MucoPEG

K190144 · Sunbio, Inc. · LFD · Nov 5, 2019 · DE

Device Facts

• Record ID: K190144
• Device Name: MucoPEG
• Applicant: Sunbio, Inc.
• Product Code: LFD · DE
• Decision Date: Nov 5, 2019
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

MucoPEG™ is indicated to relieve the symptoms and discomfort of dry mouth, refresh, moisturize/hydrate, clean, soothe oral irritation, and lubricate oral dryness.

Device Story

MucoPEG™ is an artificial saliva powder packaged in single-use packets; intended for home use by patients suffering from xerostomia. User dissolves 1g powder in 20mL water to create an oral rinse. Main ingredient is a polyethylene glycol (PEG) derivative; additives include mint for flavor and sodium bicarbonate for pH maintenance. Device functions by lubricating and moisturizing the oral cavity, mimicking natural saliva properties. Healthcare providers recommend use to alleviate discomfort and protect oral epithelial cells from dryness. Benefits include symptom relief and improved oral comfort.

Clinical Evidence

Bench testing only. Comparative performance testing against Hydris™ included appearance, pH (7.29 vs 5.91), viscosity (0.0019 vs 0.0126 Pa-s), surface tension (49.28 vs 30.24 dyn/cm), and moisturization/hydration of cultured epithelial cells (71.9% vs 12.0%, p=0.093). Biocompatibility testing performed per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and sensitization).

Technological Characteristics

Artificial saliva powder containing PEG derivative, mint, and sodium bicarbonate. Reconstituted in water to 20mL dose. pH 7.29; viscosity 0.0019 Pa-s; surface tension 49.28 dyn/cm. Biocompatibility per ISO 10993-1. Non-sterile. Storage at -20 ± 5 °C.

Indications for Use

Indicated for patients experiencing symptoms of dry mouth (xerostomia) to provide relief, refreshment, moisturization, cleaning, soothing of oral irritation, and lubrication of the oral cavity.

Predicate Devices

• Hydris™ Oral Rinse (K163029)

Reference Devices

• Neutrasal® (K093642)
• Coseal® (P030039)

Submission Summary (Full Text)

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November 5, 2019

SunBio. Inc. % Stuart Goldman Sr. Consultant, RA/QA Emergo by UL 2500 Bee Cave Road; Bldg. 1, Suite 300 Austin, Texas 78746

Re: K190144

Trade/Device Name: MucoPEG Regulatory Class: Unclassified Product Code: LFD Dated: August 9, 2019 Received: August 13, 2019

Dear Stuart Goldman:

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

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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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for 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

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## Indications for Use

510(k) Number (if known) K190144

Device Name MucoPEGTM

Indications for Use (Describe)

MucoPEG™ is indicated to relieve 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) | |
|--|-------------------------------------------------|--|
|--|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# K190144

# 510(k) Summary

# MucoPEG™

### 1. Submission Sponsor

SunBio, Inc. 95 Sanbon-ro Gunpo-si Gyeonggi-do South Korea 15849

Contact: Ms. Sun S. Kim Title: Executive Director, Clinical Research Phone: [phone] (USA); 82-31-423-5467 (S. Korea)

### 2. Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746

Contact: Stuart R. Goldman Title: Senior Consultant RA/QA Phone: [phone]

## 3. Date Prepared

March 13, 2019

### 4. Device Identification

Trade Name: MucoPEG™ Common Name: Artificial Saliva Classification Name: Pre-Amendment Regulation Number: Pre-Amendment Product Code: LFD Class: Unclassified Classification Panel: Dental

### 5. Legally Marketed Predicate Device

Predicate Device – Hydris™ Oral Rinse (K163029; Product Code LFD)

## 6. Indications for Use Statement

MucoPEG™ is indicated to relieve the symptoms and discomfort of dry mouth, refresh, moisturize/hydrate, clean, soothe oral irritation, and lubricate oral dryness.

