(231 days)
Relieves the symptoms and discomfort of dry mouth, refresh, moisturize/hydrate, clean, soothe oral irritation and lubricate oral dryness.
Hydris™Oral Rinse(Hydris) is a specially formulated water soluble artificial saliva substitute with a pH between 5.00 to 7.00 for use at home in the oral cavity. The proposed device is formulated with water, humectants/moisturizers, including two moisture-rich humectants that are plant based, thickeners/binders, buffers, sweeteners, flavor, and colorant that collectively have moisturizing/hydrating, soothing, and refreshing properties. The device is provided ready to use as a non-sterile, semi-viscous blue colored liquid packaged in three sizes, including 8.5 FL OZ, 16.9 FL OZ and 33.8 FL OZ white polyethylene terephthalate (PET) bottles with white polypropylene caps. The shelf-life is 2 years.
Here's a breakdown of the acceptance criteria and study information for Hydris™ Oral Rinse based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the comparison to the predicate device (Biotene® Dry Mouth Oral Rinse). The objective was to demonstrate that Hydris™ Oral Rinse is "not significantly different" in key performance characteristics.
| Acceptance Criteria (Implicit from Predicate Comparison) | Reported Device Performance (Hydris™ Oral Rinse) |
|---|---|
| Not significantly different in ability to retain moisture/hydration | Pass / Not statistically different from Biotene® Dry Mouth Oral Rinse |
| Not significantly different in moisturization/hydration of soft tissue at a specific time and temperature | Pass / Not statistically different from Biotene® Dry Mouth Oral Rinse |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the bench testing.
The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It is described as "Nonclinical Testing" and "Bench testing," implying laboratory-based testing rather than clinical trials with human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For this type of bench testing, "ground truth" would typically refer to established scientific methods and instruments used for measurement, rather than expert consensus on medical cases.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluations were bench tests comparing physical properties, not interpretations of medical data requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
An MRMC study was not done. This document describes the clearance of an oral rinse, not an AI-assisted diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is an oral rinse, not an algorithm or AI system. The performance testing was standalone in the sense that it was bench testing of the product itself.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation was established through bench testing results using scientific measurements to assess properties like moisture retention and moisturization/hydration. The predicate device (Biotene® Dry Mouth Oral Rinse) served as the comparative standard.
8. The Sample Size for the Training Set
This document does not describe the development of a machine learning algorithm, so there is no training set in this context.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there was no training set for a machine learning model.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 10, 2017
Biopharm Consult, L.L.C. David S. Johnson President 5609 Hard Rock Place Henrico, Virginia 23230
Re: K163029
Trade/Device Name: Hydris™ Oral Rinse Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: LFD Dated: May 19, 2017 Received: May 22, 2017
Dear Mr. David Johnson:
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
{1}------------------------------------------------
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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/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.
Mary S. Runner -A
Lori A. Wiggins, MPT, CLT 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) K163029
Device Name
Hydris™ Oral Rinse
Indications for Use (Describe)
"Relieves the symptoms and discomfort of dry mouth, refresh, moisturize/hydrate, clean, soothe oral irritation and lubricate oral dryness."
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ✓ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K163029
510(k) SUMMARY
| Submission Date: | June 19, 2017 |
|---|---|
| 510(k) Number: | K163029 |
| Submitter | Biopharm Consult, L.L.C.5609 Hard Rock PlaceHenrico, VA 23230Contact: David S. JohnsonPhone: (973)-229-3731Email: tampicoblue@yahoo.com |
Proposed Device
| Trade Name | Hydris™ Oral Rinse |
|---|---|
| Common Name | Oral Rinse |
| Classification Name | Saliva, Artificial |
| Regulatory Classification | Unclassified (pre-amendment) |
| Product Code | LFD |
| Review Panel | Dental Devices Panel |
Primary Predicate Device
The predicate device for this submission is Biotene® Dry Mouth Oral Rinse (K123731), cleared on January 4, 2013. The primary predicate is one of three Biotene dry mouth products cleared in K123731 which contains both a gel and a spray formulation.
