The Medi Lift PLUS is composed of a mask made of silcone rubber which is worn on the lower part of the user's face, and covers the user's cheeks and nose. The mask contains two controllers with electrodes, which are attached to the mask. These controllers and electrodes deliver electrical pulses to stimulate facial muscles. The controllers are operated independently by pressing buttons on each controllers attached to the mask contain two charging pins which allows for the built-in Lithium-ion battery that powers the device to be charged using a USB charging cable and an adapter that is provided as part of the device. The device is not operated during charging.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of diagnostic or screening performance (e.g., sensitivity, specificity, accuracy). Instead, it's a 510(k) summary for a medical device (Medi Lift PLUS) and focuses on establishing substantial equivalence to a predicate device.

The "Performance Data" section lists several compliance standards (e.g., IEC, ISO) and tests (e.g., chemical characterization, tensile strength, electrical output, software verification). These are typically related to safety, electrical performance, biocompatibility, and manufacturing quality, rather than clinical efficacy or diagnostic accuracy.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth used, training set sample size, ground truth for training set) are not applicable or cannot be extracted from this document, as they pertain to clinical performance studies, which are not detailed here.

However, I can provide information based on the available text regarding the characteristics of the device and its safety/performance testing in a regulatory context.

Here's an attempt to answer the questions based only on the provided text, noting its limitations:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative "acceptance criteria" for clinical performance (e.g., a specific improvement percentage in facial stimulation) or directly report "device performance" in that context. Instead, it lists standards the device was assessed against, which imply that compliance with these standards is the "acceptance criterion" for regulatory approval of substantial equivalence.

Acceptance Criteria (Implied by Standards Compliance)	Reported Device Performance (Compliance)
IEC 60601-1-2:2014 (Electromagnetic compatibility)	Assessed in accordance with standard
ANSI AAMI ES60601-1:2005 (Basic safety and essential performance)	Assessed in accordance with standard
IEC 60601-1-11: 2015 (Home healthcare environment)	Assessed in accordance with standard
IEC 60601-2-10:2012 (Nerve and muscle stimulators)	Assessed in accordance with standard
ISO 10993-5:2009 (Cytotoxicity)	Assessed in accordance with standard
ISO 10993-10:2010 (Irritation and skin sensitization)	Assessed in accordance with standard
ISO 10993-18:2020 (Chemical characterization)	Assessed in accordance with standard
Tensile strength of the mask	Assessed
Electrical output of the Medi Lift PLUS	Assessed
Software verification and validation	Assessed

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The listed performance data relates to engineering and biocompatibility testing, not human clinical trials with a test set of patients or subjects.

3. 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)

This information is not provided. "Ground truth" in the context of facial stimulation for cosmetic use is not typically established by experts in the same way it would be for a diagnostic medical device (e.g., diagnosis of disease). The document focuses on safety and technical specifications.

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

Not applicable, as no clinical test set requiring adjudication of "ground truth" is described.

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. The Medi Lift PLUS is a transcutaneous electrical nerve stimulator for cosmetic facial stimulation, not an AI-assisted diagnostic or screening device involving human "readers."

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

Not applicable. This device is not an algorithm, but a physical electrical stimulator.

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

Not applicable for clinical efficacy in the sense of comparing against a definitive medical diagnosis. The "ground truth" in this context would be compliance with the performance specifications of the device itself and safety standards.

8. The sample size for the training set

Not applicable. The Medi Lift PLUS is not an AI/ML device that requires a training set.

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 28, 2023

YA-MAN Ltd % Jonathan Kahan Regulatory Counsel Hogan Lovells US LPP 555 Thirteenth Street NW Washington, District of Columbia 20004

Re: K220198

Trade/Device Name: Medi Lift PLUS Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NFO Dated: June 26, 2023 Received: June 26, 2023

Dear Jonathan Kahan:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/5 description: The image shows the name "Tushar Bansal -S" in a large, sans-serif font. The text is black and stands out against a white background. The letters are evenly spaced, and the overall impression is clean and legible. The image appears to be a cropped section of a larger document or presentation.

for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220198

Device Name Medi Lift PLUS

Indications for Use (Describe)

The Medi Lift PLUS is intended for facial stimulation and 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

YA-MAN Ltd's Medi Lift PLUS

Submitter

YA-MAN 2-4-2 Toyo, Koto-ku, Tokyo, 1350016 JAPAN Phone: +81-3-5665-7321 Facsimile: +81-5665-7370 Contact Person: Jun Takada

Date Prepared: June 28, 2023

Name of Device: Medi Lift PLUS

Common or Usual Name: Stimulator, Transcutaneous Electrical, Aesthetic Purposes

Regulatory Class: Class II

Product Code: NFO

Predicate Device

510(k) Number: K120511 Trade Name: Ageless Wonder Facial Muscle Stimulation System Manufacturer: Leto Enterprise Ltd Product Code: NFO

Reference Device

510(k) Number: K103031 Trade Name: BMR face Manufacturer: Bio-Medical Research, Ltd. Product Code: NFO

Device Description

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Intended Use / Indications for Use

The Medi Lift PLUS is intended for facial stimulation and indicated for over-the-counter cosmetic use.

