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The PhySoft Anemia Management System® (PhySoftAMS®) is a software application used to obtain, track and trend patient data pertaining to the management of anemia, and to provide a schedule of erythropoiesis-stimulating agent (ESA) dosage recommendations to help achieve and maintain target hemoglobin levels in dialysis patients. PhySoftAMS® is intended to help physicians. nurses, clinicians, and anemia managers manage anemia in adult stage 5 chronic kidney disease (CKD) patients. PhySoftAMS® is not a substitute for, but is rather intended to assist, clinical judgment. The erythropoiesis-stimulating agent (ESA) dosing regimen options calculated by this device are intended to be used by qualified and trained medical personnel to inform the optimization of the dosage of ESAs in accordance with their approved labeling in conjunction with clinical history, symptoms, and other diagnostic measurements, as well as the medical professional's clinical judgment. No medical decision should be based solely on the patient Hgb response to dosing regimen options calculated by this device.

PhySoftAMS® is a software application used to obtain, track and trend patient data pertaining to the management of anemia and to provide a schedule of erythropoiesis-stimulating agent (ESA) dosage recommendations to help achieve and maintain target hemoglobin levels in dialysis patients. PhySoftAMS® is intended to help physicians, nurses, clinicians and anemia managers manage anemia in adult stage 5 chronic kidney disease (CKD) patients. PhySoftAMS® is intended for use by medical personnel such as clinicians, nurses, and physicians in dialysis clinics or other settings where anemia management for hemodialysis patients is conducted. Healthcare professionals access PhySoftAMS® directly using a web application graphical user interface (GUI) or indirectly using the drug dosing-related screens of a third party's electronic health record (EHR) system via an application programming interface (API) provided by the PhySoftAMS® application server. PhySoftAMS® evaluates whether adequate historical data is available to model patient ESA dose-Hgb response dynamics and project future ESA dose-Hgb response. If adequate data is available, PhySoftAMS® enables a physician to model a patient and select from one or more dosing schedule options most likely to result in achieving target Hgb levels or, at the physician's discretion. override the presented dosing schedule options.

SAM is a web application used to obtain, track and trend patient data pertaining to the management of anemia, and to provide a schedule of erythropoiesis-stimulating agent (ESA) dosage recommendations to help achieve and maintain target hemoglobin (Hgb) levels in hemodialysis patients. The device is intended to help clinicians manage chronic anemia. The device is not a substitute for, but rather intended to assist, clinical judgment. The ESA dosing regimen options calculated by this device are intended to inform the optimization of the dosage of ESAs in accordance with their approved labeling in conjunction with clinical history, symptoms, and other diagnostic measurements, as well as the clinicians' judgment. No medical decision should be based solely on the patient Hgb response to dosing regimen options calculated by this device.

SAM is a web application used to obtain, track and trend patient data pertaining to the management of anemia, and to provide a schedule of erythropoiesis-stimulating agent (ESA) dosage recommendations to help achieve and maintain target hemoglobin (Hgb) levels in hemodialysis patients. The device is intended to help clinicians manage chronic anemia. Healthcare professionals access SAM using a web-enabled application (for example, a web browser or a web-enabled electronic health record system) communicating with the SAM web application server. Patient information is obtained by SAM from healthcare provider Electronic Medical Records. No components of SAM are required to be installed at end user or healthcare provider locations. SAM estimates individual patient's Hgb response to ESAs. The results of this estimation are used to generate new patient-specific ESA dose recommendation to achieve target Hgb level specified by the physician. The ESA dose recommendation is reviewed by the physician, who after considering any additional relevant information about patient's condition, decides whether to follow or override the presented ESA dose recommendation.

PhySoft AMS™ is a web application used to obtain, track and trend patient data pertaining to the management of anemia, and to provide a schedule of erythropoiesis-stimulating agent (ESA) dosage recommendations to help achieve and maintain target hemoglobin levels in dialysis patients. PhySoft AMS™ is intended to help physicians, nurses, clinicians and anemia managers manage anemia in adult stage 5 chronic kidney disease (CKD) patients. The PhySoft AMS™ is not a substitute for, but rather intended to assist, clinical judgment. The ESA dosing regimen options calculated by this device are intended to be used by qualified and trained medical personnel to inform the optimization of the dosage of ESAs in accordance with their approved labeling in conjunction with clinical history, symptoms, and other diagnostic measurements, as well as the medical professional's clinical judgment. No medical decision should be based solely on the patient Hgb response to dosing regimen options calculated by this device.

