Search Results

A pleasant tasting solution that diminishes dry mouth discomfort, mouth odors and other symptoms of a dry mouth. MouthKote has the same intended use/indications as the predicate devices:

Laclede Inc. Oral Balance
Laboratoires Carilene TGO Spray
Inpharma AB Caphasol
Gebauer Company Salivart
Sinclair Pharmaceuticals Salinum/Oraclair

Relieves dry mouth conditions

MouthKote is an artificial saliva substitute which contains moisturizers. polysaccharides and flavones that have lubricating and moistening properties. It contains patented Yerba Santa extract which has a FDA GRAS number and FEMA number. Products are supplied in 5ml tube, 2 fluid oz. and 8 fluid oz. bottles.

This K062653 510(k) summary is for the MouthKote Oral Moisturizer, an artificial saliva substitute intended to relieve dry mouth conditions.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific quantitative acceptance criteria or detailed reported device performance metrics in the way one typically sees for diagnostic devices (e.g., sensitivity, specificity, AUC).

Instead, the submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. The "acceptance criteria" can be inferred as successfully demonstrating that MouthKote is as safe and effective as the predicates for its intended use.

The "reported device performance" is a general statement about its safety and effectiveness without specific metrics.

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

The document does not provide information on a specific "test set" sample size or data provenance (e.g., country of origin, retrospective/prospective). This is because the submission primarily relies on demonstrating substantial equivalence to predicates based on technological characteristics and intended use, rather than presenting a de novo clinical trial with a traditional "test set" and performance metrics.

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

This information is not applicable and not provided in the document. As explained above, a traditional "test set" requiring expert ground truth establishment for diagnostic performance evaluation was not central to this 510(k) submission.

4. Adjudication Method for the Test Set

This information is not applicable and not provided for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

An MRMC comparative effectiveness study was not mentioned or indicated in the provided 510(k) summary. This type of study is more common for diagnostic imaging AI devices where human reader performance is a key metric.

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

This concept is not applicable to MouthKote as it is a direct-use medical device (an artificial saliva substitute), not an algorithm or diagnostic software.

7. The Type of Ground Truth Used

The concept of "ground truth" (e.g., expert consensus, pathology, outcomes data) is not directly applicable in the context of this 510(k) submission. The "truth" in this case is the established safety and effectiveness of the predicate devices, to which MouthKote is compared for substantial equivalence. The submission does not detail any de novo clinical studies with specific ground truth data for MouthKote itself.

8. The Sample Size for the Training Set

This information is not applicable and not provided. MouthKote is a chemical formulation, not an AI/ML algorithm that requires a training set.

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

This information is not applicable and not provided for the same reasons as point 8.

Study that Proves the Device Meets Acceptance Criteria:

While the document states, "The Mouthkote formulation has been shown to be safe and effective for its intended over-the-counter use," it does not describe a specific study, clinical trial, or scientific data in this 510(k) summary that proves this statement.

Instead, the primary "study" or justification for meeting the "acceptance criteria" (defined as substantial equivalence) is the comparison of MouthKote's characteristics to five predicate devices as detailed in the "Summary of Technological Characteristics of the Device compared to the Predicate Devices" table. The FDA's issuance of the 510(k) clearance letter (K062653) signifies that they have reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices, thereby establishing its presumed safety and effectiveness for its intended use without the need for new clinical data explicitly presented in this summary.

Ask a specific question about this device