The InMode PLUS System with the PLUS/PLUS90 Hand pieces is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.

Device Description

The InMode PLUS System delivers RF energy to gradually heat the skin and subcutaneous tissue. The RF power levels used by the device can be adjusted from 10 to 50 Watts and the maximum skin temperature cutoff can be adjusted from 35℃ to a maximum of 42℃. The hand pieces are operated while continuously moving them over the treatment area. This ensures uniform and safe heating of the entire trea.

Each InMode PLUS hand piece is comprised of the hand piece handle, a cable 250 cm long, and a connector, which connects to the rear connector of the InMode PLUS System.

Two InMode PLUS hand pieces are available:

InMode PLUS hand piece (held perpendicular to the treatment area)
InMode PLUS90 hand piece (held parallel to the treatment area)

Following are the InMode PLUS System specifications: Maximal RF Output Power: 50 Watt RF Output Frequency: 1.0[MHz] ± 2% Maximum Temperature (skin surface): 42°C ± 2°C

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for the InMode PLUS System. It details the device's indications for use, technical specifications, and the basis for its substantial equivalence to a predicate device.

However, it does not contain information about a clinical study involving human patients, human readers, or AI assistance for diagnostic purposes. The document explicitly states "Clinical Performance Data: Not Applicable."

The performance data presented is based on bench testing and ex-vivo tissue studies, not in-vivo human studies. Therefore, I cannot provide information on acceptance criteria related to human performance, multi-reader multi-case studies, or AI-assisted diagnoses.

The document discusses the following performance tests relevant to the device's substantial equivalence for its stated indications (temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation):

1. Acceptance Criteria and Device Performance (Bench and Ex-vivo Studies Only):

Acceptance Criteria Category	Specific Criteria (Implicit from study design)	Reported Device Performance
RF Output Power Settings	Emitting RF energy within specified range.	"The InMode Plus System operates in compliance with the system requirements, emitting RF energy of up to 50W." (Maximum RF Output Power: 50 Watt)
Temperature Elevation Profile	Elevating tissue temperature to specified maximum safely.	"while elevating the tissue temperature up to 42ºC." (Maximum Temperature (skin surface): 42°C ± 2°C)
Ex-vivo Tissue Study	Evaluation of safety and temperature tissue penetration/depth profile.	Results demonstrated safety and appropriate penetration. (Specific numerical depth not provided, but deemed acceptable for comparison to predicate.)
Side-by-Side Bench Tests	Comparison of device RF performance settings to the predicate device for substantial equivalence.	"the InMode Plus System is as safe and effective as the predicate device for the same intended use." and "the InMode Plus System is substantially equivalent to the predicate Viora V10 System with the ST hand piece."
Cleaning Validation	Device can be effectively cleaned for re-use.	"The device had successfully passed the cleaning validation test."
Biocompatibility	Materials in contact with patients are biocompatible.	"All of the handpiece materials are biocompatible based on the established biocompatibility of the materials and per ISO 10993-1."
Electrical & Mechanical Safety	Compliance with relevant safety standards (IEC 60601-1, IEC 60601-2-2).	"The performance tests demonstrated that the minor differences in the device specifications meet the system requirements and do not raise new safety or effectiveness concerns." and "safety features and compliance with safety standards in the InMode Plus System are similar to the safety features and compliance with safety standards found in the predicate device."
Electromagnetic Compatibility (EMC)	Compliance with relevant EMC standards (IEC 60601-1-2).	"...electromagnetic compatibility testing according to IEC 60601-1-2." (Implied successful compliance).
Software Verification & Validation	Software meets requirements and performs as intended.	"The InMode Plus System underwent additional performance tests, including software verification and validation testing..." (Implied successful completion).

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

Test Set Sample Size: Not applicable in the context of a clinical test set with human subjects/data. The testing involved benchtop components and ex-vivo tissue. Specific quantities of tissue or bench components are not detailed, but the studies were sufficient to demonstrate substantial equivalence for the stated indications.
Data Provenance: The studies were non-clinical (bench) and ex-vivo tissue studies. The country of origin of the data is not specified beyond the manufacturer being in Israel and the regulatory submission to the USA. They were not retrospective or prospective human clinical studies.

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

Number of Experts: Not applicable. Ground truth, in this context, refers to the physical and electrical parameters measured during the bench and ex-vivo tests, as well as the established safety and performance characteristics of the predicate device. These are objective measurements rather than subjective interpretations by human experts for diagnostic purposes.
Qualifications of Experts: N/A. The evaluation was based on engineering and scientific measurements and comparisons to established standards and the predicate device.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. There was no need for adjudication as the testing involved objective physical measurements and comparisons, not subjective interpretations requiring consensus among multiple readers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Done?: No. This was a non-clinical submission, and no human studies (including MRMC studies) were conducted or reported.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):

Done?: Not applicable. This device is an electrosurgical cutting and coagulation device, not an AI algorithm. Its performance is inherent to its physical operation and energy delivery, not an independent algorithmic output.

7. Type of Ground Truth Used:

The "ground truth" used was based on:
- Objective Physical and Electrical Measurements: RF output power, temperature elevation, energy delivery profiles, etc.
- Established Material Properties and Safety Standards: Biocompatibility testing (ISO 10993-1), electrical and mechanical safety (IEC 60601-1, IEC 60601-2-2), and EMC (IEC 60601-1-2).
- Comparison to Legally Marketed Predicate Device: The performance and safety profile of the Viora V-ST Handpiece (K150035) served as the benchmark for substantial equivalence.

