(64 days)
TurboTRACKERs are intended to assist in the delivery of diagnostic agents such as contrast media and therapeutic agents such as occlusion coils into the peripheral, coronary, and neuro vasculature.
TurboTRACKERs are single lumen devices designed to aid the physician in the access of distal vasculature when used with a guiding catheter and steerable guidewire. Graded shaft stiffness ranging from a highly flexible tip to a semi-rigid proximal section aids the physician in tracking over the selectively placed guidewire. TurboTRACKERs are externally coated with Hydrolene™, a hydrophilic surface that reduces friction during manipulation. TurboTRACKERs are available in one and two tip marker versions.
This 510(k) summary does not contain the information required to complete the requested table and answer many of the questions. This document describes a medical device (TurboTRACKER) and its substantial equivalence to a predicate device, focusing on bench and biocompatibility testing rather than a clinical study evaluating diagnostic or therapeutic accuracy against specific acceptance criteria.
Here's what can be inferred and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified for clinical performance. The document mainly focuses on engineering and biocompatibility criteria. | The results of bench testing (Tensile Test, Tip Flexibility Test, Static Pressure Strength Test, Post Steam Shaping Outer Diameter Hydrophilic Coating Durability Test, Forces Required to Deliver Occlusion Coils Test, Flow Rate Test, Forces Required to Withdraw the Catheter Through a Guiding Catheter Test, Tip Buckling Test, Coefficient of Friction Test . O.D., Minimum Bend Radius Test, and Steam Shaping Shrinkage Test) and biocompatibility testing support the substantial equivalence claims of the TurboTRACKER for its intended use. This implies the device met internal specifications for these performance attributes, but the specific numerical criteria and results are not provided. |
2. Sample size used for the test set and the data provenance:
- Not Applicable / Not provided. The "testing" referred to is bench testing and biocompatibility testing, not a clinical study on a human "test set" in the context of diagnostic or therapeutic performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not provided. This information is relevant for studies validating diagnostic or therapeutic accuracy with expert ground truth, which is not described here.
4. Adjudication method for the test set:
- Not Applicable / Not provided.
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:
- No, this was not done. This document pertains to a medical device (catheter) and its physical/biological properties, not an AI or imaging-based diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, this was not done. This is not relevant to the type of device described.
7. The type of ground truth used:
- Not Applicable / Not provided. For the bench testing, the "ground truth" would be the engineering specifications and established test methods used to evaluate the device's physical properties. For biocompatibility, it would be established toxicological and biological safety standards.
8. The sample size for the training set:
- Not Applicable / Not provided. This document describes a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established:
- Not Applicable / Not provided.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).