(259 days)
Not Found
No
The summary describes a gel for dry mouth relief and does not mention any AI or ML components or functionalities.
Yes.
The device is intended to provide comfort for individuals suffering from dry mouth, relieve dry mouth symptoms, and provide a protective coating inside the mouth, which are therapeutic benefits.
No
Explanation: The "Intended Use / Indications for Use" section clearly states that GC Oral Moisturizing Gel is "designed to provide comfort for individuals suffering from dry mouth" and "is indicated for the relief of dry mouth symptoms". This product is a comfort/relief product, not one that measures, analyzes, or diagnoses a condition.
No
The device description clearly indicates it is a gel product with physical ingredients, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the gel is designed to provide comfort and relief for dry mouth symptoms. This is a therapeutic or palliative use, not a diagnostic one.
- Device Description: The description focuses on the ingredients and how they function to moisturize and lubricate the mouth, mimicking saliva. It does not describe any components or processes used to analyze biological samples for diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting specific markers, diseases, or conditions through in vitro testing.
- Performance Studies: The performance studies described are physical tests (consistency, pH, moisture desorption) and comparisons to predicate devices with similar intended uses. These are not diagnostic performance studies (like sensitivity, specificity, etc., in a diagnostic context).
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This oral moisturizing gel does not fit that description.
N/A
Intended Use / 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.
Product codes
LFD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Summary of Physical tests:
Consistency and pH of GC Oral Moisturizing Gel, BioXtra Moisturizing Gel, and Oral Balance Gel were measured.
GC Oral Moisturizing Gel: Consistency (mm) 32.5, pH 7.2
BioXtra Moisturizing Gel: Consistency (mm) 26.5, pH 5.4
Oral Balance Gel: Consistency (mm) 28.0, pH 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.
GC Dry Mouth Gel: 6.9%
Biotene Oral Balance: 10.1%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
CC
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.
-
- 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:
- Submitter Information: GC AMERICA INC.
May 7, 2010 Date Prepared:
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- 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 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.
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.
1
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:
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.
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.
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- Summary of Physical tests:
Summary of Performance Specification
- Summary of Physical tests:
| 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.
2
Section 9 - Specifications and Substantial Equivalence Comparison
Specifications and Substantial Equivalence Comparison
1. Device description and Intended Use
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 morth,
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 |