(158 days)
The D-Stat Dry 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 4-6 Fr. introducer sheaths.
The D-Stat Dry Hemostatic Bandage consists of the following components:
- Lyophilized pad consisting of thrombin, sodium carboxymethylcellulose (CMC) and calcium chloride
- Adhesive bandage
The D-Stat Dry Hemostatic Bandage achieves its principal intended action (hemostasis) by creating a physical barrier to blood flow with compression supplied by the bandage. 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.
The provided text describes the D-Stat Dry Hemostatic Bandage and its FDA 510(k) clearance, but it does not provide detailed acceptance criteria or a study that proves the device meets specific performance criteria in the format requested.
Here's a breakdown of why and what information is available:
Key Takeaways from the Document:
- Device: D-Stat Dry Hemostatic Bandage
- Intended Use: Applied topically as an adjunct to manual compression for control of surface bleeding from vascular access sites and percutaneous catheters/tubes, and reducing time-to-hemostasis in patients undergoing diagnostic endovascular procedures using 4-6 Fr. introducer sheaths.
- Regulatory Clearance: 510(k) substantial equivalence to predicate devices (D-Stat Dry Hemostatic Bandage K030836 and Syvek excel Vascular Access Hemostasis System K053300).
- Testing:
- No non-clinical testing was conducted.
- A "prospective, randomized, non-significant risk clinical investigation" was conducted. This study provided "clinical evidence that use of the D-Stat Dry Hemostatic Bandage in the intended study population was safe and reduced the time-to-hemostasis following diagnostic catheterization procedures."
- Absence of Specific Performance Data: The document explicitly states "No performance standards have been developed under section 514 for this device" and does not present a table of acceptance criteria or reported device performance metrics (e.g., specific time-to-hemostasis in seconds, success rates). The clinical study is mentioned but no results are detailed.
Therefore, I cannot populate the requested table or answer questions 2-9 with the provided text. The document focuses on regulatory clearance via substantial equivalence rather than detailing performance studies against specific acceptance criteria.
Hypothetical Example of what the document would need to contain to answer your questions (this is NOT in the provided text):
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria | Reported Device Performance (D-Stat Dry) |
|---|---|---|
| Time-to-Hemostasis (TTH) | Mean TTH 5cm) | 0.8% |
2. Sample sized used for the test set and the data provenance
* Test Set Sample Size: [e.g., 200 patients (100 control, 100 device)]
* Data Provenance: Prospective, multi-center study conducted in the USA and Canada.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
* Not applicable for this type of device where objective measurements (time, re-bleeding) are typically used rather than subjective expert consensus on images/data. For a device like this, the "ground truth" is typically the directly measured clinical outcome.
4. Adjudication method for the test set
* Not applicable as the outcomes (e.g., time to hemostasis, re-bleeding) are objectively measured during the procedure and follow-up. An independent Clinical Events Committee (CEC) might adjudicate serious adverse events, but not the primary efficacy endpoint.
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 direct application, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
* Clinical outcomes directly measured: Time-to-hemostasis, presence/absence of re-bleeding, adverse event rates.
8. The sample size for the training set
* Not applicable. This is a physical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
* Not applicable.
In summary, the provided document serves as an FDA clearance letter based on substantial equivalence and briefly mentions a clinical study, but it lacks the detailed performance data and study specifics needed to fully answer your request.
N/A