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NexStat® Plus Topical Hemostat Powder and NexFoam® Plus Topical Hemostat Sponge are intended for use under the care of a health care professional as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological), cuts and lacerations and for the treatment of mild bleeding from topical ENT surgical wounds and nosebleeds. It is also indicated for control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites.

The Hemostasis NexStat® Plus Topical Hemostat Powder and NexFoam® Plus Topical Hemostat Sponge are sterile, topical wound dressings comprised of plant based polysaccharides. The hemostatic particles and foam quickly dehydrate blood cells, resulting in hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding.

The NexStat® Plus Topical Hemostat Powder and NexFoam® Plus Topical Hemostat Sponge are identical to the NexStat® Topical Hemostat Powder and NexFoam® Topical Hemostat Sponge cleared for market under 510(k) K102459, with the exception of the cross-linking manufacturing process. The cross-linking process for the manufacture of polysaccharide hemostatic particles is being changed for the NexStat® Plus and NexFoam® Plus devices. The new cross linking process utilizes the identical cross linker used in the predicate Medafor MPH® product subject of K033666. All other materials and processes remain the same as NexStat® and NexFoam®. The indications for use remain the same as NexStat® and NexFoam®

The provided text is a 510(k) summary for the NexStat® Plus Topical Hemostat Powder and NexFoam® Plus Topical Hemostat Sponge. It outlines the device, its intended use, and its substantial equivalence to predicate devices, but does not contain information about specific acceptance criteria or a study proving the device meets those criteria with statistical data.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not provided in the document. The 510(k) summary states that "Design verification testing was performed on NexStat® Plus Topical Hemostat Powder and NexFoam® Plus Topical Hemostat Sponge to demonstrate physical and functional requirements were met," but it does not specify what those requirements or acceptance criteria were, nor does it present the results in detail.

2. Sample Size Used for the Test Set and Data Provenance:

• Not provided in the document. The document mentions "Design verification testing" but does not detail the sample size for any test set or the provenance of the data. Given it's a 510(k) for a topical hemostat, the testing would likely involve in-vitro or in-vivo animal models, but specifics are absent.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not applicable / Not provided in the document. This type of information is typically relevant for studies involving subjective interpretations (e.g., imaging diagnostics). For a hemostatic device, ground truth would likely be based on objective measures of bleeding control, not expert consensus on interpretations.

4. Adjudication Method for the Test Set:

• Not applicable / Not provided in the document. Similar to point 3, adjudication methods like 2+1 or 3+1 are used for reconciling discordant expert opinions. This is not typically relevant for the performance evaluation of a hemostatic device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, not explicitly stated or implied. MRMC studies are primarily for evaluating diagnostic devices where reader variability is a factor. This document concerns a hemostatic device, not a diagnostic one, and there's no mention of human readers evaluating the device's performance in a comparative effectiveness study.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

• Not applicable / Not provided in the document. This question is usually for AI-powered devices. The NexStat® Plus and NexFoam® Plus are physical hemostatic devices, not algorithms.

7. The Type of Ground Truth Used:

• Implied objective measures, but not specified. For hemostatic devices, ground truth for performance would typically be objective measures such as time to hemostasis, amount of blood loss, or success/failure of bleeding control, likely established in bench or animal models. The document only generically refers to "physical and functional requirements."

8. The Sample Size for the Training Set:

• Not applicable / Not provided in the document. There is no mention of a "training set" as this is not an AI/machine learning device. The development process would involve formulation, material characterization, and performance testing.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable / Not provided in the document. As this is not an AI/machine learning device, the concept of a "training set" and its associated ground truth establishment methods (like expert annotations) does not apply.

In summary, the provided document is a 510(k) letter and summary emphasizing "substantial equivalence" to predicate devices. It highlights that design verification testing was performed and requirements were met, and biocompatibility and sterilization were evaluated, but it does not delve into the specific details of acceptance criteria or the study data proving those criteria were met, which is common for a 510(k) submission focused on equivalence rather than de novo approval or clinical superiority. This level of detail is typically found in the full submission, not the summary publicly available without redaction.

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