Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the chemical composition and physical properties of the oral rinse and lozenges, with no mention of AI or ML.

Therapeutic

Yes
The device is intended for the relief of dry mouth symptoms and its description indicates it is formulated as an artificial saliva substitute with lubricating, moisturizing, and soothing properties to alleviate discomfort, which aligns with the definition of a therapeutic device.

Diagnostic

No

The device is intended for the relief of dry mouth symptoms by providing moisturizing, lubricating, and soothing properties, not for diagnosing a condition.

SaMD (Software as a Medical Device)

No

The device description clearly states the products are an oral rinse and lozenges, which are physical substances, 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 for the relief of dry mouth symptoms by refreshing, moisturizing, lubricating, and soothing the oral cavity. This is a therapeutic or palliative use, not a diagnostic one.
Device Description: The description focuses on the composition and properties of the rinse and lozenges as artificial saliva substitutes. There is no mention of analyzing samples from the body to diagnose a condition.
Performance Studies: The performance studies described are related to product composition, physical properties, biocompatibility, and shelf-life. These are typical tests for a therapeutic or cosmetic product, not an IVD which would involve analytical performance studies related to detecting specific analytes or markers.
Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like saliva, blood, etc.), detecting specific substances, or providing information for the diagnosis of a disease or condition.

In summary, the purpose of this device is to alleviate symptoms of dry mouth, not to diagnose the underlying cause of dry mouth or any other condition. This aligns with the definition 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

TheraBreath Dry Mouth Oral Rinse is intended for relief of dry mouth symptoms and is indicated for use to refresh, moisturize, lubricate and soothe the oral cavity, and alleviate discomfort due to dry mouth.

TheraBreath Dry Mouth Lozenges are intended for relief of dry mouth symptoms, and are indicated for use to refresh, moisturize, lubricated, and soothe the oral cavity, and alleviate discomfort due to dry mouth.

Product codes

LFD

Device Description

TheraBreath Dry Mouth Oral Rinse and TheraBreath Dry Mouth Lozenges are specifically formulated as an artificial saliva substitute with moisturizers, humectants and salivary enzymes with lubricating, moisturizing and soothing properties to relieve the symptoms of dry mouth. In addition. TheraBreath Dry Mouth Lozenges continuously moisten the mouth to relieve the symptoms of Dry Mouth and to refresh breath. TheraBreath Dry Mouth Oral Rinse and TheraBreath Dry Mouth Lozenges are sugar-free, alcohol-free, and gluten-free.

TheraBreath Dry Mouth Oral Rinse is packaged in 16 ounce size bottles and is Tingling Mint flavored. TheraBreath Dry Mouth Lozenges are Mandarin Mint flavored and are sold in boxes of 24, 72, or 100 lozenges.

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

Unsupervised

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)

Testing of the TheraBreath dry mouth products was performed to determine product composition and demonstrate conformity with product specifications for color, appearance, pH, specific gravity, and preservative efficacy. Biocompatibility testing of the TheraBreath oral rinse and lozenge formulations was performed according to ISO 10993-5 for cytotoxicity and according to ISO 10993-10 for mucosal sensitization and irritation. The products passed all tests in conformity with the standards and testing determined that the TheraBreath dry mouth products were non-cytotoxic, non-sensitizing, and non-irritating. Accelerated aging testing was performed to establish a 3 year shelf-life for TheraBreath Dry Mouth Oral Rinse and real-time aging was performed to establish a 2 year shelf-life for TheraBreath Dry Mouth Lozenges.

Comparative laboratory testing was performed for TheraBreath Dry Mouth Oral Rinse and Dr. Fresh Orazyme Dry Mouth Mouthwash and confirmed that the physical properties were similar for the two products for pH, specific gravity, odor, color and appearance.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K152201

Reference Device(s)

K111250, K023046

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

N/A

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 16, 2018

Dr. Harold Katz, LLC (dba TheraBreath) % Barbara Fant President Clinical Research Consultants, Inc. 3308 Jefferson Avenue, Upper Level Cincinnati. Ohio 45220

Re: K171542

Trade/Device Name: TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges Regulatory Class: Unclassified Product Code: LFD Dated: February 7, 2018 Received: February 9, 2018

Dear Barbara Fant:

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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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 (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.

