(280 days)
MucoPEG™ is indicated to relieve the symptoms and discomfort of dry mouth, refresh, moisturize/hydrate, clean, soothe oral irritation, and lubricate oral dryness.
MucoPEG™ is an artificial saliva to relieve xerostomia symptoms and discomfort. The main ingredient of MucoPEG™ is a polyethylene glycol (PEG) derivative. The additives to MucoPEG™ are mint (for flavor) and sodium bicarbonate (for pH maintenance when dissolved in water). MucoPEG™ is formulated as a powder and packaged in a single-use packet.
The provided text describes the regulatory clearance for a device called MucoPEG™. It does not contain information about a study that proves the device meets specific acceptance criteria in the context of AI/ML performance, human reader studies, or ground truth establishment. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance and biocompatibility.
Therefore, the following information cannot be extracted from the provided text:
- Table of acceptance criteria and reported device performance: The document presents a comparison table between the subject device (MucoPEG™) and a predicate device (Hydris™ Oral Rinse) in terms of regulatory information, ingredients, conditions of use, physical properties, and biocompatibility. It does not define explicit "acceptance criteria" for MucoPEG™ in the typical sense of a performance study with a target metric. Instead, it aims to show similarity or non-inferiority to the predicate.
- Sample size used for the test set and data provenance: No test set is described in the context of an AI/ML or reader study. The "test" mentioned refers to non-clinical performance testing and biocompatibility.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable as there is no mention of a test set with ground truth established by experts.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. There is no mention of an MRMC study or human reader improvement with AI assistance.
- Standalone (algorithm-only without human-in-the-loop performance) study: Not applicable. The device is an artificial saliva product, not an AI algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document highlights the following non-clinical performance data and criteria for demonstrating substantial equivalence:
Acceptance Criteria (Implicit from Substantial Equivalence Comparison) and Reported Device Performance
The device MucoPEG™ demonstrated substantial equivalence to the predicate device Hydris™ Oral Rinse based on the following comparisons:
| Attribute | Predicate Device (Hydris™ Oral Rinse) Performance / Characteristic | Subject Device (MucoPEG™) Performance / Characteristic | Similarity / Difference and "Acceptance" |
|---|---|---|---|
| Regulatory Information | |||
| Product Code | LFD | LFD | Same |
| Regulation | Pre-Amendment | Pre-Amendment | Same |
| Class | Unclassified | Unclassified | Same |
| Review Panel | Dental | Dental | Same |
| Intended Use | Temporary relief of xerostomia (i.e., dry mouth). | Temporary relief of xerostomia (i.e., dry mouth). | Same |
| Indications for Use | To relieve the symptoms and discomfort of dry mouth, refresh, moisturize/hydrate, clean, soothe oral irritation, and lubricate oral dryness. | To relieve the symptoms and discomfort of dry mouth, refresh, moisturize/hydrate, clean, soothe oral irritation, and lubricate oral dryness. | Same |
| Ingredients (Key for Mechanism) | |||
| Humectants/Moisturizers | Glycerin, Propylene Glycol (PG) | Polyethylene Glycol (PEG) Tetra Succinimidyl Glutarate | Similar. Both PEG and PG provide the same mechanical mechanism of action and are alkylene oxide by-products purified to USP grade. |
| Buffers | Disodium Phosphate, Sodium Phosphate | Sodium Bicarbonate | Similar. Both are GRAS, providing similar pH levels. |
| Conditions of Use | |||
| Area of Use | Oral cavity | Oral cavity | Same |
| Dosage Form | Oral rinse | Oral rinse | Same |
| Dosage (per use) | 20 mL (4 teaspoons) | 1g dissolved in 20 mL water. | Same |
| Applications/Day | Up to 2 times daily. | As often as needed. | Similar |
| Method of Use | Ready to use liquid. | Powder to be mixed with H2O prior to use. | Similar, both are in liquid form when used. |
| Environment of Use | Home | Home | Same |
| Prescription/OTC | OTC | Rx | Different (Rx for subject device to maintain prescribed storage conditions and integrity) |
| Physical Properties (Performance Testing) | |||
| Appearance | Viscous liquid, when applied | Viscous liquid, when applied | Same |
| pH | 5.91 | 7.29 | Similar. Both are near the pH of saliva (5.3 - 7.8). |
| Viscosity (Pa-s) | 0.0126 | 0.0019 | Similar. Not significantly different from saliva viscosity (0.0078 Pa-s). |
| Surface Tension (dyn/cm) | 30.24 | 49.28 | Similar. Not significantly different from saliva surface tension (58 dyn/cm). |
| Moisturization/Hydration of Cell | 12.0 ± 3.38% | 71.9 ± 47.26% | Similar. The difference was not statistically significant in protecting epithelial cells from dryness (p-value = 0.093). |
| Sterility | Non-Sterile | Non-Sterile | Similar. |
| Shelf-Life | 24 months | 18 months | Similar. Validated for 18 months. |
| Storage Condition | Not specified | -20 ± 5 °C (-4 ± 9°F) | Different (specific condition for subject device to maintain integrity). |
| Biocompatibility Testing | |||
| Biocompatibility | Conforms with ISO 10993-1 cytotoxicity, sensitization, irritation | Conforms with ISO 10993-1 cytotoxicity, sensitization, irritation | Same |
Summary of Relevant Information from the Document:
- Non-Clinical Performance Data: SunBio submitted the device for testing in accordance with ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation), and ISO 10993-10 (sensitization).
- Physical Properties Tests: Side-by-side comparative testing was performed against the predicate device for:
- Appearance
- pH
- Viscosity
- Surface Tension
- Moisturization/Hydration of cultured epithelial layer cells
The conclusion was that the device does not raise any new questions of safety and effectiveness when compared to the predicate device, leading to a determination of substantial equivalence.
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