(88 days)
For use in a kit for nerve blocks or wound site pain management. To provide continuous or intermittent delivery of local anesthetics or other medications to surgical wound sites and/or close proximity to nerves outside the epidural space. Routes of administration may be intraoperative or percutaneous. As an accessory to Sorenson medical infusion pumps or as a standalone device, but not for use with gravity feed. Single patient use only.
The infusion catheter is a small bore, 20 gauge, tube with holes at the tip to permit dispersion of the modication into the site. The overall cather is 30" in length with various lengths of holes (fenestrations) of - 1.5", 3.0", and 5.0" with a standard Touly Borst connector. The catheter has markings on the shaft to provide a reference guide for the clinician. May be available in a kit. Provided stcrilc.
The provided text is a 510(k) Summary of Safety and Effectiveness for a Fenestrated Infusion Catheter. It focuses on device description, intended use, and a declaration of substantial equivalence to predicate devices. Crucially, this document does not contain information about acceptance criteria or specific studies proving device performance against such criteria.
The 510(k) process primarily demonstrates substantial equivalence to a legally marketed predicate device rather than outright proof of meeting specific performance metrics through detailed studies. The absence of this information is typical for a 510(k) summary, which often relies on comparative claims rather than standalone performance studies with quantified acceptance criteria.
Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them because it is not present in the provided document.
To clarify, a 510(k) submission generally includes:
- Device Description: What the device is and how it works.
- Indications for Use: What the device is intended for.
- Technological Characteristics Comparison: How the new device is similar to and different from predicate devices.
- Performance Data (if applicable): Bench, animal, or clinical data may be submitted to support substantial equivalence, particularly if there are new technological characteristics or safety/effectiveness concerns. However, the summary provided here does not detail such studies or specific acceptance criteria.
The document's statement: "The data within the submission demonstrates that the proposed device is safe, effective, and substantially equivalent when compared to the predicate devices" indicates that such data was submitted to the FDA, but the specific details of that data, including acceptance criteria and study designs, are not included in this "Non-Confidential Summary."
§ 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).