(90 days)
The Arrow® Nitinol Wires are intended to facilitate the placement of central circulatory system or peripheral vasculature devices for diagnostic and interventional procedures.
The Arrow® Nitinol Wires are composed of a coil wire wrapped around a solid core wire, designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel to ensure proper tip placement of the catheter. The clinical benefit of the Arrow® Nitinol Wire is allow the clinician the ability to guide and control the advancing movement of the catheter body through the vessel gaining access to the vascular system through a single puncture site. The guidewires in Arrow / Teleflex Vascular finished goods are typically provided as Spring Wire Guide assemblies including additional components (straightener, Arrow Advancer, tubing clamps, snubber) for easier handling.
The provided document is a 510(k) Premarket Notification from the FDA for the Arrow® Nitinol Wire. It details the device description, indications for use, comparison to a predicate device, and various performance and biocompatibility tests conducted to support its substantial equivalence.
The document does NOT describe the acceptance criteria and study that proves the device meets the acceptance criteria for a software or AI/ML-driven medical device.
Instead, it pertains to a physical medical device – a guide wire – and the testing focuses on its physical properties, material compatibility, and engineering performance. Therefore, many of the requested points, such as "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone (i.e., algorithm only without human-in-the-loop performance)," "sample size for the training set," and "how the ground truth for the training set was established," are not applicable to this type of device submission.
However, I can extract the relevant information from the document regarding the acceptance criteria and performance studies for the Arrow® Nitinol Wire.
Acceptance Criteria and Device Performance (for a Physical Medical Device)
1. Table of Acceptance Criteria and the Reported Device Performance:
The document provides two tables: one for Biocompatibility and one for Performance Data.
Biocompatibility Testing:
| Test Name | Acceptance Criteria | Result |
|---|---|---|
| Cytotoxicity - L 929 Proliferation | The test article will meet the requirements of the test if it obtains a Grade of 0,1,or 2 (not more than 50% of the cells are round, devoid of intracytoplasmic granules, and no extensive cell lysis) | Acceptable |
| Sensitization - Kligman Maximization Assay | The test article will be considered a non-irritant if the difference between the test article mean score and the vehicle control mean score is 1.0 or less. | Acceptable |
| Intracutaneous Reactivity Test (Polar and Non-Polar (ISO)) | The test article will meet the requirements of the test if it receives a Grade of 1, 0 or less using the Kligman scoring system. | Acceptable |
| Acute Systemic Toxicity - Systemic Injection Test | The test article will meet the requirements of the test if it does not induce a significantly greater biological reaction than the control. | Acceptable |
| Acute Systemic Toxicity - Material Mediated Test | The test article will meet the requirements of the test if no rabbit shows an individual rise in temperature of 0.50C or more above the baseline temperature. | Acceptable |
| Hemocompatibility – Rabbit Blood Hemolysis (Complete) ASTM Test | The test article will meet the requirements of the test and is not considered to have hemolytic activity potential, if the hemolytic index above the negative control article and negative control article extract is |
§ 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.