(75 days)
ChitoGauze™XR is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
The ChitoGauze dressing is composed of standard polyester/rayon blend non-woven medical gauze that is coated with chitosan. This submission for ChitoGauze™XR adds a radiopaque filament to models of various dimensions of the legally marketed dressing. The ChitoGauze™XR dressings are z-folded to the appropriate size and packaged in a single heat-sealed foil pouch. The pouched dressing is terminally sterilized with gamma irradiation to a sterility assurance level (SAL) of 10 - The hemostatic properties of chitosan enhance the ability of the medical gauze to control bleeding. The radiopaque filament allows for easy detection via x-ray to prevent the dressing from being inadvertently left on the wound.
The provided document is a 510(k) summary for the medical device ChitoGauze™ XR, a hemostatic dressing. It describes the device, its intended use, and the non-clinical performance data supporting its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it describes various non-clinical tests performed to demonstrate the device's characteristics and equivalence. The "acceptance criteria" are implied by successful completion and equivalence to standards or predicate devices.
| Acceptance Criteria / Performance Aspect | Reported Device Performance |
|---|---|
| Biocompatibility | Demonstrated per ISO 10993. The addition of the radiopaque filament had no effect on biocompatibility. |
| In Vivo Hemostatic Efficacy | Two separate studies: |
- Ability of 4-inch by 4-yard size to control bleeding in a 6mm femoral perforation injury in swine.
- Ability of a 2-inch by 2-inch 8-ply size to control bleeding in a splenic capsular strip injury in swine.
In both cases, the device successfully controlled bleeding at least as well as the competitive product used as a reference. |
| Reduction of Microorganisms | Tested for reduction against 25 different species (e.g., Staphylococcus aureus (MRSA), Pseudomonas aeruginosa, Escherichia coli, Clostridium difficile).
Achieved high log reductions, generally >4.0 and often >5.0, demonstrating antibacterial effectiveness. (Note: "The clinical utility of these results is unknown" is stated, suggesting this is a characteristic rather than a strict performance benchmark for clinical outcome). |
| Sterility | Sterility validation completed following ISO 11137:2006 requirements to demonstrate a 10⁻⁶ Sterility Assurance Level (SAL) using the VDmax 5 method. |
| Radiopacity | Determined via testing performed in accordance with ASTM F640-07 Method C. The product was found to be equivalent to the radiopacity of the ASTM Radiopacity Standard (101x76x0.9 mm 99+% 1100 alloy aluminum sheet) and was therefore determined to be acceptable. |
| Clinical Performance | No clinical data was required for evaluation of this device. |
| Fundamental Scientific Technology | The modification (addition of radiopaque filament) is stated to not alter the fundamental scientific technological characteristics of the original ChitoGauze, ensuring equivalence to the predicate device. Additionally, it did not change the intended use. |
2. Sample Size Used for the Test Set and the Data Provenance:
- In Vivo Efficacy:
- The document mentions "two separate in vivo studies" using "swine" models. It does not specify the exact number of animals (sample size) used in each study or the total number, nor does it specify the country of origin.
- The studies were designed and conducted to establish hemostatic efficacy. These would be considered prospective animal studies.
- Reduction of Microorganisms:
- No specific sample size for each microorganism test is provided, but it implies laboratory testing against listed species. This is non-clinical, in vitro data.
- Radiopacity:
- No specific sample size (number of dressings tested) is given for radiopacity testing. This is non-clinical, bench testing.
- Sterility & Biocompatibility:
- These are standardized tests (ISO 11137, ISO 10993). While validation requires specific sample sizes of test materials, these are not detailed in the summary. This is non-clinical, laboratory/bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- This information is not provided in the document. The studies are primarily non-clinical (animal models, lab tests) where an "expert consensus" for ground truth in the human diagnostic context typically doesn't apply. For the animal studies, the "ground truth" would be direct observational outcomes of bleeding control by the researchers/veterinarians involved in the study.
4. Adjudication Method for the Test Set:
- This information is not provided and is generally not applicable to the types of non-clinical tests described (e.g., animal model bleeding control, microbial reduction, radiopacity measurement). Adjudication usually refers to resolving disagreements among human readers or evaluators in diagnostic studies.
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 document describes a medical device (hemostatic dressing), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effect size data is presented.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. As stated above, this is not an AI algorithm.
7. The Type of Ground Truth Used:
- Biocompatibility: Ground truth is established by adherence to ISO 10993 standards and specific test results (e.g., cytotoxicity, sensitization).
- In Vivo Efficacy: Ground truth is direct physiological observation of bleeding control in a standardized animal model compared to a reference product.
- Reduction of Microorganisms: Ground truth is quantifiable log reduction values obtained from standardized microbiological assays.
- Sterility: Ground truth is defined by achieving a 10⁻⁶ SAL demonstrated via ISO 11137 procedures.
- Radiopacity: Ground truth is measured radiopacity shown to be equivalent to a defined ASTM standard.
- Clinical Data: No clinical data was required or provided, so no clinical ground truth was established for this submission.
8. The Sample Size for the Training Set:
- Not applicable. This document describes the testing and performance of a physical 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 there is no AI algorithm, there is no training set or ground truth establishment method for it.
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