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

Device Description

The BeShape One™ device is a non-invasive, high intensity, non-focused US device intended for disruption of the subcutaneous adipose tissue and indicated for noninvasive waist circumference reduction. The BeShape One™ device utilizes continuous wave (CW) ultrasonic energy applied to the adipose tissue at a temperature of 47-49ºC. A cooling system maintains the skin temperature at below 35℃. The device consists of hardware and software. These elements are integrated in the BeShape One™ console and applicator/hand piece. BeShape One™ is supplied as a console and two identical applicators. The device is portable and was specifically designed to be utilized in clinic environments.

The console is floor-standing and portable. It is controlled by a touch screen and consists of the following subsystems:

Power Source
Controller unit (CPU) .
Water cooling system (Chiller) ●
Vacuum System
. Block Amplifier
Touchscreen display monitor ●
Personal computer and proprietary software .
Two designated applicator cradles .
Two designated applicator connector ports .

The BeShape One™ device applicator is a mechanical handpiece with an internal rectangular bathtub-shaped chamber and consists of the following elements:

Two parallel facing US transducers Each transducer includes four piezoelectric . (PZT) ceramic elements which convert electrical energy into acoustic energy in the ultrasound frequency range. Each transducer can transmit up to 1.5W/cm2 of acoustic energy at a frequency of 2MHz.
. Vacuum - The vacuum provides effective fixation of the adipose tissue under the skin in the cup-shaped chamber of the Applicator.
The cooling system which includes thermoelectric coolers (TEC) for ultrasound ● (US) transducers (TD) and a water-cooling system for the hot side of the thermoelectric coolers (TEC). The cooling system is intended to cool the applicator and skin to below 35°C.

The Applicator uses vacuum during the procedure, which draws adipose tissue under the skin into the inner cup-shaped chamber, thereby heating the subcutaneous adipose tissue.

AI/ML Overview

The provided text is a 510(k) summary for the BeShape One™ Device, which is a medical device for non-invasive waist circumference reduction. It describes the device, its intended use, performance testing, and comparison with a predicate device (LIPOcel).

Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:

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

The document doesn't explicitly present a formal "acceptance criteria table" with specific numerical targets. However, it implicitly defines success by demonstrating statistical significance, clinical meaningfulness, and positive user/investigator ratings compared to baseline.

Performance Metric	Acceptance Criteria (Implicit from Study Design/Goals)	Reported Device Performance at 12 Weeks Post-Treatment
Waist Circumference Reduction	Statistically significant decrease from baseline and clinically meaningful.	Statistically significant decrease of -1.87 cm (STD=2.62). This met the performance goal.
Subject Self-Reported GAIS	Significant percentage of subjects rating improvement in waist circumference reduction.	55% of subjects rated an improvement.
Investigator Rated CGAIS	Significant percentage of subjects rating improvement in waist circumference reduction.	72.3% of subjects rated an improvement.
Subject Satisfaction Self-Rating	High level of satisfaction. (Though a decline was noted from 6 to 12 weeks, the 6-week satisfaction may be an implicit target met)	53.7% satisfaction at 6 weeks (declined at 12 weeks).
Abdominal Fat Thickness Reduction	Reduction indicated. (No specific threshold mentioned as an "acceptance criteria")	-0.20 cm (STD=0.43).
Safety (Adverse Events/LSR)	No significant or unmanageable adverse effects; acceptable Local Skin Reactions (LSRs).	Most frequent LSRs: erythema and application site bruise. No abnormal vital signs. No adverse effect mentioned.

The "performance goal" for waist circumference reduction having been met indicates an implicit acceptance criterion was defined for this key efficacy endpoint.

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

Sample Size for Test Set: The "Clinical Performance Data" section states, "The SAS comprised 72 participants." (SAS likely stands for Safety Analysis Set or Statistical Analysis Set, representing the main study cohort).
Data Provenance: The study was a "prospective, multi-center, single-arm study." The country of origin is not explicitly stated, but the applicant company is based in Israel, which suggests the study was likely conducted there or in regions accessible to them. It was a prospective study.

