(123 days)
The B. Braun Nerve Block Catheter is a device intended to provide, via percutaneous administration, continuous and/or intermittent infusion of local anesthetics near a nerve for regional anesthesia and pain management during the pre-operative, perioperative and postoperative periods associated with general and orthopedic surgery.
The B. Braun Nerve Block Catheter consists of polyamide tubing with an open or closed rounded tip, and will be available in sizes ranging from 18 G to 24 G, with a length ranging from 400 mm to 1010 mm. A soft tip version of the catheter (with a Pebax soft tip welded to the catheter body) will also be available in a closed tip configuration.
The provided 510(k) summary for the "B. Braun Nerve Block Catheter" does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. This type of document, a 510(k) summary, primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance study results against pre-defined acceptance criteria.
The information provided describes:
- Device Name: B. Braun Nerve Block Catheter
- Intended Use: To provide continuous and/or intermittent infusion of local anesthetics near a nerve for regional anesthesia and pain management.
- Predicate Devices: B. Braun Medical Inc. Soft Tip Epidural Catheter Kit (K971233), B. Braun Medical Inc. Perifix® Set for Epidural Anesthesia with Tuohy Needle and Catheter (K813186), I-Flow Corporation Nerve Block Infusion Kit (K984502), I-Flow Corporation Intra Op Catheter (K991543).
- Substantial Equivalence Argument: The device has similar materials, construction, design, and intended use as the predicate devices. Differences mentioned are in the location of catheter markings and size range compared to the B. Braun predicate, and similar indications for use to the I-Flow predicates.
Therefore, I cannot fulfill your request for the table of acceptance criteria and associated study details because this information is not present in the provided text.
To reiterate, a 510(k) submission generally focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technological characteristics and intended use, and may involve bench testing to ensure safety and effectiveness, but it rarely includes detailed clinical or performance studies with pre-defined acceptance criteria and statistical analysis as would be found for a novel device or a PMA submission.
§ 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).