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510(k) Data Aggregation
(14 days)
GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT
The Abbott GemStar® Infusion Pump is intended for use in intravenous, arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments.
The Abbott GemStar® Infusion Pump can function as both a pole-mounted and an ambulatory infusion pump and it is intended for use in hospital, ambulatory and home care environments. All GemStar® pumps are single channel pumps and they are offered for sale in the following configurations: 7 Therapy Pump, 6 Therapy Pump, Pain Management Pump. The Abbott GemStar® Infusion Pump is an electromechanical infusion pump that functions on a volumetric, piston driven, fluid displacement principle. The pump delivers I.V. fluids through an intravenous administration set that is also manufactured and distributed by Abbott Laboratories. The sets are described as "GemStar Pump Sets" because they are dedicated for use in this system. The user interface of the infusion pump allows the healthcare practitioner to program fluid delivery through a variety of weight and medication based units including grams. micrograms, milliliters and other units per specified time interval. The display on the pump provides visible indication of multiple functions including active pump operations, alarm and program status and the parameters of fluid flow. The pump can also be used for standard or piggyback fluid delivery. The administration set incorporates integral, set-based free flow protection through a flow stop cassette and other free flow protection measures such as a roller or slide clamp, and an anti-siphon valve. The pump includes a check cassette software function in all modes. Lastly, the labeling for both the sets and the user manual has been revised to highlight these features.
Here's an analysis of the provided text regarding the Abbott GemStar® Infusion Pump System, focusing on acceptance criteria and study details:
This document is a 510(k) Summary for a device modification, not an initial market clearance. Therefore, the "study" described is a design validation and verification rather than a full clinical trial establishing initial safety and efficacy for a novel device. The core argument for clearance is substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly list specific numerical acceptance criteria or detailed quantitative performance metrics for the modified device. Instead, it makes a general statement about the outcome of testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Acceptable functional performance of the modified device and sets. | "The results of testing conducted to validate and verify the design modifications demonstrate acceptable performance of the device." |
| No new issues of safety and effectiveness raised by modifications. | "These differences [minor changes to mechanical parts, software enhancements, anti-siphon valve, revised labeling] do not raise new issues of safety and effectiveness nor do they alter the fundamental technology of the predicate device." |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not specified. The document states "Data regarding the functional performance... has been generated and reviewed" and "results of testing conducted to validate and verify the design modifications." This implies a series of engineering and functional tests rather than a patient-based clinical study with a defined sample size.
- Data Provenance: Not specified, but given the nature of a 510(k) for a device modification involving mechanical and software changes, the testing would almost certainly have been conducted retrospectively in a lab/engineering environment at Abbott Laboratories, rather than involving prospective patient data acquisition. The country of origin of the data is not mentioned and likely not relevant for this type of submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This was a technical validation and verification of device modifications, not a study requiring expert clinical assessment to establish ground truth for a test set. The "ground truth" would have been defined by the device's technical specifications and intended functional performance.
4. Adjudication Method for the Test Set
Not applicable. This was a technical validation, not a multi-expert review or adjudication scenario.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document describes a 510(k) submission for a modification to an existing infusion pump, focused on technical validation. MRMC studies are typically performed for diagnostic imaging devices or AI algorithms where human interpretation is involved, which is not the case here.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
The device is an infusion pump, which inherently involves human interaction for programming and operation. While there are software enhancements mentioned ("modifying and enhancing the software to incorporate changes requested by users"), the term "standalone performance" in the context of AI algorithms is not directly applicable. The device's software performs its functions (e.g., controlling fluid delivery, displaying information) in a "standalone" computational sense, but it operates within a system where a human programs and oversees its use. The "testing" referred to would have evaluated the software's functional correctness.
7. The Type of Ground Truth Used
The ground truth for this submission would have been established by:
- Engineering Specifications: The design requirements and specifications for the modified mechanical parts and enhanced software.
- Predicate Device Performance: The established, acceptable performance of the original Abbott GemStar™ I.V. Infusion Pump served as the baseline for substantial equivalence.
- Regulatory Standards: Adherence to relevant performance standards for infusion pumps.
The documentation relies on "functional performance" as the basis for acceptability.
8. The Sample Size for the Training Set
Not applicable. This project involves a medical device (infusion pump) with embedded software, not a machine learning or AI algorithm that requires a training set in the conventional sense. The software changes were enhancements and modifications, likely developed and tested against defined engineering requirements rather than trained on a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set in the context of machine learning. The "ground truth" for the software development (if one were to loosely interpret it) would be the correct implementation of the new features and modifications as per design specifications and user requirements.
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