| Trade Name | Biotene® Dry Mouth Oral Rinse |
|---|---|
| Common Name | Oral Rinse |
| Classification Name | Saliva, Artificial |
| Regulatory Classification | Unclassified (pre-amendment) |
| Product Code | LFD |
| Review Panel | Dental Devices Panel |
| 501(k) Number | K123731 |
| Submitter | GlaxoSmithKline Consumer Healthcare |
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Reference Device
| Trade Name | Medactive Oral Relief Spray/Gel |
|---|---|
| Common Name | Oral Rinse |
| Classification Name | Saliva, Artificial |
| Regulatory Classification | Unclassified (pre-amendment) |
| Product Code | LFD |
| Review Panel | Dental Devices Panel |
| 501(k) Number | K152201 |
| Submitter | GlaxoSmithKline Consumer Healthcare |
Device Description
Hydris™Oral Rinse(Hydris) is a specially formulated water soluble artificial saliva substitute with a pH between 5.00 to 7.00 for use at home in the oral cavity. The proposed device is formulated with water, humectants/moisturizers, including two moisture-rich humectants that are plant based, thickeners/binders, buffers, sweeteners, flavor, and colorant that collectively have moisturizing/hydrating, soothing, and refreshing properties. The device is provided ready to use as a non-sterile, semi-viscous blue colored liquid packaged in three sizes, including 8.5 FL OZ, 16.9 FL OZ and 33.8 FL OZ white polyethylene terephthalate (PET) bottles with white polypropylene caps. The shelf-life is 2 years.
Indications for Use
Relieves the symptoms and discomfort of dry mouth, refresh, moisturize/hydrate, clean, soothe oral irritation and lubricate oral dryness.
Comparison to Predicate Device
Hydris™Oral Rinse is substantially equivalent to Biotene® Dry Mouth Oral Rinse. The proposed device is not intended to be a drastic advance with new or medically significant benefits as compared to the predicate and thus does not lead to a new standard of care. The subject and predicate device have similar indication for use statements. They utilize the same fundamental scientific technology (a formulation of water, humectants or moisturizers, thickening/binding agents, buffering agents, sweeteners, flavor, surfactants and preservatives) and are similar in design, ingredients and packaging. The table 1 below provides a comparison between the proposed device and the predicate device.
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| Comparison of Predicate Device to Proposed device | ||
|---|---|---|
| Predicate Device | Proposed device | |
| Trade Name | Biotene® Dry Mouth OralRinse | Hydris™ Oral Rinse |
| 510(k) Number | K123731 | K163029 |
| Classification Name | Artificial Saliva | Artificial Saliva |
| Product Code | LFD | LFD |
| Classification | Unclassified | Unclassified |
| Disease State | Xerostomia (Dry Mouth) | Xerostomia (Dry Mouth) |
| Intended Use | 1. Provides symptom relief from DryMouth and low saliva including:● Oral discomfort● Mucosal soft tissue dryness● Oral side effects of illness, therapies, and medications2. Soothes moistens and lubricates3. Hydrates soft tissue" | To relieve the symptoms anddiscomfort of dry mouth, refreshmoisturize/hydrate, clean, sootheoral irritation and lubricate oraldryness. |
| Indications for Use | Relieves the symptoms of drymouth, refresh, moisturize,clean, soothe oral irritation andlubricate oral dryness | Relieves the symptoms anddiscomfort of dry mouth, refreshmoisturize/hydrate, clean, sootheoral irritation and lubricate oraldryness. |
| Dosage Form | Oral Rinse | Oral Rinse |
| Dosage (Per Use) | 1 Tablespoon (~ 15 mL) | 20 mL (4 teaspoons) |
| Method of Use | Ready to use liquid | Ready to use liquid |
| Area of Use | Oral cavity | Oral cavity |
| Applications/day | Up to 5 times daily | Up to 2 times daily |
| Prescription/OTC | OTC | OTC |
| Environment of Use | Home use | Home Use |
| Solvent | Water | Water |
| Humectants/Moisturizers | Glycerin, Propylene Glycol | Glycerin, Propylene Glycol |
| Sweeteners/Humectants | Xylitol, Sorbitol | Sorbitol, Sodium Saccharin,Sucralose |
| Thickeners/Binders | Hydroxyethyl Cellulose | Cellulose Gum, Xanthan Gum,Carbomer |
| Surfactant | Poloxamer 407 | Poloxamer 407 |
| Preservatives | Sodium Benzoate,Methylparaben, Propylparaben | Cetylpyridinium chloride,Sodium Benzoate |
| Flavor | Flavor | Flavor |
| Buffers | Disodium Phosphate,Sodium Phosphate | Disodium Phosphate,Sodium Phosphate |
| Colorant | None | FD&C Blue 1 |
| Summary of Technological Characteristics Compared to Predicate Device | ||
| Predicate Device | Proposed Device | |
| Appearance | Semi-viscous liquid | Semi-viscous blue liquid |
| Specific Gravity | 1.08 | 1.04-1.08 |
| pH | 6.4 | 5.0-7.0 |
| Solubility | Water Soluble | Water Soluble |
| Packaging Unit | 8 FL OZ, 16 FL OZ, 33.8 FL OZ bottles | 8 FL OZ, 16.9 FL OZ, 33.8 |
| Packaging Material - Bottle | White polyethylene terephthalate (PET) | White polyethylene terephthalate (PET) |
| Packaging Material - Cap | Polypropylene | Polypropylene |
| Prescription/OTC | OTC | OTC |
| Sterility | Non-Sterile | Non- Sterile |
| Shelf-Life | 36 months | 24 Months |
Comparison of Predicate Device to Proposed device
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Indications for Use Discussion
The wording found in the indications for use statement of the proposed Hydris™ Oral Rinse is consistent with that of the legally marketed primary predicate device. Biotene® Dry Mouth Oral Rinse. While there are differences in the wording of the indications-foruse statement for primary predicate Biotene Dry Mouth Oral Rinse and the proposed device Hydris Oral Rinse™ both devices share the same intended use, namely to provide symptomatic relief/treatment of dry mouth. Both the subject and predicate devices are also OTC.
