(53 days)
The Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit (PT-03000-R), permits mechanical declotting of synthetic dialysis grafts.
The device is a 5 Fr. X 65cm sterile, single use rotatable catheter with a 9mm fragmentation basket. The design of the Arrow-Trerotola PTD™ consists of a 5 Fr. outer sheath with and inner cable connected to a self-expanding fragmentation basket. The device is attached to a hand-held, disposable rotator drive unit that spins at 3000-RPM. The catheter is placed into the thrombosed graft via an introducer sheath. Once placed inside the clotted graft, the basket is deployed to expand and conform to the graft wall. The rotator is then activated and the spinning basket is withdrawn through the graft to macerate the thrombus. The homogenized clot can then be aspirated from the graft via the introducer sheaths.
Acceptance Criteria and Study for Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD) Modification
This document outlines the acceptance criteria and study proving the modified Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD) meets those criteria, based on the provided text.
The device modification is a "Special 510(k)" submission, which typically focuses on demonstrating that a modified device is as safe and effective as its legally marketed predicate device, rather than establishing de novo effectiveness against a clinical outcome. Therefore, the "acceptance criteria" here refer to the performance requirements demonstrating equivalence, and the "study" is a series of laboratory tests.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this Special 510(k) are implicitly defined by the safety and effectiveness profile of the predicate device. The performance tests conducted aimed to demonstrate that the modified device maintains this same profile. The reported performance is that the results of the laboratory tests demonstrated that the device modification is as safe, and as effective as the legally marketed predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Strength and Integrity: |
- Basket cap tensile/torque strength not reduced.
- Basket wires tensile/torque strength not reduced.
- Basket sleeve tensile/torque strength not reduced.
- Torque cable tensile/torque strength not reduced.
- Torque cable drive hub tensile/torque strength not reduced.
- Outer catheter sleeve mold tensile strength not reduced.
- Outer catheter extrusion tensile/torque strength not reduced.
- Extrusion tip tensile strength not reduced. | All tests (tensile/torque, friction) demonstrated that the device modification is as safe and effective as the legally marketed predicate device. |
| Durability and Functionality: - Basket/cable fatigue performance maintained.
- Cable torque transmission efficiency maintained.
- Cable/catheter friction within acceptable limits.
- Basket speed in radius maintained.
- Basket abrasion characteristics maintained. | All simulated use tests (fatigue, torque transmission, friction, speed, abrasion) demonstrated that the device modification is as safe and effective as the legally marketed predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each individual test. The phrasing "The performance test information in the submission includes" a list of 13 tests, implying that each test was conducted on a sufficient number of samples to generate reliable results.
- Data Provenance: The tests were laboratory-based ("The results of the laboratory tests demonstrated..."), conducted by Arrow International, Inc.
- Country of Origin: United States (company address is Reading, PA).
- Retrospective or Prospective: Prospective (tests were conducted specifically for this submission).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable for this type of submission. The ground truth for these engineering performance tests would be defined by established manufacturing specifications, engineering standards, and direct comparison to the predicate device, not by expert consensus in the medical sense.
4. Adjudication Method for the Test Set
Not applicable. The "adjudication" would involve engineering review and comparison to established specifications, rather than a clinical adjudication method like 2+1 or 3+1.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This submission is for a device modification and relies on engineering performance testing to demonstrate substantial equivalence to a predicate device, not a comparative effectiveness study involving human readers or clinical outcomes.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a mechanical medical device, not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used was based on engineering specifications and performance data of the legally marketed predicate device. The modified device's performance in the listed tests had to meet or exceed the performance of the predicate to demonstrate substantial equivalence in safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is a mechanical device, not an AI or machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set or associated ground truth establishment process for this device as it is not an AI algorithm.
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).