← Product Code LFD · K163476 # Lubricity (K163476) _You First Services, Incorporated · LFD · May 10, 2017 · DE · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K163476 ## Device Facts - **Applicant:** You First Services, Incorporated - **Product Code:** LFD - **Decision Date:** May 10, 2017 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** DE - **Attributes:** Therapeutic ## Intended Use The Lubricity® Moisturizing Mouth Spray's intended use is to relieve the symptoms of dry mouth, refresh, moisturize, soothe oral irritation and lubricate dryness in and around the oral cavity. ## Device Story Lubricity is an oral saliva substitute formulated with gel film-forming polysaccharides and Sodium Hyaluronate. It functions by increasing viscosity and forming a protective film on hard and soft oral surfaces to provide lubrication and moisture. The device is supplied as a non-sterile liquid in a polyethylene terephthalate bottle with a metered-dose spray fitting. It is intended for over-the-counter use by patients to manage xerostomia symptoms. Patients apply the spray to the oral cavity 3 to 4 times per day as needed. The device provides symptomatic relief of dry mouth, helping to soothe irritation and improve oral comfort. ## Clinical Evidence Clinical evaluation demonstrated that Lubricity met the primary study objective of improved oral lubrication. No serious adverse events were reported. ## Technological Characteristics Oral saliva substitute solution. Ingredients: Water, Xylitol, Sodium Hyaluronate, Sodium Benzoate, Potassium Sorbate, Hydrochloric Acid. Packaging: Polyethylene terephthalate bottle; metered-dose spray fitting (polypropylene, high-density polyethylene, polymethoxylene copolymer, stainless steel spring). Non-sterile. Biocompatibility testing included cytotoxicity, delayed hypersensitivity, oral mucosal irritation, and LD50 short-term toxicity. ## Predicate Devices - Salinum®/Oraclair ([K024148](/device/K024148.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three faces in profile, one behind the other. The seal is in black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 10, 2017 You First Services, Incorporated Jeffrey Eberhard Ouality Systems and Regulatory Affairs Manager 1576 Sweet Home Road Amherst, New York 14228 Re: K163476 Trade/Device Name: Lubricity Regulatory Class: Unclassified Product Code: LFD Dated: March 31, 2017 Received: April 3, 2017 Dear Jeffrey Eberhard: 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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, # Michael J. Ryan -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) K163476 Device Name Lubricity®, Artificial Saliva #### Indications for Use (Describe) The Lubricity® Moisturizing Mouth Spray's intended use is to relieve the symptoms of dry mouth, refresh, moisturize, soothe oral irritation and lubricate dryness in and around the oral cavity. | BARRENA PARTIE PARTIE PERSONAL PARTICITY CONTROLLERS PARTIES PARTIES PARTIES PARTIES PARTIES PARTIES PARTIES PARTIES PARTIES PARTIES PARTIES PARTIES PARTIES PARTIES PARTIES P
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 PRAStaff(@fda.hhs.gov "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}------------------------------------------------ Image /page/3/Picture/0 description: The image is a logo for YouFirst Group of Companies. The logo features a circular graphic on the left, composed of blue and purple curved lines. To the right of the graphic, the word "YouFirst" is written in a purple sans-serif font, with a small "TM" symbol in the upper right corner. Below "YouFirst", the words "GROUP OF COMPANIES" are written in a smaller, teal sans-serif font. ## Section 5 - 510(k) Summary | Date Prepared | May 8, 2017 | |------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter | You First Services, Incorporated | | Primary Contact | Jeffrey Eberhard, Ph.D. | | | Quality Systems and Regulatory Affairs Director | | | Baird Research Complex | | | 1576 Sweet Home Road | | | Amherst, New York 14228 | | | Telephone-716-204-7215 | | | jeberhard@youfirstservices.com | | Device Common Name | Saliva, artificial | | Trade Name | Lubricity® | | Product Code and
Classification | LFD, unclassified | | Predicate Device | Salinum®/Oraclair, Sinclair Pharmaceuticals, 510(k) Number K024148 | | Device Description | Lubricity® is an oral saliva substitute containing gel film forming
polysaccharides, Sodium Hyaluronate, which has lubricating and
moisturizing properties in the buccal cavity. The product is formulated,
preserved and packed in blow molded polyethylene terephthalate bottles
with a closure system comprising a metered dose liquid spray fitting
manufactured from polypropylene, high density polyethylene,
polymethoxylene copolymer and stainless steel (spring). All container
closure components have appropriate status under FDA food contact or
GRAS regulations. The device components are summarized in the following
table.

