(56 days)
Stryker Neurovascular's Tracker-17 Microcatheters 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.
Stryker Neurovascular's Tracker-17 Microcatheter is a single lumen device designed to aid the physician in accessing 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 selectively placed guidewires. A luer fitting located on the microcatheter hub is used for the attachment of accessories. A radiopaque tip facilitates fluoroscopic visualization. Hydrophilically coated Reinforced Microcatheters are coated on the outer surface with Hydrolene™ Coating that reduces friction during manipulation in the vessel.
The provided FDA 510(k) summary for the Tracker-17 Microcatheter describes a device that is substantially equivalent to a predicate device, the Tracker Excel-14 Microcatheter. This document focuses on the mechanical and material characteristics of the microcatheter, rather than its performance in diagnostic or therapeutic tasks, which would typically involve AI/ML components and human reader studies.
Therefore, the requested information on acceptance criteria, reader studies, ground truth, and training sets as they relate to AI/ML device performance is not applicable to this submission. This document describes a traditional medical device's substantial equivalence based on engineering and material comparisons, not a software-driven diagnostic or prognostic tool.
However, I can extract information related to the device's functional equivalence and the testing performed to demonstrate that.
Acceptance Criteria and Device Performance (for a non-AI/ML device):
The acceptance criteria for this type of device are primarily based on demonstrating substantial equivalence to a predicate device in terms of functionality, method of operation, intended use, indication for use, and biological safety, as well as meeting predefined engineering specifications.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functionality (design, operation, intended use, indications for use) | Substantially equivalent to predicate (Tracker Excel-14 Microcatheter) |
| Material Composition (Shaft Material Proximal) | Offered with Pebax (predicate used Carbothane) |
| Other Material Compositions (Mid, Distal Shaft) | Same as predicate |
| Shaft Design | Same as predicate |
| Distal Shaft Length | Same as predicate |
| Mid Shaft Length | Same as predicate |
| Mid Transition Length | Same as predicate |
| Proximal Shaft Length | Same as predicate |
| Proximal ID/OD | Same as predicate |
| Distal ID/OD | Same as predicate |
| Tip Marker | Same as predicate |
| Coating | Same as predicate |
| Effective Length | Same as predicate |
| Hydrolene Uncoated Length | Increased from 35 cm to 50 cm (compared to predicate) |
| Indication (for labeling) | Same as predicate (with contractual note on peripheral/coronary) |
| Sterilization Method | Same as predicate |
| Packaging Material | Same as predicate |
| Packaging Artwork | Offered as Stryker branded products |
| Packaging Carton/Closure Strip | Offered with perforated opening (vs flap-insert) and smaller closure strip (vs predicate) |
| Risk Assessment (modifications to predicate) | No new questions of safety or effectiveness raised per EN ISO 14971:2012 |
| Verification Testing | Demonstrated substantial equivalence to predicate |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated as a "test set" in the context of AI/ML. The "test set" here refers to the actual physical devices (Tracker-17 Microcatheters) that underwent verification testing. The number of devices tested for each characteristic (e.g., burst pressure, tensile strength, kink resistance, etc., though not detailed in this summary) is not specified.
- Data Provenance: The data comes from internal verification testing conducted by Stryker Neurovascular. The geographic origin of this testing is not specified but would typically be at their manufacturing or R&D facilities. This is a prospective evaluation of the newly designed device against engineering specifications and comparison to the predicate.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable. This is a hardware device. "Ground truth" would refer to established engineering standards, material properties, and performance benchmarks, not expert consensus on medical images or patient outcomes. The "experts" would be engineers, material scientists, and regulatory specialists.
4. Adjudication Method for the Test Set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers in a diagnostic or clinical assessment context. For a physical device, performance is measured objectively against specifications. Decisions on whether a test passes or fails are typically based on predefined acceptance limits.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done and Effect Size:
- No, Not Applicable. MRMC studies are designed to compare the performance of human readers, often with and without AI assistance, especially in image interpretation. This device is a microcatheter, a physical tool for delivery of agents, not an AI diagnostic software.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- No, Not Applicable. This question relates to AI algorithm performance.
7. The type of ground truth used:
- The "ground truth" for this device's evaluation is primarily engineering specifications, material science standards, and performance characteristics of the predicate device. For instance, burst pressure, tensile strength, flexibility, trackability, radiopacity, and biocompatibility would be measured and compared against established limits and the predicate's performance. The "clinical ground truth" for its intended use is derived from its design to assist in the delivery of diagnostic and therapeutic agents.
8. The sample size for the training set:
- Not Applicable. This question relates to AI algorithm training.
9. How the ground truth for the training set was established:
- Not Applicable. This question relates to AI algorithm training.
In summary, the provided document describes a 510(k) submission for a non-AI/ML medical device. The "acceptance criteria" revolve around demonstrating substantial equivalence to a legally marketed predicate device through engineering analysis, material characterization, and verification testing against predefined specifications. The concepts of "AI models," "human readers," "ground truth determination" in a clinical context, and "training sets" are not relevant to this submission.
§ 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).