(24 days)
No
The summary mentions image processing but does not explicitly mention AI, ML, or related terms like neural networks or deep learning. The testing described focuses on performance relative to a predicate device and adherence to standards, not on the evaluation of an AI/ML algorithm's performance.
No
The device is described as a diagnostic and interventional angiography system, used for imaging blood vessels and for diagnostic and angiographic procedures, not for treating conditions.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures..."
No
The device description explicitly states that the system consists of hardware components such as a C-arm, X-ray tube, beam limiter, X-ray receptor, X-ray controller, and a patient radiographic table, in addition to computers with system and processing software. The description also mentions hardware changes to the DFP.
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 a digital radiography/fluoroscopy system used for diagnostic and interventional angiography procedures. This involves imaging the inside of the body using X-rays.
- Device Description: The description details an X-ray system with components like a C-arm, X-ray tube, and detector. These are all characteristic of imaging devices, not devices that analyze samples taken from the body.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not perform such tests.
The device is an imaging device used for diagnostic and interventional procedures, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
Product codes
OWB
Device Description
The Alphenix, INFX-8000F/B, V8.0, is a single or dual plane X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm (either one or two) which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and processing software, and a patient radiographic table.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
heart, brain, abdomen and lower extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
interventional setting
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
This submission contains test data that demonstrates that the system modifications result in performance that is equal to or better than the predicate system. Testing of the modified system was conducted in accordance with the applicable standards published by the International Electromechanical Commission (IEC) for Medical Devices and XR Systems.
Risk analysis and verification/validation testing, conducted through bench testing, are included in this submission which demonstrates that the requirements for the modifications made to the system have been met. Additionally, Image Quality metrics utilizing phantom image evaluations were employed in bench testing which demonstrates that the requirements for the modifications made to the system have been met.
Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission. Software modules were subject to verification and/or validation testing to ensure that they were properly integrated into the existing software platform. Cybersecurity documentation, per the FDA cybersecurity premarket guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" issued on October 2, 2014, is also included as part of this submission. Additionally, the design controls used for this device included risk management and all known risks were mitigated to an acceptable level.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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September 28, 2018
Canon Medical Systems Corporation % Janine Reyes Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive TUSTIN, CA 92780
Re: K182415
Trade/Device Name: Alphenix, INFX-8000F/B. V8.0 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB Dated: August 31, 2018 Received: September 4, 2018
Dear Janine Reyes:
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
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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Hole 2. Nils
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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Indications for Use
510(k) Number (if known)
Device Name
Alphenix, INFX-8000F/B, V8.0
Indications for Use (Describe)
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
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/1 description: The image shows the logo for Canon Medical Systems USA, Inc. The word "Canon" is written in a bold, red font. Below the logo, the text "CANON MEDICAL SYSTEMS USA, INC." is written in a smaller, black font.
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92
1. CLASSIFICATION and DEVICE NAME
| Classification Name | Image-Intensified Fluoroscopic X-ray System |
|---|---|
| Product Code | OWB |
| Regulation Number | 21 CFR 892.1650 |
| Regulatory Class | Class II |
| Trade Proprietary Name | Alphenix, INFX-8000F/B, V8.0 |
2. SUBMITTER'S NAME
Canon Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550
3. OFFICIAL CORRESPONDENT
Naofumi Watanabe Senior Manager, Regulatory Affairs and Vigilance
4. CONTACT PERSON, U.S. AGENT and ADDRESS
Contact Person
Janine F. Reyes Manager, Regulatory Affairs Canon Medical Systems USA 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 669-7853 Fax: (714) 730-1310 jfreyes@us.medical.canon
5. MANUFACTURING SITE
Canon Medical Systems Corporation (TMSC) 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
6. ESTABLISHMENT REGISTRATION 9614698
-
- DATE PREPARED August 31st, 2018
8. TRADE NAME(S)
Alphenix, INFX-8000F/B, V8.0
Official Correspondent/U.S. Agent
Paul Biggins Sr. Director, Regulatory Affairs Canon Medical Systems USA 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 669-7808 Fax: (714) 730-1310 pbiggins@us.medical.canon
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9. DEVICE NAME
Interventional Fluoroscopic X-ray System
10. CLASSIFICATION PANEL
Radiology
11. DEVICE CLASSIFICATION
Class II (per 21 CFR 892.1650)
12. PRODUCT CODE / DESCRIPTION
Product Code: OWB - Image-Intensified Fluoroscopic X-ray System
13. PERFORMANCE STANDARD
This device conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard].
14. PREDICATE DEVICE
Primary Predicate Device: Infinix, INFX-8000F, V3.52 (K081624) Reference Predicate Device (added software functionalities): Alphenix, INFX-8000V/B, V8.0 (K181670)
TABLE 1: Primary Predicate Device
| Trade Proprietary Name | Infinix, INFX-8000F, V3.52 |
|---|---|
| Marketed by | Canon Medical Systems USA, Inc. |
| 510(k) Number | K081624 |
| Clearance Date | June 23rd, 2008 |
| Classification Name | Image-Intensified Fluoroscopic X-ray System |
| Product Code | OWB |
| Regulation Number | 21 CFR 892.1650 |
| Regulatory Class | Class II |
15. REASON FOR SUBMISSION
Modification of a cleared device
16. SUBMISSION TYPE
Traditional 510(k)
17. DEVICE DESCRIPTION
The Alphenix, INFX-8000F/B, V8.0, is a single or dual plane X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm (either one or two) which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and processing software, and a patient radiographic table.
