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510(k) Data Aggregation
(206 days)
Axiostat Chitosan Hemostatic Dressing
Axiostat Chitosan Hemostatic Dressing is indicated to control bleeding of lacerations, minor cuts and abrasions.
Axiostat is a single use, hemostatic dressing made of 100% chitosan is a wellknown natural polysaccharide generally derived from shellfish which has widely recognized hemostatic properties. When applied on the bleeding site with firm pressure, the Axiostat Chitosan Hemostatic Dressing acts as a mechanical barrier against bleeding. The Axiostat is intended for a maximum duration of use of 24 hours, including bandage changes that may be needed. Axiostat is individually packaged in foil bags and sterilized using gamma irradiation. Axiostat is provided in six different sizes for over the counter use as listed below.
This looks like a 510(k) premarket notification for a medical device. Based on the provided text, the device is the Axiostat Chitosan Hemostatic Dressing. Here's an analysis of the acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The submission is a 510(k) for a medical device, which means the primary "acceptance criterion" is demonstrating substantial equivalence to a legally marketed predicate device. The document explicitly states that the device is substantially equivalent to the predicate device Chito-SAM™ Active (K133121).
The acceptance criteria are not explicitly numerical thresholds for performance metrics (like sensitivity/specificity for AI, for example), but rather a demonstration that the Axiostat Chitosan Hemostatic Dressing is as safe and effective as the predicate device.
Here's a table summarizing the comparison:
| Characteristic | Acceptance Criterion (Predicate: Chito-SAM™ Active K133121) | Reported Device Performance (Axiostat Chitosan Hemostatic Dressing) | Notes |
|---|---|---|---|
| Regulatory Status | Unclassified; Product Code FRO | Unclassified; Product Code FRO (initially); QSY (subsequent administrative change) | Both products are unclassified and initially shared the same product code. The change to QSY for Axiostat was an administrative categorization by the FDA and did not involve a re-review of the 510(k) submission. |
| Material | Chitosan | Chitosan | Same. "The chemical composition of the chitosan material in both products is the same." |
| Intended Use | Hemostasis | Hemostasis | Same. |
| Indications for Use | Control bleeding of lacerations, minor cuts and abrasions. | Control bleeding of lacerations, minor cuts and abrasions. | Identical. |
| Biocompatibility | Non-cytotoxic, Negative (Skin Irritation, Sensitization, Acute Intravenous Systemic Toxicity, Acute Intraperitoneal Systemic Toxicity, Hemolysis) | Non-cytotoxic, Negative (Skin Irritation, Sensitization, Acute Intravenous Systemic Toxicity, Acute Intraperitoneal Systemic Toxicity, Hemolysis, Pyrogenicity Test) | The subject device includes a Pyrogenicity Test, which the predicate device's data does not explicitly list in the provided table comparison, but "identical biocompatibility characteristics" is claimed. All other listed tests show Same results (e.g., Non-cytotoxic for cytotoxicity). |
| Sterilization | Gamma irradiation | Gamma irradiation | Same. |
| OTC/Prescription | OTC | OTC | Same. |
| Anatomical Site | External wounds | External wounds | Same. |
| Package Material | Foil bag | Foil Bag | Same. |
| Physical Properties | Not explicitly listed for predicate, but included in bench performance. | Evaluated (Physical, Absorbency, Moisture, pH, Tensile strength) | The "bench performance testing" for the subject device indicates these were tested, and the conclusion is that "the Axiostat Chitosan Hemostatic Dressing functions to its specifications, performs as intended, and exhibits the appropriate characteristics of a hemostatic dressing," implying they are equivalent to what would be expected from the predicate. |
| Hemostatic Activity | Not explicitly listed for predicate, but included in bench performance. | Evaluated (In-Vitro Hemostatic Activity, In Vivo rabbit hemostasis study) | Same as above. The "In Vivo rabbit hemostasis study" directly supports the hemostatic function. |
2. Sample Size Used for the Test Set and Data Provenance
Since this is a hemostatic dressing (a physical device, not an AI/software device), the "test set" concept as used in AI/software evaluation (e.g., for sensitivity/specificity) doesn't directly apply here. Instead, it refers to the samples used in non-clinical testing.
- Biocompatibility testing: "performed per the requirements of ISO 10993-1:2009, under the section 'surface devices used in breached and compromised surfaces with limited exposure (. The sample sizes for these tests are not provided.
Data Provenance: The studies are non-clinical (laboratory and animal studies) conducted by Advamedica for their device. The country of origin for the data is not specified but would likely be the location of the testing laboratories. These are prospective tests conducted specifically for this device submission.
3. Number of Experts and Qualifications for Ground Truth
This question is typically relevant for studies involving subjective human assessment, particularly in fields like radiology where experts establish "ground truth" for AI models. For a hemostatic dressing, the "ground truth" is established by direct measurement and observation in laboratory and animal studies, rather than expert consensus on interpretive tasks. Therefore, this section is not applicable in the same way it would be for an AI device. The ground truth is objective (e.g., cytotoxicity present/absent, metal levels, pH value, successful hemostasis).
4. Adjudication Method for the Test Set
As explained above, the concept of an adjudication method (like 2+1 or 3+1 for human readers) is not applicable here because the "test set" involves non-clinical studies with objective measurements rather than subjective expert interpretation for ground truth.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
This is not applicable for this type of device. An MRMC study is typically used for diagnostic or interpretive devices (often AI) to assess how human readers' performance changes with or without AI assistance. The Axiostat Chitosan Hemostatic Dressing is a physical therapeutic device, not an interpretive one.
6. Standalone Performance Study (Algorithm Only)
This is not applicable as the Axiostat Chitosan Hemostatic Dressing is a physical product, not an algorithm or AI.
7. Type of Ground Truth Used
The ground truth for the non-clinical studies relies on:
- Standardized laboratory assays: For biocompatibility tests (e.g., cytotoxicity, irritation, hemolysis, pyrogenicity), heavy metal analysis, and bench performance tests (e.g., pH, tensile strength, absorbency).
- In-vivo observation and measurement: For the rabbit hemostasis study, where the ability of the dressing to control bleeding is directly observed and measured within a living system.
- Validated microbiological and physical testing: For sterility assurance level (SAL), package integrity, and shelf-life studies.
Essentially, the ground truth is based on objective scientific measurements and observations according to established standards (ISO, USP, ASTM).
8. Sample Size for the Training Set
This is not applicable. The concept of a "training set" is specific to machine learning algorithms. This device is a physical product, and its development and testing do not involve machine learning.
9. How the Ground Truth for the Training Set Was Established
As section 8 is not applicable, this section is also not applicable.
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