(122 days)
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.
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.
The provided document is a 510(k) premarket notification for a medical device called MucoLock Oral Gel. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive human studies. Therefore, many of the requested elements for a study proving device performance against acceptance criteria, especially those related to AI/MRMC studies or human clinical outcomes, will not be present in this document.
Here's an analysis of the document based on your request:
Acceptance Criteria and Device Performance:
The primary "acceptance criteria" for a 510(k) submission revolve around demonstrating substantial equivalence to a predicate device. This is achieved by showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The performance testing conducted is primarily non-clinical.
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) and not a clinical efficacy trial, the "acceptance criteria" are not framed as clinical endpoints or specific performance metrics like sensitivity/specificity for an AI device. Instead, they are related to equivalence.
| Acceptance Criteria (based on Substantial Equivalence tenets) | Reported Device Performance (Summary from Document) |
|---|---|
| Intended Use Equivalence: | Identical: Both MucoLock Oral Gel and the predicate device (GelX Oral Gel) are indicated for the management and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies (Oral Mucositis/Stomatitis, irritation from oral surgery, traumatic ulcers from braces/dentures, or disease), and diffuse aphthous ulcers. |
| Technological Characteristics Equivalence: | Similar, with justified differences:- Formulation: Different ingredients (e.g., MucoLock uses Water, Isomalt, Pullulan, Glycerin, Beta-glucan, etc.; GelX uses Purified Water, PVP, Taurine, Zinc Gluconate, etc.). The document states that while ingredients differ, they are all listed in GRAS SCOGS, GRAS Notice Inventory, or commonly used in approved oral products at consistent levels, implying no new safety/effectiveness concerns.- Method of Use: Both are "Use undiluted" and involve rinsing/coating oral tissue.- Application Frequency: Both are "3 times a day or as needed".- Claims: Both claim "Management of pain and relief of pain."- Area of Use: Both are "Oral Mucosa."- Disease State: Both address "Oral Mucositis/Stomatitis/Oral Lesions."- Product Type/Presentation: Both are "Ready for use" and "Non-Sterile." |
| Safety Testing (Biocompatibility): | Meets ISO Standards for Contact Duration:- Cytotoxicity (ISO 10993-5: 2009): Not Cytotoxic- Sensitization (ISO 10993-10: 2010 - Buehler Guinea Pig Skin Sensitization Test): Not Sensitizing- Irritation (ISO 10993-10: 2010 - Primary Direct Oral (Buccal) Irritation Test): Non-Irritant to the buccal tissues |
| Functional/Performance Testing (Non-Clinical): | 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." |
| No New Questions of Safety/Effectiveness Raised: | Addressed: The submission argues that the differences do not raise new concerns because ingredients are GRAS/commonly used, and non-clinical testing supports similar performance. |
Study Details from the Document:
2. Sample size used for the test set and the data provenance:
- Test Set: No human clinical test set (i.e., patient data for clinical efficacy/performance) was used for the primary evaluation of this device as part of the 510(k). The document explicitly states: "Clinical performance testing is not included."
- Provenance: N/A for clinical data. The biocompatibility and bioadhesiveness tests were laboratory-based. The bioadhesiveness test used "human oral buccal tissue constructs," which implies ex vivo or in vitro testing, not human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No human clinical data or expert-adjudicated ground truth for a test set was part of this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No human clinical data or adjudication process was involved.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm. Its performance is assessed through non-clinical laboratory tests (biocompatibility, bioadhesiveness) demonstrating its physical and chemical properties and safety.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests:
- Biocompatibility: Ground truth is established by adherence to ISO standards (e.g., cell viability for cytotoxicity, skin reaction for sensitization, tissue reaction for irritation).
- Bioadhesiveness: Ground truth is established by in vitro or ex vivo measurements of adherence and retention time on tissue constructs, compared to the predicate.
8. The sample size for the training set:
- Not applicable. This is not a machine learning/AI device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable.
In summary: This 510(k) submission for MucoLock Oral Gel relies on demonstrating substantial equivalence to a predicate device through:
- Identical intended use.
- Similar technological characteristics, with justified differences based on ingredient safety and common usage.
- Non-clinical laboratory testing (biocompatibility and bioadhesiveness) to show the new device is safe and performs functionally similarly to the predicate.
No clinical efficacy studies or AI-related performance evaluations were performed or submitted for this specific 510(k) clearance.
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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 (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.
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| Product Name | Subject Device:PCCA MucoLock (K203091) | Predicate Device:GelX Oral Gel (K081372) |
|---|---|---|
| Ingredients | Water, Isomalt, Pullulan,Glycerin, Beta-glucan, SodiumHyaluronate, TamarindusIndica Seed Polysaccharide,Zea Mays (Corn) Starch,Poloxamer 407, Carbomer,Disodium EDTA, SodiumBenzoate, Potassium Sorbate,Methylparaben,Propylparaben. | Purified Water, PVP, Taurine,Zinc Gluconate, PEG-40Hydrogenated Castor Oil,Sodium Saccharin, SodiumHydroxide, Flavor. |
| Method of Use | Use undiluted | Use undiluted |
| Number of applications perday | Rinse around the mouth, or theaffected area of the mouth forat least one minute or as long aspossible to coat all oral tissuethoroughly. Spit out. Use 3times a day or as needed asdirected by your doctor.MucoLock® Oral Gel is to beused no longer than thetimeframe prescribed by thedoctor or dentist, ideally nolonger than the period of timewherein oral ulcers, lesions,irritation, mucositis orstomatitis persists. | Rinse around the mouth for atleast one minute or aslong as possible to coat tongue,palate, throat, insideof cheeks and all oral tissuethoroughly.Use 3 times a day oras needed. Do not eat ordrink for least one hourfollowing treatment. |
| Claim | Management of pain and reliefof pain. | Management of pain and reliefof 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 |
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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 | BiocompatibilityTesting | Result Summary |
|---|---|---|
| ISO 10993-5: 2009 | Cytotoxicity | Not Cytotoxic |
| ISO 10993-10: 2010 | Buehler Guinea PigSkinSensitization 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 thefluorescently labelled gel on the human oralbuccal tissue constructs were similar for both thesubject 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.
N/A