(295 days)
No
The summary describes a topical lacquer for nail protection and does not mention any computational or data-driven components indicative of AI/ML.
Yes
The device is indicated to protect nails and relieve symptoms and signs of nail dystrophy, which are therapeutic claims.
No
Ecocel is indicated to protect and relieve symptoms of nail dystrophy, not to diagnose a condition. It is a protective lacquer.
No
The device description explicitly states it is a "water-soluble lacquer contained in a glass bottle... with a nylon brush," indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect nails and relieve symptoms of nail dystrophy. This is a topical application for a physical condition, not a test performed on a sample taken from the body to diagnose a disease or condition.
- Device Description: The device is a lacquer applied to the nail. This is consistent with a topical treatment, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process that would be performed outside of the body to obtain diagnostic information.
Therefore, Ecocel® is a medical device, but it falls under a different classification than an IVD.
N/A
Intended Use / Indications for Use
Ecocel® is a hydrosoluble lacquer 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).
Product codes
KMF
Device Description
Ecocel® is a water-soluble lacquer contained in a glass bottle (1.5 or 3.3 mL) with a nylon brush fitted on the polypropylene screw cap.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nails
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Polichem has submitted summaries of preclinical studies, including biocompatibility and laboratory studies, and the reports from clinical studies as well as the post market experience in Europe that substantiate Ecocel's performance both in vitro as well as its in vivo use.
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.
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Attachment I
510(k) Summarv
| Trade Name: | Ecocel® | |
|---|---|---|
| Sponsor: | Polichem S.A. | |
| 50 Val Fleuri | ||
| Luxembourg 1526 | AUG 07 2009 | |
| Contact: | Hari Nagaradona, PhD | |
| Kendle International Inc. | ||
| Rockville, MD 2-855 | ||
| Phone: 301-295-1370 | ||
| Device Generic Name: | Liquid Bandage | |
| Classification: | CFR 880.5090 Class I | |
| Product Code: | KMF |
Product Description:
Ecocel® is a water-soluble lacquer contained in a glass bottle (1.5 or 3.3 mL) with a nylon brush fitted on the polypropylene screw cap.
Indications for Use:
Ecocel® is a hydrosoluble lacquer 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).
Predicate Devices:
Ecocel is substantially equivalent to predicate devices, Liquiderm, Closure Medical Corp. (K002338) and LiquiShield S, MedLogic Global Ltd. (K023163).
Technological Characteristics
Polichem has submitted summaries of preclinical studies, including biocompatibility and laboratory studies, and the reports from clinical studies as well as the post market experience in Europe that substantiate Ecocel's performance both in vitro as well as its in vivo use.
Conclusion
Polichem believes the preclinical lab test results, clinical studies and information comparing Ecocel's technological features provided in the application demonstrate that Ecocel® is substantially equivalent to predicate Liquid Bandage devices legally marketed in the U.S.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wings, representing the department's mission to protect the health of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
PolichemS.A % Kendle International, Inc. Hari Nagaradone, Ph.D. Associate Director 7361 Calhoun Place, Suite 500 Rockville, Maryland 20855
AUG 0 7 2009
Re: K083087
Trade/Device Name: Ecocel® Regulation Number: 21 CFR 880.5090 Regulation Name: Liquid bandage Regulatory Class: I Product Code: KMF Dated: July 10, 2009 Reccived: July 14, 2009
Dear Dr. Nagaradone:
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.
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 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.
2
Page 2 - Hari Nagaradone, Ph.D.
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/ucm1158091htm.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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
Mark N. Melkerson
Director
Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K0 F 56 f 7
1 Page of
510(k) Number (if known): K083087
Device Name: Ecocel®
Indications for Use:
Ecocel® is a hydrosoluble lacquer 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).
Prescription Use X (PART 21 CFR 801.109) Over-the -Counter Use -
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
AND / OR
Daniel Kronebermxm
510(k) Number L063087
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices