HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX OF 12, 4 DRESSING, BOX OF 12

• K Number: K060363
• Device Name: HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX OF 12, 4 DRESSING, BOX OF 12
• Manufacturer: HEMCON, INC.
• Date Cleared: 2006-07-07 ( 144 days)
• Product Code: OLR , MGQ , UNC
• Regulation Number: N/A
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: K043050 , K023298

Intended Use

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.

Device Description

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.

AI/ML Overview

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.

Regulation Number and Section

N/A