(46 days)
MedTrade Products CELOX Topical Hemostatic Granules are intended to be used to achieve hemostasis in emergency situations for the temporary control of severe topical bleeding.
MedTrade Products CELOX Topical Hemostatic Granules OTC are indicated for the local management of bleeding such as lacerations, minor cuts and abrasions.
MedTrade CELOX Topical Hemostatic Granules are intended as a temporary external wound treatment for the control of severely bleeding wound for emergency use. MedTrade CELOX Topical Hemostatic Granules is intended for emergency use as an external temporary traumatic wound treatment to achieve Hemostatis and prevent blood loss. The product is designed and packaged to be easily packed, carried and applied using only one hand. It is well suited for moderate to large eviscerating wounds, to create hemolysis by coagulation.
The device is packed in a foil sachet and is provided sterile. It is sterilized by gamma irradiation.
This document is a 510(k) premarket notification for MedTrade Products CELOX Topical Hemostatic Granules, indicating its substantial equivalence to previously marketed devices. It primarily focuses on regulatory approval and comparisons to predicate devices, rather than detailed study results for acceptance criteria.
Therefore, the full depth of information requested to describe acceptance criteria and associated studies is not available within the provided text.
However, I can extract the information that is present and highlight what is missing based on your request.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics (e.g., specific hemostasis rates, time to hemostasis, or reduction in blood loss that would be considered "acceptable"). The document focuses on demonstrating substantial equivalence to predicate devices, implying that their performance is considered acceptable.
- Reported Device Performance:
- Biocompatibility Testing: Dermal Irritation, Dermal Sensitisation, Cytotoxicity, Acute Systemic Toxicity, Hemolysis have been conducted. The results are reported and discussed with the application (though not detailed here).
- Sterilization: The product will be sterilized by gamma irradiation in accordance with ANSI/AAMI/ISO11137-1994 and AAMI TIR8-1991, with a sterility assurance level of 10^-6 and a dose of 25-35 kGys.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance/Characteristics |
|---|---|---|
| Material Chemistry | Substantially equivalent to predicate chitosan-based hemostatic agents. | Chitosan, a material consisting of cellulosic polymer, poly-N-acetylglucosamine. Self-affirmed as GRAS (Generally Recognized As Safe) food ingredient in accordance with 21 CFR s 170.30. (Same as HemCon's HemCon Bandage). |
| Physical Composition | Granular form, similar to predicate granular hemostatic agents. | Granules (Similar to On Site Gas System's / Z-Medica's QuickClot). |
| Indications for Use | For temporary control of severely bleeding wounds to achieve hemostasis in emergency situations, and OTC for lacerations, minor cuts, abrasions. | MedTrade CELOX Topical Hemostatic Granules for external temporary control of severely bleeding wounds to achieve hemostasis and prevent blood loss, intended for emergency use. Also OTC for Bleeding / Lacerations (Substantially equivalent to HemCon Bandage and QuickClot in aspects of emergency use; specific OTC indication noted for MedTrade and HemCon). |
| Packaging | Foil Pouch. | Foil Pouch (Same as HemCon Bandage and QuickClot). |
| Sterilization Method | Gamma Irradiation, meeting specified standards and sterility assurance levels. | Gamma Irradiation in accordance with ANSI/AAMI/ISO11137-1994 and AAMI TIR8-1991. Sterility assurance level of 10^-6. Dose of 25-35 kGys (Same as HemCon Bandage and QuickClot for method, specific standards not listed for predicates but implied for device). |
| Biocompatibility | Acceptable safety profile for topical application. | Biocompatibility testing including Dermal Irritation, Dermal Sensitisation, Cytotoxicity, Acute Systemic Toxicity, Hemolysis has been conducted and results reported and discussed with the application (details not provided in this document, but implied to be acceptable for 510(k) clearance). |
| Ease of Use | Designed for easy packing, carrying, and one-hand application for emergency situations. | "The product is designed and packaged to be easily packed, carried and applied using only one hand." (This is a design characteristic, not a direct performance metric with acceptance criteria from a study in this document). |
Missing Information (Not found in the provided text):
The document does not describe a clinical study with quantitative performance metrics for the MedTrade CELOX Topical Hemostatic Granules against specific acceptance criteria. The approval is based on "substantial equivalence" to predicate devices K023298 (HemCon Bandage) and K013390 (QuickClot). This means the FDA has determined that the new device is as safe and effective as a legally marketed device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not applicable/Not provided. The document describes a comparison to predicate devices, not a standalone clinical trial with a "test set" in the context of AI/diagnostic device validation. Biocompatibility testing was mentioned, but no sample sizes for those tests are detailed.
- Data Provenance: Not applicable/Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Number of Experts/Qualifications: Not applicable. This information is relevant for studies involving subjective human interpretation (e.g., image reading), which is not the nature of this device or the information provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable.
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:
- MRMC Study: Not applicable. This device is a topical hemostatic granule, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is not an algorithmic device. The biocompatibility tests represent "standalone" assessments of the material's safety, but not performance in the clinical sense asked for in your prompt.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: For the purpose of regulatory clearance, the "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices. The applicant demonstrates that their device shares similar characteristics and performs equivalently to these legally marketed devices. For biocompatibility, the ground truth would be accepted scientific standards for toxicity, irritation, etc.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This is not a machine learning/AI device that requires a training set.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable.
In summary, the provided document details a 510(k) application for a medical device (hemostatic granules) based on substantial equivalence to predicate devices, rather than a clinical study with detailed performance acceptance criteria and study results against those criteria. Therefore, most of the specific questions related to AI/diagnostic study design are not applicable to this document.
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