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.

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.

AI/ML Overview

This document describes the 510(k) premarket notification for three dry mouth products: G•U•M® HYDRAL™ Dry Mouth Oral Gel, Oral Rinse, and Oral Spray. The main focus is on establishing substantial equivalence to a predicate device (Biotene® Oral Balance® Dry Mouth Moisturizing Gel and associated rinse/spray, K123731).

Here's an analysis of the acceptance criteria and supporting study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the goal of demonstrating substantial equivalence to the predicate device, particularly in terms of technological characteristics and intended use. The performance reported is primarily a comparison against the predicate device's characteristics.

Parameter	Acceptance Criteria (based on Predicate)	G•U•M® HYDRAL™ Performance (Reported)
Gel
Appearance	clear, transparent gel	Clear, translucent gel
Color	clear, colorless	Colorless to Pale Yellow
Odor	odorless	slight mint odor
pH	5.5 to 7.0	5.5 to 7.0
Viscosity	146,600 cps	120,000 cps
Specific Gravity	1.18	1.11
Rinse
Appearance	clear, transparent liquid	clear, transparent liquid
Color	clear, colorless	clear, colorless
Odor	spearmint odor	slight mint odor
pH	5.5 to 7.0	5.5 to 7.0
Viscosity	10.26 Sct	20.39 Sct
Specific Gravity	1.08	1.06
Spray
Appearance	clear, transparent liquid	clear, transparent liquid
Color	clear, colorless	clear, colorless
Odor	spearmint odor	slight mint odor
pH	5.5 to 7.0	5.5 to 7.0
Specific Gravity	1.10	1.06
Intended Use	Relieve and manage symptoms of dry mouth	Same as predicate, relieve and manage symptoms of dry mouth
Fundamental Technology	Same as predicate (artificial saliva)	Same as predicate
Mode of Action	Substantially equivalent to predicate	Substantially equivalent to predicate
Formulation (general)	Water, humectants/moisturizers, sweeteners, flavors, preservatives	Contains similar categories of ingredients
Design & Packaging	Similar to predicate	Similar to predicate
Biocompatibility	Conforms to 10993-1 (predicate standard)	Conforms to 10993-1
Shelf-life Stability	Demonstrated (predicate would have this)	Stability Report included

Study Proving Acceptance Criteria:

The document states that "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."

This bench testing, along with a shelf-life stability report and biocompatibility testing, forms the basis for the substantial equivalence determination. The variations in formulation and characteristics like color, odor, and viscosity were assessed and deemed not to "affect the functions or equivalency of the proposed products," being primarily related to viscosity control and flavor. New components were identified as GRAS ingredients, food additives, or having a significant history of use.

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

The document does not explicitly state the sample size used for the bench testing. It only mentions "Bench testing comparing predicate and proposed devices' technological characteristics was performed." There is no information regarding data provenance (e.g., country of origin, retrospective/prospective).

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

This information is not provided in the document. For these types of devices (artificial saliva), "ground truth" typically relates to chemical and physical property measurements rather than expert clinical assessment of individual cases for the purpose of demonstrating substantial equivalence based on technological characteristics.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the bench testing described (measurement of physical and chemical parameters), an adjudication method in the typical sense (e.g., for clinical diagnoses) would not be applicable.

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

There was no MRMC comparative effectiveness study done. This document concerns a medical device that is a topical oral product (artificial saliva), not an AI-powered diagnostic or imaging device used by human readers.

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

There was no standalone (algorithm-only) performance study done. This product is not an algorithm or AI.

7. The Type of Ground Truth Used

For the technological characteristics, the "ground truth" implicitly refers to standardized physical and chemical measurement methods and specifications. For ingredients, it refers to chemical composition and regulatory status (e.g., GRAS, food additive, history of use). For biocompatibility, the ground truth is conformance with ISO 10993-1 standards.

8. The Sample Size for the Training Set

There is no training set in the context of this device. A training set is typically relevant for machine learning or AI models, which this device is not. The "study" here is a set of bench tests and validations of the product's physical, chemical, and biological properties.

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

As there is no training set for this type of device, this question is not applicable.

Summary

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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.

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K181134

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

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Indications for Use

510(k) Number (if known)

K181134

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

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.

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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

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:

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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.

K181134

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.

Regulation Number and Section

N/A