(257 days)
The BNLE Hydrophilic Jacketed Peripheral Guidewires are intended to direct a catheter to a desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions.
The BNLE Hydrophilic Jacketed Peripheral Guidewire is available in 150 cm - 260 cm lengths and in 0.018" - 0.035" diameter ranges. The hydrophilic coated guidewire consists of a nickel-titanium alloy core wire and tungsten infused polyurethane jacket in configurations of wire stiffness and tip shape. The finished guidewire is placed in a dispenser hoop and Tyvek pouch. Five (5) Tyvek pouches are placed into a shelf box with an IFU, and 26 shelf cartons are placed into a shipper box. Labels are placed on the Tyvek pouch and shelf box. The finished product is EO sterilized.
The provided text is a 510(k) summary for a medical device (BNLE Hydrophilic Jacketed Peripheral Guidewire). It does not describe a study involving an AI/Machine Learning device or a diagnostic device that would have acceptance criteria related to accuracy metrics like sensitivity, specificity, or AUC, nor does it involve expert readers establishing ground truth.
Instead, this document details the substantial equivalence of a physical medical device (a guidewire) to a predicate device. The "performance testing" described is for the physical and biological characteristics of the guidewire itself, not for an algorithm's performance.
Therefore, most of the requested information (e.g., sample size for test/training sets, experts for ground truth, MRMC study, standalone algorithm performance, AI-related ground truth types) is not applicable to this document.
However, I can extract the acceptance criteria and performance as described for this physical device.
Acceptance Criteria and Device Performance (for a physical medical device - Guidewire)
Since this document pertains to a physical medical device (a guidewire) and not an AI/diagnostic algorithm, the "acceptance criteria" discussed are related to the device's physical and biocompatibility characteristics. The document doesn't provide specific numerical acceptance criteria or performance metrics for each test, but it states the overarching conclusion that the device "met all predetermined acceptance criteria."
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Physical Performance Tests | Met all predetermined acceptance criteria |
| Visual Inspection | Pass |
| Dimensional | Pass |
| Device Compatibility | Pass |
| Tensile | Pass |
| Torqueability | Pass |
| Torque Strength | Pass |
| Kink Resistance | Pass |
| Flex Resistance | Pass |
| Fracture Resistance | Pass |
| Tip Flexibility | Pass |
| Radiopacity | Pass |
| Particulate Evaluation / Coating Integrity | Pass |
| Lubricity and Durability | Pass |
| **Biocompatibility Tests (per ISO 10993-1 for 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.