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

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.

AI/ML Overview

This K062653 510(k) summary is for the MouthKote Oral Moisturizer, an artificial saliva substitute intended to relieve dry mouth conditions.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific quantitative acceptance criteria or detailed reported device performance metrics in the way one typically sees for diagnostic devices (e.g., sensitivity, specificity, AUC).

Instead, the submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. The "acceptance criteria" can be inferred as successfully demonstrating that MouthKote is as safe and effective as the predicates for its intended use.

The "reported device performance" is a general statement about its safety and effectiveness without specific metrics.

Acceptance Criteria (Inferred from Substantial Equivalence Goal)	Reported Device Performance (as stated in 510(k) Summary)
Intended Use: Symptomatic treatment of xerostomia	MouthKote has the same intended use/indications as the predicate devices.
Method of Use: Ready to use liquid	Ready to use liquid
Applications per Day: As needed	As needed
Disease State: Xerostomia	Xerostomia
Area of Use: Oral cavity	Oral cavity
Type of Product: Solution	Solution
Presentation: Non-sterile	Non-sterile
Safety and Effectiveness (General): Safe and effective for intended use	"The Mouthkote formulation has been shown to be safe and effective for its intended over-the-counter use."

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide information on a specific "test set" sample size or data provenance (e.g., country of origin, retrospective/prospective). This is because the submission primarily relies on demonstrating substantial equivalence to predicates based on technological characteristics and intended use, rather than presenting a de novo clinical trial with a traditional "test set" and performance metrics.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable and not provided in the document. As explained above, a traditional "test set" requiring expert ground truth establishment for diagnostic performance evaluation was not central to this 510(k) submission.

4. Adjudication Method for the Test Set

This information is not applicable and not provided for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

An MRMC comparative effectiveness study was not mentioned or indicated in the provided 510(k) summary. This type of study is more common for diagnostic imaging AI devices where human reader performance is a key metric.

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

This concept is not applicable to MouthKote as it is a direct-use medical device (an artificial saliva substitute), not an algorithm or diagnostic software.

7. The Type of Ground Truth Used

The concept of "ground truth" (e.g., expert consensus, pathology, outcomes data) is not directly applicable in the context of this 510(k) submission. The "truth" in this case is the established safety and effectiveness of the predicate devices, to which MouthKote is compared for substantial equivalence. The submission does not detail any de novo clinical studies with specific ground truth data for MouthKote itself.

8. The Sample Size for the Training Set

This information is not applicable and not provided. MouthKote is a chemical formulation, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

This information is not applicable and not provided for the same reasons as point 8.

Study that Proves the Device Meets Acceptance Criteria:

While the document states, "The Mouthkote formulation has been shown to be safe and effective for its intended over-the-counter use," it does not describe a specific study, clinical trial, or scientific data in this 510(k) summary that proves this statement.

Instead, the primary "study" or justification for meeting the "acceptance criteria" (defined as substantial equivalence) is the comparison of MouthKote's characteristics to five predicate devices as detailed in the "Summary of Technological Characteristics of the Device compared to the Predicate Devices" table. The FDA's issuance of the 510(k) clearance letter (K062653) signifies that they have reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices, thereby establishing its presumed safety and effectiveness for its intended use without the need for new clinical data explicitly presented in this summary.

Summary

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K062653

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

1. Submission Applicant & Correspondent: Name: Address: San Rafael, CA 94901
  Phone: Fax: Contact Person:
1. Name of Device: Trade/Proprietary/Model Name: Common or Usual Name: Classification Names:
1. 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:

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
1. Device Description:

1. 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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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.

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

Product	MouthKote	Oral Balance	TGO Spray	Caphasol	Salivart	Salinum/Oraclair
IntendedUse	Symptomatictreatment ofxerostomia	Symptomatictreatment ofxerostomia	Symptomatictreatment ofxerostomia	Symptomatictreatment ofxerostomia	Symptomatictreatment ofxerostomia	Symptomatictreatment ofxerostomia
Method ofUse	Ready to useliquid	Ready to useliquid andgel	Ready to usespray	Mix partsA & Bampoules	Ready to usespray	Ready to useampoules
Applicationsper Day	As needed	As needed	As needed	As needed	As needed	As needed
DiseaseState	Xerostomia	Xerostomia	Xerostomia	Xerostomia	Xerostomia	Xerostomia
Area of Use	Oral cavity	Oral cavity	Oral cavity	Oral cavity	Oral cavity	Oral cavity
Type ofProduct	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.

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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.

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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 (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

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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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Regulation Number and Section

N/A