(26 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 submission (K221876) 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 proposed changes to the predicate device, CXDI-Pro, includes the addition of the new detector, CXDI-803C Wireless (also called the AR-D2735W) to the CXDI-Pro series; a firmware update from 01.01.03.00 to 01.02.00.01; and a CXDI Control Software version update from 3.10.2.2 to 3.10.2.6. The new detector, CXDI-803C Wireless, which differs in pixel count, imaging area, external dimensions, and weight, has the same image performance as the predicate detectors. None of the CXDI-Pro detectors have any dynamic functions (such as fluoroscopy).
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" in the format of a table with thresholds and corresponding performance values. Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing technological characteristics and ensuring continued conformance with safety and performance standards.
The closest to "reported device performance" are the shared technical specifications and the statement that the new detector has the "same image performance as the predicate detectors."
| Characteristic / Standard | Acceptance/Conformance Statement (Implied Criteria) | Reported Device Performance |
|---|---|---|
| Intended Use | Identical to predicate device: Digital image capture for conventional film/screen radiographic examinations, displaying radiographic images of human anatomy, replacing film/screen systems in all general diagnostic procedures (excluding mammography). | The proposed device's Indications for Use are identical to the predicate device. |
| Functional Design | Substantially equivalent to predicate device. | The flat panel detector units are functionally the same, using the same components. The fundamental scientific technology has not been modified. |
| Device Components | Primarily identical, with specific modifications in detector model additions and firmware/software updates not impacting safety or effectiveness. | Proposed Device: CXDI-703C, CXDI-803C (NEW), CXDI-403C Wireless detectors. CXDI Control Software V3.10.2.6. Detector Firmware V01.02.00.01. Predicate Device: CXDI-703C, CXDI-403C Wireless detectors. CXDI Control Software V3.10.2.2. Detector Firmware V01.01.03.00. (The table lists the predicate as also having CXDI-803C, implying it was part of the earlier submission, but the text states the addition of 803C.) |
| Image Performance | Same as predicate detectors. | The new detector, CXDI-803C Wireless, has the same image performance as the predicate detectors. |
| Safety Standards | Conformance with U.S. Performance Standard for radiographic equipment and relevant voluntary safety standards for Electrical safety and Electromagnetic Compatibility testing (specifically IEC 60601-1, 60601-1-2, 60601-1-6, and 60601-2-54). Changes did not impact conformance and raised no new questions regarding safety or effectiveness. | Evaluation and verification/validation activities successfully demonstrated that the device continues to meet the standards for areas impacted by modifications. |
| Cybersecurity | Conformance with "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" guidance. | Not explicitly detailed, but stated as followed for applicable guidance documents. |
| Wireless Technology | Conformance with "Radio Frequency Wireless Technology in Medical Devices" guidance. | Not explicitly detailed, but stated as followed for applicable guidance documents. |
| Mechanical/Electrical | Conformance with "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices" guidance. | Not explicitly detailed, but stated as followed for applicable guidance documents. |
2. Sample size used for the test set and the data provenance
The document states: "Adequate detector bench testing should be sufficient to demonstrate that the subject detector. CXDI-Pro, works as intended."
It also mentions "verification/validation activities" which included "detector bench testing."
- Sample Size for Test Set: Not explicitly stated in terms of number of images or cases. The testing appears to be primarily at the component level (detector, firmware, software) through bench testing and conformance to standards, rather than a clinical study with a specific number of patient cases.
- Data Provenance: Not specified, but given the nature of "bench testing" and "conformance with U.S. Performance Standard," it would likely involve laboratory test data and manufactured test images, rather than patient data from specific countries. This is a "Special 510(k) Submission" for modifications, so extensive new clinical data is often not required if substantial equivalence can be demonstrated through non-clinical means.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was a non-clinical submission focused on technical equivalency, safety, and performance standards. There was no clinical ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was a non-clinical submission; no adjudication method for a clinical test set was required or mentioned.
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. The device described is a digital radiography detector system, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study regarding human reader improvement with AI assistance is not relevant or reported.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a hardware component (detector) and associated software/firmware for image acquisition and display, not an algorithm providing a standalone diagnostic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this specific submission, the "ground truth" was established against technical specifications, engineering performance metrics (e.g., MTF, DQE), and conformance to internationally recognized safety and performance standards (e.g., IEC 60601 series). There was no clinical ground truth (expert consensus, pathology, outcomes data) as this was a non-clinical submission for device modifications.
8. The sample size for the training set
Not applicable. This device is a diagnostic imaging system component, not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. There was no training set for a machine learning algorithm.
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October 17, 2022
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Canon Inc. % Ms. Saori Sawaki Business Manager, Regulatory Consultant Ken Block Consulting LLC 800 E. Campbell Road, Suite 202 RICHARDSON TX 75081
Re: K222855
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: September 21, 2022 Received: September 21, 2022
Dear Ms. 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 DHT8B: Division of Radiological Imaging Devices 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) K222855
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) | |
|---|---|
| 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 features the word "Canon" in a bold, red font. The letters are closely spaced together, creating a solid block of text. The font appears to be sans-serif, with rounded edges, giving the word a modern and clean look.
