The Medi Lift Mask is composed of a mask made of silicone 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 controller. The 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 is not operated during charging.

AI/ML Overview

This document is a 510(k) Summary for the Medi Lift Mask, a medical device. The information provided heavily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and performance data for a new AI/software-driven device.

Therefore, many of the requested categories for a study proving device performance against acceptance criteria for an AI-driven device cannot be extracted from this document, as the device is not an AI/software device and the clearance is based on substantial equivalence and minor material change, not a performance study of AI.

However, I will extract what is available and note what is not applicable or not provided.

Here's the breakdown based on the provided text:

Device Type: Transcutaneous Electrical Nerve Stimulator For Pain Relief (Aesthetic Purposes) – This is a hardware device, not an AI/software device.

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

The document does not present acceptance criteria for a performance study in the way an AI/software device submission would. Instead, it demonstrates equivalence to a predicate device. The "performance" described is in the context of safety and effectiveness, shown by:

Risk Analysis: Per ISO 14971:2019 (determined no new risks compared to predicate).
Biocompatibility Evaluation: Per ISO 10993-1:2018, with testing for Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2021), and Intracutaneous reactivity (ISO 10993-23:2021).
Prior Tests (Applicable to predicate, deemed still applicable to new device due to no relevant changes): Tensile strength, polycyclic aromatic hydrocarbons, software verification and validation, electrical stimulation outputs, electrical safety, and electromagnetic compatibility.

Acceptance Criteria Category	Reported Device Performance/Conclusion
Safety (Risk Profile)	Risk analysis per ISO 14971:2019 determined no new types of safety and effectiveness questions compared to the predicate due to the UV varnish change.
Biocompatibility	Met ISO 10993-1:2018 requirements, confirmed by: - Cytotoxicity per ISO 10993-5:2009 - Sensitization per ISO 10993-10:2021 - Intracutaneous reactivity per ISO 10993-23:2021
Effectiveness (Equivalence)	"The Medi Lift Mask has the same intended use and indications for use as the predicate device... Thus, the Medi Lift Mask is substantially equivalent."
Material Change Impact	The new UV varnish on the controller housing "does not raise different types of safety and effectiveness questions."

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

Sample Size for Test Set: Not applicable in the context of a clinical performance study for an AI algorithm. The testing described is primarily material and electrical safety/biocompatibility testing, which typically uses defined sample sizes for specific component tests as per standards, but a "test set" of patient data is not relevant here.
Data Provenance: Not applicable for patient data. The provenance of the testing conducted would be controlled laboratory conditions in Japan (where YA-MAN Ltd. is located).

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

Not applicable. This is not an AI diagnostic/prognostic device requiring expert-established ground truth from medical images or patient data.

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

Not applicable. No clinical test set requiring adjudication was used.

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. This is not an AI-assisted diagnostic device.

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

No. This is not an AI device.

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

Not applicable. The "ground truth" for this device revolves around established safety standards (ISO for biocompatibility, electrical safety) and the functional equivalence to the cleared predicate device.

8. The sample size for the training set

Not applicable. This device does not use a training set for machine learning.

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

Not applicable. This device does not use a training set for machine learning.

Summary of the K244048 Submission:

The provided text is an FDA 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (Medi Lift Mask). The submission seeks clearance based on substantial equivalence to a previously cleared predicate device (Medi Lift PLUS, K220198). The primary "change" is a different UV varnish material on the controller housing.

The testing performed and documented focuses on confirming that this minor material change does not introduce new safety or effectiveness concerns. This is demonstrated through:

Risk analysis (confirming no new risks).
Biocompatibility testing of the new material.
Reliance on prior testing of the predicate for aspects not affected by the material change (electrical safety, software, etc.).

Therefore, the document does not contain the information typically found in an FDA submission for an AI/software device that requires extensive clinical performance studies with defined acceptance criteria for AI model performance (e.g., sensitivity, specificity, accuracy against human readers or pathology).

