ORAMAGIC PLUS ORAL WOUND RINSE

K060340 · Mpm Medical., Inc. · OLR · May 10, 2006 · SU

Device Facts

• Record ID: K060340
• Device Name: ORAMAGIC PLUS ORAL WOUND RINSE
• Applicant: Mpm Medical., Inc.
• Product Code: OLR · SU
• Decision Date: May 10, 2006
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

For the management of, and temporary relief of pain associated with, all types of mouth sores, ulcers of the oral mucosa including canker sores, aphthous ulcers, and injuries such as traumatic ulcers caused by braces and ill-fitting dentures.

Device Story

OraMagic™ Plus Oral Wound Rinse is a hydrogel wound dressing containing 10% w/w benzocaine as a topical anesthetic. Supplied as a dry powder in 7.1g or 25g plastic bottles; requires reconstitution with water by the user prior to application. Used for local management of painful oral mucositis/stomatitis and various oral ulcers/injuries. Provides temporary pain relief via the anesthetic agent. Intended for over-the-counter use.

Clinical Evidence

No clinical data. Biocompatibility established via primary dermal irritation (rabbits), sensitization (guinea pigs), and in vivo cytotoxicity testing.

Technological Characteristics

Hydrogel wound dressing; contains 10% w/w benzocaine; supplied as dry powder for reconstitution with water; non-sterile; plastic bottle packaging.

Indications for Use

Indicated for patients suffering from mouth sores, oral mucosal ulcers (canker sores, aphthous ulcers), and traumatic oral injuries (braces, ill-fitting dentures) requiring pain relief.

Regulatory Classification

Identification

Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ.

Predicate Devices

• OramagicRx™ Oral Wound Rinse (K024180)

Submission Summary (Full Text)

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K060340

MAY 10 2005

## 510 (K) SUMMARY

#### I. ADMINISTRATIVE

Submitter: MPM Medical, Inc. 2301 Crown Court Irving, Texas 75038 [phone]

Contact Person: Paul R. Miller

Date of Preparation: February 3, 2006

### II. DEVICE NAME

Proprietary Name: Oramagic™Plus Oral Wound Rinse

Common Name: Mucositis/Stomatitis Oral Rinse

Classification Name: Dressing, Wound and Bum, Hydrogel w/Drug and/or Biologic

#### III. PREDICATE DEVICE

OramagicRx™ Oral Wound Rinse KO24180 (MPM Medical, Inc.)

#### IV. DEVICE DESCRIPTION

OraMagic™ Plus Oral Wound Rinse is a wound dressing containing 10% w/w benzocaine as a topical anesthetic intended for use in the local management of painful oral mucositis/stomatitis. The device is supplied non-sterile in plastic bottles containing 7.1 g or 25g of dry powder for reconstitution with water prior to use.

#### V. INTENDED USE

For the management of, and temporary relief of pain associated with, all types of mouth sores, ulcers of the oral mucosa including canker sores, aphthous ulcers, and injuries such as traumatic ulcers caused by braces and ill-fitting dentures.

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K060340

The biocompatibility of the predicate device has been established by a primary dermal irritation test in rabbits, a sensitization test in guinea pigs, and an in vivo cytotoxicity test. Since the safety of topical benzocaine (up to 20%) has been well established through a long history of over-the-counter use, the addition of 10% benzocaine to the original formulation does not raise any new biocompatibility issues.

#### VI. COMPARISON TO PREDICATE DEVICE

OraMagic™ Plus Oral Wound Rinse is similar in composition, function and intended use to MPM Medical's OraMagicRx™ Oral Wound Rinse and other legally marketed hydrogel wound dressing products.

Accordingly, MPM Medical, Inc. concluded that OraMagic™Plus Oral Wound Rinse is safe and effective for its intended use and performs as least as well as legally marketed predicate devices, such as MPM Medical's OraMagicRx™ Oral Wound Rinse.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its head and neck. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 0 2006

MPM Medical, Incorporated C/O Mr. Richard A. Hamer Richard Hamer Associates, Incorporated 897 Chancery Court Monroe, Michigan 48161

Re: K060340

Trade/Device Name: OraMagic™ Plus Oral Wound Rinse Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: MGO Dated: February 3, 2006 Received: February 15, 2006

Dear Mr. Hamer:

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. Hamer

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

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 if known: 5060340

Device Name: OraMagic™ Plus Oral Wound Rinse

Indications for Use: For the management of, and temporary relief of pain associated with, all types of mouth sores, ulcers of the oral mucosa including canker sores, aphthous ulcers, and injuries such as traumatic ulcers caused by braces and ill-fitting dentures.

#### Prescription Use AND/OR Over-The-Counter Use X (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Devaluation (ODE)

Susa Runge

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f Anesthesiology, General Hospital,
ion Control, Dental Devices

Number: K060386