(148 days)
Not Found
No
The document describes a physical medical device (needle, catheter, set) used for nerve blocks, relying on electrical stimulation or ultrasound visualization. There is no mention of AI/ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is used to administer local anesthetics or analgesics to targeted nerve bundles for pain management and anesthesia, directly impacting the patient's condition.
No
The device is used to locate peripheral nerves and inject/administer local anesthetics/analgesics, which are therapeutic actions, not diagnostic. While it uses ultrasound for visualization, this is for guidance during a procedure, not for diagnosing a condition.
No
The device description clearly states it is a needle and catheter, which are physical hardware components. The testing also includes biocompatibility and performance testing on these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function in regional anesthesia and pain therapy, involving the location of peripheral nerves and the administration of local anesthetics/analgesics within the patient's body.
- Device Description: The description details a needle, catheter, and related accessories used for insertion into the body.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens outside of the body (in vitro) to provide diagnostic information. IVDs are typically used to test blood, urine, tissue samples, etc., in a laboratory setting.
This device falls under the category of a medical device used for therapeutic and procedural purposes in vivo (within a living organism).
N/A
Intended Use / Indications for Use
The Continuous Peripheral Nerve Block Needle is intended for use in regional anesthesia and pain therapy to locate peripheral nerves by transferring electrical impulses from a nerve stimulator or through ultrasound visualization of the device. 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 Continuous Peripheral Nerve Block Set, consisting of the peripheral nerve block needle, catheter, and related peripheral nerve block procedural accessories, is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for peripheral plexus anesthesia and pain management during pre-operative, perioperative and post-operative periods associated with general and orthopedic surgery. The catheter may remain indwelling for up to 72 hours.
Product codes
BSP
Device Description
The Contiplex C Continuous Peripheral Nerve Block Needle is a needle comprised of an open tip catheter over an insulated needle with a positioning component, a needle hub with integrated injection tubing and cable, and connection tubing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
peripheral nerves, peripheral plexus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was performed with the Contiplex C Continuous Peripheral Nerve Block Needle to support substantial equivalence to the predicate device. Testing included biocompatibility and performance testing. Biocompatibility testing was performed based on the nature and duration of patient contact in accordance with ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. The insulated needle components were tested per the ISO 10993-1 requirements for an externally communicating device with tissue contact for a limited duration ( 24 hours.
§ 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).
0
K12.1846
B. Braun Medical Inc. 510(k) Premarket Notification Contiplex C® Continuous Peripheral Nerve Block Needle
5. 510(k) SUMMARY
DATE:
November 20, 2012
NOV 2 0 2012
SUBMITTER:
B. Braun Medical Inc. 901 Marcon Boulevard Allentown, PA 18109-9341 610-266-0500
Contact: Nancy Skocypec, Regulatory Affairs Specialist Phone: (610) 596-2796 Fax: (610) 266-4962 E-mail: nancy.skocypec@bbraun.com
Continlex® C Continuous Peripheral Nerve Block Needle
DEVICE NAME:
Peripheral Nerve Block Needle
K100241, Class II, BSP, 868.5150
COMMON NAME:
DEVICE CLASSIFICATION:
Needles. Conduction, Anesthetic, W/Wo introducer (21 CFR 868.5150. Product Code BSP)
Contiplex D Insulated Needle, Stimuplex D Insulated Needle PREDICATE DEVICE: B. Braun Medical, Inc., Contiplex D Continuous Nerve Block Set,
DESCRIPTION:
INTENDED USE:
The Contiplex C Continuous Peripheral Nerve Block Needle is a needle comprised of an open tip catheter over an insulated needle with a positioning component, a needle hub with integrated injection tubing and cable, and connection tubing.
The Contiplex C Continuous Peripheral Nerve Block Needle is intended for use in regional anesthesia and pain therapy to locate peripheral nerves by transferring electrical impulses from a nerve stimulator or by ultrasound visualization of the device. The needle is used to inject and facilitate the continuous administration of local anesthetics or analgesics to the targeted nerve bundle in general and orthopedic surgery.
In set configuration, the B. Braun Contiplex C Continuous Peripheral Nerve Block Set, consisting of the peripheral nerve block needle, catheter, and related peripheral nerve block procedural accessories, is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for peripheral plexus anesthesia and pain management during pre-operative, perioperative
1
and post-operative periods associated with general and orthopedic surgery. The catheter may remain indwelling for up to 72 hours.
SUBSTANTIAL EQUIVALENCE:
Technological Characteristics
The Continuous C Continuous Peripheral Nerve Block Needle has the same intended use as the Contiplex D Insulated Needle (K100241). The proposed device and predicate device both incorporate insulated needles to locate by stimulation, targeted nerve bundles, in order to perform peripheral nerve block procedures. Both devices are advanced toward the target nerve with direction being guided by stimulation and both are used to place an in-dwelling catheter in position local to the target nerve. Both devices include a catheter over needle design.
The primary difference between the proposed Contiplex C Continuous Peripheral Nerve Block Needle and the predicate Contiplex D Insulated Needle relate to the in-dwelling catheter over needle assembly and the resultant methodology used to place the open tip catheter at the targeted nerve bundle. As a result, the needle and catheter dimensions are different from those of the predicate device. Additional differences include connection tubing, needle coating material, catheter material and the option to utilize ultrasound as a placement guide.
Performance Data
Testing was performed with the Contiplex C Continuous Peripheral Nerve Block Needle to support substantial equivalence to the predicate device. Testing included biocompatibility and performance testing.
Biocompatibility testing was performed based on the nature and duration of patient contact in accordance with ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. The insulated needle components were tested per the ISO 10993-1 requirements for an externally communicating device with tissue contact for a limited duration ( 24 hours.