(75 days)
This device is intended to be used only as (and only indicated as) an accessory to our Arrow-Trerotola PTD™ Percutaneous Thrombolytic Device. It is intended to be used on patients who are experiencing hemodialysis graft malfunction, due to thrombosis. This device is to be used to pull the arterial plug, located at the arterial anastamosis, into the arterial limb of the graft so it can be macerated by using the Arrow-Trerotola PTD™ Percutaneous Thrombolytic Device and removed.
The Arrow Balloon Embolectomy Catheter is indicated for use as an accessory to the Arrow-Trerotola PTD™ Percutaneous Thrombolytic Device. It is intended to be used to remove the arterial plug from the arterial anastamosis of a thrombosed hemodialysis access graft.
The proposed device is identical to the legally marketed Arrow Single-Lumen 5F x 60 cm Balloon Wedge Pressure Catheter with regards to materials, construction, and manufacturing processes. Minor modifications have been made to the catheter tip and the latex balloon to enhance performance.
The functions and indications for use of the new device are substantially equivalent to those of the Baxter Fogarty® Thru-Lumen Embolectomy Catheter, K892410.
The device has the same technological characteristics as the predicates, with the only difference being the longer catheter tip and heavier wall latex balloon to enhance performance.
The acceptance criteria and study proving the device meets these criteria are as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety | Demonstrated through laboratory tests (Biocompatibility tests, Catheter Integrity tests). |
| Effectiveness | Demonstrated through laboratory tests (Latex balloon tensile test, Biocompatibility tests, Catheter Integrity tests), showing it is "safe, and as effective, if not more effective, as the legally marketed predicate devices." Also, the device's functions and indications for use are "substantially equivalent" to a legally marketed predicate device (Baxter 4 Fr Fogarty® Thru-Lumen Embolectomy Catheter, K892410). |
| Performance | Minor modifications to the catheter tip and latex balloon were made "to enhance performance." Performance tests included: Latex balloon tensile test, Biocompatibility tests, and Catheter Integrity tests. The results of these tests demonstrated safety and effectiveness. |
| Substantial Equivalence | The device was found substantially equivalent to predicate devices: Arrow 5 Fr Balloon Wedge Pressure Catheter (pre-amendment) and Baxter 4 Fr Fogarty® Thru-Lumen Embolectomy Catheter (K892410). This equivalence applies to materials, construction, manufacturing processes (compared to Arrow predicate), and functions/indications for use (compared to Baxter predicate). |
2. Sample size used for the test set and the data provenance:
- Sample size: Not applicable. No clinical testing was performed. The evaluation relied on laboratory testing and comparison to predicate devices.
- Data provenance: Not applicable. The "study" was based on device description, material characteristics, manufacturing processes, and laboratory performance tests, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical test set or ground truth established by experts for a test set was mentioned. The evaluation was based on engineering and laboratory data.
4. Adjudication method for the test set:
- Not applicable. No clinical test set required adjudication.
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:
- Not applicable. This device is a mechanical catheter and not an AI-powered diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical catheter and not an algorithm.
7. The type of ground truth used:
- The "ground truth" for the device's performance was established through laboratory testing (Latex balloon tensile test, Biocompatibility tests, Catheter Integrity tests) and comparison to the established performance and safety profiles of legally marketed predicate devices. The regulatory body (FDA) determined substantial equivalence based on these comparisons and test results.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device; therefore, there is no concept of a training set.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set for this mechanical device.
§ 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).