CP-01)Ready Indicator (RI-3A)Detector Stand (DS-01) | IDENTICAL | ||
| Other CompatibleComponents | Multi Box (MB-02)Status Indicator (SI-01/SI-4A) | N/A | MODIFIED | ||
| Detector Sensor | CXDI-703C WirelessAR-D3543W | CXDI-403C WirelessAR-D4343W | CXDI-703C WirelessAR-D3543W | CXDI-403C WirelessAR-D4343W | IDENTICAL |
| External Dimensions | 384 x 460 x 15.5 mm | 460 x 460 x 15.7 mm | 384 x 460 x 15.5 mm | 460 x 460 x 15.7 mm | IDENTICAL |
| Case Material | Magnesium alloy | Magnesium alloy | IDENTICAL | ||
| Detector Technology | TFT | TFT | IDENTICAL | ||
| Pixel Pitch | 140um | 140μm | IDENTICAL | ||
| Scintillator | CsI(Tl)[Cesium Iodide doped with Thallium] | CsI(Tl)[Cesium Iodide doped with Thallium] | IDENTICAL | ||
| SpatialResolution | 35% [MTF@2lp/mm] | 35% [MTF@2lp/mm] | IDENTICAL | ||
| DQE | 58% [@0.5 lp/mm, 3.5 uGy] | 58% [@0.5 lp/mm, 3.5 uGy] | IDENTICAL | ||
| IP Level | IP55 | IP55 | IDENTICAL | ||
| Software | CXDI Control Software V3.10.2.2 | CXDI Control Software V3.10.0.8 | MODIFIED | ||
| WirelessCommunication | IEEE 802.11n/ac/a/g/b2.4GHz/5GHzBluetooth Low Energy | IEEE 802.11n/ac/a/g/b2.4GHz/5GHzBluetooth Low Energy | IDENTICAL | ||
| Photographing Mode | Standard Synchronization Mode,Non Generator Connection Mode | Standard Synchronization Mode,Non Generator Connection Mode | IDENTICAL |
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Image /page/5/Picture/1 description: The image shows the word "Canon" in a large, red, bold font. Below that, the words "510(k) SUMMARY" are printed in a smaller, black, bold font. The text is centered on the image.
| Summary ofNon-Clinical /Test Data: | The fundamental scientific technology of the CXDI-Pro has not been modified.The changes are the addition of optional accessories, a Multi Box and StatusIndicator; the update to the detector firmware from 01.00.02.00 to 01.01.03.00;and the update to the CXDI Control Software from 3.10.0.8 to 3.10.2.2. |
|---|---|
| Evaluation of the addition of the new detector and optional accessories confirmedthat the changes did not impact CXDI-Pro conformance with the U.S. PerformanceStandard for radiographic equipment and with relevant voluntary safety standardsfor Electrical safety and Electromagnetic Compatibility testing, specifically IECstandards 60601-1, 60601-1-2, 60601-1-6, and 60601-2-54. | |
| These verification/validation activities successfully demonstrated that the devicecontinues to meet the standards for the areas impacted by the modifications to thepredicate device and raises no new questions regarding either safety oreffectiveness when compared to the predicate device. Clinical testing is notnecessary for the current submission, based on the minor differences from thepredicate device. Adequate verification and validation activities should besufficient to demonstrate that the CXDI-Pro works as intended. Therefore, theverification/validation activities conducted support a determination of substantialequivalence for the CXDI-Pro. | |
| The proposed device follows the applicable elements of the following FDAguidance documents: Guidance for the Submission of 510(k)s for Solid State X-rayImaging Devices, Guidance for the Content of Premarket Submissions forSoftware contained in Medical Devices, Content of Premarket Submissions forManagement of Cybersecurity in Medical Devices, and Use of InternationalStandard ISO 10993-1, "Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk management process." | |
| Conclusion: | Canon Inc. considers the DIGITAL RADIOGRAPHY CXDI-Pro / D1 to besubstantially equivalent to the predicate device listed above. This conclusion isbased 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.