(119 days)
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 6 hours.
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.
Here's an analysis of the acceptance criteria and study as described in the provided document:
This document is a 510(k) summary for the Oral-B® Dry Mouth Oral Rinse (K203567), which seeks to update its "Indications for Use" from providing relief for "up to 4 hours" to "up to 6 hours." The device itself is identical to a previously cleared predicate device (K201277).
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document presents the acceptance criteria implicitly through the study's objective: to demonstrate longer-lasting relief. The performance is reported as the outcome of that demonstration, not against explicit, pre-defined quantitative thresholds in the same way one might see for, say, diagnostic accuracy.
| Acceptance Criteria (Implied) | Reported Device Performance (K203567) |
|---|---|
| Demonstrate efficacy in relieving dry mouth symptoms immediately post-use. | Oral-B® Dry Mouth Oral Rinse was more effective than water at providing immediate dry mouth moisturization. |
| Demonstrate efficacy in relieving dry mouth symptoms up to 6 hours post-use. | Oral-B® Dry Mouth Oral Rinse was more effective than water at providing overnight and up to 6 hours of relief of dry mouth symptoms. |
| Support the modified "Indications for Use" statement: "Provides long lasting relief for up to 6 hours". | Analysis of the clinical study results support the Indication for Use statement of "Provides long lasting relief for up to 6 hours". The majority of study subjects using the subject device achieved dry mouth symptom relief at all time points including 4- and 6- hours post-treatment. |
| No new safety concerns compared to predicate. | No formulation/technological changes from the predicate; device is considered as safe as the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number. The document mentions "subjects with self-reported dry mouth symptoms."
- Data Provenance: Not explicitly stated (e.g., country of origin). The study was a "controlled, randomized, 3-treatment, parallel clinical study," indicating it was prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- The study used "an Oral Examination" to identify subjects who experienced dry mouth symptoms. It's not specified how many experts conducted these examinations or their particular qualifications (e.g., dentist, physician, etc.).
- Ground truth was also partly established by "subject responses to the Dry Mouth Inventory (DMI) questionnaire," which is a self-reported measure.
4. Adjudication Method for the Test Set
- The document does not mention an adjudication method for the test set or for establishing ground truth. The primary endpoints appear to be direct comparison of product efficacy against a control based on symptom relief.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This study evaluated the direct clinical effect of an oral rinse on dry mouth symptoms, not the performance of an AI algorithm assisted by human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This document describes a medical device that is an oral rinse, not an AI algorithm. Therefore, there is no "algorithm only" performance to report.
7. Type of Ground Truth Used
- The ground truth for effectiveness was based on a combination of:
- Clinical assessment: "Oral Examination" to determine dry mouth symptoms.
- Patient-reported outcomes: "subject responses to the Dry Mouth Inventory (DMI) questionnaire" measuring dry mouth symptom relief.
8. Sample Size for the Training Set
- N/A. As this is not an AI/machine learning device, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- N/A. As this is not an AI/machine learning device, there is no "training set" or ground truth establishment for one.
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April 5, 2021
The Procter & Gamble Company Brenda Fuentes Regulatory Affairs Scientist 1 Procter & Gamble Plaza Cincinnati. Ohio 45202
Re: K203567
Trade/Device Name: Oral-B Dry Mouth Oral Rinse Regulatory Class: Unclassified Product Code: LFD Dated: January 4, 2021 Received: January 5. 2021
Dear Brenda Fuentes:
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 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
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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(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael E. Adjodha -S
Michael E. Adjodha, M.Ch.E. 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
Enclosure
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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 6 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)
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Procter & Gamble
The Procter & Gamble Company Mason Business Center Mason, Ohio 45040-9462
510(k) Summary
SUBMITTER
| 510(k) Owner: | The Procter & Gamble Company1 Procter & Gamble PlazaCincinnati, Ohio 45202Telephone: (513) 206-4331Owner/Operator Registration Number: 9915005 |
|---|---|
| Contact Person: | Brenda S. Fuentes, B.S.Regulatory Affairs ScientistThe Procter & Gamble Co.Telephone: (513) 622-1384E-Mail: fuentes.bs@pg.com |
| Date Prepared: | December 3, 2020 |
DEVICE
| 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
Oral-B® Dry Mouth Oral Rinse (K201277)
The predicate device has not been the subject of any design-related recalls.
