(22 days)
The Hospira GemStar® Infusion Pump System with Hospira GemStar® Pump Sets and Hospira GemStar® Spring Assist Mechanism Lockbox 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 an AC main adaptor, 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, alarm and program status, and the parameters of fluid flow. The infusers function as both pole mounted and ambulatory infusion pumps.
This document is a 510(k) summary for the Hospira GemStar® Infusion Pump System and related components. It seeks to establish substantial equivalence to previously cleared devices rather than providing a performance study against specific acceptance criteria. Therefore, much of the requested information regarding detailed acceptance criteria and a study proving those are met is not present in the provided text.
Based on the content, here's what can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics. Instead, it relies on demonstrating equivalence to predicate devices, implying that the subject device meets the performance characteristics demonstrated by those predicates. The "Performance Features" section in the comparison table mentions categories such as "Delivery Rates, VTBI Range, Dose Units, Delivery Accuracy, Delivery Modes, Therapies, Distal Occlusion Limits, Proximal Occlusion Limits, Alarm Types and Conditions, Default Drug Library." The subject device is stated to have the "Same" performance features as the predicate device.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Delivery Rates | Same as predicate device |
| VTBI Range | Same as predicate device |
| Dose Units | Same as predicate device |
| Delivery Accuracy | Same as predicate device |
| Delivery Modes | Same as predicate device |
| Therapies | Same as predicate device |
| Distal Occlusion Limits | Same as predicate device |
| Proximal Occlusion Limits | Same as predicate device |
| Alarm Types and Conditions | Same as predicate device |
| Default Drug Library | Same as predicate device |
| Overall Safety and Effectiveness | Meets functional claims as described in product labeling; as safe and effective as predicate devices. |
2. Sample size used for the test set and the data provenance:
The document does not describe a specific "test set" in the context of a performance study with a sample size. The information provided is a 510(k) summary, which typically relies on demonstrating equivalence through comparison to existing devices and verification/validation testing without necessarily detailing a large-scale, controlled clinical "test set" as one might find in a drug trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
No information is provided regarding experts establishing ground truth for a test set, as a standalone performance study with such a methodology is not described.
4. Adjudication method for the test set:
No information is provided regarding an adjudication method for a test set, as a standalone performance study with such a methodology is not described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This device is an infusion pump system, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving "human readers" and "AI assistance" is not applicable or mentioned in this document.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The document focuses on the entire system (infusion pump and administration sets). While the pump is a "software controlled, electromechanical infusion pump," the submission is about the device as a whole and its equivalence. There is no mention of a standalone algorithm-only performance study.
7. The type of ground truth used:
Given the nature of the device (infusion pump) and the 510(k) submission type, the "ground truth" for demonstrating safety and effectiveness would likely be based on established engineering principles, recognized standards (if any, though the document states no performance standards exist under Section 514 for these pumps), detailed design specifications, and performance testing data to confirm the device operates as intended and is equivalent to the predicate. The document highlights "functional claims" and "performance specifications."
8. The sample size for the training set:
As this is a physical medical device (infusion pump) and not a machine learning model, the concept of a "training set" in that context is not applicable.
9. How the ground truth for the training set was established:
Same as above, the concept of a "training set" is not applicable for this type of device.
Summary of Study (as described in the 510(k) context):
The "study" presented here is a substantially equivalent comparison to predicate devices. The document asserts that the Hospira GemStar® Infusion Pump System with the new lockbox and pump sets is substantially equivalent to previously cleared Hospira/Abbott GemStar Infusion Pump Systems and pump sets.
The core of this "proof" lies in demonstrating similarities across various factors:
- Intended Use and Indications for Use: Stated to be the same.
- Fundamental Scientific Technology: Stated to be the same (volumetric, piston-driven, fluid displacement).
- Physical, Operational, and Performance Specifications: Stated to be the same. This implies that testing (e.g., for delivery accuracy, occlusion limits) would have been performed to ensure these specifications are met and are comparable to the predicate.
- Materials of Construction: Stated to be the same for infuser components and administration sets.
The document does not provide raw data, specific test protocols, or results of detailed performance testing. Instead, it makes assertions of equivalence for these characteristics, which would have been supported by underlying design documents and testing reports submitted to the FDA as part of the 510(k) process. The FDA's clearance (K051079) signifies their agreement that sufficient evidence of substantial equivalence was provided.
§ 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).