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510(k) Data Aggregation
(15 days)
EXCELARREST FOAM
The Hemostasis, LLC wound dressings are intended for use as topical dressings for the management of bleeding wounds.
Prescription: ExcelArrest™ is indicated for use as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (post-operative, do noralites, dermatological), cuts and lacerations and is also indicated for control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites.
OTC: ExcelArrest™ is indicated for use as a topical dressing on minor bleeding wounds such as cuts, lacerations and abrasions and for minor nose bleeds.
As described above, the Hemostasis, LLC hemostats are comprised of modified chitin particles and polysaccharide binders. The particles are dissolved in water, poured into appropriate trays and using a lyophylization process, the water is removed to form a foam bandage. Chitin has well known hemostasis properties and when combined with the sodium carboxymethylcellulose and hydroxyethylcellulose binders, has an affinity to hold water. The Hemostasis foam quickly dehydrates blood cells, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding in moderate to severe lacerations.
The provided text is a 510(k) summary for a medical device called ExcelArrest™ Foam Hemostat Bandage. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria with reported numerical performance metrics.
Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not available in this document.
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance:
This document does not provide a table of specific numerical acceptance criteria for performance metrics (e.g., clotting time, blood loss reduction). Instead, it states that the device "met the performance criteria" in a porcine model. The acceptance criteria are implicitly defined by the performance of the predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Implicit: Performance comparable to legally marketed predicate devices in a relevant animal model for hemostasis. | "Comparative testing was performed using a Porcine Model and the devices met the performance criteria." |
| Biocompatibility: Meet guidelines of ISO 10993 and FDA guidance G95-1. | "The criteria have been satisfied for biocompatibility." |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document only mentions "a Porcine Model" without detailing the number of animals or trials.
- Data Provenance: Porcine Model (animal study). Specific country of origin is not mentioned, but it's likely a controlled laboratory setting. The study appears to be prospective as it's comparative testing being performed for the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not specified. Animal studies typically rely on veterinary assessment or quantitative measurements, rather than human expert consensus for "ground truth" in the way clinical studies do.
4. Adjudication method for the test set:
Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. The performance testing was conducted in a porcine model, not involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This device is a physical medical device (hemostatic bandage), not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm doesn't apply here.
7. The type of ground truth used:
The ground truth for the performance testing in the porcine model would be based on direct physiological measurements of hemostasis (e.g., time to hemostasis, blood loss volume) as observed and measured by researchers during the animal study.
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.
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