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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 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 dressing is also indicated for the control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites.

HemCon ChitoFlex™ Surgical is intended for use as a dressing for local management of bleeding wounds such as cuts, lacerations and abrasions.

It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatalogical, etc.) and traumatic injuries.

The dressing is also indicated for the control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites.

The HemCon dressings are a hemostatic chitosan dressing for the external temporary control of severely bleeding wounds intended for emergency use. In addition, the dressing also controls bleeding in patients following hemodialysis.

The provided text is a 510(k) Substantial Equivalence Determination letter and associated documents for the HemCon Bandage, HemCon Bandage OTC, and ChitoFlex-Surgical devices. It does not include information about acceptance criteria or a specific study proving the device meets those criteria, as it's primarily focused on demonstrating substantial equivalence to predicate devices for expanded indications for use.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving their fulfillment from this document.

However, I can extract information related to the device's indications for use and the basis for its substantial equivalence. The document states:

"In vivo testing evaluated the efficacy of the Hemcon Bandage versus control to provide hemostasis in femoral artery catheter puncture sites. This data supports the effectiveness of the Hemcon Bandage in achieving hemostasis at percutaneous catheter sites."

This indicates that some in vivo testing was performed to support the effectiveness of the device for a specific new indication. However, it does not provide details on:

• Specific acceptance criteria used in that test.
• The exact study design (e.g., sample size, methodology, statistical analysis, full results).
• Details about the ground truth methods, experts, or training data for any AI component (as this is a medical device, not an AI/ML device in this context).
• Any multi-reader multi-case (MRMC) or standalone comparative effectiveness studies.

The document focuses on establishing substantial equivalence based on similar intended use, indications, and the fact that the majority of predicate devices are chitosan-based dressings. It lists several predicate devices, implying that their performance and safety data would have been considered during the initial clearance of those devices and serve as a basis for comparison.

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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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The HemCon™ Bandage OTC Is indicated for the local management of bleading such as laceration and minor bleeding.

The HemCon™ Bandage OTC is manufactured from chilosan, a material consisting of callulosic polymer, poly-N-acetylgiucosamine. The HemCon™ Bandage OTC device is packaged in a foll package and are provided sterile.

The provided document is a 510(k) premarket notification for the HemCon™ Bandage OTC. It confirms the device's substantial equivalence to predicate devices and does not contain detailed information about a specific study proving acceptance criteria. Instead, it refers to performance data previously submitted for a referenced device.

Therefore, many of the requested elements about acceptance criteria, study design, and ground truth cannot be extracted directly from this document. However, I can infer some points based on the nature of a 510(k) submission for this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

This document does not explicitly state acceptance criteria or provide a table of reported device performance. For a device like a hemostatic bandage, common performance criteria would likely revolve around its ability to stop bleeding, biocompatibility, and safety. The document states:

• "Performance data for the HemCon™ Bandage OTC has been previously submitted in the referenced device submission."
• "In summary, the HemCon™ Bandage OTC is expected to achieve the same safety and effectiveness as the predicate devices mentioned above."

Therefore, the acceptance criteria would implicitly be that the device performs equivalently to the predicate devices in terms of safety and effectiveness for its intended use (local management of bleeding such as laceration and minor bleeding).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not available in the provided text. A 510(k) summary typically doesn't include specific details on sample sizes or data provenance for studies, especially if relying on previous submissions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not available in the provided text. For a medical device like a bandage, clinical trials or material safety tests would typically involve medical professionals (e.g., surgeons, emergency room physicians) if human studies were conducted, or lab personnel for bench testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not available in the provided text.

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

This document describes a hemostatic bandage, not an AI-powered diagnostic or assistive device. Therefore, an MRMC comparative effectiveness study involving human readers with or without AI assistance is not applicable and was not performed.

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

This is not applicable as the HemCon™ Bandage OTC is a physical medical device, not an algorithm, and does not involve human-in-the-loop performance in the context of an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not explicitly stated. For a hemostatic bandage, ground truth would likely be established through objective measures of bleeding cessation, wound healing, safety (e.g., infection rates, allergic reactions), and biocompatibility, often compared against established standards or predicate device performance. Outcomes data (e.g., time to hemostasis, adverse event rates) would be a key component.

8. The sample size for the training set

This information is not available in the provided text, as this is a physical medical device and the concept of a "training set" (as used in machine learning) does not apply in the same way. Performance data would likely come from pre-clinical (in vitro, in vivo animal) and possibly clinical human studies.

9. How the ground truth for the training set was established

This information is not available in the provided text for the reasons mentioned in point 8.

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