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 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.

AI/ML Overview

The provided documentation for the Ecocel® device (K083087) does not contain sufficient information to describe specific acceptance criteria or a detailed study proving the device meets acceptance criteria in the format requested.

The document is a 510(k) summary for a Class I liquid bandage, Ecocel®, seeking substantial equivalence to existing predicate devices. It primarily focuses on the regulatory submission process and the determination of substantial equivalence by the FDA.

Here's an analysis based on the available information:

A table of acceptance criteria and the reported device performance
- Not provided. The document states that Polichem 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." However, no specific acceptance criteria (e.g., minimum efficacy rates, safety thresholds, or performance metrics) or corresponding reported performance data are detailed.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The summary mentions "clinical studies" and "post market experience in Europe" but does not specify sample sizes, design (retrospective or prospective), or the exact country of origin for the data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. This type of information is typically relevant for medical imaging or diagnostic devices where expert consensus is used to establish ground truth for classification tasks. For a liquid bandage, ground truth would likely be established through objective measures of efficacy (e.g., reduction in nail splitting) or patient-reported outcomes, rather than expert interpretation of images. The document does not detail how outcomes were assessed or by whom.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Similar to point 3, adjudication methods are usually applied to expert reviews in diagnostic studies. For a liquid bandage, if patient-reported outcomes or clinical assessments were used, the method of resolving discrepancies would be detailed, but this is not present in the summary.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. MRMC studies are specific to diagnostic devices where human readers interpret cases, often with or without AI assistance. This device is a liquid bandage, not an AI-powered diagnostic tool. Therefore, an MRMC study would not be relevant.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a topical medical product, not an algorithm, so a standalone algorithm performance study is not relevant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Inferred to be outcomes data and possibly subjective assessments. The indications for use state "relieving symptoms and signs of nail dystrophy (i.e. nail splitting and fragility)." "Relief of symptoms and signs" would likely be measured through patient diaries, clinical assessments (e.g., visual scores of nail integrity), or other objective measures of nail health. The document does not explicitly state the methodology.
The sample size for the training set
- Not applicable/Not provided. As this is not an AI/machine learning device, there is no "training set" in the conventional sense. If clinical studies were performed, the number of subjects in those studies would be the relevant "sample size," but this is not specified.
How the ground truth for the training set was established
- Not applicable/Not provided. As there is no training set for an algorithm, this question is not relevant. For the clinical studies mentioned, the "ground truth" (i.e., whether the treatment was effective) would be based on the pre-defined endpoints and measurement methodologies of those studies, which are not detailed.

In summary, the provided 510(k) summary for Ecocel® confirms its regulatory clearance based on substantial equivalence. However, it does not offer the granular detail on acceptance criteria, study methodologies, sample sizes, or ground truth establishment that would be present in a comprehensive study report, especially one for an AI or diagnostic device. The document states that the device's performance was substantiated by "preclinical studies" and "clinical studies," but the specifics of these studies are not disclosed in this summary.

Summary

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K083087

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Attachment I

510(k) Summarv

Trade Name:	Ecocel®
Sponsor:	Polichem S.A.50 Val FleuriLuxembourg 1526	AUG 07 2009
Contact:	Hari Nagaradona, PhDKendle International Inc.Rockville, MD 2-855Phone: 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:

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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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.

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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 (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:

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

Regulation Number and Section

§ 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.