(156 days)
Not Found
No
The 510(k) summary describes a simple liquid spray for dry mouth relief and includes physical testing results, with no mention of AI, ML, or any computational analysis of data.
Yes
The device is intended to provide comfort, rapid relief of symptoms, and a protective coating for individuals suffering from dry mouth, which are therapeutic claims.
No
Explanation: The device is intended to provide comfort and relief for dry mouth symptoms, not to diagnose a condition. Its actions are palliative, focusing on symptom management rather than identifying or characterizing a disease.
No
The device is described as a "viscous liquid dispensed from a spray bottle," 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 provide comfort and relief from dry mouth symptoms. This is a therapeutic or palliative use, not a diagnostic one.
- Device Description: The device is a spray that coats the inside of the mouth to provide relief. It does not analyze any biological samples or provide information about a patient's health status.
- Performance Studies: The performance study described is a physical test (desorption testing) to evaluate the product's ability to retain moisture, which is relevant to its intended use for dry mouth relief. It is not a study evaluating diagnostic accuracy.
- Predicate Device: The predicate device (Biotene Moisturizing Mouth Spray) is also a product for dry mouth relief, not an IVD.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
- Elevate Moisturizing Spray is indicated to provide comfort for individuals suffering from
dry mouth. It is recommended to be used by people who may experience difficulties in
eating, speaking or are suffering from discomfort due to dry mouth. - Elevate Moisturizing Spray is indicated for rapid relief of dry mouth symptoms, to
provide a protective coating inside the mouth and to help control bad breath. - A mouth spray that quickly reduces mouth discomfort, oral malodor and other symptoms of
dry mouth.
Product codes (comma separated list FDA assigned to the subject device)
LFD
Device Description
Elevate Moisturizing Spray is a viscous liquid dispensed from a spray bottle into the mouth. The spray will coat the inside of the mouth for a period of time and create relief from dry mouth symptoms in those who suffer oral malodor, discomfort, difficulties eating or speaking from dry mouth complications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Inside the mouth
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)
Study Type: Physical Tests - Desorption Testing
Sample Size: Not specified (tested against Biotene Mouth Spray and GC Mint Moisturizing Gel)
Key Results:
| Product | Percent Loss (%) |
|---|---|
| Elevate Moisturizing Spray (21914-1) | 21.96 |
| Biotene Mouth Spray | 36.8 |
| GC Mint Moisturizing Gel | 17.15 |
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/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around a stylized image of three human profiles. The profiles are stacked on top of each other, creating a sense of unity and collaboration. The seal is simple, yet recognizable, and represents the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 19, 2015
Elevate Oral Care Mr. Steve Pardue Managing Member 346 Pike Road, Suite 5 West Palm Beach, Florida 33411
Re: K150074
Trade/Device Name: Elevate Moisturizing Spray Regulation Number: Unclassified Regulation Name: Artificial Saliva Regulatory Class: Unclassified Product Code: LFD Dated: March 19, 2015 Received: March 20, 2015
Dear Mr. Pardue:
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
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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Medical Devices/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 yours.
Erin | Keith -S
Erin I. Keith, M.S. Division 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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4. Indications for Use Statement
Indications for Use
510(k) Number (if known):
Device Name: Elevate Moisturizing Spray
Indications for Use:
- Elevate Moisturizing Spray is indicated to provide comfort for individuals suffering from ● dry mouth. It is recommended to be used by people who may experience difficulties in eating, speaking or are suffering from discomfort due to dry mouth.
- Elevate Moisturizing Spray is indicated for rapid relief of dry mouth symptoms, to provide a protective coating inside the mouth and to help control bad breath.
- A mouth spray that quickly reduces mouth discomfort, oral malodor and other symptoms of dry mouth.
Prescription Use ____ ___ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X_____X___ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page __ of ___________________________________________________________________________________________________________________________________________________________________
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Image /page/3/Picture/0 description: The image shows the logo for Elevate Oral Care. The logo consists of a blue globe-like icon on the left, followed by the word "elevate" in a blue, sans-serif font. Below "elevate" are the words "ORAL CARE" in a smaller, sans-serif font, also in blue. The logo is clean and professional, suggesting a focus on global oral health solutions.
5. 510(k) Summary
Submitter:
| Company: | Elevate Oral Care |
|---|---|
| Street: | 346 Pike Road, Suite 5 |
| City, State Zip: | West Palm Beach, FL 33411 |
| Country: | USA |
| Estab. Registration #: | 3009603151 |
| Correspondent: | Steve Pardue |
| Managing Member | |
| Phone: | 877-866-9113 |
| Fax: | 561-244-1927 |
| Email: | spardue@elevateoralcare.com |
| Date: | June 19, 2015 |
346 Pike Road, Suite 5 · Vest Palm Beach, FL 33411 e: 877-866-9113 · Fax: 561-244-1927
Name of Device
| Proprietary Name: | Elevate Moisturizing Spray |
|---|---|
| Classification Name: | Saliva, Artificial |
| Unclassified, pre-amendment | |
| Common Name: | Saliva, Artificial |
| Product Code: | LFD |
Predicate Devices
| Primary Predicate Device | 510(k) |
|---|---|
| Biotene Moisturizing Mouth Spray | K123731 |
| Reference Device | 510(k) |
Description
Elevate Moisturizing Spray is a viscous liquid dispensed from a spray bottle into the mouth. The spray will coat the inside of the mouth for a period of time and create relief from dry mouth symptoms in those who suffer oral malodor, discomfort, difficulties eating or speaking from dry mouth complications.
