(498 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of a liquid spray, with no mention of AI or ML.
No
The device is described as an artificial saliva substitute that helps maintain the oral environment and provides relief from dry mouth symptoms, which is a supportive rather than therapeutic function.
No
The device is described as an artificial saliva substitute for instant relief of dry mouth symptoms, indicating a therapeutic or palliative purpose rather than diagnosis.
No
The device description clearly states it is a liquid spray in a bottle, which 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 instant relief and protection against dry mouth symptoms by maintaining the oral environment. This is a therapeutic or palliative use, not a diagnostic one.
- Device Description: The device is an artificial saliva substitute applied to the oral cavity. It contains ingredients that provide moisturizing, lubricating, soothing, and refreshing properties. This describes a product that acts on the body to alleviate symptoms, not a product used to test a sample from the body to diagnose a condition.
- Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze any substance or characteristic in a sample from the human body for the purpose of providing information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information about a person's health. This device is used in vivo (inside the body) to treat symptoms.
N/A
Intended Use / Indications for Use
Use as needed for instant relief. OraLabs Dry Mouth Pocket Spray helps maintain the oral environment and helps provide protection against dry mouth symptoms.
Product codes (comma separated list FDA assigned to the subject device)
LFD
Device Description
OraLabs Dry Mouth Pocket Spray is a specially formulated water soluble artificial saliva substitute with a pH between 5.20 to 7.20 for use at home in the oral cavity. OraLabs manufactures the products in a 0.25 FL OZ polyethylene bottle with a non-aerosol pump.
The formula contains water, moisturizers, thickeners/binders, buffers, flavor, sweetener and preservatives. The combination of ingredients collectively provides moisturizing, lubricating, soothing, and refreshing properties.
OraLabs uses a Natural Mint Blend (PE-116) that is recognized as safe (GRAS) on the FEMA/GRAS list.
OraLabs owns the formula, manufacture, label and packaging of this product.
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
Home
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)
The testing OraLabs selected to perform on OraLabs Dry Mouth Pocket Spray was to objectively prove substantial equivalence in safety and effectiveness of the proposed device to the declared predicate.
OraLabs Dry Mouth Pocket Spray is equivalent to Biotene based on performance testing of visual, sensory, pH, viscosity, moisture deabsorption and biocompatibility.
The results from these tests demonstrate that OraLabs Dry Mouth Pocket Spray is substantially equivalent.
OraLabs Dry Mouth Pocket Spray is substantially equivalent based on performance testing of stability, biocompatibility, anti-bacterial activity, efficacy of preservative, and elemental impurity testing. Biocompatibility testing for Biotene and OraLabs Dry Mouth Pocket Spray exhibited the same result on L929 Direct Contact Cytotoxicity Test. These results were contributed to the presence of the Surfactant Preservatives - Cetylpyridinium Chloride and Sodium Benzoate.
OraLabs Dry Mouth Pocket Spray tested favorably to the predicate device on appearance and sensory properties, pH, viscosity, and moisture absorption.
Stability studies indicate an expiration date of 24 months compared to Biotene's 36 months. USP testing shows the preservatives OraLabs added to OraLabs Dry Mouth Pocket Spray are acceptable for the expiration date.
An elemental impurity test was performed on OraLabs Dry Mouth Pocket Spray with acceptable results.
OraLabs conducted biocompatibility testing as listed in Use of International Standard ISO 10993-1 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Biocompatibility results show the OraLabs Dry Mouth Pocket Spray to be as safe as the predicate product to use to relieve dry mouth symptoms.
OraLabs performed accelerated stability according to ICH requirements. OraLabs Dry Mouth Pocket Spray was filled into individual spray bottles and sealed with the pump assembly. The product was placed into a stability chamber at 40°C/75% Relative Humidity (40_75). The product was tested at Baseline, 3 months, and 6 months for analytical, microbial, and organoleptic properties. Total Aerobic Count, Yeasts & Molds, pH, and organoleptic properties maintained an acceptable result at each stage of testing. Accelerated testing did not significantly alter the pH and the preservatives added to the OraLabs Dry Mouth Pocket Spray were acceptable as no growth was found on Total Aerobic Count and Yeasts & Molds. These results support OraLabs applying a 24 month expiration date.
