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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)

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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The HemCon® Bandage is intended as an external temporary wound treatment for the control of severely bleeding wounds for emergency use. In addition, the HemCon® Bandage also controls bleeding in patients following hemodialysis. The HemCon® Bandage OTC is intended for the local management of bleeding such as laceration and minor bleeding.

The HemCon® Bandage and the HemCon® Bandage OTC are each applied to the wound and held in place until it adheres to the wound and hemostasis is achieved. Then, an outer bandage is applied to secure the dressing on the wound site. The HemCon® Bandage and the HemCon® Bandage OTC are manufactured from chitosan, a material consisting of cellulosic polymer, poly[ß(1->4)-2-amino-2-deoxy-D-dlucopyranose]. These devices are packaged in a foil package and provided sterile. They are sterilized by gamma irradiation at a dose adequate to ensure a SAL of 10 %.

This document is a 510(k) summary for the HemCon® Bandage and HemCon® Bandage OTC. It refers to previous submissions for performance data and states that the current devices are identical to predicate devices in intended use, material, performance, sterilization method, and method of application. This means a new study specifically for this 510(k) submission was not required as equivalence was based on prior data and minor modifications.

Therefore, many of the requested details about a new study (like sample size, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a new study) are not applicable to this specific 510(k) submission.

However, I can extract information regarding acceptance criteria and reported performance from the provided text, as well as details about the previous studies that established equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

This 510(k) submission states, "Performance data for the HemCon® Bandage and the HemCon® Bandage OTC have been previously submitted in the referenced predicate device submissions."

Therefore, for this specific submission K043050, a new test set was not used. The data provenance and sample sizes would be found in the predicate submissions (K023298 for HemCon® Bandage and K030946 for HemCon® Bandage OTC), which are not provided in this document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable for this 510(k) submission, as it relies on previously submitted data.

4. Adjudication Method for the Test Set

Not applicable for this 510(k) submission, as it relies on previously submitted data.

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 device is a hemostatic bandage, not an AI-powered diagnostic device involving human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

Based on the description of the device (hemostatic bandage), the ground truth for performance in the predicate device studies would likely involve:

• Clinical outcomes data: Direct observation of hemostasis (cessation of bleeding) in human or animal subjects for the hemostatic claims.
• Laboratory test results: For antibacterial properties (AATCC Test Method 100-2004) and biocompatibility.
• Sterilization validation data: For sterility claims (ISO 11137).

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not a machine learning algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the same reason as above.

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