Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a simple pump system with preprogrammed, user-selectable flow rates. There is no mention of adaptive learning, data analysis for personalized delivery, or any other characteristic typically associated with AI/ML. The "Not Found" entries for AI/ML mentions and training/test set descriptions further support this conclusion.

Therapeutic

Yes
The device is indicated to provide relief of dry mouth symptoms by coating and lubricating oral structures, which directly addresses a health condition.

Diagnostic

No

The device is indicated to provide relief of dry mouth by coating and lubricating oral structures, relieving symptoms of xerostomia. It delivers potable water to the mouth and is described as a treatment device, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of hardware components including a circuit board controlled pump, fluid reservoir bottle, and tubing extension.

IVD (In Vitro Diagnostic)

Based on the provided information, the Voutia™ system is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is to provide relief of dry mouth by coating and lubricating oral structures. This is a therapeutic or symptomatic relief function, not a diagnostic one.
Device Description: The device delivers potable water to the mouth. It does not analyze biological samples (like blood, urine, saliva, etc.) to provide diagnostic information.
Lack of Diagnostic Activity: There is no mention of the device performing any tests or measurements on biological samples to diagnose a condition or provide information about a patient's health status.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Voutia™ system operates in vivo (within the body) by delivering water to the oral cavity for symptomatic relief.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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).

Product codes (comma separated list FDA assigned to the subject device)

LFD

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.

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

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

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

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.

Xeros Dry Mouth Pump Lorin Technologies Corporation K110116

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.

Not Found

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

Regulation Number and Section

N/A

Summary

0

Image /page/0/Picture/0 description: The image contains 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.

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)

1

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

2

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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3

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, FICD
10149 Bon Air Crest Drive
North 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 Technologies
Corporation K110116
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.
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).

| Technological

Characteristics		Voutia K173808	Xeros-1 K110116
	Device
	Intended use	Systematic Treatment of
Xerostomia	Systematic Treatment of
Xerostomia
	Method of use	Ready to use Liquid	Ready to use Liquid
	Applications per
day	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

4

Virginia Head and Neck Therapeutics, LLC

| Performance
Testing | Non - Clinical Performance testing Bench testing was conducted to confirm reproducibility of the water flow
rate as intended on each selected level, meeting the predetermined
internal testing criteria. Biocompatibility assessment of fluid path components Clinical Performance testing was performed using a volunteer beta testing
population who utilized the system during waking and sleeping hours to confirm
proof of concept and functionality of the system. Evaluation of use was over a 16
month period and no adverse physiological events were reported by the
participants. |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial
Equivalence | Both devices utilize the same modality of fluid delivery (positive displacement
pump) and both are controlled by a microprocessor driven pump delivering
defined dose volumes. The submission device has reduced weight, visible profile
and increased use between charges in comparison to the predicate device. The
submission 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 submission
incorporates the use of a piezoelectric diaphragm pump instead of the
predicate's peristaltic pump. Both systems give the desired result while
eliminating a transported fluid's contact with contaminants. The
piezoelectric pump also been used in numerous medical and laboratory
devices to date with a high degree of safety and success. The lithium polymer battery has been tested by Underwriters Laboratory
and passed all safety testing consistent with a single cell power source.
Unlike the predicate device the submission's battery is housed in a
protective urethane housing which sequesters it from inadvertent
environmental damage. The Polyimide tubing is routinely used in more invasive medical devices
and procedures and meets USP Class VI testing evaluation. Consistent and
historical biocompatibility has been established for this material. |
| Conclusion | The similarities in technology, intended use, and performance testing data
provided for the Voutia system device support the conclusion that Voutia is
substantially equivalent to the cited predicate device |