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 21, 2019
OraLabs. Inc. Teresa Purdue Vice President of Quality 18685 East Plaza Drive Parker, Colorado 80134
Re: K181839
Trade/Device Name: CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray Regulatory Class: Unclassified Product Code: LFD Dated: August 20, 2019 Received: August 23, 2019
Dear Teresa Purdue:
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. 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
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181839
Device Name OraLabs Dry Mouth Pocket Spray
Indications for Use (Describe)
Use as needed for instant relief. OraLabs Dry Mouth Pocket Spray helps maintain the oral environment and helps provide protection against dry mouth symptoms.
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 shows the OraLabs logo. The logo is white text on a blue background. The text is in a sans-serif font and is slightly rounded. There is a registered trademark symbol in the upper right corner of the logo. The background is a rounded rectangle.
510(k) Summary
1. Purpose of the 510(k) Notice
OraLabs requests this 510(k) as it is a new device.
There are no prior submissions for OraLabs Dry Mouth Pocket Spray, or from manufacturer OraLabs for a Dry Mouth Spray.
OraLabs initially submitted documentation in July 2018 and was assigned number K181839. Additional correspondence was submitted in January 2019 and April 2019.
2. Submitter's Information - Name, Address, Telephone Number, Contact Person and Date Prepared
OraLabs, Inc. Gary Schlatter, CEO 18685 East Plaza Drive Parker, CO 80134 Phone:(303) 783-9499, Extension 3202 Fax: (303) 783-5759 www.oralabs.com
This revised summary was prepared on 07/19/19 and any questions shall be addressed to:
Teresa Purdue Vice President of Quality 18685 East Plaza Drive Parker, CO 80134 Phone:(303) 783-9499, Extension 3249 Fax: (303) 783-5759 teresap@oralabs.com www.oralabs.com
3. Device Name
- Proprietary name Dry Mouth Spray ●
- Common Name of Device Saliva, artificial ●
- Classification Name Unclassified ●
- Classification Product Code LFD ●
- Review Panel – Dental Device Panel
To my knowledge, the Food and Drug Administration has not classified this device.
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Image /page/4/Picture/0 description: The image is the logo for OraLabs. The logo is white text on a blue background. The text says "OraLabs".
4. Devices to Which Substantial Equivalence is Claimed:
OraLabs claims equivalence to Biotene®Moisturizing Mouth Spray, 510(k) Number K123731.
| Trade Name | Biotene® Dry Mouth Spray |
|---|---|
| Common Name | Oral Spray |
| Classification Name | Saliva, Artificial |
| Regulatory Classification | Unclassified (pre-amendment) |
| Product Code | LFD |
| Review Panel | Dental Devices Panel |
| 510(k) Number | K123731 |
| Submitter | GlaxoSmithKline Consumer Healthcare |
5. Device Description
OraLabs Dry Mouth Pocket Spray is a specially formulated water soluble artificial saliva substitute with a pH between 5.20 to 7.20 for use at home in the oral cavity. OraLabs manufactures the products in a 0.25 FL OZ polyethylene bottle with a non-aerosol pump.
The formula contains water, moisturizers, thickeners/binders, buffers, flavor, sweetener and preservatives. The combination of ingredients collectively provides moisturizing, lubricating, soothing, and refreshing properties.
OraLabs uses a Natural Mint Blend (PE-116) that is recognized as safe (GRAS) on the FEMA/GRAS list.
OraLabs owns the formula, manufacture, label and packaging of this product.
6. Performance Data
The testing OraLabs selected to perform on OraLabs Dry Mouth Pocket Spray was to objectively prove substantial equivalence in safety and effectiveness of the proposed device to the declared predicate.
5
Image /page/5/Picture/0 description: The image is a logo for OraLabs. The logo is set on a blue background with rounded corners. The text "OraLabs" is written in white, sans-serif font. There is a registered trademark symbol in the upper right corner of the logo.
OraLabs Dry Mouth Pocket Spray is equivalent to Biotene based on performance testing of visual, sensory, pH, viscosity, moisture deabsorption and biocompatability.
The results from these tests demonstrate that OraLabs Dry Mouth Pocket Spray is substantially equivalent.
