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This device has the following intended use.

NasalCEASE® is intended to be used as a topical dressing for the local management of bleeding wounds such as minor cuts, lacerations, and about and case is already approved for treatment of minor nosebleeds.

It is intended to be marketed and sold as an Over-The-Counter device.

The device is not intended to be used for medium or severe wounds or bleeding.

NasalCEASE® is comprised of calcium alginate and is manufactured as a sheet (2x4x0.5 cm) of interwoven threads or as particles.

I am sorry, but based on the provided text, I cannot provide a table of acceptance criteria, device performance, or details about a study to prove the device meets acceptance criteria. The documents are FDA 510(k) letters and a 510(k) summary for a device called NasalCEASE®.

Here's why I cannot fulfill your request:

• Nature of the Documents: These documents primarily concern the regulatory clearance of a medical device (NasalCEASE®) by the FDA. The 510(k) process is about demonstrating "substantial equivalence" to a legally marketed predicate device, not necessarily providing a full clinical trial report with detailed acceptance criteria and study results.
• Missing Information: The text states:
  • "No performance standards have been established under Section 514 of the Food, Drug, and Cosmetic Act for this device." This implies that specific, quantifiable acceptance criteria for performance might not have been formally set in the same way as for a device with established performance standards.
  • "The products have been extensively tested and found to be biocompatible. They have been the test article used to support several previous 510(k) products (K905314, K922540, and K984069) used for medical/surgical applications." This indicates some testing was done, but it doesn't provide details on specific studies, acceptance criteria, or performance metrics in a way that would allow me to construct the table you requested.
  • There is no mention of a standalone algorithm study, MRMC comparative effectiveness study, ground truth establishment methods, or sample sizes for training or test sets.

What the documents do provide:

• Device Name: NasalCEASE®
• Intended Use: As a topical dressing for the local management of bleeding wounds such as minor cuts, lacerations, and abrasions. (Already approved for minor nosebleeds). Intended for Over-The-Counter use. Not for medium or severe wounds or bleeding.
• Device Description: Comprised of calcium alginate, manufactured as a sheet (2x4x0.5 cm) of interwoven threads or as particles.
• Mechanism of Action: Adsorbs blood/physiological fluids, swells to apply compressive force. (Mechanism for predicate BleedArrest® is also mentioned: adsorbs fluid and causes hemoconcentration to accelerate coagulation).
• Predicate Devices: BleedArrest® (K070211) and NasalCEASE® (K041446).
• Performance (General): "extensively tested and found to be biocompatible."

In summary, the provided FDA letters and 510(k) summary confirm the regulatory clearance of NasalCEASE® and describe its properties and intended use. However, they do not contain the detailed study information, acceptance criteria, or performance metrics that you are requesting.

Ask a specific question about this device

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