The InMode System with the Morpheus8 (Fractora) Applicators is intended for use in Dermatological and General Surgical procedures for Electrocoagulation and Homeostasis.

At higher energy levels greater than 62 ml/pin, use of the Morpheus8 (Fractora) Applicators is limited to Skin Types I-V.

Device Description

The InMode System with the Morpheus8 (Fractora) Applicators is a computerized, programmed, RF technology-based device intended for dermatological applications which requires skin electrocoagulation and hemostasis.

The device platform is basically constituted on the same system platform as FDA cleared for the proposed predicate device; The InMode System with the Fractora3D/3D-90 Applicators (K180189). The device applicators employ fractional RF multi-electrode technology for procedures requiring electrocoagulation and hemostasis. The Morphues8 (Fractora) Applicators are designed to deliver radiofrequency energy to the skin in a fractional manner, via an array of multielectrode pins.

The Device provides enhanced safety while minimizing possible side effects by monitoring RF parameters. The InMode System with the Morpheus8 (Fractora) Applicators consists of an AC/DC power supply unit, RF generator, controller and user interface including LCD touch screen. The Morpheus8 (Fractora) Applicators are connected to the console via a cable and a foot switch activates the energy delivery to the applicator. The subject device applicator comprises a disposable, single use, fractional RF electrode pins tip head.

The InMode System with the Morpheus8 (Fractora) Applicators comprises the following applicator tip heads:

Morpheus8 24 Pin Applicator (Fractora3D) tip (FDA Cleared in K180189)
Morpheus8 40 Pin treatment tip (New tip) .
. Morpheus8 12 Pin treatment tip (New tip)
. Morpheus8 T Pin treatment tip (New tip)

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "InMode System with the Morpheus8 (Fractora) Applicators." It establishes the substantial equivalence of this new device to a previously cleared predicate device.

Crucially, this document is for an electrosurgical cutting and coagulation device, not an AI/ML-based medical device. Therefore, the questions related to AI/ML device performance, such as ground truth, multi-reader multi-case studies, training sets, and expert consensus, are not applicable to the information contained in this document.

The primary acceptance criteria for this type of device, as per the document, revolve around substantial equivalence to a predicate device in terms of:

Intended Use/Indications for Use
Technological Characteristics
Safety and Effectiveness (demonstrated through performance testing and compliance with recognized standards).

Here's a breakdown of the relevant information provided in the document concerning the device's acceptance criteria and the study proving it meets those criteria:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate device (InMode System with the Fractora3D/3D-90 Applicators, 510(k) No. K180189). The 'studies' are non-clinical bench performance tests.

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance
Intended Use Equivalence: Device intended for Dermatological and General Surgical procedures for Electrocoagulation and Hemostasis. Specific limitation: At higher energy levels (>62 mJ/pin), use is limited to Skin Types I-IV.	The subject device's Indications for Use are identical: "The InMode System with the Morpheus8 (Fractora) Applicators is intended for use in Dermatological and General Surgical procedures for Electrocoagulation and Hemostasis. At higher energy levels greater than 62 mJ/pin, use of the Morpheus8 (Fractora) Applicator is limited to Skin Types I-IV."
Technological Characteristics Equivalence:
- Dimensions (physical size)	Predicate: 46cm W x 46cm D x 100cm H (18.2" W x 18.2" D x 40" H) Subject: Identical
- Weight (Platform & Applicator)	Predicate: Platform: 32 Kg (70.5 lbs.); Applicator: 0.4 Kg (1.26 lbs.), Tip: 0.02 Kg Subject: Identical
- Applicator Tip Heads	Predicate: Morpheus8 (Fractora3D) 24 tip head Subject: Morpheus8 (Fractora) 12 tip head (New), 24 tip head (Predicate tip), 40 tip head (New), T tip head (New)
- Number of Pins	Predicate: 24 pins Subject: 12-40 pins
- Maximal Treatment Depth	Predicate: 4.0mm Subject: 4.0mm (T tip head - 0.5mm Fixed)
- Cable Dimensions	Predicate: 250 cm Subject: Identical
- Performance (RF Frequency)	Predicate: 1 MHz Subject: Identical
- Performance (Maximal RF Output Power)	Predicate: 65W Subject: Identical
Safety and Performance Standards Compliance: Compliance with recognized electrical safety and EMC standards.	Predicate: IEC 60601-1, IEC 60601-1-2, ANSI AAMI 60601-2-2 Subject: Identical compliance, confirmed through testing.
Biocompatibility: Patient contact materials are safe.	Predicate: Materials defined Subject: "All of the modified device materials which come in direct contact with the patient skin are biocompatible and identical to the materials used in the predicate device manufacturing."
Sterilization: Methods for applicator tip heads are valid.	Predicate: For single use, non-sterilized, to be sterilized prior to use. Subject: For single use, all applicator tip heads are gamma sterilized. "Sterilization methods applied on the device applicator tip heads were validated in accordance with ISO 11137-1."
RF Output Performance Specifications: Equivalent performance across key RF parameters (pulse duration, energy per pin, total energy, pick-to-pick voltage).	"The results demonstrate equivalent measurements obtained for the subject and predicate devices." Testing done with new and existing tips across different RF energy levels and resistance loads.
Software Validation: Software meets requirements.	"Software validation testing" was conducted. (No details on whether it was formal criteria or simply "meets requirements")
Electrical and Mechanical Safety Testing: Meets requirements.	"Electrical and mechanical safety testing to IEC 60601-1" was conducted. (No details on whether it was formal criteria or simply "meets requirements")
Electromagnetic Compatibility Testing (EMC): Meets requirements.	"Electromagnetic compatibility testing according to IEC 60601-1-2 and IEC 60601-2-2" was conducted. (No details on whether it was formal criteria or simply "meets requirements")

