(205 days)
The B. Braun Tear-Away Introducer Needle is intended to allow for the percutaneous placement of catheters in close proximity to nerves and around or into surgical wound or non-surgical wound sites.
The B. Braun Tear-Away Introducer Needle is a sterile, single-use, disposable device, that consists of a Stainless Steel Needle Hub. Tear-Away Sheath Hub. Tear-Away Sheath Shaft (tube) and a Protective Guard over the needle.
The B. Braun Tear-Away Introducer Needle is a manually operated device inserted into a patients skin by a surgeon in a clinical hospital setting for the percutaneous introduction of a catheter.
The plastic guard is removed and the B. Braun Tear-Away Introducer Needle is placed through the patient's skin with the bevel tip up. The needle is then withdrawn from the Tear-Away Introducer Sheath and discarded.
The Tear-Away Introducer Needle Sheath remains in the patient to facilitate the placement of an introduction catheter. An introduction catheter is inserted thru the Tear-Away Introducer Needle Sheath and into the patient. Once the introduction catheter is placed to the desired location, the Tear-Away Introducer Needle Sheath is withdrawn by sliding the sheath back towards the hub of the catheter. The Tear-Away Introducer Needle Sheath is then split apart and peeled away from the catheter while holding the hub of the sheath at the T-handle. The Tear-Away Introducer Needle Sheath is then discarded.
The provided text describes the B. Braun Tear-Away Introducer Needle and its substantial equivalence to a predicate device (Summit Medical Products, ambIT® Introducer) for FDA 510(k) clearance.
Based on the document, this is not an AI/ML device. It is a physical medical device (an introducer needle). Therefore, many of the requested criteria related to AI/ML device testing (such as sample size for test/training sets, expert ground truth adjudication, MRMC studies, standalone algorithm performance, etc.) are not applicable to this submission.
However, I can extract and present the information provided regarding the device's acceptance criteria and the (non-clinical) study that proves it meets them.
Device: B. Braun Tear-Away Introducer Needle
Type of Device: Physical Medical Device (Catheter Introducer/Introducer Needle) - NOT AI/ML
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this medical device are based on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and compliance with relevant ISO standards.
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance (Summary) |
|---|---|---|
| Physical and Dimensional Characteristics | Visual Inspection | Visual inspection was performed. |
| Dimensional Inspection | Dimensional inspection was performed. | |
| Luer Compatibility | Luer Compatibility - Gauging (ISO 594-1:1986, ISO 80369-7:2016) | Testing performed. |
| Needle/Sheath Functionality & Integrity | Needle Removal Force | Testing performed. |
| Occlusion | Testing performed. | |
| Pressure | Testing performed. | |
| Cannula Deflection (ISO 9626:2016) | Testing performed. | |
| Cannula Breakage (ISO 9626:2016) | Testing performed. | |
| Tensile Strength | Testing performed. | |
| Associated Device (likely compatibility/function with other devices) | Testing performed. | |
| Stress Cracking | Testing performed. | |
| Fluid Leakage by Pressure Decay | Testing performed. | |
| Subatmospheric Pressure Air Leakage | Testing performed. | |
| Resistance to Separation from Unscrewing | Testing performed. | |
| Resistance to Separation from Axial Load | Testing performed. | |
| Resistance to Overriding | Testing performed. | |
| Strength of Union (implied by separation/tensile tests) | Testing performed. | |
| Sterility | Sterilization Method (Ethylene Oxide, SAL 10^-6) | The device undergoes Ethylene Oxide sterilization to a Sterility Assurance Level (SAL) of 10^-6. |
| Biocompatibility | Biocompatibility requirements per ISO 10993-1:2009 (Cytotoxicity, Sensitization, Intracutaneous reactivity, Systemic toxicity, Rabbit Pyrogen) | Materials meet biocompatibility requirements. The device is a "Limited ( |
§ 868.5120 Anesthesia conduction catheter.
(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).