NeuroTrigger Basic (NTB)

K223027 · Neurotrigger · IPF · Oct 10, 2023 · Physical Medicine

Device Facts

• Record ID: K223027
• Device Name: NeuroTrigger Basic (NTB)
• Applicant: Neurotrigger
• Product Code: IPF · Physical Medicine
• Decision Date: Oct 10, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

NeuroTrigger Basic is indicated for the prevention of disuse atrophy, muscle re-education, and for maintaining or increasing range of motion.

Device Story

NeuroTrigger Basic (NTB) is a powered muscle stimulator for neuromuscular electrical stimulation (NMES). The system consists of a stimulator unit, disposable Y-shaped pre-gelled electrodes, and an Android-based mobile application. The stimulator is worn on the body, attached via double-sided tape. It generates biphasic, symmetric, rectangular electrical pulses delivered through electrodes to stimulate nerves and muscles. The device is controlled wirelessly via Bluetooth Low Energy (BLE) from an Android smartphone app, which serves as the user interface for patients and clinicians to adjust stimulation parameters (frequency, pulse duration, amplitude, ramp time, and on/off cycles). The stimulator includes current measurement circuitry for monitoring and safety. It is housed in a charging cradle when not in use. The device is intended for use under the guidance of a supervising physician to prevent disuse atrophy, re-educate muscles, and maintain/increase range of motion, potentially benefiting patients by facilitating muscle contraction and rehabilitation.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-5, -10, -23), packaging/shelf-life/transit simulation (ASTM D4332-14, D4169-16, F1980-16), mechanical/electrical/functional performance, software verification/validation, and electrical safety/EMC (EN60601-1, IEC60601-1-2, FCC 47CRF15).

Technological Characteristics

Powered muscle stimulator; ABS plastic housing; Li-ion battery; BLE 5.2 connectivity. Electrodes: PET base, Ag/AgCl conductive ink, medical polyethylene film, hydrogel. Waveform: Pulsed, symmetric, balanced biphasic, rectangular. Output: Constant current. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-10, ISO 10993-1.

Indications for Use

Indicated for the prevention or retardation of disuse atrophy and muscle re-education to maintain or increase range of motion in patients requiring neuromuscular electrical stimulation.

Regulatory Classification

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.

Predicate Devices

• Shenzhen XFT-2000 (K193275)

Reference Devices

• Shoulder Pacemaker (K220994)
• Sonicator Plus (K071137)
• VitalStim (K153224)
• PowerDot (K210938)

Submission Summary (Full Text)

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October 10, 2023

NeuroTrigger Nikolai Kuincher CEO Nirim 3 Tel Aviv, Israel 67060 Israel

Re: K223027

Trade/Device Name: NeuroTrigger Basic (NTB) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: September 23, 2022 Received: September 29, 2022

Dear Nikolai Kuincher:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Jitendra V. Virani -S

CDR Jitendra Virani 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

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# Indications for Use

510(k) Number (if known) K223027

Device Name NeuroTrigger basic (NTB)

#### Indications for Use (Describe) Device Name: NeuroTrigger Basic

#### INDICATION FOR USE:

NeuroTrigger Basic is indicated for the prevention of disuse atrophy, muscle re-education, and for maintaining or increasing range of motion.

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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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## 510K Summary

### Submitter:

| Submitter's Name | NeuroTrigger LTD |
|----------------------|---------------------------------|
| Address: | Nirim 3, Tel Aviv 67060, Israel |
| Phone | [phone] |
| Contact Person Name: | Nikolai Kunicher, PhD |
| Title: | CEO |
| Phone Number: | [phone] |
| Dated: | September 27, 2023 |

### Submitted Device:

Proprietary Name: NeuroTrigger Basic (NTB)

Common or Usual Name: Stimulator, power, muscle

Classification Name: Powered Muscle Stimulator

Product Code: IPF

Device Class: II

Review Panel: Physical Medicine

Regulation Number: 21 CFR 890.5850

Predicate Device: Shenzhen XFT-2000 (K193275)

#### Device Description:

The NeuroTrigger Basic (NTB) powered muscle stimulator is composed of a hardware component encased in Acrylonitrile Butadiene Styrene (ABS) plastic that attaches to the body with double-sided tape (DST) and delivers electrical stimulation to different body regions through a single use/disposable pre-gelled Y-shaped electrode. The Y-shaped electrodes consist of a PET base, with silver/silver chloride conductive ink, covered by a double coated medical polyethylene DST film, and hydrogel circles at the center of the Y heads.

The NTB System is made up of the following components and accessories:

Main components:

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- Stimulator ●
- Electrodes ●
- Android app ●

Accessories:

- Stimulator holder, with double-sided adhesive stickers ●
- Charging cradle
- USB-C charge cable ●
- AC/DC Charger ●

The NTB stimulator contains embedded software that controls the generation of the stimulation signals, provides current measurement circuitry to monitor the delivered current, provides a Bluetooth Low Energy (BLE) wireless communication with remote control SW running on Android based App. The electrical stimulation is delivered to different body regions through the 2 electrode sizes (either wide or narrow span electrodes). The stimulator is stored in the NTB charging cradle, the housing case for the device, when not in use. Both components (the stimulator and the cradle) are made of ABS, but the NTB stimulator contains a PCB board and a lithium battery, and fits into the cradle by magnetized coupling and is held in place with pogo pins. The cradle acts as a charging station for the stimulator in addition to being a housing storage unit. The cradle, built of two parts, contains magnets that allow for the single axis magnetic opening and closure of the case.

