(175 days)
The Intra Op Catheter is intended to provide continuous or intermittent delivery of local anesthetics or narcotics to surgical wound sites and nerve trunks outside of the epidural space. Routes of administration may be either, intraoperative, intramuscular, subcutaneous or percutaneous.
The Intra Op Catheter is identical to the Teleflex Medical (TFX) Epidural Catheter (K840202, originally submitted by Aries Medical) with the exception of the inner diameter of the distal end of the catheter. The catheter is manufactured by TFX using their current plastic formulation. The catheter has a closed end tip with multiple holes along the lateral surface at the distal end of the device. The catheter package may contain a "T" Peel catheter over needle or a catheter connector (e.g. Touhy Borst) in addition to the catheter defined herein. The catheter is designed to be distributed in two basic configurations: with a catheter connector (Touhy Borst type) attached, or with a bonded or insert molded luer lock catheter connector.
The provided text is a 510(k) premarket notification for a medical device called the "Intra Op Catheter." This document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than establishing acceptance criteria or reporting performance from a clinical study for a novel device.
Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert involvement, adjudication, MRMC studies, standalone performance), and ground truth establishment is not available in the provided document.
The core of this submission is a comparison of the Intra Op Catheter's physical and operational specifications, biological specifications, and intended use with three predicate devices:
- Teleflex Medical (TFX) Epidural Catheter (K840202)
- B. Braun Perifix Set (K813186)
- Epimed Internation FETH-R_KATH catheter
The document concludes that the Intra Op Catheter is "substantially equivalent" to these predicates based on its design, materials, and intended use. This is a regulatory pathway that allows a device to be marketed without requiring new clinical trials to establish safety and effectiveness if it can be demonstrated to be as safe and effective as a legally marketed 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).