(53 days)
The Fogarty Fortis Arterial Embolectomy Catheters are indicated for use in adult patients for the removal of fresh, soft emboli and thrombi from vessels in the peripheral arterial system.
The Fogarty Fortis Arterial Embolectomy Catheters provide a means of clearing emboli and thrombi from vessels in the arteries of the peripheral system through inflation of the balloon and engagement with the arterial wall beyond the vascular obstruction followed by gentle withdrawal of the catheter thereby removing the obstruction from its position. The device catheter size is 4F and are available in 40 cm and 80 cm lengths. The device consists of a radiopaque catheter shaft with an integrated elastomeric latex balloon and an atraumatic tip that is inserted surgically into arterial vessels of the peripheral system. A hub at the proximal end is used for balloon inflation.
This document is a 510(k) summary for the Fogarty Fortis Arterial Embolectomy Catheter. It outlines the device description, indications for use, and a comparative analysis to a predicate device. The document states that "All testing met the existing predetermined acceptance criteria." However, it does not provide any specific acceptance criteria or detailed study results for device performance.
Therefore, I cannot extract the detailed information requested regarding acceptance criteria and the study proving the device meets them because it is not present in the provided text.
Based on the available information:
- 1. A table of acceptance criteria and the reported device performance: This information is not provided in the document. The document only states, "All testing met the existing predetermined acceptance criteria."
- 2. Sample size used for the test set and the data provenance: This information is not provided. The document mentions "Bench testing was performed in accordance with Edwards' current design requirements," but no details on sample size or data provenance are given.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
- 4. Adjudication method for the test set: This information is not provided.
- 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: This is a medical device (catheter), not an AI/software device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is a physical medical device, not an algorithm, so this concept is not applicable.
- 7. The type of ground truth used: For a physical medical device like an embolectomy catheter, "ground truth" would typically refer to established engineering standards, biocompatibility testing guidelines (e.g., ISO 10993-1), and internal design requirements. The document states:
- "Biocompatibility testing was performed in accordance with ISO 10993-1: 2018..."
- "Bench testing was performed in accordance with Edwards' current design requirements."
- 8. The sample size for the training set: This is a physical medical device, not a machine learning model, so there is no "training set."
- 9. How the ground truth for the training set was established: Not applicable, as there is no training set.
The document focuses on substantiating equivalence to a predicate device through bench testing and biocompatibility assessments, stating that the new device meets "existing predetermined acceptance criteria" without detailing what those criteria are or the specific performance metrics achieved.
§ 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).