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 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.

AI/ML Overview

The document provided is a 510(k) summary for the device "Lubricity®", an artificial saliva product. It aims to demonstrate substantial equivalence to a predicate device, Salinum®/Oraclair (K024148). The summary includes information on performance testing, but it does not detail specific acceptance criteria or provide a full study report with quantitative results needed to populate all the requested fields.

Here's the information that can be extracted or inferred from the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric/Objective	Acceptance Criteria (Not explicitly stated as numerical criteria)	Reported Device Performance
Oral lubrication improvement	Implied: Demonstrate improved oral lubrication.	Met primary study objective of improved oral lubrication.
Serious Adverse Events (SAEs)	Implied: No serious adverse events.	No serious adverse events were reported.
Biocompatibility: Cytotoxicity	Not explicitly stated.	Tested and implied to be acceptable (no specific results provided).
Biocompatibility: Delayed Hypersensitivity	Not explicitly stated.	Tested and implied to be acceptable (no specific results provided).
Biocompatibility: Oral Mucosal Irritation	Not explicitly stated.	Tested and implied to be acceptable (no specific results provided).
Biocompatibility: LD50 Short Term Toxicity	Not explicitly stated.	Tested and implied to be acceptable (no specific results provided).
Stability Testing	Not explicitly stated.	Tested and implied to be acceptable (no specific results provided).

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated. The document mentions "In clinical evaluation, Lubricity® met the primary study objective...", but does not provide the number of participants in this clinical evaluation.
Data Provenance: Not explicitly stated, but it is a premarket notification for a US FDA clearance, so the data is presumed to be submitted to the FDA for review. It's not specified if the clinical evaluation was retrospective or prospective, nor the country of origin of the data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. For a dry mouth product, "ground truth" might refer to expert assessment of symptoms or patient-reported outcomes, but the document does not specify.

4. Adjudication method for the test set

This information is not provided in the document.

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

This information is not applicable as the device is an artificial saliva product, not an AI-powered diagnostic or imaging device that would typically involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as the device is an artificial saliva product, not an algorithm.

7. The type of ground truth used

The document states "Lubricity® met the primary study objective of improved oral lubrication". This suggests the ground truth was based on clinical evaluation outcomes, likely involving patient-reported symptoms and/or clinician assessments of oral lubrication and dry mouth symptoms. It does not mention pathology or other objective outcomes data in detail.

8. The sample size for the training set

This information is not applicable as the device is an artificial saliva product, not an algorithm that requires a training set in the typical machine learning sense.

9. How the ground truth for the training set was established

This information is not applicable for the reasons stated in point 8.

Summary

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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

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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

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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 PType 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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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 andClassification	LFD, unclassified
Predicate Device	Salinum®/Oraclair, Sinclair Pharmaceuticals, 510(k) Number K024148
Device Description	Lubricity® is an oral saliva substitute containing gel film formingpolysaccharides, Sodium Hyaluronate, which has lubricating andmoisturizing properties in the buccal cavity. The product is formulated,preserved and packed in blow molded polyethylene terephthalate bottleswith a closure system comprising a metered dose liquid spray fittingmanufactured from polypropylene, high density polyethylene,polymethoxylene copolymer and stainless steel (spring). All containerclosure components have appropriate status under FDA food contact orGRAS regulations. The device components are summarized in the followingtable.Lubricity® is equivalent to the predicate device Salinum®/Oraclair in itsintended use. Both of the products are artificial saliva agents designed forrelief from dry mouth symptoms.

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Intended Useof 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.
TechnologicalCharacteristics
	PRODUCT NAME	Lubricity ®	Salinum®/Oraclair
	INGREDIENTS	Water, Xylitol, SodiumHyaluronate, SodiumBenzoate, PotassiumSorbate, Hydrochloric Acid	Linseed extract,Methylparaben,Propylparaben, Dipotassiumphosphate
	INTENDED USE	Symptomatic Treatment ofXerostomia	Symptomatic Treatment ofXerostomia
	METHOD OF USE	Ready to use liquid	Ready to use liquid
	APPLICATION PERDAY	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
PerformanceTesting	Non-clinical Performance TestingBiocompatibilityCytotoxicityDelayed HypersensitivityOral Mucosal IrritationLD50 Short Term ToxicityStability TestingClinical Performance TestingIn clinical evaluation, Lubricity® met the primary study objective of improved oral lubrication with no serious adverse events.
SubstantialEquivalence	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

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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.

Regulation Number and Section

N/A