MucoLock Oral Gel

K203091 · Pcca, Inc. · OLR · Feb 12, 2021 · DE

Device Facts

• Record ID: K203091
• Device Name: MucoLock Oral Gel
• Applicant: Pcca, Inc.
• Product Code: OLR · DE
• Decision Date: Feb 12, 2021
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

MucoLock has a mechanical action which provides management of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including: Oral Mucositis or Stomatitis (may be caused by chemotherapy or radiotherapy), irritation due to oral surgery, traumatic ulcers caused by braces and ill-fitting dentures, or disease. Also indicated for diffuse aphthous ulcers.

Device Story

MucoLock Oral Gel is a low-viscosity, pourable, swish-able gel used as an oral wound dressing. The patient rinses the gel around the mouth for at least one minute to coat oral tissues, then spits it out. The gel functions via mechanical action, forming a protective, bioadhesive layer over the oral mucosa to soothe lesions and manage pain. It is intended for use in clinical or home settings to provide symptomatic relief for oral mucositis, stomatitis, and various oral ulcers. The device does not require specialized operation and is used as directed by a physician or dentist.

Clinical Evidence

No clinical data. Bench testing included biocompatibility (ISO 10993-5 cytotoxicity, ISO 10993-10 sensitization and buccal irritation) and performance testing (bioadhesiveness on human oral buccal tissue constructs), showing results similar to the predicate.

Technological Characteristics

Oral wound dressing; non-sterile, pourable gel. Ingredients include water, isomalt, pullulan, glycerin, beta-glucan, sodium hyaluronate, tamarindus indica seed polysaccharide, corn starch, poloxamer 407, carbomer, and preservatives. Mechanical film-forming principle. Biocompatibility tested per ISO 10993-5 and ISO 10993-10.

Indications for Use

Indicated for patients suffering from oral pain due to oral mucositis, stomatitis (chemotherapy/radiotherapy-induced), oral surgery irritation, traumatic ulcers (braces/dentures), disease, or diffuse aphthous ulcers.

Regulatory Classification

Identification

Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ.

Predicate Devices

• GELX Oral Gel (K081372)

Submission Summary (Full Text)

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February 12, 2021

PCCA, Inc. Gus Bassani Chief Scientific Officer 9901 S. Wilcrest Drive Houston, Texas 77099

Re: K203091

Trade/Device Name: MucoLock Oral Gel Regulatory Class: Unclassified Product Code: OLR Dated: October 12, 2020 Received: October 13, 2020

Dear Gus Bassani:

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/cfpmp/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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael E. Adjodha, M.ChE. 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) K203091

Device Name MucoLock Oral Gel

#### Indications for Use (Describe)

MucoLock has a mechanical action which provides management of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including: Oral Mucositis or Stomatitis (may be caused by chemotherapy or radiotherapy), irritation due to oral surgery, traumatic ulcers caused by braces and ill-fitting dentures, or disease. Also indicated for diffuse aphthous ulcers.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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### 510(K) SUMMARY K203091

| Owner's Name: | PCCA |
|----------------------|---------------------------------------------------|
| Address: | 9901 South Wilcrest Dr.<br>Houston, TX 77099-5132 |
| Phone Number: | [phone] |
| Contact Person: | Gus Bassani, Pharm.D.<br>PCCA |
| Date of Preparation: | February 7, 2021 |

| Device Name: | MucoLock® Oral Gel |
|-------------------|---------------------|
| Common Name: | MucoLock® Oral Gel |
| Classification: | Oral Wound Dressing |
| Regulatory class: | I, Unclassified |
| Product Code: | OLR |

### Legally Marketed Device:

K081372 - GELX Oral Gel

### Device Description:

MucoLock® is a low viscosity, pourable, and swish-able gel, which is presented in 16 fl. oz. bottles. This product, when washed around the mouth, forms a protective layer over the oral mucosa.

