Relieves the symptoms of dry mouth, cleans, soothes oral irritation, lubricates and moisturizes dry mouth irritation and diminishes dry discomfort. Indications for Use: Relieves the symptoms of dry mouth, while moisturizing and lubricating oral dryness.

Device Description

Dr. Fresh Dry Mouth Mouthwash is a specifically formulated artificial saliva substitute which contains moisturizers, humectants and patent pending salivary enzymes that have lubricating, moisturizing and soothing properties to relieve the symptoms of Dry Mouth. The liquid product is supplied in 1.5 oz, 16 oz and 33.8 oz PET bottles.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device, specifically Dr. Fresh Dry Mouth Mouthwash, and focuses on demonstrating substantial equivalence to a predicate device. This type of submission does not typically involve detailed clinical studies with acceptance criteria based on quantifiable performance metrics of the device as it would for a novel device. Instead, the "study" is a comparison to an already approved device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, the "acceptance criteria" are typically defined by demonstrating that the new device has the same intended use and similar technological characteristics as a legally marketed predicate device, and that any differences do not raise new questions of safety or effectiveness. The reported "device performance" is the comparison itself.

Characteristic / "Acceptance Criteria"	Dr. Fresh Dry Mouth Mouthwash (Reported Device Performance)	Predicate Device: Biotene Dry Mouth Oral Rinse (Reference)	Meets Criteria?
Intended Use	Relieves the symptoms of dry mouth, cleans, soothes oral irritation, lubricates and moisturizes dry mouth irritation and diminishes dry discomfort.	Relieves and treats the symptoms of dry mouth; refreshes mouth odors, cleans soothes oral irritations, moisturizes, lubricates, and diminishes dry discomfort.	Yes (Substantially Equivalent)
Dosage	As Needed, One tablespoon for every use	As Needed, One tablespoon for every use	Yes
Disease State	Xerostomia	Xerostomia	Yes
Packaging	1.5 oz, 16 oz and 33.8 oz PET bottles with flip caps	16 OZ brick shaped white PETE bottle with flip cap	Yes (Similar)
Functional Ingredients	See Ingredient Comparison chart in Substantial Equivalence Discussion	See Ingredient Comparison chart in Substantial Equivalence Discussion	Yes (Based on reference to chart not provided)
Area of Use	Oral Cavity	Oral Cavity	Yes
Type of Product	Liquid Solution	Liquid Solution	Yes
Presentation	Non-Sterile	Non-Sterile	Yes
Biocompatibility	Tested in accordance with ISO 10993 (irritation, cytotoxicity, contact sensitization)	Implied to meet similar standards for predicate	Yes

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

Sample Size: Not applicable in the context of this 510(k) summary. There is no "test set" of patient data for performance evaluation in the way a clinical trial would have. The "test" is the comparison of characteristics.
Data Provenance: Not applicable. The "data" are the technical characteristics of the device being compared to a predicate, not patient data from a study.

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

Not applicable. Ground truth, in the sense of expert consensus on patient outcomes or diagnoses, is not established for this type of submission. The "ground truth" is essentially the established characteristics and regulatory approval of the predicate device. The FDA's review committee (Division of Anesthesiology, General Hospital, Infection Control and Dental Devices) acts as the expert body determining substantial equivalence.

4. Adjudication Method for the Test Set

Not applicable for the reasons stated above. The "adjudication" is the FDA's regulatory decision based on the submitted information.

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 artificial saliva substitute, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study is irrelevant to this submission.

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

Not applicable. This device is a physical product (mouthwash), not an algorithm or an AI system.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established regulatory acceptance and performance profile of the legally marketed predicate device, GlaxoSmithKline Consumer Healthcare Biotene Dry Mouth Oral Rinse (K101477). The substantial equivalence argument relies on demonstrating that the new device is sufficiently similar to this already approved device.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this type of device submission.

Summary

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KIII 250

PRIVATE LABEL DRYMOUTH RINSE DR. FRESH, INC.

510(K) Summary: Product Code LFD

1. Submitter Information
Name:	Dr. Fresh, Inc.
Address:	6645 Caballero Blvd.Buena Park, CA 90620
Contact Person:	Gary Pendyala
Telephone:	714.690.1573 Office714.690.1572 FAX
2. Device Name
Device Name:	Dry Mouth Mouthwash
Trade or Proprietary Name:	Dr. Fresh Dry Mouth Mouthwash
Common or Usual Name:	Saliva, Artificial
Classification Name:	Saliva, Artificial
3. Identification of Equivalence

GlaxoSmithKline Consumer Healthcare Biotene Dry Mouth Oral Rinse (K101477)

Device Description 4.

ನ. Statement of Intended Use

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Summary of Technological Characteristics 6. Characteristics of the Device Compared to the Predicate Device

Product	Dr. Fresh Dry MouthMouthwash	Biotene Dry Mouth Oral Rinse
Intended Use	Relieves the symptoms of drymouth, cleans, soothes oralirritation, lubricates andmoisturizes dry mouth irritationand diminishes dry discomfort.	Relieves and treats the symptomsof dry mouth; refreshes mouthodors, cleans soothes oralirritations, moisturizes, lubricates,and diminishes dry discomfort
Dosage	As NeededOne tablespoon for every use	As NeededOne tablespoon for every use
Disease State	Xerostomia	Xerostomia
Packaging	1.5 oz, 16 oz and 33.8 oz PETbottles with flip caps	16 OZ brick shaped white PETEbottle with flip cap
FunctionalIngredients	See Ingredient Comparisonchart in Substantial EquivalenceDiscussion	See Ingredient Comparison chartin Substantial EquivalenceDiscussion
Area of Use	Oral Cavity	Oral Cavity
Type of Product	Liquid Solution	Liquid Solution
Presentation	Non-Sterile	Non-Sterile

SUBSTANTIAL EQUIVALENCE COMPARISON CHART

7. Biocompatibility .

Dr. Fresh Dry Mouth Mouthwash has been tested in accordance with ISO 10993 and was shown to meet the requirements of biocompatibility testing in the categories of irritation, cytotoxicity and contact sensitization.

8. · Discussion and Conclusion

Based on the comparison of intended use and technical characteristics, we conclude that Dr. Fresh Dry Mouth Mouthwash is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized eagle emblem. The eagle is depicted with its wings spread, symbolizing protection and service. The overall design is simple and professional, reflecting the department's role in public health and welfare.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

APR 2 7 2012

Dr. Fresh. Inc. C/O Ms. Camille Thornton Senior Regulatory Specialist Registrar Corp 144 Research Drive Hampton, Virginia 23666

Re: K111250

Trade/Device Name: Dry Mouth Mouthwash Regulation Number: Unclassified Regulation Name: None Regulatory Class: Unclassified Product Code: LFD Dated: October 25, 2011 Received: March 28, 2012

Dear Ms. Thornton:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Ms. Thornton

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Suen Ruans

Anthony D. Watson, B.S., M.S., M.B.A. 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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K III 250

Indications for Use

510(k) Number (if known): N/A

Device Name: Dry Mouth Mouthwash

Indications For Use:

Relieves the symptoms of dry mouth, while moisturizing and lubricating oral dryness.

Prescription Use: (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use: X (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)

Susan Runner

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

Regulation Number and Section

N/A