(280 days)
K093642, P030039
No
The device description and performance studies focus on the chemical composition and physical properties of an artificial saliva product, with no mention of AI or ML technologies.
Yes
The device is indicated to "relieve the symptoms and discomfort of dry mouth," and studies its performance in "moisturization/hydration" and compares it to an "artificial saliva product." These indications point to a therapeutic purpose rather than just a diagnostic or general wellness purpose.
No
Explanation: The device, MucoPEG™, is an artificial saliva intended to relieve symptoms of dry mouth. It does not identify or detect a disease, condition, or state of health, which would be the function of a diagnostic device.
No
The device is a physical substance (powder) intended for oral use, not a software program.
Based on the provided information, MucoPEG™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use of MucoPEG™ is to relieve symptoms of dry mouth and provide comfort within the oral cavity. This is a therapeutic or palliative use, not a diagnostic one.
- Device Description: MucoPEG™ is described as an "artificial saliva" and its function is to moisturize, lubricate, and soothe the oral cavity. It does not perform any tests on biological samples to diagnose a condition.
- Lack of Diagnostic Function: There is no mention of MucoPEG™ being used to detect, measure, or examine any substances or characteristics in vitro (outside the body) for diagnostic purposes.
IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. MucoPEG™ does not fit this description.
N/A
Intended Use / Indications for Use
MucoPEG™ is indicated to relieve the symptoms and discomfort of dry mouth, refresh, moisturize/hydrate, clean, soothe oral irritation, and lubricate oral dryness.
Product codes (comma separated list FDA assigned to the subject device)
LFD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home
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)
SunBio 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
Results:
- Appearance: Viscous liquid, when applied (Same as predicate)
- pH: Subject device: 7.29, Predicate device: 5.91. (Similar, both near pH of saliva 5.3 - 7.8)
- Viscosity (Pa-s): Subject device: 0.0019, Predicate device: 0.0126. (Similar, not significantly different compared to saliva viscosity 0.0078 Pa-s)
- Surface Tension (dyn/cm): Subject device: 49.28, Predicate device: 30.24. (Similar, not significantly different compared to saliva surface tension 58 dyn/cm)
- Moisturization/Hydration of Cell: Subject device: 71.9 ± 47.26%, Predicate device: 12.0 ± 3.38%. (Similar, difference not statistically significant in protecting epithelial cells from dryness (p-value = 0.093))
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Moisturization/Hydration of Cell (p-value = 0.093)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K093642, P030039
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 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 | | |
| Solvent | H2O | H2O | Same |
| Humectants/Moisturizers | Glycerin, Propylene
Glycol (PG) | Polyethylene Glycol (PEG)
Tetra Succinimidyl
Glutarate | Similar. The PEG used
in the subject device
and the PG used in
the predicate device
provide the same
mechanical
mechanism of action
and are alkylene
oxide by-products
sourced from the
petroleum refining
process, and then
purified to USP
grade. |
| Buffers | Disodium Phosphate,
Sodium Phosphate | Sodium Bicarbonate | Similar. These
different buffering
agents are generally
recognized as safe
(GRAS) and provide
similar pH levels for
the subject and
predicate devices. |
| Flavors | Mint | Mint | Same |
| Thickeners | Cellulose Gum, Xanthan
Gum, Carbomer | None | Thickeners are not
used in the subject
device. |
| Surfactants | Poloxamer 407 | None | Surfactants are not
used in the subject
device. |
| Preservatives | Cetylpyridinium Chloride,
Sodium Benzoate | None | Preservatives are not
used in the subject
device. |
| Colorants | FD&C Blue 1 | None | Colorants are not
used in the subject
device. |
| Sweeteners | Sorbitol, Sodium
Saccharin, Sucralose | None | Sweeteners are not
used in the subject
device. |
| 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 | The subject device is
sold by prescription
to maintain its
prescribed storage
condition and
product integrity
while it remains at
the pharmacy prior to
being sold to the end
user. |
| Packaging Unit | 8/16/33.8 fl-oz bottles | 30 (1g) packets / box
Dissolution Bottle | Similar. The
differences between
the way the subject
and predicate devices
are packaged is a
function of their
physical state. |
| Physical Properties (Performance Testing) | | | |
| Appearance | Viscous liquid, when
applied | Viscous liquid, when
applied | Same |
| pH | 5.91 | 7.29 | Similar. The subject
and predicate devices
have pH values near
the pH of saliva
(5.3 - 7.8). |
| Viscosity
(Pa-s) | 0.0126 | 0.0019 | Similar. The values
are not significantly
different when
compared to the
viscosity of the saliva
(0.0078 Pa-s). |
| Surface Tension
(dyn/cm) | 30.24 | 49.28 | Similar. The values
are not significantly
different when
compared to the
surface tension of
saliva (58 dyn/cm). |
| Moisturization/Hydration
of Cell | $12.0\pm3.38%$ | $71.9\pm47.26%$ | Similar. The
difference is not
statistically
significantly different
in protecting
epithelial cells from
dryness (p-value =
0.093). |
| Sterility | Non-Sterile | Non-Sterile | Similar. |
| Shelf-Life | 24 months | 18 months | Similar. The validated
shelf-life of the
subject device is 18
months when stored
as instructed. |
| Storage Condition | Not specified | -20 $\pm$ 5 °C (-4 $\pm$ 9°F) | The subject device is
stored under the
prescribed storage
condition to maintain
the integrity
(stability) of the
product. |
| Biocompatibility Testing | | | |
| Biocompatibility | Conforms with
ISO 10993-1
cytotoxicitysensitizationirritation | Conforms with
ISO 10993-1
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.