(123 days)
No
The device description and performance studies focus on the physical and chemical properties of the gel and its components, with no mention of AI or ML. The mechanism of action is described as physical.
Yes.
The device is intended to relieve pain and protect against irritation for various oral lesions, which are therapeutic claims.
No
Explanation: The device, Silatrix Oral Gel, is intended to form a protective layer over oral mucosa to relieve pain and protect against irritation. Its mechanism of action is described as a physical barrier. There is no mention of it being used to identify or characterize a disease or condition.
No
The device is a gel, which is a physical substance, not software. The description details its chemical composition and physical mode of action.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is applied directly to the oral mucosa to form a protective layer and relieve pain. This is a physical action on the body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description emphasizes the physical action of forming a protective film and acting as a physical barrier. It explicitly states there is "no chemical action or metabolic effect associated with the mechanism of action of this device." IVDs typically involve chemical, biological, or immunological reactions to detect substances or characteristics in a sample.
- Lack of Diagnostic Elements: There is no mention of analyzing a sample (blood, saliva, tissue, etc.) or providing information about a patient's health status based on such analysis. The device's function is purely therapeutic and protective.
Therefore, Silatrix Oral Gel is a therapeutic device intended for direct application to the oral mucosa, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OLR, FRO
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.
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
Pediatric & Adult
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 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.
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.
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.
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.
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 & 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:
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.
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
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.
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 | Sucralfate, malic acid,
calcium carbonate, xanthan
gum, calcium sulfate
dihydrate, purified water,
sucralose, propylene glycol | Sucralfate, malic acid, calcium
carbonate, xanthan gum,
calcium sulfate, purified water,
methyl parabens, propyl
parabens, sodium saccharin | Water, sorbitol, glycerin,
betaine, (benzoic acid- Synvaza
II) chitosan derivatives, sodium
hydroxide |
|-------------------------------|-----------------------------------------------------------------|------------------------------------------|-----------------------------------------------------------------|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Device Number | K202000 | K123904 | K193336 | No. Application
per Day | Apply to mucosal wounds 2
to 3 times daily. | Application to mucosal wounds
2 -3 times daily. | Swish 1-3 teaspoons of rinse in
mouth for 1 minute and spit
out; use up to 10 times daily. | | | |
| Product Name | Silatrix Oral Gel
(Proposed Device) | ProThelial & Orafate
Sucralfate Paste | Synvaza and Synvaza II | Claim | Management and relief of
pain, does not sting,
nonirritating, safe if
swallowed. | Management and relief of pain,
non- irritating, safe if
swallowed. | Management of pain and
maintenance of a moist wound
environment. | | | |
| Applicant | SA3, LLC | Mueller Medical International
LLC | Synedgen, Inc. | Mechanism of
Action | Amorphous hydrogel binds
reversibly to wounds and is
intended to form a
protective film that covers
wounds, protects against
further irritation and
relieves pain. | Device binds reversibly to
wounds to form a protective
film where local wound bed
acidity is not available or
present on oral mucosa.
Provides an adherent physical
covering of the wound bed. | Polysaccharide polymer from a
natural source that adheres to
oral mucosa and protects it
from irritation by forming a
protective barrier. It also
creates a moist wound
environment, which is
necessary for the natural
healing process. | | | |
| Classification
Name | Dressing, Wound and Burn,
Hydrogel W/Drug and/or
Biologic | Dressing, Wound, Drug | Dressing, Wound and Burn
Hydrogel W/ Drug and/or
Biologic | Intended Use | Form a protective film that
covers oral wounds, protects
against further irritation and
relieves pain | Form a protective film over
oral mucosal wounds; relieves
pain. | Management of pain and
maintenance of a moist wound
environment. | | | |
| Classification | Unclassified | Unclassified | Unclassified | Indication | 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 | ProThelialTM & Orafate
Sucralfate Malate Paste 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
paste may be used in the
management of mouth lesions
of all types 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. | Synvaza manages the pain in
many types of oral wounds,
mouth sores, injuries, and
ulcers of the oral mucosa. It
adheres to oral tissue and forms
a protective barrier between the
wound and further irritation
and contamination. It provides
the moist wound environment
required for optimal wound
healing. Manages pain
associated with oral wounds,
mouth sores, injuries and ulcers
of the mouth such as: canker
sores, irritation and traumatic
ulcers; aphthous ulcers. | | | |
| Product Code | OLR, FRO | FRO | OLR, FRO | Description | 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 | ProThelial & Orafate
Sucralfate Paste is an
amorphous hydrogel paste
formed by the controlled
reaction of sucralfate with a
limited quantity of malic acid
and calcium carbonate
solution. The amorphous
hydrogel paste formed by this
reaction binds reversibly to
wounds and is intended to | Synvaza is an oral wound rinse
specifically formulated with
moisturizers, humectants, and
mucoadhesive biopolymers that
are designed to manage the pain
in many types of oral wounds,
mouth sores, injuries, and ulcers
of the oral mucosa. When
swished around the mouth, the
mucoadhesive formulation | | | |
| Type | Rx Medical device | Rx Medical Device | OTC Medical Device | | | | | | | |
| Patient Group | Pediatric & Adult | Pediatric & Adult | Pediatric & Adult | | | | | | | |
6
7
| | wounds, protects against
further irritation and
relieves pain.
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
reaction of sucralfate with an
acid, the polymerized
sucralfate self-buffers to a
pH 5.0 - 7.0. | form a protective film that
covers wounds, protects
against further irritation and
relieves pain.
ProThelial"" & Orafate
Sucralfate Paste may be
administered directly to an
accessible oral wound to
provide an adherent physical
covering of the wound bed.
Although prepared by reaction
of sucralfate with an acid, the
polymerized sucralfate self-
buffers to a pH 5.0 - 7.0. | results in a temporary formation
of a protective coating over the
oral mucosa. The liquid also
provides a moist wound
environment, which is required
for 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.