AS-10

K200887 · Canon, Inc. · OWB · Apr 15, 2020 · Radiology

Device Facts

• Record ID: K200887
• Device Name: AS-10
• Applicant: Canon, Inc.
• Product Code: OWB · Radiology
• Decision Date: Apr 15, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The AS-10 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.

Device Story

AS-10 is a solid-state X-ray imager (flat panel detector) using a CsI(Tl) scintillator and a-Si photo-detector array. It intercepts X-ray photons, converts them to visible light, then to electrical signals, and finally to digital values. Used in clinical settings for angiography, diagnostic, and interventional procedures; operated by trained healthcare professionals. Modifications allow the PowerBox, power supply cable, and optical cable to be optional, permitting use of third-party power sources and cables meeting specified requirements. Firmware updates implemented for bug fixes and functional improvements. Output is digital X-ray imagery used by clinicians for diagnostic and interventional decision-making. Benefits include replacement of traditional spot-film and image intensifier technology with digital imaging.

Clinical Evidence

Bench testing only. Verification and validation activities confirmed conformance with IEC 60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 62366, 60601-2-54, 60825-1, 62220-1, and 62304. No clinical data presented.

Technological Characteristics

Flat panel detector with CsI(Tl) scintillator and a-Si array. 160 x 160 µm pixel pitch; 2,688 x 2,688 pixels; 430 x 430 mm image size. 16-bit A/D conversion. Connectivity via optional PowerBox and cables. Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 62304 (software).

Indications for Use

Indicated for human patients undergoing angiography, diagnostic, and interventional procedures requiring fluoroscopic or radiographic imaging. Not indicated 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

• Canon AS-10 / CXDI-401RF (K171194)

Submission Summary (Full Text)

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April 15, 2020.

Canon, Inc % Mr. Gregory Woodard Biomedical Engineer Ken Block Consulting 800 East Campbell Road, Suite 202 RICHARDSON TX 75081

Re: K200887

Trade/Device Name: AS-10 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, MQB, JAA Dated: March 27, 2020 Received: April 2, 2020

Dear Mr. Woodard:

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 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

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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 (QS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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)

K200887

Device Name AS-10

Indications for Use (Describe)

The AS-10 is indicated for use in generating fluoroscopic images of human anatomy for angiography, diagnostic, and interventional procedures. The device is intended to replace spot-film devices 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) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-weight: bold;">Prescription Use (Part 21 CFR 801 Subpart D)</span> </span> </span> | <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-weight: bold;">☑</span> </span> </span> |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-weight: bold;">Over-The-Counter Use (21 CFR 801 Subpart C)</span> </span> </span> | <span style="font-size: 10pt;"><span style="font-family: Arial;"><span style="font-weight: bold;">☐</span></span></span> |

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## 5. 510(k) SUMMARY

| Submitter: | Canon, Inc.<br>30-2 Shimomaruko, 3-chrome<br>Ohta-ku, Tokyo 146-8501 Japan |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Akira Hirai<br>General Manager<br>TEL: [phone]<br>FAX: [phone]<br>[e-mail] |
| Date Prepared: | April 1, 2020 |
| Submission Type: | Special 510(k) Submission |
| Trade Name: | AS-10 |
| Common Name: | Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| Classification Name: | Image-intensified Fluoroscopic X-ray System |
| Classification: | Primary: 892.1650 (Image-intensified fluoroscopic x-ray system)<br>Subsequent: 892.1680 (Stationary X-ray System) |
| Predicate Device: | Canon AS-10 / CXDI-401RF<br>510k Number: K171194<br>Product Codes: OWB, MQB, JAA |
| Device Description: | The AS-10 is a solid state x-ray imager. It intercepts x-ray photons and the scintillator<br>of the AS-10 emits visible spectrum photons that illuminate an array of photo-detectors<br>that create electrical signals. After the electrical signals are generated, it is converted<br>to digital value.<br><br>The subject of this Special 510(k) submission is a change to the AS-10 to make the<br>PowerBox (PB-09), Power Supply Cable, and Optical Cable optional components.<br>This change will allow for the use of any power source and non-Canon cables, given<br>they meet the provided specifications. In addition, changes have been made to the<br>firmware in the AS-10 detector unit and PowerBox to implement bug fixes and<br>functional improvements. Together, these changes make up the AS-10. |
| Indication for Use: | The Indication for Use statement is identical to the predicate device. The intended use<br>of the modified device, as described in the labeling, has not changed as a result of the<br>modification(s).<br><br>The AS-10 is indicated for use in generating fluoroscopic and radiographic images of<br>human anatomy for angiography, diagnostic, and interventional procedures. The<br>device is intended to replace spot-film devices. The device is also intended to replace<br>fluoroscopic images obtained through image intensifier technology. Not intended for<br>mammography applications. |

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Summary of Technological Characteristics:

