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The Medley PCA Module is intended for use in today's growing professional healthcare environment for facilities that utilize infusion devices for the delivery of medications or fluids. The Medley PCA Module is indicated for use on adults, pediatrics, and neonates for continuous or intermittent delivery through clinically acceptable routes of administration; such as intravenous (IV), subcutaneous, or epidural. The addition of the PCA/Monitoring Protocol provides an optional and hospitalconfigurable feature that is intended to align with healthcare facilities' current protocols that require monitoring of patients while on PCA therapy. All device programming, data entry and validation of PCA/Monitoring Protocol parameters is performed by the trained healthcare professional according to hospital-defined protocol or a physician's order. The Medley PCA Module with PCA/Monitoring Protocol is intended for use with patients that are prescribed PCA pain management therapy with opioid medications, specifically: Fentanyl, Demerol, Morphine, and Hydromorphone. The Medley PCA Module with PCA/Monitoring Protocol is intended for use by healthcare professionals in clinical environments. The Protocol does not replace clinician assessment or therapy decision making, but adds an additional safety net for the clinician at the point of care. All device programming, data entry and validation of the Medley PCA Module with PCA/Monitoring Protocol is performed by the trained healthcare professional according to hospital-defined protocol or a physician's order.

Due to the potential for opioid-induced respiratory depression, hospitals require regular monitoring and assessment of patients prescribed opioid medications. By allowing for the combination of a PCA Module and monitoring module (EtCO2 Module and/or SpO2 module) on the same platform, the Medley System provides a readily available way for the clinician to continuously monitor the patient's respiratory response while receiving opioid infusion therapy. This submission will utilize the current system modularity to add a new hospitalconfigured Guardrails parameter (PCA/ Monitoring Protocol) to the Medley PCA Module. This Protocol is designed to help ensure patient safety when administering opioid medications. This Protocol will be available for use when a PCA Module and monitoring module(s) are attached to the same Medley Point of Care Unit (PCU). The PCA/Monitoring Protocol will be part of the Guardrails data set and will consist of a specified list of opioid medications and hospital-specified pre-configured monitoring limits. The Protocol will activate only when hospital-specified protocol indicates an unsafe state of respiratory depression is detected.

The Medley System with Bar Code Module is intended for use in today's growing professional healthcare environment for facilities that utilize infusion devices for the delivery of fluids, medications, blood and blood products. The Medley System with Bar Code Module is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by the trained healthcare professional according to a physician's order.

The Medley Bar Code Module functions as part of the Medley System and can operate as a fifth module (when all four infusion and/or monitoring positions are in use). The Medley Bar Code Module attaches to and receives its power from the Medley System consistent with the modular design. The Bar Code Module does not directly interface with the Medley System; all communications are routed using a separate and dedicated communications interface channel resident in the Medley System. Through the dedicated communications channel, the Medley Bar Code Module exchanges information between itself and other sources, such as the patient wristband, medication or device packaging, Medley, or MMS System components such as the ALARIS Server and Hospital Information Management Systems. As with the Medley System with MMS, there is an information protocol for proprietary data exchange and a method to verify the integrity of the information sent or received prior to programming a Medley System infusion module. The software incorporates error checking to ensure the correct acquisition, exchange, and integrity of acquired bar coded data. All data entry and verification of infusion parameters using the Medley System with Bar Code Module is performed by trained healthcare professionals prior to administration of medication(s). The Medley Bar Code Module does not affect the operation of the Medlev System. All Medley System functionality and performance specifications remain unchanged. An attachable/detachable handheld scanner will be provided as an accessory to the Medley System with Bar Code Modulc as alternative way to acquire bar code data.

The Medley™ EtCO2 Module is a capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR). The monitor is intended for use by professional healthcare providers where continuous, non-invasive monitoring of these parameters is desired. The Medley™ EtCO2 Module is indicated for use on adults, pediatrics and infant/neonates for both intubated and non-intubated patients.

