INFX-8000V WITH

K120073 · Toshibamedical Systems Corporation · OWB · Jan 26, 2012 · Radiology

Device Facts

• Record ID: K120073
• Device Name: INFX-8000V WITH
• Applicant: Toshibamedical Systems Corporation
• Product Code: OWB · Radiology
• Decision Date: Jan 26, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

This device is intended to perform interventional studies of the head, body, heart and lower extremities in an angiographic situation. 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

Digital radiography/fluoroscopy system for interventional angiography; utilizes C-arm with X-ray tube, beam limiter, receptor, controller, and computer processing. Modification adds capability to import external CT DICOM images as reference data. Clinicians use 3D roadmapping feature to overlay fluoroscopic images onto imported 3D CT datasets; assists in navigation of catheters and interventional devices. Used in clinical interventional settings; operated by physicians. Benefits include reduced X-ray exposure by utilizing existing CT datasets instead of acquiring new 3D-DSA images. Output displayed to clinician to guide real-time procedural decision-making.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Digital radiography/fluoroscopy system; C-arm configuration. Connectivity via DICOM import for CT datasets. Software-based image fusion/overlay. Conforms to 21 CFR Subchapter J, 21 CFR 1020, IEC standards, and ISO 13485.

Indications for Use

Indicated for diagnostic and interventional angiography procedures of 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

• INFX-8000V (K101868)

Submission Summary (Full Text)

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K120073

JAN 2 6 2012

Toshiba America Medical Systems. Inc Pre-Market Notification 510(k) INFX-8000V; Infinix-V w/3D Roaadmapping

## 510(k) - SUMMARY OF SAFETY AND EFFECTIVENESS

- 1. SUBMITTER'S NAME: Toshiba America Medical Systems. Inc.
- 2. ADDRESS: 2441 Michelle Drive Tustin, CA. 92780-2068

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- 3. ESTABLISHMENT REGISTRATION: 2020563
- 4. CONTACT PERSON: Paul Biggins Director, Regulatory Affairs [phone]
- 5. TRADE NAME(S): INFX-8000V [Infinix-V] w/ 3D Roadmapping
- 6. COMMON NAME: Solid State X-ray System, Interventional
- 7. DEVICE CLASSIFICATION: Class II (per 21 CFR 892.1650)
- 8. PRODUCT CODE / DESCRIPTION: OWB, and JAA, 12/ 12/12/2018
- 9. PERFORMANCE STANDARD: 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard
- 10. PREDICATE DEVICE: INFX-8000V (K101868)
- 11. REASON FOR SUBMISSION:

Modification of a cleared device - 3D Roadmapping is modified to add the use of CT DICOM images to be used as the reference image.

#### 12. DEVICE DESCRIPTION:

This device in 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 , that is equipped with

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an x-ray tube, beam limiter and x-ray receptor, x-ray controller, computers with system and processing software, and a patient radiographic table.

### 13. SUMMARY OF INTENDED USES:

This device is intended to perform interventional studies of the head, body, heart and lower extremities in an angiographic situation.

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.

#### 14. Indication 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

## 15. SUBSTANTIAL EQUIVALENCE:

The modification to this device is to provide the ability to import CT images via the DICOM import function. These images will be used in lieu of the 3D-DSA images that are acquired by the device. This does not change the functionality of the road map features (imposition of fluoroscopy image over the 3D images) which is to aid the clinician in navigating catheters and related in interventional devices.

## 16. 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 IEC standards and its collateral standards. 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 an initial report.

#### 17. CONCLUSION

The INFX-8000V with 3D Roadmapping and CT Image fusion is an improvement to the operation of the current configuration. The use of existing data sets from CT allows the clinician to perform the same task as the cleared configuration without having to make additional x-ray exposures. There are no other significant changes to the hardware or software of this device. Safety is assured through a risk management process and manufacturing is in compliance with the Quality System Regulations.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's emblem on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The emblem is a stylized image of a human figure, and the text is in a blue serif font.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Toshiba Medical Systems Corporation % Mr. Paul Biggins Director Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780

JUL 30 2012

Re: K120073

Trade/Device Name: INFX-8000V, Infinix-V with 3D Roadmap Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA and IZI Dated: January 6, 2012 Received: January 10, 2012

Dear Mr. Biggins:

This letter corrects our substantially equivalent letter of January 26, 2012.

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. 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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use Form

510(k) Number (if known):

Device Name: INFX-8000V, Infinix-V with 3D RoadMap

Indications for Use:

This device is a digital radiography/fluoroscopy system used in a diagnostic 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.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S Pastel

Division Sigh-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K120073

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