The InMode RF System (InMode MD Ltd.) is a computerized system generating RF energy with integral temperature and impedance feedback mechanism for procedures requiring electrocoagulation and hemostasis. The InMode RF System constantly monitors the temperature and impedance of the target treatment tissue, automatically adjusting energy delivery to maintain effective and safe tissue heating.

The InMode RF System consists of an AC/DC power supply unit, RF generator, controller and user interface including touch screen. The RF 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 is comprised of a disposable, single use; internal and external electrodes.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the InMode RF System, focusing on its substantial equivalence to a previously cleared device. The document does not contain information about explicit acceptance criteria with numerical thresholds for performance metrics and a study directly demonstrating the device meets these specific criteria. Instead, it details that the device complies with recognized consensus standards and underwent non-clinical (bench) and ex-vivo animal performance testing to support its substantial equivalence to a predicate device.

Here's an analysis of the requested information based on the provided text:

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

The document does not specify quantitative acceptance criteria or corresponding reported device performance values. It states that the device "complies with the following FDA recognized consensus standards" and that "The results of the bench tests demonstrate that the InMode RF System with the HP172206A hand piece performed in a similar way to the predicate device."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size:
- Bench Performance Data: Not explicitly stated as a number of devices or tests. It mentions "The InMode RF System with the HP172206A hand piece was utilized in bench performance tests."
- Animal Performance Data: The ex-vivo study "was conducted on three different porcine tissue models (muscle, liver & fat)." The number of tests or specific tissue samples within each model is not provided.
Data Provenance: The studies were conducted by InMode MD Ltd., an Israeli company. The text doesn't explicitly state the country where the studies were performed, but it's reasonable to infer they were likely conducted under the company's purview, possibly in Israel. The studies appear to be prospective in nature, as they involve testing the device (bench and ex-vivo).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The studies described are non-clinical (bench and ex-vivo animal studies) and do not involve human subjects or expert assessment of clinical outcomes in the way a diagnostic AI device would. The ground truth for the animal study was established through TTC staining analysis, which is a laboratory technique, not expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As noted above, this study does not involve human expert assessment of a test set that would require an adjudication method.

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 done. The device is not an AI diagnostic tool and does not involve human readers for interpretation.

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

Yes, in a sense. The "performance data" presented (bench and animal studies) describes the standalone performance of the device (InMode RF System with the HP172206A hand piece) in achieving electrocoagulation and hemostasis. This is an algorithm-only (or device-only) performance without human-in-the-loop as it's an electrosurgical device, not a diagnostic AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Bench Performance Data: Ground truth would be based on engineering specifications and measurements to confirm output power, frequency, safety parameters, etc.
Animal Performance Data: The ground truth for evaluating thermal effects was established via TTC staining analysis.

8. The sample size for the training set

Not applicable. This device is an electrosurgical system, not an AI/ML algorithm that requires a "training set" in the context of machine learning. Its operation is based on pre-programmed parameters and real-time feedback mechanisms, not learned from a dataset.

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

Not applicable. As mentioned, there is no "training set" in the machine learning sense for this device. Its development would involve engineering design, testing against physical properties, and safety standards.

Summary

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

December 12, 2016

InMode MD Ltd. % Amit Goren, Ph.D. A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba, 4442520 Israel

Re: K163190

Trade/Device Name: InMode RF System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 9, 2016 Received: November 14, 2016

Dear Dr. 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 (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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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.

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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" (21 CFR 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) K163190

Device Name InMode RF System

Indications for Use (Describe)

The InMode RF System is indicated for use in dermatological and general surgical procedures for electro-coagulation and hemostasis.

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 RF SYSTEM

510(k) Number K163190

Applicant Name:

Company Name:	InMode MD Ltd
Address:	Tabor Building, Shaar YokneamPOB 44, Yokneam 20692Israel
Tel:	+972-4-9097470
Fax:	+972-4-9097471
E-mail:	amit@asteinrac.com; ahava@asteinrac.com

Contact Person:

Official Correspondent:	Dr. Amit Goren
Company Name:	A. Stein – Regulatory Affairs Consulting Ltd.
Address:	20 Hata'as Str., Suite 102Kfar Saba 4442520 IsraelTel: +972-9-7670002Fax: +972-9-7668534E-mail: amit@asteinrac.com
Date Prepared:	November 17, 2016
Trade Name:	InMode RF System
Classification Name:	CFR Classification section 878.4400; (Product code GEI)
Classification:	Class II Medical Device

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Predicate Device:

InMode RF System is substantially equivalent to the previously cleared, InMode RF System, also manufactured by InMode MD Ltd.

