ECOCEL

K083087 · Polichem S.A · KMF · Aug 7, 2009 · General Hospital

Device Facts

• Record ID: K083087
• Device Name: ECOCEL
• Applicant: Polichem S.A
• Product Code: KMF · General Hospital
• Decision Date: Aug 7, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

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).

Device Story

Ecocel is a water-soluble lacquer applied to nails to provide a protective barrier against moisture, friction, and shear. The device consists of a glass bottle containing the lacquer and a nylon brush attached to a polypropylene screw cap. It is intended for use on nails suffering from dystrophy, such as splitting or fragility. The lacquer acts as a physical shield to relieve symptoms. It is a topical application used to protect the nail surface.

Clinical Evidence

The submission includes reports from clinical studies and post-market experience in Europe, alongside preclinical biocompatibility and laboratory studies, to substantiate performance.

Technological Characteristics

Water-soluble lacquer; glass bottle container; nylon brush applicator; polypropylene screw cap. No electronic components or software.

Indications for Use

Indicated for patients with intact or damaged nails experiencing nail dystrophy, including nail splitting and fragility, to protect against moisture, friction, and shear.

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

• Liquiderm (K002338)
• LiquiShield S (K023163)

Submission Summary (Full Text)

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K083087

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## Attachment I

### 510(k) Summarv

| Trade Name: | Ecocel® | |
|----------------------|-------------------------------------------------------------------------------------------------|-------------|
| Sponsor: | Polichem S.A.<br>50 Val Fleuri<br>Luxembourg 1526 | AUG 07 2009 |
| Contact: | Hari Nagaradona, PhD<br>Kendle International Inc.<br>Rockville, MD 2-855<br>Phone: [phone] | |
| 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.

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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.

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### 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 [phone] or [phone] 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