(287 days)
No
The device description and performance studies focus on the chemical composition and physical properties of an oral rinse, with no mention of AI or ML technology.
Yes
The device is described as providing relief for symptoms of dry mouth, lubricating oral dryness, and soothing oral irritation, which are therapeutic effects.
No
This device provides relief of symptoms and discomfort, and its description focuses on its physical and chemical properties and patient comfort benefits, not on detecting, diagnosing, or monitoring a disease or condition.
No
The device description clearly states it is a liquid oral rinse packaged in bottles, which is a physical product, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it provides relief of symptoms and discomfort of dry mouth, refreshes, moisturizes, cleans, soothes oral irritation, and lubricates oral dryness. While it doesn't explicitly mention diagnosing a condition, the relief of symptoms associated with dry mouth falls under the scope of devices used to manage or treat conditions.
- Device Description: The description of the product as an "artificial saliva" and its formulation with various ingredients to provide moisturizing, soothing, and refreshing properties aligns with the characteristics of devices intended for use within the body (in this case, the oral cavity) to address a physiological issue (dry mouth).
- Anatomical Site: The device is used in the "Oral cavity," which is an internal part of the body.
- Predicate Device: The predicate device listed, "Biotene Dry Mouth Oral Rinse (K123731)," is also an oral rinse intended for dry mouth relief, and such devices are typically classified as medical devices, often IVDs.
While the document doesn't mention processing biological samples or providing diagnostic information in the traditional sense of a lab test, the definition of an IVD can encompass devices used to manage or treat conditions within the body, especially when they are intended to address a physiological issue like dry mouth. The fact that it's regulated through a 510(k) submission and compared to predicate devices further supports its classification as a medical device, and given its intended use within the oral cavity to address a symptom, it fits the criteria for an IVD.
N/A
Intended Use / Indications for Use
Provides relief of the symptoms and discomfort of dry mouth; refreshes, moisturizes, cleans, soothes oral irritation and lubricates oral dryness. Freshens breath.
Product codes (comma separated list FDA assigned to the subject device)
LFD
Device Description
SmartMouth® DryMouth Oral Rinse is a specially formulated water soluble artificial saliva with for use at home in the oral cavity. It is formulated with water, humectants/moisturizers, including two moisture-rich humectants that are plant based, thickeners/binders, buffers, sweeteners, flavor, and colorant that collectively have moisturizing, soothing, and refreshing properties. The device is provided ready to use as a non-sterile, two-part semi-viscous green colored liquid packaged in white polyethylene terephthalate (PET) bottles with a clear polypropylene cap that present the liquid out of the polypropylene spout.
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
Home use; OTC
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)
Non Clinical Tests performed:
Shelf-life stability testing, physical property comparison data, and a biocompatibility assessment demonstrate that the SmartMouth® DryMouth Oral Rinse (a) meets device specifications, and (b) is substantially equivalent to the predicate devices:
- Shelf-Life Stability Testing provides for a 36 month shelf life of the subject device, which is the same as the primary predicate device.
- Comparative physical property data of SmartMouth® DryMouth Oral Rinse and Predicate/Reference Devices demonstrate substantial equivalence in terms of Appearance, Color, Odor, pH, Viscosity, Specific Gravity, Water Content.
- Biocompatibility assessment accordance with the FDA guidance document "Use of International Standard ISO 10993-1. Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and an analysis based on use of the product as an oral rinse, demonstrates that SmartMouth® DryMouth Oral Rinse is safe for use as directed.
