(450 days)
Not Found
No
The device description and performance studies focus on the physical properties and performance of a liquid bandage, with no mention of AI or ML.
Yes.
The device covers and protects the skin from infection due to minor cuts, scrapes, burns, irritations, and abrasions, which fits the definition of a therapeutic device.
No
The device description indicates it is a protective, elastic polymer film used to cover and protect skin injuries, not to diagnose medical conditions.
No
The device description clearly states it is a "protective, elastic polymer film" applied to the skin, indicating a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to cover and protect the skin from infection in minor wounds. This is a topical application for wound care, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a liquid bandage that forms a protective film on the skin. This is a physical barrier, not a reagent or instrument used to analyze biological samples.
- No mention of in vitro testing: The description and performance studies focus on the physical properties and performance of the bandage on the skin, not on any diagnostic testing of biological samples.
IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
KeriCure™ Liquid Bandage and KeriCure Natural Seal™ Liquid Bandage: To help cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions.
KeriCure™ Advanced Liquid Bandage: To cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions, as well as closed surgical incisions and excisions.
Product codes
KMF
Device Description
The KeriCure™ Liquid Bandage family of products is comprised of a protective, elastic polymer film (proprietary polyacrylate polymer). As applied to the skin, the liquid bandage is slightly more viscous than water and sets within minutes to form a clear. breathable and completely transparent film. The Liquid Bandage is capable of adhering to both intact and compromised body tissue. The device is available with either a dropper or spray applicator.
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
Not Found
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 for KeriCure™ Liquid Bandages was performed according to the following standards: ASTM 570, ASTM D638-10, ASTM D789, E96/ E96M-10. The applicant device passed all testing requirements with results similar to the predicate devices in terms of performance capabilities.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
0
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health and Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other. The faces are facing to the right and are connected by a flowing line.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2014
KeriCure Incorporated % Mr. Jonathan Ward AJW Technology Consultants Incorporated 445 Apollo Beach Boulevard Apollo Beach, Florida 33572
Re: K131384
Trade/Device Name: KeriCure™ Advanced Liquid Bandage Regulation Number: 21 CFR 880.5090 Regulation Name: Liquid bandage Regulatory Class: Class I Product Code: KMF Dated: June 27, 2014 Received: July 1, 2014
Dear Mr. Ward:
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
1
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 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 yours,
David Krause -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
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510(k) Number (if known): K131384
Device Name: KeriCure™ Liquid Bandage, KeriCure Natural Seal™ Liquid Bandage
Indications for Use:
To help cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jiyoung Dang -S
Page 1 of 1
3
510(k) Number (if known): K131384
Device Name: KeriCure™ Advanced Liquid Bandage
Indications for Use:
To cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions, as well as closed surgical incisions and excisions.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jiyoung Dang -S
Page 1 of 1
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510(k) SUMMARY (as required by 807.92)
| Regulatory Correspondent: | AJW Technology Consultants, Inc
445 Apollo Beach Blvd
Apollo Beach, FL 33572
Lauren Chrapowitzky
laurenc@ajwtech.com
813-645-2855 |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter of 510(k): | KeriCure Inc
26620 Easy St
Wesley Chapel, FL 33544
Kerriann Greenhalgh
kgreenha@kericure.com |
| Date of Summary: | June 25, 2014 |
| Trade/Proprietary Name: | KeriCure™ Liquid Bandage, KeriCure Natural
Seal™ Liquid Bandage, KeriCure™ Advanced
Liquid Bandage |
| Classification Name: | Liquid Bandage |
| Product Code: | KMF |
| Indications for use: | KeriCure™ Liquid Bandage and KeriCure Natural
Seal™ Liquid Bandage: To help cover and protect
the skin from infection in minor cuts, scrapes,
burns, irritations and abrasions.
KeriCure™ Advanced Liquid Bandage: To cover
and protect the skin from infection in minor cuts,
scrapes, burns, irritations and abrasions, as well as
closed surgical incisions and excisions. |
| Device Description: | The KeriCure™ Liquid Bandage family of products
is comprised of a protective, elastic polymer film
(proprietary polyacrylate polymer). As applied to the
skin, the liquid bandage is slightly more viscous
than water and sets within minutes to form a clear. |
| breathable and completely transparent film. The | |
| Liquid Bandage is capable of adhering to both intact | |
| and compromised body tissue. The device is | |
| available with either a dropper or spray applicator. | |
5
| Predicate Device(s): | K083913 – NUVADERM – Chesson Labs |
|---|---|
| K991920 – Dermaphylyx Hydrophilic Wound | |
| Dressing, Dermaphylyx, Inc. |
Biocompatilibity Testing:
The KeriCure "10 Liquid Bandages passed biocompatibility testing requirements according to ISO ISO 10993-10 for irritation and skin sensitization. Additionally, cytotoxicity testing was performed according to 10993-5. The liguid bandage devices available in the spray applicator passed cytotoxicity testing with a score of 1.
Shelf Life:
KeriCure™ Liquid Bandages are provided non-sterile. Shelf-life testing and microbial barrier testing has been performed according to ISO11737-1, ASTM F1980, USP-51 and USP-35. The results of these tests indicate that the KeriCure™ Liquid Bandages are safe and effective for use over a 12 month period.
Performance Testing:
Performance testing for KeriCure™ Liquid Bandages was performed according to the following standards: ASTM 570, ASTM D638-10, ASTM D789, E96/ E96M-10. The applicant device passed all testing requirements with results similar to the predicate devices in terms of performance capabilities.
Substantial Equivalence:
The liquid bandages have the same fundamental technological characteristics as the predicate devices in that they are all flexible wound management devices that provide a moisture barrier, have absorptive qualities, and provide protection from infection. Test results have confirmed substantial equivalence in design, materials and intended use, and confirmed there are no significant differences between the proposed and predicate devices that raise new questions of safety or efficacy.