(10 days)
The LifeCare PCA® Infusion System with Hospira MedNet™ Software is indicated for accurate, volumetric, infusion of analgesic drugs by continuous or patient-demanded (PCA) intravenous administration. The LifeCare PCA® Infusion System with Hospira MedNet™ Software is also indicated for short-term (less than 96 hours) continuous administration of analgesic drugs.
The LifeCare PCA® Infusion System with Hospira MedNet™ Software is an electromechanical infusion pump that uses a stepper motor that exerts pressure on an inserted drug vial to control the infusion of analgesic into a patient. The infuser is pole-mounted and includes an attached patient pendant that allows a patient to self-administer analgesia within physician-prescribed, programmed parameters that include delivery mode, PCA dose, lockout interval, and/or dose limits.
The LifeCare PCA® Infusion System with MedNet™ Software consists of:
- an infuser that is compliant with IEC 60601-1-2 2nd Edition requirements .
- a bar code reader that recognizes Hospira- or Abbott-manufactured drug . vials as well as hospital pharmacy-generated bar codes
- . a Nurse Call Port
- networked communication capability (Ethernet wired and wireless) with . Medication Management compatible hospital information systems
- hardware that is compatible with Hospira MedNet™ Software. .
This document is a 510(k) summary for the LifeCare PCA® Infusion System with Hospira MedNet™ Software. As such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for device performance. It does not contain the information requested in your prompt regarding acceptance criteria, specific performance studies, sample sizes, expert involvement, or ground truth establishment.
Here's why the requested information is absent:
- 510(k) Summary Purpose: A 510(k) submission primarily aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device. This is often achieved by showing similar technological characteristics and intended use, rather than conducting new, elaborate performance studies with predefined acceptance criteria for the new device as if it were a novel technology.
- Focus on Substantial Equivalence: The document explicitly states: "The subject and predicate devices are similar in design, materials of construction, components, intended use, labeling and manufacturing processes. The proposed modifications do not raise new issues of safety and/or Frio proposou moome, the LifeCare PCA® Infusion System with Hospira™ MedNet Software is substantially equivalent to the predicate infusion pumps." This highlights the core of a 510(k) submission.
- Type of Device: This is an infusion pump, a well-established medical device type. Performance is typically assured through adherence to recognized standards (e.g., IEC 60601-1-2 mentioned for electrical safety) and comparison to existing, cleared devices, rather than new studies proving clinical efficacy or diagnostic accuracy with AI-like metrics.
Therefore, I cannot extract the information you requested from the provided text.
§ 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).