Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a computerized electrical stimulation device with user-controlled parameters and standard bench testing, with no mention of AI/ML terms, image processing, or data sets for training/testing.

Therapeutic

Yes
The device is described as providing electrical stimulation and neuromuscular reeducation for the rehabilitation of weak pelvic floor muscles to treat urinary incontinence, which is a therapeutic purpose.

Diagnostic

No.
The device is intended for "rehabilitation of weak pelvic floor muscles" through electrical stimulation and neuromuscular reeducation, which is a therapeutic function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as an AC/DC power supply unit, controller, LCD touch screen, fans, and a single-use applicator, indicating it is a hardware-based medical device with integrated software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to provide electrical stimulation and neuromuscular reeducation for the rehabilitation of weak pelvic floor muscles. This is a therapeutic treatment applied directly to the patient's body.
Device Description: The device description details a system that delivers electrical energy through an applicator. This is consistent with a therapeutic device, not a device that analyzes samples from the human body.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to directly treat a condition within the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The InMode System with the vTone Applicator is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge, and mixed urinary incontinence in women.

Product codes (comma separated list FDA assigned to the subject device)

KPI

Device Description

The InMode System is a computerized device intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge, and mixed urinary incontinence in women. . The System consists of an AC/DC power supply unit, controller and user interface including an LCD touch screen. The single use vTone Applicator is connected to the console via pulse generator adaptor.

The delivery of the electrical energy is controlled by a Start/Stop button positioned on the LCD screen.

The System emits an electrical signal of rectangular bi-phasic wave, and allows selecting intensity level of stimulation pulses from 1 to 50 intensity levels (equivalent to 5-54V). The system pulse width ranges from 50 to 450usec.

The system pulse frequency ranges from 3 to 100Hz. In addition, the device emits the pulses in bursts of 1-60 sec, with a succeeding relaxation time of 1-60 sec, depending on the intensity level chosen by the user.

The System supports the following components:

LCD display touch screen
Audio loudspeaker
48V AC/DC power supply
Controller
Fans

The System operates while connected to the following applicator:

vTone Applicator

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Body parts requiring treatment as specified in the indication for use

Indicated Patient Age Range

Adult Population which require treatment as specified in the indication for use

Intended User / Care Setting

Hospital or Clinic setting

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench testing was conducted to demonstrate that the InMode System with vTone Applicator performs as expected under anticipated conditions of use and to verify that the device performance meets the device design requirements. The device was tested for validation of output waveform, basic unit characteristics, and output specifications.

The bench testing results demonstrated that the device performs as expected under anticipated conditions of use

The biocompatibility of the vTone Applicator outer components (handle and electrodes) was verified in a set of Biocompatibility Tests in accordance with the Biocompatibility classification set forth in ISO 10993-1:2018 and in compliance with the FDA Guidance Document on Medical Device Biocompatibility; "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" Issued June 16, 2016.

The following biocompatibility tests were performed as part of the biocompatibility assessment:

Cytotoxicity Study Using the ISO Elution Method: The test article extract showed no evidence of causing cell lysis or toxicity. Conclusion: Non-toxic.
ISO Acute Systemic Toxicity Study in Mice: There was no mortality or evidence of systemic toxicity from the extracts injected into mice. Conclusion: Non-toxic.
ISO Guinea Pig Maximization Sensitization Test: The test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig. Conclusion: No irritation/sensitization.
ISO Vaginal Irritation sensitization in rabbit: The test article extract was considered a nonirritant to vaginal tissue of the rabbit. Conclusion: No irritation.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K081480

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 876.5320 Nonimplanted electrical continence device.

(a)
Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

May 5, 2020

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

Re: K200293

Trade/Device Name: InMode System with vTone Applicator Regulation Number: 21 CFR§ 876.5320 Regulation Name: Nonimplanted electrical continence device Regulatory Class: II Product Code: KPI Dated: January 30, 2020 Received: February 5, 2020

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.

