MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098

K062653 · Parnell Pharmaceuticals, Inc. · LFD · Oct 27, 2006 · DE

Device Facts

• Record ID: K062653
• Device Name: MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098
• Applicant: Parnell Pharmaceuticals, Inc.
• Product Code: LFD · DE
• Decision Date: Oct 27, 2006
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

A pleasant tasting solution that diminishes dry mouth discomfort, mouth odors and other symptoms of a dry mouth.

Device Story

MouthKote is an artificial saliva substitute formulated with moisturizers, polysaccharides, and Yerba Santa extract. It provides lubricating and moistening properties to the oral cavity. The device is supplied as a liquid solution in various container sizes (5ml tube, 2 oz and 8 oz bottles). It is intended for over-the-counter use by patients experiencing xerostomia to diminish dry mouth discomfort and mouth odors. The patient applies the solution to the oral cavity as needed. The device functions as a topical oral moisturizer to provide symptomatic relief.

Clinical Evidence

No clinical data provided. The device relies on the established safety and effectiveness of its formulation and substantial equivalence to legally marketed predicate devices.

Technological Characteristics

Artificial saliva solution containing moisturizers, polysaccharides, and Yerba Santa extract. Non-sterile liquid formulation. Ready-to-use. No electronic components or software.

Indications for Use

Indicated for the relief of dry mouth conditions (xerostomia) in patients requiring oral moisturization. Available for over-the-counter use.

Predicate Devices

• Laclede, Inc. Oral Balance (K061331)
• Inpharma AB Caphasol (K991938)
• Gebauer Company Salivart (K981693)
• Sinclair Pharmaceuticals Salinum/Oraclair (K024148)
• Laboratoires Carilene S.A.S. TGO Spray (K051812)

Submission Summary (Full Text)

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K062653

5-1

PARNELL PHARMACEUTICALS, INC. 1525 FRANCISCO BLVD SAN RAFAEL, CA 94901 USA 415) 256-1800 · FAX [phone] [e-mail] www.parnellpharm.com

## 5. 510(k) Summary

October 23, 2006

OCT 2 7 2006

- 1. Submission Applicant & Correspondent: Name: Address: San Rafael, CA 94901
Phone: Fax: Contact Person:

- 2. Name of Device: Trade/Proprietary/Model Name: Common or Usual Name: Classification Names:
- 3. Regulatory Information: Device Class: Product Code:

Parnell Pharmaceuticals, Inc. 1525 Francisco Blvd., Ste. 15 [phone] [phone] 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:

- 1. Laclede, Inc. Oral Balance cleared in K061331 2. Inpharma AB Caphasol cleared in K991938 3. Gebauer Company Salivart cleared in K981693 4. Sinclair Pharmaceuticals Salinum/Oraclair cleared in K024148 5. Laboratoires Carilene S.A.S. TGO Spray cleared in K051812
- 5. 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.

- 6. 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:

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5. 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.

- 7. Summary of Technological Characteristics of the Device compared to the Predicate Devices:

| Product | MouthKote | Oral Balance | TGO Spray | Caphasol | Salivart | Salinum/<br>Oraclair |
|-------------------------|-------------------------------------------|-------------------------------------------|-------------------------------------------|-------------------------------------------|-------------------------------------------|-------------------------------------------|
| Intended<br>Use | Symptomatic<br>treatment of<br>xerostomia | Symptomatic<br>treatment of<br>xerostomia | Symptomatic<br>treatment of<br>xerostomia | Symptomatic<br>treatment of<br>xerostomia | Symptomatic<br>treatment of<br>xerostomia | Symptomatic<br>treatment of<br>xerostomia |
| Method of<br>Use | Ready to use<br>liquid | Ready to use<br>liquid and<br>gel | Ready to use<br>spray | Mix parts<br>A & B<br>ampoules | Ready to use<br>spray | Ready to use<br>ampoules |
| Applications<br>per Day | As needed | As needed | As needed | As needed | As needed | As needed |
| Disease<br>State | Xerostomia | Xerostomia | Xerostomia | Xerostomia | Xerostomia | Xerostomia |
| Area of Use | Oral cavity | Oral cavity | Oral cavity | Oral cavity | Oral cavity | Oral cavity |
| Type of<br>Product | Solution | Solution | Solution | Solution | Solution | Solution |
| Presentation | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Non-sterile |

# Substantial Equivalence Comparison Chart

8. Tests and Conclusion:

The Mouthkote formulation has been shown to be safe and effective for its intended over-the-counter use.

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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.

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### 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 [phone]. 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 [phone] or [phone] 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

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K062653

# 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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