Silatrix Oral Gel forms a protective layer over the oral mucosa by adhering to the mucosal surface which allows it to protect against further irritation and relieve pain. The oral gel may be used in the management of mouth lesions including aphthous ulcer, stomatitis, mucositis, minor lesions, chafing and traumatic ulcers, abrasions caused by braces and ill-fitting dentures, and lesions associated with oral surgery.

Device Description

The proposed Silatrix Oral Gel is an amorphous hydrogel formed by the controlled reaction of sucralfate with a limited quantity of malic acid and calcium carbonate solution. The amorphous hydrogel formed by this reaction binds reversibly to wounds and is intended to form a protective film that covers wounds, protects against further irritation and relieves pain. The intended use of this device is achieved by physical action. Silatrix Oral Gel may be administered directly to an accessible oral wound to provide an adherent physical covering of the wound bed. Although prepared by the reaction of sucralfate with an acid, the polymerized sucralfate self-buffers to a pH 5.0 - 7 .0, the subject device achieves its primary mode of action through serving as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. There is no chemical action or metabolic effect associated with the mechanism of action of this device.

Silatrix Oral Gel contains sucralfate, malic acid, calcium carbonate, calcium sulfate dihydrate, sucralose, xanthan gum, propylene glycol, and purified water. Silatrix Oral Gel, which is labeled for prescription use only, is supplied non-sterile in a small tube.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Silatrix Oral Gel, structured to answer your specific questions.

Important Note: The provided document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with strict acceptance criteria and performance metrics for a novel AI/software device. Therefore, many of your questions related to AI-specific elements (like AI-assisted MRMC studies, training set details, ground truth for AI, etc.) are not applicable to this type of submission. This summary primarily details non-clinical performance and comparisons to existing devices.

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a medical device (oral gel) and not a software/AI device, the "acceptance criteria" are viewed through the lens of demonstrating substantial equivalence to a legally marketed predicate device. The primary acceptance criteria would be that the device has the same intended use, similar technological characteristics, and similar principles of operation, and that any differences do not raise new questions of safety or effectiveness.

Acceptance Criteria (Demonstrates Substantial Equivalence to Predicate)	Reported Device Performance (Silatrix Oral Gel)
Intended Use: Same as predicate device (ProThelial & Orafate Sucralfate Paste).	Same: "to serve as a physical barrier on oral mucosal tissues, to protect against further irritation and manage or relieve pain."
Indications for Use: Identical or highly similar to predicate device.	Identical language as predicate: "Silatrix Oral Gel forms a protective layer over the oral mucosa by adhering to the mucosal surface which allows it to protect against further irritation and relieve pain. The oral gel may be used in the management of mouth lesions including aphthous ulcer, stomatitis, mucositis, minor lesions, chafing and traumatic ulcers, abrasions caused by braces and ill-fitting dentures, and lesions associated with oral surgery."
Technological Characteristics: Similar to predicate device, with any differences not raising new safety/effectiveness questions.	Similar: Both are viscous aqueous gel formulations, semi-solid for topical application, free of fatty vehicles, and comprise sucralfate as the clinically effective component. The primary difference (gel vs. paste dosage form and excipients) is deemed not to raise new questions of safety or effectiveness.
Principles of Operation: Similar to predicate device.	Similar: Amorphous hydrogel binds reversibly to wounds, forming a protective film that covers wounds, protects against irritation, and relieves pain, acting via physical action. The sucralfate self-buffers to pH 5.0 - 7.0.
Biocompatibility: Non-cytotoxic, non-sensitizing, non-irritating (for direct contact oral mucosal topical use).	Cytotoxicity: Not considered cytotoxic.
	Sensitization: Not considered a contact skin sensitizer.
	Irritation: Not considered an oral irritant.
Shelf-life: Demonstrated stability over time.	Shelf-life testing was conducted for the proposed device (results not explicitly detailed in the summary, but implied to be acceptable for market clearance).
Composition (Clinically Effective Component): Identical to predicate device.	Identical: Contains sucralfate USP, which is the "o-D-glucopyranoside, ß-D-fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex, molecular weight of 2,086.75" as verified by USP national standards.