8. Sample Size for the Training Set:

Sample Size: Not applicable. This device does not involve a "training set" in the context of machine learning or AI algorithms. Its design and operational parameters are set by engineering principles.

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

Not applicable as there is no training set for this type of device.

Summary

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

July 12, 2016

InMode MD Ltd. Ms. Ahava Stein A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba, 44425 Israel

Re: K153568

Trade/Device Name: InMode Plus System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: PBX Additional Product Code: ISA Dated: June 7, 2016 Received: June 10, 2016

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 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.

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

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

Jennifer R. Stevenson -A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K153568

Device Name InMode PLUS System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY INMODE PLUS SYSTEM

510(k) Number K153568

Applicant Name:

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

Contact Person:

	Official Correspondent: Ahava Stein

Company Name:	A. Stein Regulatory Affairs Consulting Company Ltd.
Address:	20 Hata'as Str., Suite 102Kfar Saba 44425Israel
Tel:	+972-9-7670002
Fax:	+972-9-7668534
E-mail:	ahava@asteinrac.com
Date Prepared:	July 10, 2016
Trade Name:	InMode PLUS System

Classification Name: CFR Classification sections; 878.4400 and 890.5660 (Product codes; PBX and ISA)

Classification: Class II Medical Device

Predicate Device:

The InMode Plus System is substantially equivalent to the following predicate device:

Manufacturer	Device	510(k) No.
Viora Ltd.	Viora V-ST Handpiece (clearedtogether with the Viora V-10System)	K150035

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Device Description:

Each InMode PLUS hand piece is comprised of the hand piece handle, a cable 250 cm long, and a connector, which connects to the rear connector of the InMode PLUS System.

Two InMode PLUS hand pieces are available:

InMode PLUS hand piece (held perpendicular to the treatment area) ●
InMode PLUS90 hand piece (held parallel to the treatment area)

Following are the InMode PLUS System specifications: Maximal RF Output Power: 50 Watt RF Output Frequency: 1.0[MHz] ± 2% Maximum Temperature (skin surface): 42°C ± 2°C

Intended Use/Indication for Use:

Performance Standards:

The InMode Plus device complies with the following voluntary recognized standards:

. IEC 60601-1:2005, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance; + CORR. 1 (2006) + CORR. 2 (2007) + Amd.1(2012)
IEC 60601-1-2 (2007): Medical Electrical Equipment-Part 1: General . requirements for safety and Part 1-2 Collateral standard: Electromagnetic Compatibility-Requirements and tests; and IEC 60601-2-2 (2009): Medical Electrical Equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment (section 202.6.1 (Emission) and section 202.6.2 (Immunity).
IEC 60601-2-2 (2009): Medical Electrical Equipment Part 2: Particular . requirements for the safety of high frequency surgical equipment; for use in conjunction with IEC 60601-1:2005

Non-Clinical (Bench) Performance Data:

The following performance tests were conducted utilizing the InMode PLUS System with the Plus/Plus90 hand piece:

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1. RF output power settings and temperature elevation profile
1. Ex-vivo tissue study to evaluate the safety and temperature tissue penetration/depth profile
1. Side by side bench tests to evaluate the device RF performance settings in comparison to the predicate device

The results of the performance tests demonstrated that the InMode Plus System operates in compliance with the system requirements, emitting RF energy of up to 50W, while elevating the tissue temperature up to 42ºC. Moreover, the side by side bench test results showed that the InMode Plus System is as safe and effective as the predicate device for the same intended use.

In all, the results of the performance tests demonstrated substantial equivalence of the InMode Plus System compared to the predicate device, the Viora V10 System with the ST hand piece.

Clinical Performance Data:

Not Applicable

Sterilization and Biocompatibility:

The InMode Plus is a non-sterile, reusable device, intended for multiple patients. The device had successfully passed the cleaning validation test. All of the handpiece materials are biocompatible based on the established biocompatibility of the materials and per ISO 10993-1.

Substantial Equivalence:

The indications for use and technological characteristics of the InMode Plus System are substantially equivalent to the indications for use and technological characteristics of the Viora V10 System with the ST hand piece.

The design and components of the InMode Plus System, including the console and its components (including the power supply, RF generator, controller and display panel) and the hand piece applicators (including the cable and connector to console) are similar to the design and components found in the predicate Viora V10 System. The performance specifications (including RF Frequency and output power) of the InMode Plus System are substantially equivalent to those in the predicate device. The safety features and compliance with safety standards in the InMode Plus System are similar to the safety features and compliance with safety standards found in the predicate device. Patient contact materials are identical. The minor differences in the technological characteristics (electrode configuration and pulse vs. continuous mode) do not raise new safety or effectiveness concerns and are demonstrated to be substantially equivalent through relevant performance tests. Furthermore, the InMode Plus System underwent additional performance tests, including software verification and validation testing and electrical and mechanical safety testing according to IEC 60601-1, IEC60601-2-2 and

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electromagnetic compatibility testing according to IEC 60601-1-2. The performance tests demonstrated that the minor differences in the device specifications meet the system requirements and do not raise new safety or effectiveness concerns.

Conclusions:

Based on the substantial equivalence demonstration and the device performance tests, it can be concluded that the InMode Plus System is substantially equivalent to the predicate Viora V10 System, cleared under 510(k) K150035.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.