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### 7. Device Overview

MucoPEG™ is an artificial saliva to relieve xerostomia symptoms and discomfort. The main ingredient of MucoPEG™ is a polyethylene glycol (PEG) derivative. The additives to MucoPEG™ are mint (for flavor) and sodium bicarbonate (for pH maintenance when dissolved in water). MucoPEG™ is formulated as a powder and packaged in a single-use packet.

### 8. Substantial Equivalence Discussion

The substantial equivalence comparison of MucoPEG™ to Hydris™ with respect to its intended use and technological characteristics (ingredients, conditions of use, physical properties and biocompatibility) is shown in Table 5-1 and provides detailed information regarding the basis for the determination of substantial equivalence between the subject and predicate devices. Two additional reference devices, Neutrasal® (K093642) and Coseal® (P030039), are being added to this 510(k) for MucoPEG™ to incorporate technological features of the subject device that are not contained in the predicate device Hydris™.

| Attributes | Predicate Device | Subject Device | Similarities /<br>Differences |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | |
| Regulatory Information | | | |
| Device Name | Hydris™ Oral Rinse | MucoPEG™ | - |
| Manufacturer | Colgate-Palmolive | SunBio | - |
| 510(k) # | K163029 | K190144 | - |
| Product Code | LFD | LFD | Same |
| Regulation | Pre-Amendment | Pre-Amendment | Same |
| Class | Unclassified | Unclassified | Same |
| Review Panel | Dental | Dental | Same |
| Intended Use | Temporary relief of<br>xerostomia (i.e., dry<br>mouth). | Temporary relief of<br>xerostomia (i.e., dry<br>mouth). | Same |
| Indications for Use | To relieve the symptoms<br>and discomfort of dry<br>mouth, refresh,<br>moisturize/hydrate,<br>clean, soothe oral<br>irritation, and lubricate<br>oral dryness. | To relieve the symptoms<br>and discomfort of dry<br>mouth, refresh,<br>moisturize/hydrate,<br>clean, soothe oral<br>irritation, and lubricate<br>oral dryness. | Same |
| | Ingredients | | |
| Solvent | H2O | H2O | Same |
| Humectants/Moisturizers | Glycerin, Propylene<br>Glycol (PG) | Polyethylene Glycol (PEG)<br>Tetra Succinimidyl<br>Glutarate | Similar. The PEG used<br>in the subject device<br>and the PG used in<br>the predicate device<br>provide the same<br>mechanical<br>mechanism of action<br>and are alkylene<br>oxide by-products<br>sourced from the<br>petroleum refining<br>process, and then<br>purified to USP<br>grade. |
| Buffers | Disodium Phosphate,<br>Sodium Phosphate | Sodium Bicarbonate | Similar. These<br>different buffering<br>agents are generally<br>recognized as safe<br>(GRAS) and provide<br>similar pH levels for<br>the subject and<br>predicate devices. |
| Flavors | Mint | Mint | Same |
| Thickeners | Cellulose Gum, Xanthan<br>Gum, Carbomer | None | Thickeners are not<br>used in the subject<br>device. |
| Surfactants | Poloxamer 407 | None | Surfactants are not<br>used in the subject<br>device. |
| Preservatives | Cetylpyridinium Chloride,<br>Sodium Benzoate | None | Preservatives are not<br>used in the subject<br>device. |
| Colorants | FD&C Blue 1 | None | Colorants are not<br>used in the subject<br>device. |
| Sweeteners | Sorbitol, Sodium<br>Saccharin, Sucralose | None | Sweeteners are not<br>used in the subject<br>device. |
| Conditions of Use | | | |
| Area of Use | Oral cavity | Oral cavity | Same |
| Dosage Form | Oral rinse | Oral rinse | Same |
| Dosage<br>(per use) | 20 mL (4 teaspoons) | 1g dissolved in 20 mL<br>water. | Same |
| Applications/Day | Up to 2 times daily. | As often as needed. | Similar |
| Method of Use | Ready to use liquid. | Powder to be mixed with<br>H2O prior to use. | Similar, both are in<br>liquid form when<br>used. |
| Environment of Use | Home | Home | Same |
| Prescription/OTC | OTC | Rx | The subject device is<br>sold by prescription<br>to maintain its<br>prescribed storage<br>condition and<br>product integrity<br>while it remains at<br>the pharmacy prior to<br>being sold to the end<br>user. |
| Packaging Unit | 8/16/33.8 fl-oz bottles | 30 (1g) packets / box<br>Dissolution Bottle | Similar. The<br>differences between<br>the way the subject<br>and predicate devices<br>are packaged is a<br>function of their<br>physical state. |
| Physical Properties (Performance Testing) | | | |
| Appearance | Viscous liquid, when<br>applied | Viscous liquid, when<br>applied | Same |
| pH | 5.91 | 7.29 | Similar. The subject<br>and predicate devices<br>have pH values near<br>the pH of saliva<br>(5.3 - 7.8). |
| Viscosity<br>(Pa-s) | 0.0126 | 0.0019 | Similar. The values<br>are not significantly<br>different when<br>compared to the<br>viscosity of the saliva<br>(0.0078 Pa-s). |
| Surface Tension<br>(dyn/cm) | 30.24 | 49.28 | Similar. The values<br>are not significantly<br>different when<br>compared to the<br>surface tension of<br>saliva (58 dyn/cm). |
| Moisturization/Hydration<br>of Cell | $12.0\pm3.38\%$ | $71.9\pm47.26\%$ | Similar. The<br>difference is not<br>statistically<br>significantly different<br>in protecting<br>epithelial cells from<br>dryness (p-value =<br>0.093). |
| Sterility | Non-Sterile | Non-Sterile | Similar. |
| Shelf-Life | 24 months | 18 months | Similar. The validated<br>shelf-life of the<br>subject device is 18<br>months when stored<br>as instructed. |
| Storage Condition | Not specified | -20 $\pm$ 5 °C (-4 $\pm$ 9°F) | The subject device is<br>stored under the<br>prescribed storage<br>condition to maintain<br>the integrity<br>(stability) of the<br>product. |
| Biocompatibility Testing | | | |
| Biocompatibility | Conforms with<br>ISO 10993-1<br>cytotoxicitysensitizationirritation | Conforms with<br>ISO 10993-1<br>cytotoxicitysensitizationirritation | Same |

