(156 days)
No
The device description and performance studies focus on the chemical composition and antimicrobial properties of a gel, with no mention of AI or ML technologies.
Yes
The device is described as a gel intended to manage and relieve symptoms of various dermatoses, facilitate autolytic debridement, and aid in the healing process of acute and chronic dermal lesions and wounds, which are therapeutic functions.
No
The device is an antimicrobial gel intended for wound care and relief of dermatological symptoms, not for diagnosing conditions.
No
The device description clearly states it is a gel with specific ingredients and physical properties, supplied in a bottle with a sprayer. This indicates a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being applied topically to the skin and wounds to manage symptoms, facilitate healing, and moisten the wound bed. This is a direct interaction with the patient's body surface.
- Device Description: The description details a topical gel with specific ingredients and packaging for application to the skin.
- Anatomical Site: The anatomical sites mentioned are "dermal tissue," "wound bed," and "skin," all external parts of the body.
- Performance Studies: The performance studies focus on biocompatibility (interaction with living tissue) and bench testing related to the gel's physical properties and antimicrobial effectiveness within the gel itself as a preservative. These are not tests performed on patient samples to diagnose a condition.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description. It is a topical medical device.
N/A
Intended Use / Indications for Use
Rx Indications: Alevicyn SG Antimicrobial Gel is intended to moisten the wound bed and facilitate autolytic debridement of acute and chronic dermal lesions. Alevicyn SG Antimicrobial Gel is indicated to manage and relieve the burning, itching, erythema, scaling, and pain experienced with various types of dermatoses, including atopic dermatitis, radiation dermatitis, seborthea and sebortheic dermal irritation, sores, injuries, and ulcers of dermal tissue in addition to moistening and lubricating absorbent wound dressings. The Alevicyn SG Antimicrobial Gel may also be used to manage partial or full thickness wounds such as first and second degree burns, stage I - IV pressure ulcers, diabetic and stasis ulcers, abrasions and skin irritations, surgical wounds (donor and graft sites, incisions), and trauma wounds. Alevicyn SG Antimicrobial Gel helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
OTC Indications for Use: Alevicyn SG Antimicrobial Gel is intended for OTC use to relieve itch and pain from minor skin irritations, minor cuts, exit sites, minor abrasions and minor burns, including sunburns. Hydrogel is also intended to moisten and lubricate absorbent wound dressings and moisten the wound bed. A moist wound and skin environment facilitates autolytic debridement and is beneficial to wound management and the healing process.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
The Alevicyn SG Antimicrobial Gel is an opaque gel, slightly chlorinated odor, low viscosity spray gel. The product will be supplied in polyethylene terephthalate (PET) round-bottles with polypropylene (PP) screw-top closure and a finger pump sprayer. Ingredients: Water, sodium lithium magnesium fluorosilicate, dimethicone, sodium phosphate, sodium bicarbonate, sodium chloride, sodium sulfate, with hypochlorous acid and sodium hypochlorite as gel preservatives.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dermal tissue, skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Rx Indications: medical professional supervision
OTC Indications: personal use
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)
Biocompatibility Testing: The biocompatibility evaluation for the Alevicyn SG Antimicrobial Gel was conducted in accordance with the FDA biocompatibility guidance issued on June 16, 2016 and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1 : Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The Alevicyn SG Antimicrobial Gel was evaluated for cytotoxicity, irritation, sensitization. In addition, a toxicological risk assessment was conducted to support the prolonged use of the device.
Bench Testing: The following tests were performed to support the performance of Alevicyn SG Antimicrobial Gel: visual inspection, pH, viscosity, Free Available Chlorine (FAC) and Antimicrobial Preservative Effectiveness Testing against the following bacteria in the gel while on the shelf: Proteus mirabilis, Serratia marcescens, antibiotic resistant Methicillin-Resistant Staphylococcus aureus (MRSA), and Acinetobacter baumannii. The Alevicyn SG Antimicrobial Gel meets specification and performance characteristics and is substantially equivalent to the predicate devices.