Comparisons with the predicate devices show the characteristics of the proposed modifications (change to make the PowerBox, Power Supply Cable, and Optical Cable optional accessories) to the AS-10 to be substantially equivalent to the predicate device.

| | Proposed Device | Predicate Device | |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Trade Name | AS-10 | AS-10 / CXDI-401RF | |
| 510(k) Submitter<br>[Number] | Canon, Inc.<br>[TBD] | Canon, Inc.<br>[K171194] | IDENTICAL |
| Indication for Use | The AS-10 is indicated for use in<br>generating fluoroscopic and<br>radiographic images of human<br>anatomy for angiography,<br>diagnostic, and interventional<br>procedures. The device is intended<br>to replace spot-film devices. The<br>device is also intended to replace<br>fluoroscopic images obtained<br>through image intensifier<br>technology. Not intended for<br>mammography applications. | The AS-10 / CXDI-401RF is<br>indicated for use in generating<br>fluoroscopic and radiographic<br>images of human anatomy for<br>angiography, diagnostic, and<br>interventional procedures. The<br>device is intended to replace spot-<br>film devices. The device is also<br>intended to replace fluoroscopic<br>images obtained through image<br>intensifier technology. Not intended<br>for mammography applications. | IDENTICAL |
| Application | Fluoroscopy and Spot Radiology | Fluoroscopy and Spot Radiology | IDENTICAL |
| Technology | Flat panel detector:<br>Scintillator and a-Si | Flat panel detector:<br>Scintillator and a-Si | IDENTICAL |
| Scintillator | CsI(Tl) | CsI(Tl) | IDENTICAL |
| Pixel Pitch | 160 x 160 µm | 160 x 160 µm | IDENTICAL |
| Pixels | 2,688 x 2,688 (~ 7.2 million) | 2,688 x 2,688 (~ 7.2 million) | IDENTICAL |
| Image Size | 430 x 430 mm | 430 x 430 mm | IDENTICAL |
| Overall<br>Dimensions | 469 x 468 x 58 mm | 469 x 468 x 58 mm | IDENTICAL |
| Weight | 13 kg | 13 kg | IDENTICAL |
| Acquisition Mode<br>(Binning mode) | Up to 15 fps (1x1)<br>Up to 30 fps (2x2)<br>Up to 30 fps (3x3) | Up to 15 fps (1x1)<br>Up to 30 fps (2x2)<br>Up to 30 fps (3x3) | IDENTICAL |
| A/D Conversion | 16-bit | 16-bit | IDENTICAL |
| Required<br>Components | Detector Unit | Detector Unit<br>Power Supply Cable<br>Optical Cable<br>PowerBox | MODIFIED |
| Optional<br>Components | Power Supply Cable<br>Optical Cable<br>PowerBox | N/A | MODIFIED |
| Rated Power<br>Supply Input<br>(Detector Unit) | Ch1: 22V DC (17.0V – 23.1V)<br>1.1A (Max 1.5A)<br>Ch2: 15V DC (12.0V – 15.3V)<br>0.6A (Max 1.0A) | N/A | MODIFIED |
| Rated Power<br>Supply Input<br>(PowerBox) | 100 - 240V AC<br>50/60 Hz<br>0.9A - 0.3A | 100 - 240V AC<br>50/60 Hz<br>0.9A - 0.3A | IDENTICAL |
| Firmware Version<br>(PowerBox) | 01.00.00.00 | 00.02.00.0c | MODIFIED |
| Firmware Version<br>(Detector Unit) | 01.00.00.00 | 00.02.00.0c | MODIFIED |

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| | The User's and Installation Manuals provide detailed instructions and information<br>for safe and effective use of the device and users are expected to adhere to the<br>instructions and other information. The User's Manual explains how to use the<br>detector and other equipment. Connected medical equipment, such as X-ray<br>generators, must comply with IEC 60601-1. Before using the product, be sure to read<br>the manual thoroughly in order to utilize it more effectively. |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance: | The fundamental scientific technology of the AS-10 has not been modified. The<br>detector unit of the AS-10 has not been modified, and the change is to allow the use<br>of commercial components in place of the PowerBox, Optical Cable, and Power<br>Supply Cable.<br>Evaluation of the changes to the AS-10 confirmed that the changes did not impact<br>AS-10 conformance with the U.S. Performance Standard for radiographic equipment<br>and with relevant voluntary safety standards for Electrical safety and<br>Electromagnetic Compatibility testing, specifically IEC standards 60601-1, 60601-1-<br>2, 60601-1-3, 60601-1-6, 62366, 60601-2-54, 60825-1, 62220-1, and 62304.<br>These verification/validation activities successfully demonstrated that the device<br>continues to meet the standards for the areas impacted by the device modifications to<br>the predicate device and raises no new questions regarding either safety or<br>effectiveness when compared to the predicate device. Therefore, the<br>verification/validation conducted supports a determination of substantial equivalence<br>for the AS-10 device. |
| | Conclusion: |