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510(k) Data Aggregation
(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 <5%. | Acceptable |
Performance Testing:
| Test Name | Acceptance Criteria | Result |
|---|---|---|
| Dimensional Verification | All dimensions shall be statistically inside tolerance limits according to the drawing with assurance of 95%. | Pass |
| Visual Inspection / Surface | When examined by normal or corrected-to-normal vision with minimum 2.5x magnification, the external surface of the effective length of the device shall appear free from extraneous matter. | Pass |
| Tensile Strength / Peak Tensile Force | When tested in accordance with the method given in BS EN ISO 11070, Annex H, the minimum peak tensile force of the guidewire and any critical junctions shall be: - 2 N for diameters <0.55mm (0.022") - 5 N for diameters ≥0.55mm (0.022") - <0.75 mm (0.030") - 10 N for spring wire guides with diameter ≥0.75 mm (0.030"). | Pass |
| Tip Pull | When tested in accordance with the method given in BS EN ISO 11070, Annex H, the minimum peak tensile force of the guidewire and any critical junctions shall be: - 2 N for diameters <0.55mm (0.022") - 5 N for diameters ≥0.55mm (0.022") - <0.75 mm (0.030") - 10 N for spring wire guides with diameter ≥0.75 mm (0.030"). | Pass |
| Torque Strength | Torque strength of subject device is substantially equivalent to the predicate device. | Pass |
| Corrosion Resistance | When tested in accordance with the method given in BS EN ISO 11070, Annex B, metallic components of the device shall show no visible signs of corrosion that can affect functional performance or biocompatibility test results. | Pass |
| Kink Resistance (Fracture test) | When tested in accordance with BS EN ISO 11070, Annex F, the spring wire guide shall not fracture, loosen, or fail in such a manner that:a. any section of the coil is left free to stretchb. a sharp, or potentially traumatic fracture surface is exposed, orc. any part of the device becomes separated such that it would not be removable by withdrawing the device from use. | Pass |
| Kink Resistance (Flexing test) | When tested in accordance with BS EN ISO 11070, Annex G, Neither the distal end of the guide wire nor the remaining portion of the guide wire shall show signs of defects or damage. | Pass |
| Kink Resistance (Comparison to predicate) | Test samples after being subjected to the test with pin gauge of particular radius did not show worse kink or plastic deformation or/and fracture compared to the predicate device. | Pass |
| Tip Flexibility | The tip shall visually exhibit higher flexibility than the rest of the wire. | Pass |
| Radiopacity | The spring wire guide has to be clearly visible on X-ray picture in its full length despite of shadowing by the water tank or human body. | Pass |
The following points are not applicable to this 510(k) submission for a physical medical device, as they relate specifically to AI/ML or software-driven devices, or human-in-the-loop studies. However, I will address them to confirm their non-applicability based on the provided document.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not Applicable in the context of AI/ML or software test sets. For this physical device, "test set" refers to the tested physical units of the guide wire. The documentation does not specify the number of units tested for each performance or biocompatibility test, nor does it specify data provenance in the sense of clinical data (e.g., country of origin or retrospective/prospective). The testing is laboratory-based on manufactured samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not Applicable. "Ground truth" in this context would refer to objective, measurable physical properties, or standard biological responses, not expert interpretation of diagnostic images. The performance and biocompatibility tests are based on established ISO standards and
in-vitro/in-vivo laboratory methods, not human expert consensus.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are relevant for subjective interpretations, often in diagnostic imaging by multiple readers. The testing for a guide wire is objective and measurable against predefined physical and biological criteria.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is a physical device, not an AI or software product. MRMC studies are for assessment of reader performance, typically with diagnostic imaging.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical device. There is no algorithm or software component being submitted for standalone performance evaluation in this 510(k).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable in the AI/ML context. For physical device testing, the "ground truth" equates to the objective acceptance criteria derived from engineering specifications and relevant ISO standards (e.g., BS EN ISO 11070 for guidewires, ISO 10993-1 for biocompatibility).
8. The sample size for the training set:
- Not Applicable. This concept is only relevant for machine learning models.
9. How the ground truth for the training set was established:
- Not Applicable. This concept is only relevant for machine learning models.
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