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The D-Stat Dry Clear is applied topically as an adjunct to manual compression and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes and reducing the time-to-hemostasis in patients undergoing diagnostic endovascular procedures utilizing a 4-6 Fr. introducer sheath.

The D-Stat® Dry Clear Hemostatic Bandage consists of a lyophilized pad containing bovinederived thrombin as an aid to hemostasis (King Pharmaceutical license number 0977), sodium carboxymethylcellulose (CMC), and calcium chloride. Included is a transparent sterile bandage attached to the primary packaging to apply over the hemostatic pad. The only difference between the D-Stat® Dry Clear Hemostatic Bandage and the predicate is the replacement of the opaque sterile bandage included with the device with a transparent sterile bandage.

The D-Stat® Dry Clear is applied directly over the source of bleeding, creating a physical barrier to blood flow through the application of adjunctive manual compression. The lyophilized components (thrombin, CMC, and calcium chloride) establish an environment in which a natural blood clot can build and form a physical barrier to bleeding.

The thrombin facilitates hemostasis by enhancing the surface-activated clotting cascade through enzymatic cleavage and conversion of fibrinogen to fibrin. This fundamental scientific technology is exactly the same as the predicate D-Stat Dry hemostatic bandage.

The provided document is a 510(k) Pre-market Notification for the D-Stat® Dry Clear Hemostatic Bandage. It is a submission to the FDA seeking to demonstrate substantial equivalence to a predicate device. This type of document is generally for regulatory approval and does not contain specific acceptance criteria, device performance data, or detailed study results in the manner that would be expected for a comprehensive clinical study report.

Based on the content of the provided document, here's what can be extracted:

The document explicitly states: "No human clinical testing was required for this device." This means that a clinical study with a test set, ground truth, experts, or statistical analysis of device performance against acceptance criteria, as typically understood in a medical device efficacy study, was not performed for this submission.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device by highlighting commonalities.

Therefore, the requested information elements (1-9) cannot be fully populated as they pertain to a type of performance study that was not conducted for this 510(k) submission.

Here's an attempt to address the questions based on the available information, noting where information is explicitly absent:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document explicitly states "No human clinical testing was required for this device." Therefore, there were no specific acceptance criteria for a new clinical performance study, nor reported device performance from such a study. The submission relies on equivalence to a predicate device already on the market.

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

Not applicable. No human clinical testing was required, so there was no test set or associated data provenance.

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

Not applicable. No human clinical testing was required; therefore, no ground truth was established by experts for a test set.

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

Not applicable. No human clinical testing was required; therefore, no adjudication method for a test set was employed.

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

Not applicable. The device is a hemostatic bandage, not an AI-assisted diagnostic or therapeutic device. No MRMC study was conducted.

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

Not applicable. The device is a hemostatic bandage, not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable. No human clinical testing was required to establish ground truth for a new device performance claim. The "ground truth" for the submission is the established safety and efficacy of the predicate device.

8. The Sample Size for the Training Set

Not applicable. The device is not an algorithm that requires a training set.

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

Not applicable. The device is not an algorithm that requires a training set.

Summary of the 510(k) Submission's Approach:

The K073264 submission for the D-Stat® Dry Clear Hemostatic Bandage is a Special 510(k). As stated in the document, "No human clinical testing was required for this device." The basis for clearance is demonstrating substantial equivalence to an already legally marketed predicate device, the D-Stat® Dry Topical Hemostat (K030836).

The key argument for equivalence is:

• The only difference between the D-Stat® Dry Clear and the predicate is the replacement of an opaque sterile bandage with a transparent sterile bandage.
• All other core components and principles are the same: same lyophilized pad containing bovine-derived thrombin, CMC, and calcium chloride; same mechanism of action; same intended use/indications for use; same operating principle; same basic device design; same materials (for the active components); same shelf life; and same packaging and sterilization processes.
• A risk analysis (Failure Modes and Effects Criticality Analysis) was performed, and based on this assessment, "no design verification tests were required for inclusion of the sterile clear compression bandage to the D-Stat Dry Clear device."

Therefore, this submission relies on engineering and design control assessments to demonstrate that the minor change (transparent bandage) does not alter the fundamental safety or effectiveness established by the predicate device, obviating the need for new clinical trials.

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