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Felts:
Indicated for Ventricular aneurysmectomy; tissue prosthesis, and suture buttressing.
Pledgets:
Indicated for Tissue, prosthesis, and suture buttressing.

The PTFE Felts and Pledgets are manufactured from 100% polytetraflouroethylene fibers. The felt is purchased from an outside supplier in bulk, which is then heat set, scoured and cut into squares, offering two sizes, or punched into oval, round, square or rectangular pledgets. The Felts have a nominal thickness of 1.245mm (0.049"). The Pledgets have a nominal thickness of either 0.99mm (0.039") or 1.245mm (0.049") depending upon size.

The provided document is a 510(k) summary for PTFE Felts and Pledgets and does not contain the acceptance criteria or refer to any study that proves the device meets specific performance criteria. This document primarily focuses on establishing substantial equivalence to a predicate device, which is a common pathway for medical device clearance in the US, especially for older or less complex devices.

Therefore, I cannot provide the requested information from this document.

Here's why and what's typically expected for a device where such information would be available:

• Type of Device: The PTFE Felts and Pledgets are described as surgical implants used for buttressing and tissue repair in cardiac procedures. These are generally considered low to moderate risk devices that rely on well-established material properties and manufacturing processes.
• Predicate Device Pathway: The 510(k) summary explicitly states its reliance on "Preamendment devices" as predicates. This means the device is being cleared because it is substantially equivalent to devices marketed before May 28, 1976 (the enactment date of the Medical Device Amendments) or to devices that have previously gone through the 510(k) process.
• Focus of the Document: The content of the 510(k) summary (and the FDA's letter) is on establishing this "substantial equivalence" based on similar intended use, indications for use, technological characteristics, and safety/efficacy profile to the predicate devices. It doesn't detail performance studies in the way you might expect for novel devices or those reliant on complex algorithms.
• "No new issues of safety and efficacy have been raised.": This statement, often found in 510(k) summaries for substantially equivalent devices, indicates that the manufacturer believes their device, being similar to previously cleared devices, does not introduce new risks or questions regarding its performance that would necessitate extensive new clinical or performance studies.

What you would typically see for devices requiring performance studies (e.g., AI/ML-enabled devices):

For a device that would have acceptance criteria and a study to prove it, especially an AI-enabled device, you would look for sections detailing:

• Performance Data: Often found under "Summary of Safety and Effectiveness" or a dedicated "Performance Data" section.
• Bench Testing: Mechanical properties, biocompatibility, durability, etc.
• Clinical Studies: If required, these would detail study design, patient population, endpoints, results, and statistical analysis.
• Software Validation/Verification: For AI-enabled devices, this would include details on the validation of the algorithm itself, addressing points 1-9 of your request.

In summary, as the provided document is a 510(k) summary for a legacy-type device cleared via substantial equivalence, it does not contain the detailed performance study information you are seeking.

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