Summary of Technological Characteristics

The intended use of the Medi Lift PLUS is identical to that of the predicate device, namely both devices are indicated for over the counter facial stimulation, and use the same technology of energy delivered through electrodes placed on the user's face.

The output waveform of the Medi Lift PLUS is Symmetric Pulsed biphasic and quadphasic, and the maximum output voltage of the Medi Lift PLUS is in the range of the that of the predicate device. The maximum output current of the Medi Lift PLUS is higher than the predicate device, but that is lower than the reference device.

The differences regarding main output specifications between Medi Lift PLUS device and the predicate or reference devices do not raise new or different questions of safety and effectiveness.

A table comparing the key features of the subject and predicate devices is provided below.

Characteristics	Medi Lift PLUS	Predicate DeviceAgeless Wonder(K120511)	Reference DeviceBMR face(K103031)
Product code	NFO	NFO	NFO
Regulation Number	21 CFR 882.5890	21 CFR 882.5890	21 CFR 882.5890
OTC or Prescriptiveuse	OTC	OTC	OTC
Intendeduse	The Medi Lift PLUS isintended for facialstimulation andindicated for over-the-counter cosmetic use.	Ageless Wonder FacialToning Device isintended for facialstimulation andindicated for over-the-counter cosmetic use.	BMR Face. Type371/372, is a facialtoning product whichdelivers electricalstimulation to the facefor cosmetic use.
Intended anatomicalposition in the face	Cheeks	Cheeks (headset)/Forehead, Chin andjawline, under eye area(handheld)	Cheeks
Wearable or handheld	Wearable	Wearable andHandheld	Wearable
Operation of the device	A user attaches twocontrollers to the rightand left sides of thesilicone mask so thatthe silicone mask holdsthe controllers. Theuser moistens cheekswith tap water andthen wears the	A user attaches theconductive spongesonto the twoapplication wands andwets the sponges. Thewands are applied tothe headset. The userfits the headset to theface. The wands with	A user attaches the gelpads to the twopaddles of the headsetand fits the headset tothe face. The paddleswith gel pads deliverelectrical impulsesfrom the controller tothe face. The headset
Characteristics	Medi Lift PLUS	Predicate DeviceAgeless Wonder(K120511)	Reference DeviceBMR face(K103031)
	silicone mask whichcovers lower part ofthe user's face. Thesilicone mask isadjusted to positions ofuser's eyes, nose, andmouth. The user fixesthe mask with a hookand loop fastener inthe distal parts of themask. The controllershave electrodes whichdeliver electricalimpulses to thecheeks. Also, thecontrollers have +/ONbutton for turning onthe device andincreasing intensityand -/OFF button forturning off the deviceand decreasingintensity. The useroperates the deviceusing the controllers.	wet sponges deliverelectrical impulsesfrom the controller tothe face. The headsetis connected to thecontrol unit which hasON/OFF button,increase or decreaseintensity on bothwands of the headset,mode button, anddisplay. The useroperates the deviceusing the control unit.The user can hold thewands with the handsand place and operatethe device on theforehead, the chin andjawline, and under eyearea.	is connected with thecontrol unit which hasON/OFF/pause button,increase or decreaseintensity on the left andright sides of theheadset, informationbutton, program buttonand display. The useroperates the deviceusing the control unit.
Number of Controller(signal generator)	2	1	1
Conductive Media	Water	Water	N/A because thereference devicecontains gel pads.
Power source	One 3.7 V Lithium ionbattery/one signalgenerator	Two of 1.5 V AAAbattery	3.6V NiMHrechargeable batterypack
Patient LeakageCurrent	Protection method:Type BF applied part	Protection method:Type BF applied part	Not applicable, no lineconnection, no ACcharger connection oroperation. Connectionmethod does not allowAC chargerconnection.Normal condition: 0µASingle fault condition:0µA
Number of OutputModes	One treatment area /one mode	One treatment area/one mode x 6treatment areas	One treatment area/Three treatmentmodes
Number of OutputChannels	2/ one controller	1	2
Characteristics	Medi Lift PLUS	Predicate DeviceAgeless Wonder(K120511)	Reference DeviceBMR face(K103031)
Timer Range (minutes)	Fixed 10 minutes. Theuser cannot changethe default setting.	5 – 20 minutes. Theuser can select thetreatment time form 5,10, 15, or 20 minutes.	20 minutes for program1,10 minutes for program2,20 minutes for program3/The user cannotchange the defaultsetting.
Compliance withVoluntary Standards	IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-10ISO 10993-5ISO 10993-10	IEC 60601-1IEC 60601-1-2IEC 60601-2-10ISO 10993-5ISO 10993-10	IEC60601-1IEC 60601-2-10IEC 60601-1-2Battery chargerIEC60950 and UL1950
Weight	28 g / one controller,Silicone mask 120 g:Total 176 g	90 g (including aheadset)	63 g
Dimensions [W x H xD]	Controller 90 x 55x 20(mm)Mask 615 x 170 (mm)	98.5x 53 x 27.5 (mm)	6.0 x 8.0 x 2.1 (cm)
Housing Materials andConstruction	ABS	Unknown	ABS

