(15 days)
DIGITAL RADIOGRAPHY CXD1-55G provides digital image capture for conventional film/screen radiographic examinations. The device is intended to replace radiographic film/screen systems in all general purpose diagnostic proceduros. This device is not intended for mammography applications.
The DIGITAL RADIOGRAPHY CXDI-55G is a solid state x-ray imager which has 35x 43cm imaging area. The DIGITAL RADIOGRAPHY CXDI-55G intercepts x-ray photons and the scintillator of the CXDI-55G emits visible spectrum photons that illuminate an array of photo-detectors that create an clectrical signals. After the electrical signals are generated, it is converted to digital value, and the images will be displayed on monitors.
This Canon CXDI-55G submission is a 510(k) for a new model of a digital radiography device. The submission explicitly states, "The Performance Data demonstrate that CXDI-55G is as safe and effective as CXDI-50G." This indicates that the study performed was a substantial equivalence study. Therefore, the acceptance criteria are not explicitly defined as they would be for a direct performance claim. Instead, the "acceptance criteria" are implicitly met by demonstrating equivalence to the predicate device, the CXDI-50G.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| As safe and effective as the predicate device (Canon CXDI-50G) | Performance data demonstrates CXDI-55G is as safe and effective as CXDI-50G. |
| Equivalent intended use to predicate device | CXDI-55G's intended use is the same as CXDI-50G. |
| Non-inferiority in imaging quality and diagnostic capability compared to predicate. | Not explicitly quantified in this summary, but implied by the overall conclusion of substantial equivalence based on "design control activities and non-clinical testing." |
2. Sample Size Used for the Test Set and the Data Provenance
The provided 510(k) summary does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "Performance Data" and "non-clinical testing."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not provide any information regarding experts used to establish ground truth or their qualifications. Given that this is a technological upgrade and not a diagnostic AI device, such expert review for ground truth might not have been a primary focus of this 510(k) summary.
4. Adjudication Method for the Test Set
No information is provided regarding adjudication methods. This type of detail is typically not found in summary documents for device upgrades.
5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No mention of an MRMC comparative effectiveness study is made in the provided text. This type of study is more common for AI-powered diagnostic aids, not for hardware upgrades of a digital radiography system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device, a solid-state X-ray imager, is a hardware component that captures images. Its performance is inherent in the image acquisition process, not an algorithm's standalone diagnostic ability. Therefore, the concept of "standalone performance" as typically applied to diagnostic algorithms is not directly applicable here. The performance is tied to the output image quality.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used. For a device like this, the "ground truth" for performance would generally relate to objective image quality metrics (e.g., DQE, MTF, SNR) established through physical testing and comparison to the predicate device. Clinical outcomes or pathology are unlikely to be direct ground truths for a basic image acquisition device.
8. The Sample Size for the Training Set
No training set is mentioned as this device is a hardware imager, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a hardware device like this.
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K091435 Page 1 of 1
Section 10: Summary 510(k) Summary
Prepared:
April 6, 2009
MAY 2 9 2009
Submitter:
Company Name: Canon USA, Inc. (U.S. agent for Canon Inc.) Company Address: One Canon Plaza Lake Success, NY 11042 Contact Person: Ms. Sheila Driscoll Phone Number: (216) 328-2602 Fax Number: (516) 328-2169
Proposed Device:
Reason For 510(k): New Model Manufacturer: Canon Inc. Trade Name: Canon Model Name: CXDI-55G Classification Name: MQB, Solid State X-ray Imager FDA 510(k) #: To be assigned
Predicate Device:
| Manufacturer: | Canon Inc. |
|---|---|
| Trade Name: | Canon |
| Model Name: | CXDI-50G |
| Classification Name: | 90MQB, Solid State X-ray Imager |
| FDA 510(k) #: | K031447 |
Description of Device:
The DIGITAL RADIOGRAPHY CXDI-55G is a solid state x-ray imager which has 35x 43cm imaging area.
The DIGITAL RADIOGRAPHY CXDI-55G intercepts x-ray photons and the scintillator of the CXDI-55G emits visible spectrum photons that illuminate an array of photo-detectors that create an clectrical signals.
After the electrical signals are generated, it is converted to digital value, and the images will be displayed on monitors.
Intended Use: DIGITAL RADIOGRAPHY CXDI-55G provides digital image capture for conventional
film/screen radiographic examinations.
The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
This device is not intended for mammography applications.
Comparison to Predicate: CXDI-55G's intended use is the same as that of CXDI-50G However, the differences in the external dimensions and the weight are as follows:
The External dimensions of CXDI-55G is changed from 491x 477x 23mm to 480x 481x 15mm. And the weight of CXDI-55G is changed from 4.8Kg to 3.4Kg.
Conclusion: The Performance Data demonstrate that CXDI-55G is as safe and effective as CXDI-50G Based on the information in this submission, similarity to the predicate device (Digital Radiography CXDI-50G), and the results of our design control activities and non-clinical testing, it is the opinion of Canon Inc. that the DIGITAL RADIOGRAPHY CXD1-55G described in this submission is substantially equivalent to the predicate device.
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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a blue stylized human figure and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in blue font. The text is positioned to the right of the human figure. The logo is simple and professional, conveying the organization's focus on health and human well-being.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Canon USA. Inc. % Mr. Jeff D. Rongero Third Party Reviewer-Senior Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle Park, NC 27709
AUG 2 3 2013
Re: K091435
Trade/Device Name: CXDI-55G Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: May 12, 2009 Received: May 14. 2009
Dear Mr. Rongero:
This letter corrects our substantially equivalent letter of May 29, 2009.
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 of
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Page 2
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 809), please contact the Office 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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 Division of Small Manufacturers, 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 Statement
091435
510(K)Number(if known):
Device Name: CXDI-55G
Indications for Use:
DIGITAL RADIOGRAPHY CXD1-55G provides digital image capture for
conventional film/screen radiographic examinations.
The device is intended to replace radiographic film/screen systems in all general
purpose diagnostic proceduros.
This device is not intended for mammography applications.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHERT PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation(ODE)
Arvil M. Dhaz
(Division Sign-On)
Division of Renroductive, Auchminal and Radiological Devices 510(k) Number
Page l of 대
§ 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.