(112 days)
No
The device description and performance studies focus on the chemical formulation and clinical efficacy of an oral rinse, with no mention of AI or ML technology.
Yes
The device is intended to relieve symptoms of dry mouth and oral irritation, which indicates a therapeutic purpose.
No
Explanation: The device is intended to relieve symptoms and discomfort of dry mouth, not to diagnose a condition. It functions as an artificial saliva and provides symptomatic relief.
No
The device description clearly states it is a "non-sterile clear liquid formulated as an artificial saliva" and is supplied in a bottle with a closure and dosing cup, 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:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Oral-B® Dry Mouth Oral Rinse is a liquid applied directly to the oral cavity to relieve symptoms of dry mouth. It does not analyze a sample taken from the body to diagnose or monitor a condition.
- Intended Use: The intended use is to relieve symptoms and discomfort, not to diagnose or detect a disease or condition.
- Mechanism of Action: The device works by providing lubrication and moisture to the oral cavity, acting as an artificial saliva. This is a physical effect, not a diagnostic test.
Therefore, the Oral-B® Dry Mouth Oral Rinse falls under the category of a medical device, but not specifically an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Relieves the symptoms and discomfort of dry mouth, refreshes, moisturizes/hydrates, soothes oral irritation and lubricates oral dryness.
Provides long lasting relief for up to 4 hours.
Product codes
LFD
Device Description
The Oral-B® Dry Mouth Oral Rinse is a non-sterile clear liquid formulated as an artificial saliva (LFD) intended to be marketed over the counter for at-home use. The artificial saliva for dry mouth is formulated with gel film forming polysaccharides, sodium hyaluronate, which possess lubricating and moisturizing properties. Oral-B® Dry Mouth Oral Rinse also contains water, moisturizers/humectants, thickener, surfactant, pH adjusters, preservative, sweetener and flavor that collectively form the device formulated at a pH of 6 and designed to help relieve and manage the symptoms of dry mouth. A list of device components can be found in Table 5-1. None of the constituents used in the device are novel materials not previously used in a legally marketed US-medical device).
The device is intended to be used for 30 seconds each use, up to five times daily for consumers 12 years or older. Oral-B® Dry Mouth Oral Rinse is supplied in a 16-fluid ounce white Polyethylene Terephthalate (PET) bottle, with a white polypropylene closure and a clear polypropylene dosing cup.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral Cavity/Mouth
Indicated Patient Age Range
12 years or older
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)
A controlled, randomized, 3-treatment, 3-period crossover clinical study was conducted to evaluate if Oral-B® Dry Mouth Oral Rinse and a marketed dry mouth rinse were more effective in relieving dry mouth symptoms, immediately and four hours after use, compared to water on day 1 and after four days of product use. The results of this study demonstrated that Oral-B® Dry Mouth Oral Rinse was more effective than water at providing immediate dry mouth moisturization and overnight and long-term relief of dry mouth symptoms. Analysis of the pilot study results support the Indications for Use statement of duration of effectiveness for up to 4 hours. Additionally, the data suggest that Oral-B® Dry Mouth Oral Rinse may be more effective than the comparator dry mouth oral rinse device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
February 23, 2021
The Procter & Gamble Company Michael Kaminski Principal Scientist 8700 Mason Montgomery Road Mason, Ohio 45040
Re: K201277 Trade/Device Name: Oral-B Dry Mouth Oral Rinse Regulatory Class: Unclassified Product Code: LFD
Dear Michael Kaminski:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated September 2, 2020. Specifically, FDA is updating this SE Letter to correct a misspelling of the company name as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Michael Adjodha, OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, 301-796-6276, michael.adjodha@fda.hhs.gov.
Sincerely.
