(337 days)
HemCon® Bandage is a hemostatic dressing for the external temporary control of severely bleeding wounds intended for emergency use. In addition, the HemCon® Bandage also controls bleeding in patients following hemodialysis.
The HemCon® Bandage OTC is indicated for the local management of bleeding such as laceration and minor bleeding.
The HemCon® Bandage is manufactured from chitosan. When applied directly to the wound, the HemCon® Bandage controls bleeding. The HemCon® Bandage is a sterile chitosan based dressing intended for use for the external temporary control of severely bleeding wounds intended for emergency use. In addition, the HernCon® Bandage also controls bleeding in patients following hemodialysis. The HemCon® Bandage OTC is indicated for the local management of bleeding such as laceration and minor bleeding.
The original HemCon® Bandage and HemCon® Bandage OTC were cleared via 510(k) K043050 on 03 June 2005 to include the description that the bandage provides an antibacterial barrier as demonstrated by AATCC Test Method 100-2004, Evaluation of Antibacterial Finishes (Technical Manual of the America Association of Textile Chemists and Colorists) in laboratory testing for two microorganisms. This submission expands this antibacterial claim to a total of twenty-four micro-organisms.
The HemCon® Bandage is similar to the original HemCon® Bandage and another antibacterial wound dressing, Maersk Medical's Arglaes-AB Antimicrobial (K990810, cleared 17 September 1999), the HemCon® Bandage was challenged with microbial strains in vitro to support the claim of antibacterial barrier activity and extend the list of microorganisms used in the challenge test.
The provided documents are a 510(k) summary and FDA clearance letters for the HemCon® Bandage and HemCon® Bandage OTC. This submission, K072486, primarily addresses an expansion of the antibacterial claim for the device. However, this document does not describe the acceptance criteria or a study that proves the device meets the acceptance criteria for its primary hemostatic function.
Instead, it focuses on the antibacterial properties of the device. Here's an analysis based on the information provided:
Section 1: Acceptance Criteria and Reported Device Performance (related to antibacterial claims)
| Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|
| Log reduction of microbial strains (AATCC Test Method 100-2004) | Demonstrated "log 4 reductions of multiple organisms" |
| Barrier to microbial penetration | Demonstrated "barrier to microbial penetration against log 6 inoculum" |
Section 2: Sample Size and Data Provenance for the Antibacterial Test Set
- Sample Size: Not explicitly stated. The document mentions "multiple organisms" for log reduction and "log 6 inoculum" for barrier testing, but not the number of individual tests or replicates performed.
- Data Provenance: The testing was "in vitro" and performed by HemCon Medical Technologies, Inc. No information on country of origin beyond the company's US address. It is a retrospective analysis of laboratory data used to support the expanded claim.
Section 3: Number and Qualifications of Experts for Ground Truth (Antibacterial Claims)
- Not applicable. The ground truth for the antibacterial claims was established through in vitro laboratory testing using standardized methods, not expert consensus on medical images or clinical outcomes.
Section 4: Adjudication Method for the Antibacterial Test Set
- Not applicable. This type of in vitro laboratory testing does not involve adjudication.
Section 5: Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. This submission focuses on the antibacterial properties of a hemostatic dressing, not a diagnostic imaging device, and therefore does not involve human readers evaluating cases with or without AI assistance.
Section 6: Standalone (Algorithm Only) Performance Study
- Not applicable. This device is a physical dressing, not an algorithm. The "performance" being described relates to its physical and chemical properties in an in vitro setting.
Section 7: Type of Ground Truth Used (Antibacterial Claims)
- In vitro laboratory testing results: The antibacterial claims (log reduction and barrier properties) were established through "in vitro laboratory testing" following AATCC Test Method 100-2004.
Section 8: Sample Size for the Training Set
- Not applicable. This isn't an AI/ML device that requires a training set. The data presented is observational from in vitro tests.
Section 9: How the Ground Truth for the Training Set Was Established
- Not applicable.
Summary regarding the device's primary function (hemostasis):
The provided documents are lacking information regarding acceptance criteria and studies for the primary hemostatic function of the HemCon® Bandage.
- The Indications for Use statement for the Rx bandage is "a hemostatic dressing for the external temporary control of severely bleeding wounds intended for emergency use. In addition, the HemCon® Bandage also controls bleeding in patients following hemodialysis."
- The Indications for Use statement for the OTC bandage is "indicated for the local management of bleeding such as laceration and minor bleeding."
While the document references previous clearance (K043050) for the original device, it
"This submission expands this antibacterial claim to a total of twenty-four micro-organisms."
It does not include details about the studies or acceptance criteria that supported the initial clearance for hemostasis. The current submission (K072486) is specifically about expanding the device's antibacterial claims.
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