(101 days)
Not Found
No
The device description and performance studies focus on the chemical and physical properties of a hydrogel, with no mention of AI or ML technologies.
Yes
The device is intended for the management of various skin conditions and to relieve pain, directly serving a therapeutic purpose.
No
The device description indicates it is a hydrogel intended for management and relief of conditions, not for diagnosing them. This is further supported by the types of performance studies, which focus on biocompatibility and bench testing to support its physical and chemical properties and safety, not diagnostic accuracy.
No
The device is a hydrogel, which is a physical substance applied to the skin, not a software program. The description clearly outlines its physical properties and composition.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the management of skin conditions and relief of pain and itch from minor skin irritations. This involves direct application to the body surface.
- Device Description: The description details a topical hydrogel.
- Performance Studies: The performance studies focus on biocompatibility and bench testing related to the physical and chemical properties of the gel, not on analyzing samples taken from the body to diagnose or monitor a condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is applied in vivo (on the body).
N/A
Intended Use / Indications for Use
Rx: Under the supervision of a health care professional Microcyn Antimicrobial Hydrogel is intended for the management of post non ablative laser therapy procedures, post microdermabrasion therapy and following superficial chemical peels. Microcyn Antimicrobial Hydrogel may also be used to relieve itch and pain from minor skin irritations, lacerations, abrasions and minor burns.
OTC: Microcyn Antimicrobial Hydrogel is intended for the management of minor skin irritations following post non ablative laser therapy procedures, microdermabrasion therapy or superficial chemical peels. Microcyn Antimicrobial Hydrogel may also be used to relieve itch and pain from minor skin irritations, abrasions and minor burns.
Product codes
FRO
Device Description
The Microcyn Antimicrobial Hydrogel is a clear hydrogel, slightly chlorinated odor, viscous gel. The product has a pH range of 6.2-7.8 and a viscosity target of >1000 cP and will be supplied in polyethylene terephthalate (PET) tube-bottles with polypropylene (PP) screw-top closure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Rx: Under the supervision of a health care professional
OTC: Not specified, implies general public
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 Microcyn Antimicrobial Hydrogel was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, 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 gel is considered a breached/compromised surface device with limited contact. The biocompatibility evaluation for the Microcyn Antimicrobial Hydrogel 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 Microcyn Antimicrobial Hydrogel was evaluated for cytotoxicity, systemic toxicity, irritation, and sensitization. In addition, a toxicological risk assessment was provided to support the prolonged use of the device.
Bench Testing:
The following tests were performed to support the performance of Microcyn Antimicrobial Hydrogel: package integrity, visual inspection, viscosity, pH, Free Available Chlorine (FAC), Preservative Effectiveness Testing in the gel while on the shelf. Microcyn Antimicrobial Hydrogel meets specification and performance characteristics and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 2, 2018
Sonoma Pharmaceuticals, Inc. Brian Martin VP Regulatory and Quality 1129 N. McDowell Blvd. Petaluma, California 94954
Re: K173896
Trade/Device Name: Microcyn Antimicrobial Hydrogel Regulatory Class: Unclassified Product Code: FRO Dated: March 6, 2018 Received: March 7, 2018
Dear Brian 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 medical devices and radiation-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,
Jennifer R. Stevenson -S3
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) K173896
Device Name Microcyn Antimicrobial Hydrogel
Indications for Use (Describe)
Rx: Under the supervision of a health care professional Microcyn Antimicrobial Hydrogel is intended for the management of post non ablative laser therapy procedures, post microdermabrasion therapy and following superficial chemical peels. Microcyn Antimicrobial Hydrogel may also be used to relieve itch and pain from minor skin irritations, lacerations, abrasions and minor burns.
OTC: Microcyn Antimicrobial Hydrogel is intended for the management of minor skin irritations following post non ablative laser therapy procedures, microdermabrasion therapy or superficial chemical peels. Microcyn Antimicrobial Hydrogel may also be used to relieve itch and pain from minor skin irritations, abrasions and minor burns.
| 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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1 510(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, Vice President of RA, QC, QA Date Prepared: March 6, 2018
II. DEVICE
Name of Device: Microcyn Antimicrobial Hydrogel Common or Usual Name: Wound Gel Classification Name: Dressing, Wound, Drug Regulatory Class: Unclassified Product Code: FRO
III. PREDICATE DEVICE
Microcyn Plus Skin and Wound Gel manufactured by Oculus Innovative Sciences (K153648) and Alevicyn SG Antimicrobial Gel by Sonoma Pharmaceuticals, Inc., (K171935)
IV. DEVICE DESCRIPTION
The Microcyn Antimicrobial Hydrogel is a clear hydrogel, slightly chlorinated odor, viscous gel. The product has a pH range of 6.2-7.8 and a viscosity target of >1000 cP and will be supplied in polyethylene terephthalate (PET) tube-bottles with polypropylene (PP) screw-top closure.
