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

K181804 · Canon Medical Systems Corporation · OWB · Aug 2, 2018 · Radiology

Device Facts

• Record ID: K181804
• Device Name: Alphenix, INFX-8000C/B, V8.0
• Applicant: Canon Medical Systems Corporation
• Product Code: OWB · Radiology
• Decision Date: Aug 2, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended 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.

Device Story

Alphenix INFX-8000C/B V8.0 is an interventional fluoroscopic X-ray system; utilizes C-arm with X-ray tube, beam limiter, and receptor to acquire radiographic/fluoroscopic images. System includes patient table, X-ray controller, and workstation. Operated by clinicians in interventional settings. New features include tablet console for remote examination control (program selection, auto-positioning, playback, image switching), AlphaCT (CBCT) programs, multi-phase CBCT, and improved DSA roadmapping workflow. Hardware upgrades to Digital Fluoroscopy Processor (DFP) enhance image quality and system operability. Output displayed on monitors for real-time guidance during diagnostic and interventional vascular procedures. Benefits include improved workflow, reduced machine room space, and enhanced image quality for clinical decision-making.

Clinical Evidence

Bench testing only. Performance evaluated using phantoms to assess spatial resolution, low-contrast resolution, dynamic range, and DSA artifacts. Validated image quality for 3D-DA, 3D-DSA, and AlphaCT acquisitions. Software validation and cybersecurity documentation provided per FDA guidance. No clinical data presented.

Technological Characteristics

Digital radiography/fluoroscopy system; C-arm configuration. Components: X-ray tube, beam limiter, receptor, DFP hardware. Connectivity: Networked workstation, tablet console. Power: 400V input. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-28, IEC 60601-2-43, IEC 62304, IEC 62366. Software: Moderate level of concern.

Indications for Use

Indicated for diagnostic and angiographic procedures of blood vessels in the heart, brain, abdomen, and lower extremities in patients requiring digital radiography/fluoroscopy.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Infinix, INFX-8000C, V6.20 (K152697)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA) along with the Department of Health & Human Services. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. To the left of the FDA logo is the Department of Health & Human Services logo, which consists of a stylized human figure and the words 'DEPARTMENT OF HEALTH & HUMAN SERVICES-USA' arranged around it.

August 2, 2018

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

Re: K181804

Trade/Device Name: Alphenix, INFX-8000C/B, V8.0 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB Dated: July 5, 2018 Received: July 6, 2018

Dear Ms. Reves:

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

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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 (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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Hse 2. Mild

Robert 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K181804

Device Name

Alphenix, INFX-8000C/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 [e-mail]

"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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# 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, 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: [phone] Fax: [phone] [e-mail]

# 5. MANUFACTURING SITE

Canon Medical Systems Corporation (TMSC) 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan

# 6. ESTABLISHMENT REGISTRATION 9614698

- 7. DATE PREPARED July 5th, 2018
# 8. TRADE NAME(S)

Alphenix, INFX-8000C/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: [phone] Fax: [phone] [e-mail]

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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

Infinix, INFX-8000C, V6.20 (K152697)

| TABLE 1: Predicate Device | |
|---------------------------|--|
|---------------------------|--|

| Trade Proprietary Name | Infinix, INFX-8000C, V6.20 |
|------------------------|---------------------------------------------|
| Marketed by | Canon Medical Systems USA, Inc. |
| 510(k) Number | K152697 |
| Clearance Date | January 15, 2016 |
| 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-8000C/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, 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.

#### 19. SUMMARY OF CHANGE(S)

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

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# DICAL SYSTEMS USA, INC.

*Made For life*

- . V8.0 Software: System software changed from V6.20 to V8.0 for improved usability.
- Tablet Console: used in combination with the Alphenix, INFX-8000C/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.
- UPS (Uninterruptible Power System) Connection Kit ●
- . Specification for System Input Power: system input power is changed from 400V and 200V to 400V only.
- Auto-Angle: table top longitudinal axis is added to the Auto-Angle feature
- . Space Improvement: to reduce machine room space requirements, racks were introduced for the chiller, water-cooled heat exchanger and large screen monitor system.
- . Fluoroscopy Roadmapping: DSA workflow improvement enables automatic display of subtracted images after completion of mask generation.
- . 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.

#### 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 ●

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# 21. TESTING

Risk analysis and verification/validation testing conducted through bench testing demonstrate that the established specifications for the device have been met.

# System evaluation of image quality:

Image quality metrics were performed, utilizing phantoms, to asses spatial resolution, low-contrast resolution/dynamic range, fluoroscopic still image resolution/dynamic image resolution/afterimage, artifacts/contrast/dynamic range of DSA, reconstructed image spatial resolution in 3D-DA acquisition, reconstructed image spatial resolution in 3D-DSA acquisition, reconstructed image spatial resolution in AlphaCT Vessel acquisition, reconstructed image spatial resolution in AlphaCT acquisition, reconstructed image density resolution in AlphaCT acquisition.

# Evaluation of items supported to improve image quality:

Image quality metrics were performed, utilizing phantoms, to assess image quality improvements, improvement in fluoroscopy roadmapping and multiphase AlphaCT acquisition.

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.

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, V8.0, is substantially equivalent to the INFX-8000C, V6.20, (K152697), marketed by Canon Medical Systems USA. The Alphenix, INFX-8000C/B, V8.0, includes system software change from V6.20 to V8.0, tablet console, new examination menu, longitudinal axis added to Auto Angle feature, programing restructuring, multi-phase CBCT (Cone Beam CT), sleep mode, UPS connection kit, specification for system input power change, space improvement, fluoroscopy roadmapping DSA workflow improvement, DFP (Digital Fluoroscopy Processor) hardware changes.

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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, 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-8000C/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.