(234 days)
Chito-SAM™ Active (over-the-counter use):
To control bleeding of lacerations, minor cuts and abrasions.
Chito-SAM™ 100 (prescription use):
For use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions and lacerations.
The Chito-SAM" Gauze (refers to both the Chito-SAM" 100 for prescription use and Chito-SAM" Active for over-the-counter use) is made of a non-woven fabric derived from chitosan fibers. Chitosan is a naturally occurring polysaccharide usually derived from shellfish, and its hemostatic properties are widely recognized in the biomedical field. When applied directly on a wound with firm pressure, the Chito-SAM Gauze will turn into a gel-like condition to absorb the blood and assist in temporarily controlling moderate to severe bleeding. The Chito-SAM Gauze is provided in three (3) different sizes for prescription use and two (2) different sizes for over-the-counter use to accommodate a variety of treatment regions. The Chito-SAM Gauze is individually packaged in a foil pouch and is gamma-sterilized.
Please note: The provided FDA 510(k) summary for the Chito-SAM™ Active device does not explicitly state acceptance criteria or direct device performance against those criteria in a table format. It primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.
Therefore, the response below will synthesize information regarding "acceptance criteria" from the described non-clinical tests and the "reported device performance" will be derived from the general statements of a successful outcome in these tests. Information that is not present in the provided document will be explicitly stated as "Not provided in the document."
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Non-Clinical Testing) | Reported Device Performance (Summary from Non-Clinical Testing) |
|---|---|
| Liquid Absorption performance | Performed adequately; comparison to predicate devices showed similar functional characteristics. |
| pH within established range | Maintained appropriate pH levels; comparison to predicate devices showed similar functional characteristics. |
| Tensile Strength (wet and dry) maintained | Met established specifications; comparison to predicate devices showed similar functional characteristics. |
| Platelet Aggregation performance | Demonstrated appropriate platelet aggregation; comparison to predicate devices showed similar functional characteristics. |
| Biocompatibility (Cytotoxicity) | Passed according to ISO 10993-1. |
| Biocompatibility (Skin Irritation) | Passed according to ISO 10993-1. |
| Biocompatibility (Skin Sensitization) | Passed according to ISO 10993-1. |
| Biocompatibility (Hemolysis) | Passed according to ISO 10993-1. |
| Biocompatibility (Acute Systemic Toxicity) | Passed (intraperitoneal and intravenous) according to ISO 10993-1. |
| Hemostatic Efficacy (in-vivo) | Demonstrated performance comparable to predicate devices in the swine model. |
| Shelf-life | Confirmed a three-year shelf life for packaged, sterilized product through sterilization validation and packaging testing. |
| New Safety/Effectiveness Issues | No new issues of safety or effectiveness were raised compared to predicate devices, based on non-clinical testing results. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not explicitly provided. The document mentions "non-clinical testing" which includes functional testing, biocompatibility testing (per ISO 10993-1), in-vivo hemostasis testing, and shelf-life testing. The specific number of samples or animals used for each test is not detailed.
- Data provenance:
- Country of origin: Not explicitly stated for specific tests.
- Retrospective or prospective: The non-clinical tests described (functional testing, biocompatibility, in-vivo hemostasis, shelf-life) are generally prospective studies designed to evaluate the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. For non-clinical (bench and animal) testing, "ground truth" is typically established by objective measurements, laboratory analyses, and physiological observation, rather than expert consensus on subjective data. The document does not mention the involvement of experts for "ground truth" establishment in the context of these non-clinical tests.
4. Adjudication method for the test set
- Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers/interpreters where there is potential for disagreement in subjective assessments. The non-clinical tests described do not involve such a process.
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
- Not applicable. This device is a hemostatic dressing, not an AI software/algorithm requiring human interpretation or assistance. Therefore, an MRMC study related to AI assistance for human readers was not performed or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a hemostatic dressing, not an AI algorithm. Its performance is evaluated through direct physical, chemical, and biological testing, not by an algorithm.
7. The type of ground truth used
- For non-clinical testing:
- Functional Testing (Liquid Absorption, pH, Tensile Strength, Platelet Aggregation): Ground truth is based on established laboratory standards, specifications, and comparison against predicate devices' known performance.
- Biocompatibility Testing (ISO 10993-1): Ground truth is determined by the specific criteria and endpoints defined in the ISO standard for cytotoxicity, irritation, sensitization, hemolysis, and systemic toxicity.
- In-vivo Hemostasis Testing: Ground truth is established by physiological outcomes (e.g., control of bleeding, time to hemostasis) observed in the animal model, often compared to an untreated control or predicate device.
- Shelf-life Testing: Ground truth is based on physical, chemical, and microbiological stability over time, validated through accelerated and real-time aging studies against predefined acceptance limits.
8. The sample size for the training set
- Not applicable. This is a medical device (hemostatic dressing), not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As stated above, this is not an AI algorithm requiring a training set.
N/A