(70 days)
No
The 510(k) summary describes a topical gel and its physical properties and testing, with no mention of AI or ML.
Yes
The device is indicated to manage and relieve symptoms of various dermatoses and burns, which are therapeutic actions.
No
Explanation: The device is a gel intended to manage and relieve symptoms of various dermatoses and burns, and to maintain a moist skin environment. It does not perform any diagnosis or provide diagnostic information.
No
The device description clearly states it is a gel product supplied in bottles with a sprayer, indicating it is a physical substance and 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 states that Alevicyn SG Gel is applied topically to the skin to manage and relieve symptoms of various dermatoses and burns. This is a direct application to the body for therapeutic or symptomatic relief, not for testing samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details a topical gel with specific physical properties (pH, viscosity) and packaging. This aligns with a topical medical device, not an IVD which would typically involve reagents, instruments for analysis, or collection devices for biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information based on test results.
Therefore, Alevicyn SG Gel is a topical medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Rx Indication: Under the supervision of a health care professional, Alevicyn SG 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, and sebortheic dermatitis. Alevicyn SG Gel may be also 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.
Product codes
FRO
Device Description
The Alevicyn SG Gel is an opaque gel, slightly chlorinated odor, low viscosity spray gel. The product has a pH range of 5.5-7.0 and a viscosity target of 500-5000 cP and will be supplied in polyethylene terephthalate (PET) round-bottles with polypropylene (PP) screw-top closure and a finger pump sprayer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professional
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 Gel 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 solution is considered a breached/compromised surface device with limited contact.
Bench Testing
The following tests were reviewed to support the performance of Alevicyn SG Gel: package integrity, visual inspection, pH, Free Available Chlorine (FAC). The Alevicyn SG Gel 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)
K143590, K121134, K123724, K120730
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines above them that resemble a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 15, 2015
Oculus Innovative Sciences Incorporated Mr. Brian Martin Director of Regulatory Affairs and Quality Control 1129 North Mcdowell Boulevard Petaluma, California 94954
Re: K152945
Trade/Device Name: Alevicyn SG Antipruritic Gel Regulatory Class: Unclassified Product Code: FRO Dated: October 5, 2015 Received: October 6, 2015
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. Iisting 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. For 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) K152945
Device Name Alevicyn SG Antipruritic Gel
Indications for Use (Describe)
Rx Indication: Under the supervision of a health care professional, Alevicyn SG 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, and sebortheic dermatitis. Alevicyn SG Gel may be also 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.
| 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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Image /page/3/Picture/1 description: The image shows the logo for Oculus Innovative Science. The logo features the word "OCULUS" in bold, black letters. Above the word, there are three overlapping golden ellipses. Below the word "OCULUS", the words "Innovative Science" are written in a smaller font.
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
Oculus Innovative Sciences. 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: October 5, 2015
II. DEVICE
Name of Device: Alevicyn SG Antipruritic Gel Common or Usual Name: Antipruritic Gel Classification Name: Dressing, Wound, Drug Regulatory Class: Unclassified, Pre-amendment status Product Code: FRO
III. PREDICATE DEVICE
Alevicyn SG Gel (K143590) manufactured by Oculus Innovative Sciences, Inc., TL Triseb Cream (K121134), manufactured by Trigen Laboratories, Inc., Dermiseb Cream (K123724) manufactured by IGI Laboratories, Inc., and Loutrex Topical Cream (K120730) manufactured by Acella Pharmaceuticals, LLC
IV. DEVICE DESCRIPTION
The Alevicyn SG Gel is an opaque gel, slightly chlorinated odor, low viscosity spray gel. The product has a pH range of 5.5-7.0 and a viscosity target of 500-5000 cP and will be supplied in polyethylene terephthalate (PET) round-bottles with polypropylene (PP) screw-top closure and a finger pump sprayer.
INDICATIONS FOR USE V.
Rx Indication: Under the supervision of a health care professional, Alevicyn SG 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, and seborrhea and seborrheic dermatitis. Alevicyn SG Gel may be also used to relieve the pain of first and second degree burns. Alevicyn SG Gel helps to relieve dry
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Image /page/4/Picture/1 description: The image shows the logo for Oculus Innovative Science. The logo consists of a stylized golden graphic above the word "OCULUS" in bold, black letters. Below "OCULUS" is the text "Innovative Science" in a smaller, non-bold font.
waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
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Image /page/5/Picture/0 description: The image shows the alphanumeric string "K152945" in a simple, sans-serif font. The characters are uniformly sized and spaced, with a clear distinction between the letter "K" and the numerical digits that follow. The text is presented in black against a white background, ensuring high contrast and readability.