Elevate Moisturizing Spray is equivalent to the primary predicate device Boitene Moisturizing Mouth Spray, and GC Moisturizing Gel in its intended use. All three products are artificial saliva agents designed for relief from dry mouth symptoms.
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Indications for Use Comparison
Primary Predicate Device - Biotene Moisturizing Mouth Spray
-
. The Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse and Biotene Moisturizing Mouth Spray intended use is to relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness.
Reference Predicate Device - GC Moisturizing Gel -
. GC Oral Moisturizing Gel is designed to provide comfort for individuals suffering from dry mouth. It is recommended to be used for people who may experience difficulties in eating, speaking or are suffering from discomfort due to dry mouth.
-
. GC Oral Moisturizing Gel is indicated for the relief of dry mouth symptoms, to provide a protective coating inside the mouth, and help to control bad breath.
Elevate Moisturizing Spray
- . Elevate Moisturizing Spray is designed to provide comfort for individuals suffering from dry mouth. It is recommended to be used by people who may experience difficulties in eating, speaking or are suffering from discomfort due to dry mouth.
- Elevate Moisturizing Spray is indicated for rapid relief of dry mouth symptoms, to ● provide a protective coating inside the mouth and to help control bad breath.
- A mouth spray that quickly reduces mouth discomfort, oral malodor and other symptoms of dry mouth.
All claims of all three devices are similar in nature and are for the relief of dry mouth symptoms and/or oral malodor.
Technological Characteristics
The chemical composition of Elevate Moisturizing Spray is similar to the predicate devices. These products contain ingredients such as water, sodium carboxymethylcellulose, flavorings, sweeteners, glycerol and various thickening agents. The combination of these ingredients provides a pleasant flavor, lubrication and increased retention in the mouth when used.
The mode of action of Elevate Moisturizing Spray is substantially equivalent to the predicate devices.
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Summary of Physical Tests
Desorption Testing:
0.4g of each product was placed on a weighing dish and weighed followed by incubation at 37 degrees Celsius for 2 hours. A value obtained by dividing the weight change by the initial weight in terms of percentage was designated as moisture desorption degree.
Mean Percent Loss
| Product | Percent Loss (%) |
|---|---|
| Elevate Moisturizing Spray (21914-1) | 21.96 |
| Biotene Mouth Spray | 36.8 |
| GC Mint Moisturizing Gel | 17.15 |
Discussion of Differences
The variations in formula/composition for Elevate Moisturizing Spray from the predicate devices are as follows:
- Solvent: The main solvent in the current device and predicate devices is water. Other ● predicate devices used PEG-60 or Polyglycerol as additional solvents. Additional solvents were not needed to prepare Elevate Moisturizing Spray.
- Mucoadhesive Agents: A proprietary blend of ingredients were chosen as the . mucoadhesive agent over Polyvinyl Alcohol (VP/VA) or carboxymethylcelulose (CMC). These base ingredients work together to create a semi-viscous fluid (similar to the predicate devices) that can be retained in the mouth for a period of time. While present, these ingredients will act as a lubricant and carry a humectant, maintaining a moist mouth feel for the patient.
- Rheology Modifiers: The same blend of ingredients that act as mucoadhesive agents, . also increase the viscosity of the Elevate Moisturizing Spray to that of a semi-viscous liquid. This viscosity is similar in nature to the predicate devices.
- . Flavoring, Aromas, Sweeteners: The flavorings in Elevate Moisturizing spray are similar in nature to the predicate devices although the specific flavor may differ based on stated label flavor. All devices use aqueous solutions and a sweetener such as xylitol as the sweetener.
- Preservatives: Xylitol, sugar and other sugar substitutes have been shown to act as . preservatives in high concentrations (Int J Cosmet Sci. 2011 Oct;33(5):391-7). Xylitol was used to prevent microbial growth in the product.
- All other variations in the formula/composition are concentration and volume variations . of common ingredients to allow proper dispensing and use of the product and do not affect the function, indications, or performance of the product.
- These differences in formulation to the predicate devices do not alter the function, indications or performance of the product.
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Description of Substantial Equivalence
The chemical components in Elevate Moisturizing Spray have been used in predicate devices, are listed as GRAS ingredients, are approved food additives/ingredients, or a combination these conditions. We believe these facts well support the compatibility of Elevate Moisturizing Spray, and that the applicant device is substantially equivalent to the predicate devices properties, intended use and composition.
Information provided in this submission confirms the substantial equivalence to the predicate devices with common indications. The data provided in this 510(k) submission also shows that the composition is safe for its intended use based on the biocompatibility assessment and risk assessment conduced according to ISO 10993 and ISO 14971.
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.