Device	Manufacturer	510(k) No.
InMode RF System	InMode MD Ltd.	K151793

Device Description:

The InMode RF System is compatible with the following hand pieces:

HP101306A (optional sterile/non-sterile)
HP172206A (non-sterile) ●

Device Specifications:

Main Line Frequency (nominal)	50 - 60 Hz
Input Voltage (nominal)	100 - 240 VAC
Electrosurgical Unit dimensions (inch)	14.2"W x 18.2"D x 40"H
Platform weight (lb.)	33
RF Max Output Power (Watt)	20
RF Output Frequency (MHz)	$1\pm2%$

Intended Use/Indication for Use:

The InMode RF System is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.

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Performance Standards:

InMode RF System complies with the following FDA recognized consensus standards:

AAMI/ANSI 60601-1 (2012), Medical Electrical Equipment Part 1: General . Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, Mod).
IEC 60601-1-2 (Edition 3.0, 2007), Medical Electrical Equipment Part 1-2: . General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.
IEC 60601-2-2 Edition 5.0 2009-02, Medical Electrical Equipment Part 2-2: ● Particular Requirements For The Basic Safety And Essential Performance Of High Frequency Surgical Equipment And High Frequency Surgical Accessories.
AAMI / ANSI / ISO 11137-1:2006/(R)2010. Sterilization Of Health Care . Products - Radiation - Part 1: Requirements For Development, Validation, And Routine Control Of A Sterilization Process For Medical Devices
AAMI / ANSI / ISO 11137-2:2013, Sterilization Of Health Care Products -. Radiation - Part 2: Establishing The Sterilization Dose.
AAMI / ANSI / ISO 11737-1:2006 (R) 2011, Sterilization Of Health Care . Products - Microbiological Methods - Part 1: Determination Of The Population Of Microorganisms On Product.
AAMI / ANSI / ISO 11737-2:2009/(R) 2014, Sterilization Of Medical Devices -. Microbiological Methods - Part 2: Tests Of Sterility Performed In The Definition, Validation And Maintenance Of A Sterilization Process.
. AAMI / ANSI / ISO 11607-1:2006/(R)2010, Packaging For Terminally Sterilized Medical Devices - Part 1: Requirements For Materials, Sterile Barrier Systems And Packaging Systems
ASTM F1980-07 (Reapproved 2011). Standard Guide For Accelerated Aging Of . Sterile Barrier Systems For Medical Devices.

Non-Clinical (Bench) Performance Data:

The InMode RF System with the HP172206A hand piece was utilized in bench performance tests to evaluate the system performance specifications. The tests were performed in a similar manner as to the tests performed with the cleared predicate device. The results of the bench tests demonstrate that the InMode RF System with the HP172206A hand piece performed in a similar way to the predicate device.

Animal Performance Data / Histology Data:

The thermal effects of the InMode RF System with the HP172206A hand piece on the target tissue were evaluated in an ex-vivo study. The study was conducted on three different porcine tissue models (muscle, liver & fat) and included a single RF treatment followed by TTC staining analysis. The ex-vivo study results show that the InMode RF

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System with the HP172206A hand piece is safe for use and effective in achieving the specified indications of dermatological and general electrocoagulation and hemostasis.

Clinical Performance Data:

Not Applicable

Substantial Equivalence:

The subject of this special 510(k) pre-market notification is the InMode RF System. It is composed of the same main device components as its predicate device the InMode RF System FDA cleared under 510(k) file No.K151793 accept for the addition of modified hand piece versions. The components of modified InMode RF System, similarly to cleared, predicate device, generate its mechanism of operation using the same underlying technology for the same intended use. Delivery of monopolar RF energy through each specific hand piece is monitored and controlled by the device ESU. The user interface control panel provides the user with the optimal treatment settings. Using both modified and cleared devices the device user can decide on the optimal treatment settings and adjust these treatment settings through the control panel. Furthermore, the modified device, as the cleared device, introduces similar safety features and comply with same relevant consensus standards.

The device modifications were evaluated under design control activities and in the frame of conformity with relevant consensus standards and all potential hazards were mitigated in a set of performance activities. Performance bench and ex-vivo tests results show that the modified device was able to produce and deliver the desired RF energy according to the design requirements, which are comparable with the predicate device. Labeling material was revised to support the device modifications. All performance activates show that the modifications made to the cleared device do not pose any new safety and effectiveness concerns.

Conclusions:

Based on the comparison to predicate device and on the performance testing, the InMode RF System is substantially equivalent to the predicate InMode RF System for the mentioned indication for use.

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.