(280 days)
MucoPEG™ is indicated to relieve the symptoms and discomfort of dry mouth, refresh, moisturize/hydrate, clean, soothe oral irritation, and lubricate oral dryness.
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.
The provided text describes the regulatory clearance for a device called MucoPEG™. It does not contain information about a study that proves the device meets specific acceptance criteria in the context of AI/ML performance, human reader studies, or ground truth establishment. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance and biocompatibility.
Therefore, the following information cannot be extracted from the provided text:
- Table of acceptance criteria and reported device performance: The document presents a comparison table between the subject device (MucoPEG™) and a predicate device (Hydris™ Oral Rinse) in terms of regulatory information, ingredients, conditions of use, physical properties, and biocompatibility. It does not define explicit "acceptance criteria" for MucoPEG™ in the typical sense of a performance study with a target metric. Instead, it aims to show similarity or non-inferiority to the predicate.
- Sample size used for the test set and data provenance: No test set is described in the context of an AI/ML or reader study. The "test" mentioned refers to non-clinical performance testing and biocompatibility.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable as there is no mention of a test set with ground truth established by experts.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. There is no mention of an MRMC study or human reader improvement with AI assistance.
- Standalone (algorithm-only without human-in-the-loop performance) study: Not applicable. The device is an artificial saliva product, not an AI algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document highlights the following non-clinical performance data and criteria for demonstrating substantial equivalence:
Acceptance Criteria (Implicit from Substantial Equivalence Comparison) and Reported Device Performance
The device MucoPEG™ demonstrated substantial equivalence to the predicate device Hydris™ Oral Rinse based on the following comparisons:
| Attribute | Predicate Device (Hydris™ Oral Rinse) Performance / Characteristic | Subject Device (MucoPEG™) Performance / Characteristic | Similarity / Difference and "Acceptance" |
|---|---|---|---|
| Regulatory Information | |||
| 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 xerostomia (i.e., dry mouth). | Temporary relief of xerostomia (i.e., dry mouth). | Same |
| Indications for Use | To relieve the symptoms and discomfort of dry mouth, refresh, moisturize/hydrate, clean, soothe oral irritation, and lubricate oral dryness. | To relieve the symptoms and discomfort of dry mouth, refresh, moisturize/hydrate, clean, soothe oral irritation, and lubricate oral dryness. | Same |
| Ingredients (Key for Mechanism) | |||
| Humectants/Moisturizers | Glycerin, Propylene Glycol (PG) | Polyethylene Glycol (PEG) Tetra Succinimidyl Glutarate | Similar. Both PEG and PG provide the same mechanical mechanism of action and are alkylene oxide by-products purified to USP grade. |
| Buffers | Disodium Phosphate, Sodium Phosphate | Sodium Bicarbonate | Similar. Both are GRAS, providing similar pH levels. |
| Conditions of Use | |||
| Area of Use | Oral cavity | Oral cavity | Same |
| Dosage Form | Oral rinse | Oral rinse | Same |
| Dosage (per use) | 20 mL (4 teaspoons) | 1g dissolved in 20 mL 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 H2O prior to use. | Similar, both are in liquid form when used. |
| Environment of Use | Home | Home | Same |
| Prescription/OTC | OTC | Rx | Different (Rx for subject device to maintain prescribed storage conditions and integrity) |
| Physical Properties (Performance Testing) | |||
| Appearance | Viscous liquid, when applied | Viscous liquid, when applied | Same |
| pH | 5.91 | 7.29 | Similar. Both are near the pH of saliva (5.3 - 7.8). |
| Viscosity (Pa-s) | 0.0126 | 0.0019 | Similar. Not significantly different from saliva viscosity (0.0078 Pa-s). |
| Surface Tension (dyn/cm) | 30.24 | 49.28 | Similar. Not significantly different from saliva surface tension (58 dyn/cm). |
| Moisturization/Hydration of Cell | 12.0 ± 3.38% | 71.9 ± 47.26% | Similar. The difference was not statistically significant in protecting epithelial cells from dryness (p-value = 0.093). |
| Sterility | Non-Sterile | Non-Sterile | Similar. |
| Shelf-Life | 24 months | 18 months | Similar. Validated for 18 months. |
| Storage Condition | Not specified | -20 ± 5 °C (-4 ± 9°F) | Different (specific condition for subject device to maintain integrity). |
| Biocompatibility Testing | |||
| Biocompatibility | Conforms with ISO 10993-1 cytotoxicity, sensitization, irritation | Conforms with ISO 10993-1 cytotoxicity, sensitization, irritation | Same |
Summary of Relevant Information from the Document:
- Non-Clinical Performance Data: SunBio submitted the device for testing in accordance with ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation), and ISO 10993-10 (sensitization).
