(13 days)
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 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.
The provided document describes a Special 510(k) submission for the Canon AS-10 device, detailing changes made to its optional components and firmware. The focus of this submission is to demonstrate substantial equivalence to its predicate device (Canon AS-10 / CXDI-401RF, K171194), rather than a de novo performance study. Therefore, the document does not contain specific acceptance criteria, reported device performance metrics against those criteria, or a study design involving expert readers, ground truth establishment, or multi-reader multi-case (MRMC) comparative effectiveness.
Instead, the submission focuses on affirming that the modifications did not negatively impact the device's conformance with existing performance and safety standards.
Here's a breakdown of the information that is and is not available based on your request:
1. Table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) or reported performance metrics against such criteria. The "Performance" section focuses on demonstrating continued conformance with regulatory standards after modifications.
2. Sample size used for the test set and the data provenance
Not applicable. This is a Special 510(k) submission for modifications, not a new device requiring a clinical performance study with a test set. The changes involved making PowerBox, Power Supply Cable, and Optical Cable optional components, and updating firmware for bug fixes and functional improvements.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set requiring ground truth establishment is described.
4. Adjudication method for the test set
Not applicable, as no clinical test set requiring adjudication 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 MRMC study is mentioned. The AS-10 is an imaging device (Solid State X-Ray Imager), not an AI-driven interpretive tool for physicians.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The AS-10 is the imaging hardware itself, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical performance study requiring ground truth is described.
8. The sample size for the training set
Not applicable. This document describes a hardware and firmware modification, not a machine learning model that would require a training set.
9. How the ground truth for the training set was established
Not applicable, as no training set for a machine learning model is described.
Summary of Device Modifications and Performance Activities (as per document):
The submission for the Canon AS-10 is a Special 510(k), indicating minor modifications to an already cleared device (predicate K171194).
The modifications are:
- Making the PowerBox (PB-09), Power Supply Cable, and Optical Cable optional components. This allows for the use of any power source and non-Canon cables that meet provided specifications.
- Updating firmware in the AS-10 detector unit and PowerBox to implement bug fixes and functional improvements.
How Performance was Addressed in this Submission:
The document states:
- "The fundamental scientific technology of the AS-10 has not been modified."
- "The detector unit of the AS-10 has not been modified..."
- "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, and 62304." (Note: IEC 62220-1 is also listed elsewhere but not explicitly linked to the conformance statement here).
- "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 "acceptance criteria" in this context are adherence to established international and U.S. performance/safety standards for medical electrical equipment and X-ray systems, and the "study" involves verification and validation (V&V) activities to confirm that the modifications did not degrade this conformance. This is a common approach for Special 510(k) submissions where the changes are limited and do not introduce new risks or alter the fundamental operating principles of the device.
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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 (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-chromeOhta-ku, Tokyo 146-8501 Japan |
|---|---|
| Contact Person: | Mr. Akira HiraiGeneral ManagerTEL: 81-3-3758-2111FAX: 81-44-739-6695hirai.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-401RF510k Number: K171194Product Codes: OWB, MQB, JAA |
| Device Description: | The AS-10 is a solid state x-ray imager. It intercepts x-ray photons and the scintillatorof the AS-10 emits visible spectrum photons that illuminate an array of photo-detectorsthat create electrical signals. After the electrical signals are generated, it is convertedto digital value.The subject of this Special 510(k) submission is a change to the AS-10 to make thePowerBox (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, giventhey meet the provided specifications. In addition, changes have been made to thefirmware in the AS-10 detector unit and PowerBox to implement bug fixes andfunctional 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 useof the modified device, as described in the labeling, has not changed as a result of themodification(s).The AS-10 is indicated for use in generating fluoroscopic and radiographic images ofhuman anatomy for angiography, diagnostic, and interventional procedures. Thedevice is intended to replace spot-film devices. The device is also intended to replacefluoroscopic images obtained through image intensifier technology. Not intended formammography 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 ingenerating fluoroscopic andradiographic images of humananatomy for angiography,diagnostic, and interventionalprocedures. The device is intendedto replace spot-film devices. Thedevice is also intended to replacefluoroscopic images obtainedthrough image intensifiertechnology. Not intended formammography applications. | The AS-10 / CXDI-401RF isindicated for use in generatingfluoroscopic and radiographicimages of human anatomy forangiography, diagnostic, andinterventional procedures. Thedevice is intended to replace spot-film devices. The device is alsointended to replace fluoroscopicimages obtained through imageintensifier technology. Not intendedfor 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 |
| OverallDimensions | 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 |
| RequiredComponents | Detector Unit | Detector UnitPower Supply CableOptical CablePowerBox | MODIFIED |
| OptionalComponents | Power Supply CableOptical CablePowerBox | N/A | MODIFIED |
| Rated PowerSupply 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 PowerSupply Input(PowerBox) | 100 - 240V AC50/60 Hz0.9A - 0.3A | 100 - 240V AC50/60 Hz0.9A - 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 informationfor safe and effective use of the device and users are expected to adhere to theinstructions and other information. The User's Manual explains how to use thedetector and other equipment. Connected medical equipment, such as X-raygenerators, must comply with IEC 60601-1. Before using the product, be sure to readthe manual thoroughly in order to utilize it more effectively. | |
|---|---|
| Performance: | The fundamental scientific technology of the AS-10 has not been modified. Thedetector unit of the AS-10 has not been modified, and the change is to allow the useof commercial components in place of the PowerBox, Optical Cable, and PowerSupply Cable.Evaluation of the changes to the AS-10 confirmed that the changes did not impactAS-10 conformance with the U.S. Performance Standard for radiographic equipmentand with relevant voluntary safety standards for Electrical safety andElectromagnetic 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 devicecontinues to meet the standards for the areas impacted by the device modifications tothe predicate device and raises no new questions regarding either safety oreffectiveness when compared to the predicate device. Therefore, theverification/validation conducted supports a determination of substantial equivalencefor the AS-10 device. |
| Conclusion: |
§ 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.