Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the chemical and physical properties of the liquid polymer and its function as a barrier. There is no mention of AI or ML in the device description, intended use, or performance studies.

Therapeutic

No
The device is a liquid bandage designed to cover and protect skin and minor cuts, which is not considered a therapeutic function. Its purpose is to provide a physical barrier rather than to treat a disease or condition.

Diagnostic

No

The device is described as a liquid bandage that forms a protective coating on the skin to prevent infection and cracking/peeling as skin heals. Its intended use and function are solely for protection and healing support, not for diagnosing any condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "liquid polymer in a spray format" and describes its physical properties and application as a topical coating, indicating it is a physical product, not software.

IVD (In Vitro Diagnostic)

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 intact skin or minor cuts, scrapes, burns, and irritations of the skin. This is a topical application for wound protection and healing, not for diagnosing a condition.
Device Description: The device is a liquid polymer that forms a protective coating on the skin. This is a physical barrier, not a diagnostic test performed on a sample taken from the body.
Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.

The device is clearly described as a "liquid bandage," which falls under the category of wound dressings or topical protectants, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

To cover intact skin or minor cuts, scrapes, burns, and irritations of the skin, to help keep them clean and dry and help protect them from infection

Product codes

KMF

Device Description

This product is a liguid polymer in a spray format. The solution is topically applied to the affected area and the carrier solvent evaporates allowing polymerization of the remaining constituents to form a non-toxic, hydrophobic, elastomeric polymer coating that provides a barner against moisture but that is permeable to oxygen. The intended use is as a liquid bandage, as this coating is biocompatible and forms a tough yet pliable seal, preventing it from cracking and peeling as the skin heals.

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

Physician, OTC

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 ability of the dried product film to act as a microbial barrier was validated by testing in a modification of ASTM F1608 (Standard Test Method for Microbial Ranking of Porous Packaging Materials) with five species of bacteria. The film formed an effective barrier to all organisms tested.

Biocompatibility of the product was evaluated per ISO-10993 for cytotoxicity, sensitization, and irritation, acute systemic toxicity, genotoxicity, mutagenicity, and implantation, Twelve different types of tests were run and the product was shown to be biocompatible.

Bench testing of the bulk formulation and packaged product included molecular weight, purity, and residual components, water content, setting/drying time, viscosity, percent solids, color and particulates, heat of polymerization, as well as moisture vapor transmission rate and tensile strength of the dried film, and distribution/ship tests of the packaged product. All product lots met specifications.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K063202, K022645

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

K083913

Image /page/0/Picture/1 description: The image shows the logo for ChessonLabs. The logo consists of a chess knight piece inside of a circle. Below the circle is the text "ChessonLabs" in a sans-serif font.

1/4

JUL 3 I 2009

510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.

510(k) owner's name: Chesson Laboratory Associates, Inc.

Address: 3100 Tower Blvd, Suite 117, Durham, NC 27707

Phone and fax numbers: (919) 419-4900; (919) 419-4923

Name of contact person: Lance L. Swick, PhD

Date of summary: 31 October 2008

1

K0839 1.3

Name of device:

Trade or proprietary name: to be determined

Common or usual name: liquid bandage

Classification name: liguid bandage; skin protectant

Legally marketed device to which equivalence is claimed: Pro-Derma Liquid Bandage (K063202) or Curad Spray Bandage (K022645)

Description of device:

This product is a liguid polymer in a spray format. The solution is topically applied to the affected area and the carrier solvent evaporates allowing polymerization of the remaining constituents to form a non-toxic, hydrophobic, elastomeric polymer coating that provides a barner against moisture but that is permeable to oxygen. The intended use is as a liquid bandage, as this coating is biocompatible and forms a tough yet pliable seal, preventing it from cracking and peeling as the skin heals.

Intended use of device: to cover intact skin or minor cuts, scrapes, burns, and irritations of the skin, to help keep them clean and dry and help protect them from infection

Performance characteristics:

The ability of the dried product film to act as a microbial barrier was validated by testing in a modification of ASTM F1608 (Standard Test Method for Microbial Ranking of Porous Packaging Materials) with five species of bacteria. The film formed an effective barrier to all organisms tested.

Biocompatibility of the product was evaluated per ISO-10993 for cytotoxicity, sensitization, and irritation, acute systemic toxicity, genotoxicity, mutagenicity, and implantation, Twelve different types of tests were run and the product was shown to be biocompatible.

