The InMode WMbody device is intended for the treatment of the following medical conditions, using the WMbody applicator for delivering non-thermal RF combined with massage:

· Relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of blood circulation; and
Temporary reduction in the appearance of cellulite. ●

Device Description

The InMode WMbody device is designed to deliver mechanical vacuum skin massaging and nonthermal RF energy to the skin and subdermal fat. RF energy does not cause thermal damage to the treated skin and adipose tissue.

The device provides individual adjustment of non-thermal RF power and vacuum pulse duration to achieve maximum efficiency and safety for each patient. The ergonomic hand piece allows efficient treatment of large tissue surfaces.

The InMode WMbody device consists of an AC/DC power supply unit, RF generator, controller and user interface including a LCD screen and functional buttons. The hand piece is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The hand piece comprises a vacuum pump, vacuum chamber with two electrodes and a pressure sensor.

Following are the InMode WMbody device specifications: RF Output Power: 10-50 Watt RF Output Frequency: 1[MHz] ± 2% Dimension: 36cm W x 36cm D x 100cm H (14.2" W x 14.2" D x 40'' H) Weight: 30 Kg (66 lbs) Main Line Frequency (nominal): 50-60 Hz Inout Voltage (nominal): 100-240 VAC

AI/ML Overview

The provided document is a 510(k) summary for the InMode WMbody device, seeking substantial equivalence to a predicate device. It primarily focuses on demonstrating that the new device has similar technological characteristics, performance, and safety features as an already cleared device, rather than performing a de novo study with strict acceptance criteria and clinical trials in the way one might expect for a novel device.

Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical trial with specific performance metrics (like sensitivity, specificity, accuracy) is not directly applicable or explicitly stated in this document.

Instead, the "acceptance criteria" here implicitly refers to demonstrating substantial equivalence to the predicate device, the Viora Reaction System (K090221). The "study" demonstrating this involves non-clinical (bench) performance data and a comparative analysis of specifications and safety.

Here's an analysis based on the information provided, addressing your points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

As explained above, explicit performance acceptance criteria in terms of diagnostic accuracy or clinical efficacy are not provided in this 510(k) summary. The "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device based on technical specifications and safety.

Feature/Metric	Acceptance Criteria (Implicit - Substantial Equivalence Goal)	Reported InMode WMbody Device Performance
Indications for Use	Substantially equivalent to predicate.	- Relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of blood circulation; and - Temporary reduction in the appearance of cellulite. (Identical to predicate)
Technological Characteristics	Similar design and components to predicate (RF generator, control, handpiece, vacuum, electrodes).	Similar design and components: AC/DC power supply, RF generator, controller, user interface (LCD screen, functional buttons), hand piece (vacuum pump, vacuum chamber, two electrodes, pressure sensor).
RF Output Power	Substantially equivalent to predicate.	10-50 Watt
RF Output Frequency	Substantially equivalent to predicate.	1[MHz] ± 2%
Vacuum Pulse Duration	Substantially equivalent to predicate.	Adjustable
Safety Features	Similar to predicate, compliance with standards.	Similar safety features, compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2.
Non-Clinical RF Output Accuracy	RF output parameters (power, frequency) match or are similar to predicate.	"The results of the bench test demonstrate that the InMode WMbody device has the same RF output specifications as the predicate Viora Reaction System and therefore, is substantially equivalent to the predicate device."
Software Validation	Software meets system requirements and does not raise new safety/effectiveness concerns.	Underwent software validation testing (details in Section 16, not provided in excerpt). "These performance tests demonstrated that the minor differences in the device software and specifications meet the system requirements and do not raise new safety or effectiveness concerns."
Electrical/Mechanical Safety	Complies with relevant safety standards.	Complies with IEC 60601-1 (electrical & mechanical safety) and IEC 60601-1-2 (EMC).

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

Test Set Sample Size:
- Clinical Performance Data: "Not Applicable." The document explicitly states that clinical performance data was not used for this submission.
- Non-Clinical (Bench) Performance Data: The sample size for the bench test is not specified, nor is the number of units tested. It simply states "A bench test was performed."
Data Provenance:
- Clinical: Not applicable.
- Non-Clinical: Performed by the manufacturer (InMode MD Ltd.). Country of origin is likely Israel, where the applicant is located. It is inherently a prospective test performed for the regulatory submission.

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

Not applicable. Since clinical performance data was deemed "Not Applicable" for this 510(k) submission, there was no clinical test set requiring expert ground truth establishment. The non-clinical bench test involved comparing instrument measurements.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set or subjective assessment requiring an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. A MRMC comparative effectiveness study was not done. The document explicitly states "Clinical Performance Data: Not Applicable."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, implicitly, for certain aspects. The "standalone" performance here refers to the device's inherent technical capabilities rather than a diagnostic algorithm. The non-clinical bench test assessed the device's RF output parameters (power, frequency) in a standalone manner, comparing them to the predicate device's specifications. This is a technical performance test, not a diagnostic algorithm performance.

7. The Type of Ground Truth Used

For Non-Clinical Bench Test: The "ground truth" was the specifications and measured performance of the predicate device (Viora Reaction System) and the expected electrical/mechanical engineering specifications for the InMode WMbody device itself. The goal was to show that the InMode device's technical specifications and output were "the same" as or "substantially equivalent" to the predicate.
For Clinical Efficacy: Not applicable, as clinical data was not submitted.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device (energy delivery system), not an AI algorithm requiring a training set in the machine learning sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable. (See point 8).

