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.

Summary

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K060363

JUL - 7 2006

14 June 2006

HemCon® Dental Dressing 510(k) Notification

5. SECTION 5 - 510(K) SUMMARY

Name and Address of Sponsor:

Device Name:

HemCon. Inc. 10575 SW Cascade Avenue, Suite 103 Portland, OR 97223

Proprietary Name: Hemcon® Dental Dressing

Common Name: Oral Wound Dressing Classification Name: Dressing Product Code: Unclassified

Establishment Registration Number:

9053189

General Description:

Indication for 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.

Contact Person(s) and Phone Number:

Kevin Hawkins Director - Quality & Regulatory Phone (503)245.0459 x114 Fax (503)245.1326

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the snake and staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular fashion around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 7 2006

Mr. Kevin Hawkins Director-Quality & Regulatory HemCon, Incorporated 10575 SW Cascade Boulevard. Suite 103 Portland, Oregon 97223

Re: K060363

Trade/Device Name: HemCon® Dental Bandage Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: MGQ Dated: June 14, 2006 Received: June 15, 2006

Dear Mr. Hawkins:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 -- Mr. Hawkins

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Snite y. Michin Omp.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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14 June 2006

4. SECTION 4- INDICATIONS FOR USE STATEMENT

Applicant: HemCon, Inc. 510(k) Number (if known): K060363 Device Name: HemCon® Dental Bandage

Indications for 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.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(Please Do Not Write Below This Line - Continue On Another Page If Needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sivan Runor

: Sign-Off)
on of Anesthesiology, General Hospital,
Jon Control, Pental Devices

Number: 12060363

Page ੀ

(Posted November 13, 2003)

Regulation Number and Section

N/A