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 mediation-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.

Andrew I. Steen -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

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4. Indications for Use Statement

510(k) Number (if known): To Be Assigned K171542

Device Name:

TheraBreath Dry Mouth Oral Rinse TheraBreath Dry Mouth Lozenges

Indications for Use:

TheraBreath Dry Mouth Oral Rinse is intended for relief of dry mouth symptoms and is indicated for use to refresh, moisturize, lubricate and soothe the oral cavity, and alleviate discomfort due to dry mouth.

TheraBreath Dry Mouth Lozenges are intended for relief of dry mouth symptoms, and are indicated for use to refresh, moisturize, lubricated, and soothe the oral cavity, and alleviate discomfort due to dry mouth.

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)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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5. 510(k) Summary

510(k) Submission, Traditional; as required by (21CFR§807.92(c))

| 510(k) Owner: | Dr. Harold Katz, LLC (dba TheraBreath)
5802 Willoughby Avenue
Los Angeles, California 90038
Telephone: 323-762-8518
Facsimile: 323-993-8327
E-Mail: harold@drkatz.com |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Barbara S. Fant, Pharm.D.
Clinical Research Consultants, Inc.
3308 Jefferson Avenue, Upper Level
Cincinnati, Ohio 45220
Telephone: (513) 961-8200
Facsimile: (513) 961-2858
E-Mail: bsfant@crc-regulatory.com |
| Date: | March 15, 2018 |
| Trade Name: | TheraBreath Dry Mouth Oral Rinse
TheraBreath Dry Mouth Lozenges |
| Common name: | Dry mouth oral rinse
Dry mouth mouthwash
Dry mouth lozenges |
| Classification Name: | Saliva, Artificial; Unclassified |
| Product Code: | LFD |

Identification of a Legally Marketed Predicate Device

TheraBreath Dry Mouth Oral Rinse and TheraBreath Dry Mouth Lozenges are substantially equivalent to the legally marketed predicate device: MedActive Oral Relief Spray and MedActive Oral Relief Gel, marketed by Medactive Oral Pharmaceuticals, LLC, Premarket Notification Number: K152201, FDA Product Code LFD (Saliva, Artificial; Unclassified); and

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to the reference devices: Dr. Fresh Orazyme Dry Mouth Mouthwash marketed by Dr. Fresh, LLC, 510(k) Premarket Notification Number: K111250, FDA Product Code LFD (Saliva, Artificial; Unclassified); and, SST 100 Lozenges marketed by Hexim Pharmaceuticals, 510(k) Premarket Notification Number: K023046, FDA Product Code LFD (Saliva, Artificial; Unclassified).

General Description

TheraBreath Dry Mouth Oral Rinse and TheraBreath Dry Mouth Lozenges are specifically formulated as an artificial saliva substitute with moisturizers, humectants and salivary enzymes with lubricating, moisturizing and soothing properties to relieve the symptoms of dry mouth. In addition. TheraBreath Dry Mouth Lozenges continuously moisten the mouth to relieve the symptoms of Dry Mouth and to refresh breath. TheraBreath Dry Mouth Oral Rinse and TheraBreath Dry Mouth Lozenges are sugar-free, alcohol-free, and gluten-free.

TheraBreath Dry Mouth Oral Rinse is packaged in 16 ounce size bottles and is Tingling Mint flavored. TheraBreath Dry Mouth Lozenges are Mandarin Mint flavored and are sold in boxes of 24, 72, or 100 lozenges.

Intended Use/Indications for Use

TheraBreath Dry Mouth Oral Rinse is intended for relief of dry mouth symptoms and is indicated for use to refresh, moisturize, lubricate and soothe the oral cavity, and alleviate discomfort due to dry mouth.

