(146 days)
- Provides symptom relief from Dry Mouth and low saliva including:
- Oral discomfort
- Mucosal soft tissue dryness
- Oral side effects of illness, therapies, and medications
- Soothes moistens and lubricates
- Hydrates soft tissue
MedActive Oral Gel and Spray are liquid delivery systems for ingredients that coat the inside of the mouth for a period of time and create relief from dry mouth symptoms in those who suffer oral malodor, discomfort, difficulties eating or speaking from dry mouth complications. They are applied by either a spray or gel to the user's mouth. MedActive Oral Gel and Spray are nonsterile ready to use devices to be used as needed or directed by a health care professional.
This document describes the premarket notification (510(k)) for MedActive Oral Gel and MedActive Oral Spray. This is a submission to demonstrate substantial equivalence to legally marketed predicate devices, not an AI/ML device, therefore much of the requested information (e.g. acceptance criteria, ground truth, sample size for training/test sets, expert qualifications, adjudication, MRMC studies) is not applicable.
Here's the available information relevant to product performance and testing:
1. A table of acceptance criteria and the reported device performance:
| Test | Acceptance Criteria (Implied by Comparison) | Reported Device Performance |
|---|---|---|
| Desorption Testing | MedActive products perform similar to predicate devices (Biotene Spray, GC Gel) in terms of moisture desorption. | Mean Percent Loss: |
- Biotene Spray (U4E291): 38.1%, 35.0%
- GC Gel (040109M): 17.4%, 13.9%
- MedActive Spray (4077): 56.9%, 57.8%
- MedActive Gel (2661015): 34.3%, 33.5%
(The document states "result of the desorption testing shows that MedActive Oral Relief Gel and MedActive Oral Relief Spray perform similar to the predicate devices." While the numerical values show differences (e.g., MedActive Spray has higher % loss than predicate Biotene Spray, and MedActive Gel is similar to Biotene but higher than GC Gel), the conclusion drawn is similarity.) |
| Rheology Testing | MedActive products exhibit viscosity and rheological behavior equivalent to predicate devices. | "The results of the rheological evaluation demonstrate the MedActive Oral Relief Gel and Spray exhibits viscosity and rheological behavior in equivalence to the predicate devices." |
| Shelf Life Testing | MedActive products maintain form and function for a specified shelf life. | "The results of these rheology and desorption tests show that MedActive Oral Relief Gel and Spray exhibit similar form and function after three years of real time aging and result in a three year shelf life." |
| Biocompatibility Testing | Results in accordance with ISO 10993 (for limited exposure mucosal membrane devices). | "The results from Acute Toxicity, Oral, Eye, and skin Irritation testing show biocompatibility results in accordance with ISO 10993." (Note: This was completed for MedActive Oral Gel, though not required for this device type). |
| pH Testing | MedActive products perform similar to predicate devices in terms of pH. | pH Results: - MedActive Spray: 5.78, 5.76 (Predicate Biotene Moisturizing Mouth Spray: 6.2-7.1)
- MedActive Gel: 5.35, 5.36 (Predicate GC Moisturizing Gel: 7.2; Predicate Laclede Oral Balance Liquid/Gel: 5.6)
(The document states "the results of the pH testing shows that MedActive Oral Relief Gel and MedActive Oral Relief Spray perform similar to the predicate devices," while also noting that MedActive products have a "slightly more acidic pH than some predicate devices" due to preservatives.) |
2. Sample sized used for the test set and the data provenance:
- Desorption Testing: 2 samples of each product (MedActive Spray, MedActive Gel, Biotene Spray, GC Gel) were used. The provenance is not specified beyond being laboratory testing performed by the submitter.
- Rheology Testing: Not specified.
- Shelf Life Testing: Not specified for the initial tests, but "three years of real time aging" for the duration component.
- Biocompatibility Testing: Not specified.
- pH Testing: 2 samples of each Medactive product (VM 4077-1, VM 4077-2 for spray; OC266-1, OC266-2 for gel) were tested. The provenance is not specified beyond being laboratory testing performed by the submitter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a 510(k) submission for a non-AI/ML medical device based on physical and chemical equivalence to predicate devices, not requiring expert-labeled ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not 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:
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable in the typical sense for AI/ML devices. The "ground truth" for this 510(k) submission is the performance parameters (desorption, rheology, pH, etc.) of the legally marketed predicate devices, against which the applicant's device is compared. The intended use and technological characteristics are also deemed "ground truth" for comparison purposes.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable.
N/A