Search Results

HemaDerm™ is intended for use under the care of a health care professional as a topical dressing for the temporary treatment of severely bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological,) minor cuts, and lacerations and for the temporary treatment of mild bleeding from topical ENT surgical wounds and nosebleeds.

HemaDerm™ is intended for use under the care of a health care professional for the local management and control of bleeding from percutaneous needle access, vascular access sites and percutaneous catheters.

HemaDerm™ containing MPH (Microporous Polysaccharide Hemospheres™ ) is manufactured from purified plant based polysaccharide. The porosity is controlled such that the particles act as molecular sieves excluding large proteins and cells. The bleeding cessation is accomplished by the rapid dehydration and subsequent hemoconcentration of blood in contact with the particles. The concentration of serum proteins and cells produces a viscous gel. Normal platelet activation and fibrin deposition within the congealed blood produces a clot that limits further bleeding.

This document is a 510(k) Premarket Notification from Medafor, Inc. for their device, HemaDerm™. It details the device's intended use and demonstrates its substantial equivalence to predicate devices, but it does NOT contain an acceptance criteria table or the results of a study designed to prove the device meets said criteria.

Therefore, the requested information cannot be extracted from the provided text.

Ask a specific question about this device

The T-Scientific T-Pad™ is intended for use in the:

• 1. Local management of bleeding wounds such as lacerations, abrasions, nose bleeds, vascular access site, percutaneous catheters or tubes and surgical debridement, and
• 2. The promotion of rapid control of bleeding in patients following hemodialysis and in patients on anticoagulation therapy.

The T-Scientific T-Pad™ is a soft, non-woven pad of poly-N-acetylglucosamine. T-Pad™ is packed in a foil pouch and sterilized by E-beam radiation to a 10-6 SAL.

The provided documents are a 510(k) summary for the T-Scientific T-Pad™. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria based on a clinical study with detailed performance metrics.

Therefore, the documents do not contain the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement. The 510(k) summary focuses on demonstrating that the T-Pad™ is technologically equivalent and has the same intended use as its predicate devices (Marine Polymer Technologies' Syvek Patch, K972914 and K984177).

Specifically, the document states:

• "The T-Scientific T-Pad™ technological characteristics are the same as the Marine Polymer Technologies predicate devices. The T-Scientific T-Pad™ works in the same manner as the approved predicate devices."

This indicates that the main "proof" of meeting performance expectations is through demonstrating equivalent technology and mechanism of action to already approved devices. There is no mention of a de novo study with acceptance criteria and performance results for the T-Pad™ itself.

Ask a specific question about this device