TheraBreath Dry Mouth Lozenges are intended for relief of dry mouth symptoms, and are indicated for use to refresh, moisturize, lubricated, and soothe the oral cavity, and alleviate discomfort due to dry mouth.

TheraBreath Dry Mouth Program

When the TheraBreath dry mouth products are used together along with routine oral cleansing (i.e., toothbrushing), it provides a simple three-step solution to clean and moisturize the mouth:

Step 1. Cleansing: Brush with TheraBreath Dry Mouth Toothpaste at least twice daily.
Step 2, Rinsing: Rinse with TheraBreath Dry Mouth Oral Rinse after brushing, for up to ● 12 hours of dry mouth relief.
Step 3, Moisturizing: Use TheraBreath Dry Mouth Lozenges for convenience and ● moisturizing during the day, as often as required, to effectively relieve oral dryness by temporarily lubricating and moisturizing the mouth.

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Comparison of Technological Characteristics

TheraBreath Dry Mouth Oral Rinse and TheraBreath Dry Mouth Lozenges are substantially equivalent to Dr. Fresh Orazyme Dry Mouth Mouthwash (K111250) and to MedActive Oral Relief Spray and Gel (K152201) in intended use, design, materials, chemical composition, and performance. The products are all artificial saliva agents designed for relief from dry mouth symptoms. TheraBreath Dry Mouth Oral Rinse and Dr. Fresh Orazyme Dry Mouth Mouthwash both contain salivary enzymes. The TheraBreath and MedActive products contain Spilanthes Extract as a flavor. TheraBreath Dry Mouth Oral Rinse and TheraBreath Dry Mouth Lozenges are both manufactured for and distributed in the U.S.A. by Dr. Harold Katz. LLC (dba TheraBreath; Los Angeles, California). Dr. Fresh Orazyme Dry Mouth Mouthwash is manufactured and distributed in the U.S.A. by Dr. Fresh, LLC (Buena Park, California). MedActive Oral Relief Spray and Gel are manufactured and distributed in the U.S.A. by MedActive Oral Pharmaceuticals, LLC (Odessa, Florida).

The primary technological differences between the oral rinses are that: (1) the proprietary composition of the salivary enzymes in TheraBreath and Orazyme products are very similar, but not identical; (2) the product raw materials and chemical composition are similar, but not identical; and, (3) the TheraBreath products are directed for use as needed, whereas, Orazyme is directed for use 2 to 3 times per day.

Brief Summary of Non-Clinical Tests and Results

Testing of the TheraBreath dry mouth products was performed to determine product composition and demonstrate conformity with product specifications for color, appearance, pH, specific gravity, and preservative efficacy. Biocompatibility testing of the TheraBreath oral rinse and lozenge formulations was performed according to ISO 10993-5 for cytotoxicity and according to ISO 10993-10 for mucosal sensitization and irritation. The products passed all tests in conformity with the standards and testing determined that the TheraBreath dry mouth products were non-cytotoxic, non-sensitizing, and non-irritating. Accelerated aging testing was performed to establish a 3 year shelf-life for TheraBreath Dry Mouth Oral Rinse and real-time aging was performed to establish a 2 year shelf-life for TheraBreath Dry Mouth Lozenges.

Comparative laboratory testing was performed for TheraBreath Dry Mouth Oral Rinse and Dr. Fresh Orazyme Dry Mouth Mouthwash and confirmed that the physical properties were similar for the two products for pH, specific gravity, odor, color and appearance.

