(79 days)
The B. Braun Contiplex® D Insulated Needle is intended for use in regional anesthesia and pain therapy to locate, by stimulation, peripheral nerves by transferring electrical impulses from a nerve stimulator. The needle is used to inject and facilitate the continuous administration of local anesthetics or analgesics to the targeted nerve bundle for general and orthopedic surgery.
The Contiplex D Continuous Nerve Block Set is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for peripheral plexus anesthesia and pain management during the pre-operative, perioperative and post-operative periods associated with general and orthopedic surgery. The Contiplex D polyamide catheter may remain indwelling for up to 72 hours.
The B. Braun Stimuplex® D Insulated Needle is intended for use in regional anesthesia and pain therapy to locate by stimulation peripheral nerves by transferring electrical impulses from a nerve stimulator. The needle is used to inject a single dose of anesthetic or analgesic fluid to the targeted nerve bundle for general and orthopedic surgery.
The B. Braun Stimuplex® D' Plus Insulated Echogenic Needle is intended for use in regional anesthesia and pain therapy to target peripheral nerves by transferring electrical impulses from a nerve stimulator and by visualization of an echogenic reflective pattern at the needle tip using an ultrasound imaging device. The needle is used to inject a single dose of anesthetic or analgesic fluid to the targeted nerve bundle for general and orthopedic surgery.
The Contiplex® D Insulated Needles are intended for locating by stimulation, peripheral nerves for the administration of anesthetic or analgesic fluid to the targeted nerve. The Contiplex D needle includes an introducer catheter over the needle to facilitate the advancement of an indwelling catheter. The dielectric needle coating and electrical connection within the hub facilitate the transfer of electrical impulses from a nerve stimulator to the tip of the needle. The needle hubs include an aspiration or injection tubing line in order to facilitate the initial injection of anesthetic or analgesic fluid as well as a connecting cable, which can be attached to the cables of any of the B. Braun Nerve Stimulators listed on the product labeling. The Contiplex D needle/catheter assemblies will be available in two lengths, gauges and bevel geometries.
The Contiplex D Insulated Needles will be available in a set configuration containing one Contiplex D introducer catheter over insulated nerve stimulating needle, one polyamide open-tip catheter with threading assist guide, and one clamp style catheter connector. After needle removal, the short introducer catheter is used to thread a longer open-tip polyamide catheter into the patient. The polyamide catheter and catheter connector are used to administer the continuous flow of anesthetic or analgesic fluid to the patient for up to 72 hours.
The Stimuplex® D Insulated Needles are individually packaged insulated needles, intended for the localization and stimulation of peripheral nerve bundles for "single shot" anesthesia. The Stimuplex D needle hubs, like the Contiplex D needles, include an aspiration or injection tubing line in order to facilitate the injection of anesthetic or analgesic fluid. The dielectric needle coating and electrical connection within the hub facilitate the transfer of electrical impulses from a nerve stimulator to the tip of the needle. The Stimuplex D needles can be used with any of the B. Braun Nerve Stimulators listed on the product labeling. The needles will be available in various lengths and gauge sizes with two bevel angles for some sizes.
The Stimuplex® D Plus Insulated Echogenic Needles are designed to provide the clinician with two modalities to locate peripheral nerves for nerve block procedures; through electrical stimulation and ultrasound imaging. The dielectric coating and electrical connection within the hub facilitate the transfer of electrical impulses from a nerve stimulator to the tip of the needle. The Stimuplex D Plus needles can be used with any of the B. Braun Nerve Stimulators listed on the product labeling. In addition, the needles are designed with etched markings to help reflect an image of the needle when using an ultrasound imaging machine. Once the nerve is located, the Stimuplex D Plus needles include a tubing line in order to permit the 'single shot' injection of local anesthetic fluid to the nerve. The needles will be available in various lengths and gauge sizes.
The provided text describes different types of insulated needles for regional anesthesia and pain therapy. It highlights their intended use, design, and comparison to predicate devices, focusing on the substantial equivalence argument for regulatory clearance. Detailed information regarding specific acceptance criteria for performance, the design of a study to prove acceptance criteria, sample sizes for test and training sets, expert qualifications, ground truth establishment, or human-in-the-loop performance is not included in the provided text.
The document primarily focuses on obtaining 510(k) clearance by demonstrating "substantial equivalence" of the new devices (Contiplex® D Insulated Needles, Stimuplex® D Insulated Needles, Stimuplex® D Plus Insulated Echogenic Needles) to legally marketed predicate devices. This regulatory pathway typically involves showing that a new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness.
The document states:
- "Biocompatibility testing was completed to address any differences in materials and to verify that no new issues of safety have been introduced with the proposed devices."
- "Additionally, performance testing was completed to verify that all design input requirements of the proposed devices have been met."
- "The following performance standards were considered in evaluating the performance of the proposed devices: ISO 9626:1991/Amd. 1:2001(E) 'Stainless steel needle tubing for the manufacture of medical devices.' ISO 7864:1993(E) 'Sterile hypodermic needles for single use.' ISO 594-2:1998 'Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment- Part 2: Lock fittings.'"
- "A comparative evaluation of the needles under ultrasound was completed to demonstrate there are no differences between the proposed and predicate device, which raise new issues of safety or effectiveness."
Based on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or AI-related performance. The information provided is at a high level of regulatory compliance rather than detailing the specifics of performance studies.
Therefore, the requested tables and information cannot be generated from the given text.
In summary, the document states that performance testing was done to verify design input requirements and that industry standards (ISO) were considered. However, it does not provide the specific numerical acceptance criteria, the detailed results, study designs, sample sizes, ground truth methods, or expert information as requested.
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).