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.

AI/ML Overview

The provided text describes information about the KeriCure™ Advanced Liquid Bandage, a medical device, and its substantial equivalence to predicate devices, focusing on performance and biocompatibility testing. However, it does not contain the specific information requested in your prompt regarding acceptance criteria, study details, human expert involvement, or AI-related effectiveness.

Here's an analysis of what is available vs. what is not:

Information Present in the Document:

Device Name: KeriCure™ Advanced Liquid Bandage, KeriCure™ Liquid Bandage, KeriCure Natural Seal™ Liquid Bandage.
Intended 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 (for Advanced version).
Product Code: KMF (Liquid bandage)
Regulatory Class: Class I
Predicate Devices: K083913 – NUVADERM – Chesson Labs; K991920 – Dermaphylyx Hydrophilic Wound Dressing, Dermaphylyx, Inc.
Biocompatibility Testing: Passed ISO 10993-10 for irritation and skin sensitization. Cytotoxicity testing performed according to 10993-5, with spray applicator scoring 1.
Shelf Life Testing: Performed according to ISO11737-1, ASTM F1980, USP-51 and USP-35, indicating a 12-month shelf life.
Performance Testing (General): "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: Claimed based on similar fundamental technological characteristics (flexible wound management, moisture barrier, absorptive qualities, infection protection) and verified by test results in design, materials, and intended use.

Information NOT present in the Document (that you requested):

A table of acceptance criteria and the reported device performance: While general statements about "passing all testing requirements" are made, specific numerical acceptance criteria (e.g., "tear strength must be > X N/mm") and the device's exact reported performance values are not provided.
Sample size used for the test set and the data provenance: The document mentions "testing requirements" and "test results" but does not specify the sample sizes (e.g., number of bandages tested, number of subjects in a trial) or the origin of the data (e.g., country, retrospective or prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This device is a liquid bandage, not typically an AI-driven diagnostic tool that relies on expert interpretation of images or other data for ground truth establishment. Therefore, this information is not relevant or present.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for this type of device testing.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is explicitly for AI-assisted diagnostic or interpretative devices. The KeriCure™ Advanced Liquid Bandage is a physical wound dressing; it does not involve AI or human readers for diagnostic purposes.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the performance characteristics mentioned (e.g., elasticity, water vapor transmission), the "ground truth" would be established by the defined parameters within the ASTM/ISO standards themselves, rather than expert consensus or pathology data. For biocompatibility, the ground truth is the absence of irritation, sensitization, or cytotoxicity as defined by the ISO standards.
The sample size for the training set: Not applicable, as this is not a machine learning/AI device requiring a training set.
How the ground truth for the training set was established: Not applicable for the same reason as above.

In summary: The provided text details the regulatory clearance for a liquid bandage, including its intended use, predicate devices, and general statements about biocompatibility and performance testing against established standards. However, it lacks the specific quantitative data, study designs, and human expert involvement details that would be found in a submission for an AI-powered diagnostic device or a study designed to evaluate human performance with and without AI assistance.

Summary

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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

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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

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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, Inc445 Apollo Beach BlvdApollo Beach, FL 33572Lauren Chrapowitzkylaurenc@ajwtech.com813-645-2855
Submitter of 510(k):	KeriCure Inc26620 Easy StWesley Chapel, FL 33544Kerriann Greenhalghkgreenha@kericure.com
Date of Summary:	June 25, 2014
Trade/Proprietary Name:	KeriCure™ Liquid Bandage, KeriCure NaturalSeal™ Liquid Bandage, KeriCure™ AdvancedLiquid Bandage
Classification Name:	Liquid Bandage
Product Code:	KMF
Indications for use:	KeriCure™ Liquid Bandage and KeriCure NaturalSeal™ Liquid Bandage: To help cover and protectthe skin from infection in minor cuts, scrapes,burns, irritations and abrasions.KeriCure™ Advanced Liquid Bandage: To coverand protect the skin from infection in minor cuts,scrapes, burns, irritations and abrasions, as well asclosed surgical incisions and excisions.
Device Description:	The KeriCure™ Liquid Bandage family of productsis comprised of a protective, elastic polymer film(proprietary polyacrylate polymer). As applied to theskin, the liquid bandage is slightly more viscousthan 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.

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Predicate Device(s):	K083913 – NUVADERM – Chesson Labs
	K991920 – Dermaphylyx Hydrophilic WoundDressing, 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.

Regulation Number and Section

§ 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.