(84 days)
MuGard™ Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces.
MuGard™ Mucoadhesive Oral Wound Rinse is a viscous liquid supplied in plastic bottles and is designed for the management of oral mucositis/stomatitis and other oral wounds. When swirled gently round the mouth, the mucoadhesive formulation results in the formation of a protective coating over the oral mucosa.
This document describes a 510(k) premarket notification for the MuGard™ Mucoadhesive Oral Wound Rinse.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria in terms of device performance metrics (e.g., specific reduction in pain score, healing time). Instead, the acceptance criteria are met by demonstrating substantial equivalence to predicate devices through:
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Functional Equivalence | Similar function and intended use to predicate devices. |
| Mode of Action | Achieves action (protective layer formation) in the same manner as predicate devices. |
| Compositional Similarity | Similar mixture of film-forming polymers, pharmaceutical aids, preservatives, and sweeteners/flavors to predicate devices. |
| Biocompatibility | Established through ISO 10993 testing (in vitro cytotoxicity, sensitization in guinea pigs, mucosal irritation in rabbits). |
| Safety and Effectiveness | Concluded to be safe and effective for its intended use and performs equivalently to identified legally marketed predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a specific clinical study with a test set of human subjects to quantify performance metrics. The safety of the device was established through biocompatibility testing, which typically involves laboratory animal studies (guinea pigs, rabbits) and in vitro tests. No information on human test subjects or data provenance (country, retrospective/prospective) is provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Since no clinical study with human subjects or a test set is described for performance evaluation, this information is not applicable. The device's safety was assessed through standard biocompatibility tests, not by expert interpretation of clinical outcomes for ground truth.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set requiring adjudication is described.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned. The submission focuses on demonstrating substantial equivalence to predicate devices rather than a comparative study against human readers or other treatments.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This device is a medical product (oral rinse), not an algorithm or AI system.
7. Type of Ground Truth Used:
The "ground truth" for the device's acceptable performance is established through:
- Demonstration of substantial equivalence to legally marketed predicate devices.
- Biocompatibility testing results (e.g., negative for cytotoxicity, sensitization, and mucosal irritation).
8. Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
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