PhySoft AMS™ is a software application used to obtain, track and trend patient data pertaining to the management of anemia, and to provide a schedule of ESA dosage recommendations to help achieve and maintain target Hgb levels in dialysis patients. PhySoft AMS™ is intended to help physicians, nurses, clinicians and anemia managers manage anemia in adult stage 5 CKD patients. PhySoft AMS™ is intended for use by medical personnel such as clinicians, nurses, and physicians in dialysis clinics or other settings where anemia management for hemodialysis patients is conducted. Healthcare professionals access PhySoft AMS™ using a web browser communicating with the PhySoft AMS™ web application server. Patient information is obtained by PhySoft AMS™ from healthcare provider information systems. No components of PhySoft AMS™ are required to be installed at end user or healthcare provider locations. PhySoft AMS™ assesses if there is adequate data to model an individual patient's Hgb response to ESAs. The results of this assessment are reviewed by the physician who, after considering any additional relevant information about the patient's condition, decides if they want to apply the PhySoft AMS™ ESA dose-Hgb response modeling capability to the particular patient's data. If adequate data are available, PhySoft AMS™ enables a physician to model a patient and select from dosing schedule options to achieve target Hgb levels or, at the physician's discretion, override the presented dosing schedule options.

Vasc-Alert vascular data analysis software is intended for use by Healthcare professionals in a non-Vasc-Afert vascular data analysis software is nave access site stenosis in patients with grafts and critical care setting for assessment of mercasse money is to be used with data generated from hemodialysis machines.

Vasc-Alert is a software program for alerting dialysis center personnel of an increased risk of access site vace institutional hemodialysis patients. Vasc-Alert utilizes measurements routinely collected during a dialysis treatment by the hemodialysis machine, such as pressure and flow rate, and applies a previously published algorithm called the Vascular Access Pressure Ratio (VAPR) test to these measurements. The average VAPR test result for each treatment session is stored in a Vasc-Alert database. If a patient has a high reading in three consecutive dialysis sessions, a report is issued to the medical staff indicating that the patient should be examined more closely for the onset of stenosis. Hemodialysis center personnel can use the report as a tool to proactively monitor for incipient stenosis and prompt proactive intervention to avoid site closure. Vasc-Alert comprises five main components or modules: - A module for recording, transferring and parsing data collected by dialysis center machines. I - A module for calculating the VAPR values from treatment data. . - A module for identifying significant patterns in the calculated VAPR data that will prompt an 트 alert (i.e., 3 high readings in a row for a patient). - A module for generating reports and sending these out to center personnel. l - An internet-based data input module. 이

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.

The M2376A Device Link System is indicated for use in data collection and clinical information management either connected directly or through networks with independent bedside devices. The M2376A is not intended for monitoring purpose, nor is the M2376A intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.

The Hewlett Packard M2376A Device Link System receives digital data produced by external devices through device specific cables, converts that data into the HL7 format and transmits that information to any networked Clinical Information System.

The CRIT-LINE MONITOR III, (CLM III) is a non-invasive hematocrit, oxygen saturation and percent change in blood volume monitor used in the treatment of hemodialysis patients. In addition, the CLM III estimates access recirculation and access blood flow in hemodialysis patients.

The CLM III consists of a state-of-the-art microprocessor which has all of the chip select logic, serial communication, timing and watchdog circuits incorporated within it. The CLM III is used in conjunction with the In-Line Diagnostics Blood Chamber. The blood chamber is connected to and becomes part of the dialysis tubing circuit. The sensor from the CLM III is connected to the blood chamber which reads critical blood parameters as blood passes through the blood chamber.

The HP M2376A Device Link System is indicated for use in data collection and clinical information management, either connected directly or through networks, with the independent bedside devices that are listed below; - 1) IMED 1310 (PC-1) channel IV Pump - 2) In-line Diagnostic HR Crit-Line Monitor - 3) Newport Wave Ventilator

The Hewlett Packard M2376A DeviceLink System receives digital data frontuced by external devices through device specific cables, converts that data into the HL7 format and transmits that information to any networked Clinical Information System. When connected to a bedside device, the HP M2376A DeviceLink System is intended for electronic data collection and clinical Information management. DeviceLink is neither patient connected, nor does it remotely control the attached source device.