(296 days)
No
The document describes a computerized device for EMS and TENS, but there is no mention of AI or ML in the intended use, device description, or performance studies. The control is described as being via a Start/Stop button and an LCD touch screen, which are typical for non-AI/ML devices.
Yes
The device is used for medical applications such as pain management, muscle re-education, and relaxation of muscle spasms, which are therapeutic functions.
No
The provided text describes the EVOLVE System as a treatment device (electro-muscle and transcutaneous nerve stimulation) used for various medical applications like muscle relaxation, pain relief, and increasing range of motion. It does not mention any function related to diagnosing medical conditions.
No
The device description explicitly details hardware components such as an AC/DC power supply, controller, LCD touch screen, cables, connection ports, and fans, in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The EVOLVE System with the Tone Applicator is an electro-muscle and transcutaneous nerve stimulation device. It applies electrical stimulation directly to the body for therapeutic purposes (muscle relaxation, pain relief, etc.).
- Lack of Specimen Analysis: The description does not mention the device analyzing any biological specimens. Its function is based on delivering electrical energy to the body.
Therefore, the device's intended use and operation clearly fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The EVOLVE System with the Tone Applicator is an electro-muscle and transcutaneous nerve stimulation device for the treatment of different body areas.
The EVOLVE System with Tone Applicator is designed to operate in two modes - EMS and TENS.
In EMS mode it is used for:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
And in TENS mode is intended for
- Symptomatic relief and management of chronic, intractable pain
- Post-surgical acute pain
- Post-trauma acute pain
Product codes
IPF, GZJ
Device Description
The EVOLVE System in combination with Tone Applicator (manufactured by InMode Ltd.), is a computerized device intended to employ EMS (Electrical Muscle Stimulation) and TENS (Transcutaneous Electrical Nerve Stimulation) technologies for various medical applications.
The EVOLVE System with the Tone Applicator consists of an AC/DC power supply unit, controller and user interface including an LCD touch screen. The Tone Applicator is connected to the console via a cable, each of the subject device applicator units consist of a designated cable and of a connection port to be directly connected to one of the four connectors positioned on the rear side of the console. Up to four Tone Applicator units can be connected to the console simultaneously.
The delivery of the electrical energy is controlled by a Start/Stop button positioned on the LCD screen.
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 Tone Applicator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
different body areas
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Bench testing was conducted to demonstrate that the EVOLVE System with the Tone 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 subject device had underwent the required performance testing and validation testing and demonstrates its conformance with device design requirements and with applicable standards.
All user-contacting materials were tested for biocompatibility and found to comply with the ISO 10993-1 standard. Furthermore, the design and development phases of the subject device were validated throughout a set of performance tests, including software validation testing, electrical and mechanical safety testing according to IEC 60601-1 standard, electromagnetic compatibility testing according to IEC 60601-1-2 standard, safety and essential performance of nerve and muscle stimulators testing according to IEC 60601-2-10 standard, and bench performance tests. All in all, these performance tests demonstrated that the device specifications meet the system requirements and do not raise new safety or effectiveness concerns.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 5, 2021
InMode Ltd. % Amit Goren Regulatory Manager A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba, 4442520 Israel
Re: K201285
Trade/Device Name: Evolve System with the Tone Applicator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, GZJ Dated: May 10, 2020 Received: May 13, 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.
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
1
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 (OS) 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 mediation-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,
Jitendra Virani Acting Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201285
Device Name
EVOLVE System with the Tone Applicator
Indications for Use (Describe)
The EVOLVE System with the Tone Applicator is an electro-muscle and transcutaneous nerve stimulation device for the treatment of different body areas.
The EVOLVE System with Tone Applicator is designed to operate in two modes - EMS and TENS.