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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 6 hours.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Oral-B® Dry Mouth Oral Rinse (K201277) was granted a finding of substantial equivalence to 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 during the 510(k) review process for K201277.
There are no formulation/technological changes to the Oral-B® Dry Mouth Oral Rinse subject device vs. the legally marketed Oral-B® Dry Mouth Oral Rinse predicate device K201277. The only change from K201277 Oral-B® Dry Mouth Oral Rinse cleared to market in September 2020 is the indication for use. The proposed indication for use change is from "4 HOURS" to "6 HOURS" in line with new clinical data supporting the efficacy duration.
There are no novel materials (i.e., materials not previously used in a legally marketed US-medical device) used in the manufacture of this device. The composition of the subject device is the same as that of the predicate device, with no differences in physical properties, biocompatibility or shelf life. The device directions for use have not changed.
The difference in indication for use does not raise any concerns of safety and effectiveness. The technological characteristics of the Oral-B® Dry Mouth Oral Rinse subject and predicate devices are summarized in the table below and support the substantial equivalence of the products.
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| Table 5-1 Summary of Technological Characteristics | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | ---------------------------------------------------- |
| Feature | Subject(K203567) | Predicate(K201277) |
|---|---|---|
| Proprietary Name | Oral-B® Dry Mouth Oral Rinse | Oral-B® 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 anddiscomfort of dry mouth, refreshes,moisturizes/ hydrates, soothes oralirritation and lubricates oraldryness. | Oral-B® Dry Mouth Oral Rinse:Relieves the symptoms anddiscomfort of dry mouth, refreshes,moisturizes/ hydrates, soothes oralirritation and lubricates oraldryness. |
| Provides long lasting relief for upto 6 hours. | Provides long lasting relief for upto 4 hours. | |
| Target Population | Xerostomic, dry mouth sufferer | Xerostomic, 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 timesa day | 15 mL for 30 seconds up to 5 timesa day |
| Prescription/OTC | Over the Counter | Over the Counter |
| DeviceComponents | Sodium Hyaluronate, Water, Xylitol,Sodium Benzoate, Benzoic Acid,Glycerin, Propylene Glycol,Poloxamer 407, CetylpyridiniumChloride Carboxymethyl Cellulose,Flavor | Sodium Hyaluronate, Water, Xylitol,Sodium Benzoate, Benzoic Acid,Glycerin, Propylene Glycol,Poloxamer 407, CetylpyridiniumChloride Carboxymethyl Cellulose,Flavor |
| Packaging | 16.9 fluid ounce PolyethyleneTerephthalate (PET) bottle withwhite polypropylene cap. | 16.9 fluid ounce PolyethyleneTerephthalate (PET) bottle withwhite 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 - 6.4 |
| Viscosity | > 29 cP | > 29 cP |
| Specific Gravity | 1.04 | 1.04 |
| Biocompatibility | Risk assessment consistent withISO 10993-1. | Risk assessment consistent withISO 10993-1. |
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PERFORMANCE DATA
There are no formulation/technological changes to the Oral-B® Dry Mouth Oral Rinse subject device vs. the legally marketed Oral-B® Dry Mouth Oral Rinse predicate device K201277. The change in indication for use is supported by the clinical trial performance data summarized below.
Clinical Testing
A controlled, randomized, 3-treatment, parallel 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 six hours after use, compared to water on day 1 and after eight 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 up to 6 hours of relief of dry mouth symptoms. Analysis of the clinical study results support the Indication for Use statement of "Provides long lasting relief for up to 6 hours".
This clinical study included subjects with self-reported dry mouth symptoms as determined by an Oral Examination and subject responses to the Dry Mouth Inventory (DMI) questionnaire. While not all subjects experienced the same efficacy due to normal variation, the majority of study subjects using the subject device achieved dry mouth symptom relief at all time points including 4- and 6- hours post-treatment. The stated Indication For Use includes the phrase "for up to" as "Provides long lasting relief for up to 6 hours" in order to address the potential variability of benefit obtainable by consumers.
CONCLUSION
Based on the intended use, technological characteristics, and the clinical data provided, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device (K201277).
N/A