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510(k) Data Aggregation
(269 days)
The StatGuard® Hemostatic Patch is indicated for use, under the direction of a healthcare professional, in the management and control of surface bleeding from wounds, including vascular access sites.
The StatGuard® Hemostatic Dressing is indicated for use, under the direction of a healthcare professional, in the management and control of surface bleeding from wounds, including vascular access sites.
The StatGuard® Devices are based on a non-woven fabric derived from chitosan fibers. The hemostatic properties of chitosan are widely recognized in the biomedical field. When applied directly on a wound with firm pressure, the chitosan material will turn into a gel-like condition to absorb the blood. It promotes control of moderate to severe wound bleeding and exudates absorption, and promotes coagulation. The dressing provides a barrier to bacterial penetration through the dressing and has antibacterial properties that reduce bacterial growth within the dressing. No clinical studies have been conducted on the subject device and the clinical benefit of this antibacterial property is unknown.
The StatGuard® Hemostatic Patch is made of the non-woven fabric derived from chitosan fibers with a polyurethane backing. The StatGuard Hemostatic Patch is a 2" by 2" dressing that is placed directly over a wound for external control of bleeding. The Patch may be used with patients following a vascular procedure, hemodialysis, or other procedures resulting in bleeding wounds.
The StatGuard Hemostatic Patch is individually packaged in a peelable foil pouch and is sterilized by gamma irradiation. The hemostatic properties of chitosan enhance the ability of the StatGuard Hemostatic Patch to control bleeding.
The StatGuard® Hemostatic Dressing is made of the non-woven fabric derived from chitosan fibers with the addition of a backing that extends past the margins of the patch, with a pressure sensitive adhere to adhere to the patient. The StatGuard Hemostatic Dressings are provided in various sizes. The Dressing may be used with patients who have wounds that are bleeding or may be prone to bleeding. The hemostatic properties of chitosan enhance the ability of the StatGuard Hemostatic Dressing to control bleeding. The StatGuard® Hemostatic Dressings are packaged in a polyester laminated film pouch. Sterilization is by gamma radiation.
The provided text describes the StatGuard® Hemostatic Patch and StatGuard® Hemostatic Dressing, which are unclassified wound dressings utilizing chitosan for hemostatic properties. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than an in-depth study proving novel device performance against specific acceptance criteria. Therefore, the information regarding acceptance criteria and a structured study demonstrating the device meets those criteria, as typically found in a clinical trial report for an AI/ML device, is not fully present or applicable in the context of this traditional medical device submission.
However, based on the non-clinical testing section, we can infer some "acceptance criteria" and "reported performance" for specific tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Specific Test | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | Meet ISO 10993 requirements (Non-cytotoxic) | Devices are non-cytotoxic. |
| Intracutaneous Irritation | Meet ISO 10993 requirements (Non-irritant) | Devices are non-irritants. | |
| Skin Sensitization | Meet ISO 10993 requirements (Non-sensitizing) | Devices are non-sensitizing. | |
| Acute Intravenous Systemic Toxicity | Meet ISO 10993 requirements (No significant systemic toxicity) | Devices are non-pyrogenic (implies acceptable systemic toxicity, as pyrogenicity is a measure of acute systemic toxicity). Acute intraperitoneal systemic toxicity and acute intravenous systemic toxicity mentioned, but only pyrogenicity explicitly linked to the non-pyrogenic conclusion. | |
| Acute Intraperitoneal Systemic Toxicity | Meet ISO 10993 requirements (No significant systemic toxicity) | (Implicitly met if "non-pyrogenic" is stated) | |
| Endotoxin | Meet ISO 10993 requirements (Acceptable endotoxin levels) | (Presumably met if "non-pyrogenic" is stated) | |
| Hemolysis | Meet ISO 10993 requirements (Non-hemolytic) | (Implicitly met, no explicit mention but part of bio-compat suite) | |
| Rabbit Pyrogen | Meet ISO 10993 requirements (Non-pyrogenic) | Devices are non-pyrogenic. | |
| Bench Performance | In-vivo Hemostasis | Substantially equivalent efficacy to predicate device | Exhibited substantially equivalent efficacy in controlling bleeding to the predicate, AnsCare ChitoClot Gauze. |
| Antibacterial (within dressing) | > 4 Log Reduction in bacterial growth (AATCC 100) | Met > 4 log reduction for Micrococcus luteus, Streptococcus mutans, Streptococcus pneumoniae, Streptococcus pyogenes, Acinetobacter baumannii, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa. Did not meet criteria for Escherichia coli (3.88 log reduction). | |
| Microbial Barrier | Demonstrated barrier properties | Demonstrated microbial barrier properties. | |
| Sterilization | Sterility | 10⁻⁶ Sterility Assurance Level (SAL) per ISO 11137 | Achieved a 10⁻⁶ SAL using the VDmax25 method and gamma irradiation. |
2. Sample Size Used for the Test Set and Data Provenance
This document is for a traditional physical medical device (hemostatic patch/dressing), not an AI/ML device. Therefore, the concepts of "test set" and "data provenance" in the context of AI/ML are not directly applicable. The non-clinical tests typically involve in-vitro, in-vivo (animal), and laboratory tests on device samples, not a clinical "test set" of patient data.
- Sample sizes for non-clinical tests: Not explicitly stated for each test (e.g., number of animals for in-vivo hemostasis, number of samples for antibacterial test).
- Data Provenance: The tests are laboratory-based, conducted on device samples. The country of origin of the data is not specified, but it would be from the testing facilities performing the evaluations according to the mentioned standards (e.g., ISO, AATCC). The studies are retrospective in the sense that they are conducted on manufactured devices before market release, but they are prospective in design, meaning the tests were planned and executed to evaluate the device.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This concept is not relevant for this traditional medical device submission. Ground truth, in the AI/ML sense, does not apply here. The "truth" is established by direct measurement against scientific and regulatory standards (e.g., ISO 10993 for biocompatibility, AATCC 100 for antibacterial properties).
4. Adjudication Method
Not applicable. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert interpretations, typically for image reviews or clinical assessments in AI/ML studies. This device's testing involves objective laboratory measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is not an AI/ML device, and therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not conducted. The comparison is between the performance of the StatGuard device and its predicate devices based on non-clinical characteristics and established safety/efficacy.
6. Standalone (Algorithm Only) Performance Study
No. This is a physical medical device. There is no algorithm to evaluate in a standalone manner.
7. Type of Ground Truth Used
The "ground truth" for this device's evaluation is primarily based on:
- Established Industry and Regulatory Standards: E.g., ISO 10993 for biocompatibility, AATCC 100 for antibacterial effectiveness, ISO 11137 for sterilization.
- Performance Metrics: Measured against predefined benchmarks or directly compared to predicate device performance (e.g., "substantially equivalent efficacy in the ability to control bleeding").
- Objective Laboratory Measurements: Data obtained from chemical analysis, biological assays, and physical tests.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set. The device manufacturing processes and materials are developed through R&D, not trained on data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the StatGuard Hemostatic Patch/Dressing.
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