18. INDICATIONS FOR USE
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
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19. SUMMARY OF CHANGE(S)
This submission is to report the following items have been changed:
System software changed from V3.52 to V8.0:
- V8.0 Software: System software changed from V3.52 to V8.0 for improved usability. ●
- Tablet Console: used in combination with the Alphenix, INFX-8000F/B, V8.0, the . following functions can be performed in the examination room using the tablet console: o Selecting a radiographic program.
- o Selecting an auto-positioning No.
- o Selecting a function.
- o Performing auxiliary operations on the Angio Workstation.
- o Performing playback, pause, and frame feeding of dynamic images.
- o Switching dynamic image files and map image files.
- New Examination Menu: enables frequently used functions to be registered into the favorites menu for improved workflow.
- . Programming Restructuring: AlphaCT encompasses CBCT (Cone Beam CT) programs 3D-DA, LD-3D and LCI.
- . Multi-phase CBCT (Cone Beam CT): Multiphase CBCT allows AlphaCT scans to be performed over multiple phases.
- . Sleep Mode: to reduce the power consumption of the system, the system automatically enters sleep mode. Note that it is possible to adjust the period of time before the system enters sleep mode.
Component Change:
- . Tilting table is changed from CAT-870B to CAT-880B.
- . X-ray tube assembly is changed from DRX-T7445GFS to DRX-7434GFS.
- . Beam Limiting Devices is changed from BLA-800C to BLA-900C and BLA-800A to BLA-900A.
- 30 cm x 30 cm FPD is added.
- High DQE type FPDs (20cm x 20cm, 30cm x 30cm x 40cm) are added.
- . Specification for System Input Power: system input power is changed from 400V and 200V to 400V only.
- DFP (Digital Fluoroscopy Processor): hardware changes to enhance both system operability and image quality. Changes include: host system PC, real time controller CPU board, image processing unit and storage.
- . Wireless footswitch is added.
- . Space Improvement: to reduce machine room space requirements, racks were introduced for the chiller, water-cooled heat exchanger and large screen monitor system.
- UPS (Uninterruptible Power System) Connection Kit
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Made For life
Application Change:
- Spot fluoroscopy function is added.
- 3D Roadmap and Multi-Modality Roadmap functions are added. ●
- QCA/QVA/LVA /LVA-BP/RVA/3DQCA/Stent enhancer kits are added (CAAS ● Workstation, K133993).
20. SAFETY
The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the IEC60601-1 standards, its collateral standards and particular standards; IEC 60601-2-43 and IEC60601-2-28. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR §1020, that apply to this device, will be met and reported via product report.
LIST OF APPLICABLE STANDARDS
- . IEC 60601-1:2005 +A1:2012
- IEC 60601-1-2:2014
- . IEC 60601-1-3:2008 +A1:2013
- IEC 60601-1-6:2010 +A1:2013
- IEC 60601-2-28:2017 ●
- IEC 60601-2-43:2010 +A1:2017
- IEC 62304:2006 +A1:2015 ●
- IEC 62366:2007 +A1:2014
21. TESTING
This submission contains test data that demonstrates that the system modifications result in performance that is equal to or better than the predicate system. Testing of the modified system was conducted in accordance with the applicable standards published by the International Electromechanical Commission (IEC) for Medical Devices and XR Systems.
Risk analysis and verification/validation testing, conducted through bench testing, are included in this submission which demonstrates that the requirements for the modifications made to the system have been met. Additionally, Image Quality metrics utilizing phantom image evaluations were employed in bench testing which demonstrates that the requirements for the modifications made to the system have been met.
Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission. Software modules were subject to verification and/or validation testing to ensure that they were properly integrated into the existing software platform. Cybersecurity documentation, per the FDA cybersecurity premarket guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" issued on October 2, 2014, is also included as part of this submission. Additionally, the design controls used for this device included risk management and all known risks were mitigated to an acceptable level.
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22. SUBSTANTIAL EQUIVALENCE
The Alphenix, INFX-8000F/B, V8.0, is substantially equivalent to the INFX-8000F (K081624), marketed by Canon Medical Systems USA. The Alphenix, INFX-8000F/B, V8.0, includes system software change from V3.52 to V8.0, tablet console, new examination menu, programing restructuring, multi-phase CBCT (Cone Beam CT), sleep mode, table change, X-ray tube assembly change, 30 cm x 30 cm FPD, specification for system input power change, DFP (Digital Fluoroscopy Processor) hardware changes, wireless footswitch, space improvement, UPS connection kit, Spot Fluoroscopy, 3D Roadmap and Multi-Modality Roadmap, addition of QCA/QVA/LVA /LVA-BP/RVA/3DQCA/Stent enhancer kits.
The basic system configuration, method of operation, base software and manufacturing process remain unchanged from the cleared device. There are no new indications for use or intended use of the device.
23. CONCLUSION
The Alphenix, INFX-8000F/B, V8.0, performs in a manner similar to and is intended for the same use as the predicate device, as indicated in product the labeling. The modifications incorporated into the Alphenix, INFX-8000F/B, V8.0, do not change the indications for use or the intended use of the device. Based upon this information, conformance to standards, successful completion of software validation, application of risk management and design controls and the performance data presented in this submission it is concluded that the subject device is substantially equivalent in safety and effectiveness to the predicate device. It is the contention of Canon Medical Systems Corporation that all new safety issues have been addressed in the design of this change and that adequate evidence of this is presented with this submission.