(213 days)
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
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.
Here's a breakdown of the acceptance criteria and the study that proves the Chesson Labs Liquid Bandage device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Parameter / Acceptance Criteria | Reported Device Performance |
|---|---|
| Microbial Barrier (per modified ASTM F1608) | The film formed an effective barrier to all organisms tested (five species of bacteria). |
| Biocompatibility (per ISO-10993) | The product was shown to be biocompatible based on twelve different types of tests for cytotoxicity, sensitization, irritation, acute systemic toxicity, genotoxicity, mutagenicity, and implantation. |
| Bench Testing (Bulk formulation & packaged product) | All product lots met specifications for: molecular weight, purity, residual components, water content, setting/drying time, viscosity, percent solids, color and particulates, heat of polymerization, moisture vapor transmission rate, tensile strength of dried film, and distribution/ship tests of packaged product. Performance characteristics are similar to those of the predicate devices. |
| Functional Characteristics (compared to predicate devices) | The Chesson Labs product is described as having "many of the same functional characteristics, such as water-tightness, water vapor permeability, oxygen permeability, flexibility, and barrier film duration." |
| Safety and Effectiveness (compared to predicate devices) | Biocompatibility and design verification testing "demonstrated that the Chesson Labs Liquid Bandage has the same performance, safety and technical characteristics and therefore raises no new issues of safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the test set for each specific experiment. However, it mentions:
- Microbial Barrier: Tested with "five species of bacteria." The sample size for the material itself isn't specified, but it implies tests against these five species.
- Biocompatibility: "Twelve different types of tests were run." No specific sample sizes (e.g., number of animals, cell cultures) are provided.
- Bench Testing: "All product lots met specifications." No specific number of lots or samples per lot is given.
The data provenance is retrospective, as this is a 510(k) submission describing tests already conducted to demonstrate substantial equivalence to existing predicate devices. The country of origin of the data is not explicitly stated.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided in the document. The studies described are primarily laboratory-based performance and safety tests (microbial barrier, biocompatibility, bench testing) and do not involve human evaluation of device efficacy that would require expert-established ground truth in the way a diagnostic imaging study would. The acceptance criteria are based on measurable physical and biological properties.
4. Adjudication Method for the Test Set:
This information is not applicable as the studies are not clinical trials or diagnostic studies requiring expert adjudication of results. The "ground truth" for the performance tests (e.g., whether a microbial barrier was effective, whether a material was biocompatible, or whether a property met a specification) would be determined by the results of the specific test methods and their defined pass/fail criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data, and the device's impact on their performance is being assessed. The Chesson Labs device is a liquid bandage, and its effectiveness is determined through physical and biological property testing, not through human reader interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study:
A standalone performance study was done, in the sense that the device's performance was evaluated inherently without human-in-the-loop interaction for its primary function. The biocompatibility, microbial barrier, and bench tests are all evaluations of the device's inherent properties and performance when applied appropriately, without requiring a human to interpret an output or act on a recommendation from the device itself.
7. Type of Ground Truth Used:
The ground truth used for these studies is based on:
- Standardized Test Methods: For microbial barrier, it's defined by the modified ASTM F1608. For biocompatibility, it's defined by ISO-10993 guidelines.
- In vitro and In vivo Laboratory Results: Direct measurements and observations from the conducted tests.
- Pre-defined Specifications: For bench testing, the ground truth is whether the measured values for molecular weight, viscosity, etc., fall within the established specifications.
- Comparison to Predicate Devices: The overall "ground truth" for substantial equivalence relies on demonstrating that the new device's performance, safety, and technical characteristics are comparable to legally marketed predicate devices.
8. Sample Size for the Training Set:
This information is not applicable/not provided. The Chesson Labs liquid bandage is a physical medical device, not an AI/ML algorithm that requires a "training set" of data in the computational sense. The "development" process would involve formulation, characterization, and iterative testing, but not a distinct "training set" similar to what's used for AI.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no "training set" in the context of this device.
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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 | PredicateDevice | Predicate Device | Predicate Device |
|---|---|---|---|---|
| Device Name | TBD | Pro-DermaLiquidBandage | Curad SprayBandage | New-Skin |
| CompanyName | ChessonLaboratoryAssociates, Inc | ProcurementTechnologySystems, 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
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K083845
34
| Class | II | Same | Same | Same |
|---|---|---|---|---|
| 21 CFRnumber | 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-useapplicator | Single-useapplicator | Topical spray | Same |
| Ancillarycomponents | None | Same | Same | Same |
| Intended Use | to cover intact skinor minor cuts,scrapes andirritations of theskin, to help keepthem clean and dryand help protectthem from infection | to cover minorcuts, scrapesand minorirritations ofthe skin andhelp protectthem frominfection | To provide acovering over minorcuts and scrapesthat are clean anddry | To protect cutsand scrapes,prevent andprotect blisters,helps prevent theformation ofcalluses, coverspainful hangnails |
| End User | Physician, OTC | OTC | OTC | OTC |
| Frequency ofUse | Once daily or asneeded to keepwound covered | Same | Same | Same |
| Method ofUse | Spray on or topicalapplication | Topicalapplication | Spray on | Same |
| Mechanism ofAction | Wound sealant,moisture barrier | Same | Same | Same |
| Materials /components | Acetone andmethyl ethylketone solvents,polyetheramine.N,N'-dialkylamino-diphenylmethane,polyether polyolethylene glycol,propylene glycol,diphenylmethanediisocyanate | 2-Octyl and N-ButylCyanoacrylatemonomers,plasticizer andD&C violet #2pigment | poly(methylacrylate-isobutene-mono-isopropylmaleate),ethyl acetate, n-pentane, carbondioxide, menthol | Acetone, Alcohol,IsobutanePropane, Oil ofCloves, PyroxylinSolution, 8Hydroxyquinoline |
| Testing | Biocompatibilityper ISO 10993 | Same | Same | Unknown |
| Performancecharacteristics | Flexible,transparent, water-tight, but allowspassage of watervapor; seals outgerms | Same | Same | Dries rapidly toform a toughprotective coverthat is antiseptic,flexible,waterproof, andlets skin breathe.Completely coversthe entire woundto keep out dirtand germs |
Chesson Laboratory Associates, Inc.
Liquid Bandage
Page 3 of 4
{3}------------------------------------------------
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
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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
{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
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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)
Page 1 of 1
Division of Surgical, Orthopedic, and Restorative Devices 3913
Liquid Bang Number.
Chesson Laboratory Associates, Inc.
§ 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.