Lubricity® is equivalent to the predicate device Salinum®/Oraclair in its
intended use. Both of the products are artificial saliva agents designed for
relief from dry mouth symptoms. | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for YouFirst Group of Companies. The logo consists of a blue and purple circular graphic on the left, followed by the text "YouFirst" in purple. Below "YouFirst" is the text "GROUP OF COMPANIES" in a smaller, teal font. | Intended Use
of Device | The Lubricity® Moisturizing Mouth Spray's intended use is to relieve the symptoms of dry mouth, refresh, moisturize, soothe oral irritation and lubricate dryness in and around the oral cavity. | | | |----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------| | Technological
Characteristics | | | | | | PRODUCT NAME | Lubricity ® | Salinum®/Oraclair | | | INGREDIENTS | Water, Xylitol, Sodium
Hyaluronate, Sodium
Benzoate, Potassium
Sorbate, Hydrochloric Acid | Linseed extract,
Methylparaben,
Propylparaben, Dipotassium
phosphate | | | INTENDED USE | Symptomatic Treatment of
Xerostomia | Symptomatic Treatment of
Xerostomia | | | METHOD OF USE | Ready to use liquid | Ready to use liquid | | | APPLICATION PER
DAY | 3 to 4 times | As needed | | | DISEASE STATE | Xerostomia | Xerostomia | | | AREA OF USE | Oral Cavity | Oral Cavity | | | TYPE OF PRODUCT | Solution | Solution | | | PRESENTATION | Non-sterile | Non-sterile | | Performance
Testing | Non-clinical Performance Testing
Biocompatibility
Cytotoxicity
Delayed Hypersensitivity
Oral Mucosal Irritation
LD50 Short Term Toxicity
Stability Testing

Clinical Performance Testing
In clinical evaluation, Lubricity® met the primary study objective of improved oral lubrication with no serious adverse events. | | | | Substantial
Equivalence | The lubricating and moisturizing properties of a saliva substitute are imparted by the Sodium Hyaluronate in Lubricity®. The saliva substitute properties of the predicate are imparted by linseed extract. The subject device and the predicate protect and lubricate hard and soft surfaces of the oral cavity. The function of device components is to increase the viscosity and provide film formation | | | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for "YouFirst Group of Companies". The logo consists of a circular graphic on the left, made up of curved lines in shades of blue and purple. To the right of the graphic is the text "YouFirst" in a purple sans-serif font, with a small trademark symbol next to it. Below "YouFirst" is the text "GROUP OF COMPANIES" in a smaller, light blue sans-serif font. Discussion of Differences The variations in formula/composition for Lubricity® from the predicate device are as follows: The lubricating and moisturizing properties of Lubricity® are imparted by Sodium Hyaluronate and the preservatives used are Sodium Benzoate and Potassium Sorbate and Xylitol as the sweetener. The predicate device imparts its lubricating effect by the ingredient linseed extract. The preservatives used in the predicate device are Methylparaben and Propylparaben. These differences in formulation to the predicate devices do not alter the function, indications or performance of the product. Conclusion Based upon similarities in intended use, and on the results of non-clinical and clinical performance testing, Lubricity® is found to be substantially equivalent to the predicate device Salinum®/Oraclair identified in K024148. --- **Source:** [https://fda.innolitics.com/device/K163476](https://fda.innolitics.com/device/K163476) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com