CLEANE / CLEANE POP by MEDICON CO., LTD.

The CLEANE and the CLEANE POP are potable had-held devices that produce accurately controlled low level sustained heat for use in treating mild to moderate acne. The devices are designed to treat individual acne blemishes for 2 1/2 minutes at a preset temperature. The treatment tip is made from a biocompatible material and delivers the specific low-level heat to the individual acne blemish.

AI/ML Overview

The provided text describes a 510(k) submission for the CLEANE and CLEANE POP acne treatment devices. This is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a predicate device, not necessarily to prove it meets specific performance criteria in the same way a clinical trial for a new drug might.

Therefore, the information requested in your prompt regarding acceptance criteria and a study proving those criteria are met is not explicitly detailed in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence, not on establishing and meeting acceptance criteria for device performance.

However, I can extract the available performance data and contextualize it within the framework of a 510(k) submission.

Here's an analysis based on the provided text, highlighting what is and is not present:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit acceptance criteria with numerical targets (e.g., "device must reduce acne by X% within Y weeks") are not provided in this 510(k) summary. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than defining new performance metrics or conducting extensive new clinical efficacy studies.

The performance aspects discussed are related to safety, usability, and regulatory compliance.

Performance Aspect	Description from Submission	Relevance to "Acceptance Criteria" (in a 510(k) context)
Biocompatibility	Tested in accordance with ISO 10993. "The tip material is considered biocompatible."	Implies meeting the pass/fail criteria of ISO 10993.
EMI/EMC	Tested in accordance with IEC 60601. "They operate within the EMI emission, susceptibility and static discharge levels specified in the IEC 60601 standard."	Implies meeting the pass/fail criteria of IEC 60601.
Self-Selection Study	Conducted to ensure usability of lay users. "Majority of study participants were able to properly self-select themselves using the box labeling."	Implies a high percentage of users successfully understood labeling for self-selection. No specific percentage is given as an "acceptance criterion."
Labeling Comprehension Study	Conducted to ensure usability of lay users. "Majority of study participants were able to properly use the device by reading the instructions for use without any assistance."	Implies a high percentage of users successfully operated the device based on instructions. No specific percentage is given as an "acceptance criterion."
Efficacy (Acne Treatment)	Indicated for "treatment of individual acne pimples in persons with mild to moderate inflammatory acne."	The 510(k) relies on the predicate device's established efficacy for this claim, rather than providing new clinical efficacy data for this device. No specific efficacy "acceptance criteria" or performance data for acne reduction are presented for this device itself.

2. Sample Size for the Test Set and Data Provenance

Test Set Sample Size:
- For biocompatibility and EMI/EMC testing, explicit sample sizes are not mentioned. These typically involve a small number of test units.
- For the Self-Selection Study and Labeling Comprehension Study, the sample size is not specified. The text only states "majority of study participants."
Data Provenance: The text does not specify the country of origin for the studies mentioned (biocompatibility, EMI/EMC, self-selection, and labeling comprehension). It is assumed to be part of the manufacturer's testing (MEDICON Co., Ltd. in South Korea). The studies are inherently prospective as they were conducted to support this 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth

This information is not provided in the summary. For studies like biocompatibility or EMI/EMC, the "ground truth" is determined by established laboratory standards and measurements, not by expert consensus on clinical outcomes.
For the self-selection and labeling comprehension studies, "ground truth" would likely refer to objective observation of user behavior and their ability to follow instructions/select correctly. This wouldn't typically involve "experts" in the clinical sense, but rather usability specialists or study administrators.

4. Adjudication Method for the Test Set

This is not applicable or mentioned. Adjudication methods (like 2+1 or 3+1) are typically used in clinical trials where there's a subjective assessment of outcomes (e.g., disease diagnosis/severity by multiple clinicians). The performance data cited in this 510(k) (biocompatibility, EMI, usability) do not involve such subjective clinical assessments requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done or mentioned. This type of study is relevant to diagnostic imaging devices where AI assists human readers. The CLEANE/CLEANE POP is an acne treatment device, not a diagnostic device.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The CLEANE/CLEANE POP is a physical device, not an algorithm. Its performance is inherent to its physical operation (heat delivery). While there's no "algorithm," the device operates independently without human intervention during the 2.5-minute treatment once activated.

