K Number

Device Name

Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist

Manufacturer

Syendgen, Inc.

Date Cleared

2018-03-19

(165 days)

Product Code

LFD

Regulation Number

N/A

Intended Use

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

Device Description

Moisyn is a specifically formulated artificial saliva substitute which contains moisturizers, humectants, and biopolymers that are designed to relieve dry mouth symptoms, soothe irritated oral surfaces, refresh, clean, and lubricate. The rinse is supplied as an 80z PET bottle or as a 20z PET spray bottle. Both bottles contain the same solution without any changes in formulation or intended use. Both the rinse and the Mist are formulated with and without spearmint flavor to provide the customer with a choice in flavoring.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K111250

Reference Devices

K041563, K810157, K143444, K142549, K062653

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the chemical formulation and clinical efficacy of an artificial saliva substitute, with no mention of AI or ML technologies.

Therapeutic

Yes
The device is intended to relieve symptoms of dry mouth, soothe irritated oral surfaces, and has demonstrated statistically significant improvements in dry mouth symptoms and reduction in oral pain in clinical studies, indicating a therapeutic effect.

Diagnostic

No
The device is described as an artificial saliva substitute intended to relieve the symptoms of dry mouth, not to diagnose a condition.

SaMD (Software as a Medical Device)

The device description clearly states it is a "specifically formulated artificial saliva substitute" supplied in "80z PET bottle or as a 20z PET spray bottle," indicating it is a physical product (liquid and packaging) and not software.

IVD (In Vitro Diagnostic)

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 the symptoms of dry mouth, while moisturizing and lubricating oral dryness." This describes a therapeutic or palliative action within the body (the oral cavity), not a diagnostic test performed on a sample taken from the body.
Device Description: The description details a topical solution applied to the oral cavity for symptomatic relief. It doesn't mention any components or processes related to analyzing biological samples for diagnostic purposes.
Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, saliva (in a diagnostic context), tissue, or any other biological sample to determine a disease state, condition, or predisposition.
Clinical Study Focus: The clinical study focuses on the improvement of symptoms and saliva production, which are related to the device's therapeutic effect, not its ability to diagnose a condition.
Predicate and Reference Devices: The listed predicate and reference devices are all artificial saliva substitutes or oral moisturizers, which are not IVDs.

In summary, the device's function is to provide symptomatic relief and lubrication within the oral cavity, which falls under the category of a therapeutic or palliative medical device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

LFD

Device Description

The rinse is supplied as an 80z PET bottle or as a 20z PET spray bottle. Both bottles contain the same solution without any changes in formulation or intended use.

Both the rinse and the Mist are formulated with and without spearmint flavor to provide the customer with a choice in flavoring.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

oral dryness (oral surfaces, 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

Biocompatibility Testing: Moisyn was tested in accordance with ISO 10993 for Cytotoxicity, Maximization Test for Delayed-Type Hypersensitivity, Dermal Irritation, Oral Mucosal Irritation, and Acute Systemic Toxicity. Results showed non-toxicity, no sensitization reaction, no erythema or edema for dermal irritation (Primary Irritation Index of 0), Oral Irritation Index of 0.0, and met requirements for Acute Systemic Toxicity.

Preservative Effectiveness: The Moisyn Dry Mouth Oral Rinse/Mist met the requirements of USP 51 for preservative effectiveness.

Shelf-Life: Stability data indicate the product meets specifications after two years of storage, with testing scheduled up to 3 years.

Viral Inactivation: Viral inactivation was assessed.

Clinical Study: An initial study of 57 patients with Xerostomia was conducted. Statistically significant improvements in dry mouth symptoms, reduction in oral pain, and improvement in taste/diet were demonstrated. Whole unstimulated/resting saliva and whole stimulated saliva improved. This study is cited as Epstein, Joel B, Dana C Villines, Mabi Singh, and Athena Papas. 2017. "Management of dry mouth: assessment of oral symptoms after use of a polysaccharide-based oral rinse." Oral Medicine 76-83.

Key Metrics

Not Found

Predicate Device(s)

K111250

Reference Device(s)

K041563, K810157, K143444, K142549, K062653

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

N/A

Summary

Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 19, 2018

Syendgen, Inc. Christopher Ryan, Ph.D. Director of Manufacturing 1420 N. Claremont Blvd. Suite 105D Claremont, California 91711

Re: K173237

Trade/Device Name: Moisyn Dry Mouth Oral Rinse. Moisyn Dry Mouth Oral Mist. Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist

Regulatory Class: Unclassified Product Code: LFD Dated: February 15, 2018 Received: February 16, 2018

Dear Christopher Ryan:

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.

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 of medical device-related adverse events) (21 CFR 803); 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K173237

Device Name

Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K173237

Synedgen, Inc.

Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist

Submitter:

Synedgen, Inc. 1420 North Claremont Blvd, Suite 105D Claremont, CA 91711 Phone: 909-447-6858 909-447-6801 Fax: Contact Person: Shenda Baker Correspondent: Christopher Ryan Date Prepared: March 19, 2018

Device:

Name of Device: Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist Dry Mouth Spray Common or Usual name: Artificial Saliva

Classification: Unclassified Product Code: LFD

Primary Predicate Device:

Dr. Fresh Dry Mouth Mouthwash K111250 (LFD) This predicate has not been subject to a design-related recall.

