FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P)

K963248 · J-Lloyd Medical, Inc. · DYG · Feb 3, 1997 · Cardiovascular

Device Facts

• Record ID: K963248
• Device Name: FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P)
• Applicant: J-Lloyd Medical, Inc.
• Product Code: DYG · Cardiovascular
• Decision Date: Feb 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1240
• Device Class: Class 2

Intended Use

The J-Lloyd catheter is intended to provide a means to obtain right heart pressure readings from various parts of the right heart and cardiac output.

Device Story

Flow-directed thermodilution/infusion balloon catheter; used for right heart pressure monitoring and cardiac output measurement. Device inserted into right heart; physician-operated. Provides pressure readings and cardiac output data to assist clinical decision-making during invasive cardiac procedures. Benefits include diagnostic monitoring of cardiac function.

Clinical Evidence

Bench testing only. Tests evaluated material strength, bond joint tensile pressure, balloon burst strength, and injection rates.

Technological Characteristics

Flow-directed thermodilution/infusion balloon catheter. Materials exceed required strength specifications. Mechanical design includes balloon component for flow direction and infusion ports for pressure/cardiac output measurement.

Indications for Use

Indicated for patients requiring right heart pressure monitoring and cardiac output measurement; intended for use by trained physicians.

Regulatory Classification

Identification

A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.

Predicate Devices

• Nova Medical Specialties, Inc. Flow Directed Thermodilution / Infusion Balloon Catheter

Submission Summary (Full Text)

{0}

K963248

# Summary of Safety and Effectiveness

Ref: Flow Directed Thermodilution / Infusion Balloon Catheter By J-Lloyd Medical, Inc.

FEB - 3 1997

The effectiveness of the J-Lloyd catheter is equivalent to the Nova Medical Specialties, Inc. design, in that they both perform their designed functions, which is to provide a means to obtain right heart pressure readings from various parts of the right heart and cardiac output. Test indicate that the materials used in both catheters exceed the strength required. The bond joints will withstand tensile pressures in excess of that required for safety and effectiveness. Tests for other design characteristics such as balloon burst strength, and injection rate showed little of significance. As with any invasive procedure, there are certain inherent hazards. These hazards have been identified in the instruction sheet under the titles of Precautions and Warnings. it is important that the physicians be aware of the basic principles involved prior to using these devices in their varied application.

Engineering tests of the design indicate the effectiveness and safety of these devices present an acceptable level of safety when properly used by a trained physician.