CHESSON LABS LIQUID BANDAGE

K083913 · Chesson Laboratory Associates, Inc. · KMF · Jul 31, 2009 · General Hospital

Device Facts

• Record ID: K083913
• Device Name: CHESSON LABS LIQUID BANDAGE
• Applicant: Chesson Laboratory Associates, Inc.
• Product Code: KMF · General Hospital
• Decision Date: Jul 31, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended 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

Device Story

Liquid polymer spray applied topically to affected skin areas; solvent evaporates to form a non-toxic, hydrophobic, elastomeric polymer coating. Acts as a wound sealant and moisture barrier; permeable to oxygen; flexible and transparent. Used by physicians or patients (OTC) to cover minor wounds, burns, and irritations. Provides a tough, pliable seal that prevents cracking and peeling during healing. Benefits patient by maintaining a clean, dry environment and protecting against infection.

Clinical Evidence

Bench testing only. Microbial barrier effectiveness validated via modified ASTM F1608 with five bacterial species. Biocompatibility evaluated per ISO 10993 (cytotoxicity, sensitization, irritation, acute systemic toxicity, genotoxicity, mutagenicity, implantation). Physical testing included molecular weight, purity, residual components, water content, drying time, viscosity, moisture vapor transmission rate, and tensile strength.

Technological Characteristics

Liquid polymer spray formulation. Materials: Acetone, methyl ethyl ketone, polyetheramine, N,N'-dialkylamino-diphenylmethane, polyether polyol, ethylene glycol, propylene glycol, diphenylmethane diisocyanate. Sensing/actuation: Passive physical barrier. Connectivity: None. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for covering intact skin, minor cuts, scrapes, burns, and skin irritations in patients requiring a protective barrier to keep wounds clean, dry, and protected from infection.

Regulatory Classification

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.

Predicate Devices

• Pro-Derma Liquid Bandage (K063202)
• Curad Spray Bandage (K022645)

Reference Devices

• New-Skin (Pre-1976)

Submission Summary (Full Text)

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K083913

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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: [phone]; [phone]

Name of contact person: Lance L. Swick, PhD

Date of summary: 31 October 2008

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

Summary Comparison of New Device to Predicate Device

Chesson Laboratory Associates, Inc.

Liquid Bandage

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K083845
34

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

Chesson Laboratory Associates, Inc.

Liquid Bandage

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K088913

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## 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

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## 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

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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 [phone] or [phone] 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

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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)

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Division of Surgical, Orthopedic, and Restorative Devices 3913

Liquid Bang Number.

Chesson Laboratory Associates, Inc.