(88 days)
The D-Stat Clamp Accessory is indicated for use with the Compressar Universal System (Advanced Vascular Dynamics) and the Femoral Artery Vascular Clamp (Pressure Products) compression devices or as a standalone device to assist in the control of bleeding following catheterization or cannulation procedures.
The D-Stat Clamp Accessory consists of a lyophilized pad containing thrombin, sodium carboxymethylcellulose and calcium chloride secured to a compressible foam pad and plastic base. The device is designed for attachment to several commercially available femoral access compression devices or as a standalone device.
D-Stat Clamp achieves its principal intended action (hemostasis) by creating a physical barrier to blood flow and facilitating wound compression. The thrombin contained in the lyophilized pad further facilitates hemostasis through enzymatic cleavage and conversion of fibrinogen to fibrin.
Here's an analysis of the provided text regarding the acceptance criteria and study for the D-Stat Clamp™ Accessory:
This device (D-Stat Clamp™ Accessory) did not undergo a clinical study or performance testing as part of this 510(k) submission. Therefore, it does not have specific acceptance criteria for device performance based on a study, nor does it present data to prove it meets such criteria.
The submission states:
- "Summary of Non-Clinical Testing: No additional non-clinical testing of this product for this use was conducted as it represents a slight modification of an existing product."
- "Summary of Clinical Testing: No clinical evaluations of this product for this use have been conducted."
The 510(k) clearance was based on its substantial equivalence to predicate devices, not on a new clinical study demonstrating performance against specific acceptance criteria.
Given this, I cannot fill in the requested table and information about a study proving the device meets acceptance criteria, as that study was not performed.
However, I can extract the general information requested, highlighting the absence of performance studies:
**No performance studies, clinical or non-clinical, were conducted for the D-Stat Clamp™ Accessory, according to this 510(k) submission ([K040730](https://510k.innolitics.com/search/K040730)).**
Therefore, there are no specific acceptance criteria defined or reported device performance data from a study for this device shown in the provided text. The regulatory clearance was based on substantial equivalence to predicate devices.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (e.g., % success rate, time to hemostasis, etc.) | Reported Device Performance (from a study) |
|---|---|
| No specific acceptance criteria defined in this submission | No performance data from a study was reported in this submission. |
Detailed Study Information (Based on the provided text, indicating absence of a study):
- Sample size used for the test set and the data provenance: Not applicable. No test set was used for a performance study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established for a test set as no performance study was conducted.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication.
- 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 not an AI device, and no MRMC study was performed.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a medical device, not an algorithm, and no standalone performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth was established as no performance study was conducted.
- The sample size for the training set: Not applicable. This is a medical device, not a machine learning model, and no training set was used.
- How the ground truth for the training set was established: Not applicable. No training set was used.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).