ENDOSONICS AUTOMATIC PULL BACK DEVICE

K962293 · Endosonics Corp. · ITX · Sep 16, 1996 · Radiology

Device Facts

• Record ID: K962293
• Device Name: ENDOSONICS AUTOMATIC PULL BACK DEVICE
• Applicant: Endosonics Corp.
• Product Code: ITX · Radiology
• Decision Date: Sep 16, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2

Intended Use

The Endosonics Automatic PBD is intended for use as a pull back accessory to the Endosonics Intravascular Ultrasound Imaging catheters. The Automatic Pull Back Device withdraws the imaging catheter from the vessel through the guide catheter.

Device Story

Battery-powered accessory for intravascular ultrasound (IVUS) imaging; used in catheterization laboratory by clinical staff. Device provides uniform, slow withdrawal of imaging catheter from vessel through guide catheter. Linear travel distance ~12 cm; selectable pull-back speeds of 0.5 mm/sec or 1 mm/sec. No direct/indirect patient contact. Facilitates consistent imaging data acquisition by ensuring uniform catheter movement, aiding physician assessment of vessel morphology.

Clinical Evidence

Bench testing only; no clinical data provided. Device is an accessory with no patient contact.

Technological Characteristics

Battery-powered electromechanical device. Linear travel distance ~12 cm. Selectable pull-back rates: 0.5 mm/sec or 1 mm/sec. Constructed of standard medical-grade materials. No patient contact. Standalone operation.

Indications for Use

Indicated for use as a pull back accessory to Endosonics Intravascular Ultrasound Imaging catheters to withdraw the imaging catheter from the vessel through the guide catheter during intravascular ultrasound assessment in the catheterization laboratory.

Regulatory Classification

Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

Predicate Devices

• CVIS Catheter Pull-Back Device
• Intertherapy Interpret Catheter Linear Translator

Submission Summary (Full Text)

{0}

Endosonics Corporation
Automatic Pull Back Device
510(k) Premarket Notification
June 13, 1996

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## ENDOSONICS Automatic Pull Back Device

**K962293**

SEP 16 1996

As an accessory, the Automatic Pull Back Device (PBD) does not affect the safe and effective use of the Endosonics Intravascular Ultrasonic Imaging System or the Endosonics Imaging catheters.

## DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The Automatic PBD is substantially equivalent in intended use and technologic characteristics to cardiovascular accessory devices: the CVIS Catheter Pull-Back Device and the Intertherapy Interpret Catheter Linear Translator. These predicate devices are legally commercially available.

## COMPANY AND CONTACT PERSON

Endosonics Corporation
3078-B Prospect Park Drive
Rancho Cordova, CA 95670

Adam Savakus
Vice President, Clinical and Regulatory Affairs
916-638-8008

## DEVICE NAME

Automatic Pull Back Device

## PREDICATE DEVICE(S)

1. CVIS Catheter Pull-Back Device
2. Intertherapy Interpret Catheter Linear Translator

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{1}

Endosonics Corporation Automatic Pull Back Device
510(k) Premarket Notification June 13, 1996

## DESCRIPTION OF DEVICE

The Automatic PBD is a battery powered device that is used in the catheterization laboratory during intravascular ultrasound assessment. The Automatic PBD has a nominal linear travel distance of approximately 12 cm and provides a uniform, slow pull back rate of the catheter’s imaging element. The speed is selectable between 1 mm/sec or 0.5 mm/sec. The Auto PBD has no direct or indirect patient contact. The device is constructed of materials common to the medical industry for both patient and non-patient contact devices and equipment.

## STATEMENT OF INTENDED USE OF THE DEVICE

The Endosonics Automatic PBD is intended for use as a pull back accessory to the Endosonics Intravascular Ultrasound Imaging catheters. The Automatic Pull Back Device withdraws the imaging catheter from the vessel through the guide catheter.

## INTENDED USE OF PREDICATE DEVICE

1. The Auto PBD is intended to be used as a pull-back accessory to CVIS intravascular ultrasound catheters. The Auto PBD pulls back the imaging element inside the catheter while the outer catheter body is stationary in the vessel.

2. The CVIS Catheter Pull-Back Device is intended to be used for uniform, slow velocity pull-back of intravascular ultrasound catheters.

2. The Intertherapy Interpret Catheter Linear Translator is intended to be used for uniform, slow velocity pull-back of intravascular ultrasound catheters.

## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS BETWEEN DEVICE AND PREDICATE DEVICE

The Automatic PBD and the predicate devices have substantially equivalent technological characteristics (materials, design, specifications, and mode of operation). These accessory devices have no patient contact. The devices are designed so catheters will attach to a movable carriage. The Automatic PBD incorporates pull-back rates comparable to predicate devices.

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