Search Results

Transonic Systems' BLF22 and BLF22A tissue perfusion monitors are intended for use in the measurement of microvascular perfusion.

The BLF22 (single-channel) Tissue Perfusion Monitor reports Flow, Mass or Velocity on its front panel digital display. Housed in a small metal case, the Monitor is equipped with a convenient multi-position handle/stand. It also features: rear panel analog outputs for Flow/Mass/Velocity in 0 - 10 Volts DC; and a USB computer interface. The BLF22A (single-channel + Indicator Tone) Tissue Perfusion Monitor incorporates all the functionality of the BLF22, plus adjustable Low Flow Indicator Tone circuitry. This will sound an audio signal when tissue perfusion flow drops below a preset level.

The intended use of the ELSA system is to provide clinically relevant data to healthcare providers treating neonatal, pediatric, adult patients with arterial and venous lines for routine monitoring of diagnostic parameters: Delivered Flow; Recirculation: Oxygenator Blood Volume and other associated hemodynamic 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 ELSA system, which is an apparatus based on transit time ultrasound indicator dilution techniques that provides clinically relevant data to healthcare providers treating patients undergoing Extracorporeal Life Support Procedures. The clinically relevant data (such as delivered flow, recirculation, oxygenator blood volume and other related hemodynamic parameters), shall indicate the efficacy of such procedures and quantify the patient's hemodynamic status. These patients could be in the intensive care units (ICU), operating room (OR) or other such environments.

The Transonic HCM103 system is intended for diagnostic assessment of cardiovascular status and circulatory variables in patients aged 1 month and older. The measurements include 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 stand-alone system, cardiac output (CO) value is entered from such devices as COstatus (HCM101) system or equivalent to calibrate the pressure wave form for measurement of continuous cardiac output. In addition the system also provides 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 HCM103 system, which is an apparatus based on arterial pressure waveform analysis to provide diagnostic assessment of cardiovascular status including continuous cardiac output and associated hemodynamic parameters (such as stroke volume variation; pulse pressure variation). In this stand-alone system, calibration value is entered from such devices as COstatus (HCM101) system or equivalent. 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 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 Transonic COstatus system is indicated for use in patients 1 month or older with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters.

The proposed device is a variation of the COstatus system (K080116) which can measure the same parameters in patients 2 years and above. The COstatus system uses a peristaltic pump to circulate a small volumes blood passed the sensors rather than using a hemodialysis circuit. The system can thereby be used on any patient with arterial and venous access lines. These patients could be in the intensive care units (ICU), operating room (OR) or other such environments.

The AureFlo Monitor is intended for use with Transonic Systems' HT300-Series-FT Surgical Flowmeters. These Flowmeters are intended for use with adult and pediatric patients for measurement of blood or liquid volume flow with Transonic perivascular Flowprobes on major and peripheral arteries, veins and ducts; on non-aerated synthetic vessel grafts; where surgery is medically indicated; intraoperatively, rather than in chronic implant; at intraoperative sites which admit and retain ultrasonic couplant; with minimal vessel manipulation or constriction (to avoid vessel spasm); where application does not unnecessarily lengthen surgical procedure. Measurement of blood or perfusate volume flow with sterile tubing Flowsensors on flexible tubing specific to the flowsensor (never on arteries, veins) and for non-aerated media which are transparent to ultrasound.

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 Systems AureFlo Monitoring System. The device is a versatile monitoring system to continuously measure, display, record and document absolute volume flow and other derived parameters. It is used during surgery with Transonic Flowprobes to measure and display blood flow in vessels. It can also be used with Sterile Tubing Flowsensors to measure and display flow of fluids through tubing circuits. AureFlo's flexible integrated system can be set up in a variety of configurations. A stand-alone HT300-Series flowmeter can be upgraded to work with Flow Trace® software. The system can also be set up on any operating room cart with an optional monitor stand: The display panel is an Intel® Pentium M® CPU touch-screen computer/monitor with Microsoft Windows XP®. The computer/monitor's manual can be accessed by selecting "Help" on the Windows Start Screen. FlowTrace® Software works exclusively with HT300-Series-FT Flowmeters to provide a real-time waveform display of volume flow, mean flow and Pulsatile Index (PI). During CABG surgery, connection with an ECG signal allows for an on-screen ECG display, diastolic/systolic shading of coronary graft waveforms and calculation of a D/S (diastolic/systolic) Ratio.

The Transonic COSTATUS System is indicated for use in patients greater than or equal to 2 years old (child, adolescent, adult) with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic 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 COstatus System which is an apparatus using an indicator dilution technique for the measurement fluid volumes. The system is a variation of the HD01 system which can measure CO during a Hemodialysis treatment. The COstatus system uses a peristaltic pump to draw a small volume of blood passed the sensors rather than using a Hemodialysis circuit. The system can thereby be used on any patient with arterial and venous access lines.

The Transonic AngioFlow meter and catheter are indicated for use during angioplasty procedures to verify the flow before, during, and after treatment. The system is intended for the measurement of blood flow within a vascular bed utilizing a catheter-based sensor. This sensor system uses thermal changes induced by a bolus injection of normal saline and thermal-dilution principles to calculate blood flow.

The Transonic Angio Flow Meter and Catheter which is intended for the measurement of blood flow within a vascular bed utilizing a catheter-based sensor. This sensor system uses thermal changes induced by a bolus injection of normal saline and thermal-dilution principles to calculate blood flow in hemodialysis grafts.

The Transonic Syringe Warmer (Model SYR1000) is indicated for use with the Transonic HD01 (HD01PMS and HD02) systems to make Cardiac output measurements. The Transonic Syringe Warmer (Model SYR1000) is an accessory to our HD01-CO Hemodialysis Monitor for Cardiac Output (K980906) which are currently marketed as the HD01046 and HD02 systems. The HD01-CO Hemodialysis Monitor for Cardiac Output (HD01P05 and HD02 systems) requires the user to make a 30cc injection of approximately body temperature saline into the hemodialysis blood circuit for the CO measurement. The syringe warmer provides the user a convenient source of the 30cc injection of approximately body temperature saline for this injection.

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 Syringe Warmer as an accessory to our HD01-CO Hemodialysis Monitor for Cardiac Output (K980906). The HD01-CO Hemodialysis Monitor for Cardiac Output requires the user to make a 30cc injection of ~ body temperature saline into the hemodialysis blood circuit for the CO measurement. The syringe warmer will provide the user a convenient source of the 30cc injection of ~ body temperature saline for this injection.

The Transonic Flow-QC Set is indicated for use as part of an extracorporeal blood circuit for hemodialysis when the Transonic HD01 System will be use to make access flow, recirculation, and/or cardiac output measurements during the patient's hemodialysis treatment.

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 Flow-QC® Sets which are Hemodialysis extension sets for connection into standard Hemodialysis circuits. These sets provide tubing segments of consistent material and wall thickness to which our HD01 Hemodialysis system can be calibrated. They also provide an injection port for making cardiac output measurements with the HD01 system.