The AC/DC charger connects to the cradle through the USB C cable during charging cycles, which is when the stimulator is not in use.

The stimulator holder is supplied to allow for different body region uses, and is also made from ABS material and can be attached to different bodily regions with DST. The cradle and stimulator display different indications (i.e. BLE pairing, connection state, battery status) through LED lights.

NTB user setup is performed under the guidance and instruction of a supervising physician and is controlled wirelessly from the Android smartphone-based mobile application (Bluetooth connection to the stimulator). The stimulator contains embedded software that generates controllable stimulation signal for stimulating nerves and muscles. The stimulation signal parameters can be controlled by special application over Bluetooth Low Energy (BLE) connection. Communication with the stimulator host application is done over BLE, data are encrypted with the standard BLE pairing and encryption/decryption that is done at the BLE level.

The SW is a remote control application installed on portable Android device with support to BLE 4.2 and above to control the HW and serve as UI. Secured login mechanism is implemented on the application to prevent unsecured using of the application also to protect patient's personal information and details

The application supports three types of users:

- . Patients
- Clinicians
- . Administrators

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The SW is programmed to show the following LEDs/Display indications for general functions:

- On/off -
- -Low power
- Effective electrode contact coupling -
- Application coupling -

### Indications for Use:

NeuroTrigger Basic is indicated for the prevention or retardation of disuse atrophy and muscle re-education to maintain or increase range of motion.

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## Predicate Comparison Tables

## Table 1: Basic Unit Characteristics (comparison with predicate device)

| Device Name | NeuroTriggerBasic<br>(Device Under<br>Review) | Shenzhen XFT-2000<br>(Predicate Device) | Comparison |
|-----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K number | K223027 | K193275 | |
| Manufacturer | NeuroTrigger | Shenzhen XFT Medical Ltd. | |
| Model number | NT-11 | XFT-2000 | |
| Product code | IPF | IPF, GZJ | Same |
| Classification Name/Regulation<br>number | 21 CFR 890.5850 | 21 CFR 890.5850 | Same |
| Intended Use | A powered muscle stimulator intended<br>for medical purposes that repeatedly<br>contracts muscles by passing<br>electrical currents through electrodes<br>contacting the affect body area. | A powered muscle stimulator<br>intended for medical purposes that<br>repeatedly contracts muscles by<br>passing electrical currents through<br>electrodes contacting the affect body<br>area. | Same |
| Device Name | NeuroTriggerBasic<br>(Device Under<br>Review) | Shenzhen XFT-2000<br>(Predicate Device) | Comparison |
| Indications for Use | NeuroTrigger Basic is indicated for<br>the prevention or retardation of<br>disuse atrophy and muscle re-<br>education to maintain or increase<br>range of motion. | XFT-2000 is intended for the<br>following use:<br>- Relaxation of muscle spasms<br>- Prevention or retardation of<br>disuse atrophy<br>- Increasing local blood circulation<br>- Muscle re-education<br>- Immediate post-surgical stimulation<br>of calf muscles to prevent venous<br>thrombosis<br>- Maintaining or increasing range<br>of motion<br>- Adjunctive treatment in the<br>management of post-surgical<br>and post-traumatic acute pain. | Substantially equivalent |
| Technology | Electrical Muscle Stimulation (EMS) | Electrical Muscle Stimulation<br>(EMS) | Same |
| Power Source<br>- method of line current isolation | N/A (battery operated) | N/A (battery operated) | Same |
| Battery | One rechargeable Lithium, Prismatic,<br>4.2V (3.7 nominal), 120 milliampere<br>hour (mAh) | 3 AAA batteries | Substantially equivalent |
| - Number | - 1 battery in stimulator | | |
| - Size | - 31 x 12 mm, 4.95 mm thick | | |
| - Type | - LiPol 4.2 V Lithium ion battery | | |
| Device Name | NeuroTriggerBasic<br>(Device Under<br>Review) | Shenzhen XFT-2000<br>(Predicate Device) | Comparison |
| - Patient leakage current<br>- Normal condition<br>- Single fault condition | <1.4 μΑ<br><1.4 μΑ | N/A<br>N/A | Although no data is available for<br>the predicate device, the leakage<br>current is similar or lower than that<br>of other cleared similar devices,<br>so this does not introduce any<br>new safety concerns. In addition,<br>the leakage current meets FDA<br>guidance requirements.<br><br>Note that this parameter is not<br>applicable to device effectiveness. |
| Average DC current through<br>electrodes when device is on but<br>no pulses are being applied | 0 μΑ | 0 μΑ | Same |
| Number of output modes | 1 mode for neuromuscular<br>stimulation (NMES) | 1 mode for NMES<br>1 mode for transcutaneous<br>electrical nervestimulation<br>(TENS) | Substantially equivalent |
| Programs | - Unlimited number of programs<br>can be created by the user<br>- Frequency, pulse duration,<br>amplitude, ramp up time, and<br>time on/offcan be adjusted | - 10 pre-set NMES programs<br>- 3 pre-set TENS programs<br>- User can create and save<br>custom programs<br>- Frequency, pulse duration,<br>amplitude, treatment time, and<br>time on/off can be adjusted | Substantially equivalent |
| Device Name | NeuroTriggerBasic<br>(Device Under<br>Review) | Shenzhen XFT-2000<br>(Predicate Device) | Comparison |
| Number of output channels | 1 channel | 2 channels | Substantially equivalent |
| - synchronous or alternating | N/A | - Both | |
| - method of channel isolation | | - Transistor | |
| Regulated current or voltage | Constant current (also referred to as regulated current) | Regulated current | Same |
| Software / Firmware/<br>MicroprocessorControl? | Yes, software and firmware | Yes | Same |
| Automatic overload trip? | Yes, if a zero load is connected, current shuts off | Yes | Same |
| Automatic no-load trip? | Yes, if no load is connected, current shuts off | Yes | Same |
| Automatic shut off | Yes | Yes | Same |
| User override control? | Yes | Yes, pause button | Same |
| Device Name | NeuroTriggerBasic<br>(Device Under<br>Review) | Shenzhen XFT-2000<br>(Predicate Device) | Comparison |
| Indicator Display:<br>- On / Off Status | - Yes | - Yes | Same |
| - Low Battery? | - Yes | - Yes | Same |
| - Voltage / Current Level? | - Yes | - Yes | Same |
| Timer Range (min)<br>(NMES mode) | Open Stimulation period | 60 min | Different.<br>The NTB IFU contains the<br>following Caution statement: "The<br>NeuroTrigger Basic device should<br>be used for a maximum duration<br>of 120 minutes per session.<br>Longer use of the device could<br>lead to skin irritation, burning, or<br>other effects related to<br>overstimulation." Other<br>neuromuscular stimulation<br>devices within product code IPF<br>that are cleared for use by<br>patients at home have a similar<br>maximum duration of use,<br>including the Shoulder Pacemaker<br>(K220994). |
| Compliance with voluntary<br>standards? | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-6<br>IEC 60601-1-11<br>IEC 60601-2-10<br>ISO 10993-1 Part 1 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10 | Same |
| Device Name | NeuroTriggerBasic<br>(Device Under<br>Review) | Shenzhen XFT-2000<br>(Predicate Device) | Comparison |
| Compliance with 21 CFR 898? | Yes | Yes | Same |
| Weight | 11.9 g | 96 g | Substantially equivalent |
| Dimensions (mm) | 65 x 60 x 13 | 114 x 66 x 20 | Substantially equivalent |
| Housing material | ABS, injection molding | Silicone & ABS | Substantially equivalent |

