(184 days)
The Vascular Solutions D-Stat-Dry Hemostatic Bandage and D-Stat Radial Hemostatic Band 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 hemostatic bandage consists of the following components:
- Lyophilized pad consisting of thrombin, sodium carboxymethylcellulose and calcium chloride
- Adhesive bandage
The D-Stat Radial hemostatic band consists of the following components: - Lyophilized pad consisting of thrombin, sodium carboxymethylcellulose and calcium chloride in a non-woven gauze
- Application device consisting of an adjustable retention strap, collar and attached gauze pad
The D-Stat Dry hemostatic bandage and D-Stat Radial hemostatic band achieves their principal intended action (hemostasis) by creating a physical barrier to blood flow with compression supplied by either the adhesive bandage or the retention band. The Iyophilized 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.
Here's an analysis of the provided text regarding the D-Stat Dry™ Hemostatic Bandage and D-Stat Radial™ Hemostatic Band, focusing on the acceptance criteria and study information:
Based on the provided FDA 510(k) summary (K030836), no specific acceptance criteria or details of a study proving the device meets acceptance criteria are documented in the traditional sense you might expect for an AI algorithm or a device with measurable performance metrics.
This document is a 510(k) premarket notification for a medical device that relies on substantial equivalence to predicate devices, rather than a de novo submission with extensive clinical trials establishing novel performance criteria. The device is a "hemostatic bandage/band," which operates based on physical properties and established biological mechanisms (thrombin) to assist with local hemostasis.
Let's break down the information based on your requested points:
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria Reported Device Performance Not Explicitly Stated for this 510(k) Submission Not Explicitly Stated for this 510(k) Submission Implicitly, the device must achieve local hemostasis as intended, and be safe and effective when compared to predicate devices. Non-clinical testing confirmed suitability for intended use, and the device is deemed substantially equivalent to predicates that perform this function. Explanation: The 510(k) summary does not define quantitative acceptance criteria (e.g., "hemostasis achieved in X% of cases within Y minutes"). Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices. The performance is "reported" as being suitable for its intended use based on non-clinical tests and the comparison to an existing product with a similar mechanism of action.
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Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable/Not provided. The document states, "No clinical evaluations of this product for this use have been conducted."
- Data Provenance: Not applicable, as there were no clinical evaluations. "Non-Clinical Testing" was performed.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. There was no clinical test set that required expert-established ground truth.
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Adjudication Method for the Test Set:
- Not applicable. There was no clinical test set requiring adjudication.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was an MRMC study done? No.
- Effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as this device is a physical hemostatic product and not an AI-assisted diagnostic or therapeutic device involving human readers.
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Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
- Was standalone performance done? Not applicable in the context of an "algorithm only." This device is a physical product directly applied by a healthcare professional ("under the direction of a healthcare professional"). Its "standalone" performance would refer to its physical and biological function (clotting ability, mechanical properties) rather than an algorithm's output. The "Summary of Non-Clinical Testing" addresses this.
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Type of Ground Truth Used:
- For the non-clinical testing: The "ground truth" was established by "assessments of the physical properties of the lyophilized pad" and "the ability of the lyophilized components to achieve its intended use (clot blood) and biocompatibility assessments." This implies laboratory measurements, material science testing, and in vitro/in vivo biocompatibility studies using established scientific methods and standards. It relies on objective measurements of physical and biological characteristics.
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Sample Size for the Training Set:
- Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set" in that sense.
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How the Ground Truth for the Training Set Was Established:
- Not applicable (see point 8).
In summary:
This FDA 510(k) document (K030836) pertains to a physical medical device (hemostatic bandage/band) that achieved market clearance through the "substantial equivalence" pathway. This pathway does not typically require the same type of detailed performance criteria and clinical study reporting as a novel device or an AI/software as a medical device (SaMD). The device's "performance" was demonstrated through non-clinical testing of its physical and biological properties and by showing it is similar enough to predicate devices that are already cleared for the same intended use. Clinical trials were explicitly stated as not having been conducted for this submission.
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