Technological Characteristic Discussion
The predicate and proposed devices utilize the same fundamental technology. The mode of action of Hydris™Oral Rinse is substantially equivalent to that of the predicate device. The chemical composition of the proposed Hydris™Oral Rinse is similar to the primary predicate device Biotene® Dry Mouth Oral Rinse. Both the proposed and predicate devices contain ingredients such as water. humectants or moisturizers, thickening/binding agents, buffering agents, sweeteners, flavor, surfactants and preservatives, and both Hydris™Oral Rinse and its primary predicate Biotene® Dry Mouth Oral Rinse are similar in design, ingredients and packaging. Below is a summary of the technological characteristics compared to the primary predicate device.
| Summary of Technological Characteristics Compared to Predicate Device | ||
|---|---|---|
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Discussion of Differences
There are also several differences between the proposed device and its primary predicate.
In particular, the variations in formula/composition for Hydris™Oral Rinse from the primary predicate device are as follows:
-
Sweeteners: Both devices use aqueous solutions and a sweetener, such as ● xylitol, sucralose or sodium saccharin as the sweetener. The proposed device features sodium Saccharin and sucralose as sweeteners, while the primary predicate employs xylitol. While the sweeteners vary between the two, in both predicate and proposed devices,
the sweeteners are used to create a plant flavoring system and were chosen for their compatibility with the formula and the flavor. -
Rheology Modifiers: Cellulose gum (carboxymethylcellulose, or CMC) was ● chosen
as a thickener/rheology modifier for the gel based on its significant history of use in dental, oral care and food products. Xanthan gum was chosen for the proposed device for similar reasons. The resulting viscosity in the proposed Hydris™Oral Rinse and its predicate Biotene® Dry Mouth Oral Rinse are similar in nature to the predicate device. -
Preservatives: An intentional decision was made not to use parabens in the proposed device. Alternatively, cetylpyridinium chloride, was added as a preservative as it is compatible with the formula at the given pH range. The choice of a binary preservative system results in an adequately preserved formulation of the proposed device when compared to its primary predicate. Despite differences in formula ingredients, these ingredients share similar functional roles within the formulas of both the proposed and predicate devices.
To address the ingredients included in the proposed device, but not found in the primary predicate, a reference device, MedActive Gel and Spray (K152201), was introduced as it is a dry mouth formulation which contains the ingredients not found in the primary predicate. The table below distinguishes the specific ingredients found in Biotene® Dry Mouth Oral Rinse from those identified in the reference device, MedActive Gel and Spray.
