RX: GC Oral Moisturizing Gel is designed to provide comfort for individuals suffering from dry mouth. It is recommended to be used for people who may experience difficulties in eating, speaking or are suffering from discomfort due to dry mouth. OTC: GC Oral Moisturizing Gel is indicated for the relief of dry mouth symptoms, to provide a protective coating inside the mouth, and help to control bad breath.

Device Description

GC Oral Moisturizing Gel contains polyglycerol (diglycerol) which, with other ingredients in the product, temporarily substitute the feel of natural saliva to moisturize, lubricate, and refresh the mouth. GC Oral Moisturizing Gel comes in five flavors: fruit salad, lemon, mint, orange and raspberry. GC Oral Moisturizing Gel is sugar free and alcohol free.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the GC Oral Moisturizing Gel:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided are primarily based on comparisons to predicate devices in physical properties (Consistency, pH) and a single performance metric (Moisture Desorption Assay). The document argues for substantial equivalence rather than setting hard numerical thresholds for acceptance in the traditional sense of a clinical trial. However, we can interpret the predicate device values as targets or benchmarks for equivalence.

Metric	Acceptance Criteria (Predicate Device Range/Value)	Reported Device Performance (GC Oral Moisturizing Gel)	Meets Criteria?
Consistency (mm)	26.5 - 28.0 (BioXtra/Oral Balance)	32.5	No
pH	5.4 - 5.6 (BioXtra/Oral Balance)	7.2	No
Moisture Desorption Degree (%)	10.1% (Biotene Oral Balance)	6.9%	Yes (Lower is better)

Notes on Meeting Criteria:

Consistency and pH: The GC Oral Moisturizing Gel's reported values fall outside the range of its predicate devices for both consistency and pH. The submission argues for substantial equivalence despite these differences, focusing on the shared "mode of action" and intended use. This suggests the FDA accepted these differences, likely because the performance (moisture desorption) was superior or equivalent, and the overall safety and effectiveness were not compromised.
Moisture Desorption Degree: The GC Oral Moisturizing Gel performs better than the predicate device (Biotene Oral Balance) in the moisture desorption assay, indicating it retains moisture more effectively.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify a "test set" in the context of human subjects or a clinical study. The performance data presented (Consistency, pH, Moisture Desorption Assay) appears to be from laboratory testing of the product itself, not from a clinical trial involving human subjects.
Data Provenance: "According to GC Corporation R & D test methods." This indicates the tests were conducted internally by the manufacturer. No country of origin for data subjects or whether it was retrospective/prospective is applicable here, as no human data is presented.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The "ground truth" for the physical and performance tests was established by direct laboratory measurement and comparison to the predicate devices, not by expert consensus on clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication. The physical tests were direct measurements.

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 a medical product (moisturizing gel), not an AI-powered diagnostic or imaging device. Therefore, no MRMC study, human readers, or AI assistance is 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. The "standalone performance" of the gel is represented by the physical and moisture desorption tests.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the physical and performance characteristics was established through laboratory measurements and direct comparison to the physical properties of legally marketed predicate devices. For the "substantial equivalence" argument, the ultimate ground truth relied on the prior regulatory acceptance and safety profile of the predicate devices and their components.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a "training set." The product's formulation was developed based on understanding chemical properties and desired effects, likely through iterative laboratory development.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set in the AI sense, there's no ground truth establishment for it. The formulation development would have been driven by material science principles and performance targets.

Summary

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K101346

GC AMERICA INC 3737 WEST 127TH STREET AL SIP III INOIS 60803 TEL (708) 597-0900 FAX (708) 371-5103

JAN 2 7 2011

Section 6 - 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

1. Submitter Information: GC AMERICA INC.
  3737 W. 127" Street Alsip, IL 60803
  Contact Person: Mark Heiss, D.D.S. (708) 897-4042 Phone: (708) 897-4031 Fax:

May 7, 2010 Date Prepared:

1. Device Name: GC Oral Moisturizing Gel Proprietary Name: Saliva, Artificial Classification Name: Device Classification: Unclassified Produce Code: LFD
Predicate Devices: 3.

Company	Device	K Number
BioXtra Moisturizing Gel	Bio-X Healthcare S.A.	K072306
Oral Balance Liquid/Gel	Lacled, inc.	K061331

Description of Device: 4.

GC Oral Moisturizing Gel is substantially equivalent to BioXtra Moisturizing Gel and Oral Balance Liquid/Gel in its intended use. Both devices are artificial saliva agent designed for relief from dry mouth symptoms.

