(79 days)
The Pronto LP extraction catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral system.
The Vascular Solutions Pronto™ Low Profile (LP) extraction catheter is a dual lumen catheter with related accessories. The Pronto LP will has a lower crossing profile to provide compatibility with small vessels and deliverability through a standard 0.066" (6F) guide catheter alongside an additional 0.014" guidewire.
The catheter has a rounded distal tip with a protected, sloped opening of the extraction lumen to facilitate advancement of the catheter into the blood vessel and maximize extraction of thrombus through the extraction lumen. Incorporated within the catheter distal tip is a non-blood contacting radiopaque marker for fluoroscopic visualization. The catheter has a rapid exchange design with a distal flexible region with stiffness along the shaft gradually increasing to the proximal region. The distal segment of the catheter that includes the guidewire lumen is coated with a hydrophilic coating to lubricate the catheter for ease of insertion.
The catheter also incorporates a Y-adapter with an aspiration port and a self sealing port with pre-loaded stylet. The stylet reinforces proximal shaft during delivery and is removed to allow aspiration of thrombus through the aspiration port.
The provided document is a 510(k) premarket notification for the "Pronto™ LP Extraction Catheter". It outlines the device description, indications for use, and a summary of non-clinical testing performed to demonstrate substantial equivalence to predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document describes "Device Verification Testing (DVT)" which includes a list of tests. While specific quantitative acceptance criteria are not explicitly stated in a table format, the general conclusion is provided.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Catheter tortuosity performance | Device performs as intended |
| Catheter curve retention performance | Device performs as intended |
| Catheter bond strength performance (hub, mid-shaft, distal tip) | Device performs as intended |
| Catheter leakage under pressure performance | Device performs as intended |
| Thrombus extraction effectiveness | Device performs as intended |
| Blood extraction rate performance | Device performs as intended |
| Aspiration testing (with extension tube) performance | Device performs as intended |
| Packaging stylet removal force performance | Device performs as intended |
| 2nd guidewire placement performance | Device performs as intended |
| Introducer passage performance | Device performs as intended |
| Catheter kink testing performance | Device performs as intended |
| Catheter deformation performance | Device performs as intended |
| Mandrel/wire removal performance | Device performs as intended |
| Guide catheter profile testing performance | Device performs as intended |
| Biocompatibility in accordance with ISO 10993 | Material demonstrated to be biocompatible |
2. Sample sized used for the test set and the data provenance:
- Sample Size for Test Set: The document does not specify the sample size for individual tests conducted as part of the Device Verification Testing (DVT). It only lists the types of tests performed.
- Data Provenance: The data provenance is described as "Non-Clinical Testing" and "Performance Testing" conducted by Vascular Solutions, Inc. This implies the data is retrospective (tests conducted on manufactured devices/components) and originates from the device manufacturer's internal testing. No specific country of origin for the data is mentioned beyond the submitter's location (Minneapolis, MN, USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The "ground truth" for the non-clinical performance tests is based on objective measurements and engineering standards, not expert consensus.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable. The non-clinical tests rely on direct measurements and pre-defined specifications rather than expert 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:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (catheter) for thrombus extraction, not an AI-powered diagnostic or assistive tool. Therefore, the concept of "human readers improve with AI" is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is not an algorithm or AI device. The "standalone" performance here relates to the physical device's mechanical and functional properties. The DVT tests constitute this standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: For the non-clinical tests, the ground truth is based on engineering specifications, physical measurements, and adherence to recognized standards (e.g., ISO 10993 for biocompatibility). For example, "catheter bond strength testing" would have a predefined acceptable range of force, and the test result either falls within that range or it does not.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This device is not an AI/ML product; therefore, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this 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).