(22 days)
DIGITAL RADIOGRAPHY CXDI-80C Wireless and CXDI-80G Wireless provide digital image capture for conventional film/screen radiographic examinations. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. These devices are not intended for mammography applications.
The DIGITAL RADIOGRAPHY CXDI-80C Wireless and CXD1-80G Wireless are solid state x-ray imagers which have 27x35cm imaging area. The DIGITAL RADIOGRAPHY CXDI-80C/80G Wireless intercept x-ray photons and the scintillator of the CXDI-80C/80G Wireless emit visible spectrum phonomy photons and the array of photo-detectors that create electrical signals. After the electrical signals are generated, it is converted to digital value, and the images will be displayed on monitors. The digital value can be communicated to the operator conselver wia wiring connection or wireless.
The provided FDA 510(k) summary for the Canon DIGITAL RADIOGRAPHY CXDI-80C Wireless and CXDI-80G Wireless devices does not include specific acceptance criteria or a detailed study proving the device meets said criteria in the way typically expected for AI/CADe devices.
Instead, this submission focuses on demonstrating substantial equivalence to predicate devices (Canon DIGITAL RADIOGRAPHY CXDI-70C Wireless and CXDI-401G) based on established performance parameters for X-ray imagers and established safety and effectiveness.
Here's an analysis based on the provided text, addressing the points you requested, with the caveat that many aspects relevant to AI/CADe performance studies are not applicable to this type of device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety & Effectiveness | Device is safe and effective as a digital radiography imager. | Performance testing for Electrical safety, Electromagnetic compatibility, and other performance tests demonstrated the devices are safe and effective. |
| Equivalence to Predicate | Devices are substantially equivalent to predicate devices (CXDI-70C Wireless and CXDI-401G). This implies equivalent imaging principle, intended use, and amorphous silicon array specifications. | The amorphous silicon array specifications, imaging principle, and intended use are stated to be the same as the predicate devices. Performance data is stated to demonstrate equivalence. |
| Intended Use | Digital image capture for conventional film/screen radiographic examinations; replace film/screen systems in all general purpose diagnostic procedures; not for mammography. | The device's intended use is precisely stated as these criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- Not applicable / Not specified. The submission refers to "performance testing" generally. This is not a clinical study involving a "test set" of patient data in the context of diagnostic accuracy for AI/CADe. It's focused on engineering performance, safety, and regulatory compliance of an imaging hardware device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. No expert ground truth establishment for a diagnostic test set is described.
4. Adjudication Method for the Test Set
- Not applicable. No diagnostic test set or adjudication method is described.
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. This is a submission for an X-ray imager (hardware device), not an AI/CADe software. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is hardware; there is no standalone algorithm being evaluated.
7. The Type of Ground Truth Used
- Not applicable. For this hardware device, "ground truth" would refer to engineering specifications and measurements (e.g., image quality metrics, electrical safety standards) rather than clinical diagnostic ground truth like pathology or expert consensus. The document states "performance testing" was done, implying these types of engineering and regulatory tests.
8. The Sample Size for the Training Set
- Not applicable. This device is hardware; there is no training set mentioned or implied.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an algorithm, there is no ground truth establishment for it.
Summary of the Study (as described in this document):
The "study" presented here is a pre-market notification (510(k)) for substantial equivalence of a new digital radiography imager (CXDI-80C Wireless and CXDI-80G Wireless) to existing legally marketed predicate devices (CXDI-70C Wireless and CXDI-401G).
The "proof" that the device meets "acceptance criteria" (which are fundamentally regulatory requirements for safety, effectiveness, and equivalence) is based on:
- Performance testing: This broadly covers "Electrical safety, Electromagnetic compatibility and other performance testings." The document states these tests demonstrated the devices are "safe and effective."
- Comparison to predicate devices: The submission explicitly states that the amorphous silicon array specifications, imaging principle, and intended use of the new devices are "the same as those of the predicate devices."
- Design Control activities and non-clinical testing: These are general regulatory requirements for medical device development, and the conclusion mentions that the results of these activities support the substantial equivalence.
In essence, the "study" for this type of hardware device demonstrates that it functions as intended, meets safety standards, and is fundamentally similar in design and performance to devices already cleared by the FDA, rather than conducting a clinical trial with patient data or comparing diagnostic accuracy as would be done for an AI/CADe medical device.
