(22 days)
QuikClot Sport™ & QuikClot Sport Silver™ are intended for temporary external use to stop bleeding of superficial wounds. minor cuts, and abrasions.
QuikClot Sport™ and QuikClot Sport Silver™ are OTC versions of Z-Medica's prescription product: QuikClot 1st Response™ (K061767). These new devices consist of mesh bags containing zeolite beads. The devices are vacuum-packed in multi-layer pouches to ensure sterility and efficacy.
The provided documents describe the substantial equivalence determination for QuikClot Sport™ and QuikClot Sport Silver™ (K070010) to predicate devices. The study detailed is an in-vitro comparison to demonstrate non-inferiority in efficacy and to show antimicrobial properties.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Biocompatibility: Meet ISO 10993-1:1997 standards. | ISO Standard 10993-1:1997 was followed for demonstrating biocompatibility of the component materials and the finished device. (Conclusion: Met) |
| Efficacy (Clotting Time): Non-inferiority to predicate device (QuikClot 1st Response™) in clotted time. | In-vitro test data measuring the clotting time of whole blood was used to demonstrate that the device modification is not inferior in efficacy to the predicate device. The zeolite formulation used in the predicate device and these two new OTC products took less than 5 minutes to form a clot, while whole blood without zeolite took longer than 9 minutes to form a clot. (Conclusion: Met) |
| Antimicrobial Properties (for QuikClot Sport Silver™): Demonstrate reduction of common infectious microorganisms. | Antimicrobial properties were demonstrated by in-vitro testing using cultures of S. aureus, E. coli, P. aeruginosa, and C. albicans. Exposure to QuikClot Sport Silver™ resulted in a greater than a 4-log reduction in viable organisms within 60 minutes. (Conclusion: Met) |
| Reduced Heat of Adsorption: Eliminate the risk of burns. | This product uses zeolite that has been reformulated to reduce the heat of adsorption. The risk of burns to caregivers and the injured person has been eliminated by the zeolite reformulation. (Conclusion: Met) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Efficacy Test (Clotting Time): Not explicitly stated. The document refers to "in-vitro test data measuring the clotting time of whole blood." The number of samples (e.g., individual blood samples, replicates) is not specified.
- Sample Size for Antimicrobial Test: Not explicitly stated. The document mentions "cultures of S. aureus, E. coli, P. aeruginosa, and C. albicans." The number of replicates or separate experiments is not provided.
- Data Provenance: The studies were in-vitro (laboratory-based) tests. The country of origin is not specified, but the submission is to the U.S. FDA by Z-Medica Corporation, a U.S.-based company. The data is retrospective in the sense that it supports a 510(k) submission based on prior testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The studies described are in-vitro laboratory tests and did not involve human subjects or expert assessment for establishing ground truth in a clinical context.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical ground truth established by experts requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The studies described are in-vitro laboratory tests, not human reader studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies were standalone in-vitro laboratory tests of the device's properties. There was no human-in-the-loop component as it's a topical hemostatic agent, not an AI or diagnostic algorithm.
7. The Type of Ground Truth Used
- Efficacy (Clotting Time): The ground truth was based on objective, quantitative measurements of clotting time in whole blood under laboratory conditions, compared to the performance of a predicate device and blood without zeolite.
- Antimicrobial Properties: The ground truth was based on objective, quantitative measurements of microbial reduction (log reduction) in bacterial and fungal cultures.
- Biocompatibility: Compliance with ISO 10993-1:1997 likely involved a battery of standardized in-vitro and/or in-vivo tests with defined endpoints, rather than a single "ground truth."
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set. The descriptions are for physical devices (clotting sponges).
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set.
N/A