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-8000C/B, INFX-8000C/S, V9.2, 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, and a patient radiographic table.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a modified medical device, the Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2. It focuses on demonstrating substantial equivalence to a predicate device (Alphenix, INFX-8000C/B, V8.0 K181804). The submission primarily discusses changes to software and hardware and verification and validation testing, rather than an acceptance criteria study with clinical performance metrics that would typically be seen for AI-based devices.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test sets, expert involvement, and ground truth establishment, which are common for AI/ML device studies, are not explicitly provided in this document. This submission is for a modification of an X-ray system, not a new AI algorithm.

However, I can extract the information that is present and indicate what is not available based on the provided text.

Acceptance Criteria and Device Performance

The document does not specify quantitative acceptance criteria for image quality or clinical performance that would typically be reported for an AI device. Instead, it refers to:

Conformance to standards: "This device conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard]." and "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."
Verification/validation testing: "Risk analysis and verification/validation testing conducted through bench testing demonstrate that the established specifications for the device have been met."
Phantom testing: "Phantom testing was conducted to verify image metrics related to improvements and changes to the predicate device."
Substantial equivalence: The overall goal is to demonstrate that "the system modifications result in performance that is equal to or better than the predicate system."

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category (Derived from text)	Specific Criteria (from text)	Reported Device Performance/Conclusion
Conformance to Regulations/Standards	- Applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard].- IEC 60601-1, IEC 60601-2-43, IEC 60601-2-28.- ANSI AAMI ES 60601-1:2005/(R)2012+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	"All requirements of the Federal Diagnostic Equipment Standard... will be met and reported via product report.""Testing of the modified system was conducted in accordance with the applicable standards..."
System Specifications	- Established specifications for the device.- Performance equal to or better than the predicate system.	"Risk analysis and verification/validation testing conducted through bench testing demonstrate that the established specifications for the device have been met.""This submission contains test data that demonstrates that the system modifications result in performance that is equal to or better than the predicate system."
Image Quality	- Verified image metrics related to improvements and changes to the predicate device.	"Phantom testing was conducted to verify image metrics related to improvements and changes to the predicate device."No specific quantitative metrics (e.g., SNR, contrast) are provided in this summary.
Software Validation	- Software Documentation for a Moderate Level of Concern, per FDA guidance.- Application of risk management and design controls that mitigated all known risks to an acceptable level.	"Successful completion of software validation, application of risk management and design controls...""Software Documentation... is also included as part of this submission.""all known risks were mitigated to an acceptable level."
Substantial Equivalence	- Modifications do not change the indications for use or the intended use of the device.	"The Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2, is substantially equivalent to the Alphenix, INFX-8000C/B, V8.0... The modifications incorporated do not change the indications for use or the intended use of the device.""It is concluded that the subject device is substantially equivalent in safety and effectiveness to the predicate device."

Additional Study Details:

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions "bench testing" and "phantom testing" but does not give the number of cases or phantoms used.
- Data Provenance: Not specified, but given it's phantom testing, it's synthetic/controlled data rather than patient data. The context (Canon Medical Systems Corporation, Japan) suggests testing likely occurred in a controlled environment by the manufacturer. It's not retrospective or prospective in the clinical sense, as it refers to engineering and phantom tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. For phantom testing of an X-ray system, ground truth is typically established by the known physical properties of the phantom and the expected image output based on system specifications, rather than expert interpretation of images. Clinical images and expert review were "deemed not necessary."
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/None specified. The testing described is technical verification and validation, not a reader study requiring adjudication of diagnostic interpretations.
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. This was not an AI device or an MRMC study. The device is an "Image-Intensified Fluoroscopic X-ray System." The software changes primarily relate to "improved usability," "operating system update," "AlphaCT IQ improvement," "2D IQ Improvement," "Dose optimization," and "ABC control optimization," rather than AI-driven diagnostic assistance. The document explicitly states "Clinical images were deemed not necessary for the aforementioned improvements via design control and risk management activities."
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a complete X-ray system, not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the technical validation described, the "ground truth" would be the known physical parameters of the phantoms and the objective measurements of the system's output (e.g., image metrics like resolution, contrast, dose, specified by engineering requirements). "Clinical images were deemed not necessary," so no pathology or outcomes data was used for this validation.
The sample size for the training set:
- Not applicable. This is not an AI/ML algorithm that requires a training set in the typical sense. The software updates are improvements to system control, image processing, and usability, based on design and engineering principles rather than machine learning from large datasets.
How the ground truth for the training set was established:
- Not applicable, as there is no mention of an AI training set.

Summary

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April 12, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. The full name is "U.S. FOOD & DRUG ADMINISTRATION".

Canon Medical Systems Corporation % Ms. Janine Reyes Manager, Regulatory Affairs Canon Medical Systems USA, INC. 2441 Michelle Drive TUSTIN CA 92780

Re: K210900

Trade/Device Name: Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB Dated: March 23, 2021 Received: March 26, 2021

Dear Ms. 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 mav 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.