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

For the Clinical Global Aesthetic Improvement Scale (CGAIS), an "investigator" rated subject improvement. The number of investigators/experts is not specified. Their qualifications are also not explicitly detailed, but as it's a clinical study, they would typically be trained medical professionals (e.g., physicians, dermatologists, or clinical research staff with experience in aesthetic assessments).
For other objective measures like waist circumference and abdominal fat thickness, these are quantitative measurements, not typically requiring "expert consensus ground truth" in the same way as image interpretation or subjective aesthetic scales. The ground truth for these would be the direct measurement itself.

4. Adjudication method for the test set:

The document does not mention any specific adjudication method (e.g., 2+1, 3+1) for the clinical study's assessments. For subjective scales like CGAIS, if multiple investigators were involved, it's common practice to have methods for ensuring consistency or resolving discrepancies, but this is not detailed in the summary.

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, an MRMC comparative effectiveness study was not conducted. This device is a treatment device, not an AI-assisted diagnostic device. The study described is a clinical trial assessing the direct efficacy and safety of the device on patients, not comparing human reader performance with and without AI.

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

This question is not applicable. The BeShape One™ Device is a physical medical device that delivers ultrasound energy for treatment, not a standalone AI algorithm for diagnosis or image analysis. Its "performance" is measured by its clinical effect on patients, not by an algorithm's output.

7. The type of ground truth used:

Clinical Efficacy Ground Truth:
- Objective Measurements: Waist circumference reduction (direct measurement).
- Objective Measurements: Abdominal fat thickness reduction (direct measurement).
- Subjective Clinical Assessment: Investigator-rated Clinical Global Aesthetic Improvement Scale (CGAIS). The "ground truth" here is the clinical judgment of the investigator(s).
- Subjective Patient Assessment: Subject self-reported GAIS and a 5-point Satisfaction Likert scale. The "ground truth" here is the patient's direct perception and experience.
Safety Ground Truth:
- Observation of Local Skin Reactions (LSRs) and vital signs.
- Pre-clinical (animal) study: Thermal safety, lipid profile, micro and macro-histopathology requirements.

8. The sample size for the training set:

The document describes a single-arm clinical study used for demonstrating safety and efficacy for the 510(k) submission. It does not mention a separate training set or any machine learning model training. The clinical study described served as the primary performance evaluation.

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

As no training set (in the context of machine learning) is mentioned or implied for this device's performance evaluation, this question is not applicable. The clinical trial data was primarily used for validation of the device's efficacy and safety.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.

September 29, 2023

BeShape Technologies Ltd. % Amit Goren Regulatory Affairs Consultant A. Stein - Regulatory Affairs Consulting Ltd. 18 Hata'as Str., Suite 21 Kfar Saba, 4442518 Israel

Re: K231628

Trade/Device Name: BeShape One™ Device Regulation Number: 21 CFR 878.4590 Regulation Name: Focused Ultrasound Stimulator System For Aesthetic Use Regulatory Class: Class II Product Code: OHV Dated: September 11, 2023 Received: September 11, 2023

Dear Amit Goren:

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.

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"

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

(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 OS 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.

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 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. Mark Trumbore - Digital റ Date: 2023.09.29 09:50:00 -04'00 Mark Trumbore, 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

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

Enclosure

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

Indications for Use

510(k) Number (if known) K231628

Device Name BeShape One™ Device

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."

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

K231628

510(K) SUMMARY BESHAPE ONE™ SYSTEM

510(k) Number K231628

Applicant Name:

Company Name:	BeShape Technologies Ltd.
Address:	23 HaTaas Str.
	Kfar Saba 4442525
	Israel
	Tel: +972-52-4854474
	E-mail: amit@asteinrac.com

Contact Person:

Official Correspondent:	Amit Goren
Company Name:	A. Stein - Regulatory Affairs Consulting Ltd.
Address:	18 Hata'as Str., Suite 21Kfar Saba 4442518IsraelTel: +972-9-7670002Fax: +972-9-7668534E-mail: amit@asteinrac.com
Date Prepared:	September 11, 2023

BeShape One™ Trade Name:

Classification Regulation:

Classification Name	Regulation No.	Product Code
Focused Ultrasound For Tissue Heat OrMechanical Cellular Disruption	878.4590	OHV

Classification: Class II Medical Device

Predicate Device: The BeShape One device is substantially equivalent to the following FDA-cleared predicate device:

Manufacturer	Device	510(k) No.
Jeisys Medical Inc.	LIPOcel	K181896

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

Device Description:

The console is floor-standing and portable. It is controlled by a touch screen and consists of the following subsystems:

Power Source
Controller unit (CPU) .
Water cooling system (Chiller) ●
Vacuum System
. Block Amplifier
Touchscreen display monitor ●
Personal computer and proprietary software .
Two designated applicator cradles .
Two designated applicator connector ports .

