(154 days)
For use in Angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
The Trailrunner™ Guidewire is comprised of a PTFE coated stainless steel proximal core body and a Nitinol distal core body, joined by a Nitinol hypotube. The distal Nitinol core is inserted into the inside diameter of two adjacent, coaxial coils: a platinum coil (distal) and a stainless steel coil (proximal). A stainless steel flat wire (ribbon) is also inserted into the inside diameter of the coils. At the proximal extent of the stainless steel coil, a solder joint binds the coil to the Nitinol core and the flat wire. A second solder joint binds both coils at their junction; the core, and the SS ribbon together, A third solder joint at the distal tip of the device bonds the ribbon to the platinum coil. Depth markings using white PTFE are applied to the proximal end of the core. The distal tip of the guidewire is coated with hydrophilic coating. The 185cm version is designed to mate with the Lake Region extension wire cleared with other Lake Region Guidewires(Reference 510(k);s K970376, K041624)
The provided text describes a 510(k) submission for the TRAILRUNNER™ Guidewires, seeking substantial equivalence to a predicate device. This type of submission does not involve clinical trials with acceptance criteria for device performance in the same way a de novo or PMA submission might. Instead, substantial equivalence is demonstrated through non-clinical testing and comparison to a legally marketed predicate device.
Here's an analysis based on the information provided, specifically addressing the points in your request:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state acceptance criteria in terms of specific performance metrics with numerical values (e.g., sensitivity, specificity, accuracy) that would be common for AI/ML devices or diagnostics. Instead, the acceptance criterion for this 510(k) is substantial equivalence to the predicate device, the GUIDANT High Torque BMW Guidewire (K983033).
The "reported device performance" is described qualitatively as:
| Acceptance Criterion (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Functional and Performance Characteristics comparable to predicate. | "The results of these tests demonstrated the functionality and performance characteristics of these Guidewires are comparable to the currently marketed devices." |
| Design Specifications substantially equivalent to predicate. | "The design specifications are substantially equivalent High Torque BMW Guidewire. Both have a bi-metal core comprised of stainless steel and Nitinol connected by a hypotube. Both designs have a platinum distal coil and a stainless steel coil and both designs have ribbon wires inserted into the inside diameter of the coils. Component joining methods are similar and both are partially coated with hydrophilic coating and contain proximal depth markings on the core." |
| Biocompatibility acceptable. | "Biocompatibility testing per ISO 10993 series has been performed on the Trailrunner™ devices and has been found to be acceptable." |
| Material Equivalence to predicate. | Details provided in the comparison table regarding core, coil, coatings, joining agents, guidewire lengths, depth markings, guidewire diameter. While differences exist (e.g., length of proximal stainless steel coil, sterilization method, white PTFE depth markings vs. ablated), the overall conclusion is substantial equivalence. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a separate "test set" for performance evaluation in the context of clinical outcomes. The non-clinical testing involved "test pieces" for visual/tactile, dimensional, and mechanical attributes. The number of these test pieces is not quantified here.
- Data Provenance: Not applicable in the sense of patient data provenance (e.g., country of origin, retrospective/prospective). This is a physical medical device and the "data" would be from lab-based non-clinical tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. For this type of 510(k) substantial equivalence submission, ground truth is established through engineering specifications, material properties, and physical performance testing against established standards or internal benchmarks, rather than expert clinical consensus on patient data.
- Qualifications of Experts: N/A.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Test results for physical and mechanical properties are typically objective measurements, not subject to expert adjudication of subjective interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging devices or AI-assisted diagnostic tools where human reader performance is a key metric. This submission is for a physical medical guide wire.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This is not an AI/ML algorithm or a diagnostic device. The performance is intrinsically linked to its physical interaction during a medical procedure, but its evaluation for this submission is based on non-clinical engineering and material properties.
7. The Type of Ground Truth Used
- Ground Truth Type:
- Engineering Specifications and Design Documents: The core "ground truth" for the device's design and materials.
- Predicate Device Characteristics: The established design, materials, and (presumably) validated performance of the legally marketed predicate device served as the primary reference for comparison.
- ISO Standards (e.g., ISO 10993 for biocompatibility): These provide the ground truth for safety aspects like biocompatibility.
- Established Test Methods and Performance Requirements: For mechanical and functional tests, the ground truth is the expected performance based on relevant engineering principles and industry norms for such guidewires.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set.
§ 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.