MUCOTROL CONCENTRATED ORAL GEL WAFER

K042400 · Belcher Pharmaceuticals, Inc. · OLR · Nov 24, 2004 · SU

Device Facts

• Record ID: K042400
• Device Name: MUCOTROL CONCENTRATED ORAL GEL WAFER
• Applicant: Belcher Pharmaceuticals, Inc.
• Product Code: OLR · SU
• Decision Date: Nov 24, 2004
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Mucotrol™ concentrated oral gel wafer has a mechanical action indicated for the management of pain and relief of pain, by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including: Oral Mucositis/Stomatitis (may be caused by chemotherapy or radiotherapy), irritation due to oral surgery and traumatic ulcers caused by braces or ill fitting dentures or disease. Also indicated for diffuse apthous ulcers.

Device Story

Mucotrol™ is a 2200 mg compressed powder wafer; functions via mechanical action. Upon oral administration, wafer dissolves slowly in saliva to form a protective hydrogel layer over oral mucosa. This physical barrier adheres to mucosal surfaces to soothe lesions and manage pain. Intended for use by patients experiencing oral pain from various etiologies. Device provides symptomatic relief by shielding sensitive tissue from further irritation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Compressed powder wafer (2200 mg); hydrogel-forming upon contact with saliva. Mechanical barrier principle of operation. Non-active device.

Indications for Use

Indicated for management and relief of oral pain in patients with oral mucositis/stomatitis (chemotherapy/radiotherapy induced), oral surgery irritation, traumatic ulcers (braces/dentures), or diffuse aphthous ulcers.

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

• Sinclair Pharmaceuticals Gelclair™ Concentrated Oral Gel (K013056)
• Carrington Labs RadiaCare™ Oral Wound Rinse (K964852)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for Belcher Pharmaceuticals, Inc. The word "Belcher" is written in a cursive font, with the "B" being much larger than the other letters. Below the word "Belcher" is the text "Pharmaceuticals, Inc.", written in a smaller, sans-serif font. The logo is simple and professional, and it is likely used on the company's products and marketing materials.

12393 Belcher Road, Suite 420 Largo, FL 33773 Ph: [phone] Fax: [phone]

K04-2400

"510(k) Summary"

Sept. 1, 2004

1. Submission applicant & correspondent:

| Name: | Belcher Pharmaceuticals, Inc. |
|-----------------|-------------------------------|
| Address: | 12393 Belcher Road, Suite 420 |
| Address: | Largo, Florida 33773. USA |
| Phone: | [phone] |
| Contact person: | Kotha Sekharam, Ph. D |

Mucotrol™ Concentrated Oral gel wafer 2. Name of device:

Trade/proprietary name: Mucotrol™ Concentrated Oral gel wafer

Common or usual name: Dressing, Wound & burn, Hydrogel with drug or biologic

Classification names: Dressing, Wound & burn, Hydrogel with drug or biologic

3. Devices to which new device is substantially equivalent:

Sinclair Pharmaceuticals Gelclair™ Concentrated Oral Gel (K013056) and Carrington Labs RadiaCare ™ Oral Wound Rinse (K964852) .

4. Device description:

Belcher Pharmaceutical's Mucotrol™ concentrated oral gel wafer is compressed powder, presented as 2200 mg slow dissolving wafer. This combination of

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substances, when slowly dissolved in the mouth, due to saliva, forms a protective layer over the oral mucosa.

## 5. Intended use of the device:

Mucotrol™ concentrated oral gel wafer has a mechanical action indicated for the management of pain and relief of pain, by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including: Oral Mucositis/Stomatitis (may be caused by chemotherapy or radiotherapy), irritation due to oral surgery and traumatic ulcers caused by braces or ill fitting dentures or disease. Also indicated for diffuse apthous ulcers.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized lines forming its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 4 2004

Dr. Kotha Sekharam President Belcher Pharmaceuticals, Incorporated 12393 Belcher Road, Suite 420 Largo, Florida 33773

Re: K042400

Trade/Device Name: Mucotrol Concentrated Oral Gel Wafer Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: FRO Dated: September 1, 2004 Received: September 3, 2004

Dear Dr. Sekharam:

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 vour 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. Sekharam

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 vour 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/dsma/dsmamain.html

Sincerely vours.

Chiu-Liang PhD

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

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Indications for Use

510(k) Number (if known): _(042400

Device Name: MUCOTROL™ CONCENTRATED ORAL GEL WAFER

Indications for Use: : MUCOTROL™ CONCENTRATED ORAL GEL WAFER HAS A MECHANICAL ACTION INDICATED FOR THE MANAGEMENT OF PAIN AND RELIEF OF PAIN, BY ADHERING TO THE MUCOSAL SURFACE OF THE MOUTH, SOOTHING ORAL LESIONS OF VARIOUS ETIQLOGIES, INCLUDING: ORAL MUCOSITIS/STOMATITIS (MAY BE CAUSED BY CHEMOTHERAPY OR RADIOTHERAPY), IRRITATION DUE TO ORAL SURGERY AND TRAUMATIC ULCERS CAUSED BY BRACES OR ILL FITTING DENTURES OR DISEASES. ALSO INDICATED FOR DIFFUSE APTHOUS ULCERS.

Over-The-Counter Use Prescription Use YES AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Susan Rump

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K042400