#### Table 5-1 – Substantial Equivalence Comparison

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### 9. Non-Clinical Performance Data

As part of demonstrating substantial equivalence of MucoPEG™ to the predicate device, SunBio submitted the subject device for testing in accordance with the applicable parts of the following voluntary standards:

- . ISO 10993-5 (cytotoxicity)
- ISO 10993-10 (irritation) .
- ISO 10993-10 (sensitization) ●

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SunBio also performed various physical properties tests on MucoPEG™ in a side-by-side manner against the predicate device for certain performance characteristics that artificial saliva products. These tests included:

- Appearance
- pH
- Viscosity
- Surface Tension
- Moisturization/Hydration of cultured epithelial layer cells

### 10. Statement of Substantial Equivalence

MucoPEG™ artificial saliva has the same intended use and indications for use, and similar technological features as Hydris™ Oral Rinse. Any minor differences in the ingredients used to make the subject device when compared to the predicate device have been successfully evaluated by SunBio through side-by-side comparative testing of the physical properties of the two devices, as well as by biocompatibility testing on the subject device, such that the information submitted to the FDA demonstrates that the subject device, when compared to the predicate device, does not raise any new questions of safety and effectiveness. MucoPEG™ artificial saliva, as designed and manufactured by SunBio, has been determined to be substantially equivalent to Hydris™ Oral Rinse.