Study Details

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This document describes non-clinical performance data (biocompatibility, shelf-life, and chemical verification of sucralfate). It does not rely on a clinical "test set" of patient data in the way an AI/software device would.
- The "study" here is primarily a comparison against a predicate device and laboratory testing. Specific sample sizes for biocompatibility or shelf-life testing are not provided in this summary. Data provenance (country, retrospective/prospective) is not detailed for these non-clinical tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. There is no clinical "test set" or ground truth requiring expert consensus for a diagnostic or AI algorithm in this submission. The determination is based on non-clinical data and comparison to a predicate device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as there is no clinical "test set" or ground truth requiring adjudication.
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/software device. There were no human readers or AI assistance involved in the evaluation presented here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/software device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical data:
  - Biocompatibility: In-vitro and in-vivo testing (e.g., cell cultures for cytotoxicity, animal models for sensitization/irritation). The "ground truth" is the established safety standard for these tests.
  - Component Verification: USP national standards (chemical analysis, e.g., spectroscopy, chromatography) to verify the presence and properties of sucralfate. The "ground truth" is adherence to these established chemical standards.
  - Equivalence: The established safety and effectiveness profile of the predicate device (ProThelial & Orafate Sucralfate Paste), which serves as a benchmark and "ground truth" for substantial equivalence.
The sample size for the training set:
- Not applicable. This is not an AI/software device, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for an AI algorithm.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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 in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.

November 20, 2020

Sa3. LLC % Daniel Schultz Principal, Devices and Combination Products Greenleaf Health, Inc. 1055 Thomas Jefferson Street, NW, Suite 450 Washington, District of Columbia 20007

Re: K202000 Trade/Device Name: Silatrix Oral Gel Regulatory Class: Unclassified Product Code: OLR, FRO Dated: August 31, 2020 Received: September 1, 2020

Dear Dr. Daniel Schultz:

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.

{1}------------------------------------------------

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 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 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 "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Statement of Indications for Use (FDA Form 3881)

Indications for Use

510(k) Number (if known): K202000

Device Name: Silatrix Oral Gel

Indications for Use:

Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for SA3, LLC. The logo consists of a green asterisk-like symbol on the left, followed by the text "SA3, LLC" in a teal color. The asterisk symbol has a circle in the center and eight lines radiating outwards.

2317 Cotner Avenue
Los Angeles, CA 90064-1803
888.495.6078
888.502.1669
info@SA3pharma.com

510(k) SUMMARY K202000

Silatrix Oral Gel

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

SA3, LLC 2317 Cotner Avenue Los Angeles, CA 90064 Phone: 310.282.8086 Fax: 888.502.1669 Contact Person: Farbod Melamed, Pharmacist

Date Prepared: 11/20/20

Name of Device and Name/Address of Sponsor

Silatrix Oral Gel SA3. LLC 2317 Cotner Avenue Los Angeles, CA 90064

Common or Usual Name

Polymerized cross-linked sucralfate gel treatment

Classification Name

Product Code: OLR, FRO Unclassified Oral Wound Dressing, Dressing, Wound, Drug

Primary Predicate

K-Number: K123904 Common or Usual Name: Sucralfate Malate Paste Trade/Proprietary/Model Name: ProThelial & Orafate Sucralfate Paste Classification Name: Dressing, Wound, Drug Product Code: FRO Classification: Unclassified Applicant: Mueller Medical International LLC

{4}------------------------------------------------

Reference Device

K-Number: K193336 Common or Usual Name: Synvaza and Synvaza II Classification Name: Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic Product Code: MGQ Classification: Unclassified Applicant: Synedgen, Inc.

Device Description

Indications for Use

Silatrix Oral Gel forms a protective laver over the oral mucosa by adhering to the mucosal surface which allows it to protect against further irritation and relieve pain. The oral gel may be used in the management of mouth lesions including aphthous ulcer, stomatitis, mucositis, minor lesions, chafing and traumatic ulcers, abrasions caused by braces and ill-fitting dentures, and lesions associated with oral surgery.

