AS-10, CXDI-401RF

K171194 · Canon, Inc. · OWB · May 24, 2017 · Radiology

Device Facts

• Record ID: K171194
• Device Name: AS-10, CXDI-401RF
• Applicant: Canon, Inc.
• Product Code: OWB · Radiology
• Decision Date: May 24, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The AS-10 / CXDI-401RF is indicated for use in generating fluoroscopic and radiographic images of human anatomy for angiography, diagnostic, and interventional procedures. The device is intended to replace spot-film devices is also intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.

Device Story

AS-10 / CXDI-401RF is a solid-state flat panel X-ray detector (FPD) for integration into dynamic and static imaging systems. Device intercepts X-ray photons via a scintillator, which emits visible light onto an amorphous silicon (a-Si) photo-detector array; signals are converted to digital values. Used in clinical settings (angiography, diagnostic, interventional) by professional operators (physicians, technicians). Device replaces spot-film and image intensifier technology. Output is digital image data provided to an integrated imaging system for clinical review and decision-making. Benefits include improved image acquisition capabilities (e.g., increased pixel count, binning modes) compared to predecessors.

Clinical Evidence

Bench testing only. Verification and validation testing performed against internal functional specifications. Non-clinical image comparisons (static and dynamic) conducted against predicate CXDI-50RF. Compliance demonstrated with IEC 60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 60601-2-54, 62304, 62366, ANSI/AAMI ES60601-1, and IEC 60825-1.

Technological Characteristics

Solid-state flat panel detector (FPD) using amorphous silicon (a-Si) and Cesium Iodide (CsI(Tl)) scintillator. 160 x 160 µm pixel pitch. 16-bit A/D conversion. Wired connectivity to image capture unit. Dimensions: 469 x 468 x 58 mm. Weight: 13 kg. Complies with IEC 60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 60601-2-54, 62304, 62366, and ANSI/AAMI ES60601-1.

Indications for Use

Indicated for generating fluoroscopic and radiographic images of human anatomy for angiography, diagnostic, and interventional procedures. Not for mammography.

Regulatory Classification

Identification

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Model CXDI-50RF (K092439)
• Model CSX-30 (K162909)

Submission Summary (Full Text)

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 24, 2017

Canon, Inc. – Medical Equipment Group % Diane Rutherford Submission Manager Ken Block Consulting 1201 Richardson Drive, Suite 160 Richardson, Texas 75080

Re: K171194

Trade/Device Name: AS-10, CXDI-401RF Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA, MQB Dated: April 24, 2017 Received: April 24, 2017

Dear Diane Rutherford:

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. 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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Michael D. O'Hara

For

Robert A. Ochs, Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K171194

Device Name AS-10 CXDI-401RF

### Indications for Use (Describe)

The AS-10 / CXDI-401RF is indicated for use in generating fluoroscopic and radiographic images of human anatomy for angiography, diagnostic, and interventional procedures. The device is intended to replace spot-film devices is also intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

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# 5. 510(k) SUMMARY

| Submitter: | Canon, Inc. - Medical Equipment Group<br>9-1, Imaikami-cho, Nakahara-ku<br>Kawasaki, Kanagawa 211-8501, Japan |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Canon, Inc. – Medical Equipment Group<br>Mr. Shinji Mori<br>Manager<br>9-1, Imaikami-cho, Nakahara-ku<br>Kawasaki, Kanagawa 211-8501, Japan<br>TEL: [phone]<br>FAX: [phone]<br>[e-mail] |
| Date Prepared: | April 18, 2017 |
| Proposed Device | Manufacturer: Canon, Inc. - Medical Equipment Group<br>Trade Name: AS-10<br>Common Name: CXDI-401RF<br>Classification Name: Solid State X-Ray Imager (Flat Panel/Digital Imager)<br>Interventional Fluoroscopic X-ray System<br>Primary Product Code / Regulatory Standard: OWB<br>892.1650, Image-intensified fluoroscopic x-ray system<br>Subsequent Product Codes: JAA, MQB |
| Predicate Devices: | Clearance: K092439 dated November 30, 2009<br>Manufacturer: Virtual Imaging, A Canon USA Company<br>Trade Name: Model CXDI-50RF<br>Common Name: Fluoroscopic Digital X-Ray Receptor Panel<br>Classification Name: Image-Intensified Fluoroscopic X-Ray System<br>Product Code(s) / Regulatory Standard(s): OWB, JAA, IZI [SE Letter correction July 30, 2012]<br>892.1650, Image-intensified fluoroscopic x-ray system<br>892.1600, Angiographic x-ray system<br>[Originally cleared under MQB, 892.1680] |
| | Clearance: K162909 dated January 27, 2017<br>Manufacturer: Canon, Inc. - Medical Equipment Group<br>Trade Name: Model CSX-30<br>Common Name: Solid State X-ray Imager (Flat Panel/Digital Imager)<br>Classification Name: Stationary X-ray system<br>Primary Product Code MQB<br>Regulatory Standard: 892.1680, Stationary X-ray System<br>Subsequent Product Code JAA<br>Regulatory Standard: 892.1650, Image-intensified fluoroscopic x-ray system |
| Device Description: | The AS-10 / CXDI-401RF is a solid state x-ray imager. It intercepts x-ray photons and<br>the scintillator of the AS-10 / CXDI-401RF emits visible spectrum photons that<br>illuminate an array of photo-detectors that create electrical signals. After the electrical<br>signals are generated, it is converted to digital value. |

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Image /page/4/Picture/0 description: The image shows the word "Canon" in red. The font is bold and slightly italicized. The background is white.

