Pobling MIITY 2 is a facial toning device and it is composed of main unit and adaptor. The micro-current is delivered to healthy facial skin through head of main unit to stimulate the face. The device is a battery-powered and hand-held device. There have heating and cooling function by pressing the button additionally.

AI/ML Overview

The document describes the acceptance criteria and supporting studies for the Pobling MIITY 2, a Transcutaneous Electrical Nerve Stimulator for facial stimulation. The primary study presented is a comparison with predicate devices to demonstrate substantial equivalence, rather than a standalone clinical trial or MRMC study.

Here's an breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate devices (Carol Cole Company, NuFACE® Plus, K103472 and Nu Skin Enterprises, Inc., NuSkin Facial Spa, K122711) across various technical characteristics and safety standards. The reported device performance is presented as a direct comparison in the table on page 4.

Feature	Acceptance Criteria (Implied by Predicate Performance)	Pobling MIITY 2 Performance
Regulation Number	21 CFR § 882.5890	21 CFR § 882.5890
Regulation Name	Transcutaneous Electrical Nerve Stimulator	Transcutaneous Electrical Nerve Stimulator
Regulatory Class	Class II	Class II
Product Code	NFO	NFO
Intended Use	Stimulate the face	Stimulate the face
Indication for Use	Over-the-Counter Cosmetic Use	Over-the-Counter Cosmetic Use
Power Source	Battery operated	Battery operated
Number output channels	1	1
Automatic shut off	Yes	Yes
Indicator Display (ON/OFF)	Yes	Yes
Indicator Display (Low-Battery)	Yes	Yes
On Time (seconds)	Constant	Constant
Off Time (seconds)	None	None
Compliance with Voluntary Standards	IEC 60601-1 / IEC 60601-1-2 / IEC 60601-1-11	IEC 60601-1 / IEC 60601-1-2 / IEC 60601-1-11
Mode	One to Five (Predicate NuSkin Facial Spa) / One (Predicate NuFACE® Plus)	Two
Waveform	Pulsed Monophasic (Predicate NuFACE® Plus) / Direct Current (Predicate NuSkin Facial Spa)	Direct
Maximum Output Voltage (@500Ω)	137mV (NuFACE® Plus); 188mV-184mV (NuSkin Facial Spa)	Mode1: 174mVMode2: 174mV
Maximum Output Voltage (@2kΩ)	769mV (NuFACE® Plus); 722mV-741mV (NuSkin Facial Spa)	Mode1: 710mVMode2: 710mV
Maximum Output Voltage (@10kΩ)	3.82V (NuFACE® Plus); 2.626V-3.787V (NuSkin Facial Spa)	Mode1: 3200mVMode2: 3200mV
Maximum Output Current (@500Ω)	274uA (NuFACE® Plus); 376uA-369uA (NuSkin Facial Spa)	Mode1: 350uAMode2: 350uA
Maximum Output Current (@2kΩ)	387uA (NuFACE® Plus); 361uA-373uA (NuSkin Facial Spa)	Mode1: 360uAMode2: 360uA
Maximum Output Current (@10kΩ)	383uA (NuFACE® Plus); 362uA-379uA (NuSkin Facial Spa)	Mode1: 320uAMode2: 320uA
Heating and Cooling	Not specified in predicates as primary function	Mode1: Heating (Temp. 41℃±3℃)Mode2: Cooling (Temp. 10℃±3℃)
Weight	9oz (NuFACE® Plus); 120g (NuSkin Facial Spa)	115g
Dimensions	3"x5.25"x1.25" (NuFACE® Plus); 143x31.2x67.5mm (NuSkin Facial Spa - Large)	150x500mm (unit)
Housing material and construction	Thermo Plastic (NuFACE® Plus); ABS, Chrome plate, ABS, rubber (elastomer) (NuSkin Facial Spa)	ABS

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

Sample Size: Not explicitly stated for specific tests beyond the overall device. The testing described for electrical safety, EMC, biocompatibility, technical characteristic, and thermal safety would involve a sample of the Pobling MIITY 2 device(s) itself.
Data Provenance: The document does not specify the origin (e.g., country) of the data for the tests. It refers to "our testing method" and compliance with international standards (IEC, ISO). The comparison data for the predicate devices would be from publicly available information or submissions related to those devices. The study is non-clinical performance assessment.