Clinical test:
No clinical tests were conducted in support of this 510(k) submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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Triumph Pharmaceuticals, Inc. % H. Jenkins Counsel Wood Burditt Group 10 E. Scranton Ave., Ste. 201 Lake Bluff, Illinois 60044
February 15, 2019
Re: K181194
Trade/Device Name: SmartMouth DryMouth Oral Rinse Regulatory Class: Unclassified Product Code: LFD Dated: January 17, 2019 Received: January 18, 2019
Dear H. Jenkins:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; 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 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. igitally signed by Mary ' Mary S. ה Runner -S3 - -Date: 2019.02.15 22:12:15
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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Indications for Use
510(k) Number (if known) K181194
Device Name SmartMouth® DryMouth Oral Rinse
Indications for Use (Describe)
Provides relief of the symptoms and discomfort of dry mouth; refreshes, moisturizes, cleans, soothes oral irritation and lubricates oral dryness. Freshens breath.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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The Wood Burditt Group LLC 10 E. Scranton Ave., Suite 201 Lake Bluff, IL 60044 847. 234. 7500 (tel.) 847. 574. 0728 (e-fax) www.woodburditt.com
K181194 510(k) Summary
Date prepared: February 15, 2019
| Submitter / Contact Person | H. Carl Jenkins
The Wood Burditt Group
10 E. Scranton Ave, Suite 201
Lake Bluff, IL 60044 |
|----------------------------|----------------------------------------------------------------------------------------------------|
| | (ph) 847-234-7500 x 205
(fax) 847-578-0728
(email) hcjenkins@woodburditt.com |
| Applicant | Triumph Pharmaceuticals, Inc.
12312 Olive Blvd., Ste. 250
St. Louis, MO 63141 |
| ----------- | ------------------------------------------------------------------------------------- |
|---|
Device
| Trade Name | SmartMouth® DryMouth Oral Rinse |
|---|---|
| Proprietary Name | SmartMouth® DryMouth Oral Rinse |
| Common Name | Oral Rinse |
| Classification Name | Artificial Saliva |
| Classification Panel | Dental |
| Regulation | N/A (Unclassified Device) |
| Product Code | LFD |
| Classification | Unclassified |
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Device Description
SmartMouth® DryMouth Oral Rinse is a specially formulated water soluble artificial saliva with for use at home in the oral cavity. It is formulated with water, humectants/moisturizers, including two moisture-rich humectants that are plant based, thickeners/binders, buffers, sweeteners, flavor, and colorant that collectively have moisturizing, soothing, and refreshing properties. The device is provided ready to use as a non-sterile, two-part semi-viscous green colored liquid packaged in white polyethylene terephthalate (PET) bottles with a clear polypropylene cap that present the liquid out of the polypropylene spout.
Indications for Use:
Provides relief of the symptoms and discomfort of dry mouth; refreshes, moisturizes, cleans, soothes oral irritation and lubricates oral dryness. Freshens breath.
| Name | Biotene Dry Mouth Oral Rinse
(Primary Predicate Device) |
|---------------|------------------------------------------------------------|
| 501(k) Number | K123731 |
| Name | Hyrdris Oral Rinse
(Reference Predicate Device) |
| 501(k) Number | K163029 |
Predicate Devices
Technological characteristics and comparison
SmartMouth® DryMouth Oral Rinse is substantially equivalent to Biotene Dry Mouth Oral Rinse and Hyrdis Oral Rinse. They utilize the same fundamental scientific technology (a formulation of water, humectants or moisturizers, thickening/binding agents, buffering agents, sweeteners, flavor, surfactants and preservatives). All three devices also have substantially equivalent Indications for Use: predominantly providing relief from dry mouth.
Although the subject device and predicate devices are similar, the subject device differs slightly in terms of exact indications for use, packaging, labeling, and ingredient composition. In particular, the subject device indications for use includes a 'freshens breath' indication, but this addition (along with the corresponding differences in labeling) is an extension of the more general "refreshes" indication of the predicate devices. The ingredient composition of the subject device aligns with the composition of the product as it is marketed for cosmetic purposes, which is the reason for the two liquid system of the device. These differences however do not raise concerns of safety and effectiveness, as demonstrated by the physical properties comparison data generated from comparative testing of the subject device and the predicate devices, as well as the biocompatibility assessment conducted on the subject device. And despite these differences between the subject device and predicate devices, the predicate devices were selected as such by
5
the applicant because of the similarities in terms of overall indications for use, intended use, and mechanics of the dry mouth relief benefits provided by all three devices.
