(29 days)
Mandrel guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
The Mandrel wire family is made of a coated (PTFE or Silicone) or uncoated Nitinol or Stainless Steel core wire that is tapered at the distal tip where a coil is secured to the distal end. The distal coil can be anywhere from 2cm to 30cm depending on specific design and can consist of Stainless Steel, Palladium, Platinum, or the proposed Tungsten materials. The guidewire may contain proximal core markers.
The provided text describes a 510(k) submission for the Mandrel Guidewire with Tungsten, focusing on demonstrating substantial equivalence to previously cleared predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in the context of AI/ML performance, human reader studies, or ground truth establishment for a diagnostic device.
The document primarily discusses bench testing for physical and material properties, and biocompatibility testing, to show that the modified device (with Tungsten) is as safe and effective as the predicate devices.
Therefore, many of the requested categories for AI/ML device evaluation are not applicable to this submission.
Here's a breakdown based on the information provided, highlighting the absence of AI/ML specific criteria:
Acceptance Criteria and Device Performance (Non-AI/ML Context)
| Acceptance Criteria Category | Reported Device Performance (Non-AI/ML Context) |
|---|---|
| Visual Inspection | Test devices manufactured and inspected according to established requirements for visual/tactile attributes, demonstrating compliance with design input summary. |
| Dimensional Conformance | Test devices manufactured and inspected according to established requirements for dimensional attributes, demonstrating compliance with design input summary. |
| Radiopacity | Bench testing performed to show compliance with design input summary. |
| Lubricity | Bench testing performed to show compliance with design input summary. |
| J-Memory Test | Bench testing performed to show compliance with design input summary. |
| Body Stiffness | Bench testing performed to show compliance with design input summary. |
| Adhesion / Durability | Bench testing performed to show compliance with design input summary. |
| Guidewire Pull test | Bench testing performed to show compliance with design input summary. |
| Torque Strength | Bench testing performed to show compliance with design input summary. |
| Torque Control | Bench testing performed to show compliance with design input summary. |
| Linear Stiffness | Bench testing performed to show compliance with design input summary. |
| Lateral Stiffness | Bench testing performed to show compliance with design input summary. |
| Particulate Test | Bench testing performed to show compliance with design input summary. |
| ISO Strength of Union | Bench testing performed to show compliance with design input summary. |
| ISO Flex Test | Bench testing performed to show compliance with design input summary. |
| ISO Corrosion Resistance Test | Bench testing performed to show compliance with design input summary. |
| ISO Fracture Test | Bench testing performed to show compliance with design input summary. |
| Hydrodurability | Bench testing performed to show compliance with design input summary. |
| Biocompatibility (Cytotoxicity) | Biocompatibility testing per design input summary requirements showed the addition of Tungsten does not affect biocompatibility and is in compliance with pre-defined acceptance criteria. |
| Biocompatibility (Hemolysis) | Biocompatibility testing per design input summary requirements showed the addition of Tungsten does not affect biocompatibility and is in compliance with pre-defined acceptance criteria. |
Study Details (Non-AI/ML Context)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated as a number of devices. The document mentions "Test devices were manufactured and inspected according to established requirements."
- Data Provenance: Not applicable in the context of clinical data. This refers to bench testing performed by Lake Region Medical.
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 as this is not a diagnostic device relying on expert interpretation for ground truth. Ground truth for physical properties (e.g., dimensions, strength) would be defined by engineering specifications and measurement standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable; no clinical adjudication process is described for this type of device and testing.
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 not an AI/ML diagnostic device, and no MRMC study or human reader improvement is discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable; this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For bench testing, the "ground truth" is based on established engineering specifications, published standards (e.g., ISO), and physical measurements. For biocompatibility, it's based on established biological safety evaluation criteria.
8. The sample size for the training set
- Not applicable; this is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable; no training set described.
§ 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.