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

Sample Size for Test Set: Not applicable in the traditional sense of a clinical or image-based AI/ML test set. The 'test set' here consists of the subject device (InMode System with new Morpheus8 applicators) comparing its performance and characteristics against the predicate device.
Data Provenance: The tests are non-clinical bench performance tests. Data is proprietary to the manufacturer (InMode MD Ltd.) and was collected as part of their device development and regulatory submission process. There is no mention of country of origin for data related to patients or clinical studies, as none were required or performed. The tests are "retrospective" in the sense that they were performed after the device was manufactured to verify its specifications.

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

This is not applicable as there is no "ground truth" established by experts in the context of an AI/ML device for diagnostic purposes. The ground truth for performance here is the physical output of the device and its compliance with engineering specifications and recognized safety standards, measured by calibrated equipment.

4. Adjudication Method for the Test Set

Not applicable for this type of device. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among human readers or labelers, typically in image interpretation for AI/ML ground truth generation. Here, the "test" is largely a comparison of engineering specifications and performance with those of a predicate device and relevant standards.

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

No. This type of study is for evaluating human performance, often with and without AI assistance, especially in diagnostic imaging. It is not relevant for an electrosurgical device like the InMode System.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) was Done

Not applicable. There is no "algorithm" in the sense of an AI/ML model being assessed independently. The performance assessed is the device's physical output and adherence to safety standards.

7. The Type of Ground Truth Used

The "ground truth" implicitly used for this device's performance evaluation comprises:
- Engineering Specifications: The design parameters and operational capabilities of the device as per its intended function (e.g., RF output power, frequency, energy per pin, dimensions).
- Recognized Consensus Standards: Compliance with international standards for medical electrical equipment (IEC 60601 series, AAMI/ANSI standards) and sterilization (ISO 11137-1).
- Predicate Device Performance: The established performance and safety characteristics of the legally marketed predicate device (K180189) serve as the benchmark for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. As no training set is involved, no ground truth needed to be established for it.

Summary

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December 27, 2019

Inmode MD Ltd. % Amit Goren Regulatory Manager A. Stein- Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba, 4442520 Il

Re: K192695

Trade/Device Name: InMode System with the Morpheus8 (Fractora) Applicators Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: November 25, 2019 Received: November 27, 2019

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 (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 located 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.

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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.

For Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name

InMode System with the Morpheus8 (Fractora) Applicators

Indications for Use (Describe)

The InMode System with the Morpheus8 (Fractora) Applicators is intended for use in Dermatological and General Surgical procedures for Electrocoagulation and Homeostasis.

At higher energy levels greater than 62 ml/pin, use of the Morpheus8 (Fractora) Applicators is limited to Skin Types I-V.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(K) SUMMARY

INMODE RF SYSTEM

510(k) Number K192695

Applicant Name:

Company Name:	InMode Ltd
Address:	Tabor Building, Shaar YokneamPOB 44, Yokneam 20692IsraelTel: +972-4-9097470Fax: +972-4-9097471E-mail: amit@asteinrac.com
Contact Person:	Amit Goren
Official Correspondent:	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 25, 2019
Trade Name:	InMode System with the Morpheus8 (Fractora) Applicators
Classification Name:	CFR Classification section 878.4400; (Product code GEI)
Classification:	Class II Medical Device

Predicate Device:

The subject device is substantially equivalent to the following predicate device:

Device	Manufacturer	510(k) No.
InMode System with theFractora3D/3D-90 Applicators	InMode MD Ltd.	K180189

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Device Description:

The InMode System with the Morpheus8 (Fractora) Applicators comprises the following applicator tip heads:

Morpheus8 24 Pin Applicator (Fractora3D) tip (FDA Cleared in K180189)
Morpheus8 40 Pin treatment tip (New tip) .
. Morpheus8 12 Pin treatment tip (New tip)
. Morpheus8 T Pin treatment tip (New tip)

Device Specifications:

Main Line Frequency (nominal)	50 - 60 Hz
Input Voltage (nominal)	100 - 240 VAC
Electrosurgical Unit dimensions (inch)	18.2"W x18.2"D x40"H
Platform weight (lb.)	70.5
Applicator weight (lb.)	1.26
RF Max Output Power (Watt)	65
RF Output Frequency (MHz)	$1\pm 2%$

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Intended Use/Indication for Use:

The InMode System with the Morpheus8 (Fractora) Applicators 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 Morrpheus8 (Fractora) Applicator is limited to Skin Types I-IV.

