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WoundStat™ wound dressing for OTC is indicated for temporary external use to control bleeding from minor cuts and abrasions of the skin.

WoundStat™ is a clay-based, granufar hemostatic agent that is poured on a moderate to severe wound and held in place until it adheres to the wound and hemostasis is achieved. The device is packaged in a foil package and is provided sterile.

This document is a 510(k) premarket notification for WoundStat™, a wound dressing intended for over-the-counter (OTC) use to control bleeding from minor cuts and abrasions. It's an administrative update to a previous 510(k) K071936 which originally cleared WoundStat™ for prescription (Rx) use.

Here's an analysis of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly define specific performance acceptance criteria (e.g., stopping bleeding within X seconds for Y% of cases) for the OTC version of WoundStat™. Instead, the core of the submission relies on demonstrating substantial equivalence to its own previously cleared Rx version and other legally marketed OTC hemostatic agents.

The reported device performance, therefore, is primarily that:

• Mechanism of action is unchanged from the Rx version.
• It is demonstrated to be as safe and effective as the WoundStat™ for Rx use (K071936).
• It is similar to other legally marketed OTC wound management devices in terms of intended use and effectiveness for temporary external use to control bleeding from minor cuts and abrasions.

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

The document does not describe a new clinical study or test set specifically for this OTC 510(k) submission. Instead, it leverages the previous clearance of WoundStat™ for Rx use (K071936). The basis for "as safe and effective" likely stems from data or analyses provided in the K071936 submission. Without access to K071936, the specifics of its test set sample size and data provenance cannot be determined from this document.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This document does not mention the use of experts to establish a ground truth for a new test set for the OTC clearance. The assessment is based on comparison to existing cleared devices and the previous Rx clearance. Any expert involvement would have been part of the K071936 submission or the development of the predicate devices.

4. Adjudication Method:

Not applicable, as no new specific test set or clinical study requiring adjudication is described in this document for the OTC clearance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This document is for a medical device (wound dressing), not an AI/imaging diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This is a physical wound dressing, not an algorithm or software. Its performance is inherent to its physical and chemical properties when applied.

7. Type of Ground Truth Used:

For this OTC submission, the "ground truth" implicitly relies on:

• Previous FDA clearance of its own Rx version (K071936): This implies that the Rx version was found safe and effective based on its own ground truth (e.g., animal studies, clinical data on hemostasis).
• Established safety and effectiveness of predicate OTC devices: The comparison to other legally marketed OTC hemostatic agents (QuikClot Sport™, CELOX, BleedArrest™, BloodStop) suggests that the "ground truth" for these devices' performance in controlling minor bleeding is generally accepted by the FDA for OTC applications.

8. Sample Size for the Training Set:

Not applicable. This is a physical device, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for a physical device.

Summary of Device Meeting Acceptance Criteria:

The device, WoundStat™ for OTC use, meets the "acceptance criteria" by demonstrating substantial equivalence to its own previously cleared prescription version (K071936) and other legally marketed OTC hemostatic agents. The study proving this essentially refers back to the data and rationale provided in the K071936 submission, along with a revised labeling conforming to OTC regulations (21 CFR 801 Subpart C). The core logic is that if the Rx version was safe and effective for its broader indications, and the mechanism of action remains the same, then the OTC version with more limited indications (minor cuts and abrasions) and appropriate labeling is also safe and effective. No new clinical trials or performance studies are described in this specific 510(k) update for the OTC clearance.

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WoundStat™ is intended for emergency use only as an external temporary traumatic wound treatment to achieve hemostasis for moderate to severe bleeding.

WoundStat™ is a clay-based, granular hemostatic agent that is poured on or into a moderate to severe wound and held in place until it adheres to the wound and hemostasis is achieved. The device is packaged in a foil package and is provided sterile.

This document is a 510(k) premarket notification for the WoundStat™ device, comparing it to a predicate device, QuikClot®. It does not describe a study that uses acceptance criteria in the way a diagnostic AI device would. Instead, it focuses on demonstrating substantial equivalence to a legally marketed predicate device through pre-clinical testing, intended use, and mechanism of action.

Therefore, many of the requested fields regarding acceptance criteria, performance metrics, sample sizes for test/training sets, expert involvement, and ground truth establishment (which are typical for AI/diagnostic studies) are not applicable to this type of regulatory submission.

Here's the information that can be extracted or deduced from the provided documents:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as quantifiable metrics with thresholds (e.g., sensitivity > X%, specificity > Y%) in the context of a diagnostic or AI device study. The "acceptance criteria" here are generally meeting the requirements of substantial equivalence to the predicate device.
• Reported Device Performance:
  "WoundStat™ has equivalent, if not better, hemostasis results in terms of speed and effectiveness as QuikClot®."
  "The results of these tests demonstrate that WoundStat™ is safe for its intended use."

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not specified in terms of patient or case numbers. Pre-clinical models were used.
• Data Provenance: Pre-clinical models.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not applicable. Ground truth was not established by human experts in a diagnostic reading context. The "truth" was determined during pre-clinical hemostasis and safety studies.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• MRMC Study: No. This is not an AI device or a diagnostic device evaluated with human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Standalone Performance: Not applicable. This is a medical device (hemostatic agent), not an algorithm.

7. The type of ground truth used:

• Type of Ground Truth: Hemostasis results (speed and effectiveness) in pre-clinical models, and biocompatibility test results (systemic toxicity, cytotoxicity, intracutaneous studies).

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This device does not involve machine learning or a "training set."

9. How the ground truth for the training set was established:

• Ground Truth Establishment for Training Set: Not applicable.

In summary, this document is a regulatory submission for a physical medical device (hemostatic agent) and not an AI or diagnostic device. Therefore, the questions tailored for AI/diagnostic study evaluations are largely not relevant or applicable to the information provided. The "study" referenced is pre-clinical testing to demonstrate safety and effectiveness comparable to a predicate device.

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