(13 days)
Not Found
No
The summary describes a solid-state x-ray imager and changes to its power supply and cables, along with firmware bug fixes and functional improvements. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as an x-ray imager used for generating diagnostic images, not for treating any medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the AS-10 is used for "diagnostic" procedures.
No
The device description explicitly states the AS-10 is a "solid state x-ray imager" that intercepts x-ray photons and has physical components like a scintillator, photo-detectors, and circuitry for converting signals to digital values. While there are firmware changes mentioned, the core device is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for generating fluoroscopic and radiographic images of human anatomy for angiography, diagnostic, and interventional procedures. This is related to medical imaging in vivo (within the living body), not in vitro (outside the body, typically involving analysis of biological samples).
- Device Description: The description details how the device captures X-ray photons and converts them into digital images. This process is entirely focused on imaging the internal structure of the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting specific substances, or performing any tests on specimens outside the body, which are hallmarks of IVD devices.
Therefore, the AS-10 is a medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
OWB, MQB, JAA
Device Description
The AS-10 is a solid state x-ray imager. It intercepts x-ray photons and the scintillator of the AS-10 emits visible spectrum photons that illuminate an array of photo-detectors that create electrical signals. After the electrical signals are generated, it is converted to digital value.
The subject of this Special 510(k) submission is a change to the AS-10 to make the PowerBox (PB-09), Power Supply Cable, and Optical Cable optional components. This change will allow for the use of any power source and non-Canon cables, given they meet the provided specifications. In addition, changes have been made to the firmware in the AS-10 detector unit and PowerBox to implement bug fixes and functional improvements. Together, these changes make up the AS-10.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The fundamental scientific technology of the AS-10 has not been modified. The detector unit of the AS-10 has not been modified, and the change is to allow the use of commercial components in place of the PowerBox, Optical Cable, and Power Supply Cable. Evaluation of the changes to the AS-10 confirmed that the changes did not impact AS-10 conformance 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, 62366, 60601-2-54, 60825-1, 62220-1, and 62304. These verification/validation activities successfully demonstrated that the device continues to meet the standards for the areas impacted by the device modifications to the predicate device and raises no new questions regarding either safety or effectiveness when compared to the predicate device. Therefore, the verification/validation conducted supports a determination of substantial equivalence for the AS-10 device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
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.(b)
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of an eagle, while the text on the right is written in blue. The logo is simple and professional, and it is easily recognizable.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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) |
|---|
| ------------------------------------------------- |
| 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 shows the word "Canon" in a bold, red font. The letters are slightly blurred, giving the logo a soft appearance. The background is plain white, which makes the red color of the logo stand out.
5. 510(k) SUMMARY
| Submitter: | Canon, Inc.
30-2 Shimomaruko, 3-chrome
Ohta-ku, Tokyo 146-8501 Japan |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Akira Hirai
General Manager
TEL: 81-3-3758-2111
FAX: 81-44-739-6695
hirai.akira@mail.canon |
| 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)
Subsequent: 892.1680 (Stationary X-ray System) |
| Predicate Device: | Canon AS-10 / CXDI-401RF
510k Number: K171194
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
of the AS-10 emits visible spectrum photons that illuminate an array of photo-detectors
that create electrical signals. After the electrical signals are generated, it is converted
to digital value.
The subject of this Special 510(k) submission is a change to the AS-10 to make the
PowerBox (PB-09), Power Supply Cable, and Optical Cable optional components.
This change will allow for the use of any power source and non-Canon cables, given
they meet the provided specifications. In addition, changes have been made to the
firmware in the AS-10 detector unit and PowerBox to implement bug fixes and
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
of the modified device, as described in the labeling, has not changed as a result of the
modification(s).
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. |
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Image /page/4/Picture/0 description: The image shows the word "Canon" in red font. The font is bold and slightly italicized. The word is centered and takes up most of the image space.
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 | |||
| [Number] | Canon, Inc. | ||
| [TBD] | Canon, Inc. | ||
| [K171194] | IDENTICAL | ||
| Indication for 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. | 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. | IDENTICAL | ||
| Application | Fluoroscopy and Spot Radiology | Fluoroscopy and Spot Radiology | IDENTICAL |
| Technology | Flat panel detector: | ||
| Scintillator and a-Si | Flat panel detector: | ||
| 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 | |||
| Dimensions | 469 x 468 x 58 mm | 469 x 468 x 58 mm | IDENTICAL |
| Weight | 13 kg | 13 kg | IDENTICAL |
| Acquisition Mode | |||
| (Binning mode) | Up to 15 fps (1x1) | ||
| Up to 30 fps (2x2) | |||
| Up to 30 fps (3x3) | Up to 15 fps (1x1) | ||
| Up to 30 fps (2x2) | |||
| Up to 30 fps (3x3) | IDENTICAL | ||
| A/D Conversion | 16-bit | 16-bit | IDENTICAL |
| Required | |||
| Components | Detector Unit | Detector Unit | |
| Power Supply Cable | |||
| Optical Cable | |||
| PowerBox | MODIFIED | ||
| Optional | |||
| Components | Power Supply Cable | ||
| Optical Cable | |||
| PowerBox | N/A | MODIFIED | |
| Rated Power | |||
| Supply Input | |||
| (Detector Unit) | Ch1: 22V DC (17.0V – 23.1V) | ||
| 1.1A (Max 1.5A) | |||
| Ch2: 15V DC (12.0V – 15.3V) | |||
| 0.6A (Max 1.0A) | N/A | MODIFIED | |
| Rated Power | |||
| Supply Input | |||
| (PowerBox) | 100 - 240V AC | ||
| 50/60 Hz | |||
| 0.9A - 0.3A | 100 - 240V AC | ||
| 50/60 Hz | |||
| 0.9A - 0.3A | IDENTICAL | ||
| Firmware Version | |||
| (PowerBox) | 01.00.00.00 | 00.02.00.0c | MODIFIED |
| Firmware Version | |||
| (Detector Unit) | 01.00.00.00 | 00.02.00.0c | MODIFIED |
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Image /page/5/Picture/0 description: The image shows the word "Canon" in red font. The font is bold and slightly italicized. The word is easily readable and the image is clear.
| | The User's and Installation Manuals provide detailed instructions and information
for safe and effective use of the device and users are expected to adhere to the
instructions and other information. The User's Manual explains how to use the
detector and other equipment. Connected medical equipment, such as X-ray
generators, must comply with IEC 60601-1. Before using the product, be sure to read
the manual thoroughly in order to utilize it more effectively. |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance: | The fundamental scientific technology of the AS-10 has not been modified. The
detector unit of the AS-10 has not been modified, and the change is to allow the use
of commercial components in place of the PowerBox, Optical Cable, and Power
Supply Cable.
Evaluation of the changes to the AS-10 confirmed that the changes did not impact
AS-10 conformance 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, 62366, 60601-2-54, 60825-1, 62220-1, and 62304.
These verification/validation activities successfully demonstrated that the device
continues to meet the standards for the areas impacted by the device modifications to
the predicate device and raises no new questions regarding either safety or
effectiveness when compared to the predicate device. Therefore, the
verification/validation conducted supports a determination of substantial equivalence
for the AS-10 device. |
| | Conclusion: |