(15 days)
The En-Snare™ Endovascular Snare and Catheter is intended for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects. Manipulation procedures include indwelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access veni-puncture procedure assistance.
The En-Snare™ Endovascular Snare and Catheter is comprised of stranded nitinol/platinum cables mechanically secured to a nitinol wire inserted into an intravascular catheter and manipulated by use of an external pin vise. The catheter is made from biocompatible FPE that has been used extensively in intravascular catheters.
Here's an analysis of the provided text regarding the En-Snare™ Endovascular Snare and Catheter, focusing on acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Functional & Safety Testing) | Reported Device Performance |
|---|---|
| Capture Function | Comparable to predicate device |
| Tip Deflection | Comparable to predicate device |
| Torqueability | Comparable to predicate device |
| Tensile Strength | Comparable to predicate device |
| Flow Rate | Comparable to predicate device |
| Hub Leakage | Comparable to predicate device |
| Stiffness | Comparable to predicate device |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the functional and safety testing (test set). It only mentions "The En-Snare™ Endovascular Snare and Catheter were subjected to..." which implies a set of devices or tests. The data provenance is not specified, but it's implied to be internal testing conducted by Medical Device Technologies, Inc. and is retrospective as it refers to testing already completed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not mention the use of experts to establish a "ground truth" for the functional and safety testing in the typical sense of clinical or diagnostic performance. The ground truth for these engineering performance tests would be defined by established engineering standards and specifications.
4. Adjudication Method for the Test Set:
Not applicable. The "adjudication method" usually refers to a process for resolving discrepancies in expert opinion for clinical ground truth. For functional and safety engineering tests, the results would be objectively measured and compared against defined thresholds or the predicate device's performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
Not applicable. This is a medical device for retrieving and manipulating foreign objects, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is not an algorithm or AI device. The "standalone performance" concept doesn't apply to a physical medical device like an endovascular snare and catheter.
7. The Type of Ground Truth Used:
For the functional and safety testing, the "ground truth" was established by objective engineering measurements and comparison against the performance of the predicate device. The document states that the results "indicated that they are comparable to the predicate device."
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device, not a machine learning model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of 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).