(201 days)
The Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD™) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous fistulae and synthetic dialysis grafts.
The Arrow-Trerotola™ PTD™ Catheter Assembly consists of two components, an outer cover sheath and an inner flexible torque cable with a self-expanding fragmentation basket attached to its distal end. The PTD™ fragmentation basket is constructed of four wires that are formed into a helical cage with a soft, flexible tip located on its distal end. The PTD™ catheter is designed to be used in conjunction with the Arrow Rotator Drive Unit that spins the basket at approximately 3000rpm. A drive hub on the proximal end of the catheter assembly mates with a drive gear in the Rotator Drive Unit. The cable stop on the catheter assembly secures the PTD™ Catheter to the Rotator Unit during operation.
The PTD™ outer sheath moves relative to the inner torque cable and is used to collapse and expand the fragmentation basket. The catheter is placed inside the clotted fistula with the basket in the closed position. After insertion, the basket is fully deployed inside the fistula to conform to the fistula wall. The basket is then rotated which pulverizes the clot; the clot is aspirated from the graft through an introducer sheath.
The PTD™ catheter is manufactured in two lengths, 65cm and 120cm, with a basket diameter of 9mm. It is also available in an Over-The-Wire (OTW) version, which allows the device to be passed over a guidewire.
Here's a breakdown of the acceptance criteria and study information based on the provided documents. Please note that the documents are primarily a 510(k) summary and FDA clearance letters, which focus on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical trial results with specific performance metrics and rigorous statistical analysis often seen in PMAs or later clinical studies.
Therefore, much of the requested information (like specific effect sizes for human readers, detailed ground truth establishment for training sets, or exact sample sizes for training) is not explicitly stated in these 510(k) documents.
Acceptance Criteria and Reported Device Performance
The documentation focuses on demonstrating substantial equivalence to a predicate device for an expanded indication for use (native arterio-venous fistulae). The implication is that if the device performs comparably to the predicate for this new indication, it meets the acceptance criteria for safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Safe and effective for mechanical declotting | As safe and effective as the legally marketed predicate device. |
| Comparable technological characteristics to predicate device | The proposed device has the same technological characteristics as the predicate device. |
| Performance for expanded indication (native AV fistulae) | Clinical data presented in the performance section supports this indication. |
Explanation of Implied Criteria: In a 510(k) submission, the primary "acceptance criterion" is often demonstrating substantial equivalence to a device already legally marketed. This means showing that the new device is as safe and effective as the predicate, often through comparable technological characteristics and, if necessary, performance data supporting any expanded or modified indications. Specific numerical performance metrics (like sensitivity, specificity, accuracy) are less common in 510(k)s unless there's a significant technological change or a new "unmet need" being addressed that requires new performance endpoints.
Study Details
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated in these documents. The submission mentions "clinical data presented in the performance section," but does not provide the specific number of patients or cases used.
- Data Provenance: Not explicitly stated. It's generally assumed to be retrospective analysis of existing clinical experience or a prospective study, but the document doesn't specify. The country of origin is also not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not explicitly stated. The 510(k) summary refers to "clinical data," implying expert interpretation and assessment, but details about the number and qualifications of experts involved in establishing ground truth for this clinical data are absent.
4. Adjudication method
- Not explicitly stated. Given the nature of a 510(k) submission and the focus on "clinical data," it's plausible that standard clinical practice and expert consensus would have been used to determine outcomes, but the specific adjudication method is not described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
- No, not specified. The document does not mention an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device described (Arrow-Trerotola PTD) is a mechanical device, not an AI-powered diagnostic tool, so an MRMC study in the context of "human readers improve with AI" would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. This device is a physical, mechanical thrombolytic device. It does not have an "algorithm-only" or "standalone AI" component in the way a diagnostic AI software would. Its performance is intrinsically linked to human execution and interaction.
7. The type of ground truth used
- Implied Clinical Outcomes/Diagnosis: The "clinical data" likely refers to patient outcomes and successful declotting as determined by clinical assessment (e.g., patency of the fistula, resolution of symptoms, absence of complications). This would be based on expert medical diagnosis and follow-up.
8. The sample size for the training set
- N/A. There is no "training set" in the context of an AI/machine learning model, as this is a mechanical device. The development process would involve engineering design, bench testing, and potentially pre-clinical (animal) studies, followed by clinical evaluation.
9. How the ground truth for the training set was established
- N/A. As above, no training set in the AI sense. The "ground truth" for the device's design and engineering would be based on principles of fluid mechanics, material science, and medical best practices for thrombus removal, established through engineering validation and pre-clinical testing.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).