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 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 1, 2017
Sonoma Pharmaceuticals, Inc. Brian Martin Director of Regulatory Affairs and Quality Control 1129 N. McDowell Boulevard Petaluma, California 94954
Re: K171935
Trade/Device Name: Alevicyn SG Antimicrobial Gel Regulatory Class: Unclassified Product Code: FRO Dated: November 2, 2017 Received: November 3, 2017
Dear Mr. Martin:
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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171935
Device Name Alevicyn SG Antimicrobial Gel
Indications for Use (Describe)
Rx Indications: Alevicyn SG Antimicrobial Gel is intended to moisten the wound bed and facilitate autolytic debridement of acute and chronic dermal lesions. Alevicyn SG Antimicrobial Gel is indicated to manage and relieve the burning, itching, erythema, scaling, and pain experienced with various types of dermatoses, including atopic dermatitis, radiation dermatitis, seborthea and sebortheic dermal irritation, sores, injuries, and ulcers of dermal tissue in addition to moistening and lubricating absorbent wound dressings. The Alevicyn SG Antimicrobial Gel may also be used to manage partial or full thickness wounds such as first and second degree burns, stage I - IV pressure ulcers, diabetic and stasis ulcers, abrasions and skin irritations, surgical wounds (donor and graft sites, incisions), and trauma wounds. Alevicyn SG Antimicrobial Gel helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
OTC Indications for Use: Alevicyn SG Antimicrobial Gel is intended for OTC use to relieve itch and pain from minor skin irritations, minor cuts, exit sites, minor abrasions and minor burns, including sunburns. Hydrogel is also intended to moisten and lubricate absorbent wound dressings and moisten the wound bed. A moist wound and skin environment facilitates autolytic debridement and is beneficial to wound management and the healing process.
| 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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3
Image /page/3/Picture/0 description: The image shows the logo for Sonoma Pharmaceuticals. The logo consists of a geometric shape on the left and the company name on the right. The geometric shape is a stylized flower or star-like design with teal and gray colors. The company name "Sonoma" is written in gray, and the word "PHARMACEUTICALS" is written in teal below it.
510(k) SUMMARY
The following is a summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.
I. SUBMITTER
Sonoma Pharmaceuticals. Inc. 1129 North McDowell Blvd. Petaluma, CA 94954 Phone: (707) 283-0550 Fax: (707) 283-0551
Contact Person: Brian W. Martin, Director of Regulatory Affairs and Quality Control Date Prepared: November 28, 2017
II. DEVICE
Name of Device: Alevicyn SG Antimicrobial Gel Common or Usual Name: Wound Gel Classification Name: Dressing, Wound, Drug Regulatory Class: Unclassified Product Code: FRO
III. PREDICATE DEVICE
Alevicyn SG Antipruritic Gel (K152945) manufactured by Sonoma Pharmaceuticals, Inc. Puracyn Plus Antimicrobial Gel (K150799), manufactured by Innovacyn, Inc.
IV. REFERENCE DEVICE Alevicyn SG Gel (K143590) manufactured by Sonoma Pharmaceuticals, Inc.
DEVICE DESCRIPTION V.
The Alevicyn SG Antimicrobial Gel is an opaque gel, slightly chlorinated odor, low viscosity spray gel. The product will be supplied in polyethylene terephthalate (PET) round-bottles with polypropylene (PP) screw-top closure and a finger pump sprayer. Ingredients: Water, sodium lithium magnesium fluorosilicate, dimethicone, sodium phosphate, sodium bicarbonate, sodium chloride, sodium sulfate, with hypochlorous acid and sodium hypochlorite as gel preservatives.
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Image /page/4/Picture/0 description: The image contains the logo for Sonoma Pharmaceuticals. The logo consists of a circular design made up of interconnected teal and gray shapes on the left. To the right of the design is the word "Sonoma" in gray, with the word "PHARMACEUTICALS" in teal underneath.
VI. INDICATIONS FOR USE
Rx Indication: Alevicyn SG Antimicrobial Gel is intended to moisten the wound bed and facilitate autolytic debridement of acute and chronic dermal lesions. Alevicyn SG Antimicrobial Gel is indicated to manage and relieve the burning, itching, erythema, scaling, and pain experienced with various types of dermatoses, including atopic dermatitis, radiation dermatitis, seborrhea and seborrheic dermal irritation, sores, injuries, and ulcers of dermal tissue in addition to moistening and lubricating absorbent wound dressings. The Alevicyn SG Antimicrobial Gel may also be used to manage partial or full thickness wounds such as first and second degree burns, stage I -IV pressure ulcers, diabetic and stasis ulcers, abrasions and skin irritations, surgical wounds (donor and graft sites, incisions), and trauma wounds. Alevicyn SG Antimicrobial Gel helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
OTC Indications: Alevicyn SG Antimicrobial Gel is intended for OTC use to relieve itch and pain from minor skin irritations, minor cuts, exit sites, minor lacerations, minor abrasions and minor burns, including sunburns. Hydrogel is also intended to moisten and lubricate absorbent wound dressings and moisten the wound bed. A moist wound and skin environment facilitates autolytic debridement and is beneficial to wound management and the healing process.