V. INDICATIONS FOR USE
Rx Indication:
Under the supervision of a health care professional Microcyn Antimicrobial Hydrogel is intended for the management of post non ablative laser therapy procedures, post microdermabrasion therapy and following superficial chemical peels. Microcyn Antimicrobial Hydrogel may also be used to relieve itch and pain from minor skin irritations, lacerations, abrasions and minor burns.
4
OTC Indication:
Microcyn Antimicrobial Hydrogel is intended for the management of minor skin irritations following post non ablative laser therapy procedures, microdermabrasion therapy or superficial chemical peels. Microcyn Antimicrobial Hydrogel may also be used to relieve itch and pain from minor skin irritations, lacerations, abrasions and minor burns.
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| VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE | |||
|---|---|---|---|
| -- | -- | --------------------------------------------------------------------------- | -- |
| Submitter/ Holder | Proposed Device:
Microcyn Antimicrobial Hydrogel,
Sonoma Pharmaceuticals | Previous 510k K153648- Microcyn Plus
Hydrogel- Oculus Innovative Sciences. | Predicate Device: K171935
Alevicyn SG Antimicrobial Gel, Sonoma
Pharmaceuticals, Inc. |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | Rx Indication:
Under the supervision of a health care
professional Microcyn Antimicrobial
Hydrogel is intended for the management of
post non ablative laser therapy procedures,
post microdermabrasion therapy and
following superficial chemical peels.
Microcyn Antimicrobial Hydrogel may also
be used to relieve itch and pain from minor
skin irritations, lacerations, abrasions and
minor burns.
OTC Indication:
Microcyn Antimicrobial Hydrogel is
intended for the management of minor skin
irritations following post non ablative laser
therapy procedures, microdermabrasion
therapy or superficial chemical peels.
Microcyn Antimicrobial Hydrogel may also
be used to relieve itch and pain from minor
skin irritations, lacerations, abrasions and
minor burns. | Rx Indications for Use:
Under the supervision of a health care
professional Microcyn Plus Skin and Wound
Gel is intended for the management of post non
ablative laser therapy procedures, post
microdermabrasion therapy and following
superficial chemical peels. Microcyn Plus
Wound Gel may also be used to relieve itch and
pain from minor skin irritations, lacerations,
abrasions and minor burns.
OTC Indications for Use:
Microcyn Plus Skin and Wound Gel is intended
for the management of minor skin irritations
following post non ablative laser therapy
procedures, microdermabrasion therapy or
superficial chemical peels. Microcyn Plus Skin
and Wound Gel may also be used to relieve itch
and pain from minor skin irritations, lacerations,
abrasions and minor burns. | 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,
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.
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
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. |
| Sterility Claim | Non-sterile
Preserved/Conforming to USP | Same | Non-sterile
Preserved/Conforming to USP |
| Mechanism of
Action | Wound moisturizer | Same | Same |
| Delivery System | Hydrogel | Same | Same |
| Ingredients | Water
Sodium Lithium Magnesium Fluorosilicate
Sodium Phosphate
Sodium Chloride
Hypochlorous Acid
Sodium Hypochlorite | Same | Water, sodium lithium magnesium fluorosilicate,
dimethicone, sodium phosphate, sodium bicarbonate,
sodium chloride, sodium sulfate, hypochlorous acid and
sodium hypochlorite |
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K173896
7
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for the Microcyn Antimicrobial Hydrogel was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, 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 gel is considered a breached/compromised surface device with limited contact. The biocompatibility evaluation for the Microcyn Antimicrobial Hydrogel 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 Microcyn Antimicrobial Hydrogel was evaluated for cytotoxicity, systemic toxicity, irritation, and sensitization. In addition, a toxicological risk assessment was provided to support the prolonged use of the device.
Bench Testing
The following tests were performed to support the performance of Microcyn Antimicrobial Hydrogel: package integrity, visual inspection, viscosity, pH, Free Available Chlorine (FAC), Preservative Effectiveness Testing in the gel while on the shelf. Microcyn Antimicrobial Hydrogel meets specification and performance characteristics and is substantially equivalent to the predicate device.
VIII. CONCLUSION
Microcyn Antimicrobial Hydrogel is substantially equivalent in intended use, technological characteristics, safety and effectiveness to the Microcyn Plus Skin and Wound Hydrogel manufactured by Sonoma Pharmaceuticals, Inc. (K153648) and Alevicyn SG Antimicrobial Gel, K171935. Therefore, the Sonoma Pharmaceuticals, Inc. Microcyn Antimicrobial Hydrogel is substantially equivalent to the predicate devices.