7. Type of Ground Truth Used

Biocompatibility: In vitro and in vivo test results against ISO 10993 standards (e.g., cytotoxicity, irritation, sensitization).
EMI/EMC: Measured emissions and susceptibility data compared to limits defined in IEC 60601.
Self-Selection/Labeling Comprehension: Objective observation of user behavior and task completion, likely based on predefined success criteria (e.g., correctly answering questions about the label, successfully activating the device).
Efficacy (Acne Treatment): For the predicate device, efficacy would have been established through clinical trials. For this 510(k), the ground truth for efficacy is effectively the established efficacy of the predicate device, which this device claims substantial equivalence to. No new efficacy "ground truth" for this specific device is generated or presented.

8. Sample Size for the Training Set

Not applicable. The CLEANE/CLEANE POP is not an AI/machine learning device that requires a "training set."

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of device.

Summary of Device Performance (Based only on the provided text):

The CLEANE and CLEANE POP devices perform as follows:

Their tip material is biocompatible according to ISO 10993 standards.
They comply with EMI/EMC standards (IEC 60601) for emission, susceptibility, and static discharge.
A majority of lay users can properly self-select themselves using the device's box labeling.
A majority of lay users can properly use the device by following the instructions for use without assistance.

The 510(k) submission relies on these safety and usability tests, as well as the principle of substantial equivalence to the predicate device (Zeno by Tyrell, Inc.), to support its indication for treating mild to moderate inflammatory acne. It does not present new, specific clinical efficacy data or defined "acceptance criteria" for acne reduction from a new study on this device.

Summary

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111/34/

510(k) Summary

FEB 2 9 2012

This summary of 510(K) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: __ 02/28/2012

1. Company making the submission

	Submitter
Name	MEDICON Co., Ltd.
Address	1642-5 Donghwa-Ri, Munmak-Eup, Gangwon T.P 204-205Wonju-Si, Gangwon-Do, South Korea
Phone	+82-33-743-1291
Fax	+82-33-743-1287

1. U.S Agent/Contact Person
  LK Consulting Group 951 Starbuck St. Unit J, Fullerton, CA 92833 Priscilla Chung Phone: 714-869-3080 Fax: 714-409-3357 Email: info@LKconsultinggroup.com

Device

Trade Name: CLEANE / CLEANE POP Common Name: Acne Treatment Device Classification: Class II Classification regulation: 21 CFR890.5740 Product Code: OZC

1. Predicate Device:
  Zeno by Tyrell, Inc. (K043377)

Description:

510(k) Submission.

510(k) summary , 1 / 2 page

P. 1 Az

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a preset temperature. The treatment tip is made from a biocompatible material and delivers the specific low-level heat to the individual acne blemish.

Indication for use:

CLEANE and CLEANE POP are indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

Performance Data

Biocompatibility testing of the tip material was conducted in accordance with ISO 10993 Biological Testing of Medical and the tip material is considered biocompatible.

CLEANE and CLEANE POP were tested for EM1 in accordance with the IEC 60601. They operate within the EMI emission, susceptibility and static discharge levels specified in the IEC 60601 standard.

Self selection study and labeling comprehension study were conducted to ensure usability of lay users. The performance data supplied in this 510K demonstrated that the majority of study participants were able to properly self-select themselves using the box labeling and were able to properly use the device by reading the instructions for use without any assistance.

Basis for Substantial Equivalence

Upon reviewing the safety and effectiveness information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the CLEANE and the CLEANE POP are determined by Medicon Co., Ltd. to be substantially equivalent to the predicate device.

510(k) Submission.

. P, 2/2

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

FEB 2 9 2012

Medicon Co., Ltd. % LK Consulting Group Ms. Priscilla Chung 951 Starbuck Street, Unit J Fullerton, California 92833

Re: K111341

Trade/Device Name: CLEANE / CLEANE POP Regulation Number: 21 CFR 890.5740 Regulation Name: Powered heating pad Regulatory Class: Class II Product Code: OZC Dated: February 01, 2012 Received: February 06, 2012

Dear Ms. Chung:

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

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Page 2 -- Ms. Priscilla Chung

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 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.htm.

Sincerely yours,

Mark N. Malkerson

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

510(k) Number (if known): _ k | | | 3 4 | ____________________________________________________________________________________________________________________________________

CLEANE / CLEANE POP Device Name:

Indications for Use:

The CLEANE and the CLEANE POP are indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

Prescription Use (Per 21 CFR 801 Subpart D)

AND/OR

Over-The Counter Use V (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEE DED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111341

Regulation Number and Section

§ 890.5740 Powered heating pad.

(a)
Identification. A powered heating pad is an electrical device intended for medical purposes that provides dry heat therapy for body surfaces. It is capable of maintaining an elevated temperature during use.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E part 807 of this chapter subject to § 890.9.