The BeShape One™ device applicator is a mechanical handpiece with an internal rectangular bathtub-shaped chamber and consists of the following elements:

Two parallel facing US transducers Each transducer includes four piezoelectric . (PZT) ceramic elements which convert electrical energy into acoustic energy in the ultrasound frequency range. Each transducer can transmit up to 1.5W/cm2 of acoustic energy at a frequency of 2MHz.
. Vacuum - The vacuum provides effective fixation of the adipose tissue under the skin in the cup-shaped chamber of the Applicator.
The cooling system which includes thermoelectric coolers (TEC) for ultrasound ● (US) transducers (TD) and a water-cooling system for the hot side of the thermoelectric coolers (TEC). The cooling system is intended to cool the applicator and skin to below 35°C.

The Applicator uses vacuum during the procedure, which draws adipose tissue under the skin into the inner cup-shaped chamber, thereby heating the subcutaneous adipose tissue.

Intended Use/Indication for Use:

The BeShape One™ device delivers High Intensity, Non-Focused Ultrasound energy that can disrupt the Subcutaneous Adipose Tissue (SAT) to provide a non-invasive

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

approach to achieve a desired aesthetic effect. The BeShape One™ device is specifically indicated for non-invasive waist circumference reduction.

Performance Standards:

The BeShape One™ device has been tested and complies with the following performance standards.

Standard Number	Standard Title
IEC 60601-1Ed 3.2 2020-08	Medical electrical equipment - Part 1: General requirements forbasic safety and essential performance.
IEC 62304Ed 1.1 2015-06	Medical device software - Software life cycle processes
IEC 60601-1-2Ed 4.1 2020-09	Medical electrical equipment - Part 1-2: General requirements forbasic safety and essential performance - Collateral Standard:Electromagnetic disturbances - Requirements and tests
IEC 60601-2-62Ed 1.0 2013-07	Medical electrical equipment - Part 2-62: Particularrequirements for the basic safety and essential performance ofhigh intensity therapeutic ultrasound (HITU) equipment
ISO 10993-5Ed 3 2009-06-01	Biological evaluation of medical devices - Part 5: Tests for invitro cytotoxicity
ISO 10993-10Ed 3 2010-08-01	Biological evaluation of medical devices - Part 10: Tests forirritation and skin sensitization
ISO 10993-23 Firstedition 2021-01	Biological evaluation of medical devices - Part 23: Tests forirritation
IEC 14971Ed 3 2019-12	Medical devices - Application of risk management to medicaldevices
IEC 60601-1-6Ed 3.2 2020-07	Medical electrical equipment - Part 1-6: General requirements forbasic safety and essential performance - Collateral standard:Usability
IEC 62366-1Ed 1.1 2020-06	Medical devices - Part 1: Application of usability engineeringto medical devices

The test report documents conclude that the BeShape One™ device complies with the requirements of all the above-mentioned standards. The test reports for the BeShape One"M device are provided in Sections 15 (Biological Evaluation), 16 (Software Validation), 17 (Electrical and EMD Safety Testing) and 18 (Ultrasound Safety Testing) of this 510(k) submission.

Non-Clinical (Bench) Performance Data:

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 and complied with the applicable standards and protocols. The acoustic output (ultrasound safety) testing is provided in Section 18 (Performance Testing - Bench) of this 510(k) submission.

{7}------------------------------------------------

Software validation testing in compliance with FDA guidelines for software validation and IEC 62304 standard requirements was also conducted. The software validation documents are provided in Section 16 (Software Validation) of this 510(k) submission.

Pre-Clinical (Animal) Performance Data:

The safety of the Beshape One™ Device for disruption of adipose tissue and noninvasive waist circumference reduction was demonstrated in a pre-clinical (animal) study. The pre-clinical, animal study demonstrated that the use of BeShape One™ device under the experimental conditions is safe, without being associated with any adverse effect. Furthermore, under the conditions of the study and in consideration of its intended clinical application, the BeShape One™ Device, intended for use for disruption of adipose tissue and indicated for use for non-invasive waist circumference reduction, passed all the pre-defined safety acceptance criteria for thermal safety, including temperature, lipid profile and micro and macro-histopathology requirements.