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

This information is not provided in the document, as the study is a non-clinical performance assessment comparing the device to predicates and demonstrating compliance with technical standards. There is no mention of experts establishing ground truth for a test set in the context of diagnostic performance or clinical outcomes.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided and is not applicable, as the study is a non-clinical performance assessment and not a reader study.

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:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is not an AI-assisted diagnostic tool, but rather a direct-action therapeutic (stimulating) device.

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

Yes, a standalone performance assessment was conducted for the Pobling MIITY 2 device, focusing on its technical characteristics, electrical safety, EMC, biocompatibility, and thermal safety. The device's performance was evaluated independently to ensure it met relevant standards and its characteristics were comparable to predicates. There is no algorithm involved; it's a hardware device.

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

The "ground truth" for the non-clinical performance tests was based on:

Compliance with international standards: IEC 60601-1, IEC 60601-1-2, ISO 10993.
Technical specifications: Measured output voltage and current values compared against the reported values of the predicate devices.
Functional verification: For heating and cooling properties.

There is no "expert consensus," "pathology," or "outcomes data" in the typical sense as this is a non-clinical technical and safety assessment for a device without a diagnostic or complex analytical function.

8. The sample size for the training set:

This information is not applicable as the device is a hardware product and does not involve AI or machine learning algorithms that require a training set.

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

This information is not applicable as there is no training set for this device.

Summary

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December 20, 2017

HABALAN Med & Beauty Co., Ltd c/o Peter Chung President Plus Global 300 Atwood Pittsburgh, Pennsylvania 15213

Re: K163550

Trade/Device Name: Pobling MIITY 2 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO Dated: December 7, 2017 Received: December 13, 2017

Dear Peter 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 or any Federal

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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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Vivek J. Pinto -S

for Carlos L. Peña. PhD. MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K163550

Device Name Pobling MIITY 2

Indications for Use (Describe)

The Pobling MITY 2 is intended for facial stimulation and is indicated for over-the counter cosmetic use.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92

1. Submitter's Information

1. Name : HABALAN Med & Beauty Co., Ltd
1. Address : 907, 219, Gasandigital 1-ro, Geumcheon-gu, Seoul, KOREA
1. Contact person : Mr. Peter Chung

300 Atwood Street Pittsburgh, PA 15213, USA

Tel : 412-512-8802

1. Date prepared : December, 05, 2016

2. Device Information

1. Trade/Proprietary Name : Pobling MIITY 2
1. Common Name : Facial Toning Device
1. Classification Name : Transcutaneous Electrical Nerve Stimulator
1. Device Class : Class II
1. Product Code : NFO
1. Regulation Number : 21 CFR 882.5890

3. Predicate Device

1. Carol Cole Company, NuFACE® Plus, K103472
1. Nu Skin Enterprises, Inc., NuSkin Facial Spa, K122711

4. Intended Use

The Pobling MIITY 2 is intended for facial stimulation.

5. Indication for Use

The Pobling MIITY 2 is indicated for over-the counter cosmetic use.

6. Device Description

7 Comparison with Predicate Device

The MITY 2 is identical with predicate devices for intended use and indications for use. It is

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Different Insight

used as same technological principle with predicate devices to accomplish its intended use. all are hand-held, battery powered device and the there is no new questions of safety and/or effectiveness.

The determination of substantial equivalence for the MITY2 is based on an assessment of non-clinical performance. This assessment included a comparison of the MIITY2 to that of predicate. The output performance testing included:

