(89 days)
CELOX Rapid Gauze (Rx) is indicated for temporary external use to control moderate to severe bleeding.
CELOX Rapid Gauze (OTC) is indicated for temporary external use to control bleeding of lacerations, minor cuts, and abrasions.
Components – CELOX Rapid is composed of chitosan
Mechanism of Action - CELOX Gauze achieves its principle intended action (hemostasis) by acting as a delivery system for the Celox Granules creating a physical barrier or seal to stop the flow of blood. When in contact with a wound and upon contact with blood or exudate, in combination with manual pressure to the wound, the CLO. C Granules heat bonded on to the CELOX Rapid quickly form a strong seai that completely covers the wound.
The provided text describes the 510(k) submission for the CELOX Rapid Gauze device. It compares the device to its predicate, CELOX Hemostatic Granules on Sheet (K080097), and outlines performance testing that supports its substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The concept of formal "acceptance criteria" for performance metrics like sensitivity, specificity, or AUC is not explicitly stated or provided in this 510(k) summary. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than meeting specific quantifiable performance targets against a clinical ground truth.
Instead, the performance reported is framed in terms of supporting claims for the device.
| Claim/Performance Area | Reported Device Performance |
|---|---|
| Biocompatibility | Reviewed in accordance with ISO10993 and FDA Blue Book memo G95-1. (Implied: Satisfactory). |
| Control of Bleeding | Rx Use: Temporary external use for moderate to severe bleeding. (Supported by predicate and animal studies). |
| OTC Use: Temporary external use for lacerations, minor cuts, and abrasions. (Supported by predicate). | |
| Hypothermic Conditions | Works in Hypothermic Conditions (previously provided and cleared under K080097). |
| Heat Generation | No Heat Generated in Use (previously provided and cleared under K080097). |
| Blood Loss Reduction | Reduces Blood Loss (previously provided and cleared under K080097). |
| Rapid Packing | Supported by In Vitro Testing. |
| High Volume Gauze Strip | Supported by In Vitro Testing. |
| Rapid Wound Adhesion | Promotes Rapid Wound Adhesion (supported by In Vitro Testing). |
| Stopping Bleeding Fast | Supported by Animal Study 1 (femoral artery wound model). "Stops bleeding fast." |
| Rapid Bleeding Control | Supported by Animal Study 1 (femoral artery wound model). "Rapidly controls bleeding." |
| Haemorrhage Control (main claim) | "CELOX Rapid Gauze has been shown in testing to provide rapid haemorrhage control in a swine model of lethal arterial extremity." (Implied: effective and comparable to predicate based on mechanism of action and prior clearance). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: The primary "test set" for efficacy assessment appears to be an animal study (Animal Study 1): "The efficacy of Celox Rapid Gauze in a femoral artery wound model."
- Sample Size: The precise number of animals used in Animal Study 1 is not specified in the provided text. It only mentions a "swine model of lethal arterial extremity."
- Data Provenance: The origin of the data (e.g., country) is not specified. The study is likely prospective, as it's an efficacy study for a new device.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable: This type of study (animal model for hemostasis) typically does not involve human expert readers establishing ground truth in the same way an imaging study would. The ground truth for hemostatic efficacy in an animal model is established by direct observation and measurement of bleeding cessation and blood loss during the experiment by the study's researchers/veterinarians.
4. Adjudication Method for the Test Set
- Not Applicable: Given that the primary efficacy data comes from an animal study and in vitro tests, a "2+1, 3+1" adjudication method is not relevant. The assessment of endpoints in these studies would be based on predefined objective criteria applied by the study investigators.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No: A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is typically for evaluating diagnostic imaging devices with multiple human readers, often comparing AI-assisted performance to unassisted performance. The CELOX Rapid Gauze is a hemostatic device, not a diagnostic imaging AI algorithm.
6. Standalone (Algorithm Only) Performance
- Not Applicable: The CELOX Rapid Gauze is a physical medical device (hemostatic gauze), not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not relevant. Its performance is its direct physical action.
7. Type of Ground Truth Used
- Animal Outcomes/Physiological Response: For the animal study, the ground truth was the direct observation and measurement of hemostasis (cessation of bleeding) and control of hemorrhage in the swine model, along with potentially other physiological parameters like blood loss, under experimental conditions.
- Biocompatibility Standards: For biocompatibility, the ground truth is adherence to internationally recognized standards (ISO10993 and FDA Blue Book memo G95-1).
- In Vitro Metrics: For in vitro tests (Rapid Packing, High Volume Gauze Strip, Promotes Rapid Wound Adhesion), the ground truth would be precise laboratory measurements using established protocols.
8. Sample Size for the Training Set
- Not Applicable: As the CELOX Rapid Gauze is a physical device and not an AI algorithm, there is no "training set" in the context of machine learning. The device's design and mechanism of action are based on scientific principles of chitosan's hemostatic properties.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: Since there is no training set as defined for AI algorithms, this question is not relevant. The "ground truth" for the device's development would stem from extensive research into material science, hemostasis, and preclinical testing over many years, culminating in its predicate device.
N/A