Summary

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January 16, 2025

YA-MAN Ltd % Lina Kontos Partner Hogan Lovells US LLP 555 Thirteenth Street, NW Columbia Square Washington, District of Columbia 20004

Re: K244048

Trade/Device Name: Medi Lift Mask Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO Dated: December 31, 2024 Received: December 31, 2024

Dear Lina Kontos:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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

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assistance/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, Tushar Bansal -S

for Heather Dean, Ph.D. 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) K244048

Device Name Medi Lift Mask

Indications for Use (Describe)

The Medi Lift Mask 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 K244048

YA-MAN Ltd.'s Medi Lift Mask

Submitter

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

Date Prepared: December 31, 2024

Name of Device: Medi Lift Mask

Regulatory Classification: Class II, 21 CFR 882.5890

Product Code: NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes)

Predicate Device

510(k) Number: K220198 Trade Name: Medi Lift PLUS Manufacturer: YA-MAN Ltd. Product Code: NFO

Device Description

Intended Use/Indications for Use

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

Summary of Technological Characteristics

The Medi Lift Mask is a modification to the previously cleared Medi Lift PLUS (K220198). The devices have the same intended use and indications for use, and the technological characteristics

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of the Medi Lift Mask are nearly identical to that of the predicate device. The only difference is a change in the UV varnish material on the housing of the controllers.

The table below provides a comparison of the technological characteristics for the subject device and the predicate device.

	Subject Device:Medi Lift Mask	Predicate Device:Medi Lift PLUS (K220198)
Product Code	NFO	NFO
Regulation Number	21 CFR 882.5890	21 CFR 882.5890
OTC or Prescription Use	OTC	OTC
Indications for Use	The Medi Lift Mask is intended for facial stimulation and indicated for over-the-counter cosmetic use.	The Medi Lift PLUS is intended for facial stimulation and indicated for over-the-counter cosmetic use.
Intended Anatomical Position on the Face	Cheeks	Cheeks
Wearable or Handheld	Wearable	Wearable
Device Components	Silicone maskControllers with electrodesCharging accessories (USB cable and AC adaptor)	Silicone maskControllers with electrodesCharging accessories (USB cable and AC adaptor)
Number of Controllers (signal generators)	2	2
Number of Electrodes	3 per controller	3 per controller
Conductive Media	Water	Water
Power Source	Rechargeable 3.7 V Lithium-ion battery (1 per controller)	Rechargeable 3.7 V Lithium-ion battery (1 per controller)
Patient Leakage Current	Protection method: Type BF applied part	Protection method: Type BF applied part
Number of Output Modes	One treatment area / one mode	One treatment area / one mode
Number of Output Channels	2 per controller	2 per controller
Indicator Display	LED indicator lights	LED indicator lights
Timer Range	Fixed 10 minutes. The user cannot change the default setting.	Fixed 10 minutes. The user cannot change the default setting.
Weight	Controllers: 28 g eachSilicone mask: 120 gTotal: 176 g	Controllers: 28 g eachSilicone mask: 120 gTotal: 176 g
Dimensions [W x H x D]	Controllers: 90 x 55 x 20 mm eachMask: 615 x 170 mm	Controllers: 90 x 55x 20 mm eachMask: 615 x 170 mm
Electrode Area	$5.04 cm^2$ per electrode	$5.04 cm^2$ per electrode
Controller Housing Materials	ABS with a UV varnish	ABS with a UV varnish

Table 1: Comparison of Technological Characteristics
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Performance Data

To evaluate the modification, the following activities were performed:

. Risk analysis per ISO 14971:2019
. Biocompatibility evaluation per ISO 10993-1:2018 and testing of:
- Cytotoxicity per ISO 10993-5:2009 o
- Sensitization per ISO 10993-10:2021 o
- Intracutaneous reactivity per ISO 10993-23:2021 o

Since there were no changes to the silicone mask, software, electrodes, or other electrical components of the device, the risk analysis determined that the prior tests performed for the predicate device regarding tensile strength, polycyclic aromatic hydrocarbons, software verification and validation, electrical stimulation outputs, electrical safety, and electromagnetic compatibility remained applicable.

Conclusions

As shown above, the Medi Lift Mask has the same intended use and indications for use as the predicate device, the Medi Lift PLUS (K220198). The new UV varnish on the controller housing does not raise different types of safety and effectiveness questions, and risk analysis and biocompatibility testing shows that the Medi Lift Mask is as safe and effective as the predicate device. Thus, the Medi Lift Mask is substantially equivalent.

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).