(122 days)
Not Found
No
The device description and performance studies focus on the mechanical and biocompatibility properties of a gel, with no mention of AI or ML.
Yes.
MucoLock is described as having a "mechanical action which provides management of pain by adhering to the mucosal surface of the mouth, soothing oral lesions" which indicates a therapeutic purpose. It is also intended to treat various conditions like oral mucositis, stomatitis, and ulcers.
No
Explanation: The device, MucoLock, is described as having a mechanical action to soothe oral lesions by forming a protective layer. Its intended use and mechanism of action do not involve identifying, detecting, or monitoring a disease or condition, which are characteristics of a diagnostic device. It provides management of pain and protection, acting as a therapeutic or palliative device.
No
The device description clearly states it is a "low viscosity, pourable, and swish-able gel," indicating a physical substance, not software. The performance studies also focus on the physical properties and biological interactions of the gel.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a mechanical action (adhering to the mucosal surface) to manage pain and soothe oral lesions. This is a direct therapeutic or palliative action within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a gel that forms a protective layer over the oral mucosa. This is a physical barrier, not a reagent or instrument used to analyze biological samples for diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like saliva, tissue biopsies, etc.), detecting specific biomarkers, or providing information for diagnosis.
- Performance Studies: The performance studies focus on biocompatibility and bioadhesiveness, which are relevant to a device that interacts directly with the body's tissues, not a diagnostic test.
IVD devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, prevention, or treatment of a disease or condition. MucoLock does not fit this description.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
OLR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral Mucosa
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-Clinical Testing Summary:
- ISO 10993-5: 2009 Cytotoxicity: Not Cytotoxic
- ISO 10993-10: 2010 Buehler Guinea Pig Skin Sensitization Test: Not Sensitizing
- ISO 10993-10: 2010 Primary Direct Oral (Buccal) Irritation Test: Non-Irritant to the buccal tissues
Performance Testing:
- Bioadhesiveness: The adherence and retention time of the fluorescently labelled gel on the human oral buccal tissue constructs were similar for both the subject and device in the predicate family.
Clinical Performance Testing:
Clinical performance testing is not included.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K081372 - GELX Oral Gel
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.
Not Found
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY K203091
| Owner's Name: | PCCA |
|---|---|
| Address: | 9901 South Wilcrest Dr. |
| Houston, TX 77099-5132 | |
| Phone Number: | (832) 295-1218 |
| Contact Person: | Gus Bassani, Pharm.D. |
| 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.
4
| Product Name | Subject Device:
PCCA MucoLock (K203091) | Predicate Device:
GelX Oral Gel (K081372) |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Ingredients | Water, Isomalt, Pullulan,
Glycerin, Beta-glucan, Sodium
Hyaluronate, Tamarindus
Indica Seed Polysaccharide,
Zea Mays (Corn) Starch,
Poloxamer 407, Carbomer,
Disodium EDTA, Sodium
Benzoate, Potassium Sorbate,
Methylparaben,
Propylparaben. | Purified Water, PVP, Taurine,
Zinc Gluconate, PEG-40
Hydrogenated Castor Oil,
Sodium Saccharin, Sodium
Hydroxide, Flavor. |
| Method of Use | Use undiluted | Use undiluted |
| Number of applications per
day | Rinse around the mouth, or the
affected area of the mouth for
at least one minute or as long as
possible to coat all oral tissue
thoroughly. Spit out. Use 3
times a day or as needed as
directed by your doctor.
MucoLock® Oral Gel is to be
used no longer than the
timeframe prescribed by the
doctor or dentist, ideally no
longer than the period of time
wherein oral ulcers, lesions,
irritation, mucositis or
stomatitis persists. | Rinse around the mouth for at
least one minute or as
long as possible to coat tongue,
palate, throat, inside
of cheeks and all oral tissue
thoroughly.
Use 3 times a day or
as needed. Do not eat or
drink for least one hour
following treatment. |
| Claim | Management of pain and relief
of pain. | Management of pain and relief
of pain. |
| Area of Use | Oral Mucosa | Oral Mucosa |
| Disease State | Oral Mucositis/
Stomatitis/Oral Lesions | Oral Mucositis/
Stomatitis/Oral Lesions |
| Type of Product | Ready for use | Ready for use |
| Presentation | Non-Sterile | Non-Sterile |
5
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
Testing | Result Summary |
|--------------------|--------------------------------------------------|------------------------------------|
| ISO 10993-5: 2009 | Cytotoxicity | Not Cytotoxic |
| ISO 10993-10: 2010 | Buehler Guinea Pig
Skin
Sensitization Test | Not Sensitizing |
| ISO 10993-10: 2010 | Primary Direct Oral
(Buccal) Irritation Test | Non-Irritant to the buccal tissues |
| Performance Testing | Result Summary |
|---|---|
| Bioadhesiveness | The adherence and retention time of the |
| fluorescently labelled gel on the human oral | |
| buccal tissue constructs were similar for both the | |
| 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.