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510(k) Data Aggregation
(353 days)
Dentilube Spray
Dentilube dry mouth spray is indicated for the symptomatic relief from the effects of chronic or temporary xerostomia (dry mouth), mouth discomfort, mouth odors and other oral symptoms associated with dry mouth.
Dentilube dry mouth spray is a viscous pink electrolyte-containing solution that is designed to mimic the compositions and actions of saliva to moisturize, and refresh the mouth. It provides a lubricating and moisturizing coating inside the mouth, thereby relieving symptoms of dry mouth. The product is supplied in 50mL or 100 mL PET bottles.
The provided text describes the acceptance criteria and performance data for the Dentilube dry mouth spray (K202689). The study is a non-clinical performance test to demonstrate substantial equivalence to a predicate device, not a comparative effectiveness study with human readers or a standalone algorithm performance study.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by demonstrating "similarity" or "sameness" to the predicate device, BioXtra® Moisturizing Gel (K072306), across various attributes and physical properties. The performance is reported against these comparative attributes.
| Attribute / Acceptance Criteria (Similarity to Predicate) | Reported Device Performance (Dentilube dry mouth spray) |
|---|---|
| Product | Dentilube dry mouth spray |
| Manufacturer | Oxy2plus, LLC |
| 510(K) # | K202689 |
| Product Code | LFD (Same as predicate) |
| Regulation | Pre-Amendment (Same as predicate) |
| Class | Unclassified (Same as predicate) |
| Review Panel | Dental (Same as predicate) |
| Indications for Use | Symptomatic relief from effects of chronic or temporary xerostomia (dry mouth), mouth discomfort, mouth odors, and other oral symptoms associated with dry mouth. (Same as predicate) |
| Mode of Action | Moisturizing and lubricating oral dryness (Same as predicate) |
| Dosage Form | Oral spray (Same as predicate) |
| Type of Product | Liquid solution (Same as predicate) |
| Area of Use | Oral cavity (Same as predicate) |
| Presentation Rx/OTC | Non-sterile OTC. (Predicate is Non-sterile Rx/OTC; subject device is OTC only) |
| Disease State | Xerostomia (Same as predicate) |
| Method of Use | Ready to use gel spray (Same as predicate) |
| Application per Day | As needed (Same as predicate) |
| Solvent | Purified water (Same as predicate) |
| Buffers | Dipotassium hydrogen phosphate, Potassium dihydrogen phosphate. (Similar to predicate's Potassium phosphate, dibasic & Sodium Chloride; both are GRAS and provide similar pH) |
| Humectants/Thickeners | Sodium carboxymethyl-cellulose. (Similar to predicate's Hydroxyethyl cellulose, Polyacrylic acid, Sodium polyacrylate, Hydrogenated starch hydrolysates (HSH); both are GRAS and provide similar viscosity/moisture-retaining quality) |
| Preservatives | Methyl P-hydroxybenzoate (Methylparaben). (Similar to predicate's Sodium methylparaben, Sodium propylparaben, Sodium benzoate, Potassium sorbate, Citric acid monohydrate, Lactoperoxidase; both are GRAS and used for maintaining/extending shelf life) |
| Colorant | FD&C Red 40 Dye (2%) (Predicate has None; colorant does not affect use) |
| Sweeteners | Sorbitol. (Similar to predicate's Sorbitol, Xylitol, Sodium Saccharin; both use sorbitol to balance solution and provide denser solution) |
| Electrolytes | Calcium chloride anhydrous, Magnesium Chloride anhydrous, Potassium Chloride, Sodium fluoride. (Similar to predicate's Calcium chloride dihydrate, Magnesium chloride hexahydrate, Potassium Chloride, Sodium monofluorophosphate; both contain electrolytes similar to natural saliva) |
| Environment of Use | Home and Clinic (Same as predicate) |
| Flavors | Lemon / Mint (Predicate is Mint; not considered a significant difference affecting intended use) |
| Appearance | Clear Viscous Liquid (Same as predicate) |
| Color | Reddish Pink (Predicate is Light Straw; different color does not affect use) |
| pH | 6.35 (Predicate is 6.82; similar, both near natural saliva pH 5.3-7.8) |
| Solubility | Water Soluble (Same as predicate) |
| Viscosity @25°C [RVT Spindle #5@10rpm] | 3500 cps (3.5 Pa-s) (Predicate is 2900 cps (2.9 Pa-s); similar, greater than natural saliva viscosity 0.0078 Pa-s) |
| Specific gravity (SPG) | 1.02 (Predicate is 1.05; similar, not significantly different from saliva SPG 1.000-1.010) |
| Sterility | Non-sterile (Same as predicate) |
| Shelf Life | 2 years (Same as predicate) |
| Biocompatibility | Conforms with ISO 10993-1 (cytotoxicity, sensitization, irritation) (Same as predicate) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not detail a specific "test set" in the context of a clinical study with human subjects. The performance testing described is primarily non-clinical performance testing (e.g., pH, viscosity, specific gravity, shelf-life, biocompatibility). It aims to demonstrate that the physical and chemical properties of the device are substantially equivalent to the predicate device. Therefore, a sample size for a clinical test set is not applicable here.
The data provenance is not specified beyond being generated by Oxy2plus, LLC for the purpose of this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not a study involving expert assessment of images or clinical outcomes. The "ground truth" for the non-clinical tests are standard physical and chemical measurements (e.g., pH meter readings, viscometer readings).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication process is described as this is a non-clinical, comparative assessment of product characteristics.
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
No. This document describes a medical device (dry mouth spray), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance tests:
- Physical Property Measurements: The ground truth for properties like pH, viscosity, specific gravity, and solubility are the direct measurements obtained through standard laboratory instruments and methods.
- Shelf-Life/Stability: Determined by degradation studies over time.
- Biocompatibility: Determined by adherence to ISO 10993 standards (e.g., cytotoxicity assays, sensitization studies, irritation tests).
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device.
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