Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5

K233107 · Canon Medical Systems Corporation · OWB · Aug 30, 2024 · Radiology

Device Facts

• Record ID: K233107
• Device Name: Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5
• Applicant: Canon Medical Systems Corporation
• Product Code: OWB · Radiology
• Decision Date: Aug 30, 2024
• 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-8000V/B, INFX-8000V/S, V9.5) is an interventional X-ray system; consists of C-arm/Ω-arm, X-ray tube, beam limiter, X-ray receptor, controller, patient table, and processing computers. Used in interventional settings by clinicians for diagnostic and angiographic imaging of vasculature (heart, brain, abdomen, lower extremities). System captures X-ray signals; transforms inputs via processing software to produce real-time fluoroscopic and radiographic images. Clinicians use output for visualization during minimally invasive procedures; aids in clinical decision-making and guidance. Benefits include high-quality visualization of blood vessels for interventional procedures.

Clinical Evidence

Bench testing only. Verification and validation testing conducted per IEC standards for medical devices and X-ray systems. Software validation completed. Risk management applied to mitigate all identified risks.

Technological Characteristics

Digital radiography/fluoroscopy system. Components: C-arm/Ω-arm, X-ray tube, beam limiter, X-ray receptor, controller, patient table. 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 62366-1, IEC 81001-5-1, IEC TR 60601-4-2, ISO 17664-2. Conforms to 21 CFR Subchapter J (Federal Diagnostic X-ray Equipment Standard).

Indications for Use

Indicated for patients requiring diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and lower extremities.

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

• Alphenix, INFX-8000V/B, INFX-8000V/S, V9.1 (K203551)

Submission Summary (Full Text)

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August 30, 2024

Canon Medical Systems Corporation % Orlando Tadeo Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems, USA 2441 Michelle Drive TUSTIN, CA 92780

Re: K233107

Trade/Device Name: Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB Dated: August 2, 2024 Received: August 2, 2024

Dear Orlando Tadeo Jr.:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K233107

Device Name Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5

Indications for Use (Describe)

This device is a digital radiography/fluoroscopy system used interventional angography 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)

| <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|----------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## K233107

# EDICAL SYSTEMS USA, INC.

### 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

#### CLASSIFICATION and DEVICE NAME 1.

| 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-8000V/B, INFX-8000V/S, V9.5 |

#### 2. SUBMITTER'S NAME

Canon Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550

#### 3. OFFICIAL CORRESPONDENT

Fumiaki Teshima Senior Manager, Quality Assurance Department

#### 4. CONTACT PERSON, U.S. AGENT and ADDRESS

#### Contact Person

Orlando Tadeo, Jr. Sr. 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 (CMSC) 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan

#### 6. ESTABLISHMENT REGISTRATION 9614698

#### 7. DATE PREPARED September 26, 2023

#### 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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# MEDICAL SYSTEMS USA, INC.

#### 8. TRADE NAME(S)

Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5

#### 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-8000V/B, INFX-8000V/S, V9.1 (K203551)

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

| Trade Proprietary Name | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.1 |
|------------------------|---------------------------------------------|
| Marketed by | Canon Medical Systems USA, Inc. |
| 510(k) Number | K203551 |
| Clearance Date | December 18, 2020 |
| 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-8000V/B, INFX-8000V/S, V9.5, 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/ Ω-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.

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#### 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. 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, IEC60601-2-28, and IEC TR 60601-4-2. 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+A2:2020
- IEC 60601-1-2:2014 + A1:2020
- IEC 60601-1-3:2008+A1:2013+A2:2021 ●
- IEC 60601-1-6:2010+A1:2013+A2:2020
- IEC 60601-2-28:2017
- IEC 60601-2-43:2010+A1:2017+A2:2019
- IEC 62304:2006+A1:2015
- IEC 62366-1:2015 + A1:2020
- IEC 81001-5-1:2021
- ISO 17664-2:2021 ●
- IEC TR 60601-4-2:2016

#### 20. TESTING

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

A Basic Documentation Level was determined, per the FDA guidance document, "Content of Premarket Submissions for Device Software Functions" issued on June 14, 2023, 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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#### 21. SUBSTANTIAL EQUIVALENCE

The Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5 is substantially equivalent to the Alphenix, INFX-8000V/B, INFX-8000V/S, V9.1, which received premarket clearance under K203551, marketed by Canon Medical Systems. Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5, includes modifications to the cleared device consisting of software changes from V9.1 to V9.5, integrating previously cleared functions/components.

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 uses of the device.

#### 22. CONCLUSION

The Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5, 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 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.