(23 days)
is intended for use under the direction of a healthcare professional for the local management and control of bleeding from vascular access sites and percutaneous catheters and tubes.
The D-Stat Dry Family Products consists of the following components:
- Lyophilized pad consisting of thrombin, sodium carboxymethylcellulose and calcium chloride .
- Adhesive bandage .
These Products achieve their principal intended action (hemostasis) by creating a physical barrier to blood flow with 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 document is a 510(k) summary for the Vascular Solutions D-Stat Dry Product Family (D-Stat Dry Hemostatic Bandage, D-Stat Radial Hemostatic Band, and D-Stat 2 Dry Hemostatic Bandage). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials for a novel device.
Therefore, the information requested about acceptance criteria and detailed study data (like sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone performance) is not typically provided or required in this context for a device of this classification (Unclassified, Product Code FRO/QSX). The original 510(k) submission (K040118) for these devices, dated January 16, 2004, stated "No additional non-clinical testing of this product for this use was conducted" and "No clinical evaluations of this product for this use have been conducted."
The "Conclusions" section in the summary (page 2/2) only refers to "12-month testing results are acceptable, within product specification and substantiate an extension in product shelf life to 12 months." This indicates stability testing rather than performance testing against specific acceptance criteria for a new device's efficacy or safety.
Based on the provided document, the following is observed:
1. A table of acceptance criteria and the reported device performance:
Since no non-clinical or clinical performance testing for the device's intended use was submitted for this 510(k), there are no specific performance acceptance criteria or reported device performance metrics in the document beyond the shelf-life testing conclusion.
2. Sample sized used for the test set and the data provenance:
Not applicable. No performance testing involving a "test set" for the device's intended use (hemostasis) was conducted or reported in this 510(k). The shelf-life testing would have its own sample sizes, but these are not disclosed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No performance testing requiring ground truth establishment by experts for the device's intended use was conducted or reported.
4. Adjudication method for the test set:
Not applicable. No performance testing was conducted.
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. This is a medical device for hemostasis, not an AI-assisted diagnostic tool, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device for hemostasis, not an algorithm.
7. The type of ground truth used:
Not applicable. No performance testing was reported.
8. The sample size for the training set:
Not applicable. No performance testing was reported.
9. How the ground truth for the training set was established:
Not applicable. No performance testing was reported.
Summary of what is stated in the document regarding "acceptance criteria" and "study":
The only "study" mentioned with an outcome, and thus an implied "acceptance criterion" (being "acceptable" and "within product specification"), is related to shelf-life.
- Acceptance Criteria for Shelf-Life: The device's stability over 12 months was "within product specification."
- Reported Device Performance: The "12-month testing results are acceptable."
- Study Type: Stability testing to extend product shelf life. No details on this study (e.g., sample size, methods, specific parameters measured) are provided in the summary.
- Rationale for 510(k): The submission relies on substantial equivalence to predicate devices (the D-Stat Dry Product Family itself, implying previous versions or closely related devices) rather than new performance data for its intended use.
N/A