GELX ORAL GEL

• K Number: K081372
• Device Name: GELX ORAL GEL
• Manufacturer: BMG PHARMA LLC.
• Date Cleared: 2009-02-04 ( 264 days)
• Product Code: OLR MGQ
• Regulation Number: N/A

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 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.

Predicate Devices

K013056

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a gel formulation with a mechanical action, and there is no mention of AI, ML, or any computational processing.

Therapeutic

Yes
The device is indicated for the management and relief of pain and soothing oral lesions of various etiologies, including oral mucositis/stomatitis, irritation due to oral surgery, and traumatic ulcers. These are all therapeutic actions.

Diagnostic

No
Explanation: The device, GelX® ORAL GEL, is described as having a "mechanical action indicated for the management of pain and relief of pain" by forming a protective layer. It is a treatment for symptoms and conditions, not a tool for identifying or diagnosing diseases.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "viscous gel formulation" presented in bottles, indicating a physical substance, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, BMG Pharma's GelX® ORAL GEL is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use describes a mechanical action for managing and relieving pain associated with oral lesions. This is a direct therapeutic effect on the body, not a diagnostic test performed on samples taken from the body.
• Device Description: The description details a gel formulation that forms a protective layer on the oral mucosa. This is a physical barrier, not a reagent or instrument used to analyze biological samples.
• Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing biological samples (blood, urine, tissue, etc.)
  • Detecting or measuring substances in samples
  • Providing information for diagnosis, monitoring, or screening
  • Using reagents or analytical methods

The device's function is to provide a physical barrier and soothing effect on the oral mucosa, which is a therapeutic action, not a diagnostic one. The predicate device (Gelclair®) also has a similar intended use and mechanism of action, further supporting that this type of product is not classified as an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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, and traumatic ulcers caused by braces or ill fitting dentures, or disease. Also indicated for diffuse aphthous ulcers.

Product codes

MGQ

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

mucosal surface of the mouth

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K013056

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

N/A

Summary

0

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:

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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