5
Image /page/5/Picture/0 description: The image shows the logo for Sonoma Pharmaceuticals. The logo consists of a geometric shape on the left and the company name on the right. The geometric shape is made up of several curved lines that form a flower-like pattern. The company name is written in a sans-serif font, with the word "Sonoma" in a larger font than the word "Pharmaceuticals."
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VII.
| Submitter/
Holder | Proposed Device:
Alevicyn SG Antimicrobial Gel,
Sonoma Pharmaceuticals | Predicate Device:
K152945 - Rx
Alevicyn SG Gel,
Sonoma Pharmaceuticals | Predicate Device:
K150799
Puracyn Plus Antimicrobial
HydroGel | Reference Device:
K143590 - OTC
Alevicyn SG Gel,
Sonoma Pharmaceuticals | |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Prescription
Indications
for
Use | Rx Indication: Alevicyn SG
Antimicrobial Gel is intended to
moisten the wound bed and facilitate
autolytic debridement of acute and
chronic dermal lesions. Alevicyn SG
Antimicrobial Gel is indicated to
manage and relieve the burning,
itching, erythema, scaling, and pain
experienced with various types of
dermatoses, including atopic
dermatitis, radiation dermatitis,
seborrhea and seborrheic dermatitis,
dermal irritation, sores, injuries, and
ulcers of dermal tissue in addition to
moistening and lubricating absorbent
wound dressings. The Alevicyn SG
Antimicrobial Gel may also be used to
manage partial or full thickness
wounds such as first and second
degree burns, stage I - IV pressure
ulcers, diabetic and stasis ulcers,
abrasions and skin irritations, surgical
wounds (donor and graft sites,
incisions), and trauma wounds.
Alevicyn SG Antimicrobial Gel helps
to relieve dry waxy skin by
maintaining a moist wound & skin
environment, which is beneficial to the
healing process. | Rx Indication: Under the
supervision of a healthcare
professional, Alevicyn SG Gel is
intended to manage and relieve
the burning, itching, erythema,
scaling, and pain experienced
with various types of dermatoses,
including atopic dermatitis,
radiation dermatitis, and
seborrhea and seborrheic
dermatitis. The Alevicyn SG Gel
may also be used to relieve the
pain of first and second degree
burns. Alevicyn SG Gel helps to
relieve dry, waxy skin by
maintaining a moist wound &
skin environment, which is
beneficial to the healing process. | Rx Indication: Puracyn® Plus
Antimicrobial Hydrogel
Professional Formula is
intended for use by healthcare
professionals to moisten the
wound bed and facilitate
autolytic debridement of acute
and chronic dermal lesions, as
indicated below. Puracyn®
Plus Antimicrobial Hydrogel
Professional Formula relieves
itch and pain associated with
dermal irritation, sores, injuries
and ulcers of dermal tissue in
addition to moistening and
lubricating absorbent wound
dressings. Puracyn® Plus
Antimicrobial Hydrogel
Professional Formula is
indicated for the management
of partial or full thickness
wounds such as 1st and 2nd
degree burns, stage I - IV
pressure ulcers, diabetic and
stasis ulcers, abrasions and skin
irritations, surgical wounds
(donor and graft sites,
incisions), trauma wounds, and
various dermatoses including
atopic dermatitis | Rx Indication: Alevicyn SG Gel
is intended to manage and relieve
the burning, itching and pain
experienced with various types of
dermatoses, including radiation
dermatitis and atopic dermatitis.
The Alevicyn SG Gel may also be
used to relieve the pain of first
and second degree burns.
Alevicyn SG Gel helps to relieve
dry waxy skin by maintaining a
moist wound & skin environment.
which is beneficial to the healing
process. | |
| Submitter/
Holder | Proposed Device:
Alevicyn SG Antimicrobial Gel, | Predicate Device:
K152945 - Rx | Predicate Device:
K150799 | Reference Device:
K143590 - OTC | |
| | Sonoma Pharmaceuticals | Alevicyn SG Gel,
Sonoma Pharmaceuticals | Puracyn Plus Antimicrobial
HydroGel | Alevicyn SG Gel,
Sonoma Pharmaceuticals | |
| OTC
Indications
for Use | OTC Indication: Alevicyn SG
Antimicrobial Gel is intended for OTC
use to relieve itch and pain from minor
skin irritations, minor cuts, exit sites,
minor lacerations, minor abrasions and
minor burns, including sunburns.
Hydrogel is also intended to moisten
and lubricate absorbent wound
dressings and moisten the wound bed.