Clinical Performance Data:

The safety and efficacy of the Beshape One™ Device for disruption of adipose tissue and non-invasive waist circumference reduction was demonstrated in a prospective, single-arm, controlled study.

The study was a prospective, multi-center, single-arm study. Subjects received one treatment with the BeShape One™ device on the anterior abdomen. A total of four to six treatment areas were marked prior to treatment administration. Subsequently, two operating applicators (including the ultrasound transducers) were placed on two of the marked treatment areas and vacuum was activated, such that two treatment areas were treated simultaneously. The follow-up period included two visits at 6 weeks (6wk FU) and 12 weeks (12wk FU) post treatment. Subjects' waist circumference and abdominal fat thickness were measured and assessment were performed using the Clinical Global Aesthetic Improvement Scale (CGAIS) and subject self-rating GAIS and a 5 point Satisfaction Likert scale. The SAS comprised 72 participants.

The change from baseline to 12 weeks follow-up in waist circumference showed that there was a statistically significant decrease of -1.87 cm. (STD=2.62) in waist circumference. This difference was also clinically meaningful and met the performance goal of the study. The subject self-reported GAIS results showed that 55% of the subjects rated an improvement in their waist circumference reduction at 12 weeks post treatment. The investigator rated subject improvement using the CGAIS demonstrated that 72.3% of the subjects rated an improvement in their waist circumference reduction at 12 weeks post treatment. The subject satisfaction self-rating scale showed that 53.7% satisfaction at the 6 week visit follow up visit, with a decline at subsequent follow-up. The subjects rated a moderate level of comfort/pain. Abdominal fat thickness reduction at 12 weeks post treatment was -0.20 cm (STD=0.43). The most frequent Local Skin Reaction (LSR) were erythema and application site bruise. No abnormal vital signs (blood pressure, heart rate and temperature) were noted during the study.

{8}------------------------------------------------

In summary, the efficacy clinical data and safety results of the BeShape One™ clinical study presented above demonstrated the safety and effectiveness of the BeShape One™ Device for waist circumference reduction.

Substantial Equivalence:

The following table provides a comparison of the BeShape One™ device and the predicate LIPOcell device:

