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510(k) Data Aggregation
(61 days)
Prescription Use: TRAUMASTAT™ Hemostatic Wound Dressing is intended for external temporary use to control moderate to severe bleeding.
Over the Counter Use: TRAUMASTAT™ Hemostatic Wound Dressing is intended for external temporary use to stop bleeding of superficial wounds, minor cuts, and abrasions.
TRAUMASTAT™ Hemostatic Wound Dressing is a unique non-woven substrate comprised of porous polyethylene fibers highly filled with precipitated silica. This substrate is coated with chitosan, manufactured from ChitoClear™, a material consisting of the cellulosic polymer, poly-N-acctylglucosamine which is generally recognized as safe in accordance with 21 CFR 170,30. Each fiber of the wound dressing is approximately 20 to 100 micrometers in diameter. The wound dressing is provided in multiple lengths and widths to accommodate varying clinical situations as appropriate for its intended use. The dressing thickness is approximately 3 mm with an average density of approximately 0.15 gram/cc.
TRAUMATAT Hemostatic Wound Dressing is hermetically sealed in a poly foil pouch and electron beam sterilized.
This document describes the TRAUMASTAT™ Hemostatic Wound Dressing, focusing on its indications for use and the safety and effectiveness information provided in its 510(k) submission (K080648).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the TRAUMASTAT™ Hemostatic Wound Dressing are implicitly derived from its intended use and comparison to predicate devices, particularly effectiveness in controlling bleeding. The study information provided is limited, but here's a structured view:
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility | No cytotoxicity, sensitization, or skin irritation. | Concluded to be safe based on in-vitro biocompatibility testing (cytotoxicity, sensitization, skin irritation) in accordance with FDA requirements and ISO 10993. |
| Hemostatic Property | Effective in arresting severe bleeding (for prescription use). | In-vivo animal testing on swine models demonstrated effectiveness in arresting severely bleeding induced traumatic wounds. |
| Sterility | Must be sterile. | Hermetically sealed in a poly foil pouch and electron beam sterilized. |
| Material Safety | Components are generally recognized as safe (GRAS) where applicable. | Chitosan manufactured from ChitoClear™, a material consisting of poly-N-acetylglucosamine, is generally recognized as safe in accordance with 21 CFR 170.30. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions "in-vivo animal testing conducted on swine models" but does not specify the number of animals (sample size) used in this test set.
- Data Provenance: The study was "in-vivo animal testing," specifically using "swine models." The country of origin for the data is not specified, but it's part of a U.S. FDA 510(k) submission, implying a U.S. regulatory context. It is a prospective study as it's an animal efficacy study designed to test the device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For animal studies, surgical teams and veterinary pathologists typically define and assess outcomes, but specific details about the number and qualifications of experts are absent.
4. Adjudication Method for the Test Set
This information is not provided in the document. For animal efficacy studies, adjudication is often performed by blinded observers or a consensus panel, but the specific method is not described here.
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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for interpretative devices (like AI-powered diagnostic tools) where human readers interact with the output. The TRAUMASTAT™ device is a physical wound dressing, not an AI-assisted diagnostic or interpretative system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. As stated above, this is a physical medical device, not a software algorithm. The "standalone performance" of the device in this context refers to its direct hemostatic action, which was assessed in the animal model.
7. The Type of Ground Truth Used
The ground truth for the effectiveness study was based on direct observation of outcomes in an in-vivo animal model. Specifically, the ground truth was the "arresting [of] severely bleeding induced traumatic wounds" in swine models. This is a form of outcomes data directly observed in a biological system.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The device is a physical wound dressing, not an AI/ML algorithm that requires a "training set" in the computational sense. The materials and manufacturing processes are developed based on established scientific principles and prior knowledge of components like chitosan and precipitated silica, rather than a data training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reasons as point 8.
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