A moist wound and skin environment
facilitates autolytic debridement and is
beneficial to wound management and
the healing process. | None | OTC Indication: Puracyn®
Plus Duo-Care™
Antimicrobial Wound & Skin
Hydrogel is intended for OTC
use to relieve itch and pain
from minor skin irritations,
minor cuts, exit sites, minor
lacerations, minor abrasions
and minor
burns, including sunburns.
Hydrogel is also intended to
moisten and lubricate
absorbent wound dressings and
moisten the wound bed. A
moist wound and skin
environment facilitates
autolytic debridement and is
beneficial to wound
management and the healing
process. | OTC Indication: Alevicyn SG Gel
is intended to relieve the burning
and itching associated with many
common types of skin irritation,
lacerations, abrasions, and minor
burns. Alevicyn SG Antipruritic
Gel is also indicated for the
management of irritation and pain
from minor burns, including
sunburn. | |
| Mechanism
of Action | Skin emollient and moisturizer | Same | Same | Same | |
| Delivery
System | Bottle, Spray Gel | Same | Bottle - Twist Top | Same | |
| Description | Appearance: Opaque Colorless semi
viscous gel
Odor: Slightly Chlorinated | Same | Same | Same | |
| Submitter/
Holder | Proposed Device:
Alevicyn SG Antimicrobial Gel,
Sonoma Pharmaceuticals | Predicate Device:
K152945 – Rx
Alevicyn SG Gel,
Sonoma Pharmaceuticals | Predicate Device:
K150799
Puracyn Plus Antimicrobial
HydroGel | Reference Device:
K143590 – OTC
Alevicyn SG Gel,
Sonoma Pharmaceuticals | |
| Ingredients | Water, sodium lithium magnesium
fluorosilicate, dimethicone, sodium
phosphate, sodium
bicarbonate, sodium chloride, sodium
sulfate, with hypochlorous acid and
sodium hypochlorite
as gel preservatives. | Same | Electrolyzed water,
Lithium Magnesium,
Sodium Silicate,
Phosphates,
Sodium Bicarbonate,
Sodium Chloride,
Sodium Sulfate,
Hypochlorous Acid
(0.01%),
Sodium Hypochlorite | Same | |
| | Sterility
Claim | Non-sterile
Preserved/Conforming to USP | Same | Non Sterile | Same |
| | | Shelf Life | 24 months | Same | 2 years |
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Image /page/6/Picture/0 description: The image contains the logo for Sonoma Pharmaceuticals. The logo consists of a stylized flower-like design on the left, with the word "Sonoma" in a gray sans-serif font to the right. Below "Sonoma" is the word "PHARMACEUTICALS" in a smaller, teal-colored font. The flower-like design is made up of teal and gray shapes arranged in a circular pattern.
7
Image /page/7/Picture/0 description: The image contains the logo for Sonoma Pharmaceuticals. The logo consists of a circular design on the left and the company name on the right. The circular design is made up of interlocking shapes in shades of gray and teal, forming a flower-like pattern around a central white space. To the right of the circular design, the word "Sonoma" is written in a gray, sans-serif font, with the word "PHARMACEUTICALS" written in a smaller, teal font directly below it.
8
Image /page/8/Picture/0 description: The image shows the logo for Sonoma Pharmaceuticals. The logo consists of a geometric design on the left and the company name on the right. The geometric design is a circular shape made up of intersecting curved lines in gray and teal. The company name "Sonoma" is in gray, and the word "PHARMACEUTICALS" is in teal below it.
VIII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for the Alevicyn SG Antimicrobial Gel was conducted in accordance with the FDA biocompatibility guidance issued on June 16, 2016 and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1 : Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The Alevicyn SG Antimicrobial Gel was evaluated for cytotoxicity, irritation, sensitization. In addition, a toxicological risk assessment was conducted to support the prolonged use of the device.
Bench Testing
The following tests were performed to support the performance of Alevicyn SG Antimicrobial Gel: visual inspection, pH, viscosity, Free Available Chlorine (FAC) and Antimicrobial Preservative Effectiveness Testing against the following bacteria in the gel while on the shelf: Proteus mirabilis, Serratia marcescens, antibiotic resistant Methicillin-Resistant Staphylococcus aureus (MRSA), and Acinetobacter baumannii. The Alevicyn SG Antimicrobial Gel meets specification and performance characteristics and is substantially equivalent to the predicate devices.
IX. CONCLUSION
Alevicyn SG Antimicrobial Gel is substantially equivalent in intended use, technological characteristics, safety and effectiveness to Alevicyn SG Gel (K152945), and Puracyn Plus Antimicrobial Gel (K150799). Therefore, the Alevicyn SG Antimicrobial Gel is substantially equivalent to the predicate devices.