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510(k) Data Aggregation
(692 days)
S.E.A.L. Hemostatic Wound Spray
Prescription Use:
S.E.A.L. Hemostatic Wound Spray is intended to be used to achieve hemostasis in emergency situations for the temporary control of severe topical bleeding.
OTC:
S.E.A.L. Hemostatic Wound Spray is indicated for the local management of minor bleeding such as minor lacerations, minor cuts and minor abrasions.
S.E.A.L. Hemostatic Wound Spray is composed of chitosan dry powder in spray form that provides a physical barrier or seal to stop the flow of blood. When sprayed on a wound and upon contact with blood or exudate, in combination with manual pressure to the wound. S.E.A.L. quickly forms a strong seal that completely covers the wound. S.E.A.L. is presented for both Prescription and over-the-counter (OTC) use.
The S.E.A.L. Hemostatic Wound Spray's acceptance criteria and the studies that demonstrate its compliance are detailed below. It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo acceptance criteria and performance against those criteria. Therefore, the "acceptance criteria" are implied by the equivalence demonstration, and performance is reported relative to the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Equivalence to Predicate) | Reported S.E.A.L. Hemostatic Wound Spray Performance |
|---|---|
| Hemostatic Efficacy | |
| Non-inferiority to predicate (CELOX) in stopping bleeding | In vitro coagulation test (viscometry) of porcine blood: Equivalent to CELOX. |
| Rat liver model: Non-inferior to CELOX. | |
| Standard swine hemorrhage model: High efficacy to achieve hemostasis, with no statistically significant differences in bleeding time, blood loss, and survival time compared to CELOX. | |
| Biocompatibility | |
| Non-cytotoxic | Cytotoxicity Study (ISO Elution Method): Severe cell lysis or toxicity (MEM extract). However, the summary states this is attributed to specific chitosan characteristics that limit or prevent fibroblastic growth, not true cytotoxicity for fibroblasts, and the benefit of stopping severe bleeding outweighs this risk for limited contact. |
| Non-irritating | ISO Intracutaneous Irritation Study: Non-irritating (saline extract). Irritating (sesame oil extract). The summary attributes the sesame oil extract irritation to particles/agglomerates increasing mechanical irritation, and not a risk for the intended use with limited contact. |
| Non-sensitizing | Guinea Pig Maximization Test: Non-sensitizing (saline and sesame oil extracts). |
| No acute systemic toxicity | ISO Acute Systemic Toxicity Study in Mice: No systemic toxicity (saline and sesame oil extracts). |
| Non-pyrogenic | USP Rabbit Pyrogen Study: Non-pyrogenic (saline extract). |
| Safety | |
| No adverse effects (animal studies) | Rat liver model: No adverse effects. |
| Standard swine hemorrhage model: Gross necropsy and histopathology did not show any signs of tissue or organ damage related to device application. Thromboemboli have not developed in surrounding tissues or other areas, and risk of thromboemboli migration to critical structures was ruled out. |
2. Sample Size Used for the Test Set and Data Provenance
The document provides details for animal studies:
- Rat liver model: Used for biological safety and non-inferiority assessment. The specific number of animals is not stated.
- Standard swine hemorrhage model: Used for efficacy assessment. The specific number of animals is not stated.
- Data Provenance: The studies were conducted as "In vivo performance animal studies" to support substantial equivalence. The country of origin is not specified but contract labs were mentioned for biocompatibility tests. The studies are prospective in nature, as they are experiments designed to evaluate the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not mention the use of human experts to establish ground truth for the test set. The efficacy and safety studies were conducted in animal models, likely assessed by researchers and veterinarians. For the biocompatibility tests, the results are based on standardized laboratory protocols (e.g., ISO, USP).
4. Adjudication Method for the Test Set
Not applicable. The "test set" here refers to animal subjects used in experimental studies, not a human reader study with adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The device is a hemostatic wound spray, not an imaging device or diagnostic tool that would typically involve human readers interpreting results.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical product (hemostatic spray), not an algorithm or AI system. The performance evaluated is the standalone performance of the physical device.
7. The Type of Ground Truth Used
- For Hemostatic Efficacy: Ground truth was established through direct observation and quantitative measurements in live animal models (e.g., bleeding time, blood loss, survival time, gross necropsy, histopathology).
- For Biocompatibility: Ground truth was established against international standards and validated laboratory methods (e.g., ISO 10993-1 for cytotoxicity, irritation, sensitization, acute systemic toxicity; USP Rabbit Pyrogen Study).
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
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