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.

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.

AI/ML Overview

This document describes the Alphenix, INFX-8000H/B, V8.0, an X-ray system. The information provided heavily emphasizes device changes and regulatory compliance, but does not contain the specific details required to answer your questions about acceptance criteria performance and the study that proves the device meets them.

This is a 510(k) Premarket Notification Summary, which primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device. It highlights modifications to an existing device (Alphenix, INFX-8000H, V3.52 to V8.0) rather than a de novo submission of a novel device requiring a full clinical trial for performance validation against specific acceptance criteria.

Therefore, the following information cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance: The document states "Testing included conformity testing to IEC standards and phantom testing was conducted to verify image metrics related to improvements in image quality" and "This submission contains test data that demonstrates that the system modifications result in performance that is equal to or better than the predicate system." However, it does not provide specific acceptance values or detailed performance metrics.
Sample size used for the test set and the data provenance: The document mentions "phantom testing" but no details on the number of phantoms or the nature of the data. It explicitly states "Clinical images were deemed not necessary for the aforementioned improvements via design control and risk management activities." This implies no human patient data was used for testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as clinical images were not used.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: The document states "Clinical images were deemed not necessary," which indicates an MRMC study was not performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is an X-ray system, not an AI algorithm for diagnosis. Performance is measured by image quality and system functionality, not diagnostic accuracy of an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth, if any, for phantom testing would be based on known phantom characteristics, not clinical ground truth methods.
The sample size for the training set: Not applicable. This is a medical imaging hardware system with associated control software, not a machine learning model that requires a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document focuses on regulatory compliance, engineering changes, and demonstrating that the updated X-ray system maintains the safety and effectiveness of its predicate device, primarily through bench and phantom testing against engineering specifications and industry standards. It does not contain information about studies designed to prove device performance against specific clinical acceptance criteria using human data, as would be expected for a novel diagnostic AI algorithm.

Summary

{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)

K182546

Device Name

Alphenix, INFX-8000H/B, V8.0

Indications for Use (Describe)

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

1. 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

18. INDICATIONS FOR USE

{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):
- o TFP-800A/C1 (20 cm x 20 cm / 8 in x 8 in). Previously cleared under K152697 o TFP-1216A/C1 (30 cm x 40 cm / 12 in x 16 in). Previously cleared under K152697 o TFP-1200A/C1 (30 cm x 30 cm / 12 in x 12 in). Previously cleared under K133535

{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.

Regulation Number and Section

§ 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.