Michael E. Adjodha -S
Michael E. Adjodha, M.ChE. Assistant 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
1
Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text and emblem on the right. The FDA part includes the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
September 2, 2020
The Proctor & Gamble Company Michael Kaminski Principal Scientist 8700 Mason Montgomery Road Mason, Ohio 45040
Re: K201277
Trade/Device Name: Oral-B Dry Mouth Oral Rinse Regulatory Class: Unclassified Product Code: LFD Dated: May 12, 2020 Received: May 13, 2020
Dear Michael Kaminski:
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 avare 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
2
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 mediation-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.
Michael E. Adjodha -S
for Srinivas "Nandu" Nandkumar, Ph.D. 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
3
Indications for Use
510(k) Number (if known)
Device Name
Oral-B® Dry Mouth Oral Rinse
Indications for Use (Describe)
Relieves the symptoms and discomfort of dry mouth, refreshes, moisturizes/hydrates, soothes oral irritation and lubricates oral dryness.
Provides long lasting relief for up to 4 hours.
| 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."
4
Procter & Gamble
The Procter & Gamble Company Mason Business Center Mason, Ohio 45040-9462
K201277 - 510(k) Summary
SUBMITTER
| 510(k) Owner: | The Procter & Gamble Company
1 Procter & Gamble Plaza
Cincinnati, Ohio 45202
Telephone: (513) 206-4331
Owner/Operator Registration Number: 9915005 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michael A. Kaminski Ph.D.
Regulatory Affairs Principal Scientist
Oral Care
The Procter & Gamble Company
Telephone: (513) 206-4331
Email: kaminski.ma@pg.com |
| Date Prepared: | September1, 2020 |
| Trade Name: | Oral-B® Dry Mouth Oral Rinse |
| Common Name: | Artificial Saliva |
| Classification Name: | Saliva, Artificial |
| Product Code: | LFD |
| Regulation Number: | Unclassified |
| Device Classification: | Unclassified |
| GMP exempt: | No |
| Review Panel: | Dental |
PREDICATE / REFFERENCE DEVICE
GUM® HYDRAL™ Dry Mouth Oral Rinse (K181134) To the best of our knowledge the predicate device has not been the subject of any design-related recalls.
5
DEVICE DESCRIPTION
The Oral-B® Dry Mouth Oral Rinse is a non-sterile clear liquid formulated as an artificial saliva (LFD) intended to be marketed over the counter for at-home use. The artificial saliva for dry mouth is formulated with gel film forming polysaccharides, sodium hyaluronate, which possess lubricating and moisturizing properties. Oral-B® Dry Mouth Oral Rinse also contains water, moisturizers/humectants, thickener, surfactant, pH adjusters, preservative, sweetener and flavor that collectively form the device formulated at a pH of 6 and designed to help relieve and manage the symptoms of dry mouth. A list of device components can be found in Table 5-1. None of the constituents used in the device are novel materials not previously used in a legally marketed US-medical device).
The device is intended to be used for 30 seconds each use, up to five times daily for consumers 12 years or older. Oral-B® Dry Mouth Oral Rinse is supplied in a 16-fluid ounce white Polyethylene Terephthalate (PET) bottle, with a white polypropylene closure and a clear polypropylene dosing cup.
INDICATIONS FOR USE
Relieves the symptoms and discomfort of dry mouth, refreshes, moisturizes/hydrates, soothes oral irritation and lubricates oral dryness.
Provides long lasting relief for up to 4 hours.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Oral-B® Dry Mouth Oral Rinse is substantially equivalent to the predicate device GUM® HYDRAL™ Dry Mouth Oral Rinse (K181134) in its intended use, indication for use, design, chemical composition, packaging, shelf life and performance as artificial saliva product designed for relief from dry mouth symptoms. There are no novel materials not previously used in a legally marketed US-medical device) used in the manufacture of this device that haven't been used in the predicate and/or reference devices. While the composition of the subject device is not the same as that of the predicate device, the differences do not raise any concerns of safety and effectiveness, as demonstrated by the similarities in physical properties, biocompatibility, shelf life and effectiveness. The technological characteristics of the Oral-B® Dry Mouth Oral Rinse and predicate devices are summarized in the table below and support the substantial equivalence of the products.