Image /page/5/Picture/1 description: The image shows the logo for Oculus Innovative Sciences. The logo features the word "OCULUS" in a bold, sans-serif font, with the words "Innovative Sciences" in a smaller font underneath. Above the word "OCULUS" is a graphic of three overlapping circles in a gold color. The logo is simple and modern, and the colors are clean and professional.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.
| Submitter/
Holder | Proposed Device:
Alevicyn SG Antipruritic Gel
Oculus Innovative Sciences | Predicate Device:
K143590
Alevicyn SG Gel,
Oculus Innovative
Sciences | Predicate Device:
K121134
TL Triseb Cream,
Trigen Laboratories,
Inc. | Predicate Device:
K123724
Dermiseb Cream,
IGI Laboratories, Inc. | Predicate Device:
K120730
Loutrex Topical Cream,
Acella Pharmaceuticals,
LLC |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | Rx Indication: Alevicyn SG 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, and
seborrhea and seborrheic
dermatitis. Alevicyn SG Gel may
be also 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: Alevicyn
SG Antipruritic Gel is
indicated to manage and
relieve the burning,
itching and pain
experienced with various
types of dermatoses,
including radiation
dermatitis and atopic
dermatitis. Alevicyn SG
Antipruritic Gel may be
also used to relieve the
pain of first and second
degree burns. Alevicyn
SG Antipruritic Gel
helps
to relieve dry waxy skin
by maintaining a moist
wound & skin
environment, which is
beneficial to the healing
process.
OTC Indication:
Alevicyn SG Antipruritic
Gel is intended to relieve
the burning and itching
associated with many | Rx Indication: Under
the supervision of a
healthcare professional,
TL Triseb Cream is
indicated to manage and
relieve the signs and
symptoms of seborrhea
and seborrheic
dermatitis such as
itching, erythema,
scaling and pain. TL
Triseb Cream helps
relieve dry waxy skin
by maintaining a moist
wound and skin
environment, which is
beneficial to the healing
process. | Rx Indication: Under the
supervision of a
healthcare professional,
Dermiseb Cream is
indicated to manage and
relieve the signs and
symptoms of seborrhea
and seborrheic dermatitis
such as itching,
erythema, scaling and
pain. Dermiseb Cream
also aids to relieve dry,
waxy skin by
maintaining a moist
wound and skin
environment. A moist
wound and skin
environment is
beneficial to the healing
process. | Rx Indication: Loutrex
Topical Cream is indicated
to manage and relieve the
signs and symptoms of
seborrhea and seborrheic
dermatitis such as itching,
erythema, scaling and
pain. Loutrex Topical
Cream helps relieve dry,
waxy skin by maintaining
a moist wound and skin
environment, which is
beneficial to the healing
process. |
| Submitter/
Holder | Proposed Device:
Alevicyn SG Antipruritic Gel
Oculus Innovative Sciences | Predicate Device:
K143590
Alevicyn SG Gel,
Oculus Innovative
Sciences | Predicate Device:
K121134
TL Triseb Cream,
Trigen Laboratories,
Inc. | Predicate Device:
K123724
Dermiseb Cream,
IGI Laboratories, Inc. | Predicate Device:
K120730
Loutrex Topical Cream,
Acella Pharmaceuticals,
LLC |
| | | 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 barrier emollient and
moisturizer | Same | Water based Emollient | Water based Emollient | Water based Emollient |
| Delivery
System | Bottle, Spray Gel | Same | Tube | Tube | Tube |
| Physical
Characteristics | Appearance: Opaque Colorless
semi viscous gel
Odor: Slightly Chlorinated | Same | Appearance: Off White
Cream
Odor: Fragrance Free | Appearance: Off White
Cream
Odor: Fragrance Free | Appearance: Off
White/Yellow Cream
Odor: Fragrance Free |
| Sterility Claim | Non-sterile
Preserved/Conforming to USP
| Same | Non Sterile | Non Sterile | Non Sterile |
| Shelf Life | 24 months | Same | >1 year | >1 year | >1 year |
| Source | Sponsor/Manufacturer | Sponsor/Manufacturer | Labeling | Labeling | Labeling |
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Image /page/6/Picture/0 description: The image shows the text "K152945" in a simple, sans-serif font. The text is black against a white background. The characters are evenly spaced and clearly legible.
Image /page/6/Picture/1 description: The image shows the logo for Oculus Innovative Sciences. The logo features a stylized gold-colored graphic above the company name. The text "OCULUS" is in a bold, sans-serif font, and below it, in a smaller font, is the text "Innovative Sciences."
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Image /page/7/Picture/1 description: The image shows the logo for Oculus Innovative Science. The logo features a stylized, abstract design of interconnected golden rings above the company name. The text "OCULUS" is in bold, black letters, and below it, in smaller font, are the words "Innovative Science".
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for the Alevicyn SG Gel 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 solution is considered a breached/compromised surface device with limited contact.
Bench Testing
The following tests were reviewed to support the performance of Alevicyn SG Gel: package integrity, visual inspection, pH, Free Available Chlorine (FAC). The Alevicyn SG Gel meets specification and performance characteristics and is substantially equivalent to the predicate device.
VIII. CONCLUSION
Alevicyn SG Gel is substantially equivalent in intended use, technological characteristics, safety and effectiveness to Alevicyn SG Gel (K143590), TL Triseb Cream (K121134), Dermiseb Cream (K123724), and Loutrex Topical Cream (K120730). Therefore, the Oculus Alevicyn SG Gel is substantially equivalent to the predicate devices.