Nonclinical Performance Data

Non-clinical performance data relied on in this determination of substantial equivalence demonstrate the identical nature of the clinically effective component of the Silatrix Oral Gel and its predicate device, the ProThelial & Orafate Sucralfate Paste. The clinically effective component is sucralfate USP, without which neither device would function. The non-clinical tests involved those required by USP national standards to verify the presence of sucralfate. The sucralfate used in each of the devices is an o-D-glucopyranoside, P- Dfructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex, molecular weight of 2,086.75.

{5}------------------------------------------------

Biocompatibility testing was conducted for the proposed device. As the proposed device is an amorphous hydrogel for topical use in oral mucosa, all components of the device are considered direct contact components. Cytotoxicity, Sensitization and Irritation testing was conducted. The results showed that the Silatrix Oral Gel is not considered to be cytotoxic and not considered to be a contact skin sensitizer or an oral irritant. Shelf life testing was also conducted for the proposed device.

Substantial Equivalence

The proposed Silatrix Oral Gel has the same intended use as its primary predicate device, namely to serve as a physical barrier on oral mucosal tissues, to protect against further irritation and manage or relieve pain. In addition, the proposed Silatrix Oral Gel features identical indications for use language, similar technological characteristics and principles of operation.

The minor technological difference between these two devices is in the dosage form and excipients. The proposed device, the Silatrix Oral Gel and its primary predicate, the ProThelial & Orafate Sucralfate Paste are described as a gel and paste respectively, which are still viscous aqueous gel formulations. Both devices are semisolid for topical application and are free of fatty vehicles. As per FDA's definitions of gel and paste, the dosage form gel describes the Silatrix Oral Gel better than the paste. The differences in the technological characteristics between closely related paste and gel dosage forms for topical application do not raise new questions of safety or effectiveness. However, to further support the substantial equivalence of the proposed device, a reference device was introduced to capture the hydrogel technology featured in the proposed device. Reference device Synvaza (and Synvaza II) is also an oral wound dressing available in a hydrogel formulation, just as found in the proposed Silatrix Oral Gel.

