The LIPOcel delivers High Intensity Focused Ultrasound (HIFU) energy that can disrupt the Subcutaneous Adipose Tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect. The LIPOcel is specifically indicated for non-invasive waist circumference reduction.

Device Description

LIPOcel, the Subject Device, is a medical device indicated for non-invasive waist circumference reduction. It consists of a control unit, Touch LCD monitor, power supply unit, and driver unit for irradiation and for setting parameters after the main power and key switch is turned on. The ultrasound energy that is generated from the pulse generator operates the HIFU transducer, and is irradiated from the cartridge when the footswitch or the finger switch on the handpiece is pressed in the READY state and the energy is delivered into the target tissue. HIFU energy is irradiated based on linear scanning method through the hand-piece depending on irradiation energy, irradiation spacing and irradiation distance, that are set in advance by the user. The Subject Device's L13 Cartridge uses the focused ultrasound energy to focus from the transducer onto the fat layer at a depth of 13mm from the surface of the skin. As a result, tissue temperature rises over 55°C and thermal coagulation occurs. Using thermal effects generated by the HIFU transducer, cellular disruption of the subcutaneous adipose tissue occurs. This thermal coagulation results in the contraction of the collagen and subsequently results in destruction of the adipose tissue. The destroyed adipose tissue is cleared via an inflammatory response.

AI/ML Overview

Here's an analysis of the provided text to extract the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the device's performance in terms of waist circumference reduction. It does not explicitly state pre-defined acceptance criteria in a quantitative format for the primary effectiveness endpoint (waist circumference reduction). However, it reports the study outcome, which implicitly serves as the performance achieved.

Acceptance Criteria (Implied)	Reported Device Performance
Significant waist circumference reduction	Mean waist circumference reduction of 3.05 ± 5.95 cm (p<0.0001) from baseline at 12 weeks follow-up.
Acceptable safety profile	Adverse events reported: erythema, ecchymosis, and dysesthesia. All resolved during the course of the study without treatment. No serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) related to treatment.
Acceptable patient tolerance	Mean pain score for the treated population was 7.35.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: The document does not explicitly state the number of subjects in the clinical study. It refers to "the subjects" and "the treated population" but doesn't give a specific 'n'.
Data Provenance: Prospective, single-center study conducted at UltraLaser Center, Monterrey, Mexico.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

The document describes a clinical study for waist circumference reduction, which uses objective physical measurements (waist circumference) as the primary endpoint. This generally does not involve "experts" establishing a subjective ground truth in the same way an imaging study would require radiologists. The measurements would typically be taken by trained clinical staff. No specific number of experts or their qualifications are mentioned for establishing the ground truth of waist circumference measurements.

4. Adjudication Method (for the test set):

Since the primary endpoint is waist circumference reduction, which is an objective measurement, an adjudication method for subjective interpretation (like 2+1 or 3+1 for imaging reads) is not applicable or described. Data collection and analysis would follow standard clinical trial protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The study described is a clinical trial evaluating the device's effectiveness in reducing waist circumference and its safety, not comparing human readers' performance with and without AI assistance.

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

This question is not applicable to the LIPOcel device. The LIPOcel is a medical device that delivers High-Intensity Focused Ultrasound (HIFU) energy to disrupt subcutaneous adipose tissue for non-invasive waist circumference reduction. It is not an AI algorithm or software that performs diagnostic or interpretive tasks. The study evaluates the physical device's direct therapeutic effect on patients.

7. The Type of Ground Truth Used:

The ground truth used for effectiveness was objective physical measurements (waist circumference reduction) from patients treated with the device. Safety was assessed through the reporting of adverse events and participant pain scores.

8. The Sample Size for the Training Set:

This question is not applicable. The LIPOcel is a physical medical device, not an AI algorithm that requires a "training set." The clinical study evaluated the device's performance directly on patients.

9. How the Ground Truth for the Training Set was Established:

This question is not applicable, as there is no "training set" for an AI algorithm.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 18, 2019

Jeisys Medical, Inc. % Parul Chansoria Regulatory Consultant Elexes Medical Consulting 6494 Tralee Village Dr. Dublin, California 94568

Re: K181896

Trade/Device Name: LIPOcel Regulation Number: 21 CFR 878.4590 Regulation Name: Focused Ultrasound Stimulator System for Aesthetic Use Regulatory Class: Class II Product Code: OHV Dated: September 19, 2019 Received: September 19, 2019

Dear Parul Chansoria:

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.

{1}------------------------------------------------

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 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 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-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.

