The InMode WMFace device with the FRF Applicator employs fractional RF multielectrode technology for procedures requiring electrocoagulation and hemostasis. The FRF Applicator is designed to deliver radiofrequency energy to the skin in a fractional manner, via an array of multi-electrode pins. The Device provides enhanced safety while minimizing possible side effects by monitoring RF parameters.

The InMode WMFace device with the FRF Applicator consists of an AC/DC power supply unit, RF generator, controller and user interface including a LCD screen and functional buttons. The FRF Applicator 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 disposable, single use, 24 electrode pin array tip.

Following are the InMode WMFace device with the FRF Applicator specifications: FRF Applicator RF Max Output Power: 65 Watt FRF Applicator RF Output Frequency: 1[MHz] ± 2% Dimension: 46cm W x 46cm 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 Input Voltage (nominal): 100-240 VAC

AI/ML Overview

The provided text describes a 510(k) premarket notification for the InMode FRF Applicator, a medical device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or clinical superiority. Therefore, the information provided does not detail a study proving the device meets specific performance acceptance criteria in the way a clinical trial for a new drug or a novel AI diagnostic device would.

Instead, the "study" proving the device meets acceptance criteria for 510(k) clearance is primarily a demonstration of its substantial equivalence to a predicate device through:

Bench testing: Verifying its output parameters are similar to the predicate and meet design requirements.
Animal study: Assessing its safety and ability to achieve specified indications in an animal model.
Compliance with recognized standards: Adhering to electrical safety and electromagnetic compatibility standards.

Given this context, I will address the questions as they relate to the information available in the document, acknowledging where the requested information (e.g., about AI performance metrics, MRMC studies, or multi-expert ground truth establishment for a test set) is not applicable to a 510(k) for an electrosurgical device.

Here's a breakdown of the acceptance criteria and the "study" evidence:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by 510(k) process)	Reported Device Performance/Evidence
Substantial Equivalence to Predicate Device (EndyMed Intensif Applicator K130501)
Similar Indications for Use	"The InMode FRF Applicator is intended for use in Dermatologic and General Surgical procedures for Electrocoagulation and Hemostasis." (Page 2). This matches the stated purpose of the predicate (implied by the substantial equivalence claim).
Similar Technological Characteristics/Design	"The design and components in the InMode FRF System...are similar to the design and components found in the predicate Endymed Intensif System." (Page 6). Includes AC/DC power supply, RF generator, controller, user interface, handpiece, disposable single-use 24-electrode pin array tip.
Similar Performance Specifications (RF output parameters)	"The performance specifications of the InMode FRF Applicator were shown to be similar and yielded RF energy per pin values in the range of the EndyMed Intensif Applicator specifications." (Page 6). Specifics: Max Output Power: 65 Watt, RF Output Frequency: 1MHz ± 2%. Bench tests demonstrated compliance with design requirements and similar RF output parameters to the predicate.
Equivalent Safety Features and Compliance with Safety Standards	"The safety features and compliance with safety standards in the InMode FRF Applicator are similar to the safety features and compliance with safety standards found in the predicate device." (Page 6). Complies with: AAMI/ANSI 60601-1 (General Requirements For Basic Safety And Essential Performance), IEC 60601-1-2 (Electromagnetic Compatibility), IEC 60601-2-2 (Particular Requirements For High Frequency Surgical Equipment).
No New Safety or Effectiveness Concerns Raised by Minor Differences	"Any minor differences in the technological characteristics do not raise new safety or effectiveness concerns." (Page 6). Confirmed through performance testing (software validation, electrical/mechanical safety, EMC), and animal pre-clinical testing.
Biocompatibility	"All of the InMode FRF Applicator tip materials are biocompatible." (Page 5).
Sterilization Efficacy (for single-use, non-sterile components)	"The InMode FRF Applicator tip is for single use and provided non-sterile to the user. The user must follow the sterilization procedures as specified in the user manual and sterilize the Applicator tip in approximation to the treatment." (Page 5). This constitutes the instruction for use, implying the procedure is effective when followed.
Safety and Effectiveness in Achieving Indications (Electrocoagulation and Hemostasis)	Demonstrated through an animal study: "The animal study results show that the InMode FRF Applicator is safe for use and effective in achieving the specified indications of dermatological and general electrocoagulation and hemostasis." (Page 5). This directly addresses a core functional criteria.

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

Test Set (for performance validation):
- Bench Test: No specific "sample size" of devices or measurements is given, but it implies multiple tests were conducted to measure accuracy and consistency of RF output. "Performance bench tests were conducted to measure the accuracy and consistency of the RF output parameters..." (Page 5).
- Animal Study: The study was conducted on a "swine model." The specific number of animals is not provided.
Data Provenance: Not specified, but standard for pre-market notification submissions implies industry-sponsored testing typically conducted in the country of origin of the manufacturer (Israel, in this case, for InMode MD Ltd.). The animal study was "pre-clinical." Both bench testing and animal studies are typically prospective tests designed for regulatory submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This question is N/A as it pertains to AI/diagnostic device ground truth establishment, which is not relevant for this electrosurgical device's 510(k) submission. The "ground truth" for this device's performance is objective measurements (RF output), observation of tissue effects in an animal model, and compliance with engineering and safety standards.

4. Adjudication Method for the Test Set

N/A. This concept applies to human reader studies for diagnostic performance, not the bench and animal testing described here.

