(74 days)
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.
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.
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.
N/A