(116 days)
Not Found
No
The description focuses on the hardware and software controlling the delivery of ultrasound energy, vacuum, and cooling. There is no mention of AI, ML, or any learning/adaptive capabilities.
No.
The device is indicated for aesthetic effect (non-invasive waist circumference reduction) by disrupting subcutaneous adipose tissue. It is not intended to diagnose, cure, mitigate, treat, or prevent disease.
No
This device is used for non-invasive waist circumference reduction by disrupting subcutaneous adipose tissue, which is a treatment, not a diagnostic, function.
No
The device description explicitly states that the BeShape One™ device consists of both hardware and software, integrated into a console and applicator/hand piece, and lists numerous hardware components.
Based on the provided information, the BeShape One™ device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "non-invasive waist circumference reduction" by disrupting subcutaneous adipose tissue using ultrasound energy. This is a therapeutic/aesthetic application, not a diagnostic one.
- Device Description: The device description details a system that delivers ultrasound energy to the body and includes components like transducers, a cooling system, and a vacuum system. These are consistent with a therapeutic device, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, urine, tissue, etc.) from the human body to provide diagnostic information. The device directly interacts with the patient's body for treatment.
In summary, the BeShape One™ device is a therapeutic device designed for body contouring, not an in vitro diagnostic device.
N/A
Intended Use / Indications 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 approach to achieve a desired aesthetic effect. The BeShape One™ device is specifically indicated for non-invasive waist circumference reduction.
Product codes
OHV
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Waist
Indicated Patient Age Range
Adult subjects
Intended User / Care Setting
General Practitioner / Dermatologist, In-office
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. Software validation testing in compliance with FDA guidelines for software validation and IEC 62304 standard requirements was also conducted.
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 study demonstrated that the use of BeShape One™ device under the experimental conditions is safe, without being associated with any adverse effect. It passed all the pre-defined safety acceptance criteria for thermal safety, including temperature, lipid profile and micro and macro-histopathology requirements.
Clinical Performance Data:
Study Type: Prospective, single-arm, controlled study, multi-center
Sample Size: The SAS comprised 72 participants.
Key Results: The study demonstrated the safety and efficacy of the Beshape One™ Device for disruption of adipose tissue and non-invasive waist circumference reduction. The change from baseline to 12 weeks follow-up in waist circumference showed a statistically significant decrease of -1.87 cm. (STD=2.62), which was also clinically meaningful and met the performance goal. 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 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 were noted during the study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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)
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.
| 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) |
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4
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 21 |
| Kfar Saba 4442518 | |
| Israel | |
| Tel: +972-9-7670002 | |
| Fax: +972-9-7668534 | |
| E-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 Or | ||
| Mechanical 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 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.
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 60601-1 | |
| Ed 3.2 2020-08 | Medical electrical equipment - Part 1: General requirements for |
| basic safety and essential performance. | |
| IEC 62304 | |
| Ed 1.1 2015-06 | Medical device software - Software life cycle processes |
| IEC 60601-1-2 | |
| Ed 4.1 2020-09 | Medical electrical equipment - Part 1-2: General requirements for |
| basic safety and essential performance - Collateral Standard: | |
| Electromagnetic disturbances - Requirements and tests | |
| IEC 60601-2-62 | |
| Ed 1.0 2013-07 | Medical electrical equipment - Part 2-62: Particular |
| requirements for the basic safety and essential performance of | |
| high intensity therapeutic ultrasound (HITU) equipment | |
| ISO 10993-5 | |
| Ed 3 2009-06-01 | Biological evaluation of medical devices - Part 5: Tests for in |
| vitro cytotoxicity | |
| ISO 10993-10 | |
| Ed 3 2010-08-01 | Biological evaluation of medical devices - Part 10: Tests for |
| irritation and skin sensitization | |
| ISO 10993-23 First | |
| edition 2021-01 | Biological evaluation of medical devices - Part 23: Tests for |
| irritation | |
| IEC 14971 | |
| Ed 3 2019-12 | Medical devices - Application of risk management to medical |
| devices | |
| IEC 60601-1-6 | |
| Ed 3.2 2020-07 | Medical electrical equipment - Part 1-6: General requirements for |
| basic safety and essential performance - Collateral standard: | |
| Usability | |
| IEC 62366-1 | |
| Ed 1.1 2020-06 | Medical devices - Part 1: Application of usability engineering |
| to 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 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. | 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 LIPOce | ||
| is specifically indicated for non- | ||
| invasive waist circumference | ||
| reduction. | ||
| Target Population | Adult subjects | Adult subjects |
| Anatomical Sites | Waist | Waist |
| Environment Used | In-office | In-office |
| Technological Characteristics | ||
| Device Description | 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. | 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 LIPOce | ||
| is specifically indicated for non- | ||
| invasive waist circumference | ||
| reduction. | ||
| 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 Device | |
| BeShape One | ||
| (BeShape Technologies Ltd.) | Predicate Device | |
| LIPOcel | ||
| (Jeisys Medical Inc., K181896) | ||
| Operation Control | General Practitioner / Dermatologist | General Practitioner / Dermatologist |
| Mechanism for Heat | ||
| Generation | High Intensity, Non-Focused | |
| Ultrasound | High Intensity, Focused Ultrasound | |
| Power source | AC/DC power: | |
| 50-60 Hz | ||
| 100-240VAC | ||
| 5.5A | AC/DC power: | |
| 50-60 Hz | ||
| 100-240VAC | ||
| 5.5A | ||
| Energy Source | Piezoelectric ultrasonic transducer | Piezoelectric ultrasonic transducer |
| Frequency of US | ||
| Energy | 2 MHz | 2 MHz |
| Cartridge Focal Length | Not Applicable | 13 mm |
| Duration of Treatment | 22 minutes of treatment | 60 minutes of treatment |
| Treatment | ||
| Temperature: | ||
| Skin | 48°C | 55°C |
| Temperature: | 15 - 35°C | 30 - 37°C |
| Temperature | ||
| regulation | Temperature at the applicator is | |
| continuously monitored to ensure it | ||
| does not exceed the maximum | ||
| allowable temperature. | Temperature at the applicator is | |
| continuously monitored to ensure it | ||
| does not exceed the maximum | ||
| allowable temperature. | ||
| Cooling System | Water based | Water based |
| Rate of Heating (time | ||
| to 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: reusable | |
| Applicators: reusable | LIPOcel device: reusable | |
| Applicators: reusable | ||
| Performance Testing | ||
| Biocompatible patient- | ||
| contacting materials | ||
| (ISO 10993-1) | Yes, medical-grade materials | Yes, medical-grade materials |
| Thermal Safety | Bench testing verified thermal safety | |
| requirements | Bench testing verified thermal safety | |
| requirements | ||
| Software | Testing was performed to validate | |
| that the software met all | ||
| requirements | Testing was performed to validate | |
| that the software met allrequirements | ||
| Electrical Safety per | ||
| IEC 60601-1 | Meets requirements | Meets requirements |
| Characteristic | Subject Device | |
| BeShape One | ||
| (BeShape Technologies Ltd.) | Predicate Device | |
| LIPOcel | ||
| (Jeisys Medical Inc., K181896) | ||
| Electromagnetic | ||
| Compatibility (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.