(67 days)
ALARIS Medical Systems infusion pumps are intended for use in today's growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion pumps for the delivery of fluids, medications, blood and blood products.
The following ALARIS Medical Systems infusion pumps are indicated for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural, enteral, or irrigation of fluid spaces:
- IMED® Gemini Infusion Pump / Controllers model PC-1® ●
- IMED® Gemini Infusion Pump / Controllers model PC-2® .
- IMED® Gemini Infusion Pump/Controller model PC-2TX® .
- IMED® Gemini Infusion Pump/Controller model PC-40 .
- IVAC® Signature Edition® Infusion Pumps
- IVAC® MedSystem III®, Multi-channel Infusion Pumps .
- IVAC® MedSystem III® Multi-channel Infusion Pumps with DLE .
- . ALARIS Medical Medley" Patient Care System
Note: See the appropriate Directions for Use (DFU) for infusion system specifications.
ALARIS Medical Systems line of infusion pumps are electrical volumetric infusion pumps that are used to control the rate or monitor the flow of solution or medication. In general, infusion pumps are used when the solution to be administered needs to be delivered with greater accuracy or at a higher flow than can be provided through a manually adjusted gravity administration set. Because they allow more accurate fluid delivery, infusion pumps have proven to be useful in applications such as continuous epidural anesthesia, enteral delivery, administration of IV cardiovascular drugs, chemotherapy, and blood transfusions.
This document is a 510(k) Premarket Notification for ALARIS Medical Systems infusion pumps. It seeks to expand the intended use statements for existing devices to include more detailed information about administration routes, target populations, and intended users. The core claim is that this expansion does not alter the device's intended use, performance, safety, or efficacy.
Here's an analysis of the provided information concerning acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not describe any new acceptance criteria or new device performance data. The submission indicates that the changes are solely to the intended use statements and do not impact the device's technical characteristics or performance.
Therefore, the table below reflects what is implied by the submission, rather than explicitly stated acceptance criteria for new performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No change in intended use of the device. (As per submission) | The expanded indications for use, including administration route, target population, and intended user, do not alter the intended use of the device. (Explicitly stated in the submission) |
| No effect on performance, safety, or efficacy of any of the devices. (As per submission) | The expanded indications for use do not affect performance, safety, or efficacy of any of the devices. (Explicitly stated in the submission) |
| Technological characteristics remain equivalent to predicate devices. (As per submission, relying on previous 510(k) clearances) | A comparison of technological characteristics was performed, concluding that the ALARIS Medical line of infusion pumps with expanded indications are equivalent to the original 510(k) devices as well as predicate devices (Abbott Plum XL Infusion Pump K010924 and Baxter Healthcare's Colleague® Infusion Pumps K002211). |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. No new test set data was generated or analyzed for this 510(k) submission.
- Data Provenance: Not applicable. As per the submission, "PERFORMANCE DATA: There are no changes to the devices to support the expansion of indications. Therefore performance data is not necessary." The original performance data for the predicate devices would have been generated during their respective 510(k) clearances, likely from various clinical and bench testing conducted by the manufacturers.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No new ground truth was established for a test set as no new performance data was required. The "ground truth" for the existing devices' performance would have been established during their original clearance processes through a combination of engineering specifications, bench testing, and potentially clinical validation against established medical standards.
4. Adjudication method for the test set
Not applicable. No test set was used for this submission.
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. This submission is for infusion pumps, which are not AI-powered devices or diagnostic tools requiring MRMC studies with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm, and its functionality involves human interaction for setup and monitoring.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable to this specific submission. The "ground truth" for infusion pump performance generally relies on:
- Engineering Specifications: Adherence to defined flow rates, accuracy, occlusion detection, alarm functionality, etc.
- Bench Testing: Validation against calibrated instruments and simulated physiological conditions.
- Clinical Studies (for initial device clearance): Demonstrating safe and effective fluid delivery in patients, potentially comparing to established methods.
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI that would require a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
§ 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).