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| HydrisTM Oral Rinse | Primary Predicate or “ReferencePredicate” | 510(k) Number |
|---|---|---|
| Water | Biotene® Dry Mouth Oral Rinse | K123731 |
| Glycerin | Biotene® Dry Mouth Oral Rinse | K123731 |
| Propylene Glycol | Biotene® Dry Mouth Oral Rinse | K123731 |
| Sorbitol | Biotene® Dry Mouth Oral Rinse | K123731 |
| Sodium Phosphate | Biotene® Dry Mouth Oral Rinse | K123731 |
| Poloxamer 407 (ethylene OxidePropylene Copolymer | Biotene® Dry Mouth Oral Rinse | K123731 |
| Sodium Benzoate | Biotene® Dry Mouth Oral Rinse | K123731 |
| Flavor | Biotene® Dry Mouth Oral Rinse | K123731 |
| Disodium Phosphate | Biotene® Dry Mouth Oral Rinse | K123731 |
| Cellulose Gum | Medactive Oral Relief Gel | K152201 |
| Xanthan Gum | Medactive Oral Relief Spray | K152201 |
| Cetylpyridinium Chloride | Biotene® Moisturizing Spray | K123731* |
| Carbomer (2-Propenoic AcidHomopolymer) | Biotene® New Oral Balance Gel | K123731* |
| Sodium Saccharin | Medactive Oral Relief Gel Spray | K152201 |
| Sucralose | Medactive Oral Relief Gel andSpray | K152201 |
Identification of Ingredients in the Proposed Hydris™Oral Rinse and the Primary Predicate or Reference Device Source
*K12373 also contained a gel and a spray dry mouth formulation.
Ingredients: Water, Glycerin, Propylene Glycol, Sorbitol, Sodium Phosphate, Poloxamer 407 (ethylene Oxide Propylene Copolymer), Sodium Benzoate, Flavor, Disodium Phosphate, Cellulose Gum, Xanthan Gum, Cetylpyridinium Chloride, Carbomer (2-Propenoic Acid Homopolymer), Sodium Saccharin, and FD&C Blue 1.
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 equivalency of the proposed product. In summary, these differences in formulation to the predicate devices do not alter the function, indications, or substantial equivalency of the products.
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In addition, the following is true:
- . Any new components/ingredients are designated GRAS ingredients, food additives or have a significant history of use in dental & medical or food applications.
- All components of the product have been manufactured using standardized and industry accepted state of the art production methods.
- All components of the product have been tested using standardized and industry ● accepted state of the art test methods.
- . The products have been tested using standardized and industry accepted state of the art test methods.
Discussion of Substantial Equivalence
The chemical components in Hydris™ Oral Rinse have been used in predicate devices, are listed as GRAS ingredients, are approved food additives/ingredients, or a combination these conditions. These facts well support the compatibility of Hydris™ Oral Rinse, and that the proposed device is substantially equivalent to the predicate devices, in terms of properties, intended use and composition.
Performance Data
The following nonclinical data have been provided in support of the substantial equivalence determination.
Nonclinical Testing
- Bench testing comparing Hydris™ Oral Rinse to Biotene® Dry Mouth Oral Rinse, the predicate device was performed. It was demonstrated that Hydris and Biotene are not significantly different in their ability to retain moisture/hydration, or in the moisturization/hydration of soft tissue at a specific time and temperature.
- · Comparative studies of Hydris™Oral Rinse with Biotene® Dry Mouth Oral Rinse by Near Infrared Spectroscopy.
- · Shelf-Life Stability Report (Hydris TM Oral Rinse)
- Post-Approval Stability Protocol and Stability Commitment
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Bench Testing Results for Hydris™ Oral Rinse
| Test | Result |
|---|---|
| Retention of Moisture | Pass / Not statistically different |
| Moisturization/Hydration of Soft tissue | Pass / Not statistically different |
Sterilization/Shelf-Life
| Predicate Device | Hydris™ Oral Rinse | |
|---|---|---|
| Packaging Unit | 8 FL OZ, 16, FL OZ, 33.8 FL OZ bottles | 8 FL OZ, 16.9 , FL OZ, 33.8 FL OZ bottles |
| Packaging Material - Bottle | White polyethylene terephthalate (PET) | White polyethylene terephthalate (PET) |
| Packaging Material - Cap | Polypropylene | Polypropylene |
| Sterility | Non-Sterile | Non- Sterile |
| Shelf-Life | 36 Months | 24 Months* |
*24 months was chosen to harmonize shelf-life with Sponsor's marketed rinses in the United States.
Conclusion
Hydris™Oral Rinse(Hydris) has the same intended use and the same fundamental scientific technology as that of the legally marketed predicate device, Biotene® Dry Mouth Oral Rinse . This is demonstrated by comparing Hydris™ Oral Rinse's indications-for-use statement and technological characteristics and performance data (retention of moisture and moisturization/hydration of soft tissue) with those of primary predicate Biotene® Dry Mouth Oral Rinse. On this basis, Hydris™Oral Rinse is substantially equivalent to the legally marketed predicate device, Biotene® Dry Mouth Oral Rinse. Results from a biocompatibility assessment and performance testing further demonstrate substantial equivalence.
This 510(k) summary is submitted in accordance with the requirements of 21 CFR 807.
N/A