Cardiac Output Thermodilution Module
by Abbott Laboratories 510(k)
Active
510(k) K771991
Overview
The Cardiac Output Thermodilution Module is a pre-programmed, single-function diagnostic computer device designed to measure cardiac output using the thermodilution principle. It injects a known volume of cold saline into the venous circulation and calculates cardiac output based on the temperature change detected by a thermistor-tipped catheter in the pulmonary artery. This measurement aids in assessing hemodynamic status, particularly in critical care settings such as intensive care units (ICUs) and operating rooms.
This module is supplied as a standalone component intended for integration with compatible hemodynamic monitoring systems. It is classified as a Class II medical device under FDA regulations (product code DXG) and requires proper calibration and connection to a thermodilution catheter for operation. The device is not sterile and must be handled in accordance with manufacturer guidelines to ensure accurate and reliable performance. No specific MRI safety information is provided, and its use is governed by the original FDA 510(k) clearance (K771991) dated November 3, 1977.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK771991 | Date3 Nov 1977 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DXG
- Regulation
- 21 CFR Part 870.1435
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What is the Cardiac Output Thermodilution Module used for?
The Cardiac Output Thermodilution Module is designed to measure cardiac output using the thermodilution principle. It injects a known volume of cold saline into the venous circulation and calculates cardiac output by detecting the temperature change via a thermistor-tipped catheter placed in the pulmonary artery. This measurement helps clinicians assess hemodynamic status, particularly in critical care settings such as intensive care units (ICUs) and operating rooms.
How is the Cardiac Output Thermodilution Module supplied and used?
The module is supplied as a standalone component and must be integrated with a compatible hemodynamic monitoring system. It is not sterile and requires proper handling to ensure accurate performance. The device operates by connecting to a thermodilution catheter, which must be placed in the pulmonary artery to detect temperature changes accurately.
Is the Cardiac Output Thermodilution Module single-use or reusable?
The device itself is not described as single-use or reusable in the provided data. However, the thermodilution catheter it requires is typically single-use, and the module must be handled in accordance with manufacturer guidelines to maintain accuracy and reliability. Always follow the manufacturer’s instructions for proper use and maintenance.
Does the Cardiac Output Thermodilution Module require calibration?
Yes, the Cardiac Output Thermodilution Module requires proper calibration to ensure accurate measurements. Calibration is essential for reliable performance, as the device relies on precise temperature detection and calculations. Follow the manufacturer’s calibration procedures to maintain optimal functionality.
What regulatory approval does the Cardiac Output Thermodilution Module hold?
The Cardiac Output Thermodilution Module holds FDA 510(k) clearance under the classification of a Class II medical device (product code DXG). The clearance was granted under the traditional review pathway, with the original submission dated November 3, 1977, and the 510(k) number being K771991. This approval indicates that the device is considered substantially equivalent to a legally marketed predicate device.