(19 days)
The Hospira GemStar IV Infusion Pump is intended for use in intravenous, arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritionals fluids, and blood/blood products to patients.
The Hospira GemStar® Infusion Pump System with Hospira GemStar Connect™ is intended for use in Intravenous (central line or peripheral access), 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 alkaline or lithium 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.
The provided document is a 510(k) summary for the Hospira GemStar I.V. Infusion Pump. It does not describe a study involving acceptance criteria and device performance in the manner typically seen for AI/ML-driven devices or diagnostic tools. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
Therefore, many of the requested sections (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and training set ground truth) are not applicable to this type of submission.
However, I can extract the information relevant to its substantial equivalence claim, which serves as a form of "acceptance criteria" for regulatory clearance in this context.
Here's an interpretation based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
In the context of a 510(k) submission for an infusion pump, "acceptance criteria" and "reported device performance" are primarily demonstrated through substantial equivalence to a predicate device. The "performance" is implicitly deemed acceptable if it matches or is sufficiently similar to the predicate.
| Acceptance Criteria (based on substantial equivalence) | Reported Device Performance (as claimed by Hospira GemStar I.V. Infusion Pump) |
|---|---|
| Intended Use (Same as predicate) | 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 to a patient. |
| Indications for Use (Same as predicate) | Hospital, ambulatory, and home care environments using sterile, dedicated, GemStar® administration sets. |
| Operating Principle (Same as predicate) | Volumetric, piston driven, fluid displacement principle. Stepper motor with in-line cassette meters IV fluids through sterile dedicated administration sets. Programmable fluid delivery through a variety of weight and medication based units. Visible indication of several functions, including active pump operations, alarm and program status, and the parameters of fluid flow. |
| Administration Sets and Fluid Contact Materials (Same as predicate) | Sterile, dedicated, non-pyrogenic, latex-free "GemStar" administration sets. |
| Physical Features (Same as predicate) | Materials, Size, Weight, Input Lines, Output Lines, Power Sources, Battery Type, Power Cord. |
| Environmental Features (Same as predicate) | Operating Temperature, Storage Temperature, Relative Humidity, Pressure. |
| Performance Features (Same as predicate) | Delivery Rates, VTBI Range, Dose Units, Delivery Accuracy, Delivery Modes, Therapies, Distal Occlusion Limits, Proximal Occlusion Limits, Alarm Types and Conditions, Default Drug Library. |
| BioMed Settings (Same as predicate) | Configuration settings available for customization. |
| Accessories (Same as predicate) | GemStar Connect™ Remote Communication Software (Clinician Kit, Patient Kit), Docking Station, Bolus Cord, Pole Clamps (2), Battery Pack, Lockboxes (3), AC Mains Adapters (2), Carrying Cases (4) and Carrier, Serial Cable. |
| Fundamental Scientific Technology (Same as predicate) | Same as predicate (implied through operating principle and performance claims). |
2. Sample size used for the test set and the data provenance
Not Applicable (N/A). This document is a 510(k) summary for a medical device (infusion pump) based on substantial equivalence, not a clinical study or performance study that would involve a "test set" of data in the context of an AI/ML device. The "test" here refers to demonstrating that the device meets its own specifications and is equivalent to the predicate, which typically involves engineering verification and validation testing, not a specific "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable (N/A). See explanation for point 2. No "ground truth" in the AI/ML sense is established from experts in this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable (N/A). See explanation for point 2.
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
Not Applicable (N/A). This device is an infusion pump, not a diagnostic or AI-assisted interpretation tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable (N/A). This device is a physical infusion pump, not a standalone algorithm. While it has software, its performance is as a complete electromechanical system, always with human interaction for programming and monitoring.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not Applicable (N/A). For an electromechanical device like an infusion pump, "ground truth" typically refers to engineering specifications, physical measurements, and adherence to established standards (e.g., fluid delivery accuracy, occlusion pressure limits) rather than biological "ground truth" like pathology or expert consensus on a diagnosis. The "truth" is whether it performs to its design specifications consistently and equivalently to a legally marketed predicate.
8. The sample size for the training set
Not Applicable (N/A). This device does not use machine learning, so there is no training set in that context.
9. How the ground truth for the training set was established
Not Applicable (N/A). See explanation for point 8.
§ 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).