(129 days)
No
The device description and performance studies focus on the physical and chemical properties of a nail lacquer, with no mention of AI or ML technologies.
Yes.
The device is indicated for managing signs and symptoms of nail dystrophy (nail splitting and nail fragility) and works by coating and adhering to the nail surface, preventing abrasion and friction, and protecting against moisture. This indicates a direct action to treat or alleviate a medical condition, which aligns with the definition of a therapeutic device.
No
The device is indicated for managing symptoms of nail dystrophy by forming a protective barrier, not for diagnosing the condition itself.
No
The device description clearly states it is a "biocompatible, polymeric lacquer that is applied directly to the nail," indicating it is a physical product, not software. The performance studies also focus on the physical and chemical properties of the lacquer.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to manage signs and symptoms of nail dystrophy by coating and protecting the nail surface. This is a topical application for a physical condition.
- Device Description: The device is a polymeric lacquer applied directly to the nail, forming a physical barrier.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The device acts directly on the nail itself.
IVD devices are used to perform tests in vitro (outside the body) on biological samples to gain diagnostic or other medical information. This device is applied in vivo (on the body) for a physical effect.
N/A
Intended Use / Indications for Use
[The device] is indicated for managing signs and symptoms of nail dystrophy, i.e., nail splitting and nail fragility, for intact or damaged nails. [The device] coats and adheres to the nail surface preventing direct abrasion and friction on the nail surface while also providing protection against the effects of moisture.
Product codes
KMF
Device Description
This product for nail dystrophy is a biocompatible, polymeric lacquer that is applied directly to the nail. The product is dispersed in a solution that dries rapidly, adhering to the contours of the nail to form a transparent, colorless, flexible, waterproof barrier.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nail surface
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription, 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
Bench testing of the bulk formulation and packaged product included molecular weight, water content, setting/drying time, viscosity, percent solids, color and particulates, heat of polymerization, as well as moisture vapor transmission rate, tensile strength, aqueous and acetonitrile extractions of the dried film to confirm absence of degradation products, and distribution/ship tests of the packaged product. Performance characteristics of the product are substantially equivalent to those of the predicate device.
Chesson Labs has submitted summaries of preclinical lab test results, including determinations for anti-abrasion and evaluations for film-forming capacity, friction, and protective properties against chemical agents. Safety of the product was further defined in a clinical study where the product was applied to the nail for approximately six months.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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MAY 17 2012
ChessonLabs
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: 603 Ellis Road, Durham, North Carolina 27703 Phone and fax numbers: (919) 957-1797, (919) 957-7072 Name of contact person: Lance L. Swick, Ph.D. Date of Summary: May 15, 2011
Chesson Laboratory Associates, Inc.
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K.J.Oorg
2/3
Name of device:
Trade or proprietary name: to be determined
Common or usual name: Liquid bandage
Classification name: CFR 880,5090 Class I
Legally marketed device to which equivalence is claimed: Ecocel® [K0830871
Product description:
This product for nail dystrophy is a biocompatible, polymeric lacquer that is applied directly to the nail. The product is dispersed in a solution that dries rapidly, adhering to the contours of the nail to form a transparent, colorless, flexible, waterproof barrier.
Intended use of device:
[The device] is indicated for managing signs and symptoms of nail dystrophy, i.e., nail splitting and nail fragility, for intact or damaged nails. [The device] coats and adheres to the nail surface preventing direct abrasion and friction on the nail surface while also providing protection aqainst the effects of moisture.
Technological characteristics:
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, water content, setting/drying time, viscosity, percent solids, color and particulates, heat of polymerization, as well as moisture vapor transmission rate, tensile strength, aqueous and acetonitrile extractions of the dried film to confirm absence of degradation products, and distribution/ship tests of the packaged product. Performance characteristics of the product are substantially equivalent to those of the predicate device.
Chesson Labs has submitted summaries of preclinical lab test results, including determinations for anti-abrasion and evaluations for film-forming capacity, friction, and protective properties against chemical agents. Safety of the product was further defined in a clinical study where the product was applied to the nail for approximately six months.
