(30 days)
No
The document does not mention AI, ML, or related terms like deep learning or neural networks in the device description, intended use, or performance studies. The focus is on hardware and software changes for image processing and system operability.
No.
The device is described as a diagnostic and interventional angiography system used for diagnostic purposes of blood vessels, not for therapeutic treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "used in a diagnostic and interventional angiography configuration" and "is indicated for use in diagnostic and angiographic procedures."
No
The device description explicitly states it is an "X-ray system" consisting of hardware components like a C-arm, X-ray tube, beam limiter, X-ray receptor, X-ray controller, and computers, in addition to software. The description of the DFP also mentions hardware changes.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states this device is a digital radiography/fluoroscopy system that uses X-rays to image blood vessels within the body. It is used in diagnostic and interventional procedures.
- No Sample Analysis: There is no mention of the device analyzing samples taken from the body. Its function is to generate images through external radiation.
Therefore, this device falls under the category of a medical imaging system, not an in vitro diagnostic device.
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 (comma separated list FDA assigned to the subject device)
OWB
Device Description
The Alphenix, INFX-8000H/B, V8.0, is an 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 which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and processing software.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray, angiography
Anatomical Site
heart, brain, abdomen and lower extremities (for blood vessels)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
interventional setting (Prescription Use)
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
Risk analysis and verification/validation testing conducted through bench testing demonstrate that the established specifications for the device have been met. Testing included conformity testing to IEC standards and phantom testing was conducted to verify image metrics related to improvements in image quality. Clinical images were deemed not necessary for the aforementioned improvements via design control and risk management activities. 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Risk analysis and verification/validation testing conducted through bench testing demonstrate that the established specifications for the device have been met. Testing included conformity testing to IEC standards and phantom testing was conducted to verify image metrics related to improvements in image quality. Clinical images were deemed not necessary for the aforementioned improvements via design control and risk management activities.
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.
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Canon Medical Systems Corporation % Janine Reyes Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive TUSTIN, CA 92780
October 17, 2018
Re: K182546
Trade/Device Name: Alphenix, INFX-8000H/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: September 13, 2018 Received: September 17, 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 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
1
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 (OS) 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 mediation-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,
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
2
Indications for Use
510(k) Number (if known)
Device Name
Alphenix, INFX-8000H/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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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-8000H/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 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
6. ESTABLISHMENT REGISTRATION 9614698
-
- DATE PREPARED September 13th, 2018
8. TRADE NAME(S)
Alphenix, INFX-8000H/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
4
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-8000H, V3.52 (K082830) Reference Predicate Device (added software functionalities): Alphenix, INFX-8000V/B, V8.0 (K181670)
TABLE 1: Primary Predicate Device
| Trade Proprietary Name | Infinix, INFX-8000H, V3.52 |
|---|---|
| Marketed by | Canon Medical Systems USA, Inc. |
| 510(k) Number | K082830 |
| Clearance Date | October 10th, 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-8000H/B, V8.0, is an 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 which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and processing software.
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.
5
Made For life
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. .
- . 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.
- . Fluoroscopy Roadmapping: DSA workflow improvement enables automatic display of subtracted images after completion of mask generation.
Component Change:
- CAS-930A C-arm support is added
- . DSRX-T7445GFS X-ray tube assembly is added
- Beam Limiting Devices is changed from BLA-800C to BLA-900C and BLA-800A to BLA-900A.
- High DQE type FPDs (20cm x 20cm, 30cm x 30cm x 40cm) are added.
- Grid Material Change from an aluminum to a fiber grid (TFP-1216A/A1 and TFP-1216A/C1)
- 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 (XBFS-880WS) is added. Previously cleared under K143225.
- 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 (XABT-UPS804). Previously cleared under K181670.
- . High DQE Flat Panel Detectors (FPD):
6
Made For life
Application Change:
- Rotational Angiography, 3D-Angio and Low Contrast Imaging rotational radiography ● techniques are available
- . Spot Fluoroscopy function is added.
- . 3D Roadmap function is 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
Risk analysis and verification/validation testing conducted through bench testing demonstrate that the established specifications for the device have been met. Testing included conformity testing to IEC standards and phantom testing was conducted to verify image metrics related to improvements in image quality. Clinical images were deemed not necessary for the aforementioned improvements via design control and risk management activities.
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.
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.
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.
7
Additionally, the design controls used for this device included risk management and all known risks were mitigated to an acceptable level.
22. SUBSTANTIAL EQUIVALENCE
The Alphenix, INFX-8000H/B, V8.0, is substantially equivalent to the INFX-8000H (K082830), marketed by Canon Medical Systems USA. The Alphenix, INFX-8000H/B, V8.0, includes system software change from V3.52 to V8.0, new examination menu, programing restructuring, multi-phase CBCT (Cone Beam CT), sleep mode, fluoroscopy roadmapping improvements, CAS-930A C-arm support, DSRX-T7445GFS X-ray tube assembly, beam limiting device changed from BLA-800C to BLA-900C and BLA-800A to BLA-900A, high DQE type FPDs TFP-800A/C1 (previously cleared under K152697), TFP-1216A/C1 (previously cleared under K152697), and TFP-1200A/C1 (previously cleared under K133535), grid material change from an aluminum to a fiber grid (TFP-1200A/C1 and TFP-1216A/C1), specification for system input power change, DFP (Digital Fluoroscopy Processor) hardware changes, wireless footswitch XBFS-880WS (previously cleared under K143225), space improvement, UPS connection kit XABT-UPS804 (previously cleared under K181670), Rotational Angiography, 3D-Angio and Low Contrast Imaging, Spot Fluoroscopy, 3D 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-8000H/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-8000H/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.