Maximum output voltaget
Maximum output current

Features	Subject Device	Predicate Device		Justification
	MIITY 2	NuFACE® Plus	NuSkin Facial Spa	—
510(k) Number	To be assigned	K103472	K122711	—
Regulation Number	21 CFR § 882.5890			Same
Regulation Name	Transcutaneous Electrical Nerve Stimulator			Same
Regulatory Class	Class II			Same
Product Code	NFO			Same
Intended Use	Stimulate the face			Same
Indication for Use	Over-the-Counter Cosmetic Use			Same
Power Source	Battery operated			Same
Number outputchannels	1			Same
Automatic shut off	Yes			Same
Indicator Display
1) ON / OFF?	Yes			Same
2) Low-Battery?	Yes			Same
On Time (seconds)	Constant			Same
Off Time (seconds)	None			Same
Compliance withVoluntary Standards	IEC 60601-1 / IEC 60601-1-2 / IEC 60601-1-11			Same
Mode	Two	One	One to Five	Similar
Wave form	Direct	Pulsed Monophasic	Direct Current	Same
Maximum OutputVoltage	@500ΩMode1: 174mVMode2: 174mV	@500Ω137mV	@500ΩMode1: 188mV(214mV)Mode2: 189mV(225mV)Mode3: 185mV(220mV)Mode4: 184mV(212mV)Mode5: 184mV(213mV)	Similar
	@2kΩMode1: 710mVMode2: 710mV	@2kΩ769mV	@2kΩMode1: 722mV(1527mV)Mode2: 746mV(812mV)Mode3: 735mV(815mV)Mode4: 740mV(802mV)Mode5: 741mV(801mV)	Similar
	Subject Device	Predicate Device		Justification
Features	MIITY 2	NuFACE® Plus	NuSkin Facial Spa	–
Maximum Output	@10kΩ	@10kΩ	@10kΩ	Similar
Voltage	Model: 3200mV	3.82V	Model: 2.626V(2.978V)
	Mode2: 3200mV		Mode2: 3.787V(4.011V)
			Mode3: 3.747V(4.014V)
			Mode4: 3.503V(3.980V)
			Mode5: 3.729V(3.980V)
Maximum Output	@500Ω	@500Ω	@500Ω	Similar
Current	Model: 350uA	274uA	Model: 376uA(427uA)
	Mode2: 350uA		Mode2: 379uA(449uA)
			Mode3: 371uA(440uA)
			Mode4: 368uA(424uA)
			Mode5: 369uA(427uA)
	@2kΩ	@2kΩ	@2kΩ	Similar
	Model: 360uA	387uA	Model: 361uA(763uA)
	Mode2: 360uA		Mode2: 373uA(406uA)
			Mode3: 367uA(407uA)
			Mode4: 370uA(401uA)
			Mode5: 370uA(400uA)
	@10kΩ	@10kΩ	@10kΩ	Similar
	Model: 320uA	383uA	Model: 362uA(398uA)
	Mode2: 320uA		Mode2: 379uA(401uA)
			Mode3: 375uA(401uA)
			Mode4: 350uA(398uA)
			Mode5: 373uA(398uA)
Heating and Cooling	Model: Heating			Minor
	(Temp. 41℃±3℃)			function
	Mode2: Cooling
	(Temp. 10℃±3℃)
Weight	115g	9oz	120g (approx. 4oz)	–
			Facial Spa with Large
Dimensions	150 x 500unit : mm	3" x 5.25" x 1.25"	143 x 31.2 x 67.5 mm
			(5.6" x 1.2" x 2.7")
			Facial Spa with Small
			136 x 31.2 x 67.5 mm
			(5.4" x 1.2" x 2.7")
Housing material	ABS	Thermo Plastic	ABS, Chrome plate	-
and construction			ABS, rubber (elastomer)

TABLE : Comparison of MIITY 2 with predicate devices

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The heating and cooling are not a major function to be used as accomplished its intended use as stimulator. That are minor for distinguishing the mode. And also conducted the performance data. Therefore, all the difference don't affect the safety and effectiveness which is concluded after all the required testing, So no safety and effectiveness issues relating to the MIITY2

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8. Performance Data

The following performance data were provided in support of the substantial equivalence determination 1) Electrical Safety and Electromagnetic compatibility(EMC)

Electrical safety and EMC testing were conducted on MITY2, it comples with the IEC 60601-1:2005 +am1:2002 for safety and the IEC 60601-1-2:2007 standard for EMC.

1. Biocompatibility Testing
  The biocompatibility evaluation for the contact part with healthy facial skin of MIITY2 was conducted in accordance with the ISO 10993, Cytotoxicity, Skin Sensitization and Skin Irritation testing, it was considered contacting part and duration (Tissue contacting, Duration of less than 24hours)
1. Technical characteristic testing
  To show the technical characteristic testing about Transcutaneous Electrical Nerve Stimulator, the test was conducted in our testing method.
1. Thermal Safety testing
  The device have the heating and cooling function with stimulation. To verify the heating and cooling properties, we performed the testing in our testing method.
1. Clinical data
  Not applicable

9. Conclusion

The fundamental technology to be accomplished its intended use in view of technological and operational characteristics between MITY2 and predicate device is same. Non-clinical performance as documented support the safety and effectiveness are similar to the predicate device. In other words, the MIITY2 is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).