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The Transonic HCM102 system is intended for diagnostic assessment of cardiovascular status and circulatory variables in patients aged 1 month and older. This includes COstatus measurements by indicator dilution for quantifying patient's cardiac and volume status as well as continuous cardiac output and associated hemodynamic parameters (such as stroke volume variation; pulse pressure variation, systemic vascular resistance and related index parameters) by continuous arterial pressure waveform analysis. In this system, cardiac output (CO) value from dilution is used to calibrate the pressure wave form and assess continuous cardiac output. In addition the system also measures heart rate, systolic, diastolic pressures, mean arterial pressure and indexed parameters.

In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, Transonic Systems Inc. intends to introduce into interstate commerce the Transonic HCM102 system, which is an apparatus based on ultrasound dilution and arterial pressure waveform analysis to provide diagnostic assessment of cardiovascular status including COstatus (HCM101) measurements by indicator dilution for quantifying patient's cardiac and volume status as well as continuous cardiac output and associated hemodynamic parameters (such as stroke volume variation; pulse pressure variation, systemic vascular resistance and related index parameters) by continuous arterial pressure waveform analysis. In this system, cardiac output is first measured by COstatus (HCM101) system and this is then automatically transferred to calibrate the arterial pressure waveform to obtain continuous cardiac output (when that mode is selected). Thus cardiac output is determined both intermittently through ultrasound technique and continuously through arterial pressure waveform analysis. In addition the system also measures heart rate, systolic, and diastolic pressures and derives mean arterial pressure. These patients could be in the intensive care units (ICU), operating room (OR) or other such environments.

The provided FDA 510(k) summary for the Transonic HCM102 System does not contain acceptance criteria or a study proving that the device meets specific performance criteria in a clinical setting.

The document discusses the device's functionality, its similarity to predicate devices, and general safety and effectiveness testing (IEC 60601-1 and EMC, bench, and animal testing). However, it lacks details on specific performance metrics, clinical study design, sample sizes for test or training sets, ground truth establishment, or expert involvement for assessing the device's accuracy or efficacy in measuring cardiovascular parameters in human patients.

Therefore, I cannot provide the requested information. The document focuses on establishing substantial equivalence based on technical aspects and general safety standards, not on detailed clinical performance data against pre-defined acceptance criteria.

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