1

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidanceregulatory-information/postmarketing-safety-reporting-combination-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-devices/medical-devicesafety/medical-device-reporting-mdr-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/medical-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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-andconsumer-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,

Purva Pandya Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K200293

Device Name InMode System with vTone Applicator

Indications for Use (Describe)

The InMode System with the vTone Applicator is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge, and mixed urinary incontinence in women.

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

510(K) SUMMARY

THE INMODE SYSTEM WITH THE VTONE APPLICATOR

510(k) Number K200293

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: amit@asteinrac.com
Contact Person:	Amit Goren
Official Correspondent:
Company Name:	A. Stein - Regulatory Affairs Consulting Ltd.
Address:	20 Hata'as Str., Suite 102
Kfar Saba 4442520 Israel
Tel: +972-9-7670002
Fax: +972-9-7668534
E-mail: amit@asteinrac.com
Date Prepared:	April 21, 2020
Trade Name:	The InMode System with vTone Applicator
Classification Name:	CFR Classification section 876.5320;
(Product code: KPI)
Nonimplanted Electrical Continence Device
Classification:	Class II Medical Device

Predicate Device:

The InMode System with vTone Applicator is substantially equivalent to the following predicate device.

Predicate	Manufacturer	510(k) No.
Kegel8 device	Mantra International (HK) Ltd	K081480

4

Device Description:

The InMode System is a computerized device intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge, and mixed urinary incontinence in women. . The System consists of an AC/DC power supply unit, controller and user interface including an LCD touch screen. The single use vTone Applicator is connected to the console via pulse generator adaptor.

The delivery of the electrical energy is controlled by a Start/Stop button positioned on the LCD screen.

The System emits an electrical signal of rectangular bi-phasic wave, and allows selecting intensity level of stimulation pulses from 1 to 50 intensity levels (equivalent to 5-54V). The system pulse width ranges from 50 to 450usec.

The system pulse frequency ranges from 3 to 100Hz. In addition, the device emits the pulses in bursts of 1-60 sec, with a succeeding relaxation time of 1-60 sec, depending on the intensity level chosen by the user.

The System supports the following components:

LCD display touch screen ●
Audio loudspeaker ●
48V AC/DC power supply ●
. Controller
Fans

The System operates while connected to the following applicator:

· vTone Applicator
Following are The InMode System with vTone Applicator specifications:

Main Line Frequency (nominal):	50-60 Hz
Input Voltage (nominal):	100-240 VAC
Input Current (rms):	2A
Dimensions:
Console	35cm W x 35cm D x 100cm H
[W x H x D]	[18.2" W x 18.2" D x 40" H]
vTone Applicator	8.8cm L x 2.8cm D

5

[L x D]	[3.5'' L x 1.1'' D]
Console Weight:	20 Kg (44 lbs)
vTone Applicator Weight:	0.11 Kg [0.25 lbs.]
vTone electrode material	Chrome coated plastic
vTone electrode size	9.58cm2
Platform modules	Converts AC input voltage (100-240VAC) to
AC/DC power supply	48Vdc, 300W
Waveform	Biphasic
Shape	Rectangular
Intensity (output Voltage)	Up to 50 intensity level (=54 Vpeak)
Pulse Width	50 to 450 usec
Frequency	3 to 100 Hz

Intended Use/Indication for Use:

The InMode System with the vTone Applicator is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge, and mixed urinary incontinence in women.

6

Performance Standards:

The InMode System with vTone Applicator has been tested and complies with the following FDA recognized consensus standards:

· IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements For Basic Safety And Essential Performance ES60601-1:2005/(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 Edition 3rd, MOD)
· IEC 60601-1-2: Medical electrical equipment; Part 1-2: Collateral Standard: Electromagnetic compatibility - Requirements and tests, Edition 4.0 (2014). Environment of intended uses: Professional Healthcare Facility Environment
· IEC 60601-2-10 Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators (IEC 60601-2-10 Edition 2.1 2016-04) IEC 60601-2-10: 2012, AMD1:2016 for use in conjunction with IEC 60601-1:2005/AMD1:2016
· IEC 60601-1-6 Medical Electrical Equipment Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability (60601-1-6 Edition 3.1 2013-10, AMD1:2013)

Non-Clinical (Bench) Performance Data:

Bench testing was conducted to demonstrate that the InMode System with vTone Applicator performs as expected under anticipated conditions of use and to verify that the device performance meets the device design requirements. The device was tested for validation of output waveform, basic unit characteristics, and output specifications.