Table 7-1: Comparison Table For Basic Technological Characteristics

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The following Table 7-2 shows the comparison between the output specification of the Medi Lift PLUS, the predicate and the reference devices.

Specification	Medi Lift PLUS	Predicate DeviceAgeless Wonder(K120511)	Reference DeviceBMR Face(K103031)
Waveform	Symmetric PulsedBiphasic andQuadphasic	Unknown	Pulsed, symmetric,biphasic
Shape	Rectangular pulses	Unknown	Rectangular, withinterphase interval
Maximum OutputVoltage	39.3 Vpp @500Ω(+/- 20%)	0 to 51V (0-1000Ω)	Output-Peak voltage15.1 V@500Ω60.6V @2kΩ30.3 V@10KΩ(+/- 10%)
Maximum OutputCurrent	3.22 mA@500Ω (+/-20%)	0 to 43.2μA (0to1000Ω)	Output-Peak current30.2 mA@500Ω30.3 mA@2kΩ3.0 mA@10kΩ(+/- 10%)
Specification	Medi Lift PLUS	Predicate DeviceAgeless Wonder(K120511)	Reference DeviceBMR Face(K103031)
Pulse Width	152/168/192 µs ±10%(@2.5-100Hz), 52µs±10%(@ 1kHz)	150 µs	300 µS max (bothphase + 100 µSinterphase delay)
Frequency (Hz)	2.5Hz, 5 Hz, 6Hz, 7Hz,8Hz, 9Hz, 10 Hz, 20Hz, 25 Hz, 33 Hz, 50Hz, 66 Hz, 100Hz, 1 kHz	Unknown	70Hz, 80Hz
For interferentialmodes only:- Beat Frequency (Hz)	NA	NA	NA
For multiphasicwaveforms only:- Symmetrical phases?	Yes	Unknown	Yes
- Phase Duration(include units)(state range, ifapplicable)(both phases, ifasymmetrical)	38/42/48 µs ±10%(@2.5-100Hz), 26µs±10%(@ 1kHz)	Unknown	80-100μSsymmetrical
Net Charge (mC perpulse)	0	Unknown	0@500ΩSymmetric, biphasicand leading polarityalternates for eachsuccessive pulse
Maximum PhaseCharge, (mC)	0.084µC@500Ω	Unknown	3.0 µC@500Ω
Maximum CurrentDensity, (mA/cm²)	0.64 mA/cm²@500Ω=3.22 mA@1kHz / 5.04cm² (area of aelectrode. All 6electrode of the deviceare the same size)	Unknown	0.4 mA/cm²@ 500Ω
Maximum PowerDensity, (W/cm²)The maximum powerdensity should be lessthan 0.25 Watts/cm2 toreduce the risk ofthermal burns.	I²×R = (0.00322)²×500=0.0052 Watts = 5.2mW0.0052 /5.04 = 0.0010W/ cm²	Unknown	0.34mW/cm²@ 500Ω
ON Time (seconds)	0.2 to 16 seconds(Depending on thepattern of output andthe intensity level)	Unknown	Unknown
OFF Time (seconds)	1 to 4 seconds(Depending on thepattern of output)	Unknown	Unknown

Table 7-2 Comparison of The Output Specification

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Performance Data

The Medi Lift PLUS device was assessed in accordance with the following standards:

. IEC60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests.
. ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text)
. Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD).
. IEC 60601-1-11: 2015, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
IEC 60601-2-10:2012, AMD1:2016, Medical electrical equipment Part 2-10: Particular ● requirements for the basic safety and essential performance of nerve and muscle stimulators.
ISO10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro . cytotoxicity.
ISO 10993-10:2010, Biological evaluation of medical devices Part 10: Tests for irritation . and skin sensitization.
· Chemical characterization with targeted analysis for polycyclic aromatic hydrocarbons, according to ISO 10993-18:2020
Tensile strength of the mask
· Electrical output of the Medi Lift PLUS
Software verification and validation

Conclusions

The Medi Lift PLUS is as safe and effective as the predicate device. The Medi Lift PLUS has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. In addition, the minor technological differences between the Medi Lift PLUS and its predicate device raise no new issues of safety or effectiveness. Thus, the Medi Lift PLUS is substantially equivalent to the predicate device.

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).