(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

Device Description

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.

AI/ML Overview

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.

Summary

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5. 510(k) Summary K093642

A. From:	Edward Kobus	(Owner)	DEC 11 2009
	25 Ravenna Drive
	Pomona, NY 10970
	Invado Pharmaceuticals
	914-715-6232
	ekobus@invadopharma.com
Trade Name:	Neutrasal®

Powder for Supersaturated Calcium Phosphate Rinse Common Name:

Classification Names: Saliva, Artificial

B. Regulatory Information:

Unclassified Device Class:

LFD Product Code:

K030802, K991938 C. Predicates:

Caphosol ®, Artificial Saliva

Product Code: LFD

K091718

Neutrasal

Product Code" LFD

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D. Device Description:

Neutrasal® facilitates chewing and speaking; loosens tough mucus; prevents mucous membranes from sticking together; and improves adherence of dentures.

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Product	Method ofUse	Applicationsper day	Type ofProduct	Presentation
Neutrasal®	DissolvePowder inWater	2-10 asdirected byphysician andindication	ElectrolyteSolution	Non-Sterile

E. Indications for Use:

(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.

F. Manufacturing

Neutrasal® will be manufactured according to product specifications and under the guidelines of current Good Manufacturing Practices (cGMP). Risk analysis has been performed to identify possible failure mode during manufacturing. Manufacturing controls have been developed

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and implement to address the identified risks factors based on the criticality of failure mode. All established GMPs will assure that device manufactured meets all established specifications prior to release and is safe and effective for its intended use.

G. Summary of Non-Clinical Testing: Performance

The Performance Testing of Neutrasal® included the assessment of the physical properties of Neutrasal® and its ability to achieve its intended use. Bench testing was completed by Scientech Laboratories, Inc., an FDA-approved analytical laboratory testing service as well internal testing done. The following bench tests were performed:

. pH
Dissolution Tests .
Activity Testing of Supersaturated State .
Content Testing of Active Ingredients .

H. Biocompatibility testing

Neutrasal® is identical to the 510(k)-approved product predicate product Neutrasal.

I. GRAS Listing of Ingredients

The EAFUS list of substances contains ingredients added directly to food or medications that FDA has either approved as food additives or listed or affirmed as GRAS (generally recognized as safe). All ingredients contained in Neutrasal® are EAFUS approved food additives labeled as GRAS. Only USP-approved chemicals, with validation, will be used during the manufacturing of Neutrasal®.

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Other Information J.

Effervescence has proved it utility as an oral drug delivery system that offers advantages to other forms of drug delivery. Neutrasal® offers more portability because it is more easily transported than liquid medication because no water is added until the product is ready to use. Additionally, Neutrasal® offers improved penetration in to the oral mucosa because of the effervescent formulation enhancement of sodium bicarbonate.

K. Substantial Equivalence Conclusion

The indications of use, technological properties, performance testing for Neutrasal® (Powder for supersaturated calcium phosphate rinse) are identical to Neutrasal (supersaturated calcium phosphate rinse). They both share the same labeling and intended uses.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

020 1 1 2009

Mr. Edward D. Kobus President Invado Pharmaceuticals 25 Ravenna Drive Pomona, New York 10970

Re: K093642

Trade/Device Name: Neutrasal® Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: LFD Dated: November 19, 2009 Received: November 24, 2009

Dear Mr. Kobus:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2- Mr. Kobus

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/ CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/Reporta Problem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

fir

Anthony D. Watson, BS, MS, MBA Director Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. Indications for Use

K093642 510(k) Number (if known):

Device Name:

Neutrasal® Supersaturated Calcium Phosphate Oral Rinse

Indications for Use:

(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 treating the 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.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

RoBetz DDS for Dr. KP. Medley (Acting)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control D

510(k) Number: K093642

Regulation Number and Section

N/A