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Section 5: 510(k) Summary
510(k) Summarv
SEP - 2 2011
Prepared:
August 10, 2011
New Model
Canon
Submitter/Holder:
Company Name: Company Address:
Contact Person: Phone Number: Fax Number:
CANON INC. 30-2 Shimomaruko 3-chome, Ohta-ku Tokyo 146-8501, Japan Naoyasu Asaka 81-3-3758-2111 81-3-5482-3960
Proposed Device:
Reason For 510(k): Trade Name: Model Name:
Classification Name: FDA 510(k) #:
Predicate Device:
Trade Name: Canon
FDA 510(k) #/Model Name
Classification Name:
DIGITAL RADIOGRAPHY CXDI-80C Wireless DIGITAL RADIOGRAPHY CXDI-80G Wireless 90MQB, Solid State X-ray Imager To be assigned
FDA 510(k) #/Model Name: K103591/ DIGITAL RADIOGRAPHY CXDI-401G K102012/ DIGITAL RADIOGRAPHY CXDI-70C Wireless 90MQB, Solid State X-ray Imager
Description of Device:
The DIGITAL RADIOGRAPHY CXDI-80C Wireless and CXD1-80G Wireless are solid state x-ray imagers which have 27x35cm imaging area.
The DIGITAL RADIOGRAPHY CXDI-80C/80G Wireless intercept x-ray photons and the scintillator of the CXDI-80C/80G Wireless emit visible spectrum phonomy photons and the array of photo-detectors that create electrical signals.
After the electrical signals are generated, it is converted to digital value, and the images will be displayed on monitors. The digital value can be communicated to the operator conselver wia wiring connection or wireless.
Intended Use:
The DIGITAL RADIOGRAPHY CXDI-80C Wireless and CXDI-80G Wireless provide digital image capture for conventional film/screen radiographic examinations. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. These devices are not intended for mammography applications.
Comparison to Predicate:
The amorphous silicon array specifications of CXDI-80C Wireless and CXDI-80G Wireless, imaging principle and intended use are the same as those of the predicate devices, (CXDI-70C Wireless and CXDI-401G).
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K112309
Page 2 of 2
Section 5: 510(k) Summary
Performance testing:
The Electrical safety, Electromagnetic compatibility and other performance testings were performed on these devices which demonstrated that these devices are safe and effective, and are equivalent to the predicate devices.
Conclusion:
The Performance Data demonstrate that CXDI-80C Wireless and CXDI-80G Wireless are as safe and effective as the predicate devices (CXDI-70C Wireless and CXDI-401G). Based on the information in this submission, similarity to the predicate devices, and the esults of Our design Control activities and non-clinical testing, it is our opinion that the DIGITAL RADIOGRAPHY CXDI-80C Wireless and CXDI-80G Wireless described in this submission are substantially equivalent to the predicate devices.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a blue emblem on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The emblem features a stylized human figure with outstretched arms, and the text is written in a clear, sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Naoyasu Asaka Staff manager Canon Inc. 30-2 Shimomaruko 3-Chrome OHTA-KU TOKYO 146-8501 JAPAN
AUG 2 3 2013
Re: K112309
Trade/Device Name: Canon/Digital Radiology, CXDI-80C Wireless, Canon/Digital Radiology, CXDI-80G Wireless Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: August 10, 2011 Received: August 11, 2011
Dear Mr. Asaka:
This letter corrects our substantially equivalent letter of September 13, 2011.
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. 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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice mouited device-related ad retos ovelity systems (QS) regulation (21 CFR Part 820). This letter requirences as bet for in are quality - device as described in your Section 510(k) premarket witi anow you to ocgin markoming your views and equivalence of your device to a legally marketed noutication. The FDT intention for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and If you desire specific davice of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 under the MDA regulation (21 Of RT at 007) promo goodem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the I ou may obain other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
K112309 510(K) Number (if known):.
Device Name: CXDI-80C Wireless and CXD1-80G Wireless
Indications for Use:
ﻟﺴﻌ
DIGITAL RADIOGRAPHY CXDI-80C Wireless and CXDI-80G Wireless provide digital image capture for conventional film/screen radiographic examinations.
These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
These devices are not intended for mammography applications.
Prescription Use × (Part 21 CFR 801 Subpart D)
OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHERT PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Page 1 of 1
Mary S Patil
Office In Vitro Diagnostic Device Evaluation and Safety
Division of Chemistry and Toxicology Devices
610k K112309
§ 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.