The following table provides a comparison between the proposed device and the predicate and reference devices:
Comparison of Predicate Devices to Proposed Device
| Primary Predicate Device | Reference Device | Proposed device | |
|---|---|---|---|
| Trade Name | Biotene Dry Mouth Oral | ||
| Rinse | Hydris Oral Rinse | SmartMouth® DryMouth Oral | |
| Rinse | |||
| 510(k) Number | K123731 | K163029 | K181194 |
| Classification Name | Artificial Saliva | Artificial Saliva | Artificial Saliva |
| Indications for Use | Relieves the symptoms of | ||
| dry mouth,refresh, | |||
| moisturize, clean, soothe | |||
| oral irritation and lubricate | |||
| oral dryness | Relieves the symptoms and | ||
| discomfort of dry mouth, | |||
| refresh, moisturize/hydrate, | |||
| clean, soothe oral irritation | |||
| and lubricate oral dryness. | Provides relief of the symptoms | ||
| and discomfort of dry mouth; | |||
| refreshes, moisturizes, rehydrates, | |||
| cleans, soothes oral irritation and | |||
| lubricates oral dryness. Freshens | |||
| breath. | |||
| Dosage Form | Oral Rinse | Oral Rinse | Oral Rinse |
| Dosage (Per Use) | 1 Tablespoon (~ 15 mL) | 20 mL (4 teaspoons) | 20 mL (4 teaspoons) |
| Method of Use | Ready to use liquid | Ready to use liquid | Ready to use liquid |
| Area of Use | Oral cavity | Oral cavity | Oral cavity |
| Applications/day | Up to 5 times daily | 2 times daily | 2 times daily |
| Prescription/OTC | OTC | OTC | OTC |
| Packaging | 8 FL OZ, 16 FL OZ, 33.8 FL OZ | ||
| bottles, designed for one-liquid | |||
| formulation. | 8 FL OZ, 16.9 FL OZ, | ||
| 33.8 FL OZ bottles, | |||
| designed for one-liquid | |||
| formulation. | 16 FL OZ, 32 FL OZ bottles, | ||
| specially designed for two-liquid | |||
| formulation of product as it is | |||
| marketed for cosmetic purposes. |
Other similarities between the subject device and predicate devices include the OTC intended home use; the same thickener/binder between the subject device and reference device; similar appearance, color, specific gravity, odor, pH, viscosity, and water content. Because of these similarities, the Biotene and Hydris products were selected by the applicant as the predicate devices, and any slight differences between the proposed device and the predicate devices do not raise issues of safety and effectiveness.
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Non Clinical Tests performed:
Shelf-life stability testing, physical property comparison data, and a biocompatibility assessment demonstrate that the SmartMouth® DryMouth Oral Rinse (a) meets device specifications, and (b) is substantially equivalent to the predicate devices:
- Shelf-Life Stability Testing provides for a 36 month shelf life of the subject device, which is the same as the primary predicate device.
- Comparative physical property data of SmartMouth® DryMouth Oral Rinse and -Predicate/Reference Devices demonstrate substantial equivalence in terms of Appearance, Color, Odor, pH, Viscosity, Specific Gravity, Water Content.
- -Biocompatibility assessment accordance with the FDA guidance document "Use of International Standard ISO 10993-1. Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and an analysis based on use of the product as an oral rinse, demonstrates that SmartMouth® DryMouth Oral Rinse is safe for use as directed.
Clinical test:
No clinical tests were conducted in support of this 510(k) submission.
Conclusion
Based upon similarities in indications for use and technology, as well as non-clinical performance testing, SmartMouth® DryMouth Oral Rinse is substantially equivalent to the predicate devices Biotene Dry Mouth Oral Rinse (K123731) and Hydris Oral Rinse (K163029).