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K181896

Device Name LIPOcel

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) SUMMARY

I. SUBMITTER

Jeisys Medical Inc., 307, Daeryung Techno Town 8th Gamasan-ro 96, Geumcheon-Gu, Seoul, Republic of Korea

Contact Person: Parul Chansoria Founder and CEO, Elexes Medical Consulting Telephone: 650-528-2445 E-mail: parul@elexes.com

Summary Prepared: July 10, 2018

FDA Establishment registration number: 3006985163

II. DEVICE

Common/Usual Name: Focused Ultrasound Stimulator System for Aesthetic Use Trade Name: LIPOcel Regulation Name: Focused Ultrasound Stimulator System for Aesthetic Use Regulatory Class: Class II Classification Panel: General and Plastic Surgery Devices Product Code: OHV Regulation Number: 21 CFR 878.4590

III. PREDICATE DEVICE

The LIPOcel is substantially equivalent to the following cleared device:

Table 1: Predicate Device

Company	Product	510(k) Number
Solta Medical Inc.	LipoSonix System Model 2	K112626

IV. DEVICE DESCRIPTION

{4}------------------------------------------------

based on linear scanning method through the hand-piece depending on irradiation energy, irradiation spacing and irradiation distance, that are set in advance by the user. The Subject Device's L13 Cartridge uses the focused ultrasound energy to focus from the transducer onto the fat layer at a depth of 13mm from the surface of the skin. As a result, tissue temperature rises over 55°C and thermal coagulation occurs. Using thermal effects generated by the HIFU transducer, cellular disruption of the subcutaneous adipose tissue occurs. This thermal coagulation results in the contraction of the collagen and subsequently results in destruction of the adipose tissue. The destroyed adipose tissue is cleared via an inflammatory response.

V. INDICATIONS FOR USE

VI. TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The key technological characteristics, such as the energy type and the operating principle of the Subject Device are equivalent to that of the Predicate Device. Also, the Subject and Predicate Device have similar indications for use. The only differences between them are the treatment area and the treatment line numbers.

Parameter	Subject DeviceLIPOcel	Predicate 1LipoSonixSystem Model 2	Remark
Energy Source	HIFU energy	HIFU energy	Same as thePredicate Device
Frequency ofUltrasound energy	2 MHz	2 MHz	Same as thePredicate Device
Maximum powerdelivered to thepatient	60 J/cm²	60 J/cm²	Same as thePredicate Device
Cartridge Focallength	13 mm	13 mm	Same as thePredicate Device
Duty Rate	50 %	50%	Same as thePredicate Device
Treatment line	16 line	24 line	Different.

Table 2: Basic Technology Comparison

{5}------------------------------------------------

			This differencedoes not affectthe safety andefficacyof the device.
Treatment line/sec	20.19 mm/sec	20.19 mm/sec	Same as thePredicate Device
Space betweeneachline	2 mm	2 mm	Same as thePredicate Device
Treatment area	30 x 30 (mm)	46 x 46 (mm)	Different.This differencedoes not affectthe safety andefficacyof the device.
Treatment Time	60 min	60 min	Same as thePredicate Device

VII. NON-CLINICAL STUDY

Electrical, mechanical, and performance testing were performed in accordance with IEC 60601-1:2005 + AMD1:2012/ EN 60601-1:2006 + A1:2013, IEC 60601-1-2:2007/ EN 60601-1-2:2007, IEC 60601-1-6:2010 + AMD1:2013/ EN 6061-1-6:2010 + A1:2015, IEC 60601-2-62:2013/ EN 60601-2-62:2015, and IEC 6255:2013. All test results were satisfactory. Refer to EMC and ES test reports in Section 17 Electromagnetic Compatibility and Electrical Safety of this submission document.

Performance testing - Acoustic power, beam profile, thermal evaluation, and focal length testing were performed according to design requirement specifications and verification and validation plan. All test results were satisfactory with no deviations from the applicable standards or protocols. Refer to summary of performance in Section 18 Performance Testing - Bench for more details.

VIII. SOFTWARE VERIFICATION AND VALIDATION TESTING

Software verification and validation testing was conducted and demonstrated as per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

{6}------------------------------------------------

IX. CLINICAL STUDY

The study was a single-center, a prospective, randomized, three-armed clinical study at UltraLaser Center, Monterrey, Mexico in compliance with international guidelines for Good Clinical Practices. An average fluence of 85 J/cm 2 was set as the initial treatment setting and the energy dose was increased or decreased in increments of 5 J/cm 2 according to the patient's tolerance. A mean waist circumference reduction of 3.05 ± 5.95cm (p<.0001) from baseline was observed at 12 weeks follow up.

The subjects were evaluated initially, with follow-up after 4, 8 and 12 weeks. The adverse events reported were erythema, ecchymosis, and dysesthesia and were resolved during the course of the study without any treatment. There were no serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) related to treatment with the investigational device. The mean pain score for the treated population was 7.35.

X. CONCLUSION

LIPOcel is substantially equivalent to the Predicate Device in terms of indications for use, handpiece size, aesthetic optimal temperature, patient contacting material, output waveform, maximum power output, and operating principle. Safety and performance testing was performed and Jeisys Medical Inc. has concluded that the device does not raise any significant questions of safety and efficacy and is substantially equivalent to the Predicate Device.

Regulation Number and Section

§ 878.4590 Focused ultrasound stimulator system for aesthetic use.

(a)
Identification. A Focused Ultrasound Stimulator System for Aesthetic Use is a device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.