6
Table 5-1 Summary of Technological Characteristics
| Feature | Subject | Predicate
(K181134) |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name | Oral-B® Dry Mouth Oral Rinse | GUM® HYDRAL™ Dry Mouth Oral Rinse |
| Intended Use | Relief of dry mouth symptoms | Relief of dry mouth symptoms |
| Indication for Use | Oral-B® Dry Mouth Oral Rinse: Relieves the symptoms
and discomfort of dry mouth, refreshes, moisturizes/
hydrates, soothes oral irritation and lubricates oral dryness.
Provides long lasting relief for up to 4 hours. | GUM® HYDRAL™ Dry Mouth Oral Rinse helps soothe oral
tissue and relieve the symptoms of dry mouth, refresh,
moisturize, clean, soothe oral irritation and lubricate oral
dryness. |
| Target Population | Xerostomic, dry mouth sufferer | Dry mouth sufferer |
| Area of Use | Oral Cavity/Mouth | Oral Cavity/Mouth |
| Dose Form | Oral Rinse | Oral Rinse |
| Dosage | 15 mL for 30 seconds up to 5 times a day | 15 mL for 30 seconds up to 5 times a day |
| Prescription/OTC | Over the Counter | Over the Counter |
| Device
Components | Sodium Hyaluronate, Water, Xylitol, Sodium Benzoate, Benzoic
Acid, Glycerin, Propylene Glycol, Poloxamer 407,
Cetylpyridinium Chloride Carboxymethyl Cellulose, Flavor | Water, Sorbitol, Sodium Citrate, Polyvinylpyrrolidone, Propanediol,
Betaine, Xylitol, PEG-40 Hydrogenated Castor Oil, Taurine, Citric
Acid, Sodium Hydroxide, Methyl Paraben, Flavor, Sodium
Hyaluronate, Cetylpyridinium Chloride, Sucralose, Stevia Extract |
| Packaging | 16.9 fluid ounce Polyethylene Terephthalate (PET) bottle
with white polypropylene cap. | 16.9 fluid ounce Polyethylene Terephthalate (PET) bottle with
white polypropylene cap. |
| Appearance | Colorless, clear, transparent liquid | Colorless, clear, transparent liquid |
| Odor | Slight mint odor | Slight mint odor |
| pH | 5.5 - 6.4 | 5.5-7.0 |
| Viscosity | > 29 cP | 20.39 Sct (22.0 cP*) |
| Specific Gravity | 1.04 | 1.06 |
| Biocompatibility | Risk assessment consistent with ISO 10993-1. | Biocompatibility testing in conformance with ISO 10993-1. |
*Viscosity as measured by P&G
7
PERFORMANCE DATA
Biocompatibility Testing
Biocompatibility was demonstrated consistent with FDA guidance "Use of International Standard ISO 10993-1. Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
Non-Clinical Bench Testing
Comparative chemical and physical property data for the subject and predicate device support a finding of substantial equivalence in terms of pH, specific gravity, surface tension and viscosity.
Shelf life stability testing provides for a 24-month shelf life of the subject device.
Clinical Testing
A controlled, randomized, 3-treatment, 3-period crossover clinical study was conducted to evaluate if Oral-B® Dry Mouth Oral Rinse and a marketed dry mouth rinse were more effective in relieving dry mouth symptoms, immediately and four hours after use, compared to water on day 1 and after four days of product use. The results of this study demonstrated that Oral-B® Dry Mouth Oral Rinse was more effective than water at providing immediate dry mouth moisturization and overnight and long-term relief of dry mouth symptoms. Analysis of the pilot study results support the Indications for Use statement of duration of effectiveness for up to 4 hours. Additionally, the data suggest that Oral-B® Dry Mouth Oral Rinse may be more effective than the comparator dry mouth oral rinse device.
CONCLUSION
Based on the intended use, technological characteristics, non-clinical performance data and the clinical data provided the subject device is as safe, as effective, and performs as well as the legally marketed predicate device (K181134).