GELX ORAL GEL

K081372 · Bmg Pharma, LLC · OLR · Feb 4, 2009 · SU

Device Facts

• Record ID: K081372
• Device Name: GELX ORAL GEL
• Applicant: Bmg Pharma, LLC
• Product Code: OLR · SU
• Decision Date: Feb 4, 2009
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

BMG Pharma's GelX® ORAL GEL 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 aphthous ulcers.

Device Story

GelX® ORAL GEL is a viscous hydrogel formulation supplied in 300 ml and 450 ml bottles. Device functions via mechanical action; user rinses gel in mouth to form protective barrier over oral mucosa. Barrier adheres to mucosal surface; soothes lesions; provides pain relief. Used in clinical or home settings; applied by patient or caregiver. Output is physical protective coating; aids in symptom management of oral lesions. No active electronic components or software.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Viscous hydrogel formulation; mechanical barrier principle; non-sterile; no electronic components; no software; no specific material standards cited.

Indications for Use

Indicated for management and relief of oral pain in patients with oral lesions of various etiologies, including oral mucositis/stomatitis (chemotherapy/radiotherapy-induced), post-surgical oral irritation, traumatic ulcers (braces/dentures), disease-related ulcers, and 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

• Gelclair® Concentrated Oral Gel (K013056)

Submission Summary (Full Text)

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K081372

## FEB - 4 2009

#### 510(k) Summary

#### December 10, 2008 Date:

- 1. Submission Applicant & Correspondent: BMG Pharma LLC Name: Address: 824 Highway 88 Gardnerville, NV 89460 USA [phone] Phone: Mobile: [phone]
Contact Person: Dr. Gary Pekoe President & CEO Arkios BioDevelopment International 421 S Lynnhaven Rd, Suite 101 Virginia Beach, VA 23451 USA [phone] [phone]

Phone: Fax:

3.

4.

Name of Device: GelX® ORAL GEL 2. Trade Name: GelX® ORAL GEL Dressing, Wound & Burn, Hydrogel w/Drug or Biologic Common Name: Classification Name: Dressing, Wound & Burn, Hydrogel w/Drug or Biologic

Devices to which new device is Substantially Equivalent: Sinclair Pharmaceuticals, Ltd., Gelclair® Concentrated Oral Gel (K013056)

Device Description:

BMG Pharma's GelX® ORAL GEL is a viscous gel formulation, which is presented in both 300 ml and 450 ml bottles. This combination of substances, when washed around the mouth, forms a protective layer over the oral mucosa.

#### 5. Intended Use of the Device:

BMG Pharma's GelX® ORAL GEL 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 aphthous ulcers.

Summary of Technological Characteristics of the Device Compared to the Predicate 6. Devices:

BMG Pharma's GelX® ORAL GEL has the same intended/indications for use as the predicate Sinclair Pharmaceuticals, Ltd., Gelclair® Concentrated Oral Gel (K013056).

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

#### Public Health Service

FEB - 4 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. William A. Goolsbee BMG Pharma LLC. 824 Highway 88 Gardnerville, Nevada 89460

Re: K081372

Trade/Device Name: GelX® ORAL GEL Regulation Number: None Regulation Name: Unclassified Regulatory Class: None Product Code: MGQ Dated: December 31, 2008 Received: January 2, 2009

Dear Mr. Goolsbee:

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. Goolsbee

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 510fks) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Arichon Osnato for
Ginette V. Richard, M.D.

Ginette Y. Michaud, M Acting · 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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# 10813 72

## Indications for Use

510(k) Number (if known): K081372

Device Name: GelX® ORAL GEL

Indications for Use:

BMG Pharma's GelX® ORAL GEL 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, traumatic ulcers caused by braces or ill fitting dentures, or disease. Also indicated for diffuse aphthous ulcers.

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

SURA Camo

(Division Sign-Off) (Division Sign-On) Division Control, Dental Devices

510(k) Number: K081372

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