Substantial Equivalence Chart							Ingredients
Device Number	K202000	K123904	K193336	No. Applicationper Day	Apply to mucosal wounds 2to 3 times daily.	Application to mucosal wounds2 -3 times daily.	Swish 1-3 teaspoons of rinse inmouth for 1 minute and spitout; use up to 10 times daily.
Product Name	Silatrix Oral Gel(Proposed Device)	ProThelial & OrafateSucralfate Paste	Synvaza and Synvaza II	Claim	Management and relief ofpain, does not sting,nonirritating, safe ifswallowed.	Management and relief of pain,non- irritating, safe ifswallowed.	Management of pain andmaintenance of a moist woundenvironment.
Applicant	SA3, LLC	Mueller Medical InternationalLLC	Synedgen, Inc.	Mechanism ofAction	Amorphous hydrogel bindsreversibly to wounds and isintended to form aprotective film that coverswounds, protects againstfurther irritation andrelieves pain.	Device binds reversibly towounds to form a protectivefilm where local wound bedacidity is not available orpresent on oral mucosa.Provides an adherent physicalcovering of the wound bed.	Polysaccharide polymer from anatural source that adheres tooral mucosa and protects itfrom irritation by forming aprotective barrier. It alsocreates a moist woundenvironment, which isnecessary for the naturalhealing process.
ClassificationName	Dressing, Wound and Burn,Hydrogel W/Drug and/orBiologic	Dressing, Wound, Drug	Dressing, Wound and BurnHydrogel W/ Drug and/orBiologic	Intended Use	Form a protective film thatcovers oral wounds, protectsagainst further irritation andrelieves pain	Form a protective film overoral mucosal wounds; relievespain.	Management of pain andmaintenance of a moist woundenvironment.
Classification	Unclassified	Unclassified	Unclassified	Indication	Silatrix Oral Gel forms aprotective layer over theoral mucosa by adhering tothe mucosal surface whichallows it to protect againstfurther irritation and relievepain. The oral gel may beused in the management ofmouth lesions includingaphthous ulcer, stomatitis,mucositis, minor lesions,chafing and traumaticulcers, abrasions caused bybraces and ill-fittingdentures, and lesionsassociated with oral surgery	ProThelialTM & OrafateSucralfate Malate Paste formsa protective layer over the oralmucosa by adhering to themucosal surface which allowsit to protect against furtherirritation and relieve pain. Thepaste may be used in themanagement of mouth lesionsof all types including aphthousulcer, stomatitis, mucositis,minor lesions, chafing andtraumatic ulcers, abrasionscaused by braces and ill-fittingdentures, and lesions associatedwith oral surgery.	Synvaza manages the pain inmany types of oral wounds,mouth sores, injuries, andulcers of the oral mucosa. Itadheres to oral tissue and formsa protective barrier between thewound and further irritationand contamination. It providesthe moist wound environmentrequired for optimal woundhealing. Manages painassociated with oral wounds,mouth sores, injuries and ulcersof the mouth such as: cankersores, irritation and traumaticulcers; aphthous ulcers.
Product Code	OLR, FRO	FRO	OLR, FRO	Description	Silatrix Oral Gel is anamorphous hydrogel formedby the controlled reaction ofsucralfate with a limitedquantity of malic acid andcalcium carbonate solution.The amorphous hydrogelformed by this reactionbinds reversibly to woundsand is intended to form aprotective film that covers	ProThelial & OrafateSucralfate Paste is anamorphous hydrogel pasteformed by the controlledreaction of sucralfate with alimited quantity of malic acidand calcium carbonatesolution. The amorphoushydrogel paste formed by thisreaction binds reversibly towounds and is intended to	Synvaza is an oral wound rinsespecifically formulated withmoisturizers, humectants, andmucoadhesive biopolymers thatare designed to manage the painin many types of oral wounds,mouth sores, injuries, and ulcersof the oral mucosa. Whenswished around the mouth, themucoadhesive formulation
Type	Rx Medical device	Rx Medical Device	OTC Medical Device
Patient Group	Pediatric & Adult	Pediatric & Adult	Pediatric & Adult

{6}------------------------------------------------

{7}------------------------------------------------

	wounds, protects againstfurther irritation andrelieves pain.Silatrix Oral Gel may beadministered directly to anaccessible oral wound toprovide an adherent physicalcovering of the wound bed.Although prepared byreaction of sucralfate with anacid, the polymerizedsucralfate self-buffers to apH 5.0 - 7.0.	form a protective film thatcovers wounds, protectsagainst further irritation andrelieves pain.ProThelial"" & OrafateSucralfate Paste may beadministered directly to anaccessible oral wound toprovide an adherent physicalcovering of the wound bed.Although prepared by reactionof sucralfate with an acid, thepolymerized sucralfate self-buffers to a pH 5.0 - 7.0.	results in a temporary formationof a protective coating over theoral mucosa. The liquid alsoprovides a moist woundenvironment, which is requiredfor optimal wound healing.
Area of Use	Oral Mucosa	Oral Mucosa	Oral Mucosa
Type of Product	Gel	Paste	Gel
Presentation	Non-Sterile	Non-Sterile	Non-Sterile

Conclusions:

The Silatrix Oral Gel and the predicate device, the ProThelial & Orafate Sucralfate Paste, have the same intended use and similar indications, technological characteristics and principles of operation. The only technological difference between the Silatrix Oral Gel and its predicate is the difference in dosage form and excipients. As explained above, these differences do not present any new issues of safety or effectiveness. The performance data also demonstrates the identical nature of the sucralfate component in these two devices. Thus, the Silatrix Oral Gel is substantially equivalent to the ProThelial & Orafate Sucralfate Paste.

Regulation Number and Section

N/A