HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30)

K964990 · Hitachi Medical Systems America, Inc. · JAA · Feb 26, 1997 · Radiology

Device Facts

• Record ID: K964990
• Device Name: HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30)
• Applicant: Hitachi Medical Systems America, Inc.
• Product Code: JAA · Radiology
• Decision Date: Feb 26, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The Hitachi SX-VA30 C-Arm Fluoroscopic/Angiographic System is intended to visualize anatomical structures by converting a pattern of x-radiation into an image through electronic amplification and recording, and, when used with injection of contrast medium, to visualize the heart or blood vessels.

Device Story

Ceiling-suspended single-plane C-arm system for angiographic/fluoroscopic imaging. Inputs: X-radiation patterns converted to electronic images. Components: High-voltage generator, X-ray tube, digital subtraction angiography (DSA) system, ceiling-traveling support, control electronics, display/table-side panels. Operation: C-arm rotates around isocenter for whole-body imaging (head to foot). Output: Real-time fluoroscopic/radiographic images displayed for clinician monitoring during procedures. Usage: Clinical setting (e.g., interventional suites); operated by physicians/technicians. Benefit: Enables visualization of anatomical structures and vasculature; real-time monitoring reduces need for repeat studies.

Clinical Evidence

Bench testing only. Compliance verified against electrical safety standards, JIS Z 4701-1988 (General Rules for Medical X-Ray Equipment), and FDA Performance Standards for Ionizing Radiation Emitting Products (21 CFR 1020), specifically 21 CFR 1020.32 for fluoroscopic equipment.

Technological Characteristics

Ceiling-suspended C-arm; X-ray imaging system. Components: High-voltage generator, X-ray tube, collimator, receptor, and digital processing system. Connectivity: Digital imaging system with optional conventional film radiography. Standards: JIS Z 4701-1988, 21 CFR 1020.32.

Indications for Use

Indicated for patients requiring angiographic and related diagnostic and therapeutic procedures involving fluoroscopic and radiographic imaging of anatomical structures, including the heart and blood vessels via contrast medium.

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

• Hitachi SF-VA100 (K945400)
• Philips Medical Systems Integris V3000 (K923813)

Submission Summary (Full Text)

{0}

FEB 26 1997

# 510(k) Summary

K964990

# Hitachi SX-VA30

Common/Classification Name: Angiographic X-ray System, 21 CFR 892.1600

Hitachi Medical Systems America, Inc.
1963 Case Parkway
Twinsburg, OH 44087
216-425-1313, 216-425-1410 (FAX)
Contact: John T. Newland, Prepared: November 26, 1996

## A. LEGALLY MARKETED PREDICATE DEVICES

The Hitachi SX-VA30 C-Arm Angiographic/Fluoroscopic System is substantially equivalent to the presently marketed Hitachi SF-VA100 as distributed by Hitachi Medical Systems America (as cleared in K945400) and the Philips Medical Systems Integris V3000 (K923813). The SX-VA30 is manufactured by Hitachi Medical Corporation, Hitachi Hagoromo Building, 1-2-10 Uchi-Kanda, Chiyoda-Ku, Tokyo, 101, Japan. This 510(k) is submitted because the SX-VA30 is a new device.

## B. DEVICE DESCRIPTION

The Hitachi SX-VA30 C-Arm Angiographic/Fluoroscopic System is a single plane, ceiling suspended C-Arm system intended for angiographic and related diagnostic and therapeutic procedures requiring fluoroscopic and radiographic imaging. It is configured with other components such as high voltage generator, x-ray tube assembly, DSA system, etc., to form a complete fluoroscopy and angiography system. The C-arm is disposed on the isocenter and is movable in a wide range to permit studies of the patient's whole body from the head to the foot from a number of angles.

The SX-VA30 system consists of the SX-VA30 Ceiling-traveling C-Arm Support with ceiling track rails, the control electronics box, the display panel, and the table-side control panel. The SX-VA30 is also configured with the DFA-100-30 digital subtraction angiography system, and several other components which have been previously cleared by FDA as a part of K945400.

While the system is configured with a digital imaging system as

000034

{1}

standard, conventional film radiography may be employed as an option.

In the digital domain, acquired images may be stored in a variety of formats. During acquisition cycles, the progress of the study can be monitored as it occurs, largely eliminating the need for studies to be redone.

## C. INTENDED USE

The Hitachi SX-VA30 C-Arm Fluoroscopic/Angiographic System is intended to visualize anatomical structures by converting a pattern of x-radiation into an image through electronic amplification and recording, and, when used with injection of contrast medium, to visualize the heart or blood vessels.

## D. SUBSTANTIAL EQUIVALENCE SUMMARY

The Hitachi SX-VA30 has the same intended use and target population as the predicate devices, and has equivalent effectiveness for its intended use.

## E. TECHNOLOGICAL CHARACTERISTICS

The technological characteristics of the Hitachi SX-VA30 are the same as for the Philips Integris V3000 C-Arm system, and except for the support system, are the same as for the SF-VA100.

Subsystem components such as X-ray generators, X-ray tubes, X-ray columnators and receptors, and digital processing systems are identical or very similar to the corresponding components of the SF-VA100.

Most of the differences between the predicate devices and the SX-VA30 are in areas of incremental improvements and have been gained using technology common to both designs.

## F. TESTING

The SX-VA30 was tested in the same manner as was the previously cleared SF-VA100. This testing addressed the following issues:

(1) Electrical Safety;
(2) Conformance to the General Rules for Medical X-Ray Equipment, JIS Z 4701-1988 (Japanese Industrial Standard); and
(3) Conformance to the applicable provisions of the FDA Performance

000035

{2}

Standards for Ionizing Radiation Emitting Products (21 CFR 1020), particularly the section for Fluoroscopic Equipment (21 CFR 1020.32).

## G. CONCLUSIONS

Hitachi Medical Systems America has demonstrated that the Hitachi SX-VA30 is substantially equivalent to the Hitachi SF-VA100 and the Philips Integris V3000.

000036