Voutia™

K173808 · Jeffrey Ward Cash, Dds · LFD · Jul 27, 2018 · DE

Device Facts

• Record ID: K173808
• Device Name: Voutia™
• Applicant: Jeffrey Ward Cash, Dds
• Product Code: LFD · DE
• Decision Date: Jul 27, 2018
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Indications for 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).

Device Story

Voutia is a non-sterile, single-person use device for xerostomia treatment. It consists of a circuit board-controlled piezoelectric diaphragm pump, a fluid reservoir bottle, and tubing. The device delivers potable water to the oral cavity via a polyimide microlumen tube routed over the user's ear. It features nine preprogrammed, user-selectable flow rates for hands-free operation. The system is intended for use by patients in both stationary and portable contexts, including during sleep. By providing controlled, automated hydration to the oral cavity, the device coats and lubricates oral structures to relieve dry mouth symptoms. The device is powered by a lithium polymer battery housed in a protective urethane casing.

Clinical Evidence

Clinical performance testing involved a volunteer beta testing population using the system during waking and sleeping hours over a 16-month period. The study served to confirm proof of concept and system functionality. No adverse physiological events were reported by participants. Bench testing confirmed reproducibility of water flow rates at all selected levels.

Technological Characteristics

System uses a piezoelectric diaphragm pump for positive displacement fluid delivery. Components include a lithium polymer battery in a protective urethane housing and polyimide microlumen tubing (USP Class VI compliant). The device is non-sterile, microprocessor-controlled, and supports nine preprogrammed flow rates. Connectivity is standalone.

Indications for Use

Indicated for patients suffering from xerostomia (dry mouth) to provide relief by coating, moistening, and lubricating oral structures.

Predicate Devices

• Xeros Dry Mouth Pump Lorin Technologies Corporation (K110116)

Submission Summary (Full Text)

{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 ([e-mail]) or phone [phone] 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{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<br>10149 Bon Air Crest Drive<br>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<br>Corporation K110116 |
| Device Description | Voutia™ is a non-sterile, single person use device<br>for the treatment of xerostomia, consisting of a<br>circuit board controlled pump, a fluid reservoir<br>bottle, and tubing extension that goes from the<br>pump, over a person's ear and transitions to a<br>smaller tube that terminates in the user's oral<br>cavity. The Voutia™ system delivers potable<br>water to the mouth at nine (9) preprogrammed<br>user selectable rates over a defined time,<br>allowing stationary or portable hands free use. |
| Intended Use | The Voutia™ system is indicated to provide relief<br>of dry mouth by coating, moistening and<br>lubricating oral structures thereby relieving the<br>symptoms of xerostomia (dry mouth). |

| Technological<br>Characteristics | | Voutia K173808 | Xeros-1 K110116 |
|----------------------------------|-------------------------|---------------------------------------|---------------------------------------|
| | Device | | |
| | Intended use | Systematic Treatment of<br>Xerostomia | Systematic Treatment of<br>Xerostomia |
| | Method of use | Ready to use Liquid | Ready to use Liquid |
| | Applications per<br>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<br>Testing | Non - Clinical Performance testing Bench testing was conducted to confirm reproducibility of the water flow<br>rate as intended on each selected level, meeting the predetermined<br>internal testing criteria. Biocompatibility assessment of fluid path components Clinical Performance testing was performed using a volunteer beta testing<br>population who utilized the system during waking and sleeping hours to confirm<br>proof of concept and functionality of the system. Evaluation of use was over a 16<br>month period and no adverse physiological events were reported by the<br>participants. |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial<br>Equivalence | Both devices utilize the same modality of fluid delivery (positive displacement<br>pump) and both are controlled by a microprocessor driven pump delivering<br>defined dose volumes. The submission device has reduced weight, visible profile<br>and increased use between charges in comparison to the predicate device. The<br>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<br>incorporates the use of a piezoelectric diaphragm pump instead of the<br>predicate's peristaltic pump. Both systems give the desired result while<br>eliminating a transported fluid's contact with contaminants. The<br>piezoelectric pump also been used in numerous medical and laboratory<br>devices to date with a high degree of safety and success. The lithium polymer battery has been tested by Underwriters Laboratory<br>and passed all safety testing consistent with a single cell power source.<br>Unlike the predicate device the submission's battery is housed in a<br>protective urethane housing which sequesters it from inadvertent<br>environmental damage. The Polyimide tubing is routinely used in more invasive medical devices<br>and procedures and meets USP Class VI testing evaluation. Consistent and<br>historical biocompatibility has been established for this material. |
| Conclusion | The similarities in technology, intended use, and performance testing data<br>provided for the Voutia system device support the conclusion that Voutia is<br>substantially equivalent to the cited predicate device |