(50 days)
The Aspirex™ Thrombectomy System is indicated for the removal of acute emboli and thrombi from vessels of the peripheral venous system.
The 6F and 8F Aspirex™ Thrombectomy Systems are indicated for the removal of acute emboli and thrombi from hemodialysis access grafts and native arteriovenous fistulas.
The Aspirex™ Thrombectomy System-composed of the Aspirex™ Thrombectomy Catheter Set and the Drive System-is designed for efficient thrombus removal with strong, continuous, and controlled aspiration. The Drive System is composed of the control unit, a motor, and a footswitch. The Drive System is small and portable, and designed for simple, quick set up and ease of use.
The Aspirex™ Thrombectomy Catheter Set is composed of multiple components, including the Aspirex™ Thrombectomy Catheter, the Aspirex™ Guidewire, collecting bag, and sterile drape. The Aspirex™ Thrombectomy Catheter consists of a braided shaft, to add strength and torque, through which runs a helix. The catheter shaft connects to a metallic head constructed with a side window(s) at the distal end. The head has a smooth, rounded, atraumatic shape so unintentional contact with the vessel wall will not cause damage to the vessel. Contact with the vessel wall is not necessary for the catheter to exert its effect. An ergonomic handle, connected to the catheter shaft at the proximal end, connects to the motorized Drive System via a magnetic clutch. The entire catheter tracks over the Aspirex™ Guidewire previously navigated across the thrombus/embolus.
The provided text is a 510(k) summary for the Aspirex™ Thrombectomy System. This document focuses on demonstrating substantial equivalence to a predicate device, not on proving a device meets specific acceptance criteria through a study with predefined performance metrics like those typically found in an AI/ML context.
Therefore, many of the requested items (e.g., acceptance criteria table, sample sizes, expert ground truth establishment, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of FDA submission for a medical device that processes human biological material.
However, I can extract information related to the device, its intended use, and the performance data that was reviewed (rather than generated by a specific study to meet acceptance criteria).
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable/Not Provided: This document does not present a table of specific acceptance criteria (e.g., target specificity, sensitivity, or image quality metrics) or reported device performance against those criteria in the way an AI/ML device would. Instead, it discusses the device's functional specifications and clinical outcomes in terms of existing literature and clinical study reports.
Here's information related to the device specifications that might be considered "performance" in a mechanical sense, but not quantitative "acceptance criteria" for an AI/ML model:
| Metric | Catheter Size (6F) | Catheter Size (8F) | Catheter Size (10F) |
|---|---|---|---|
| Minimum Vessel Diameter | 3 mm | 5 mm | 8 mm |
| Catheter External Diameter | 2.0 mm | 2.7 mm | 3.3 mm |
| Nominal Rotation (RPM) | 60,000 | 40,000 | 40,000 |
| Maximum Aspiration (ml/min) | 45 | 75 | 130 |
2. Sample sizes used for the test set and the data provenance:
- Not Provided: The document states that a "review of clinical data from scientific literature and clinical study reports" was performed. It does not specify a "test set" sample size, as it's a review of existing data, not a new, controlled study to validate a new claim against a test set.
- Data Provenance: The data provenance is "scientific literature and clinical study reports." The country of origin and whether it was retrospective or prospective is not specified.
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 is not a study involving expert readers establishing ground truth for a diagnostic AI/ML device. The "performance data" is derived from a review of clinical outcomes reported in existing literature and studies, which reflects real-world clinical results, not expert "ground truth" for a device's diagnostic performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable/Not Provided: No adjudication method is mentioned as this is not a study comparing human performance or diagnostic accuracy.
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/Not Provided: This is a physical medical device (thrombectomy system), not an AI/ML diagnostic aid. Therefore, an MRMC study and effects on human reader performance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable/None: This is a physical medical device (thrombectomy system) that is used by humans, not an algorithm.
7. The type of ground truth used:
- Clinical Outcomes/Patency Rates: The "performance data" relied on reviewing "primary patency rates" in hemodialysis access grafts and native arteriovenous fistulas. This is long-term clinical outcome data, not a diagnostic "ground truth" established by experts or pathology for a specific event.
8. The sample size for the training set:
- Not Applicable/Not Provided: This is not an AI/ML device, so there is no "training set." The device's design and manufacturing are identical to the predicate.
9. How the ground truth for the training set was established:
- Not Applicable/Not Provided: No training set exists for this type of device.
Summary of Device Performance (from the document):
The performance data reviewed for the Aspirex™ Thrombectomy System focused on:
- Type of data: Clinical data from scientific literature and clinical study reports.
- Focus: Device performance and clinical outcomes of percutaneous mechanical thrombectomy with the Aspirex™ Thrombectomy System for the removal of occlusions from hemodialysis access grafts and native arteriovenous fistulas.
- Key Metric Analyzed: Primary patency rates.
- Conclusion: Vascular access patency rates after treatment with the Aspirex™ device are similar to those observed with treatment with other mechanical thrombectomy devices or surgery. Sub-group analyses confirmed these results. The review concluded that the use of the Aspirex™ Thrombectomy System in these expanded indications "does not raise new questions of safety and effectiveness" and "provides satisfactory clinical outcomes in terms of patency rates and the functioning of hemodialysis vascular access."
§ 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).