(25 days)
The Signature Edition® Infusion System (Models 710X and 720X) is 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® Infusion System is 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.
The subject of this Special 510(k) submission is the Signature Edition® Infusion System Models 710X and 720X. This device is essentially the same as the originally submitted predicate device, the Signature Edition® Infusion System (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.
This document is a 510(k) premarket notification for a medical device (infusion pump), not a study report. Therefore, it does not contain information about acceptance criteria, study design, or device performance against specific metrics as requested.
The document primarily focuses on establishing "substantial equivalence" to a predicate device, meaning it asserts that the new device is as safe and effective as a previously cleared device. It states:
- "The subject of this Special 510(k) submission is the Signature Edition® Infusion System Models 710X and 720X. This device is essentially the same as the originally submitted predicate device, the Signature Edition® Infusion System (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." (Page 0)
- "With the exception of the device modification presented in this submission, the Signature Edition® Infusion System is 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." (Page 1)
- "A comparison of the technological characteristics of the Signature Edition® Infusion System and the predicate devices has been performed. The results of this comparison demonstrate that the modified Signature Edition® Infusion System is equivalent in technological characteristics to the unmodified device and that the fundamental scientific technology of the predicate device has not been altered." (Page 2)
Therefore, I cannot provide the requested information, as these details are not present in the provided text.
§ 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).