An oral moisturizer which temporarily relieves the discomfort of dry mouth (xerostomia) and dry throat naturally. Salivart may be used to replace human saliva, when the amount of saliva normally secreted has been reduced. Salivart lubricates the mouth and throat to soothe discomfort and assist in speaking and swallowing. Salivart relieves dry mouth caused by certain medications, therapeutic treatments, diseases, normal aging and emotional factors.

Device Description

Salivart Oral Moisturizer, an OTC device, is an aqueous electrolyte solution containing a viscosity agent and an emulsifier. The solution is aerosolized with a nitrogen propellant. It comes in two different can sizes. The smaller size is both sold and used as a promotional sample.

AI/ML Overview

The provided text is a 510(k) summary for the Salivart® Oral Moisturizer, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission relies on a comparison of technological characteristics to a predicate device, rather than new clinical studies or performance data against specific acceptance criteria. Therefore, the document does not describe acceptance criteria, a study proving the device meets them, or many of the specific details requested in your prompt.

However, I can extract information related to the comparison of technological characteristics as presented:

1. A table of acceptance criteria and the reported device performance:

This document does not present acceptance criteria in the typical sense (e.g., minimum sensitivity/specificity for a diagnostic device). Instead, it relies on the concept of substantial equivalence to a predicate device. The "acceptance criteria" here are effectively that the device's technological characteristics are similar enough to the predicate to not raise new questions of safety and effectiveness.

Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance (Salivart® Oral Moisturizer)
Chemical Components	Must be "essentially the same" as predicate, or differences must not impact safety/effectiveness.	Uses "the same chemical components" as Moi-Stir® Mouth Moistener, except for the absence of a flavor and two preservatives.
Dispensing Mechanism	Must not raise new questions of safety or effectiveness compared to predicate.	Uses an aerosol mechanism, whereas the predicate uses a pump mechanism.
Intended Use	Must be the same as the predicate.	Same intended use as the predicate ("An oral moisturizer which temporarily relieves the discomfort of dry mouth (xerostomia) and dry throat naturally...").

2. Sample size used for the test set and the data provenance:

Not applicable. This is a 510(k) submission based on comparison to a predicate, not a study involving a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No ground truth was established by experts for a test set in this submission.

4. Adjudication method for the test set:

Not applicable. No test set or adjudication was performed.

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 device is an oral moisturizer, not an AI-powered diagnostic or assistive tool.

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

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used:

Not applicable. Ground truth, in the context of diagnostic or AI studies, is not relevant to this 510(k) submission. The "truth" here is the prior marketing of the predicate device and its established safety and effectiveness.

8. The sample size for the training set:

Not applicable. This is a 510(k) submission, not a machine learning or algorithm development project.

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

Not applicable.

Summary

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Pharmaceutical Preparations

UMMARY

Establishment Name:

Gebauer Company (Specification Developer of Salivart®)

Phone Number:

Fax Number:

Address:

Contact Person:

Date Summary Prepared:

Device Name:

Classification Name:

Predicate Product:

9410 St. Catherine Ave. Cleveland, OH 44104

(216) 271-5252

(216) 271-0910

Denise E. Spellman (Official Correspondent)

5/12/98

Salivart® Oral Moisturizer

Artificial Saliva

MOI-STIR® Mouth Moistener

Device Description:

Intended Use of Device:

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:

Moi-Stir® Mouth Moistener and Salivart Oral® Moisturizer are essentially the same. They use the same chemical components with the exception of a flavor and two preservatives used by Moi-Stir. Salivart uses neither a flavor nor preservatives. The only other difference between the two products is the method of dispensing. Moi-Stir uses a pump mechanism and Salivart uses an aerosol mechanism. Therefore, the products are substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Denise E. Spellman ·Director, QA & Regulatory Affairs (Official Correspondent) Gebauer Company 9410 St. Catherine Avenue Cleveland, Ohio 44104

K981693 Re : Salivart® Oral Moisturizer Model Number Trade Name: 03866-009-75 Saliva Unclassified Requlatory Class: Product Code: LFD Dated: May 12, 1998 Received: May 13, 1998

Dear Ms. Spellman

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

AUG - 6 2001

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Page 2 - Ms. Spellman

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

S. Dutman for

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Salivart® Oral Moisturizer Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use		OR	Over-The-Counter Use		(Optional Format 1-2-96)
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	Suran Runn (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number	K9811693

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Regulation Number and Section

N/A