(1181 days)
Not Found
No
The summary describes a simple oral moisturizer with an electrolyte solution and propellant, with no mention of AI or ML capabilities or related performance metrics.
Yes.
The device is intended to relieve discomfort and replace saliva, addressing a medical condition (xerostomia) which aligns with the definition of a therapeutic effect.
No
Explanation: The device, Salivart Oral Moisturizer, is described as an oral moisturizer intended to relieve the discomfort of dry mouth and throat. Its function is to lubricate and soothe, not to diagnose any condition.
No
The device description clearly states it is an "aqueous electrolyte solution containing a viscosity agent and an emulsifier" and is "aerosolized with a nitrogen propellant," indicating it is a physical product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases, conditions, or determine the state of health.
- This device is an oral moisturizer. Its intended use is to relieve the discomfort of dry mouth and throat by lubricating those areas. It is applied directly to the mouth and throat, not used to test a specimen taken from the body.
The description clearly indicates it's a topical application for symptom relief, not a diagnostic tool.
N/A
Intended Use / Indications for Use
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.
Product codes
LFD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mouth, throat
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
AUG - 6 2001
Image /page/0/Picture/1 description: The image shows a black abstract symbol. The symbol is composed of a circle with a small circular cutout on the inside. A horizontal line extends from the circle to the right, creating a shape that resembles a stylized letter or logo. The overall design is simple and geometric.
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:
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.
Intended Use of Device:
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.
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1
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.
2
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
3
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
4
510(k) Number (if known):
Salivart® Oral Moisturizer Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
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.
(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) | ||
|---|---|---|---|---|---|
| ------------------ | ------------------------------------------------------- | ---- | ---------------------- | ------------------------------------------------------- | -------------------------- |
| | Suran Runn
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K9811693 |
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