(149 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of the mouth spray, with no mention of AI or ML technologies.
Yes
The device is intended to relieve symptoms and refresh, moisturize, soothe, and lubricate, which aligns with the definition of a therapeutic device designed to treat or alleviate a condition.
No
This device is intended to relieve symptoms of dry mouth and moisturize, not to diagnose a condition.
No
The device description clearly states it is a liquid spray product packaged in bottles with a spray fitting, indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to relieve symptoms of dry mouth, refresh, moisturize, soothe oral irritation, and lubricate dryness in and around the oral cavity. This is a therapeutic and symptomatic relief purpose, not a diagnostic one.
- Device Description: The description details an oral saliva substitute with lubricating and moisturizing properties. It does not mention any components or mechanisms for analyzing biological samples (like blood, urine, saliva, etc.) to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing information for the diagnosis of a disease or condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. This device's function is to provide symptomatic relief and lubrication within the oral cavity, which falls outside the scope of an IVD.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
LFD
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.
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
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.
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.
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
N/A
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
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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 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)
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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. |
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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 | | |
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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.