(74 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of the oral gel, rinse, and spray, with no mention of AI or ML.
Yes
The device is described as relieving symptoms of dry mouth, soothing oral tissue, and lubricating oral dryness, which are therapeutic claims.
No
The device is an artificial saliva product intended to relieve the symptoms of dry mouth, not to diagnose a condition.
No
The device description clearly indicates the product is a gel, rinse, and spray, which are physical formulations, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to soothe oral tissue, relieve dry mouth symptoms, refresh, moisturize, clean, soothe oral irritation, and lubricate oral dryness. This is a therapeutic and symptomatic relief purpose, not a diagnostic one.
- Device Description: The device is described as artificial saliva with lubricating, moisturizing, and refreshing properties. It is applied directly to the oral tissue.
- Lack of Diagnostic Function: There is no mention of the device being used to test a sample (like blood, urine, or saliva) to diagnose a disease or condition. It does not analyze biological samples for diagnostic purposes.
- Anatomical Site: The device is applied to the oral tissue, which is the site of the symptoms, not a sample being tested.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
G+U•M® HYDRAL™ Dry Mouth Oral Gel helps soothe oral tissue and relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness.
G+U•M® HYDRAL™ Dry Mouth Oral Rinse helps soothe oral tissue and relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness.
G-U·M® HYDRAL™ Dry Mouth Oral Spray helps soothe oral tissue and relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness.
Product codes
LFD
Device Description
G+U•M® HYDRAL™ Dry Mouth Oral Gel, G•U•M® HYDRAL™ Dry Mouth Oral Rinse and G•U•M® HYDRAL™ Dry Mouth Oral Spray are specifically formulated artificial saliva with a pH between 5.00 to 7.00. The proposed device is formulated with water, moisturizers /humectants including one plant-based moisture rich humectant, sweeteners and flavors that collectively have lubricating, soothing, and humectant, sweeteners and flavors that collectively have lubricating, moisturizing, and refreshing properties to help relieve and manage the symptoms of dry mouth.
The device is provided in a realy to use at home. G-U-M- HYDRAL" " Dry Mouth Oral Gel is supplied in a 1.5-oune Polyethylene Laminate tube. G-U-M " Hrise is spay i.69 fluid ounce bottle. Both rinse and spray are packaged in Polyethylene Terephthalate (PET) bottles with white polypropylene caps.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home / Over-The-Counter Use
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)
The following nonclinical data are included in the submission in substantial equivalence determination:
- 0 Bench testing comparing predicate and proposed devices' technological characteristics was performed. It was demonstrated that predicate and proposed devices are not significantly different from each other in terms of technological characteristics.
- Shelf life Stability Report
- Biocompatibility testing in conformance with 10993-1.
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
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is a symbol with three stylized human figures. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. The logos are placed side by side.
July 13, 2018
Sunstar Americas Inc Ms. Liz Bastian Regulatory Affairs Manager 301 E. Central Road Schaumburg, Illinois 60195
Re: K181134
Trade/Device Name: GUM HYDRAL Dry Mouth Oral Gel, GUM HYDRAL Dry Mouth Oral Rinse, GUM HYDRAL Dry Mouth Oral Spray
Regulatory Class: Unclassified Product Code: LFD Dated: April 27, 2018 Received: April 30, 2018
Dear Liz Bastian:
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.
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mary S. Runner -S
forTina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name G•U•M® HYDRAL™ Dry Mouth Oral Gel G•U•M® HYDRAL™ Dry Mouth Oral Rinse G.U.M® HYDRAL™ Dry Mouth Oral Spray
Indications for Use (Describe)
G+U•M® HYDRAL™ Dry Mouth Oral Gel helps soothe oral tissue and relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness.
G+U•M® HYDRAL™ Dry Mouth Oral Rinse helps soothe oral tissue and relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness.
G-U·M® HYDRAL™ Dry Mouth Oral Spray helps soothe oral tissue and relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020 See PRA Statement below.
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510(k) Summary
| Manufacturer Name: | Sunstar Americas, Inc. |
|---|---|
| Address: | 301 E. Central Rd. |
| Schaumburg, IL | |
| Contact Name: | Liz Bastian |
| Title: | Regulatory Affairs Manager |
| Phone Number: | 847 794 4231 |
| Date Prepared: | July 12, 2018 |
| Device Proprietary Name: | G•U•M® HYDRAL™ Dry Mouth Oral Gel, G•U•M® HYDRAL™ Dry Mouth Oral Rinse G•U•M® HYDRAL™ Dry Mouth Oral Spray |
| Common or Usual Name: | Artificial Saliva |
| Classification Name: | Saliva, Artificial |
| Classification Code: | LFD |
| Regulation Number: | Unclassified |
Predicate Device:
Biotene® Oral Balance® Dry Mouth Moisturizing Gel and Biotene Dry Mouth Oral Rinse and Biotene Dry Mouth Spray, K123731.
Dental Devices Panel
Unclassified
Description of the Device
Device Classification
Review Panel
G+U•M® HYDRAL™ Dry Mouth Oral Gel, G•U•M® HYDRAL™ Dry Mouth Oral Rinse and G•U•M® HYDRAL™ Dry Mouth Oral Spray are specifically formulated artificial saliva with a pH between 5.00 to 7.00. The proposed device is formulated with water, moisturizers /humectants including one plant-based moisture rich humectant, sweeteners and flavors that collectively have lubricating, soothing, and humectant, sweeteners and flavors that collectively have lubricating, moisturizing, and refreshing properties to help relieve and manage the symptoms of dry mouth.
