The Voutia™ system is indicated to provide relief of dry mouth by coating, and lubricating oral structures thereby relieving the symptoms of xerostomia (dry mouth).

Device Description

Voutia™ is a non-sterile, single person use device for the treatment of xerostomia, consisting of a circuit board controlled pump, a fluid reservoir bottle, and tubing extension that goes from the pump, over a person's ear and transitions to a smaller tube that terminates in the user's oral cavity. The Voutia™ system delivers potable water to the mouth at nine (9) preprogrammed user selectable rates over a defined time, allowing stationary or portable hands free use.

AI/ML Overview

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:

Device Name: Voutia™
K Number: K173808
Intended Use: The Voutia™ system is indicated to provide relief of dry mouth by coating, moistening, and lubricating oral structures, thereby relieving the symptoms of xerostomia (dry mouth).

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state formal "acceptance criteria" in a quantitative, measurable format with specific thresholds (e.g., "flow rate must be within X% of target"). Instead, it describes general performance evaluations. I will infer the "acceptance criteria" based on the described performance testing.

Acceptance Criteria (Inferred)	Reported Device Performance
Functional Performance (Bench Testing):
Reproducibility of water flow rate at selected levels.	Bench testing confirmed reproducibility of the water flow rate as intended on each selected level, meeting predetermined internal testing criteria.
Biocompatibility of fluid path components.	Biocompatibility assessment of fluid path components was conducted. Polyimide tubing meets USP Class VI testing evaluation and has established historical biocompatibility.
Clinical Performance (Proof of Concept & Functionality):
Confirm proof of concept and functionality during use (waking and sleeping hours).	Performed using a volunteer beta testing population who utilized the system during waking and sleeping hours to confirm proof of concept and functionality. (No specific metrics provided, but implies successful operation).
Absence of adverse physiological events.	No adverse physiological events were reported by the participants over a 16-month period.
Safety - Battery:
Lithium polymer battery safety.	The lithium polymer battery has been tested by Underwriters Laboratory and passed all safety testing consistent with a single cell power source.

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

Sample Size: "a volunteer beta testing population" is mentioned. The exact number of participants is not specified in the document.
Data Provenance: The study was a "beta testing" conducted using volunteers, which implies a prospective study. The country of origin is not specified, but given the FDA submission, it implicitly refers to data relevant for the US market.

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

This study does not involve establishing a ground truth through expert consensus in the typical sense (e.g., for diagnostic accuracy). Instead, it focuses on the functional performance, safety, and user experience for a device that delivers water.

The "ground truth" for the non-clinical performance (reproducibility of flow rate, biocompatibility) would have been established by engineering and materials science standards/tests.
For the clinical performance, the "ground truth" was likely the participants' self-reported experience regarding relief of dry mouth symptoms (confirming proof of concept and functionality) and the absence of reported adverse events. There is no mention of external "experts" establishing a ground truth for the test set or their qualifications.

4. Adjudication Method for the Test Set

Given the nature of the device (water delivery for dry mouth relief) and the described "volunteer beta testing," there is no mention of an adjudication method (like 2+1 or 3+1 consensus). The evaluation of use was likely based on direct participant experience and reporting.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This device is a water delivery system for symptomatic relief of dry mouth, not an AI-powered diagnostic or assistive tool for human readers. Therefore, this question is not applicable.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, this is not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm is not applicable. The device itself (the pump system) has standalone functional performance which was tested via bench testing.

7. The Type of Ground Truth Used

Non-Clinical Performance: Engineering standards for flow rate reproducibility and recognized materials testing standards (e.g., USP Class VI for biocompatibility).
Clinical Performance: User self-reporting of perceived symptom relief ("proof of concept and functionality") and adverse events. This aligns more with outcomes data in a general sense, focusing on user experience and safety outcomes rather than a diagnostic "ground truth."

8. The Sample Size for the Training Set

This document describes a medical device, not a machine learning or AI algorithm. Therefore, the concept of a "training set" in the context of AI is not applicable. The design and development of the device would have involved internal testing and iterations, but these are not referred to as a "training set" in the AI sense.

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

As per item 8, the concept of a "training set" for an AI algorithm is not applicable to this device.

Summary

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July 27, 2018

Jeffrey Ward Cash, DDS 10149 Bon Air Crest Drive North Chesterfield, Virginia 23235-4868

Re: K173808

Trade/Device Name: Voutia™ Regulatory Class: Unclassified Product Code: LFD Dated: June 27, 2018 Received: June 27, 2018

Dear Dr. Cash:

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 Mav 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 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)

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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,

Mary S. Runner -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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Indications for Use

510(k) Number (if known) K173808

Device Name Voutia™M

Indications for Use (Describe)

The Voutia™ system is indicated to provide relief of dry mouth by coating, and lubricating oral structures thereby relieving the symptoms of xerostomia (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)

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Virginia Head and Neck Therapeutics, LLC