Characteristic	Subject Device	Predicate Device
	BeShape One	LIPOcel
	(BeShape Technologies Ltd.)	(Jeisys Medical Inc., K181896)
Device Classification, Indication for Use, Intended Use
Device Classification	Class II	Class II
Classification Product Code	OHV	OHV
Regulation Number	878.4590	878.4590
Indications For Use	The BeShape One device deliversHigh Intensity, Non-FocusedUltrasound energy that can disruptthe Subcutaneous Adipose Tissue(SAT) to provide a non-invasiveapproach to achieve a desiredaesthetic effect. The BeShape Onedevice is specifically indicated fornon-invasive waist circumferencereduction.	The LIPOcel delivers High IntensityFocused Ultrasound (HIFU) energythat can disrupt the SubcutaneousAdipose Tissue (SAT) to provide anon-invasive approach to achieve adesired aesthetic effect. The LIPOceis specifically indicated for non-invasive waist circumferencereduction.
Target Population	Adult subjects	Adult subjects
Anatomical Sites	Waist	Waist
Environment Used	In-office	In-office
Technological Characteristics
Device Description	The BeShape One device deliversHigh Intensity, Non-FocusedUltrasound energy that can disruptthe Subcutaneous Adipose Tissue(SAT) to provide a non-invasiveapproach to achieve a desiredaesthetic effect. The BeShape Onedevice is specifically indicated fornon-invasive waist circumferencereduction.	The LIPOcel delivers High IntensityFocused Ultrasound (HIFU) energythat can disrupt the SubcutaneousAdipose Tissue (SAT) to provide anon-invasive approach to achieve adesired aesthetic effect. The LIPOceis specifically indicated for non-invasive waist circumferencereduction.
Device Components	• Power source• Controller unit• Cooling system• Vacuum System• Touchscreen display monitor• PC and proprietary software• Applicator	• Power source• Controller unit• Cooling System--• Touch LCD monitor• Software• Applicator
Characteristic	Subject DeviceBeShape One(BeShape Technologies Ltd.)	Predicate DeviceLIPOcel(Jeisys Medical Inc., K181896)
Operation Control	General Practitioner / Dermatologist	General Practitioner / Dermatologist
Mechanism for HeatGeneration	High Intensity, Non-FocusedUltrasound	High Intensity, Focused Ultrasound
Power source	AC/DC power:50-60 Hz100-240VAC5.5A	AC/DC power:50-60 Hz100-240VAC5.5A
Energy Source	Piezoelectric ultrasonic transducer	Piezoelectric ultrasonic transducer
Frequency of USEnergy	2 MHz	2 MHz
Cartridge Focal Length	Not Applicable	13 mm
Duration of Treatment	22 minutes of treatment	60 minutes of treatment
TreatmentTemperature:Skin	48°C	55°C
Temperature:	15 - 35°C	30 - 37°C
Temperatureregulation	Temperature at the applicator iscontinuously monitored to ensure itdoes not exceed the maximumallowable temperature.	Temperature at the applicator iscontinuously monitored to ensure itdoes not exceed the maximumallowable temperature.
Cooling System	Water based	Water based
Rate of Heating (timeto reach target temp)	5 minutes, at least	Not available
Treatment Area	40.5cm³	30 x 30 (mm)
Dimensions	55.6cm(W)x60.8cm(D)x139.6cm(H)	43.8cm(W)x58cm(D)x108cm(H)
Weight	55 kg	80 kg
Sterilization	Non-sterile	Non-sterile
Single Use or Reusable	BeShape One device: reusableApplicators: reusable	LIPOcel device: reusableApplicators: reusable
Performance Testing
Biocompatible patient-contacting materials(ISO 10993-1)	Yes, medical-grade materials	Yes, medical-grade materials
Thermal Safety	Bench testing verified thermal safetyrequirements	Bench testing verified thermal safetyrequirements
Software	Testing was performed to validatethat the software met allrequirements	Testing was performed to validatethat the software met allrequirements
Electrical Safety perIEC 60601-1	Meets requirements	Meets requirements
Characteristic	Subject DeviceBeShape One(BeShape Technologies Ltd.)	Predicate DeviceLIPOcel(Jeisys Medical Inc., K181896)
ElectromagneticCompatibility (EMC)per IEC 60601-1-2	Meets requirements	Meets requirements

{9}------------------------------------------------

{10}------------------------------------------------

The BeShape One™ device has the same intended use as the LIPOcel device, including disruption of Subcutaneous Adipose Tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect and the same indication for use for non-invasive waist circumference reduction.

Furthermore, the technological characteristics of the BeShape One™ device and the predicate, LIPOcel device are similar, including similar device components (i.e., power source, control unit, water-based cooling system, operator interface and display monitor, software and applicator), similar mechanism of action (heating the tissue using ultrasound energy to achieve adipose tissue disruption and thus achieve waist circumference reduction), similar treatment administration, similar energy regulation methods, biocompatible materials, validation of software component, and similar compliance with electrical. EMC and high intensity ultrasound standards, as well as similar compliance with methods and standards to validate the safety of the Ultrasound energy. The most important technological characteristic. i.e., using US energy to deliver heat to the body area to induce the adipose tissue disruption for the treatment of noninvasive waist circumference reduction, is the same in both devices. As there are slight differences in the configuration of the ultrasound transducers and the type of ultrasound energy used in the BeShape One™ device, there are acceptable scientific methods to evaluate these aspects of the device, including compliance with FDA recognized methods and standards to demonstrate ultrasound safety and testing to validate the generated ultrasound energy output in the BeShape One ™ device is at least as safe and effective as the legally marketed, predicate LIPOcel device and meets the requirements of the standards. Addition, similar acceptable methods for demonstrating the safety and effectiveness of the device were employed, including pre-clinical (animal) and clinical testing. The gamut of performance testing provided in the 510(k) demonstrates the safety and effectiveness of the BeShape One ™ device and the substantial equivalence to the predicate device.

Conclusions:

Based on the performance testing provided in the 510(k) submission and comparison to the predicate device, the BeShape One™ device is substantially equivalent to the LIPOcel device (K181896) and may be legally marketed in the US.

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.