- Indications for Use: The AS-10 / CXDI-401RF is indicated for use in generating fluoroscopic and radiographic images of human anatomy for angiography, diagnostic, and interventional procedures. The device is intended to replace spot-film devices. The device is also intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.
Summary of Comparison with the predicate devices shows the technological characteristics of the Technological AS-10 / CXDI-401RF is substantially equivalent to the predicate devices. The flat Characteristics: panel detector units are functionally identical.

> The AS-10 / CXDI-401RF is a successor model of the CXDI-50RF; however, the AS-10 / CXDI-401RF is for integration only like the CSX-30. The differences between the AS-10 / CXDI-401RF and the predicates CXDI-50RF and CSX-30 are primarily overall dimensions, increased pixels, and increased image size.

> The differences between the AS-10 / CXDI-401RF and the predicates are primarily increased size. Increased size results in larger dimensions, larger image area, more pixels, and weight differences over the predicate. An additional binning mode has been added to the AS-10 / CXDI-401RF in an effort to improve the marketability. The proposed indications for use statement differs slightly in wording from the predicates, but does not impact the intended use. The proposed and both predicate devices are indicated for fluoroscopic and radiographic use.

> In the table below, the predicates are identified as a) CXDI-50RF or b) CSX-30. If no letter precedes the predicate information, the information applies to both predicates.

| | New Device:<br>AS-10 / CXDI-401RF<br>K171194 | Predicate Devices:<br>a) CXDI-50RF K092439<br>b) CSX-30 K162909 | |
|------------------------------------------------|----------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------|
| Application | Fluoroscopy and Spot Radiology | Fluoroscopy and Spot Radiology | Identical |
| Technology | Flat panel detector:<br>Scintillator and a-Si | Flat panel detector:<br>a) Scintillator and a-Si | Identical |
| Scintillator | CsI(TI) | CsI(TI) | Identical |
| Pixel Pitch | 160 x 160 µm | 160 x 160 µm | Identical |
| Pixels | 2,688 x 2,688 (≈ 7.2 million) | a) 2,208 x 2,688 (≈ 5.9 million)<br>b) 2,496 x 1,856 (≈ 4.6 million) | Modified |
| Image Size | 430 x 430 mm | a) 350 x 430 mm<br>b) 399 x 297 mm | Modified |
| Overall Dimensions | 469 x 468 x 58 mm | a) 493 x 503 x 26 mm<br>b) 470 x 363 x 82.5 mm<br>(Except tubes protrusions) | Modified |
| Weight | 13 kg | a) 5.7 kg<br>b) 19.0 kg | Modified |
| Acquisition Mode<br>(Binning mode) | Up to 15 fps (1x1)<br>Up to 30 fps (2x2)<br>Up to 30 fps (3x3) | a) Up to 15 fps (1x1)<br>b) Up to 30 fps (2x2) | Identical<br>Identical<br>Modified |
| DQE<br>@ 1 µGy in 0 lp/mm,<br>RQA5 | 0.75 | a) 0.6<br>b) 0.79 | Modified<br>Modified |
| Spatial Resolution<br>[MTF@2cycle/mm,<br>RQA5] | 0.28 | a) 0.3<br>b) 0.22 | Modified<br>Modified |
| A/D Conversion | 16-bit | a) 14-bit<br>b) 16-bit | Modified<br>Identical |

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Summary of Tests were performed on the device which demonstrated that the device is safe and Non-Clinical /Test effective, performs comparably to and is substantially equivalent to the predicate devices. Data: Tests included verification/validation testing to internal functional specifications (including software) and non-clinical image comparisons involving flat panel display static and dynamic images taken with the new device and the predicate device CXDI-50RF. Documentation was provided demonstrating compliance of the AS-10 / CXDI-401RF 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. Documentation was provided demonstrating that the AS-10 / CXDI-401RF 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 AS-10 / CXDI-401RF compared to the CXDI-50RF, show the AS-10 / CXDI-401RF to be equivalent to the CXDI-50RF. Testing confirmed that the AS-10 / CXDI-401RF 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, 60601-2-54, 62304, and 62366 as well as ANSI/AAMI ES60601-1. Testing also confirmed compliance to relevant voluntary safety standard IEC 60825-1. Together, these verification/validation activities successfully demonstrated that the AS-10 / CXDI-401RF 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 predicate devices. Therefore, the verification/validation testing conducted supports a determination of substantial equivalence for the AS-10 / CXDI-401RF device. Integration: The AS-10 / CXDI-401RF is a hardware only FPD for integration into dynamic and static imaging systems. The AS-10 / CXDI-401RF connects to the image capture unit (compliant with IEC 60601-1 or IEC 60950-1) through a wired connection and does not connect directly to an x-ray generator. The Installation Manual provides detailed instructions and information for safe and effective system integration including: system configuration; electrical, mechanical, and cooling requirements; installation conditions; interfaces (image, command and service, and power input). Integrators are expected to adhere to the instructions and other information in the published Installation Manual. Conclusion: Canon, Inc. - Medical Equipment Group considers the AS-10 / CXDI-401RF to be substantially equivalent to the predicate devices listed above. This conclusion is based on the same intended use and similar principles of operation, functional design, and established medical use for the flat panel detector.