Reference Predicate Devices:

Oasis Dry Mouth(K041563). Moi-Stir(K810157). SynePure (K143444). Oral 7 Moisturizing Mouth Spray(K142549), Mouth Kote Oral Moisturizer (K062653)

Device Description:

The rinse is supplied as an 80z PET bottle or as a 20z PET spray bottle. Both bottles contain the same solution without any changes in formulation or intended use.

Both the rinse and the Mist are formulated with and without spearmint flavor to provide the customer with a choice in flavoring.

Indications for use:

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

Comparison with predicate:

The candidate device. Moisyn, has the same intended use and the substantially equivalent technological characteristics as the predicate device: Dr. Fresh Dry Mouth Mouthwash. Both the predicate and the proposed device are aqueous based solutions that use neutral sugars (glycerol and sorbitol) as well as polymers to assist in the moisturizing dry mouth. The proposed device and predicate use sorbitol to balance the solution and to provide a denser solution. The proposed device and predicate are preserved to control microbial content. The proposed device and predicate are delivered with a pH that is not significantly acidic or basic. Like the predicate device, Moisyn acts as an artificial saliva that utilizes moistening properties to aid in the moisturizing and lubricating of oral dryness.

	New Device (Moisyn)	Predicate Device (Dr. Fresh)
Intended Use	Symptomatic treatment of Xerostomia
(Dry Mouth)	Symptomatic treatment of Xerostomia
Indications for Use	Relieves the symptoms of dry mouth, while moisturizing and lubricating oral dryness.	Relieves the symptoms of dry mouth, while moisturizing and lubricating oral dryness.
Sterile or preservative	Non-sterile, preserved	Non-sterile, preserved
Composition	Purified water
Sorbitol
Xylitol
Glycerol
Chitosan derivatives
Betaine
Flavor

Comparison of New and Predicate Devices

The proposed device has substantially equivalent technological characteristics as a non-sterile, preserved, non-toxic, polymer-based mouthwash and is similar in design and configuration to the

predicate device. The proposed device is designed and assembled with components found in the predicate and reference devices.

Performance data:

Biocompatibility Testing

Moisyn has been tested in accordance with ISO 10993 and was shown to meet the requirements of biocompatibility testing for Cytotoxicity, Maximization Test for Delayed-Type Hypersensitivity, Dermal Irritation, Oral Mucosal Irritation, and Acute Systemic Toxicity.

Test	Description	Result
Cytotoxicity Direct Contact	Cytotoxicity was evaluated
using ISO-10993-5,	Non-toxic
	Biological evaluation of
	Medical Devices-Part 5: Tests
	for In Vitro Cytotoxicity.
Maximization Test for	The ability of Moisyn Oral	No Sensitization reaction was
Delayed-Type	Rinse/Mist to cause delayed-	observed in any of the test
Hypersensitivity	type hypersensitivity was	animals
	evaluated according to ISO
	10993-10:2010, Biological
	evaluation of medical devices
	– Part 10: Tests for Irritation
	and skin sensitization.
Dermal Irritation	To assess dermal irritation	No erythema or edema (score
	due to exposure of skin to	of () was observed on test
	Moisyn Oral Rinse and Mist,	sites at the 1, 24, 48, and 72-
	the test articles was evaluated	hour scoring. The Primary
	according to ISO 10993-	Irritation Index for the test
	10:2010, Biological	article was 0.
	evaluation of medical devices
	– Part 10: Tests for irritation
	and skin sensitization.
Oral Mucosal Irritation	To assess oral mucosal	The Oral Irritation Index for
	irritation due to exposure to	the test article was 0.0.
	Moisyn Oral Mist, the test
	article was evaluated
	according to ISO 10993-
	10:2010, Biological
	evaluation of medical devices
	– Part 10: Tests for irritation
	and skin sensitization.
To assess the acute systemic	The test article met the
Acute Systemic Toxicity	toxicity of the Moisyn Oral	requirements for the Acute
	Mist, which was tested	Systemic Toxicity Test and
	according to ISO 10993-11,	the requirements of ISO
	Biological Evaluation of	10993-11
	Medical Devices – Tests for
	Systemic Toxicity.

Preservative Effectiveness

The Moisyn Dry Mouth Oral Rinse/Mist was tested for its preservative effectiveness. The data indicate that Moisyn Dry Mouth Oral Rinse/Mist meet the requirements of USP 51.

Shelf-Life

The stability data indicate the product meets specifications after two years of storage and is scheduled to test up to 3 years.

Viral Inactivation

Viral inactivation was assessed.

Clinical Study

An initial study of 57 patients with Xerostomia was conducted to treatment with Moisyn. Substantial equivalence is based in part on this study. Statistically significant improvements in dry mouth symptoms, reduction in oral pain, and improvement in taste/diet were demonstrated. Whole unstimulated/resting saliva and whole stimulated saliva improved.

Epstein, Joel B, Dana C Villines, Mabi Singh, and Athena Papas. 2017. "Management of dry mouth: assessment of oral symptoms after use of a polysaccharide-based oral rinse." Oral Medicine 76-83

Conclusions:

Based on the Indications for Use and the data presented in this submission, Moisyn is substantially equivalent to the predicate device Dr. Fresh Dry Mouthwash (K111250).