(77 days)
For reconstruction and repair of the pericardium
Biocompatible, expanded polytetrafluoroethylene (ePTFE). The ePTFE material has a nominal pore size of
The provided document is a 510(k) Premarket Notification for the PRECLUDE® Pericardial Membrane. It details a modification to the labeling only of an already marketed device. Therefore, the information provided does not contain a study proving the device meets acceptance criteria as this submission is not introducing a new device or a change in technological characteristics. Instead, it relies on the substantial equivalence to its predicate device.
Here's an analysis based on the understanding that this is a labeling modification submission:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this submission is a modification to labeling only, there are no new acceptance criteria or reported device performance metrics established for this specific submission. The device's performance relies on the previous clearance of the predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable. | Not applicable. |
| (This submission is for a labeling modification of an already cleared device.) | (No new performance data was generated for this submission.) |
2. Sample Size Used for the Test Set and the Data Provenance:
No new test set was used for this submission. The efficacy and safety of the ePTFE material were previously established and are referenced as: "Reports of data from animal studies and from clinical experiences documented in the literature demonstrate that ePTFE material with a nominal pore size of
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).