(13 days)
The GemStar™ SP Infusion System with GemStar™ SP Infusion Suite software 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.
GemStar™ SP Infusion System is a family of single channel electromechanical infusion pumps (7-therapy, 6-therapy and Pain Management Pumps). It operates 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. The pumps display provides visible indication of several functions, including active pump operations, alarms, program status and the parameters of fluid flow. The user interface allows the healthcare practitioner to program fluid delivery through a variety of weight and medication based units. Power options include AC main adaptors, a rechargeable battery pack, a docking station, and two disposable AA batteries. The infusers function as both pole mounted and ambulatory infusion pumps.
The subject device is based on modifications of the predicate infusion pumps. The modifications to the Hospira GemStar® Infusion System are made to allow for download of the Infusion Suite to the pump from the PC –based software (GemStar™ SP Infusion Suite) in order to facilitate the programming of the pump and to provide the ability to enforce dosing limits for applicable therapies. GemStar™ SP Infusion Suite software will be distributed separately as an accessory to the pump. No changes are made to the pump performance specifications or to the administration sets used with the pump.
Here's an analysis of the provided text regarding the acceptance criteria and study for the GemStar™ SP Infusion System.
Important Note: The provided text is a 510(k) premarket notification for a medical device. This type of submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving efficacy or safety through new clinical trials as would be required for a PMA (Premarket Approval). Therefore, the document primarily highlights the similarities to existing devices and the absence of new safety/effectiveness concerns, rather than presenting a detailed study with specific acceptance criteria and performance metrics in the way one might expect for a novel device.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) submission focused on substantial equivalence and modifications to an existing device, explicit numerical acceptance criteria and a detailed "reported device performance" table are not present in the provided document. The acceptance criteria are implicitly met by demonstrating that the modified device performs "as safe and effective" as the predicate device and that "no changes are made to the pump performance specifications."
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Intended Use: Identical to predicate device. | The GemStar™ SP Infusion System with GemStar™ SP Infusion Suite software 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. This is identical to the predicate Hospira GemStar® Infusion Pump System (K060806). |
| Technological Characteristics: Similar in design, materials, components, and fundamental scientific technology to predicate device. | The subject and predicate devices are similar in design, materials of construction, components, intended use, labeling and manufacturing processes. |
| "Same fundamental scientific technology" | |
| "Same physical operational and performance specifications" | |
| Safety and Effectiveness: No new issues of safety and/or effectiveness are raised by the modifications. | The proposed modifications do not raise new issues of safety and/or effectiveness. |
| "GemStar™ SP Infusion System with GemStar™ SP Infusion Suite meets the functional claims and intended use as described in product labeling and is as safe and effective in terms of substantial equivalence as the predicate devices described in the submission." | |
| Performance Specifications: Pump performance specifications remain unchanged. | "No changes are made to the pump performance specifications or to the administration sets used with the pump." |
| Software Functionality: Similar concept of protocol download from PC application to infuser, facilitating programming and enforcing dosing limits. | Similar concept of the protocol download from GemStar™ SP Infusion Suite PC application to the GemStar™ SP Infuser as from the Hospira MedNet™ application to LifeCare PCA® Infuser. (This implies that the new software performs its intended function of downloading protocols and enforcing dose limits as effectively as the predicate software). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific "test set" in the context of an independent performance study. The 510(k) submission relies on demonstrating substantial equivalence to predicate devices already on the market and cleared by the FDA. The "testing" in such a submission typically involves verification and validation of the modified components (e.g., software functionality, electrical safety, EMC compatibility) against established standards and internal requirements, rather than a clinical performance study with a distinct test set of patients or medical scenarios.
Therefore, information on:
- Sample size used for the test set: Not applicable/not provided in this type of submission.
- Data provenance (country of origin, retrospective/prospective): Not applicable/not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable/not provided because the document does not describe a study involving human expert adjudication to establish ground truth for a test set. This is a premarket notification for a Class II medical device (infusion pump), where the primary focus is on engineering and performance specifications, and substantial equivalence to existing devices.
4. Adjudication Method for the Test Set
Not applicable/not provided. There is no described study requiring an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done according to the provided document. This type of study is more common for diagnostic imaging devices where human interpretation directly impacts clinical outcomes, and the goal is to show the AI's impact on reader performance or diagnostic accuracy. For an infusion pump, the effectiveness is primarily mechanical and software-driven, verified through engineering tests and comparison to predicate device performance.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
The document does not describe a standalone algorithm-only performance study. The device is an infusion pump system with associated software. The "performance" is a holistic function of the hardware and software working together to deliver fluids, with the software facilitating programming and safety features (dose limits). The safety and effectiveness are established through the entire system's functionality, not just an isolated algorithm. The software component, "GemStar™ SP Infusion Suite," is an accessory to the pump facilitating programming, and its performance is implicitly validated by demonstrating "similar concept of the protocol download" to a predicate device's software.
7. The Type of Ground Truth Used
For the purpose of this 510(k) submission, the "ground truth" is established by:
- Predicate Device Performance: The primary ground truth is the established safety and effectiveness of the legally marketed predicate devices (Hospira GemStar® Infusion Pump System K060806 and LifeCare PCA® Infusion System with Hospira MedNet™ Software K042800). The current device demonstrates that it is "as safe and effective" as these.
- Engineering Standards and Specifications: Implicitly, the pump's mechanical and electrical performance (e.g., flow accuracy, alarm functionality, dose limit enforcement) is verified against established engineering standards and the device's own design specifications, which are themselves benchmarked against predicate devices and regulatory requirements.
There is no mention of pathology, expert consensus on patient data, or extensive clinical outcomes data specific to this submission.
8. The Sample Size for the Training Set
The document does not mention a "training set" as described in the context of machine learning. This device, an infusion pump with programming software, would likely have its software developed and verified through standard software engineering practices (e.g., unit testing, integration testing, system testing, regression testing) rather than through training on a dataset in the AI/ML sense.
9. How the Ground Truth for the Training Set Was Established
Since a "training set" (in the AI/ML sense) is not mentioned or implied by the nature of this device and submission, the method for establishing its ground truth is not applicable/not provided. The ground truth for the product's design and verification is based on established engineering principles, regulatory compliance, and the performance characteristics of its predicate devices.
§ 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).