The EtCO2 Module is the newest module to the currently marketed Medley™ Medication Safety System (Medley™ System). ALARIS Medical will incorporate currently marketed Oridion capnograph technology and accessories into the Medley™ EtCO2 Module. The Medley™ EtCO2 Module will be used to measure inspired and expired carbon dioxide (FiCO2 and EtCO2 respectively) and Respiration Rate (RR) on patients in the operating room, ICU, NICU, transport and emergency treatment. This capnograph technology originates from the MediCap/NPB-75 (K964239).

The Medley PCA Module is intended for use in today's growing professional healthcare environment for facilities that utilize syringe pumps for the delivery of medications or fluids. The Medley PCA Module is indicated for use on adults, pediatrics, and neonates for continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), subcutaneous, or epidural.

The Medley PCA Module functions as part of the Medley™ Medication Safety System. In combination with the Medley" Programming Module (PM), the PCA Module will deliver fluids in a manner similar to current PCA pumps on the market. The Medley" PCA Module uses standard non-dedicated, single-use, administration sets and syringes with luer-lock connectors, of type designed for use on syringe-type PCA pumps.

The Signature Edition Infusion System (infusion pumps and administration sets) is intended for use in today's growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products. The Signature Edition Infusion System is indicated for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural, enteral, or irrigation of fluid spaces.

This device is essentially the same as the originally submitted devices (the predicate devices), filed as Models EZ 1 and EZ 2 Infusion Pumps (K931549) and EZ Administration Set Series (K931550). The electrical volumetric pumps and administration sets are used to control the rate or monitor the flow of solution or medication for delivery of drugs, fluids, and blood products. In general, infusion systems are used when the solution to be administered needs to be delivered with greater accuracy or at a higher flow than can be provided through a manually adjusted gravity administration set. Because they allow more accurate fluid delivery, infusion systems have been proven to be useful in applications such as continuous epidural anesthesia, administration of IV cardiovascular drugs, chemotherapy, and blood transfusions.

The ALARIS Medical Systems, Inc., Medley" System with Medication Management System (MMS) is intended for use in today's growing professional healthcare environment for facilities that utilize infusion devices for the delivery of fluids, medications, blood and blood products. The Medley™ System with MMS is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by the trained healthcare professional according to a physician's order.

The Medley *** System (K950419) is a currently marketed modular infusion and monitoring system that consists of a Programming Module (PM) and attachable/detachable modules. Current infusion modules available are a Pump Module (K950419) and a Syringe Module (K023264). Monitoring modules currently include Pulse Oximetry (SpO2) using Nellcor (K022677) and Masimo (K010966) technology. This traditional 510(k) Premarket Notification is being submitted to assist our customers in reducing the number of manual steps needed to program an infusion by allowing wireless communication capability to the currently marketed device, the Medley" Medication Safety System (Medley System) K950419. This Medication Management System (MMS) adds communication capability to the Medley" System thereby providing our customers with a "safety net" at the bedside to help reduce the number of programming errors at the point of care. This product will be called the Medley System with MMS. As with the predicate device (B. Braun Medical Inc., Horizon™ Outlook with DoseCom™) this submission adds wireless communication to a server and to an existing infusion device. The Medley System was originally cleared with the capability of wired or wireless communication to include receiving infusion protocol information, uploading/downloading system configuration information and reporting infusion or system status. However, this capability was not well defined and did not include communication with a Server. It was also not clear about the local retrieval of data using optical laser scanning (bar-coding) or RF detection of information contained in documents, labels, RF ID Chips, etc. Adding MMS to the Medley System is simply an expansion of the original 510(k) indications for use for the Medley System. This submission will allow the Medley System to transmit and receive messages with the ALARIS® Server which in turn allows communication capability with external devices, including personal computers, Personal Digital Assistants (PDA's), hospital monitoring systems and Hospital Information Management Systems (HIMS).

