(21 days)
ChitoGauze™ is a hemostatic dressing for the external, temporary control of severely bleeding wounds. ChitoGauze™ is intended for temporary external use to stop bleeding of minor wounds, minor cuts and minor abrasions.
The ChitoGauze dressing is composed of standard polyesterfrayon blend non-woven medical gauze that is coated with chitosan. This submission adds models of various dimensions to the legally marketed four inch by four yard (4" x 4 yds) dressing. ChitoGauze dressings are z-folded and packaged in a peelable foil pouch. The pouched dressing is terminally sterilized with gamma irradiation to a sterility assurance level (SAL) of 10th. The hemostatic properties of chitosan enhance the ability of the medical gauze to control bleeding.
The provided text is a 510(k) summary for the ChitoGauze™ wound dressing, which focuses on an administrative change regarding the device's product code and the addition of various dimensional sizes to the already legally marketed dressing.
Based on the content, this document does not contain the kind of information requested regarding acceptance criteria and a study proving a device meets those criteria, specifically concerning performance metrics like sensitivity, specificity, accuracy, or reader study results. The provided text is a regulatory filing, not a clinical study report.
Here's a breakdown of why the requested information cannot be extracted from this document:
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Acceptance Criteria Table & Reported Device Performance: This document does not define quantitative acceptance criteria for device performance (e.g., how effectively it stops bleeding in a clinical or simulated setting) nor does it report device performance against such criteria. The "Log Reduction" table (Image 5) shows antibacterial effectiveness, but this is a characteristic, not a primary hemostatic performance metric with predefined acceptance limits for market clearance in this context. The 510(k) summary explicitly states for the changes under review (addition of various sizes) that "Changing the dimensional size of the dressing has no effect upon the technological characteristics."
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Sample Size, Test Set, and Data Provenance: Not applicable. There is no specific test set data for performance outlined for the current submission, as it relates to adding new sizes of an already cleared device.
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Number of Experts & Qualifications for Ground Truth: Not applicable. No ground truth was established for performance metrics in this submission using experts.
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Adjudication Method: Not applicable. No adjudication process for performance data is described.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is not mentioned as it's not relevant to the administrative change and size additions. The device is a wound dressing, not an AI-assisted diagnostic tool.
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Standalone Performance Study: Not applicable in the context of typical AI/diagnostic device performance. The non-clinical performance data section (Image 5) discusses "Biocompatibility" and "Reduction of Microorganisms" testing, but these are not 'standalone performance' in the sense of an algorithm's output. The antibacterial effectiveness is presented as a characteristic.
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Type of Ground Truth Used: Not applicable for performance. The "ground truth" for the antibacterial resistance test would be the measured log reduction against known strains (Image 5), but this isn't presented as meeting a specific acceptance criterion for market clearance on its own, especially for hemostatic claims.
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Sample Size for Training Set: Not applicable. This document does not pertain to an AI/machine learning model, so there is no training set.
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How Ground Truth for Training Set Was Established: Not applicable.
Summary from the Document:
The provided 510(k) K092357 is an update (superseding a previous letter with an administrative change) and an amendment for adding various dimensional sizes to the ChitoGauze™ wound dressing. The core message is that the changes are administrative (product code) and dimensional, and do not alter the fundamental scientific technology or intended use of the device.
The "Non-Clinical Performance Data" section (Image 5) briefly mentions:
- Biocompatibility: Demonstrated per ISO 10993. The document states "Changing the dimensional size of the dressing has no effect upon the biocompatibility."
- Reduction of Microorganisms: An eight-ply version of ChitoGauze™ was tested against various bacterial species, showing log reductions typically >4.0 or >5.0. It explicitly states, "The clinical utility of these results is unknown."
- Sterility: A sterility validation was completed following ISO 11137:2006 to demonstrate a 10⁻⁶ SAL (Sterility Assurance Level) using the VDmax 25 method. "Changing the dimensional size of the dressing has no effect upon the sterility validation."
The "Clinical Performance Data" section (Image 6) explicitly states: "No clinical data was required for evaluation of this device."
Therefore, this document does not contain the detailed information requested about acceptance criteria and a study proving the device meets them in the context of clinical performance metrics typically associated with diagnostic or AI-powered devices. It focuses on demonstrating that new sizes of an existing device maintain the same safety and performance characteristics as the original cleared device.
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