510(k) Summary for K173808

Date Prepared	06/27/2018
Submitter	Jeffrey Ward Cash, DDS, FICD
Primary Contact	Jeffrey Ward Cash, DDS, FICD10149 Bon Air Crest DriveNorth Chesterfield, VA 23235-4868
Device Common Name	Saliva, Artificial
Trade Name	Voutia™
Product Code and Classification	LFD, Unclassified
Predicate Device	Xeros Dry Mouth Pump Lorin TechnologiesCorporation K110116
Device Description	Voutia™ is a non-sterile, single person use devicefor the treatment of xerostomia, consisting of acircuit board controlled pump, a fluid reservoirbottle, and tubing extension that goes from thepump, over a person's ear and transitions to asmaller tube that terminates in the user's oralcavity. The Voutia™ system delivers potablewater to the mouth at nine (9) preprogrammeduser selectable rates over a defined time,allowing stationary or portable hands free use.
Intended Use	The Voutia™ system is indicated to provide reliefof dry mouth by coating, moistening andlubricating oral structures thereby relieving thesymptoms of xerostomia (dry mouth).

	Voutia K173808	Xeros-1 K110116
Device
Intended use	Systematic Treatment ofXerostomia	Systematic Treatment ofXerostomia
Method of use	Ready to use Liquid	Ready to use Liquid
Applications perday	Use as needed	Use as needed
Disease state	Xerostomia	Xerostomia
Area of use	Oral Cavity	Oral Cavity
Dispensed	Positive Displacement Pump	Positive Displacement Pump
Presentation	Non-Sterile	Non-Sterile

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Virginia Head and Neck Therapeutics, LLC

PerformanceTesting	Non - Clinical Performance testing Bench testing was conducted to confirm reproducibility of the water flowrate as intended on each selected level, meeting the predeterminedinternal testing criteria. Biocompatibility assessment of fluid path components Clinical Performance testing was performed using a volunteer beta testingpopulation who utilized the system during waking and sleeping hours to confirmproof of concept and functionality of the system. Evaluation of use was over a 16month period and no adverse physiological events were reported by theparticipants.
SubstantialEquivalence	Both devices utilize the same modality of fluid delivery (positive displacementpump) and both are controlled by a microprocessor driven pump deliveringdefined dose volumes. The submission device has reduced weight, visible profileand increased use between charges in comparison to the predicate device. Thesubmission differs from the predicate with respect to 3 items: The pumping system the battery polyimide microlumen tube. Both submissions utilize a positive displacement pump. The submissionincorporates the use of a piezoelectric diaphragm pump instead of thepredicate's peristaltic pump. Both systems give the desired result whileeliminating a transported fluid's contact with contaminants. Thepiezoelectric pump also been used in numerous medical and laboratorydevices to date with a high degree of safety and success. The lithium polymer battery has been tested by Underwriters Laboratoryand passed all safety testing consistent with a single cell power source.Unlike the predicate device the submission's battery is housed in aprotective urethane housing which sequesters it from inadvertentenvironmental damage. The Polyimide tubing is routinely used in more invasive medical devicesand procedures and meets USP Class VI testing evaluation. Consistent andhistorical biocompatibility has been established for this material.
Conclusion	The similarities in technology, intended use, and performance testing dataprovided for the Voutia system device support the conclusion that Voutia issubstantially equivalent to the cited predicate device

PerformanceTesting

Non - Clinical Performance testing Bench testing was conducted to confirm reproducibility of the water flowrate as intended on each selected level, meeting the predeterminedinternal testing criteria. Biocompatibility assessment of fluid path components Clinical Performance testing was performed using a volunteer beta testingpopulation who utilized the system during waking and sleeping hours to confirmproof of concept and functionality of the system. Evaluation of use was over a 16month period and no adverse physiological events were reported by theparticipants.

SubstantialEquivalence

Both devices utilize the same modality of fluid delivery (positive displacementpump) and both are controlled by a microprocessor driven pump deliveringdefined dose volumes. The submission device has reduced weight, visible profileand increased use between charges in comparison to the predicate device. Thesubmission differs from the predicate with respect to 3 items: The pumping system the battery polyimide microlumen tube. Both submissions utilize a positive displacement pump. The submissionincorporates the use of a piezoelectric diaphragm pump instead of thepredicate's peristaltic pump. Both systems give the desired result whileeliminating a transported fluid's contact with contaminants. Thepiezoelectric pump also been used in numerous medical and laboratorydevices to date with a high degree of safety and success. The lithium polymer battery has been tested by Underwriters Laboratoryand passed all safety testing consistent with a single cell power source.Unlike the predicate device the submission's battery is housed in aprotective urethane housing which sequesters it from inadvertentenvironmental damage. The Polyimide tubing is routinely used in more invasive medical devicesand procedures and meets USP Class VI testing evaluation. Consistent andhistorical biocompatibility has been established for this material.

Conclusion

The similarities in technology, intended use, and performance testing dataprovided for the Voutia system device support the conclusion that Voutia issubstantially equivalent to the cited predicate device

Regulation Number and Section

N/A