(27 days)
The Signature Edition® Gold Infusion Systems, which are also known as the Alaris® SE Pumps, are intended for use in today's growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products.
The Signature Edition® Gold Infusion Systems are indicated for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (IV), intraarterial (IA), subcutaneous, epidural, enteral, or irrigation of fluid spaces.
The subject of this 510(k) submission is the Signature Edition® Gold Infusion System, which is also known as the Alaris® SE Pump (collectively referred to herein as "SE Gold Pump"). This device is essentially the same as the originally submitted predicate device, Signature Edition® Infusion System, K032147, July 25, 2003 (first submitted as the Models EZ 1 and EZ 2 Infusion Pumps, K931549, October 12, 1993), with the exception of the device modification provided in this submission.
The electrical volumetric pumps are used to control the rate or monitor the flow of solution or medication for delivery of drugs, fluids, and blood products. Infusion pumps have been proven to be useful in applications such as continuous epidural anesthesia, administration of IV cardiovascular drugs, chemotherapy, and blood transfusions.
This document is a 510(k) premarket notification for the Cardinal Health Signature Edition® Gold Infusion System (Alaris® SE Pump). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific quantitative acceptance criteria through new clinical or performance studies.
Therefore, the provided text does not contain the information requested regarding acceptance criteria that would typically be found in a study demonstrating device performance for a novel or significantly modified device. The document explicitly states:
- "This device is essentially the same as the originally submitted predicate device, Signature Edition® Infusion System, K032147, July 25, 2003"
- "With the exception of the device modification presented in this submission, the SE Gold Pumps are essentially the same as the originally submitted predicate device. The intended use, principles of operation, fundamental scientific technology, method of manufacture, and application are essentially the same."
- "The results of this comparison demonstrate that the modified SE Gold Pump is equivalent in technological characteristics to the unmodified device and that the fundamental scientific technology of the predicate device has not been altered."
Since this is a substantial equivalence submission, studies with acceptance criteria, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not present in this document. The "study" referenced is the comparison to the predicate device to establish substantial equivalence based on technological characteristics and intended use.
No information for the following points can be extracted from the provided text:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
§ 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).