- Physical Properties Tests: Side-by-side comparative testing was performed against the predicate device for:
- Appearance
- pH
- Viscosity
- Surface Tension
- Moisturization/Hydration of cultured epithelial layer cells
The conclusion was that the device does not raise any new questions of safety and effectiveness when compared to the predicate device, leading to a determination of substantial equivalence.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: (925) 876-0439 (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: (512) 327-9997
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 /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 ofxerostomia (i.e., drymouth). | Temporary relief ofxerostomia (i.e., drymouth). | Same |
| Indications for Use | To relieve the symptomsand discomfort of drymouth, refresh,moisturize/hydrate,clean, soothe oralirritation, and lubricateoral dryness. | To relieve the symptomsand discomfort of drymouth, refresh,moisturize/hydrate,clean, soothe oralirritation, and lubricateoral dryness. | Same |
| Ingredients | |||
| Solvent | H2O | H2O | Same |
| Humectants/Moisturizers | Glycerin, PropyleneGlycol (PG) | Polyethylene Glycol (PEG)Tetra SuccinimidylGlutarate | Similar. The PEG usedin the subject deviceand the PG used inthe predicate deviceprovide the samemechanicalmechanism of actionand are alkyleneoxide by-productssourced from thepetroleum refiningprocess, and thenpurified to USPgrade. |
| Buffers | Disodium Phosphate,Sodium Phosphate | Sodium Bicarbonate | Similar. Thesedifferent bufferingagents are generallyrecognized as safe(GRAS) and providesimilar pH levels forthe subject andpredicate devices. |
| Flavors | Mint | Mint | Same |
| Thickeners | Cellulose Gum, XanthanGum, Carbomer | None | Thickeners are notused in the subjectdevice. |
| Surfactants | Poloxamer 407 | None | Surfactants are notused in the subjectdevice. |
| Preservatives | Cetylpyridinium Chloride,Sodium Benzoate | None | Preservatives are notused in the subjectdevice. |
| Colorants | FD&C Blue 1 | None | Colorants are notused in the subjectdevice. |
| Sweeteners | Sorbitol, SodiumSaccharin, Sucralose | None | Sweeteners are notused in the subjectdevice. |
| Conditions of Use | |||
| Area of Use | Oral cavity | Oral cavity | Same |
| Dosage Form | Oral rinse | Oral rinse | Same |
| Dosage(per use) | 20 mL (4 teaspoons) | 1g dissolved in 20 mLwater. | Same |
| Applications/Day | Up to 2 times daily. | As often as needed. | Similar |
| Method of Use | Ready to use liquid. | Powder to be mixed withH2O prior to use. | Similar, both are inliquid form whenused. |
| Environment of Use | Home | Home | Same |
| Prescription/OTC | OTC | Rx | The subject device issold by prescriptionto maintain itsprescribed storagecondition andproduct integritywhile it remains atthe pharmacy prior tobeing sold to the enduser. |
| Packaging Unit | 8/16/33.8 fl-oz bottles | 30 (1g) packets / boxDissolution Bottle | Similar. Thedifferences betweenthe way the subjectand predicate devicesare packaged is afunction of theirphysical state. |
| Physical Properties (Performance Testing) | |||
| Appearance | Viscous liquid, whenapplied | Viscous liquid, whenapplied | Same |
| pH | 5.91 | 7.29 | Similar. The subjectand predicate deviceshave pH values nearthe pH of saliva(5.3 - 7.8). |
| Viscosity(Pa-s) | 0.0126 | 0.0019 | Similar. The valuesare not significantlydifferent whencompared to theviscosity of the saliva(0.0078 Pa-s). |
| Surface Tension(dyn/cm) | 30.24 | 49.28 | Similar. The valuesare not significantlydifferent whencompared to thesurface tension ofsaliva (58 dyn/cm). |
| Moisturization/Hydrationof Cell | $12.0\pm3.38%$ | $71.9\pm47.26%$ | Similar. Thedifference is notstatisticallysignificantly differentin protectingepithelial cells fromdryness (p-value =0.093). |
| Sterility | Non-Sterile | Non-Sterile | Similar. |
| Shelf-Life | 24 months | 18 months | Similar. The validatedshelf-life of thesubject device is 18months when storedas instructed. |
| Storage Condition | Not specified | -20 $\pm$ 5 °C (-4 $\pm$ 9°F) | The subject device isstored under theprescribed storagecondition to maintainthe integrity(stability) of theproduct. |
| Biocompatibility Testing | |||
| Biocompatibility | Conforms withISO 10993-1cytotoxicitysensitizationirritation | Conforms withISO 10993-1cytotoxicitysensitizationirritation | 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.
N/A