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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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HemCon ChitoFilex™ Surgical is intended for use as a topical 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 HemCon ChitoFlex™-Surgical Dressing is a sterile chitosan based dressing intended for use as a topical 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, donor sites, dermatalogical, etc.) and traumatic injuries.

I am sorry, but the provided text is a 510(k) premarket notification from the FDA regarding a medical device, the "HemCon ChitoFlex™ -Surgical Dressing". This document confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about:

1. Acceptance criteria and reported device performance: The document confirms substantial equivalence but does not specify performance metrics or acceptance criteria for the device itself.
2. Study details: There is no mention of any specific study conducted to prove the device meets acceptance criteria, including sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone studies, or the type of ground truth used.
3. Training set details: No information about a training set, its sample size, or how its ground truth was established is provided.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the input provided. The document is primarily an FDA clearance letter based on substantial equivalence to existing devices, not a detailed study report.

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The HemCon® Dental Dressing is an oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.

The HemCon® Dental Dressing is identical in material, design and composition to the legally marketed HemCon® Bandage (K023298, cleared 04 November 2002 with update K043050, cleared 03 June 2005). The only differences are the indication for use in the oral cavity and the reduction in size for the use in the oral cavity (10 cm x 10 cm for the legally marketed HemCon® bandage versus 10 mm x 12 mm for the dental dressing). Additionally, the HemCon® Dental Dressing is provided without the non-stick backing used on the HemCon® Bandage.

The HemCon® Dental Dressing is a lyophilized (freeze-dried) chitosan-based dressing designed to optimize the mucoadhesive surface density and structural integrity of chitosan at the wound site. The HemCon® Dental Dressing may be manufactured to any size and is currently available in 10 mm x 12 mm rectangular dressing and is packaged in a vacuum-sealed aluminum pouch and processed with gamma radiation for sterile single-use only application.

This Premarket Notification (510(k)) for the HemCon® Dental Dressing does not contain the detailed study information typically found in a clinical trial report or specific performance testing document. As such, I cannot extract acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details directly from the provided text.

The document primarily focuses on establishing substantial equivalence to a previously cleared device (HemCon® Bandage K023298, cleared 04 November 2002 with update K043050, cleared 03 June 2005). Substantial equivalence means that the new device is as safe and effective as a legally marketed device that is not subject to premarket approval. This approach typically relies on demonstrating that the new device has the same intended use, and the same technological characteristics as the predicate device, or if there are differences in technological characteristics, that these differences do not raise different questions of safety and effectiveness, and that the device is as safe and effective as the legally marketed device.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not provided. The document states that the HemCon® Dental Dressing is "identical in material, design and composition" to the legally marketed HemCon® Bandage, except for size and the absence of a non-stick backing. It infers that the performance of the Dental Dressing will be equivalent to the predicate based on this similarity. Specific performance metrics for the Dental Dressing are not presented.

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

• Not provided. There is no mention of a dedicated test set or associated data. The reliance is on the substantial equivalence to the predicate device.

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

• Not applicable. No such study or ground truth establishment is described for the Dental Dressing itself.

4. Adjudication Method for the Test Set:

• Not applicable. No test set or adjudication process is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

• Not applicable. This type of study is not mentioned as it is typically associated with diagnostic devices, not wound dressings like this.

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

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

7. The type of ground truth used:

• Not applicable for the HemCon® Dental Dressing itself. The "ground truth" for the new device's clearance is its substantial equivalence to the predicate device. The predicate device (HemCon® Bandage) would have had its own original clearance studies, which are not detailed here.

8. The sample size for the training set:

• Not applicable. As this is not an AI/algorithm-based device, there is no training set in that context.

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

• Not applicable.

Summary of what can be extracted from the document:

• The device: HemCon® Dental Dressing.
• Indication for Use: An oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.
• Basis for Acceptance: Substantial equivalence to the legally marketed HemCon® Bandage (K023298, K043050). The new device is "identical in material, design and composition" to the predicate, with only differences in size and the absence of a non-stick backing.
• Regulatory Status: Cleared by the FDA as substantially equivalent on July 7, 2006.

In essence, the "study that proves the device meets the acceptance criteria" in this case is the demonstration of substantial equivalence to a predicate device rather than a new, independent performance study for the HemCon® Dental Dressing. The acceptance criteria were met by proving it was sufficiently similar to an already approved product for its intended use.

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