(168 days)
The Dispenser DP 20 is intended for the general surgical fluid irrigation and infiltration under the direct control of a physician. The infiltration pump is not intended for intravascular infusion of fluids.
The principle of operation and technology incorporated in the Dispenser DP 20 are equivalent to peristaltic irrigation systems, which use peristalsis-type action to move fluid through a tube by alternating mechanical squeezing of fluid-filled tubing with a roller. As with all peristaltic pumps, the Dispenser DP 20 contacts only the tubing and never directly contacts the fluid, thus fluid sterility cannot be compromised by the pumping action. Sterility: Tubing set; disposable with plug-in cannula, sterile, length 4 m
The provided text is a 510(k) summary for the NOUVAG Dispenser DP 20, an infiltration pump. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a performance study with acceptance criteria in the way you've outlined.
Therefore, the information requested in your prompt regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be extracted from this document.
The 510(k) summary does contain the following relevant points:
- Device Description and Intended Use: The Dispenser DP 20 is an infiltration pump intended for general surgical fluid irrigation and infiltration under physician control, using a peristaltic action. It is not for intravascular infusion.
- Predicate Devices: The document identifies two predicate devices:
- Substantial Equivalence Claim: The manufacturer claims substantial equivalence based on the principle of operation and technology (peristaltic action for fluid delivery) being similar to other irrigation devices previously cleared by the FDA.
- Nonclinical Testing: A brief summary states: "The Dispenser DP 20 has been designed and tested to applicable safety standards. The Dispenser DP 20 does not raise any new issues of safety, effectiveness, or performance of the product." This indicates some form of testing was done to safety standards, but no specific criteria or results are provided.
In summary, this 510(k) document is a regulatory submission focused on comparing technological characteristics and intended use to existing devices, not on providing a detailed performance study with quantifiable acceptance criteria and results as typically found for novel AI/diagnostic 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).