(21 days)
The Hospira Phoenix Infusion System with Hospira MedNet Software is intended for the delivery of fluids, solutions, drugs, aqents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes of administration.
It is intended primarily for use in the hospital setting and can be used in other acute and non-acute care areas, such as, but not limited to Home Care, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion Centers, Hospice, Subacute facilities, Outpatient/Surgical Centers, Long Term Care, Urgent Care, Transport and Physician Offices.
The Abbott Phoenix Infusion System with Abbott MedNet™ Software is comprised of an Abbott Phoenix Infuser and accessories. The accessories consist of dedicated infusion administration sets, an optional wireless communications module and optional software that can manage default settings, drug limit alerts and history logs through the communications connections.
The infuser is an electromechanical infusion pump (hereinafter referred to as a pump) that uses a DC motor along with an in-line cassette to meter intravenous (I.V.) fluids through a dedicated administration set. The pump is manufactured for Abbott Laboratories and distributed by Abbott Laboratories. The administration sets are manufactured by and distributed by Abbott Laboratories.
The pump is manufactured as a one-channel or two-channel fluid delivery device. The clinician can configure the pumps by connecting them together. The two-channel pump can be connected to a one-channel pump to form a three-channel pump. Two two-channel pumps can be connected together to form a four-channel pump. However, two one-channel pumps cannot be connected together, nor can more than two pumps be connected together. When the devices are connected, local communication between the pumps is accomplished through Infrared Data Association® (IrDA) sensors.
The pump's large LCD-touch screen allows the healthcare practitioner to program fluid delivery in a variety of weight- and surface area-based units such as micrograms/kg/hour, grams/m2/hr, and other delivery specifications.
The display provides visible indication of several functions including active pump operations, alarm and program status, and fluid flow parameters.
Both the bredicate and the proposed devices can be used for primary and secondary fluid delivery.
The pumps can transmit and receive data by using a cable connected to a data port directly or through a wireless communications module. Data handling is accomplished using the Abbott MedNet Software. Data can include downloading customized drug library and/or customized pump configuration, uploading event/alarm logs, triggering a nurse callback, and/or sending current pumping parameters to another computer or device. The wireless communications module allows the pump to be connected to a hospital information system or infusion medication management software system.
The pumps manufactured without a wireless board are enabled for wireless upgrade. The pumps can be converted to have wireless functionality at a later date by inserting an optional wireless communications module in the pump.
The provided text is a 510(k) Premarket Notification for an infusion system and software from 2004. This type of document is a regulatory submission to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device.
Crucially, this document focuses on demonstrating substantial equivalence based on technological characteristics and intended use, not on clinical performance or diagnostic accuracy. It does not contain information about studies designed to prove a device meets specific performance acceptance criteria in the way that would apply to a diagnostic or AI-driven medical device.
Therefore, the requested information components related to acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for an AI/diagnostic device cannot be extracted from this document.
The document states:
- "The proposed Abbott Phoenix Infusion System with Abbott MedNet Software and the predicate devices are similar in fundamental technology (fluid delivery), programming options, materials of construction, intended use and labeling. Therefore, the Abbott Phoenix Infusion System with Abbott MedNet Software is substantially equivalent to Abbott Plum A+® Infusion Pump with HPL/RS with the plug-and-play Module and the Abbott Gemstar® I.V. Infusion Pump. The proposed device does not raise new issues of safety and effectiveness."
- "The substantial equivalence claim is supported by the information provided in the 510(k) submission."
This means the "study" proving the device meets criteria is the overall comparison presented in the 510(k) submission, detailing how the new device is similar to previously approved devices and doesn't pose new safety or effectiveness concerns. These kinds of submissions typically include engineering tests, biocompatibility tests (if applicable), and comparisons of specifications against the predicate, rather than human clinical trials for diagnostic performance.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).