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.

AI/ML Overview

This 510(k) submission (K081372) for GelX® ORAL GEL is for a medical device that received a substantial equivalence determination. As such, it does not include acceptance criteria or a study proving the device meets acceptance criteria in the same way a diagnostic AI device would.

The substantial equivalence pathway for devices like GelX® ORAL GEL relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This typically involves comparing technological characteristics and intended uses.

Therefore, many of the requested points regarding acceptance criteria, performance metrics, sample sizes, expert ground truth, and AI-specific study designs are not applicable to this type of device submission.

Here's an explanation based on the provided document:

1. A table of acceptance criteria and the reported device performance

Not Applicable. This submission is for a medical device (oral gel) where "acceptance criteria" and "device performance" are typically related to chemical composition, efficacy in relieving symptoms, and safety, demonstrated through clinical trials or comparisons to predicate devices, rather than diagnostic accuracy metrics. The document states "BMG Pharma's GelX® ORAL GEL has the same intended/indications for use as the predicate Sinclair Pharmaceuticals, Ltd., Gelclair® Concentrated Oral Gel (K013056)." This implies that its "performance" for its intended use is considered equivalent to the predicate.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This 510(k) does not present a "test set" in the context of an AI/diagnostic algorithm. The "data" proving substantial equivalence would typically be from the device's formulation, non-clinical tests (e.g., pH, viscosity, adherence properties), and potentially clinical experience with the predicate device or a small clinical study (though none is detailed here). The document does not specify any clinical study data, sample sizes, or provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. "Ground truth" in this context would relate to the clinical effect of the gel (e.g., pain relief, adhesion to mucosa). This typically involves patient reporting in clinical trials, not expert consensus on a diagnostic outcome. The document does not mention any expert review or ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. There is no "test set" or adjudication method described for this type of device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This device is an oral gel, not an AI diagnostic system. Therefore, no MRMC study or assessment of human readers improving with AI assistance would be relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable for AI/diagnostic algorithms. For a device like an oral gel, "ground truth" would be related to clinical outcomes (e.g., patient-reported pain scores, observations of mucosal healing, adherence to the mouth). The document doesn't provide specific outcome data, relying on the substantial equivalence to a predicate.

8. The sample size for the training set

Not Applicable. This is not an AI or machine learning device 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 type, this question is not relevant.

In summary, the provided 510(k) summary for GelX® ORAL GEL is for a physical medical device (an oral gel), not a diagnostic AI or imaging device. The regulatory pathway is based on demonstrating substantial equivalence to a predicate device, focusing on intended use and technological characteristics rather than the complex performance evaluation criteria typically associated with AI-powered diagnostics.

Summary

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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 (775) 265-6529 Phone: Mobile: (714) 743-9302
  Contact Person: Dr. Gary Pekoe President & CEO Arkios BioDevelopment International 421 S Lynnhaven Rd, Suite 101 Virginia Beach, VA 23451 USA (757) 631-2114 (757) 631-2115

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:

5. Intended Use of the Device:

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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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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Regulation Number and Section

N/A