Michael D. O'Hara 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K210900

Device Name

Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2

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."

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Image /page/3/Picture/0 description: The image shows the logo for Canon Medical Systems USA, Inc. The word "Canon" is written in red, with the rest of the text in black. The text is aligned to the left.

Made For life

K210900

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-8000C/B, INFX-8000C/S, V9.2

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

1. ESTABLISHMENT REGISTRATION 9614698
1. DATE PREPARED March 23, 2021
1. TRADE NAME(S) Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2

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

Alphenix, INFX-8000C/B, V8.0 (K181804)

TABLE 1: Predicate Device

Trade Proprietary Name	Alphenix, INFX-8000C/B, V8.0
Marketed by	Canon Medical Systems USA, Inc.
510(k) Number	K181804
Clearance Date	August 2, 2018
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

Special 510(k)

17. DEVICE DESCRIPTION

18. INDICATIONS FOR USE

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19. SUMMARY OF CHANGE(S)

This submission is to report the following items have been changed:

Summary of Software Changes:

V9.2 Software: System software changed from V8.0 to V9.2 for improved usability and . to support the new Angio X-ray tube, DSRX-T7735GFS.
. Summary of other software changes since K181804:

V8.0 to V8.3

o Pulsed fluoroscopy improvement
o Usability/operability improvement
o Service improvements (non-clinical)

V8.3 to V9.0

o Operating system update from Windows 7 to Windows 10
o AlphaCT IQ improvement
o 2D IQ Improvement
o Dose optimization for DSA and spot fluoroscopy
o Usability/operability improvement
o Service improvements (non-clinical)
· Cybersecurity improvement

V9.0 to V9.1

o ABC control is optimized for the Cardiac X-ray Tube, DSRX-T7634GFS
o Changes related to the combination of the Cardiac X-ray Tube, DSRX-T7634GFS
Changes related to the combination of the Hi-Def (aSi/CMOS) FPD, TFP-1216C/A1

V9.1 to V9.2

o ABC control is optimized for the Angio X-ray Tube, DSRX-T7735GFS
o Changes related to the combination of the Angio X-ray Tube, DSRX-T7735GFS
o Multi gain for the Hi-Def (aSi/CMOS) FPD, TFP-1216C/A1
o Usability/operability improvement
o Functionality improvement
o Service improvements (non-clinical)
o Support of new dosimeter

Summary of Hardware Changes:

. Angio X-ray Tube, DSRX-T7735GFS (subject modification)
This X-ray tube replaces the previous Angio X-ray tube, DSRX-T7345GFS. The changes to this tube are as follows:
o A change in the Radiography small focal spot maximum mA from 180 mA to 250 mA.
A change in the Pulsed Fluoroscopy small focal spot maximum mA from 50 mA to 120 mA.
o A change in the Radiography 0.1s small focal spot maximum input from 17 kW to 28 kW.
o A change in the Pulsed Fluoroscopy medium focal spot maximum input from 16 kW to 20 kW.
A change in the Pulsed Fluoroscopy small focal spot maximum input from 5.5 kW to 14.4 kW.

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. Summary of other hardware changes since K181804:

Cardiac X-ray Tube, DSRX-T7634GFS (K203551)

This X-ray tube replaces the previous X-ray tube, DSRX-T7444GDS. The changes to this tube are as follows:

o A change in the instantaneous output at 10% power to 28.8 kW from the previous 22kW.
o A change in the pulsed fluoroscopy maximum mA from 200 mA to 320 mA.

X-ray Generator Modification

o Increase in pulsed fluoroscopy peak power (kW) for cardiac X-ray tube DRSX-T7444GDS from 17 kW to 22 kW at duty factor of 10% or less.
o X-ray generator modification to reduce the heat generation in the power circuit.
o Change of the supplemental symbol for the DSRX-T7444GDS from RUB to RXB when used in conjunction with this X-ray generator modification.

Usability/Operability Improvements

Enabled one shot radiography at every acquisition program (DA, DSA, etc.) using footswitch.
o Modified table side consoles are available.

Combination with the Hi-Def (aSi/CMOS) FPD, TFP-1216C/A1

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

. ANSI AAMI ES 60601-1:2005/(R)2012+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 and changes to the predicate device. 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.

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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.

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-8000C/B, INFX-8000C/S, V9.2, is substantially equivalent to the Alphenix, INFX-8000C/B, V8.0, (181804), marketed by Canon Medical Systems USA, Inc. The Alphenix, INFX-8000C/B, /S, V9.2, includes system software change from V8.0 to V9.2, new Angio X-ray tube, usability improvements and operability improvements. 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-8000C/B, INFX-8000C/S, V9.2, 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 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.