Chesson Labs believes the preclinical studies, clinical safety studies and information comparing the products technological features provided in the application demonstrate the product's substantial equivalence.
| Parameter | Device | Predicate Device |
|---|---|---|
| Device Name | TBD | Ecocel |
| Company Name | Chesson Laboratory Associates, Inc. | Polichem S.A. |
| 510[k] # | TBD | K083087 |
| Class | I | I |
| 21 CFR Number | 880.5090 | 880.5090 |
| Code | KMF | KMF |
| Code Description | Liquid bandage | Liquid bandage |
Summary of New Device to Predicate Devices
Chesson Laboratory Associates, Inc.
Nail Dystrophy Product
2
K120057
5/3
| Parameter | Device | Predicate Device |
|---|---|---|
| Product Type | Device | Device |
| Format | Applicator | Applicator |
| Ancillary Components | None | None |
| Intended Use | Indicated for managing signs and | |
| symptoms of nail dystrophy, i.e., nail | ||
| splitting and nail fragility, for intact or | ||
| damaged nails. Product coats and | ||
| adheres to the nail surface preventing | ||
| direct abrasion and friction on the nail | ||
| surface while also providing | ||
| protection against the effects of | ||
| moisture. | Indicated to protect intact or | |
| damaged nails from the effects of | ||
| moisture, friction (rubbing) or shear | ||
| (tearing), relieving symptoms and | ||
| signs of nail dystrophy (i.e. nail | ||
| splitting and fragility). | ||
| End Use | Prescription, OTC | Prescription, OTC |
| Frequency of Use | Once daily | Once daily |
| Components | Poly(urea-urethane) polymer in | |
| organic solvents | Hydroxypropyl-chitosan, equisetum | |
| arvense and methyl sulfonyl | ||
| methane in organic solvents | ||
| Testing | Biocompatibility; preclinical studies; | |
| laboratory studies; clinical studies | Biocompatibility; preclinical studies; | |
| laboratory studies; clinical studies; | ||
| post-market experience in Europe |
Comparison Statement:
Chesson Labs' product is similar to the predicate device in that it provides the same functions as Ecocel®, has similar claims, and has similar indications for use. Both of these products are liquid solutions applied directly to the nail, which upon contact with the nail dry to form a film. They have many of the same functional characteristics, such as ability to cover the keratin grooves of the nail as well as protect the nail from exposure to environmental factors.
Results of biocompatibility and design verification testing have demonstrated that the Chesson Labs' product has the same descriptive, technical, and safety characteristics and therefore raises no new no new issues of safety or effectiveness. The Chesson Labs' product to manage symptoms and signs of nail dystrophy has similar technological characteristics as the previously cleared product [Ecocel; K083087]. Chesson Labs has considered the impact upon safety resulting from the extended duration of product use and has supported the safety for the new intended use of this product in clinical studies.
Chesson Laboratory Associates, Inc.
Nail Dystrophy Product
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 7 2012
Chesson Laboratory Associates, Inc. % Lance Swick, Ph.D. 603 Ellis Road Durham, North Carolina 27703
Re: K120059
Trade/Device Name: Liquid Bandage Regulation Number: 21 CFR 880.5090 Regulation Name: Liquid bandage Regulatory Class: Class I Product Code: KMF Dated: April 30, 2012 Received: May 03, 2012
Dear Dr. Swick:
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
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Page 2 - Lance Swick, Ph.D.
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 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/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 Small Manufacturers, International and Consumer Assistance 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.ham.
Sincerely yours,
yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): __
Device Name: TBD
Indications for Use:
[The device] is indicated for managing signs and symptoms of nail dystrophy, i.e., nail splitting and nail fragility, for intact or damaged nails. [The device] coats and adheres to the nail surface preventing direct abrasion and friction on the nail surface while also providing protection against the effects of moisture.
Prescription Use __ × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X
(21 CFR 801 Subpart C)
(Division Sign-Off)
Chesson Laboratory Associates, Inc.
Division of Surgical, Orthopedic, Nail Dystrophy Product and Restorative Devices Confidential, Chesson Labs Proprietary Content
510(k) Number K200591