(168 days)
Not Found
No
The 510(k) summary describes a topical gel for skin irritation and burns. There is no mention of AI, ML, image processing, or any computational analysis of data. The performance studies are limited to biocompatibility and bench testing of the gel's physical and chemical properties.
Yes
The device is intended to manage and relieve symptoms like burning, itching, and pain associated with various dermatoses and burns, and to aid in the healing process by maintaining a moist wound environment, which are therapeutic actions.
No
The device is a gel intended to manage and relieve symptoms like burning, itching, and pain associated with various skin conditions and burns. It does not perform any diagnostic function.
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 the device is a gel applied to the skin to manage and relieve symptoms like burning, itching, and pain associated with various dermatoses and burns. It also helps maintain a moist wound environment. This is a topical therapeutic or wound care device, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical properties of the gel and its packaging. This aligns with a topical product.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific biomarkers, or providing diagnostic information about a disease or condition.
- Performance Studies: The performance studies focus on biocompatibility and bench testing related to the product's physical and chemical properties, not on diagnostic accuracy or performance.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Rx: 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. 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 common types of skin irritation, lacerations, and minor burns. Alevicyn SG Antipuritic Gel is also indicated for the management of irritation and pain from minor burns, including sunburn.
Product codes (comma separated list FDA assigned to the subject device)
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) screwtop 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
Rx Indication: Under the supervision of a health care professional, 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.
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)
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility data provided 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. Biocompatibility testing completed: Cytotoxicity -Agar Diffusion Test -ISO, Direct Systemic Injection Test -ISO, Primary Ocular Irritation - ISO, Direct Contact 7 Day Cumulative Skin Irritation Study on Wounded and Intact Skin, Direct Buehler Sensitization Test -ISO.
Bench Testing
The following tests were reviewed to support the performance of Alevicyn SG Gel: package integrity, visual inspection, pH, Free Available Chlorine (FAC), and antimicrobial preservative effectiveness testing. 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): 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.
Not Found
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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, connected by flowing lines that resemble ribbons or banners.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 4, 2015
Oculus Innovative Sciences Incorporated Mr. Brian W. Martin Director of Regulatory Affairs and Quality Control 1129 North McDowell Boulevard Petaluma, California 94954
Re: K143590
Trade/Device Name: Alevicyn SG Antipruritic Gel Regulatory Class: Unclassified Product Code: FRO Dated: April 30, 2015 Received: May 1, 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, 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 (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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours.
Jennifer R. Stevenson -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) K143590
Device Name Alevicyn SG Antipruritic Gel
Indications for Use (Describe)
Rx: 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. 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 common types of skin irritation, lacerations, and minor burns. Alevicyn SG Antipuritic Gel is also indicated for the management of irritation and pain from minor burns, including sunburn.
| 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 Oculus Innovative Science. The logo consists of a stylized golden ellipse made of three curved lines, positioned above the word "OCULUS" in a bold, sans-serif font. Below "OCULUS" is the text "Innovative Science" in a smaller, lighter font.
9 510(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: December 17, 2014
II. DEVICE
Name of Device: Alevicyn SG Antipruritic Gel Common or Usual Name: Hydrogel Wound Dressing Classification Name: Wound, Dressing, Drug Regulatory Class: Unclassified, Pre-amendment status Product Code: FRO
III. PREDICATE DEVICE
Epicyn Hydrogel manufactured by Oculus Innovative Sciences (K102945)
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) screwtop closure and a finger pump sprayer.
INDICATIONS FOR USE V.
Rx Indication: Under the supervision of a health care professional, 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.
4
Image /page/4/Picture/0 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 below it. Above the word "OCULUS" is a graphic of several overlapping golden rings.
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 Gel is also indicated for the management of irritation and pain from minor burns, including sunburn.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
| Submitter/
Holder | Proposed Device:
Alevicyn SG Antipruritic Gel
Oculus Innovative Sciences | Predicate Device: K102945
Epicyn Hydrogel
Oculus Innovative Sciences |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | Rx Indication: Alevicyn SG 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 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.
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 Gel is also indicated for the
management of irritation and pain from minor
burns, including sunburn. | Epicyn hydrogel is intended indicated to
manage and relieve the burning, itching and
pain experienced with various types of
dermatoses, including radiation dermatitis and
atopic dermatitis. The Epicyn Gel may also
be used to relieve the pain of first and
second degree burns. Epicyn Gel helps to
relieve dry waxy skin by maintaining a
moist wound & skin environment, which is
beneficial to the healing process. |
| Mechanism of
Action | Skin barrier emollient and moisturizer | Same |
| Delivery
System | Hydrogel | Same |
| Physical
Characteristics | pH: 5.5-7.0
FAC: 140- 150 ppm | Same |
| Sterility Claim | Non-sterile | Same |
| Shelf Life | 24 months | Same |
| Source | Sponsor/Manufacturer | Sponsor/Manufacturer |
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Image /page/5/Picture/0 description: The image shows the logo for Oculus Innovative Science. The logo features a series of overlapping golden ellipses above the word "OCULUS" in a bold, sans-serif font. Below "OCULUS" is the text "Innovative Science" in a smaller font.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility data provided 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. Biocompatibility testing completed: Cytotoxicity -Agar Diffusion Test -ISO, Direct Systemic Injection Test -ISO, Primary Ocular Irritation - ISO, Direct Contact 7 Day Cumulative Skin Irritation Study on Wounded and Intact Skin, Direct Buehler Sensitization Test -ISO.
Bench Testing
The following tests were reviewed to support the performance of Alevicyn SG Gel: package integrity, visual inspection, pH, Free Available Chlorine (FAC), and antimicrobial preservative effectiveness testing. 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 the Epicyn Atopic Dermatitis Hydrogel manufactured by Oculus Innovative Sciences, Inc. (K102945). Therefore, the Oculus Alevicyn SG Gel is substantially equivalent to the predicate device.