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K Number
K072364
Device Name
PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES
Manufacturer
PULSION MEDICAL SYSTEMS AG
Date Cleared
2007-09-19

(28 days)

Product Code
KRB
Regulation Number
870.1915
Type
Special
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Pulsion Pulsiocath Thermodilution Catheter and Pressure Monitoring Kit with Injectate In-Line Sensor are intended for use with the Pulsion PiCCO Cardiac Output System for the measurement of cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour analysis. The Pulsion PiCCO Cardiac Output System with Thermodilution Catheter and Pressure Monitoring Kit with Injectate In-Line sensor is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. Such as patients in surgical, cardiac, and burn specialty units as well as other specialty units where cardiovascular monitoring is desired and patients undergoing surgical interventions of such magnitude that cardiovascular monitoring is necessary.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided document, there is no information about acceptance criteria for a device, a study proving it meets acceptance criteria, or any details related to AI, machine learning, or algorithms.

The document is a US FDA 510(k) clearance letter for the "Pulsion Pulsiocath Thermodilution Catheters and Accessories". It primarily focuses on:

  • Device Name: Pulsion Pulsiocath Thermodilution Catheters and Accessories
  • Regulation Number & Name: 21 CFR 870.1915, Thermodilution Probe
  • Regulatory Class: Class II
  • Product Code: KRB
  • Date of Clearance: September 19, 2007
  • Purpose: The FDA's determination that the device is substantially equivalent to legally marketed predicate devices.
  • Intended Use: For use with the Pulsion PiCCO Cardiac Output System for the measurement of cardiac output by thermodilution method, arterial blood pressure, and cardiac output determination by arterial pulse contour analysis. Indicated for patients requiring cardiovascular and circulatory volume status monitoring.

Therefore, I cannot provide the requested information because it is not present in the given text.

§ 870.1915 Thermodilution probe.

(a)
Identification. A thermodilution probe is a device that monitors cardiac output by use of thermodilution techniques; this device is commonly attached to a catheter that may have one or more probes.(b)
Classification. Class II (performance standards).