(287 days)
Provides relief of the symptoms and discomfort of dry mouth; refreshes, moisturizes, cleans, soothes oral irritation and lubricates oral dryness. Freshens breath.
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.
The provided document is a 510(k) summary for the SmartMouth® DryMouth Oral Rinse. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance criteria through extensive clinical studies like those for novel high-risk devices.
Therefore, the sections of your request regarding acceptance criteria, study details, expert involvement, and ground truth are not applicable to this document, as it describes a clearance process for a low-risk, unclassified device based on substantial equivalence.
Here's a breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: For this 510(k) submission, the primary "acceptance criteria" is demonstrating substantial equivalence to the predicate devices (Biotene Dry Mouth Oral Rinse K123731 and Hydris Oral Rinse K163029) in terms of Indications for Use, technological characteristics, safety, and effectiveness.
- Reported Device Performance:
- Indications for Use: The device provides relief of symptoms and discomfort of dry mouth; refreshes, moisturizes, rehydrates, cleans, soothes oral irritation and lubricates oral dryness. It also freshens breath. These are largely identical to the predicate devices, with "freshens breath" being an additional claim.
- Technological Characteristics: The device is a "formulation of water, humectants or moisturizers, thickening/binding agents, buffering agents, sweeteners, flavor, and colorant" for at-home oral cavity use.
- Shelf-life: 36 months, same as the primary predicate device.
- Physical Properties: Demonstrated substantial equivalence to predicate devices in Appearance, Color, Odor, pH, Viscosity, Specific Gravity, and Water Content through comparative physical property data.
- Biocompatibility: Assessed in accordance with ISO 10993-1, demonstrating safety for use as directed.
The document provides a comparison table of the proposed device against the predicate devices (see page 5 and 6 of the original document). This table effectively serves as the "performance against criteria" for this type of submission.
Table of Performance Comparison (Derived from the document):
| Feature/Criteria | Primary Predicate Device (Biotene Dry Mouth Oral Rinse K123731) | Reference Device (Hydris Oral Rinse K163029) | Proposed Device (SmartMouth® DryMouth Oral Rinse K181194) | Equivalence/Meeting Criteria |
|---|---|---|---|---|
| Indications for Use | Relieves symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation, lubricate oral dryness. | Relieves symptoms and discomfort of dry mouth, refresh, moisturize/hydrate, clean, soothe oral irritation, lubricate oral dryness. | Provides relief of symptoms and discomfort of dry mouth; refreshes, moisturizes, rehydrates, cleans, soothes oral irritation, lubricates oral dryness. Freshens breath. | Substantially Equivalent (with additional 'freshens breath' claim, deemed an extension of 'refreshes') |
| Technological Basis | Formulation of water, humectants/moisturizers, thickeners/binders, buffers, sweeteners, flavor, surfactants and preservatives. | Formulation of water, humectants/moisturizers, thickeners/binders, buffers, sweeteners, and flavor. | Formulation of water, humectants/moisturizers (plant-based), thickeners/binders, buffers, sweeteners, flavor, and colorant. | Substantially Equivalent |
| Shelf-life Stability | 36 months | (Not explicitly stated in comparison, assumed to be robust) | 36 months | Equivalent |
| Physical Properties | (Standard for oral rinses) | (Standard for oral rinses) | Appearance, Color, Odor, pH, Viscosity, Specific Gravity, Water Content demonstrated substantial equivalence. | Substantially Equivalent |
| Biocompatibility | (Assumed to be safe) | (Assumed to be safe) | Assessed per ISO 10993-1; deemed safe for use. | Sufficient |
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission did not involve a test set for clinical performance evaluation. Non-clinical tests were conducted on the device itself (e.g., shelf-life, physical properties, biocompatibility).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No clinical test set or "ground truth" establishment by experts was part of this 510(k) submission.
4. Adjudication method for the test set
- Not Applicable. No clinical test set requiring adjudication was part of this submission.
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 is a medical device (oral rinse), not an AI-assisted diagnostic tool. No MRMC studies were performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a medical device (oral rinse), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. For the non-clinical tests conducted, the "ground truth" was based on established scientific methods for measuring physical properties, stability, and biocompatibility standards (e.g., pH meters for pH, viscometers for viscosity, ISO 10993-1 for biocompatibility). There was no "ground truth" in the clinical sense with patient outcomes or expert consensus.
8. The sample size for the training set
- Not Applicable. This product is an oral rinse, not a machine learning model. There was no training set.
9. How the ground truth for the training set was established
- Not Applicable. This product is an oral rinse, not a machine learning model. There was no training set or ground truth for it.
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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
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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 JenkinsThe Wood Burditt Group10 E. Scranton Ave, Suite 201Lake 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. 250St. 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
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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 OralRinse | Hydris Oral Rinse | SmartMouth® DryMouth OralRinse |
| 510(k) Number | K123731 | K163029 | K181194 |
| Classification Name | Artificial Saliva | Artificial Saliva | Artificial Saliva |
| Indications for Use | Relieves the symptoms ofdry mouth,refresh,moisturize, clean, sootheoral irritation and lubricateoral dryness | Relieves the symptoms anddiscomfort of dry mouth,refresh, moisturize/hydrate,clean, soothe oral irritationand lubricate oral dryness. | Provides relief of the symptomsand discomfort of dry mouth;refreshes, moisturizes, rehydrates,cleans, soothes oral irritation andlubricates oral dryness. Freshensbreath. |
| 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 OZbottles, designed for one-liquidformulation. | 8 FL OZ, 16.9 FL OZ,33.8 FL OZ bottles,designed for one-liquidformulation. | 16 FL OZ, 32 FL OZ bottles,specially designed for two-liquidformulation of product as it ismarketed 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).
N/A