(17 days)
(OTC): Neutrasal® is indicated for the dryness of the mouth (hyposalivation, xerostomia)
(OTC): Neutrasal® is also indicated for dryness of the oral mucosa due to drugs such as antihistamines or atropine or other anticholinergic agents that suppress salivary secretion.
(OTC): Neutrasal® may be used as part of an oral hygiene program for patients with dry mouth. Neutrasal® also provides intensive hygiene of the oral cavity.
(Rx): Neutrasal® is also indicated as an adjunct to standard oral care in relieving the discomfort associated with oral mucositis that may be caused by radiation or high dose chemotherapy. Relief of dryness of the oral mucosa in these conditions is associated with amelioration of pain.
(Rx): Neutrasal® may be used for relief of dryness of the oral mucosa when hyposalivation results from the following: surgery, radiotherapy near the salivary glands, chemotherapy, infection or dysfunction of the salivary glands; fever; emotional factors such as fear or anxiety; obstruction of the salivary ducts; Sjögren's syndrome
Neutrasal® is a powder that when dissolved in normal tap water becomes a supersaturated calcium and phosphate rinse. Neutrasal® was designed in part to replace the normal ionic and pH balance in the oral cavity. Neutrasal® also maintains moistness in the oral cavity. It relieves diffuse dryness and fissuring of the oral mucosa, as well as painful tongue conditions due to hyposalivation.
Neutrasal® facilitates chewing and speaking; loosens tough mucus; prevents mucous membranes from sticking together; and improves adherence of dentures.
Additionally, Neutrasal® can be used as an adjunct to standard oral care for relieving the discomfort associated with oral mucositis that may be caused by high dose chemotherapy or radiation. Relief of dryness of the oral mucosa in these conditions is associated with an amelioration of pain.
Neutrasal® is a comprised of calcium chloride, sodium phosphate and sodium bicarbonate plus inactive ingredients. When Neutrasal® is dissolved in normal tap water, the water becomes supersaturated with both calcium and phosphate ions.
Silica gel, an inactive ingredient in Neutrasal, is an amorphous silica that is recommended for free-flow and anti-caking for hydrogscopic food powders, industrial powders and other applications (pharmaceuticals) where humidity must be kept to a minimum.
This document is a 510(k) summary for the medical device Neutrasal®, a powder for supersaturated calcium phosphate rinse. It does not include information about a study proving the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
Therefore, many of the requested categories of information are not applicable or cannot be extracted from this document, as they pertain to a performance study that was not conducted or reported for this submission.
Here's a breakdown based on the provided text, indicating where information is present and where it is not:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from predicate) | Reported Device Performance (Neutrasal®) |
|---|---|
| - pH | Bench Testing Performed: |
| - Dissolution Tests | - pH |
| - Activity Testing of Supersaturated State | - Dissolution Tests |
| - Content Testing of Active Ingredients | - Activity Testing of Supersaturated State |
| - Biocompatibility (identical to predicate) | - Content Testing of Active Ingredients |
| - GRAS Listing of Ingredients | - Biocompatibility: "identical to the 510(k)-approved product predicate product Neutrasal." |
| - GRAS Listing: "All ingredients contained in Neutrasal® are EAFUS approved food additives labeled as GRAS." |
- Note: The document states that the performance testing "included the assessment of the physical properties of Neutrasal® and its ability to achieve its intended use." The listed bench tests (pH, dissolution, activity, content) were performed. However, specific numerical acceptance criteria for these properties are not explicitly stated in the document, nor are the specific numerical results of these tests reported. The implicit acceptance criterion is that these properties are equivalent to the predicate device, which is implied by the "Substantial Equivalence Conclusion."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No clinical test set data is provided in this submission for substantial equivalence. The "test set" here refers to the physical properties tested in bench studies.
- Data Provenance: Bench testing was completed by Scientech Laboratories, Inc., an FDA-approved analytical laboratory testing service, as well as internal testing. No country of origin for data is specified beyond the laboratory location. The nature of these tests makes them "prospective" in the sense that they were conducted for this submission, but not on human subjects.
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 device is not an AI/diagnostic device that relies on expert interpretation of images or clinical data. Ground truth in this context refers to the chemical and physical properties of the formulation, established through laboratory testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are typically for clinical study endpoints or diagnostic interpretations, neither of which are present in this submission.
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 is a medical device (oral rinse), not an AI-assisted diagnostic tool. An MRMC study is completely irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the device's performance relies on objective laboratory measurements of its physical and chemical properties (pH, dissolution, supersaturated state activity, content of active ingredients) and established regulatory frameworks for ingredient safety (GRAS listing) and manufacturing (cGMP). The ground truth for biocompatibility is its identity to a previously approved predicate device.
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
N/A