(99 days)
The D-Stat Radial Topical Hemostat is applied topically and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.
D-Stat Radial topical hemostat (D-Stat Radial) is a hemostatic band consisting of an application device containing a lyophilized pad consisting of thrombin, sodium carboxylmethylcellulose and calcium chloride in a nonwoven gauze, and an adjustable retention strap and attached foam pads. Hemostasis is achieved by the physiological coagulation-inducing properties of the lyophilized pad combined with the compression delivered by the application device.
The D-Stat Radial has been sterilized with irradiation.
The provided text is a 510(k) Pre-market Notification for the D-Stat Radial Topical Hemostat. It focuses on demonstrating substantial equivalence to a predicate device, not on validating the device's absolute efficacy via a clinical study with detailed acceptance criteria and outcome measurements. Therefore, much of the requested information cannot be extracted directly from this document.
However, I can provide what is present regarding the device's technical validation and comparison to a predicate.
The primary change in the device is to the retention strap material. The demonstration of substantial equivalence relies on:
- Performance Testing: "Securement Force"
- Biocompatibility Testing: "Cytotoxicity", "Sensitization", "Irritation"
Here's an analysis of what can be inferred or explicitly stated from the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific acceptance criteria for "Securement Force" are not detailed in this document. | Device samples passed the securement force test. |
| Compliance with ISO 10993-1 for biological evaluation. | Device samples passed biocompatibility tests (Cytotoxicity, Sensitization, Irritation). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document only states "Device samples" were used for performance and biocompatibility tests. No specific sample sizes are mentioned.
- Data Provenance: Not specified, but generally, 510(k) testing is performed by the manufacturer or a contract research organization. The manufacturing facility is listed in Minneapolis, MN, USA.
- Retrospective/Prospective: Not applicable in this context as these are laboratory and bench tests, not clinical studies on patient cohorts.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. The validation methods described (Securement Force, Biocompatibility) are objective laboratory tests against established standards (e.g., ISO 10993-1), not subjective assessments requiring expert consensus for "ground truth".
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As mentioned above, the tests are objective, not requiring adjudication.
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
- No. This is not an AI/software device. The document describes a physical medical device (a hemostatic band).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground truth for the performance and biocompatibility tests are the established specifications and ISO standards. For example, for biocompatibility, the ground truth is compliance with the limits set by ISO 10993-1. For securement force, the ground truth would be a predetermined force range or threshold.
8. The sample size for the training set
- Not Applicable. This is not a machine learning/AI device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
- Not Applicable. There is no training set for this device.
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