(182 days)
The Vascular Solutions Duett™ Flowable Hemostat 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.
The Duett Flowable Hemostat is comprised of a three-part procoagulant mixture of collagen, thrombin and a buffered diluent. The Duett Flowable Hemostat achieves its principal intended action (hemostasis) by creating a physical barrier to blood flow and establishes an environment in which a natural blood clot can build and form a physical barrier to bleeding. The surface properties of the suspended collagen facilitate hemostasis reactions by triggering platelet adhesion and aggregation. The thrombin facilitates hemostasis by enhancing the surface-activated clotting cascade through enzymatic cleavage and conversion of fibrinogen to fibrin. The device also contains several delivery tools and mixing accessories. The device is sterilized with ethylene oxide.
This response is based on the provided text, which is an FDA 510(k) notification for the Vascular Solutions Duett™ Flowable Hemostat. As such, the information is limited to what's typically included in such documents.
Acceptance Criteria and Study Details for Vascular Solutions Duett™ Flowable Hemostat
The provided document is a 510(k) submission and subsequent FDA letters for the Vascular Solutions Duett™ Flowable Hemostat. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than strictly meeting pre-defined acceptance criteria through extensive clinical studies specifically for the new device's efficacy. Therefore, much of the requested information regarding detailed acceptance criteria, sample sizes for test sets, expert-established ground truth, and comparative effectiveness studies is not explicitly present or applicable in the same way as it would be for a direct clinical trial validating new performance claims.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) based on substantial equivalence, specific numerical "acceptance criteria" for clinical performance are not stated in the document. Instead, the device's performance is affirmed through non-clinical testing and comparison to predicate devices for its intended use.
| Acceptance Criteria (Implied by 510(k) process) | Reported Device Performance |
|---|---|
| Ability to control bleeding from vascular access sites and percutaneous catheters (intended use). | "The Duett Flowable Hemostat achieves its principal intended action (hemostasis) by creating a physical barrier to blood flow and establishes an environment in which a natural blood clot can build and form a physical barrier to bleeding." |
| Facilitate hemostasis reactions. | "The surface properties of the suspended collagen facilitate hemostasis reactions by triggering platelet adhesion and aggregation." |
| Enhance the surface-activated clotting cascade. | "The thrombin facilitates hemostasis by enhancing the surface-activated clotting cascade through enzymatic cleavage and conversion of fibrinogen to fibrin." |
| Suitability of physical properties (pH, viscosity, osmolarity, deliverability). | "The results of this battery of tests confirmed the suitability of the Duett Flowable Hemostat for its intended use." (Non-clinical testing) |
| Biocompatibility. | Confirmed by non-clinical testing. |
| Substantial equivalence to predicate devices (Syvek Patch and Hospal Tipstop). | "The Duett Flowable Hemostat is substantially equivalent to the Syvek Patch and the Hospal Tipstop." |
| Perform as intended. | "The testing performed confirms that the Duett Flowable will perform as intended." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable/Not specified in the provided document for clinical performance. The document explicitly states: "No clinical evaluations of this product for this use have been conducted."
- Data Provenance: The document only refers to "non-clinical testing" conducted by the manufacturer, Vascular Solutions, Inc., located in Minneapolis, Minnesota, USA. It does not provide details on specific test sets or the origin of any data used for substantial equivalence other than the predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified. Since no clinical evaluations were conducted for this product's use, there was no expert-established ground truth for a clinical test set from this submission.
4. Adjudication method for the test set
- Not applicable/None specified. No clinical test set was described as being used for this 510(k) submission.
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 device is a flowable hemostat, not an AI-based diagnostic or imaging device. Therefore, MRMC studies and AI-assisted performance metrics are not relevant or discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a medical product for direct application, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical testing, the "ground truth" would be established by standard scientific measurement (e.g., measuring pH, viscosity, osmolarity, observing clotting in vitro according to established biological principles, and biocompatibility testing using recognized standards).
- For the substantial equivalence claim, the "ground truth" is essentially the established safety and effectiveness of the identified predicate devices (Syvek Patch Topical Hemostat and Hospal Tipstop Compression Dressing) for their respective indications.
8. The sample size for the training set
- Not applicable/Not specified. As there was no clinical evaluation conducted for this product's use, there is no mention of a "training set" in the context of clinical data for this 510(k) submission.
9. How the ground truth for the training set was established
- Not applicable/Not specified. As there was no clinical evaluation conducted for this product's use, there is no mention of a "training set" or how its ground truth might be established.
N/A