(28 days)
The Hospira GemStar® Infusion Pump System with Hospira GemStar® Pump Sets and accessories is intended for use in intravenous, arterial, subcutaneous, short term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products. The indications for use include hospital, ambulatory, and home care environments. The pump must be used with sterile, dedicated, GemStar® administration sets.
The Hospira GemStar® Infusion Pump Systems are a family of single channel, software controlled, electromechanical infusion pumps that operate on a volumetric, piston driven, fluid displacement principle. An in-line cassette is used to meter IV fluids through sterile dedicated administration sets designed to be used exclusively with GemStar infusers. Power options included AC main adaptors, a rechargeable battery pack, a docking station, and two disposable AA batteries. The user interface allows the healthcare practitioner to program fluid delivery through a variety of weight and medication based units. The pump displays provide visible indication of several functions, including active pump operations, alarms, program status, and the parameters of fluid flow. The infusers function as both pole mounted and ambulatory infusion pumps.
This document, a 510(k) summary for the Hospira GemStar® Infusion Pump System, does not contain the specific type of information requested about acceptance criteria and a study proving a device meets those criteria, as it relates to performance metrics of an AI/ML powered device.
The provided text describes a traditional medical device (an infusion pump) and primarily focuses on establishing substantial equivalence to previously cleared predicate devices. Therefore, it details the intended use, indications for use, operating principles, physical features, and performance features of the infusion pump itself, rather than evaluating an AI/ML algorithm's performance against defined acceptance criteria using a study.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance (for an AI/ML algorithm).
- Sample size used for a test set or its provenance.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- Information about a multi-reader, multi-case (MRMC) comparative effectiveness study.
- Details about a standalone algorithm performance study.
- Type of ground truth used (in the context of an AI/ML algorithm).
- Sample size for a training set (for an AI/ML algorithm).
- How ground truth for a training set was established (for an AI/ML algorithm).
The "Performance Features" section mentions "Delivery Accuracy" for the infusion pump, which is a performance criterion, but it doesn't provide the acceptance limits or the study data demonstrating compliance. It simply states that the subject device's performance features are "Different" from the predicate device in specific ways (e.g., increased programming and delivery precision for pain management therapies), implying that these differences were evaluated without detailing the specific study design or results.
In essence, this document is a regulatory submission for a hardware medical device, not an AI/ML software as a medical device (SaMD) or a device incorporating AI/ML. Therefore, the requested information type is not present.
§ 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).