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| Device Name | NeuroTrigger Basic<br>(Device Under Review) | Shenzhen XFT-2000<br>(Predicate Device) | Comparison |
|-----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Waveform and shape | Pulsed, symmetric, balance biphasic, rectangular, with interphase interval | Pulsed, symmetric, balanced<br>Biphasic, Rectangular | Same |
| Area of electrode(s) | 1.5 cm² | 19.6 cm² | Different, but does not raise new<br>questions of safety or<br>effectiveness. |
| Dimensions of electrode(s) | 1.4 cm diameter (round) | 5 cm diameter (round) | See discussion below. |
| Maximum output voltage<br>@ 500 Ω ± 10% | 12.5 V | 29.7 V | Different, but does not raise new<br>questions of safety or<br>effectiveness. |
| @ 2 kΩ ± 10 % | 50 V | 89.1 V | See discussion below. |
| @ 10 kΩ ± 10% | 90 V (maximum voltage remains constant at a load larger than 3.6 kΩ) | 125 V | Different, but does not raise new<br>questions of safety or<br>effectiveness. |
| Maximum output current<br>@ 500 Ω ± 10 % | 25 mA | 59.4 mA | Different, but does not raise new<br>questions of safety or<br>effectiveness. |
| @ 2 kΩ ± 10% | 25 mA | 44.5 mA | See discussion below. |
| @ 10 kΩ ± 10% | 9 mA | 12.5 mA | See discussion below. |
| Device Name | NeuroTrigger Basic<br>(Device Under Review) | Shenzhen XFT-2000<br>(Predicate Device) | Comparison |
| Maximum Phase Charge | | | Substantially equivalent |
| @ 500 Ω | 15.0 µC | 10.8 µC | The calculation of the maximum |
| @ 2 kΩ | 15.0 µC | 15.6 µC | phase charge of the predicate<br>device was based on the<br>maximum phase duration and the<br>maximum current amplitude<br>delivered into the corresponding<br>load |
| @ 10KΩ | 5.4 µC | 4.4 µC |…