Performance Standards:

The InMode System with the Morpheus8 (Fractora) Applicators 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.

Non-Clinical (Bench) Performance Data:

The InMode System with the Morpheus8 (Fractora) Applicators was tested for its applicator tip RF output performance specifications. The device utilizing the Morphues8 12, 24, 40 pin and T tip heads preset to different RF energy levels, was tested under different resistance loads with the following parameters measured and compared to the results obtained in similar testing conducted on the predicate device: pulse duration, energy per pin, total energy, and pick to pick voltage. The results demonstrate equivalent measurements obtained for the subject and predicate devices.

Animal Performance Data / Histology Data:

Not Applicable

Clinical Performance Data:

Not Applicable

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Biocompatibility

All of the modified device materials which come in direct contact with the patient skin are biocompatible and identical to the materials used in the predicate device manufacturing.

Substantial Equivalence:

A comparison table is provided below comparing the intended use and basic technological characteristics of the InMode System with the Morpheus8 (Fractora) Applicators to the intended use and basic technological characteristics of the predicate device.

TechnologicalCharacteristic	InMode System with theMorpheus8 (Fractora)ApplicatorsInMode Ltd.(K192695)	InMode System with theFractora3D/3D-90ApplicatorsInMode MD Ltd.(K180189)
Dimensions	46cm W x 46cm D x100cm H[18.2" W x 18.2" D x40" H]	46cm W x 46cm D x100cm H[18.2" W x 18.2" D x40" H]
Weight
Platform weight	32 Kg (70.5 lbs.)	32 Kg (70.5 lbs.)
Applicator weight	0.4 Kg (1.26 lbs.)Tip weight - 0.02 Kg	0.4 Kg (1.26 lbs.)Tip weight - 0.02 Kg
Applicator Tip Heads:	Morpheus8 (Fractora) 12 tip head Morpheus8 (Fractora) 24 tip head Morpheus8 (Fractora) 40 tip head Morpheus8 (Fractora) T tip head	Morpheus8 (Fractora3D)24 tip head
Number of pins	12-40 pins	24 pins
Maximal Treatmentdepth	4.0mmT tip head - 0.5mm(Fixed)	4.0mm
Cable Dimensions:	250 cm	250 cm
Performance	Frequency: 1 MHz	Frequency: 1 MHz

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TechnologicalCharacteristic	InMode System with theMorpheus8 (Fractora)ApplicatorsInMode Ltd.(K192695)	InMode System with theFractora3D/3D-90ApplicatorsInMode MD Ltd.(K180189)
	Maximal RF outputpower: 65W	Maximal RF outputpower: 65W
Standards Met	IEC 60601-1IEC 60601-1-2ANSI AAMI 60601-2-2for safety of highfrequency surgicalequipment	IEC 60601-1IEC 60601-1-2ANSI AAMI 60601-2-2for safety of highfrequency surgicalequipment
Reprocessing &Sterilization	For single use.All applicator tip headsare gamma sterilized.	For single use.Non-sterilized. To besterilized prior to use.

Comparison Discussion:

The indications for use and technological characteristics of the modified device are substantially equivalent to the indications for use and technological characteristics of the predicate device.

The design and components of the modified device, including the console (with power supply, RF generator, controller and display panel) and the Applicator handle (with cable and connector to console) are identical to the design and components found in the predicate device. The modified device comprises the predicate device Morpheus8 (Fractora) 24 pin tip head and additional three compatible tip heads; the Morpheus8 (Fractora) 12, 40 pin and T tip heads. The performance specifications (including RF frequency, pulse duration, RF current distribution and RF energy per pin) of the modified device are comparable to those of the predicate device. The safety features and compliance with safety standards in the modified device are identical to the safety features and compliance with safety standards found in the predicate device. Patient contact materials are also identical. Any minor differences in the technological characteristics do not raise new safety or effectiveness concerns. Furthermore, the modified device underwent bench performance testing, including software validation testing, electrical and mechanical safety testing to IEC 60601-1 and electromagnetic compatibility testing according to IEC 60601-1-2 and IEC 60601-2-2. Sterilization methods applied on the device applicator tip heads were validated in accordance with ISO 11137-1.

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The 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 System with the Morpheus8 (Fractora) Applicators is substantially equivalent to the predicate InMode System with the Fractora3D/3D-90 Applicators, FDA cleared in 510(k) K180189, and therefore, may be legally marketed in the USA.

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.