The MEDLEY™ Syringe Pump is intended for use in today's growing professional healthcare environment for facilities that utilize syringe pumps for the delivery of fluids, medications, blood and blood products. The MEDLEY™ Syringe Pump is indicated for use on adults, pediatrics and neonates for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural, enteral, or irrigation of fluid spaces.

The MEDLEY Syringe Pump Module functions as part of the MEDLEY™ Medication Safety System. In combination with the MEDLEY™ Programming Module (PM), the Syringe Module will deliver fluids in a manner similar to current syringe pumps on the market. Up to four Syringe Modules may be connected to each PM. The MEDLEY™ Syringe Pump uses standard, single-use, administration sets (with and without pressure disc) and syringes with luer-lock connectors, of type designed for use on syringe pumps. The MEDLEY™ Syringe Pump may be used with administration sets that contain a pressure disc. If the pressure disc is used, the following features are available: - Back-off . - . Fast Start - Customizable Pressure Alarm Settings ● - Pressure Tracking Display ● - Auto Pressure .

The MEDLEY SpO2 Module and accessories are intended for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal patients in hospitals and hospital-type facilities. The MEDLEY SpO2 Module and accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonatal, pediatric, and adult patients during both no motion and motion conditions, and for patients who are either well or poorly perfused, in hospitals and hospital-type facilities.

The MEDLEY SpO2 Module, Model 8210, is essentially the same as the previously cleared device (MEDLEY SpO2 Module, Model 8220). The MEDLEY SpO2 Module (Models 8220 and 8210) and accessories is a device capable of non-invasively monitoring functional oxygen saturation of arterial hemoglobin and pulse rate. The system consists of an SpO2 Module, a Programming Module, connecting cable, and oximetry sensors. The MEDLEY Programming Module (PM) and SpO2 Module snap together. The Nellcor board contains all of the pulse oximetry algorithms used to measure saturation and pulse rate. The patient cable and oximetry sensors, manufactured by Nellcor, work in combination with the MEDLEY SpO2 Module to utilize Nellcor's technology to measure functional oxygen saturation and pulse rate.

The following ALARIS Medical Infusion Systems are intended for use in today's growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products: - IVAC® Signature Edition® Infusion Pumps and Administration Sets. ● - IVAC® MedSystem III® Multi-Channel Infusion Pump and IVAC MedSystem III® Multi-. Channel Infusion Pump with DLE and Administration Sets. - IMED® Gemini Infusion Pumps/Controllers and Administration Sets. . - ALARIS Medical Medication Safety System and Administration Sets. ● - IVAC®, IMED®, and ALARIS® Gravity, Extension, Components, and Secondary . Administration Sets.

The following ALARIS Medical Infusion Systems are included in this Special 510(k): - . IVAC Signature Edition Infusion Pumps & Administration Sets. - IVAC MedSystem III Multi-Channel Infusion Pump & IVAC MedSystem III Multi-Channel Infusion Pump with DLE & Administration Sets. - . IMED Gemini Infusion Pumps/Controllers & Administration Sets. - ALARIS Medical Medication Management System & Administration Sets. - IVAC, IMED, and ALARIS Medical Gravity, Extension, Components, & Secondary Administration Sets.

The Single Dose Dispensing Pin is a stand-alone, single use, disposable access device which permits syringe access to a medication vial without the use of a needle. The device is intended for use by healthcare professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies. The Single Dose Dispensing Pin is indicated for use with standard medication vials and needleless syringes for withdrawal and/or injection of fluid.

The Single Dose Dispensing Pin (Dispensing Pin) is a stand-alone, single use, disposable syringe access device which permits access to a medication vial without the use of a needle. The Dispensing Pin is connected to a needleless syringe and is inserted into the rubber stopper of a medication vial. The healthcare provider uses the Dispensing Pin to inject or withdraw fluid from a vial.