(162 days)
Not Found
No
The device description and performance studies focus on the chemical composition and clinical efficacy of a hydrogel for scar management, with no mention of AI or ML technologies.
Yes
The device is intended for the management of scars resulting from burns, general surgical procedures, and trauma wounds, which is a therapeutic purpose.
No
The device is intended for the management (treatment) of scars, not for diagnosing medical conditions.
No
The device description clearly states it is a "translucent, silicone oil containing hydrogel," which is a physical substance, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of scars on the skin. This is a topical application for a physical condition, not a test performed in vitro (outside the body) on biological samples to diagnose a disease or condition.
- Device Description: The description details a hydrogel applied to intact skin. It mentions a preservative to inhibit microbial growth in the product itself, not for analyzing a biological sample.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes (biomarkers, pathogens, etc.)
- Providing diagnostic information about a patient's health status.
The device is a topical product intended to treat or manage a physical condition (scarring).
N/A
Intended Use / Indications for Use
Rx INDICATIONS: Under the supervision of a health care professional, Microcyn® Scar Management HydroGel is intended for the management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.
OTC INDICATIONS: Microcyn® Scar Management HydroGel is intended for the management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.
Product codes (comma separated list FDA assigned to the subject device)
PFP
Device Description
Microcyn® Scar Management HydroGel is a translucent, silicone oil containing hydrogel which is intended for the management of old and new scars including hypertrophic and keloid scarring, on scars resulting from general surgical procedures, as well as trauma wounds, and burns. The product is intended to be applied to intact skin. The product is preserved with a unique mixture of hypochlorous acid and sodium hypochlorite generated through a proprietary process. The mixture of hypochlorous acid and sodium hypochlorite act as a preservative in the non-sterile product to inhibit microbial growth during storage and repeat use. The preservative is identified by the Center for Drug Evaluation and Research (CDER) as an inactive ingredient based on the
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
Prescription Use: Under the supervision of a 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)
Performance Testing: The Microcyn® Scar Management HydroGel meets specification and performance characteristics and is substantially equivalent to the predicate device.
Biocompatibility Testing: Biocompatibility Testing of the Microcyn® Scar Management HydroGel confirmed that the device meets the applicable requirements of the Blue Book Memorandum G95-1 entitled Use of International Standards ISO-10993 Biological Evaluation of Medical Devices and is biocompatible.
Clinical Testing: The Microcyn® Scar Management HydroGel was well tolerated in the study population and efficacy results indicate substantial equivalence to the predicate device, Kelo-cote® Scar Gel.
Safety and Effectiveness: The Microcyn® Scar Management HydroGel does not raise any new safety and efficacy concerns when compared to a similar device already legally marketed.
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
§ 878.4025 Silicone sheeting.
(a)
Identification. Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
0
510(k) SUMMARY
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The following is a summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.
510(k) Owner
Oculus Innovative Sciences, Inc. 1129 North McDowell Blvd. Petaluma, CA 94954 Phone: (707) 283-0550 Fax: (707) 283-0551
NOV 15 2013
Official Contact
Brian W. Martin Director of Regulatory Affairs and Quality. Control
Device Information
| Trade or Proprietary Name: | Microcyn® Scar Management HydroGel |
|---|---|
| Common Name: | Silicone Scar Gel |
| Classification Name: | Elastomer, Silicone, for Scar Management |
| Regulation: | Class 1 per 21CFR §878.4025 |
| Product Code(s) | PFP |
| Legally marketed device(s) | |
| to which equivalence is | |
| claimed: | Kelo-Cote Topical™ Gel manufactured by Advanced Bio- |
| Technologies, cleared for distribution via 510(k) K002488 | |
| Beau Rx Scar Care Gel currently marketed as Atopiclair® | |
| manufactured by Beau Rx Solutions, LLC, cleared for | |
| distribution via 510(k) K083718 | |
| Reason for 510(k) | |
| submission | New Device |
| Device Description | Microcyn® Scar Management HydroGel is a translucent, silicone |
| oil containing hydrogel which is intended for the management of | |
| old and new scars including hypertrophic and keloid scarring, on | |
| scars resulting from general surgical procedures, as well as | |
| trauma wounds, and burns. The product is intended to be applied | |
| to intact skin. The product is preserved with a unique mixture of | |
| hypochlorous acid and sodium hypochlorite generated through a | |
| proprietary process. The mixture of hypochlorous acid and | |
| sodium hypochlorite act as a preservative in the non-sterile | |
| product to inhibit microbial growth during storage and repeat use. | |
| The preservative is identified by the Center for Drug Evaluation | |
| and Research (CDER) as an inactive ingredient based on the | |
| Intended Use | Rx INDICATIONS: Under the supervision of a health care |
| professional, Microcyn® Scar Management HydroGel is intended | |
| for the management of old and new hypertrophic and keloid | |
| scarring on scars resulting from burns, general surgical | |
| procedures and trauma wounds. |
OTC INDICATIONS: Microcyn® Scar Management HydroGel
is intended for the management of old and new hypertrophic and
keloid scarring on scars resulting from burns, general surgical
procedures and trauma wounds. |
| Performance Testing | The Microcyn® Scar Management HydroGel meets specification
and performance characteristics and is substantially equivalent to
the predicate device. |
| Biocompatibility Testing | Biocompatibility Testing of the Microcyn® Scar Management
HydroGel confirmed that the device meets the applicable
requirements of the Blue Book Memorandum G95-1 entitled Use
of International Standards ISO-10993 Biological Evaluation of
Medical Devices and is biocompatible. |
| Clinical Testing | The Microcyn® Scar Management HydroGel was well tolerated
in the study population and efficacy results indicate substantial
equivalence to the predicate device, Kelo-cote® Scar Gel. |
| Safety and Effectiveness | The Microcyn® Scar Management HydroGel does not raise any
new safety and efficacy concerns when compared to a similar
device already legally marketed. |
| Substantial Equivalence
(SE) Rationale | The Microcyn® Scar Management HydroGel is substantially
equivalent in intended use, technological characteristics, safety,
and effectiveness to the Kelo-Cote Topical™ Gel and Beau Rx
Scar Care Gel. Therefore, the Microcyn® Scar Management
HydroGel is substantially equivalent to the predicate devices. |
| Submitted by: | Brian W. Martin
Director of Regulatory Affairs and Quality Control |
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.
Date Submitted:
ﺔ ﺍﻟﻘﺪﻡ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ
11/13/2013
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-00002
November 15, 2013
Oculus Innovative Sciences Mr. Brian W. Martin Director of Regulatory Affairs and Quality Control 1129 North McDowell Boulevard Petaluma. California 94954
Rc: K131672
.
Trade/Device Name: Microcyn™ Scar Management HydroGel Regulation Number: 21 CFR 878.4025 Regulation Name: Elastomer, Silicone, for Scar Management Regulatory Class: Class I Product Code: PFP Dated: September 24. 2013 Received: October 1, 2013
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
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Page 2 - Mr. Brian W. Martin
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 Small Manufacturers, International and Consumer Assistance 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,
David Krause -S
for Mark N. Melkerson
Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510{k} Number (if known) K131672
Device Name
Microcyn® Scar Management HydroGel
Indications for Use (Describe)
Rx INDICATIONS: Under the supervision of a health care professional, Microcyn® Scar Management HydroGel is intended for the management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.
OTC INDICATIONS: Microcyn® Scar Management HydroGel is intended for the management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
[x] Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY . . . . . . · . ..
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)