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510(k) Data Aggregation
(193 days)
Axiostat Gauze
Prescription: The Axiostat Gauze is intended for use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions, lacerations.
Over-the-Counter: The Axiostat Gauze is indicated for the local management of bleeding wounds such as minor cuts, lacerations, and abrasions.
The Axiostat Gauze is a single-use, non-absorbable non-woven hemostatic gauze. It is made of non-woven fabric derived from chitosan, which is a natural polymer. Chitosan is known for its mucoadhesive and hemostatic properties. When applied directly to a wound the dressing controls bleeding and can be removed after the clotting has occurred. The dressing should be removed within 24 hours. The dressing is not intended to be implanted. The Axiostat Gauze is individually packed in a moisture proof packaging and terminally sterilized by gamma radiation to a sterility assurance level (SAL) of 10-6.
Here's an analysis of the acceptance criteria and study information for the Axiostat Gauze, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| S.No | Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| 1. | Appearance | Color - Cream/off yellow, No loose fibers, no holes/tears, no dust particles | Product visually checked before packing to ensure it meets the set criteria (implies compliance). |
| 2. | Moisture content | Not more than 35% in the test device | Moisture content results in the stability study are less than 35% at all time points. |
| 3. | Absorbency | Not less than 15 times of product weight | Axiostat Gauze absorbs fluids up to 15 times its own weight (implies meeting or exceeding). |
| 4. | pH | 5 to 7 | A mildly acidic to neutral pH is required for adhesion and hemostatic activity (implies compliance with this range for optimal function). |
| 5. | Tensile strength | Dry - >5N/25mm | |
| Wet - >1N/25mm | The adhesive strength to the tissue/application site is less than the set acceptance criteria for Tensile strength, preventing product breakage during removal (implies compliance). | ||
| 6. | Integrity (dispersion test) | Product remain intact | The outcome demonstrates the integrity of Axiostat Gauze on the application site (implies compliance). |
| 7. | In-vitro clot assessment: Blood clotting time | Not more than 60% average clotting of control (recalcified blood) | Faster clotting compared to recalcified blood (control) (implies meeting or exceeding, aiming for higher efficacy). |
| 7. | In-vitro clot assessment: Blood clotting index | Not more than 5% Blood clotting Index | Lower BCI for better clotting (implies meeting or exceeding, aiming for higher efficacy). |
| - | Biocompatibility (Cytotoxicity) | Non-cytotoxic | Non-cytotoxic |
| - | Biocompatibility (Skin Sensitization) | Non-toxic | Non-toxic |
| - | Biocompatibility (Acute Dermal Irritation) | Non-toxic | Non-toxic |
| - | Biocompatibility (Acute Systemic Toxicity) | Non-toxic | Non-toxic |
| - | Biocompatibility (Hemolysis) | Non-hemolytic | Non-hemolytic |
| - | Biocompatibility (Bacterial Endotoxin Test) | Complies | Complies |
| - | Heavy metal testing | Met USP-232 limits | Met USP-232 limits |
| - | Residual solvent testing (IPA & Acetic Acid) | Within safety limit | Within the safety limit |
| - | Animal Study (Hemostasis) | Hemostasis in under 5 minutes; no rebleeding for 2 hours | Successfully achieved hemostasis in under 5 minutes in all test animals; no rebleeding observed in any animals during the observation period of two hours. |
| - | Shelf Life (Package Integrity) | Validated for 30 months | Confirmed by real time and accelerated stability studies. |
2. Sample Size Used for the Test Set and Data Provenance
- Animal Studies: The text states "all test animals" but does not specify the exact number.
- Other tests (Biocompatibility, Bench, Heavy Metal, Residual Solvent, Sterilization, Shelf-life): The text does not provide specific sample sizes for these tests.
- Data Provenance: The animal study followed an existing methodology ("Safety Evaluation of New Hemostatic Agents... in Swine; Kheirabadi, et al., J Trauma. 2010 Feb;68(2):269-78."), indicating a prospective, controlled experimental design in a swine model. The other tests are non-clinical, laboratory-based tests. The country of origin for the data is not specified, other than the manufacturer being Advamedica Inc. in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- The document does not mention using experts to establish ground truth for any of the performance tests. The ground truth for these tests is based on established scientific standards, protocols, and measurements (e.g., ISO standards, USP monographs, in-vitro assays, animal study observations).
4. Adjudication Method for the Test Set
- The document does not describe an adjudication method for the test set. Given the types of tests (biocompatibility, bench, animal study observations), adjudication by experts, as might be seen in imaging studies, is not applicable or mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study typically involves human readers interpreting diagnostic images or information, often with and without AI assistance, to assess performance and clinical utility. The Axiostat Gauze is a physical medical device (hemostatic gauze), not a diagnostic AI tool, so an MRMC study is not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- This question is not applicable as the Axiostat Gauze is a physical medical device and not an algorithm or AI system.
7. The Type of Ground Truth Used
- For Biocompatibility, Heavy Metal, and Residual Solvent Tests: The ground truth is established by regulatory standards and recognized scientific methodologies (e.g., ISO 10993 series, USP 161, USP 232, USP 30 ).
- For Bench Performance Tests: The ground truth is based on defined physical and chemical properties measured against specified acceptance criteria (e.g., color, moisture content, absorbency, pH, tensile strength, integrity, in-vitro clotting parameters).
- For Animal Studies: The ground truth is physiological observation and measurement of hemostasis (cessation of bleeding) and the absence of rebleeding in a live animal model, following a published experimental protocol.
8. The Sample Size for the Training Set
- This question is not applicable as the Axiostat Gauze is a physical medical device and not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable for the same reason as above.
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