510(k) Summary
K222855
| Applicant/ Sponsor: Canon Inc. | ||
|---|---|---|
| 9-1 Imaikami-cho | ||
| Nakahara-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: October 3, 2022
Submission Type: Special 510(k) Submission
| Proposed Device | Manufacturer:Trade Name:Common Name:Classification Name:Product Code:Regulation:Class: | Canon Inc.DIGITAL RADIOGRAPHY CXDI-ProDIGITAL RADIOGRAPHY D1Solid State X-Ray Imager (Flat Panel/Digital Imager)Stationary X-ray SystemMQB892.1680, Stationary X-ray SystemII |
|---|---|---|
| Predicate Device: | Clearance:Manufacturer:Trade Name:Common Name:Classification Name:Product Code:Regulation:Class: | K221876Canon Inc.DIGITAL RADIOGRAPHY CXDI-ProDIGITAL RADIOGRAPHY D1Solid State X-ray Imager (Flat Panel/Digital Imager)Stationary X-ray SystemMQB892.1680, Stationary X-ray SystemII |
| 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 submission(K221876) 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 values.The 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/monitors.The PC/monitors used with the CXDI-Pro are not a part of this submission.The proposed changes to the predicate device, CXDI-Pro, includes the addition ofthe new detector, CXDI-803C Wireless (also called the AR-D2735W) to the CXDI-Pro series; a firmware update from 01.01.03.00 to 01.02.00.01; and a CXDI ControSoftware version update from 3.10.2.2 to 3.10.2.6.The new detector, CXDI-803C Wireless, which differs in pixel count, imaging area,external dimensions, and weight, has the same image performance as the predicatedetectors. None of the CXDI-Pro detectors have any dynamic functions (such asfluoroscopy). |
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Image /page/4/Picture/0 description: The image shows the word "Canon" in a bold, red font. The letters are closely spaced together, creating a solid block of text. The font is sans-serif, and the overall impression is one of a strong, recognizable brand logo. The red color is vibrant and eye-catching.
510(k) Summary
K222855
| Indications for Use: | The DIGITAL RADIOGRAPHY CXDI-Pro / DIGITAL RADIOGRAPHY 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. |
|---|---|
| Summary of Technological Characteristics: | Comparison with the predicate device shows the technological characteristics of the CXDI-Pro is substantially equivalent to the predicate device. The flat panel detector units are functionally same, using the same components. |
| Proposed Device | Predicate Device | ||
|---|---|---|---|
| Trade Name | DIGITAL RADIOGRAPHY CXDI-Pro / D1 | DIGITAL RADIOGRAPHY CXDI-Pro / D1 | |
| 510(k) Submitter[Number] | Canon Inc.[K222855] | Canon Inc.[K221876] | 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 | IDENTICAL |
| 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, 1.5/7.5/10/15/25m (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, 1.5/7.5/15/25m (WC-01)PC Connection Cable (CP-01)Ready Indicator (RI-3A)Detector Stand (DS-01) | MODIFIED |
| Other CompatibleComponents | Multi Box (MB-02)Status Indicator (SI-01/SI-4A) | Multi Box (MB-02)Status Indicator (SI-01/SI-4A) | IDENTICAL |
| Detector Sensor | CXDI-703C Wireless (AR-D3543W)CXDI-803C Wireless (AR-D2735W)CXDI-403C Wireless (AR-D4343W) | CXDI-703C Wireless (AR-D3543W)CXDI-803C Wireless (AR-D2735W)CXDI-403C Wireless (AR-D4343W) | MODIFIED |
| External Dimensions | CXDI-703C Wireless: 384 x 460 x 15.7 mmCXDI-803C Wireless: 384 x 307.5 x 15.7 mmCXDI-403C Wireless: 460 x 460 x 15.7 mm | CXDI-703C Wireless: 384 x 460 x 15.7 mmCXDI-403C Wireless: 460 x 460 x 15.7 mm | MODIFIED |
| Case Material | Magnesium alloy | Magnesium alloy | IDENTICAL |
| Detector Technology | TFT | TFT | IDENTICAL |
| Pixel Pitch | 140μm | 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 V3.10.2.6 | CXDI Control Software V3.10.2.2 | MODIFIED |
| Detector Firmware | V01.02.00.01 | V01.01.03.00 | 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/0 description: The image shows the word "Canon" in a bold, red font. The letters are closely spaced together, creating a solid block of text. The font appears to be sans-serif, with rounded edges on the letters. The overall impression is a strong and recognizable brand logo.
510(k) Summary
Summary of The fundamental scientific technology of the CXDI-Pro has not been modified. Non-Clinical / The major differences between the proposed CXDI-Pro and the predicate are Test Data: differences in the new detector and a newer version of the firmware and the CXDI control software. The proposed indications for use statement is identical to the indications for use statement of the predicate device. Evaluation of the addition of the new detector and optional accessories confirmed that the changes did not impact CXDI-Pro conformance with the 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, 60601-1-6, and 60601-2-54. 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-Pro, works as intended. Therefore, the verification/validation activities conducted support a determination of substantial equivalence for the CXDI-Pro. 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. Conclusion: Canon Inc. considers the DIGITAL RADIOGRAPHY CXDI-Pro / D1 to be substantially equivalent to the predicate device listed above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use.
K22855
§ 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.