KJ MASK

• K Number: K103019
• Device Name: KJ MASK
• Manufacturer: KJ MEDITECH CO., LTD
• Date Cleared: 2011-06-09 ( 240 days)
• Product Code: DZB
• Regulation Number: 872.5500
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: K923556
• Predicate For: N/A

Intended Use

KJ Mask is used as a treatment option for Class III malocclusions.

Device Description

KJ Mask (KM 102-S, KM 201-L) is a device made of materials such as aluminum alloy, stainless steel and plastic intended to be placed on face for the purpose of orthodontics. The device is constructed of four parts, a chip cup, forehead rest, cross bar and main frame. It is intended to exert orthopedic or orthodontic forces of the maxillary arch in order to effect a change in the position of the maxilla in relation to the mandible and other facial structures.

AI/ML Overview

The provided document, K103019 for the "KJ Mask", is a 510(k) Premarket Notification to the FDA. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and performance data in the same way a PMA (Premarket Approval) submission would.

Therefore, the document does not contain information on:

• A table of acceptance criteria and reported device performance (as defined by specific metrics like sensitivity, specificity, or accuracy).
• Sample sizes for test sets, data provenance, number or qualifications of experts, or adjudication methods for establishing ground truth for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Type of ground truth used (pathology, outcomes data, etc.) for a test set.
• Sample sizes for training sets or how ground truth for a training set was established.

Explanation of why this information is not present:

The 510(k) pathway, under which this device was submitted, focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparisons of:

• Indications for Use: The KJ Mask's indication is for "Class III malocclusions," which is compared to the predicate device's indication.
• Technological Characteristics: The document states, "KJ Mask and the predicate device consist of almost the same components. The similarity in design between KJ Mask and the predicate device supports the safety and effectiveness of KJ mask for the indicated use." This includes materials, design, and construction.
• Safety and Effectiveness: This is argued by drawing parallels to the predicate device, assuming the predicate's established safety and effectiveness extend to the new device due to their substantial similarity.

Since the device is an orthodontic face mask, not an AI/ML-driven diagnostic or therapeutic device, the concepts of "acceptance criteria" based on statistical performance metrics (like sensitivity, specificity), ground truth, training/test sets, MRMC studies, or standalone algorithm performance are not applicable to this 510(k) submission.

Summary based on the provided document:

The provided document describes the KJ Mask, an orthodontic face mask intended to treat Class III malocclusions. Its acceptance for marketing by the FDA was based on demonstrating substantial equivalence to a predicate device, the "ADP Face Mask by Ormco Corp. (K923556)".

1. Table of Acceptance Criteria and Reported Device Performance:

• Not applicable/Not present. The submission relies on substantial equivalence to a predicate device rather than performance against predefined statistical acceptance criteria.

2. Sample size used for the test set and the data provenance:

• Not applicable/Not present. No test set or clinical study data is reported for the KJ Mask itself in this 510(k) summary; the focus is on comparison to the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not present. No ground truth establishment is described for a test set.

4. Adjudication method for the test set:

• Not applicable/Not present.

5. 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/Not present. This device is not an AI-driven diagnostic system; it is a physical medical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable/Not present.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable/Not present.

8. The sample size for the training set:

• Not applicable/Not present.

9. How the ground truth for the training set was established:

• Not applicable/Not present.

Essentially, the "study" proving the device met the "acceptance criteria" in this context is the 510(k) submission process itself, which concluded that the KJ Mask is substantially equivalent to marketed predicate devices based on its design, materials, and intended use. The FDA's issuance of the 510(k) clearance acts as the "proof" that it meets the regulatory requirements for marketing, which, for this class of device, is substantial equivalence.

Summary

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K/03019

JUN - 9 2011

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510(k) Summary

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

Date: __ 09/29/2010 ___________________________________________________________________________________________________________________________________________________________________

• 1. Company making the submission

	Submitter
Name	KJ Meditech Co., Ltd.
Address	959-21 Daechon-dong, Buk-gu,Gwang-ju, 500-470,South Korea
Phone	[phone]
Fax	[phone]
Contact	Nam-goong San, Assistant Manager

• 2. U.S Agent/Contact Person
     LK Consulting Group 2341 W. Crescent Ave. # 3, Anaheim, CA 92801 Priscilla Juhee Chung Phone: [phone] Fax: [phone] Email: [e-mail]

:

3. Device

Trade Name: KJ Mask Common Name: Orthodontic Face Mask Classification Name: Extraoral Orthodontic Headgear Classification regulation: 21CFR872.5500 Product Code: DZB

• 2. Predicate Device:
     ADP Face Mask by Ormco Corp. (K923556)
• 3. Description:
     KJ Mask (KM 102-S, KM 201-L) is a device made of materials such as aluminum alloy, stainless steel and plastic intended to be placed on face for the purpose of

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orthodontics.

The device is constructed of four parts, a chip cup, forehead rest, cross bar and main frame. It is intended to exert orthopedic or orthodontic forces of the maxillary arch in order to effect a change in the position of the maxilla in relation to the mandible and other facial structures.

4. Indication for use:

KJ Mask is used as a treatment option for Class III malocclusions.

5. Basis for Substantial Equivalence

KJ Mask and the predicate device consist of almost the same components. The similarity in design between KJ Mask and the predicate device supports the safety and effectiveness of KJ mask for the indicated use.

KJ Mask is substantially equivalent to the predicate device in terms of indications, compositions, material, design, safety and effectiveness.

6. Conclusion

Based on the information provided in this premarket notification, KJ Meditech Co., Ltd. concludes that KJ Mask is safe, effective and substantially equivalent to the predicate devices as described herein.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Inside the circle is a stylized symbol that resembles a bird or a human figure with outstretched arms. The symbol is composed of three curved lines that create a sense of movement and dynamism.

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

KJ Meditech Company, Limited C/O Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group 951 Starbuck Street, Unit J Fullerton, California 92833

JUN - 9 2011

Re: K103019

Trade/Device Name: KJ Mask Regulation Number: 21 CFR 872.5500 Regulation Name: Extraoral Orthodontic Headgear Regulatory Class: II Product Code: DZB Dated: May 31, 2011 Received: June 3, 2011

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.

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Page 2- Ms. Chung

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 (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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

103619 510(k) Number (if known):

Device Name: KJ Mask

Indications For Use:

KJ Mask is used as a treatment option for Class III malocclusions.

Prescription Use ど (Per 21 CFR 801 Subpart D)

AND

Over-The Counter Use (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)

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number:	K103019
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Regulation Number and Section

§ 872.5500 Extraoral orthodontic headgear.

(a)
Identification. An extraoral orthodontic headgear is a device intended for use with an orthodontic appliance to exert pressure on the teeth from outside the mouth. The headgear has a strap intended to wrap around the patient's neck or head and an inner bow portion intended to be fastened to the orthodontic appliance in the patient's mouth.(b)
Classification. Class II.