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| | TheraBreath
Dry Mouth
Oral Rinse | TheraBreath
Dry Mouth
Lozenges | Dr. Fresh
Orazyme Dry
Mouth
Mouthwash
(Reference
Device) | MedActive
Oral Relief
Spray, Gel
(Predicate) | Same or
Different |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatible | Yes | Yes | Yes | Yes | Same.
TheraBreath
products passed
testing criteria
in conformity
with ISO
10993-5 and
10993-10 for
cytotoxicity,
irritation, and
sensitization. |
| Physiologic
Physico-Chemical
Characteristics | Yes | Yes | Yes | Yes | Similar pH,
specific gravity,
color, odor and
appearance for
oral rinse
formulations |
| | TheraBreath
Dry Mouth
Oral Rinse | TheraBreath
Dry Mouth
Lozenges | Dr. Fresh
Orazyme Dry
Mouth
Mouthwash
(Reference
Device) | MedActive
Oral Relief
Spray, Gel
(Predicate) | Same or
Different |
| Intended Use | Relief of dry
mouth
symptoms | Relief of dry
mouth
symptoms | Relief of dry
mouth
symptoms | Relief of dry
mouth
symptoms | Same |
| Indications for Use | TheraBreath
Dry Mouth
Oral Rinse is
intended for
relief of dry
mouth
symptoms and
is indicated for
use to refresh,
moisturize,
lubricate and
soothe the oral
cavity, and
alleviate
discomfort due
to dry mouth. | TheraBreath
Dry Mouth
Lozenges are
intended for
relief of dry
mouth
symptoms, and
are indicated
for use to
refresh,
moisturize,
lubricated, and
soothe the oral
cavity, and
alleviate
discomfort due
to dry mouth. | Relieves the
symptoms of
dry mouth,
while
moisturizing
and
lubricating oral
dryness. | Provides
symptom relief
from Dry
Mouth and low
saliva including:
Oral discomfort,
Mucosal soft
tissue dryness,
Oral side effects
of illness,
therapies, and
medications.
Soothes
moistens and
lubricates.
Hydrates soft
tissue. | Indications for
artificial
salivas differ
slightly based
on product
offering |
| Disease State | Xerostomia | Xerostomia | Xerostomia | Xerostomia | Same |
| Area of Use | Oral cavity | Oral cavity | Oral cavity | Oral cavity | Same |
| Product Offering | Liquid oral
rinse | Oral Lozenge | Liquid Oral
Rinse | Spray, Gel | Different,
unique to each
Product |
| Enzymes | Yes | No | Yes | No | Similar for
products
containing
enzymes |
| Flavor/Moisturizer | Yes | Yes | Yes | Yes | Similar,
formulation
unique to each
product |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Same |
| Xylitol | Yes | Yes | Yes | Yes | Same |
| Color Additive | No | No | No | No | Same |
| Sugar-Free/Gluten-
Free | Yes | Yes | Yes | Yes | Same |
| Intended Population | Unsupervised | Unsupervised | Unsupervised | Unsupervised | Same |
| Applications Per Day | As needed | As needed | 2-3 times/day | As needed | Similar, instructions for use are unique to each product offering |
| | | | | | |

Basis of Substantial Equivalence

TheraBreath Dry Mouth Oral Rinse and TheraBreath Dry Mouth Lozenges are substantially equivalent to Dr. Fresh Orazyme Dry Mouth Mouthwash (K111250) and to MedActive Oral Relief Spray and Gel (K152201) in intended use, design, materials, chemical composition, and performance as artificial saliva products designed for relief from dry mouth symptoms. The ingredients used to formulate TheraBreath Dry Mouth Oral Rinse and TheraBreath Dry Mouth Lozenges are used in the predicate and reference devices, which are legally marketed for the same intended use and indications. Technological characteristics of the TheraBreath products and predicate and reference devices are summarized in the table below and support the substantial equivalence of the products.

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8

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| | TheraBreath
Dry Mouth
Oral Rinse | TheraBreath
Dry Mouth
Lozenges | Dr. Fresh
Orazyme Dry
Mouth
Mouthwash
(Reference
Device) | MedActive
Oral Relief
Spray, Gel
(Predicate) | Same or
Different |
|-----------------------------------------------------|----------------------------------------|--------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatible | Yes | Yes | Yes | Yes | Same.
TheraBreath
products
passed testing
criteria in
conformity
with ISO
10993-5 and
10993-10 for
cytotoxicity,
irritation, and
sensitization. |
| Physiologic Physico-
Chemical
Characteristics | Yes | Yes | Yes | Yes | Similar pH,
specific
gravity, color,
odor and
appearance for
oral rinse
formulations |