MuGard™ Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces.

Device Description

MuGard™ Mucoadhesive Oral Wound Rinse is a viscous liquid supplied in plastic bottles and is designed for the management of oral mucositis/stomatitis and other oral wounds. When swirled gently round the mouth, the mucoadhesive formulation results in the formation of a protective coating over the oral mucosa.

AI/ML Overview

This document describes a 510(k) premarket notification for the MuGard™ Mucoadhesive Oral Wound Rinse.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria in terms of device performance metrics (e.g., specific reduction in pain score, healing time). Instead, the acceptance criteria are met by demonstrating substantial equivalence to predicate devices through:

Acceptance Criteria Category	Reported Device Performance (Summary)
Functional Equivalence	Similar function and intended use to predicate devices.
Mode of Action	Achieves action (protective layer formation) in the same manner as predicate devices.
Compositional Similarity	Similar mixture of film-forming polymers, pharmaceutical aids, preservatives, and sweeteners/flavors to predicate devices.
Biocompatibility	Established through ISO 10993 testing (in vitro cytotoxicity, sensitization in guinea pigs, mucosal irritation in rabbits).
Safety and Effectiveness	Concluded to be safe and effective for its intended use and performs equivalently to identified legally marketed predicate devices.

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

The document does not describe a specific clinical study with a test set of human subjects to quantify performance metrics. The safety of the device was established through biocompatibility testing, which typically involves laboratory animal studies (guinea pigs, rabbits) and in vitro tests. No information on human test subjects or data provenance (country, retrospective/prospective) is provided.

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

Since no clinical study with human subjects or a test set is described for performance evaluation, this information is not applicable. The device's safety was assessed through standard biocompatibility tests, not by expert interpretation of clinical outcomes for ground truth.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication is described.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study is mentioned. The submission focuses on demonstrating substantial equivalence to predicate devices rather than a comparative study against human readers or other treatments.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is a medical product (oral rinse), not an algorithm or AI system.

7. Type of Ground Truth Used:

The "ground truth" for the device's acceptable performance is established through:

Demonstration of substantial equivalence to legally marketed predicate devices.
Biocompatibility testing results (e.g., negative for cytotoxicity, sensitization, and mucosal irritation).

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

Summary

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510(K) SUMMARY

DEC 1 1 2006

Submitter Information 5.1

A. Company Name:	Access Pharmaceuticals, Inc.
B. Company Address:	2600 Stemmons Freeway, Suite 176Dallas, TX 75207
C. Company Phone:	(214) 905-5100
D. Company Facsimile:	(214) 905-5101
E. Contact Person:	David P. NowotnikSenior Vice-President, Research & Developmentdavid.nowotnik@accesspharma.com

Device Identification 5.2

A.	Device Trade Name:	MuGardTM Mucoadhesive Oral Wound Rinse
B.	Common Name:	Dressing, Wound and Burn, Hydrogel w/ Drugand/or Biologic
C.	Classification Name:	Unclassified
D.	Device Class:	Unclassified
E.	Device Code:	MGQ
E.	Advisory Panel:	General and Plastic Surgery

5.3 Identification of Predicate Devices

The MuGard™ Mucoadhesive Oral Wound Rinse is substantially equivalent to the following predicate devices:

OraMagicRx™ Oral Wound Rinse manufactured by MPM Medical, Inc. and cleared . for commercial distribution under 510(k) K024180.
Gelclair® Concentrated Oral Gel manufactured by Sinclair Pharmaceuticals, Ltd. and . cleared for commercial distribution under 510(k) K013056.

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5.4 Device Description

ર્સ્ડ Indications for Use

5.6 Comparison to Predicate Devices

MuGard™ Mucoadhesive Oral Wound Rinse is similar in function and has the same intended use as OraMagicRx™ Oral Wound Rinse (MPM Medical, Inc.), Gelclair® Concentrated Oral Gel (Sinclair Pharmaceuticals, Ltd.) and other legally marketed hydrogel wound dressing products.

The mode of action of MuGard™ Mucoadhesive Oral Wound Rinse is achieved in an same manner to OraMagicRx™ Oral Wound Rinse and Gelclair® Concentrated Oral Gel. i.e., through the formation of a protective layer over the oral mucosa.

The composition of MuGard™ Mucoadhesive Oral Wound Rinse is similar to OraMagicRx™ Oral Wound Rinse and Gelclair® Concentrated Oral Gel, i.e., a mixture of film-forming polymers, pharmaceutical aids, preservatives and sweeteners/flavors.

The safety of MuGard™ Mucoadhesive Oral Wound Rinse has been established through biocompatibility testing according to ISO 10993. i.e., in vitro cytotoxicity tests. sensitization testing in guinea pigs and mucosal irritation testing in rabbits.

On the basis of this information. Access Pharmaceuticals concluded that MuGard™ Mucoadhesive Oral Wound Rinse is safe and effective for its intended use and performs equivalently to the identified legally marketed predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of four stylized human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 1 2006

Dr. David P. Nowotnik Senior Vice President, Research & Development Access Pharmaceuticals, Incorporated 2600 Stemmons Freeway, Suite 176 Dallas, Texas 75207

Re: K062795

Trade/Device Name: MuGard™ Mucoadhesive Oral Wound Rinse Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: MGQ Dated: September 15, 2006 Received: September 18, 2006

Dear Dr. Nowotnik:

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 - Dr. Nowotnik

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 (QS) 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-. 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,

Chiu Lin, Ph.D.

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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INDICATIONS FOR USE

510(k) Number: To Be Assigned By FDA

MuGard™ Mucoadhesive Oral Wound Rinse Device Name:

Indications for Use:

Prescription Use X (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)

Signature

	Henry General Hospital

	KA062795

CONFIDENTIAL

Regulation Number and Section

N/A