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Indications for use E-PiCCO Continuous Cardiac Output Module: The E-PiCCO is intended for determination and monitoring of cardiopulmonary and circulatory variables. Cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. In addition, the E-PiCCO measures systolic, and diastolic and derives mean arterial pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered. the compatible patient monitor presents the derived parameters indexed to body surface area. The E-PiCCO is intended for hospitalized patients. The E-PiCCO and accessories are for use by qualified medical personnel only. The E-PiCCO patient module is intended for use on one patient at a time. Cardiac output measurement with E-PiCCO is intended for patients weighing over 2 kg (4.4 lb) and therefore it is not available for smaller patients. E-PiCCO indexed values are available for patients weighing over 15 kg (33 lb) only.

Indications for use PiCCO Continuous Cardiac Output Cable (M1154585): The reusable, continuous cardiac output adapter cables are intended to be used for connecting a continuous cardiac output catheter to GE Medical Systems Information Technologies monitoring equipment requiring a rectangular 11-pin connector cable. These accessories are indicated for use by qualified medical personnel only.

Indications for use PiCCO Injectate Sensor Cable (M1182448): The reusable PiCCO Injectate Sensor Cable (M1182448) is intended to be used for connecting the PiCCO Injectate Sensor Housing (PV4046) to PiCCO Continuous Cardiac Output Cable (M1154585) of GE Healthcare monitoring equipment. These accessories are indicated for use by qualified medical personnel only.

The E-PiCCO Continuous Cardiac Output Module and accessories is a new, single width E-series plug-in parameter module for pulse contour continuous cardiac output (PCCO) measurement and associated parameters. E-PiCCO Continuous Cardiac Output Module and accessories uses interconnect cables for both for injected bolus temperature measurement and for continuous cardiac output measurement. Patient access is via a clinician inserted arterial catheter, provided by Pulsion Medical Systems AG. The E-PiCCO Continuous Cardiac Output Module and accessories can be used with the CARESCAPE Monitor B850 with ESP V2 software, the CARESCAPE Monitor B650 with ESP V2 software and CARESCAPE Monitor B450 with ESP V2 software.

The provided text does not contain information about acceptance criteria and a study proving a device meets them. Instead, it is a 510(k) summary for the GE Healthcare E-PiCCO Continuous Cardiac Output Module and accessories, focusing on regulatory information, device description, intended use, and a determination of substantial equivalence to a predicate device.

Specifically, the document states: "The subject of this premarket submission, the E-PiCCO Continuous Cardiac Output Module and accessories did not require clinical studies to support substantial equivalence." This means no clinical study, with acceptance criteria, sample sizes, ground truth, or MRMC analysis, was conducted or reported in this submission for this device.

The study described here relates to non-clinical tests focused on quality assurance, risk analysis, requirements reviews, design reviews, and various levels of testing (unit, integration, final acceptance, performance, safety) to ensure compliance with relevant IEC standards. However, these are not tied to specific performance metrics or acceptance criteria as would be found in a clinical study report.

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