### Indications for Use:

MucoLock has a mechanical action indicated for the management of pain and relief of pain, by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including: Oral Mucositis or Stomatitis (may be caused by chemotherapy or radiotherapy), irritation due to oral surgery, traumatic ulcers caused by braces or ill-fitting dentures, or disease. Also indicated for diffuse aphthous ulcers.

# Summary of Technological Characteristics of the Device Compared to the Predicate Device:

With the exception of the product name, MucoLock has the same intended/indications for use as the predicate GelX Oral Gel.

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| Product Name | Subject Device:<br>PCCA MucoLock (K203091) | Predicate Device:<br>GelX Oral Gel (K081372) |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Ingredients | Water, Isomalt, Pullulan,<br>Glycerin, Beta-glucan, Sodium<br>Hyaluronate, Tamarindus<br>Indica Seed Polysaccharide,<br>Zea Mays (Corn) Starch,<br>Poloxamer 407, Carbomer,<br>Disodium EDTA, Sodium<br>Benzoate, Potassium Sorbate,<br>Methylparaben,<br>Propylparaben. | Purified Water, PVP, Taurine,<br>Zinc Gluconate, PEG-40<br>Hydrogenated Castor Oil,<br>Sodium Saccharin, Sodium<br>Hydroxide, Flavor. |
| Method of Use | Use undiluted | Use undiluted |
| Number of applications per<br>day | Rinse around the mouth, or the<br>affected area of the mouth for<br>at least one minute or as long as<br>possible to coat all oral tissue<br>thoroughly. Spit out. Use 3<br>times a day or as needed as<br>directed by your doctor.<br>MucoLock® Oral Gel is to be<br>used no longer than the<br>timeframe prescribed by the<br>doctor or dentist, ideally no<br>longer than the period of time<br>wherein oral ulcers, lesions,<br>irritation, mucositis or<br>stomatitis persists. | Rinse around the mouth for at<br>least one minute or as<br>long as possible to coat tongue,<br>palate, throat, inside<br>of cheeks and all oral tissue<br>thoroughly.<br>Use 3 times a day or<br>as needed. Do not eat or<br>drink for least one hour<br>following treatment. |
| Claim | Management of pain and relief<br>of pain. | Management of pain and relief<br>of pain. |
| Area of Use | Oral Mucosa | Oral Mucosa |
| Disease State | Oral Mucositis/<br>Stomatitis/Oral Lesions | Oral Mucositis/<br>Stomatitis/Oral Lesions |
| Type of Product | Ready for use | Ready for use |
| Presentation | Non-Sterile | Non-Sterile |

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# Comparison to Predicate Device:

The mode of action of MucoLock Oral Gel, which is via the formation of a protective layer over the oral mucosa, is similar to GelX.

While the chemical composition of film-forming polymers, preservatives and sweeteners differ, the differences do not raise concerns of safety and effectiveness because all MucoLock ingredients are listed in the GRAS SCOGS Database, in the GRAS Notice Inventory, or are commonly utilized in other approved oral products at levels consistent with those uses in the Inactive Ingredient Database. In addition, the proposed MucoLock Oral Gel features similar indications for use language, technological characteristics, and mode of action as stated above.

# Non-Clinical Testing Summary:

| Standard | Biocompatibility<br>Testing | Result Summary |
|--------------------|--------------------------------------------------|------------------------------------|
| ISO 10993-5: 2009 | Cytotoxicity | Not Cytotoxic |
| ISO 10993-10: 2010 | Buehler Guinea Pig<br>Skin<br>Sensitization Test | Not Sensitizing |
| ISO 10993-10: 2010 | Primary Direct Oral<br>(Buccal) Irritation Test | Non-Irritant to the buccal tissues |

| Performance Testing | Result Summary |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Bioadhesiveness | The adherence and retention time of the<br>fluorescently labelled gel on the human oral<br>buccal tissue constructs were similar for both the<br>subject and device in the predicate family. |

# Clinical Performance Testing:

Clinical performance testing is not included.

# Conclusion:

Based upon similarities in indications for use and technology, together with the results of non clinical performance testing, we believe that MucoLock is substantially equivalent to the predicate device GelX.