In EMS mode it is used for:
- Relaxation of muscle spasms
- · Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- · Muscle re-education
- · Maintaining or increasing range of motion
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
And in TENS mode is intended for
- · Symptomatic relief and management of chronic, intractable pain
- · Post-surgical acute pain
- Post-trauma acute pain
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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3
510(K) SUMMARY
THE EVOLVE SYSTEM WITH THE TONE APPLICATOR
510(k) Number K201285
Applicant Name: Company Name: InMode Ltd. Tabor Building, Shaar Yokneam Address: Yokneam 20692 Israel Tel: +972-4-9097470 Fax: +972-4-9097471 E-mail: amit(@asteinrac.com Contact Person: Official Correspondent: Amit Goren A. Stein - Regulatory Affairs Consulting Ltd. Company Name: 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: February 11, 2021 Trade Name: EVOLVE System with the Tone Applicator Powered muscle stimulator, Transcutaneous electrical Classification Name: nerve stimulator for pain relief Regulation No .: 890.5850, 882.5890 Product Codes: IPF, GZJ Classification: Class II Medical Device
Predicate Device:
The EVOLVE System with the Tone Applicator is substantially equivalent to the following main and reference predicate devices.
| Manufacturer | Device | 510(k) No. |
|---|---|---|
| Main Predicate | ||
| InMode System with the Tone Applicator | InMode Ltd. | K192249 |
| Reference Predicate | ||
| The EVOLVE System | InMode Ltd. | K183450 |
4
Device Description:
The EVOLVE System in combination with Tone Applicator (manufactured by InMode Ltd.), is a computerized device intended to employ EMS (Electrical Muscle Stimulation) and TENS (Transcutaneous Electrical Nerve Stimulation) technologies for various medical applications.
The EVOLVE System with the Tone Applicator consists of an AC/DC power supply unit, controller and user interface including an LCD touch screen. The Tone Applicator is connected to the console via a cable, each of the subject device applicator units consist of a designated cable and of a connection port to be directly connected to one of the four connectors positioned on the rear side of the console. Up to four Tone Applicator units can be connected to the console simultaneously.
The delivery of the electrical energy is controlled by a Start/Stop button positioned on the LCD screen.
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 Tone Applicator.
Following are The EVOLVE System with the Tone Applicator specifications:
| Main Line Frequency (nominal): | 50-60 Hz |
|---|---|
| Input Voltage (nominal): | 100-240 VAC |
| Input Current (rms) | 4A |
| Dimension: | |
| Console | 46cm W x 46cm D x 100cm H [18.2" W x |
| 18.2" D x 44" H] | |
| [W x H x D] | |
| Applicator | Tone Applicator |
| [L x D] | 12cm L x 10cm D [4.7'' L x 4'' D] |
| Weight Console: | 33 Kg (73 lbs.) |
5
| Tone Applicator Weight: | 0.22 Kg [0.5 lbs.] |
|---|---|
| Platform modules | |
| AC/DC power supply | Converts AC input voltage (100-240Vac) to |
| 6Vdc | |
| Waveform | Symmetrical Biphasic |
| Shape | Rectangular |
| Intensity (output Voltage) | Up to 50 intensity level (=54 Vpeak) |
| Pulse Width | |
| Tone Applicator | 20 to 400 $ μ$ S |
| Frequency | |
| Tone Applicator | 3 to 200 Hz |
Intended Use/Indication for Use:
The EVOLVE System with the Tone Applicator is an electro-muscle and transcutaneous nerve stimulation device for the treatment of different body areas.
The EVOLVE System with Tone Applicator is designed to operate in two modes – EMS and TENS.
In EMS mode it is used for:
- . Relaxation of muscle spasms
- . Prevention or retardation of disuse atrophy
- . Increasing local blood circulation
- . Muscle re-education
- . Maintaining or increasing range of motion
- Immediate postsurgical stimulation of calf muscles to prevent venous . thrombosis
And in TENS mode is intended for:
- Symptomatic relief and management of chronic, intractable pain
- Post-surgical acute pain
- Post-trauma acute pain
6
Performance Standards:
The EVOLVE System with the Tone Applicator has been tested and complies with the following FDA recognized consensus standards:
[Rec. Number 19-4] ANSI AAMI ES 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
[Rec. Number 19-8] IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests
[Rec. Number 17-16] IEC 60601-2-10 Edition 2.1 2016-04 Medical Electrical Equipment - Part 2-10: Particular Requirements for The Basic Safety and Essential Performance of Nerve and Muscle Stimulators
[Rec. Number 5-89] IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance -Collateral standard: Usability
Sterilization/Disinfection/Cleaning:
The cleaning and reprocessing instructions set forth in the device user manual for all of the reprocessed device Applicator components. The handle should be thoroughly cleaned by the user by using 70% alcohol absorbed pad for at least 30 sec. The user should carefully examine the applicator components prior to their assembly and usage for complete drying and for any visible damage.