The bench testing results demonstrated that the device performs as expected under anticipated conditions of use

The biocompatibility of the vTone Applicator outer components (handle and electrodes) was verified in a set of Biocompatibility Tests in accordance with the Biocompatibility classification set forth in ISO 10993-1:2018 and in compliance with the FDA Guidance Document on Medical Device Biocompatibility; "Use of International Standard ISO

7

10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" Issued June 16, 2016.

The following biocompatibility tests were performed as part of the biocompatibility assessment:

Test	Test Summary	Conclusions
Cytotoxicity Study Using the ISO
Elution Method	The test article extract
showed no evidence of
causing cell lysis or
toxicity	Non-toxic
ISO Acute Systemic Toxicity Study
in Mice	The test article extracts
showed no evidence of
causing delayed dermal
contact sensitization in the
guinea
pig.	Non-toxic
ISO Guinea Pig Maximization
Sensitization Test	There was no mortality or
evidence of systemic
toxicity from the extracts
injected into mice	No irritation/
sensitization
ISO Vaginal Irritation sensitization
in rabbit	The test article extract was
considered a nonirritant to
vaginal tissue of the rabbit	No irritation

Pre-Clinical (Animal) Performance Data:

Non-Applicable.

Clinical Performance Data:

Non-Applicable.

8

Substantial Equivalence:

The below table summarizes the main comparison aspects between the InMode System with vTone Applicator and the proposed predicate devices; The InMode System with the vTone Applicator is substantially equivalent to the previously FDA cleared Kegel 8 device (manufactured by Mantra International (HK) Ltd.), subject of 510(k) files no. K081480

Characteristic	Subject Device	Predicate
510(k) file No.	K200293	K081480
Device Name	InMode System with
vTone Applicator	Kegel8
Equivalence	Platform vTone Applicator	NA Applicator
Manufacturer	InMode Ltd.	Mantra International (HK) Ltd
Prescription/O
TC	Prescription	Prescription
Class, Product
Code.	Class II
KPI	Class II
KPI
Indications for
Use	The InMode System with
the vTone Applicator is
intended to provide
electrical stimulation and
neuromuscular re-
education for the purpose
of rehabilitation of weak
pelvic floor muscles for
the treatment of stress,
urge, and mixed urinary
incontinence in women	The 'Kegel8' Pelvic Muscle
Trainer is intended to provide
electrical stimulation and
neuromuscular re-education for
the purpose of rehabilitation of
weak pelvic floor muscles for
the treatment of stress urge and
mixed urinary incontinence in
women
Target
Population	Adult Population which
require treatment as
specified in the indication
for use	Idem
Anatomical
Sites	Body parts requiring
treatment as specified in
the indication for use	Idem
Environment
Used	Hospital or Clinic setting	Idem
Characteristic	Subject Device	Predicate
510(k) file No.	K200293	K081480
Device Name	InMode System with
vTone Applicator	Kegel8
Equivalence	• Platform
• vTone Applicator	• NA
• Applicator
Manufacturer	InMode Ltd.	Mantra International (HK) Ltd
Design:	The InMode System with
vTone Applicator consists
of an AC/DC power
supply unit, controller and
user interface including
an LCD touch screen. The
delivery of the electrical
energy is controlled by a
Start/Stop button
positioned on the front
panel.

The System support the
following components:

• LCD display touch
screen
• Audio loudspeaker
• 48V AC/DC power
supply
• Controller

The System operates
while connected to the
following applicator:

• vTone Applicator | The Kegel8 Pelvic Muscle
Trainer is a small lightweight
battery powered dual
channel neuromuscular
stimulation device supplied with
a vaginal two electrode
stimulation probe.