Summary of Approach:

This 510(k) submission for the InMode WMbody device followed the substantial equivalence pathway, which often does not require new clinical studies if the device's technological characteristics, indications for use, and safety profile are demonstrably similar to a legally marketed predicate device. The primary "proof" relies on non-clinical (bench) testing to show that the device meets the same technical standards and performance as the predicate, along with compliance with recognized safety standards.

Summary

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A. STEIN - REGULATORY AFFAIRS CONSULTING LTD

510(K) SUMMARY

INMODE SR DEVICE

510(k) Number K131362

Applicant Name:

. .

InMode MD Ltd. Company Name: Tabor Building, Shaar Yokneam Address: Yokneam 20692 Israel Tel: +972-4-9097470 Fax: +972-4-9097471 E-mail: ahava@asteinrac.com

OCT 08 2013

Contact Person:

Official Correspondent: Ahava Stein Company Name: A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Address: Kfar Saba 44425 Israel Tel: +972-9-7670002 Fax: +972-9-7668534 E-mail: ahava@asteinrac.com

May 6. 2013 Date Prepared:

Trade Name: InMode WMbody Device

Classification Name: CFR Classification section 878.4810; (Product code NUV, ISA)

Classification: Class II Medical Device

Predicate Device:

The InMode WMbody device is substantially equivalent to the following predicate devices.

Manufacturer	Device	510(k) No.
Viora Ltd.	Reaction System	K090221

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A. STEIN - REGULATORY AFFAIRS CONSULTING LTD

Device Description:

Intended Use/Indication for Use:

The InMode WMbody device is intended for the treatment of the following medical conditions, using the WMbody applicator for delivering non-thermal RF combined with massage:

Relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement . of blood circulation; and
Temporary reduction in the appearance of cellulite. .

Performance Standards:

The InMode WMbody Device has been tested and complies with the following voluntary recognized standards:

IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, . 1988: Amendment 1, 1991-11, Amendment 2, 1995
IEC 60601-1-2, (Second Edition, 2001), Medical Electrical Equipment Part 1-2: General . Requirements for Safety - Collateral Standard: Electromagnetic Compatibility --Requirements and Tests
IEC 60601-2-2 (2006): Medical Electrical Equipment Part 2: Particular requirements for . the safety of high frequency surgical equipment.

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A. STEIN - REGULATORY AFFAIRS CONSULTING LTD

Non-Clinical (Bench) Performance Data:

A bench test was performed to measure the accuracy of the RF output parameters in the InMode WMbody device and compare them to the RF output measurements in the predicate device (Viora Reaction System). The results of the bench test demonstrate that the InMode WMbody device has the same RF output specifications as the predicate Viora Reaction System and therefore, is substantially equivalent to the predicate device.

Clinical Performance Data:

Not Applicable

Substantial Equivalence:

The indications for use and technological characteristics of the InMode WMbody device are substantially equivalent to the indications for use and technological characteristics of the Viora Reaction device.

The design and components in the InMode WMbody device, including the console (with power supply, RF generator, controller and display panel) and the hand piece applicator (with cable, connector to console and vacuum pump) are similar to the design and components found in the predicate Viora Reaction device. The performance specifications (including frequency, nonthermal RF electrical power, pulse duration and vacuum power) of the InMode WMbody device are substantially equivalent to those in the Viora Reaction device. The safety features and compliance with safety standards in the InMode WMbody device are similar to the safety features and compliance with safety standards found in the predicate device. Patient contact materials are also similar. Any minor differences in the technological characteristics do not raise new safety or effectiveness concerns. Furthermore, the new InMode WMbody device underwent performance testing, including software validation testing (provided in Section 16) and electrical and mechanical safety testing according to IEC 60601-1 and electromagnetic compatibility testing according to IEC 60601-1-2 (provided in Section 17). These performance tests demonstrated that the minor differences in the device software and specifications meet the system requirements and do not raise new safety or effectiveness concerns.

Consequently, it can be concluded that the InMode WMbody device is substantially equivalent to the predicate Viora Reaction device, cleared under 510(k) K090221, and therefore, may be legally marketed in the USA.

Conclusions:

Based on the performance testing and comparison to predicate devices, the InMode WMbody device is substantially equivalent to the Viora Reaction predicate device.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 8, 2013

Inmode Md Ltd. % Ms. Ahava Stein Regulatory Manager 20 Hata'as Street. Suite 102 Kfar Saba, 44425 Israel

Rc: K131362

Trade/Device Name: Inmode WMbody device Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: NUV, ISA Dated: August 8, 2013 Received: August 22, 2013

Dear Ms. Stein:

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. 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 vou; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal 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

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Page 2 - Ms. Ahava Stein

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K | 3 | 362

Device Name: InMode WMbody Device

Intended Use Statement:

The InMode WMbody device is intended for the treatment of the following medical conditions, using the WMbody applicator for delivering non-thermal RF combined with massage:

· Relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of blood circulation; and
Temporary reduction in the appearance of cellulite. ●

Prescription Use V (Per 21 C.F.R. 801 Subpart D) C)

Over-The-Counter Use (Optional Format Subpart

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IP NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Digitally signed by	Long H. Chen -A
OU: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Long H. Chen -A
0.9.2342.19200300.100.1.1=1100369056
Date:	2013.10.04 10:17:00 -04'00'

for MXM

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K131362

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.