The device is provided in a realy to use at home. G-U-M- HYDRAL" " Dry Mouth Oral Gel is
supplied in a 1.5-oune Polyethylene Laminate tube. G-U-M " Hrise is spay i.69 fluid ounce bottle. Both rinse and spray are packaged in Polyethylene Terephthalate (PET) bottles with white polypropylene caps.
4
G•U•M® HYDRAL™ Dry Mouth Oral Gel G•U•M® HYDRAL™ Dry Mouth Oral Rinse G•U•M® HYDRAL™ Dry Mouth Oral Spray
Intended Use/Indications for Use
G+U•M® HYDRAL™ Dry Mouth Oral Gel helps soothe oral tissue and relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness.
G•U•M® HYDRAL™ Dry Mouth Oral Rinse helps soothe oral tissue and relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness.
G.U.M® HYDRAL™ Dry Mouth Oral Spray helps soothe oral tissue and relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness
Indications for Use Discussion
The intended use statements of the GrUpM® HYDRAL™ Dry Mouth Oral Gel, G-U•M® HYDRAL™ Dry Mouth Oral Rinse and G+U•M® HYDRAL™ Dry Mouth Oral Spray are the same as the predicate devices; hence there are no differences in the intended therapeutic use of the device, both the subject and predicate devices are intended to relieve and manage symptoms of dry mouth.
Technological Characteristics
G+U•M® HYDRAL™ Dry Mouth Oral Gel, G•U•M® HYDRAL™ Dry Mouth Oral Rinse and G•U•M® HYDRAL™ Dry Mouth Oral Spray are intended for over the counter use and are provided ready to use. The predicate and the proposed devices use the same fundamental technology. The mode of action of G-J-M® HYDRAL™ Dry Mouth Oral Gel, G-U·M® HYDRAL™ Dry Mouth Oral Rinse and G+U•M® HYDRAL™ Dry Mouth Oral Spray are substantially equivalent to that of the predicate devices (Biotene®) Oral Balance® Dry Mouth Moisturizing Gel and Biotene Dry Mouth Oral Rinse and Biotene Dry Mouth Spray, K123731).
Both the proposed and predicate devices contain ingredients such as water, humectants/moisturizers, sweeteners, flavors and preservatives. The proposed and predicate devices are also similar in design and packaging. Below is a summary of the technological characteristics compared to the primary predicate device:
5
Sunstar Americas, Inc. K181134
G-U-M® HYDRAL™ Dry Mouth Oral Gel,
G+U-M® HYDRAL™ Dry Mouth Oral Rinse,
G+U+M® HYDRAL™ Dry Mouth Oral Spray
Table 1: Comparison of Technological Characteristics
| Parameter | G•U•M® HYDRAL™ | Biotene® K123731 |
|---|---|---|
| Gel | ||
| Appearance | Clear, translucent gel | clear, transparent gel |
| Color | Colorless to Pale Yellow | clear, colorless |
| Odor | slight mint odor | odorless |
| pH | 5.5 to 7.0 | 5.5 to 7.0 |
| Viscosity | 120,000 cps | 146,600 cps |
| Specific Gravity | 1.11 | 1.18 |
| Rinse | ||
| Appearance | clear, transparent liquid | clear, transparent liquid |
| Color | clear, colorless | clear, colorless |
| Odor | slight mint odor | spearmint odor |
| pH | 5.5 to 7.0 | 5.5 to 7.0 |
| Viscosity | 20.39 Sct | 10.26 Sct |
| Specific Gravity | 1.06 | 1.08 |
| Spray | ||
| Appearance | clear, transparent liquid | clear, transparent liquid |
| Color | clear, colorless | clear, colorless |
| Odor | slight mint odor | spearmint odor |
| pH | 5.5 to 7.0 | 5.5 to 7.0 |
| Specific Gravity | 1.06 | 1.10 |
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Sunstar Americas, Inc.
Discussion of differences
G•U•M® HYDRAL Dry Mouth Oral Gel G•U•M® HYDRAL Dry Mouth Oral Rinse G•U•M® HYDRAL Dry Mouth Oral Spray
The formulations for the submission devices differ from those of the predicate device; however, many of the submission device components have been cleared for use in previously FDA cleared devices with the same or highly similar indications for use.
The variations in the formula / composition do not affect the functions or equivalency of the proposed products, they are primarily related to viscosity control and flavor. In summary, these differences in formulation to the predicate devices do not alter the functions, or substantial equivalency of the products. Any new components/ingredients are designated as GRAS ingredients, food additives or have a significant history of use in dental and medical or food applications. All components of the product have been manufactured and tested using standardized and industry accepted state of the art production/test methods. The finished products have been tested using standardized and industry accepted test methods. Additionally, we commissioned a Biological Risk Assessment of the ingredients performed by NAMSA and the results do not raise any safety questions. The report begins on page 431 and ends on page 464.
Performance Data
The following nonclinical data are included in the submission in substantial equivalence determination:
- 0 Bench testing comparing predicate and proposed devices' technological characteristics was performed. It was demonstrated that predicate and proposed devices are not significantly different from each other in terms of technological characteristics.
- Shelf life Stability Report
- Biocompatibility testing in conformance with 10993-1.
Conclusion
Based upon the similarity of the intended use and fundamental technology, together with non-performance testing, GUM Hydral is substantially equivalent to K123731.