Bench testing of the bulk formulation and packaged product included molecular weight, purity, and residual components, water content, setting/drying time, viscosity, percent solids, color and particulates, heat of polymerization, as well as moisture vapor transmission rate and tensile strength of the dried film, and distribution/ship tests of the packaged product. All product lots met specifications. Performance characteristics of the product are similar to those of the predicate devices.

| Parameter | Device | Predicate
Device | Predicate Device | Predicate Device |
|-----------------|------------------------------------------|-------------------------------------------|------------------------|----------------------------------------|
| Device Name | TBD | Pro-Derma
Liquid
Bandage | Curad Spray
Bandage | New-Skin |
| Company
Name | Chesson
Laboratory
Associates, Inc | Procurement
Technology
Systems, LLC | Beiersdorf AG | Medtech Products,
Inc (distributor) |
| 510(k) # | TBD | K063202 | K022645 | Pre-1976 |

Summary Comparison of New Device to Predicate Device

Chesson Laboratory Associates, Inc.

Liquid Bandage

Page 2 of 4

2

K083845
34

Class	II	Same	Same	Same
21 CFR
number	880.5090	Same	Same	Same
Code	KMF	Same	Same	Same
Product Type	Device	Same	Same	Same
Description	Liquid bandage	Same	Same	Same
Format	Topical spray;
Single-use
applicator	Single-use
applicator	Topical spray	Same
Ancillary
components	None	Same	Same	Same
Intended Use	to cover intact skin
or minor cuts,
scrapes and
irritations of the
skin, to help keep
them clean and dry
and help protect
them from infection	to cover minor
cuts, scrapes
and minor
irritations of
the skin and
help protect
them from
infection	To provide a
covering over minor
cuts and scrapes
that are clean and
dry	To protect cuts
and scrapes,
prevent and
protect blisters,
helps prevent the
formation of
calluses, covers
painful hangnails
End User	Physician, OTC	OTC	OTC	OTC
Frequency of
Use	Once daily or as
needed to keep
wound covered	Same	Same	Same
Method of
Use	Spray on or topical
application	Topical
application	Spray on	Same
Mechanism of
Action	Wound sealant,
moisture barrier	Same	Same	Same
Materials /
components	Acetone and
methyl ethyl
ketone solvents,
polyetheramine.
N,N'-dialkylamino-
diphenylmethane,
polyether polyol
ethylene glycol,
propylene glycol,
diphenylmethane
diisocyanate	2-Octyl and N-
Butyl
Cyanoacrylate
monomers,
plasticizer and
D&C violet #2
pigment	poly(methylacrylate-
isobutene-mono-
isopropylmaleate),
ethyl acetate, n-
pentane, carbon
dioxide, menthol	Acetone, Alcohol,
Isobutane
Propane, Oil of
Cloves, Pyroxylin
Solution, 8
Hydroxyquinoline
Testing	Biocompatibility
per ISO 10993	Same	Same	Unknown
Performance
characteristics	Flexible,
transparent, water-
tight, but allows
passage of water
vapor; seals out
germs	Same	Same	Dries rapidly to
form a tough
protective cover
that is antiseptic,
flexible,
waterproof, and
lets skin breathe.
Completely covers
the entire wound
to keep out dirt
and germs

Chesson Laboratory Associates, Inc.

Liquid Bandage

Page 3 of 4

3

K088913

uli

Comparison statement

The Chesson Labs product is similar to the predicate devices in that they are polymers in organic solvents. They provide the same functions as a liquid bandage, are for over-thecounter (OTC) consumer use, have similar claims, and they have the same indications for use. All of these products are liquid solutions applied directly to the wound, which upon contact with the skin dry to form a clear barrier film. They have many of the same functional characteristics, such as water-tightness, water vapor permeability, oxygen permeability, flexibility, and barrier film duration.

Results of biocompatibility and design verification testing provided in the submission have demonstrated that the Chesson Labs Liquid Bandage has the same performance, safety and technical characteristics and therefore raises no new no new issues of safety or effectiveness.

5.004

4

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Chesson Laboratory Associates, Inc. % Mr. Scott E. Neuville President and CEO 3100 Tower Boulevard, Suite 117 Durham, North Carolina 27707

'JUL 3 1, 2009

Re: K083913

Trade/Device Name: Regulation Number: 21 CFR 880.5090 Regulation Name: Liquid bandage Regulatory Class: Class II Product Code: KMF Dated: June 3, 2009 Received: June 4, 2009

Dear Mr. Neuville:

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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

5

Page 2 - Mr. Scott E. Neuville

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrl/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A. Milbers

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

6

Indications for Use 1083913 510(k) Number (if known):

Device Name:

Indications for Use:

To cover intact skin or minor cuts, scrapes, burns, and irritations of the skin, to help keep them clean and dry and help protect them from infection

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X
(21 CFR 801 Subpart C)

Ok

Daniel Krone for Mxu

(Division Sign-Off)

Page 1 of 1

Division of Surgical, Orthopedic, and Restorative Devices 3913

Liquid Bang Number.

Chesson Laboratory Associates, Inc.