(137 days)
NuStat is indicated to temporarily control bleeding in minor cuts, lacerations, punctures, abrasions and incisions.
NuStat XR is a single-use hemostatic wound dressing applied externally with mechanical compression to temporarily control bleeding in lacerations, punctures, abrasions and incisions.
The NuStat® range of hemostatic wound dressings are textiles composed of continuous filament silica and bamboo cellulose. This submission adds a radiopaque filament to the NuStat XR models of the legally marketed dressing. The dressings are produced in various sizes to accommodate different wound sizes, ranging from a width of 2" to 8" and length of 2" to 60". The dressings are either z-folded or rolled into a medical grade Tyvek pouch which is then sterilized using gamma irradiation to a SAL of 10-6. The NuStat® range of hemostatic wound dressings have a number of hemostatic properties which enhance the ability of the dressing to temporarily control bleeding. The cellulose and continuous filament silica influence the contact activation pathway of the coagulation cascade by absorbing blood fluids, resulting in the localized concentration of platelets and clotting factors. The negatively charged fibers of the continuous filament silica simulate the negative ions secreted by activated platelets, which further influence the coagulation cascade. The radiopaque element allows for detection via x-ray.
The provided text describes the NuStat® Hemostatic Dressing, an unclassified medical device. While it mentions performance data, this primarily pertains to biocompatibility, sterility, and radiopacity, and does not include a study proving the device meets acceptance criteria related to its primary function of controlling bleeding. The document explicitly states that efficacy testing was not required for this submission.
Therefore, many of the requested sections about acceptance criteria and a study proving device performance in that context cannot be directly extracted from the provided text. However, I can provide information based on what is available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test/Evaluation | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity | Passed (conducted in accordance with ISO 10993) |
| Sensitization | Passed (conducted in accordance with ISO 10993) | |
| Irritation | Passed (conducted in accordance with ISO 10993) | |
| Sterility | Sterilization Validation | Demonstrated a 10⁻⁶ SAL (Sterility Assurance Level) using the VDmax25 method (following ISO 11137:2006 requirements) |
| Radiopacity (for NuStat® XR) | ASTM F640-07 Method C | Equivalent to radiopacity of 1.73 ± 0.13 mm thickness 99+% 110 alloy aluminum sheet; determined to be acceptable. |
2. Sample size used for the test set and the data provenance
The document does not provide specific sample sizes for the biocompatibility, sterility, or radiopacity tests. It implies these were standard tests performed according to recognized international standards. Data provenance is not specified, but these are likely laboratory tests conducted for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The tests described (biocompatibility, sterility, radiopacity) are typically performed in a laboratory setting by qualified technicians following established protocols, rather than requiring expert consensus on a ground truth in the way a diagnostic AI model might.
4. Adjudication method for the test set
Not applicable for the types of tests described (biocompatibility, sterility, radiopacity). These are objective measurements against defined standards.
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. An MRMC study is not mentioned. This device is a hemostatic dressing, 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 hemostatic dressing, not an algorithm or AI product.
7. The type of ground truth used
For the biocompatibility, sterility, and radiopacity tests, the "ground truth" would be the established scientific and regulatory standards/benchmarks as defined by ISO and ASTM, against which the device's performance was measured. For example, for sterility, the ground truth is a 10⁻⁶ SAL.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device.
Key Clarification from the Document Regarding Efficacy:
The document explicitly states: "In vivo and in vitro testing to evaluate the efficacy of the NuStat® range of dressings was not required as the addition of a radiopaque element does not affect the performance of the device as a hemostatic wound dressing." This indicates that for this specific 510(k) submission (K142363), the efficacy of the hemostatic function was considered established through the predicate device (Stasilon FR K072890), and the new submission focused on the safety aspects related to the radiopaque element and general device properties. Therefore, the document does not contain a study "proving the device meets acceptance criteria" for its primary hemostatic function.
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