(50 days)
Not Found
No
The device description and performance studies focus on the chemical composition and moisturizing properties of the artificial saliva substitute, with no mention of AI or ML.
Yes.
The device is intended to relieve dry mouth conditions, which is a therapeutic purpose.
No
Explanation: The device is described as an artificial saliva substitute that relieves dry mouth conditions. Its intended use is to provide lubrication and moistening, and it is an over-the-counter product. There is no mention of diagnostic functions like identifying or measuring a disease or condition.
No
The device description clearly states it is an artificial saliva substitute supplied in tubes and bottles, indicating a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "Relieve dry mouth conditions." This is a therapeutic or palliative use, not a diagnostic one.
- Device Description: The description focuses on the composition and properties of the product as a saliva substitute for lubrication and moistening. It doesn't mention any components or functions related to testing or analyzing biological samples.
- Lack of Diagnostic Indicators: There is no mention of analyzing samples (like saliva, blood, etc.) to diagnose a condition or provide information about a patient's health status.
- Over-The-Counter Use: IVDs are typically used in clinical settings or require specific instructions for home use related to diagnostic testing. This product is intended for general over-the-counter use for symptom relief.
- Predicate Devices: The listed predicate devices are all artificial saliva substitutes or oral moisturizers, which are not IVDs.
In summary, the device's purpose is to provide relief for a symptom (dry mouth) through lubrication and moistening, not to diagnose or provide information about a disease or condition based on in vitro testing.
N/A
Intended Use / Indications for Use
A pleasant tasting solution that diminishes dry mouth discomfort, mouth odors and other symptoms of a dry mouth. MouthKote has the same intended use/indications as the predicate devices:
Laclede Inc. Oral Balance
Laboratoires Carilene TGO Spray
Inpharma AB Caphasol
Gebauer Company Salivart
Sinclair Pharmaceuticals Salinum/Oraclair
Relieves dry mouth conditions
Product codes (comma separated list FDA assigned to the subject device)
LFD
Device Description
MouthKote is an artificial saliva substitute which contains moisturizers. polysaccharides and flavones that have lubricating and moistening properties. It contains patented Yerba Santa extract which has a FDA GRAS number and FEMA number. Products are supplied in 5ml tube, 2 fluid oz. and 8 fluid oz. bottles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral cavity
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)
The Mouthkote formulation has been shown to be safe and effective for its intended over-the-counter use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K061331, K991938, K981693, K024148, K051812
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
5-1
PARNELL PHARMACEUTICALS, INC. 1525 FRANCISCO BLVD SAN RAFAEL, CA 94901 USA 415) 256-1800 · FAX (415) 256-8099 ail@parnellpharm.com www.parnellpharm.com
5. 510(k) Summary
October 23, 2006
OCT 2 7 2006
-
- Submission Applicant & Correspondent: Name: Address: San Rafael, CA 94901
Phone: Fax: Contact Person:
- Submission Applicant & Correspondent: Name: Address: San Rafael, CA 94901
-
- Name of Device: Trade/Proprietary/Model Name: Common or Usual Name: Classification Names:
-
- Regulatory Information: Device Class: Product Code:
Parnell Pharmaceuticals, Inc. 1525 Francisco Blvd., Ste. 15 (415)256-1800 (415)256-8099 Francis Parnell, M.D. - President
MouthKote Oral Moisturizer MouthKote Oral Moisturizer Dental: Saliva, Artificial Dental: Saliva, Artificial
Unclassified LFD
4. Devices to which new device is substantially equivalent:
-
- Device Description:
MouthKote is an artificial saliva substitute which contains moisturizers. polysaccharides and flavones that have lubricating and moistening properties. It contains patented Yerba Santa extract which has a FDA GRAS number and FEMA number. Products are supplied in 5ml tube, 2 fluid oz. and 8 fluid oz. bottles.
-
- Intended Use of the Device:
A pleasant tasting solution that diminishes dry mouth discomfort, mouth odors and other symptoms of a dry mouth. MouthKote has the same intended use/indications as the predicate devices:
- Intended Use of the Device:
1
- 510(k) Summary
Laclede Inc. Oral Balance Laboratoires Carilene TGO Spray Inpharma AB Caphasol Gebauer Company Salivart Sinclair Pharmaceuticals Salinum/Oraclair
Please refer to the table below.
-
- Summary of Technological Characteristics of the Device compared to the Predicate Devices:
| Product | MouthKote | Oral Balance | TGO Spray | Caphasol | Salivart | Salinum/
Oraclair |
|-------------------------|-------------------------------------------|-------------------------------------------|-------------------------------------------|-------------------------------------------|-------------------------------------------|-------------------------------------------|
| Intended
Use | Symptomatic
treatment of
xerostomia | Symptomatic
treatment of
xerostomia | Symptomatic
treatment of
xerostomia | Symptomatic
treatment of
xerostomia | Symptomatic
treatment of
xerostomia | Symptomatic
treatment of
xerostomia |
| Method of
Use | Ready to use
liquid | Ready to use
liquid and
gel | Ready to use
spray | Mix parts
A & B
ampoules | Ready to use
spray | Ready to use
ampoules |
| Applications
per Day | As needed | As needed | As needed | As needed | As needed | As needed |
| Disease
State | Xerostomia | Xerostomia | Xerostomia | Xerostomia | Xerostomia | Xerostomia |
| Area of Use | Oral cavity | Oral cavity | Oral cavity | Oral cavity | Oral cavity | Oral cavity |
| Type of
Product | Solution | Solution | Solution | Solution | Solution | Solution |
| Presentation | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
Substantial Equivalence Comparison Chart
- Tests and Conclusion:
The Mouthkote formulation has been shown to be safe and effective for its intended over-the-counter use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the caduceus symbol.
ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Dr. Francis W. Parnell President Parnell Pharmaceuticals, Incorporated 1525 Francisco Boulevard, Suite 15 San Rafael, California 94901
OCT 27 2006
Re: K062653
Trade/Device Name: MouthKote Oral Moisturizer Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: LFD Dated: October 23, 2006 Received: October 24, 2006
Dear Dr. Parnell:
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 such 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.
3
Page 2 -Dr. Parnell
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Kumar
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K062653 510 (k) Number:
MouthKote Oral Moisturizer Device Name:
Indications For Use: Relieves dry mouth conditions
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
X Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Concertion Comments of Concession Comes of Comments of Comments of Comments of Comments of Comments of Comments of Comments of Comments of Comments of Comments of Comments of . Denia, Davioss
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