GC Oral Moisturizing Gel is designed to provide comfort for people suffering from dry mouth. It is recommended to be used for people who may experience difficulties in eating, speaking or are suffering from discomfort due to dry mouth.

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ડ. Indications for Use:

RX:

GC Oral Moisturizing Gel is designed to provide comfort for individuals suffering from dry mouth. It is recommended to be used for people who may experience difficulties in eating, speaking or are suffering from discomfort due to dry mouth.

OTC:

GC Oral Moisturizing Gel is indicated for the relief of dry mouth symptoms, to provide a protective coating inside the mouth, and help to control bad breath.

6. Technological characteristics:

This mode of action of the applicant devices is substantially equivalent to that of the predicate devices, BioXtra Moisturizing Gel and Oral Balance Liquid/Gel.

1. Summary of Physical tests:
  Summary of Performance Specification

	Consistency (mm)	pH
GC Oral Moisturizing Gel	32.5	7.2
BioXtra Moisturizing Gel	26.5	5.4
Oral Balance Gel	28.0	5.6

According to GC Corporation R & D test methods.

Moisture Desorption Assay

0.4g of products were placed on a weighing dish and weighed followed by incubation under the condition of humidity of 20% and a temperature of 37 degrees Celsius for 2 hours. A value obtained by dividing the weight change by the initial weight in terms of percentage was designated as moisture desorption degree. The results obtained are shown below.

GC Dry Mouth Gel: 6.9% Biotene Oral Balance: 10.1%

Description of Safety and Substantial Equivalence: 8.

The applicant device is substantially equivalent to the predicate devices in its intended use. Both devices are artificial saliva agent designed for relief from dry mouth symptoms.

All of the chemical components that constitute GC Oral Moisturizing Gel are previously used in the predicate devices which are legally marketed for the same indications and the same type of tissue contact. We believe that this fact well supports the compatibility of GC Oral Moisturizing Gel, and the safety of the applicant device is substantially equivalent to the predicate devices.

GC Oral Moisturizing gel is a wetting/moisturizing device.

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Section 9 - Specifications and Substantial Equivalence Comparison

Specifications and Substantial Equivalence Comparison

1. Device description and Intended Use

The applicant device, GC Oral Moisturizing Gel, is substantially equivalent to BioXtra Moisturizing Gel and Oral Balance Liquid/Gel in its intended use. Both devices are artificial saliva agent designed for relief from dry mouth symptoms.

2. Components and Mode of Action

GC Oral Moisturizing Gel contains polyglycerol) which, with other ingredients in the product, temporarily substitute the feel of natural saliva to moisturize, lubricate, and refresh the mouth.

This mode of action of the applicant devices is substantially equivalent to that of the predicate devices, BioXtra Moisturizing Gel and Oral Balance Liquid/Gel.

All of the chemical components that constitute GC Oral Moisturizing Gel are:

Chemical Formulation

Component	Weight %	Predicate devices in prior use
Polyglycerol (Diglycerol)	60
Pure Water	36	GC MI Paste Plus (K070854)
Sodium carboxymethylcellulose	2.5	GC MI Paste Plus (K070854)
Carrageenan*	1.5
Sodium Citrate	<0.5
Flavour	<0.5
Ethyl p-hydroxybenzoate	<0.1	GC MI Paste Plus (K070854)

GC Oral Molsturizing Gel

*Carrageenan is a thickening agent, CAS# 9000-07-1

Page 9.1 of 9.2

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Dr. Mark Heiss Director, Academic & Regulatory Affairs GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803

JAN 2 7 2011 -

Re: K101346 Trade/Device Name: GC Oral Moisturizing Gel Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: LFD Dated: December 8, 2010 Received: December 9, 2010

Dear Dr. Heiss:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- Dr. Heiss

Enclosure

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRI1's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

hr for

Anthony D. Watson, B.S., M.S., M.B.A. 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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Section 5 - Indications for Use Statement

Indications for Use

510(k) Number (if known):

Device Name: GC Oral Moisturizing Gel

Indications for Use:

RX:

OTC:

GC Oral Moisturizing Gel is indicated for the relief of dry mouth symptoms, to provide a protective coating inside the mouth.

Prescription Use X 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 Evaluation (ODE)

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

510(k) Number: R101346

Page 5.1 of 5.1

Regulation Number and Section

N/A