OraLabs Dry Mouth Pocket Spray is substantially equivalent based on performance testing of stability, biocompatibility, anti-bacterial activity, efficacy of preservative, and elemental impurity testing. Biocompatibility testing for Biotene and OraLabs Dry Mouth Pocket Spray exhibited the same result on L929 Direct Contact Cytotoxicity Test. These results were contributed to the presence of the Surfactant Preservatives - Cetylpyridinium Chloride and Sodium Benzoate.
The proposed medical device, OraLabs Dry Mouth Pocket Spray, is demonstrated to be substantially equivalent to the predicate device, Biotene Moisturizing Mouth Spray.
7. Comparison Statements
OraLabs Dry Mouth Pocket Spray is substantially equivalent to Biotene® Moisturizing Mouth Spray.
They utilize the same fundamental scientific technology (a mixture of water, moisturizers, thickening/binding agents, buffering agents, sweeteners, flavor, and preservatives).
OraLabs Dry Mouth Pocket Spray is packaged in a smaller size than the Biotene® Moisturizing Mouth Spray, volume of 0.25 FL OZ vs. 1.5 FL OZ.
See next page for a Comparison Table.
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Image /page/6/Picture/0 description: The image shows the logo for OraLabs. The logo consists of the word "OraLabs" in white text on a blue background. The logo is rectangular with rounded corners and has a registered trademark symbol in the upper right corner.
| Trade Name | Predicate Device Biotene | Proposed Device |
|---|---|---|
| Moisturizing Mouth | OraLabs Dry Mouth | |
| Spray | Pocket Spray | |
| 510(k) Number | K123731 | K181839 |
| Classification Name | Artificial Saliva | Artificial Saliva |
| Product Code | LFD | LFD |
| Classification | Unclassified | Unclassified |
| Disease State | Xerostomia (Dry Mouth) | Xerostomia (Dry Mouth) |
| Intended Use | ||
| Indications for Use | Soothing Moisturization. | Use as needed for instant |
| Immediate symptom relief | relief. OraLabs Dry Mouth | |
| that lasts for up to four | Pocket Spray helps | |
| hours. Helps keep mouth | maintain the oral | |
| fresh. | environment and helps | |
| provide protection against | ||
| dry mouth symptoms. | ||
| Dosage Form | Oral Spray | Oral Spray |
| Dosage (Per Use) | ||
| Method of Use | Spray | Spray |
| Area of Use | Oral cavity | Oral Cavity |
| Applications/dav | Up to 5 times daily | As needed for relief of dry |
| Prescription/OTC | mouth symptoms. | |
| Environment of Use | OTC | OTC |
| Solvent | Home | Home |
| Humectants/Moisturizers | Water | Water |
| Sweeteners/Humectants | Glycerin | Glycerin |
| Xylitol, Sodium Saccharin | Xylitol, Sodium Saccharin | |
| Thickeners/Binders | VP/VA Copolymer | VP/VA Copolymer |
| Xanthan Gum | Xanthan Gum | |
| Surfactant Preservatives | Cetylpyridinium Chloride | Cetylpyridinium Chloride. |
| Sodium Benzoate | Sodium Benzoate | |
| Methylparaben | ||
| Propylparaben | ||
| Flavor | Mint Flavor | Mint Flavor |
| Area of Use | Oral Cavity | Oral Cavity |
| Disease State | Xerostomia (Dry Mouth) | Xerostomia (Dry Mouth) |
| Appearance | Cloudy, semi-viscous | Cloudy, semi-viscous |
| pH | 6.02, 6.11 | 5.2 — 7.2 |
| Viscosity | 7700 mPas; 7820 mPas | 5120 mPa*s |
| Moisture Deabsorption | 8.16% | 9.97% |
| Solubility | Water Soluble | Water Soluble |
| Packaging Unit | 1.5 FL OZ | 0.25 FL OZ |
| Packaging Material - | ||
| Bottle | White polyethylene | |
| terephthalate (PET) | Clear polyethylene | |
| terephthalate (PET) | ||
| Packaging Material - | ||
| Cap | Polypropylene | Polypropylene |
| Prescription/OTC | OTC | OTC |
| Sterility | Non-sterile | Non-Sterile |
| Shelf-Life | 36 months | 24 months |
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Image /page/7/Picture/0 description: The image shows the logo for OraLabs. The logo is white text on a blue background. The text is in a sans-serif font and is slightly rounded. There is a registered trademark symbol in the upper right corner of the logo.
