(57 days)
The Turnpike catheters are intended to be used to access discrete regions of the coronary and/or peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and to subselectively infusedeliver diagnostic and therapeutic agents.
The Turnpike catheters are single lumen catheters designed for use in the coronary and peripheral vasculature. The catheter's shaft is constructed of two polymer layers that encapsulate a braid and a dual-layer coil. The Turnpike catheters have a radiopaque tip (polymer or gold-plated) and are available in various tip and shaft configurations. The distal 60cm of each catheter has a hydrophilic coating. The Turnpike catheters are available in 135 cm or 150 cm working lengths and are compatible with 0.014" guidewires and 5F guide catheters.
The provided document is a 510(k) summary for the Turnpike Catheter, which is a medical device used to access vascular regions, facilitate guidewire placement, and deliver diagnostic and therapeutic agents. The document describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to predicate devices.
Here's an analysis of the acceptance criteria and study information based on your request:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance | Study that Proves Device Performance |
|---|---|---|
| Deliverability | Passed | Performance tests |
| Hydrophilic Coating | Passed | Hydrophilic Coating Evaluation |
| Tensile Strength | Passed | Performance tests |
| Torque Strength | Passed | Performance tests |
| Strain Relief Markings | Passed | Performance tests |
| ISO 10555-1 Verification | Passed | ISO 10555-1 Verification |
| ISO 594 Hub Verification | Passed | ISO 594 Hub Verification |
| Biocompatibility: Cytotoxicity | Passed | ISO 10993-1 Biocompatibility tests |
| Biocompatibility: Sensitization | Passed | ISO 10993-1 Biocompatibility tests |
| Biocompatibility: Irritation | Passed | ISO 10993-1 Biocompatibility tests |
| Biocompatibility: Systemic Toxicity | Passed | ISO 10993-1 Biocompatibility tests |
| Biocompatibility: Material Mediated Pyrogenicity | Passed | ISO 10993-1 Biocompatibility tests |
| Biocompatibility: Hemolysis | Passed | ISO 10993-1 Biocompatibility tests |
| Biocompatibility: Complement Activation | Passed | ISO 10993-1 Biocompatibility tests |
| Biocompatibility: Thrombogenicity | Passed | ISO 10993-1 Biocompatibility tests |
Additional Information
-
Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes (number of devices or tests performed) for the performance and biocompatibility tests.
- The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given that these are laboratory compliance tests for a medical device prior to market, they are typically conducted prospectively in a controlled laboratory setting.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of device and study. The testing described involves engineering performance and biocompatibility, which are measured objectively against defined standards (e.g., ISO standards) and internal specifications. There is no "ground truth" derived from expert interpretation of medical images or clinical outcomes in the way this question implies. Instead, the "ground truth" (or acceptance criteria) is established by regulatory standards (e.g., ISO 10555-1, ISO 10993-1) and internal design specifications.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This question is not applicable for the same reasons as above. The tests performed are objective and yield pass/fail results based on predefined criteria, not subjective interpretations requiring adjudication.
-
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:
- This is not applicable. The device (Turnpike Catheter) is a physical medical device (catheter) used for vascular access and delivery of agents, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and AI-related effect sizes are not relevant to this submission.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable as the device is a physical catheter, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the performance tests (e.g., deliverability, tensile strength), the "ground truth" is defined by engineering specifications and ISO standards (e.g., ISO 10555-1, ISO 594).
- For the biocompatibility tests, the "ground truth" is defined by biological safety standards as outlined in ISO 10993-1.
- There is no "expert consensus," "pathology," or "outcomes data" in the typical clinical sense used to establish ground truth for this type of device validation.
-
The sample size for the training set:
- This is not applicable. The Turnpike Catheter is a physical device, and the testing described is not related to training an algorithm or AI model.
-
How the ground truth for the training set was established:
- This is not applicable for the same reason as above.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).