(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.

Syloid, 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

The provided text describes a medical device, Neutrasal®, and its clearance based on substantial equivalence to a predicate device, Caphosol®. The document is a 510(k) summary submitted to the FDA.

However, the information provided does not contain acceptance criteria for a device algorithm, nor does it detail a study that proves the device meets specific performance acceptance criteria in the way typically expected for an AI/ML medical device. This is because Neutrasal® is a pharmaceutical product (a powder for an oral rinse) and not a software algorithm or AI device.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, MRMC study, standalone performance, training set size) are not applicable to the non-AI product described.

Here's an attempt to answer the questions based on the closest available information, acknowledging the limitations:

1. Table of Acceptance Criteria and the Reported Device Performance

This product is a pharmaceutical formulation, not an algorithm. Therefore, "acceptance criteria" for an algorithm's performance are not defined or reported. The "performance" assessment focuses on physical and chemical properties and achieving the intended use through bench testing.

Acceptance Criterion (Proxy for Performance)	Reported Device Performance
Physical Properties	Bench testing performed
- pH	Bench testing performed
- Dissolution	Bench testing performed
- Activity Testing (Supersaturated State)	Bench testing performed
- Content Testing (Active Ingredients)	Bench testing performed
Biocompatibility	Technologically identical to 510(k)-approved predicate device
Manufacturing Compliance	Manufactured according to product specifications and cGMP guidelines; meets established specifications
Safety of Ingredients	All ingredients EAFUS approved (GRAS); Only USP-approved chemicals used

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not applicable. Performance testing was "bench testing" of the product's physical and chemical properties, not a clinical trial with a "test set" of patients or data.
Data Provenance: Not applicable. Bench testing was performed by Scientech Laboratories, Inc. (an FDA-approved analytical laboratory testing service) and Bartor Pharmacal (internal testing).

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. As a pharmaceutical product, there is no "ground truth" to establish for a test set in the context of an algorithm's diagnostic or predictive performance.

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 device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the context of an algorithm. The "truth" for this product lies in its chemical composition, physical properties, and safety, which are evaluated through analytical testing and regulatory review of ingredients and manufacturing.

8. The sample size for the training set

Not applicable. This is not an AI device, so there is no training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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5. 510(k) Summary

A. From:

(Agent)

SEP - 2 2009

25 Ravenna Drive Pomona, NY 10970 Invado Pharmaceuticals 914-715-6232 ekobus@invadopharma.com

Edward Kobus

Bartor Pharmacal (Owner) 70 High Street Rye, NY 10580 Frank Bardani, RPh.

B. Trade Name: Neutrasal®

K091718

Common Name: Powder for Supersaturated Calcium Phosphate Rinse

Classification Names:

Saliva, Artificial

C. Regulatory Information:
Device Class:

Unclassified

Product Code:

LFD

D. Predicates:

K030802, K991938

Caphosol ®, Artificial Saliva

Product Code: LFD

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E. 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

F. 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.

G. Manufacturing

Neutrasal® will be manufactured according to product specifications and under the guidelines of current Good Manufacturing Practices (cGMP). Bartor Pharmacal, owner, is a cGMP-approved manufacturer.

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Risk analysis has been performed to identify possible failure mode during manufacturing. Manufacturing controls have been developed and implement to address the identified risks factors based on the criticality of failure mode. All established GMPs will assure that device manufactured at Bartor Pharmacal meets all established specifications prior to release and is safe and effective for its intended use.

H. 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 by Bartor Pharmacal. The following bench tests were performed:

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

l. Biocompatibility testing

Neutrasal® is technologically identical to the 510(k)-approved product predicate with the exception that Neutrasal® is in a powder from to be reconstituted in water rather than being a pre-made oral solution.

J. 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

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GRAS. Only USP-approved chemicals, with validation, will be used during the manufacturing of Neutrasal®.

K. Other Information

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.

Substantial Equivalence Conclusion L.

The indications of use, technological properties, performance testing for Neutrasal® (Powder for supersaturated calcium phosphate rinse) are substantially equivalent to those of the predicate device Caphosol (supersaturated calcium phosphate rinse). They both share the same labeling and intended uses. Thus, Neutrasal® and Caphosol are substantially equivalent.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized eagle with its wings spread, clutching a caduceus, a symbol associated with medicine and healthcare.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Bartor Pharmacal Company, Incorporated C/O Mr. Edward D. Kobus Invado Pharmaceuticals 25 Ravenna Drive Pomona, New York 10970

Re: K091718

SEP - 2 2009

Trade/Device Name: Neutrasal® Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: LFD Dated: June 19, 2009 Received: June 23, 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/ CDRHOffices/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infusion Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. Indications for Use

510(k) Number (if known): K091718

Device Name:

Neutrasal®

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 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.

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)

Kee Murley for MSR

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K091718

Regulation Number and Section

N/A