Table A - Comparison of Predicate Device to Formula SPY DMS
8. Discussion of Differences
-
. Size and color of container
OraLabs designed the OraLabs Dry Mouth Pocket Spray to be a pocket spray size that consumers can carry with them. The size of 0.25 fl oz (7.5 ml) is smaller than Biotene's 1.5 fl oz (44.3 ml). OraLabs used a clear plastic bottle instead of a white bottle like the predicate device, Biotene. -
Preservatives .
OraLabs uses two preservatives that the predicate device, Biotene has in their formula, Cetylpyridinium Chloride and Sodium Benzoate. Biotene adds methylparaben and propylparaben. OraLabs intentially opted to omit the parabens due to published literature on the use of parabens in cosmetic and OTC drug products. Performance testing (Stability) demonstrated that Cetylpyridinium Chloride and Sodium Benzoate are adequate to support a 24 month expiration date. -
Expiration date ●
The predicate device. Biotene, applies a 36 month expiration date. OraLabs stability protocol supports a 24 month expiration date.
9. Bench Testing
OraLabs Dry Mouth Pocket Spray tested favorably to the predicate device on appearance and sensory properties, pH, viscosity, and moisture absorption.
Stability studies indicate an expiration date of 24 months compared to Biotene's 36 months. USP testing shows the preservatives OraLabs added to OraLabs Dry Mouth Pocket Spray are acceptable for the expiration date.
An elemental impurity test was performed on OraLabs Dry Mouth Pocket Spray with acceptable results.
Biocompatibility Test Results
OraLabs conducted biocompatibility testing as listed in Use of International Standard ISO 10993-1 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
8
Image /page/8/Picture/0 description: The image shows the logo for OraLabs. The logo is set against a blue background. The text "OraLabs" is written in white, with the "R" symbol in a circle next to the "s" in "Labs".
OraLabs found the predicate device, Biotene Dry Mouth Moisturizing Spray, received identical readings for the cytotoxicity testing. As stated in Section 6, Performance Data, in this 510(k) Summary, these results were attributed to the presence of the Surfactant Preservatives - Cetylpyridinium Chloride and Sodium Benzoate.
| Biological Effect | Result |
|---|---|
| Cytotoxicity | OraLabs - Fail |
| Sensitization | OraLabs - Pass |
| Irritation or Intracutaneous Reactivity | OraLabs - Pass |
| Cytotoxicity | Biotene - Fail |
Biocompatibility results show the OraLabs Dry Mouth Pocket Spray to be as safe as the predicate product to use to relieve dry mouth symptoms.
10. Stability
OraLabs performed accelerated stability according to ICH requirements. OraLabs Dry Mouth Pocket Spray was filled into individual spray bottles and sealed with the pump assembly. The product was placed into a stability chamber at 40°C/75% Relative Humidity (40_75).
The product was tested at Baseline, 3 months, and 6 months for analytical, microbial, and organoleptic properties.
Total Aerobic Count, Yeasts & Molds, pH, and organoleptic properties maintained an acceptable result at each stage of testing.
Accelerated testing did not significantly alter the pH and the preservatives added to the OraLabs Dry Mouth Pocket Spray were acceptable as no growth was found on Total Aerobic Count and Yeasts & Molds.
These results support OraLabs applying a 24 month expiration date.
11. Conclusion
OraLabs Dry Mouth Pocket Spray is substantially equivalent to Biotene Moisturizing Mouth Spray as it has the same intended use and the same fundamental scientific technology as the legally marketed predicate device. Biotene Moisturizing Mouth Spray.
This is demonstrated by comparing the ingredients, and the purpose of each ingredient, in the OraLabs Dry Mouth Pocket Spray and Biotene.
OraLabs Dry Mouth Pocket Spray contains water, moisturizers, thickeners/binders, buffers, flavor, sweetener and preservatives. The combination of ingredients collectively provides moisturizing, lubricating, soothing, and refreshing properties.
Performance testing and biocompatibility assessment further show substantial equivalence.