(25 days)
The LimFlow V-Ceiver™ is intended for use in the cardiovascular system to manipulate and retrieve guidewires specified in the IFU.
The LimFlow V-Ceiver consists of an intravascular catheter which incorporates a nitinol basket (the "Snare") at its distal tip. The nitinol basket has an outer diameter of 6 mm. The catheter has a built-in coaxial sheathing system and incorporates radiopaque markers at the distal tip on either end of the basket for added visibility. The catheter if compatible with 4 Fr introducer sheaths and has a working length of 100 cm.
The provided text describes the LimFlow V-Ceiver, an embolectomy catheter, and its non-clinical performance tests to establish substantial equivalence with a predicate device. It does not contain information about a study involving human readers, AI assistance, or related ground truth evaluations that would typically be associated with an AI/ML device.
However, I can extract the information related to the device's acceptance criteria and the studies performed to meet these criteria, as described in the context of a medical device submission.
Here's a summary of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines several performance tests conducted for the LimFlow V-Ceiver, each with a statement of meeting predetermined acceptance criteria. Specific quantitative acceptance criteria are not provided in detail, but the outcomes are stated as successful.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Performance | |
| Tensile Strength | Met predetermined acceptance criteria for joint strengths (in conformance with ISO 10555-1). |
| Leak Testing | Met predetermined acceptance criteria (in conformance with ISO 10555-1). |
| Simulated Use Testing | Demonstrated the device can grasp guidewires during simulated clinical use, meeting predetermined acceptance criteria. |
| Kink Testing | Demonstrated the catheter would not kink during clinical use, meeting predetermined acceptance criteria. |
| Opening and Closing Basket Width | Demonstrated the basket could be opened and closed, meeting predetermined acceptance criteria. |
| Retraction Force | Demonstrated the snare can be retracted with a clinically acceptable amount of force, meeting predetermined acceptance criteria. |
| Radiopacity | Confirmed acceptable radiopacity during clinical use. |
| Corrosion | Confirmed acceptable corrosion performance. |
| Biocompatibility | |
| Cytotoxicity | Confirmed biocompatibility (in conformance with ISO 10993-5). |
| Sensitization | Confirmed biocompatibility (in conformance with ISO 10993-10). |
| Irritation | Confirmed biocompatibility (in conformance with ISO 10993-10). |
| Acute Systemic Toxicity | Confirmed biocompatibility (in conformance with ISO 10993-11). |
| Material Mediated Pyrogenicity | Confirmed biocompatibility (in conformance with ISO 10993-11). |
| Hemolysis | Confirmed biocompatibility (in conformance with ISO 10993-4). |
| PTT (Partial Thromboplastin Time) | Confirmed biocompatibility (in conformance with ISO 10993-4). |
| Complement Activation | Confirmed biocompatibility (in conformance with ISO 10993-4). |
| Thromboresistance | Confirmed biocompatibility (in conformance with ISO 10993-4). |
| Packaging | |
| Packaging Validation | Demonstrated the packaging system can maintain package integrity and met predetermined acceptance criteria. |
| Pre-clinical Study | |
| Guidewire Snaring Performance | Demonstrated the device is appropriate with the stated indications by snaring various guidewires. |
| Thrombogenicity | Evaluated and confirmed to be acceptable. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set (Non-clinical Performance Tests): The document does not specify exact sample sizes for each mechanical or biocompatibility test. It mentions that "a series of testing was conducted" and that "the below were shown to meet the acceptance criteria." The tests are typically conducted on multiple units or samples to ensure reproducibility and statistical significance, but specific numbers are not provided.
- Test Set (Pre-clinical Study): "An acute swine model" was used. The specific number of animals is not provided.
- Data Provenance: Not explicitly stated, but these are laboratory and animal model studies, not human patient data from a specific country.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable to the provided context. The studies described are non-clinical performance and pre-clinical animal studies, which do not involve expert human readers establishing ground truth in the way described for AI/ML performance evaluation studies.
4. Adjudication Method for the Test Set:
Not applicable for the non-clinical and pre-clinical studies described.
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 document describes the testing of a physical medical device (embolectomy catheter), not an AI/ML diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML algorithm.
7. The Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" is defined by established engineering and biological standards (e.g., ISO 10555-1, ISO 10993 series) and predetermined acceptance criteria derived from these standards and clinical relevance.
For the pre-clinical swine model, the "ground truth" for performance would be the observable success of guidewire snaring and the observed thrombogenicity outcomes within the animal model, judged against pre-defined acceptable ranges.
8. The Sample Size for the Training Set:
Not applicable. There is no mention of a training set as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established:
Not applicable.
§ 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).