INFX-8000V, INFINIX-CFI AND INFINIX VFI

K081582 · Toshiba America Medical Systems, In.C · JAA · Jun 17, 2008 · Radiology

Device Facts

• Record ID: K081582
• Device Name: INFX-8000V, INFINIX-CFI AND INFINIX VFI
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: JAA · Radiology
• Decision Date: Jun 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

This device is a digital x-ray system configured for use as a diagnostic x-ray angiography system. This x-ray angiography system is used for diagnostic and interventional procedures for cardiac blood vessels, cerebral blood vessels, abdominal blood vessels and lower extremities.

Device Story

INFX-8000V (Infinix CFi/VFi) is a digital x-ray angiography system; single or dual plane configurations. System components: x-ray generator, tube, solid-state detector, patient table, support arms, and computer system. Used in clinical settings for diagnostic and interventional procedures involving cardiac, cerebral, abdominal, and lower extremity vasculature. Device captures x-ray signals to produce fluoroscopic and radiographic images. Healthcare providers (physicians/technicians) operate the system to visualize blood vessels; output assists in guiding interventional procedures and diagnostic assessment. Benefits include real-time visualization of vascular anatomy to support minimally invasive interventions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Digital x-ray angiography system; ionizing radiation source. Components: x-ray generator, tube, solid-state detector, patient table, support arms. Conforms to IEC 60601-1, IEC 60601-2-32, IEC 60601-2-28, and 21 CFR Subchapter J. Single or dual plane configuration.

Indications for Use

Indicated for diagnostic and interventional angiographic procedures of cardiac, cerebral, abdominal, and lower extremity blood vessels in patients requiring vascular imaging.

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

• GE Innova 3130 (K060259)
• Toshiba DFP-8000D/FPD (K052884)

Submission Summary (Full Text)

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K081582
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## Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) for INFX-8000V

# 510(k) Summary

| Date: | May 29, 2008<br>JUN 17 2008 |
|---------------------------------------|---------------------------------------------------------------------------------------------|
| Submitter's Name: | Toshiba America Medical Systems, Inc. |
| Submitter's Address: | P.O. Box 2068, 2441 Michelle Drive,<br>Tustin, CA 92781-2068 |
| Submitter's Contact: | Paul Biggins, Director Regulatory Affairs<br>[phone] |
| Establishment Registration<br>Number: | 2020563 |
| Device Proprietary Name: | INFX-8000V (Infinix CFi and Infinix VFi) |
| Common Name: | Electrostatic Fluoroscopic x-ray System)<br>[Fed. Reg. No. 892.1650, Pro. Code: 90MQB] |
| Regulatory Class: | II (per 21 CFR 892.1650) |
| Performance Standard: | 21 CFR Subchapter J,<br>Federal Diagnostic X-ray Equipment Standard |
| Predicate Device(s): | GE Innova 3130; 510(k) Control # k060259<br>Toshiba DFP-8000D/FPD; 510(k) Control # K052884 |
| Reason For Submission | Model Number Change |

#### Description of this Device:

These systems are single or dual plane systems that employ x-rays to obtain fluoroscopy or radiography images of the body. The system is comprised of a computer system, support arms that contain the tube and solid state detector (either one or two), x-ray generator and a patient table.

#### Summary of Intended Uses:

This device is a digital x-ray system configured for use as a diagnostic x-ray angiography system. This x-ray angiography system is used for diagnostic and interventional procedures for cardiac blood vessels, cerebral blood vessels, abdominal blood vessels and lower extremities.

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K081582
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### Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) for INFX-8000V

#### Technological Characteristics:

This device employs similar materials and processes as found in the predicate device. The device produces ionizing radiation that is employed to generate fluoroscopic and radiographic images of the anatomy.

#### Safety and Effectiveness Concerns:

This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820. 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. Additionally this system is in conformance with the applicable parts of the IEC 60601-1 {applicable portions}; IEC 60601-2-32, and IEC 60601-2-28. - Medical Device Safety standards.

#### Substantial Equivalence:

The INFX-8000V is of comparable type and substantially equivalent to:

GE Innova 3130; 510(k) Control # k060259 Toshiba DFP-8000D/FPD; 510(k) Control # K052884

Therefore the INFX-8000V complies with the same or equivalent standards and has the same intended use as the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized image of a human figure, and the text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES".

Public Health Service

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

Toshiba America Medical Systems. Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

AUG 2 0 2013

Re: K081582

Trade/Device Name: INFX-8000V; Infinix-CFi and Infinix-VFí Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA and MOB Dated: June 4, 2008 Received: June 5. 2008

Dear Mr. Job:

This letter corrects our substantially equivalent letter of June 17, 2008.

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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Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) for INFX-8000V

# Indications for Use

510(k) Number (if known):

K081582

Device Name: INFX-8000V; Infinix-CFi and Infinix- VFi

Indications for Use:

This device is a digital radiography/fluoroscopy system used in a diagnostic angiography configuration. This system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Azu Nathing
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Division of Reproductive, Abdominal and Radiological Devices 510(k) Number