(350 days)
The BNLE Access Guidewire is intended for percutaneous entry of peripheral vessels using the Seldinger Technique. This device is not intended for use in the coronary or cerebral vasculature.
The BNLE Access Guidewires are available in 40 cm to 80 cm lengths and in the 0.018" – 0.021" diameter range. The BNLE Access Guidewires are available with Nitinol or Stainless Steel (SS) shafts and in configurations with SS coils or radiopaque Tungsten coils.
The BNLE Access Guidewires consist of a solid core shaft with a ground tapered section at the distal end of the guidewire. A micro-coil is wound with a lumen that is then placed over the tapered distal section. The distal end is secured to the shaft via a weld and the proximal end is bonded to the shaft using adhesive. The micro-coil will provide tip radiopacity in designated models. The finished guidewire is placed in a protective polymer dispenser hoop for either sterile packaging in a labeled Tyvek pouch or shipped in bulk non-sterile condition to use with in a procedure tray by a customer.
The provided text is a 510(k) summary for the BNLE Access Guidewire, a medical device classified as a catheter guide wire (Product Code: DQX, Regulation Number: 21 CFR 870.1330). This document focuses on demonstrating substantial equivalence to a predicate device, the VSI Guidewire (K112631), rather than outlining a study to prove acceptance criteria for a new AI/ML-driven device.
Therefore, the following information, typically requested for AI/ML device studies, is not available in the provided text:
- Acceptance Criteria and Reported Device Performance Table: The document explicitly states "BNLE Access Guidewire raised no new concerns regarding safety or efficacy" and aims to prove "substantially equivalent" rather than meeting specific performance metrics against a predefined acceptance criterion.
- Sample size used for the test set and data provenance: No information on a test set (clinical or otherwise for performance evaluation) is provided. The testing described is primarily mechanical and material-based.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable as there is no mention of a test set requiring expert ground truth.
- Adjudication method for the test set: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable. This is a conventional medical device, not an AI-assisted one.
- Standalone (algorithm only without human-in-the-loop performance) study: Not applicable.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
However, the document does list the performance testing conducted to support the substantial equivalence claim for the BNLE Access Guidewire:
Performance Testing Items:
- Simulated Use/Device Compatibility
- Corrosion
- Kink Resistance
- Tip Flexibility
- Radiopacity
- Tensile
- Dimensional
- Visual Inspection
- Reverse Bend / Flex
- Fracture Resistance
- Torqueability
- Torque Strength
- Shelf Life
**Biocompatibility Testing (per ISO 10993-1 for an external communicating device, limited (
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.