The device user manual and device labels, provide users with the proper symbolling and instructions/warnings for safe and effective device use and for a safe discard of the single use components upon their usage.
7
All device materials in contact with the patient are biocompatible.
Non-Clinical (Bench) Performance Data:
Bench testing was conducted to demonstrate that the EVOLVE System with the Tone 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.
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 EVOLVE System with the Tone Applicator and the proposed predicate device.
| Characteristic | Subject Device | Predicate |
|---|---|---|
| 510(k) file No. | K201285 | K192249 |
| Device Name | EVOLVE System with | |
| the Tone Applicator | InMode System with the | |
| Tone Applicator | ||
| Manufacturer | InMode MD Ltd. | InMode MD Ltd. |
| Class, Product Code. | Class II | |
| IPF GZJ | Class II | |
| IPF, GZJ | ||
| Design: | The EVOLVE System with | |
| Tone 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 supports the
following components:
● LCD display touch
screen
● Audio loudspeaker
● 48V AC/DC power
supply
● Controller
● The System operates
while connected to the
Tone Applicator. | The InMode System with
Tone 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 supports the
following components:
● LCD display touch
screen
● Audio loudspeaker
● 48V AC/DC power
supply
● Controller
● The System operates while
connected to the Tone
Applicator. |
| Mechanism of Action | Muscle contraction by
electrical pulsing. | Muscle contraction by
electrical pulsing. |
| Components
Console | The EVOLVE System
consists of the following
components:
● Console, including a
power supply unit,
controller and user
interface including an
LCD touch screen. | The InMode System consists
of the following components:
● Console, including a
power supply unit,
controller and user
interface including an
LCD touch screen. |
| Characteristic | Subject Device | Predicate |
| 510(k) file No. | K201285 | K192249 |
| Device Name | EVOLVE System with
the Tone Applicator | InMode System with the
Tone Applicator |
| Manufacturer | InMode MD Ltd. | InMode MD Ltd. |
| | • Tone applicator with up
to 4 units connected to
the console via 4
designated cables and 4
designated connection
ports. | • Tone applicator with up to
2 units connected to the
console via a cable with
splitter and a single
connection port. |
| Dimension
Console
[W x H x D] | 46cm W x 46cm D x
100cm H [18.2" W x
18.2" D x 44" H] | 35cm W x 35cm D x 100cm
H [18.2" W x 18.2" D x
40" H] |
| Applicator
[L x D] | Tone Applicator
12cm L x 10cm D
[4.7" L x 4" D] | Tone Applicator
12cm L x 10cm D
[4.7" L x 4" D] |
| Weight Console | 33.0 Kg [73 lbs.] | 20.0 Kg [44 lbs.] |
| Weight applicator | Tone: 0.22 Kg [0.5 lbs.] | Tone: 0.22 Kg [0.5 lbs.] |
| Performance
Specifications:
Components
Console | Main Line Frequency
(nominal)
50-60Hz
Input Voltage (nominal)
100-240VAC
Input Current (rms)
4A | Main Line Frequency
(nominal)
50-60Hz
Input Voltage (nominal)
100-240VAC
Input Current (rms)
2A |
| Method of Line Current
Isolation | Independent transformer
isolated | Independent transformer
isolated |
| Electrical Type | Type BF | Type BF |
| Patient Leakage Current
- Normal Condition (μΑ) |