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

No, an MRMC study was not done. This type of study is relevant for AI-assisted diagnostic tools measuring human reader performance. The document explicitly states "Clinical Performance Data: Not Applicable" (Page 5).

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

N/A. This device is not an algorithm; it is an electrosurgical tool. Its "standalone" performance is assessed through its physical outputs (RF energy) and effects on tissue, as demonstrated in bench and animal studies.

7. The Type of Ground Truth Used

For Bench Testing: The "ground truth" was the predefined design requirements and the RF output parameters of the predicate device. The device's measured RF output was compared to these established values.
For Animal Performance Data: The "ground truth" for safety and effectiveness was established by histology analysis of tissue post-treatment in the swine model, performed immediately, 7, 14, and 21 days post-treatment. This is a form of pathology/histological outcomes data. The observation of electrocoagulation and hemostasis in vivo also serves as direct evidence.

8. The Sample Size for the Training Set

N/A. This device is not an AI algorithm that requires a training set.

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

N/A. This device is not an AI algorithm.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center of the logo is an abstract symbol of a human figure, represented by three overlapping profiles.

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

January 4, 2016

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

Re: K151273

Trade/Device Name: InMode FRF Applicator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: OUH Dated: December 1, 2015 Received: December 4, 2015

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 (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 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/Resourcesfor You/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,

David Krause -S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K151273

Device Name InMode FRF Applicator

Indications for Use (Describe)

The InMode FRF Applicator is intended for use in Dermatologic and General Surgical procedures for Electrocoagulation and Hemostasis.

At higher energy levels greater than 62 m.Jpin, use of the FRF applicator is limited to Skin Types I-IV.

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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510(K) SUMMARY INMODE FRF APPLICATOR

510(k) Number K151273

Applicant Name:

Company Name:	InMode MD Ltd.
Address:	Tabor Building, Shaar Yokneam
	Yokneam 20692
	Israel
	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 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:	December 29, 2015

Trade Name: InMode FRF Applicator

Classification Name: CFR Classification section 878.4400; Classification Product Code: OUH Subsequent Product Code: GEI

Classification: Class II Medical Device

Predicate Device:

The InMode FRF Applicator is substantially equivalent to the following predicate device;

Manufacturer	Device	510(k) No.
EndyMedMedical Ltd.	Intensif Applicator	K130501

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Device Description:

The InMode FRF Applicator is a treatment hand piece attached the FDA cleared InMode WMFace treatment system (K140926).

Intended Use/Indication for Use:

The InMode FRF Applicator is intended for use in Dermatologic and General Surgical procedures for Electrocoagulation and Hemostasis .

At higher energy levels greater than 62 mJ/pin, use of the FRF applicator is limited to Skin Types I-IV.

Performance Standards:

The InMode FRF Applicator has been tested and complies with the following voluntary recognized standards:

AAMI/ANSI 60601-1:2005/(R)2012 And A1:2012,, C1:2009/(R)2012 And ● A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, Mod).
IEC 60601-1-2 Edition 3: 2007-03. Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.

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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.

Biocompatibility & Sterilization

All of the InMode FRF Applicator tip materials are biocompatible.

The InMode FRF Applicator tip is for single use and provided non-sterile to the user. The user must follow the sterilization procedures as specified in the user manual and sterilize the Applicator tip in approximation to the treatment.

Non-Clinical (Bench) Performance Data:

Performance bench tests were conducted to measure the accuracy and consistency of the RF output parameters of the InMode FRF Applicator and compare them to the specific design requirements and to the RF output parameters of the predicate device. The results of the bench tests demonstrate that the InMode FRF Applicator complies with the design requirements and consists of similar RF output specifications as the predicate device and therefore, is substantially equivalent to the predicate device.

Animal Performance Data / Histology Data:

The thermal effects of the InMode FRF Applicator and tissue healing processes were evaluated in a pre-clinical study. The study was conducted on swine model and included a single RF treatment followed by histology analysis performed immediately. 7, 14 and 21 days post treatment. The animal study results show that the InMode FRF Applicator 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 indications for use and technological characteristics of the InMode FRF Applicator are substantially equivalent to the indications for use and technological characteristics of the EndyMed Intensif Applicator.

The design and components in the InMode FRF System, including the console (with power supply, RF generator, controller and display panel) and the hand piece Applicator (with cable, connector to console, handle and tip) are similar to the design and components found in the predicate Endymed Intensif System. The performance specifications of the InMode FRF Applicator were shown to be similar and yielded RF energy per pin values in the range of the EndyMed Intensif Applicator specifications. The safety features and compliance with safety standards in the InMode FRF Applicator are similar to the safety features and compliance with safety standards found in the

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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 FRF Applicator underwent performance testing, including software validation testing, electrical and mechanical safety testing according to IEC 60601-1 and electromagnetic compatibility testing according to IEC 60601-1-2, performance bench testing and animal pre-clinical testing to evaluate the thermal effect of the device and the tissue healing process. These performance tests demonstrated that the minor differences in the device design and specifications meet the system requirements and do not raise new safety or effectiveness concerns.

Consequently, it can be concluded that the InMode FRF Applicator is substantially equivalent to the predicate EndyMed Intensif Applicator, cleared under 510(k) K130501, and therefore, may be legally marketed in the USA.

Conclusions:

Conclusively, based on the performance testing, pre-clinical testing and comparison to predicate device, the InMode FRF Applicator is substantially equivalent to the EndyMed Intensif Applicator predicate device.

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.