(376 days)
No
The summary describes a standard electrical muscle stimulator controlled by an app, with no mention of AI or ML capabilities for signal generation, parameter adjustment, or any other function.
Yes
The device's intended uses, such as "prevention of disuse atrophy, muscle re-education, and for maintaining or increasing range of motion," are therapeutic in nature, directly addressing medical conditions or their symptoms.
No
The "Intended Use / Indications for Use" states that the device is "indicated for the prevention of disuse atrophy, muscle re-education, and for maintaining or increasing range of motion." These are therapeutic uses, not diagnostic ones. The "Device Description" also describes it as a "powered muscle stimulator" which delivers electrical stimulation for these therapeutic purposes. There is no mention of the device being used to identify or analyze a condition or disease.
No
The device description explicitly states that the NeuroTrigger Basic is composed of a hardware component encased in ABS plastic that delivers electrical stimulation. It also lists several hardware components like the stimulator, electrodes, charging cradle, and cables. While it includes software (Android app and embedded software), it is not solely software.
Based on the provided information, the NeuroTrigger Basic device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "prevention of disuse atrophy, muscle re-education, and for maintaining or increasing range of motion." These are therapeutic applications related to muscle function and rehabilitation, not diagnostic testing performed on samples taken from the body.
- Device Description: The device is a powered muscle stimulator that delivers electrical stimulation to the body through electrodes. This is a physical intervention, not a test that analyzes biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information about a disease or condition based on such analysis.
Therefore, the NeuroTrigger Basic is a therapeutic medical device, specifically a muscle stimulator, and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
NeuroTrigger Basic is indicated for the prevention of disuse atrophy, muscle re-education, and for maintaining or increasing range of motion.
Product codes
IPF
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:
- 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
The SW is programmed to show the following LEDs/Display indications for general functions:
- On/off
- Low power
- Effective electrode contact coupling
- Application coupling
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
NTB user setup is performed under the guidance and instruction of a supervising physician.
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
Nonclinical, bench testing was performed to assure safety and effectiveness and conformance to design specifications.
- Biocompatibility testing: Cytotoxicity, sensitization, and irritation testing were performed for components in direct contact with intact skin. Passed ISO 10993-5 (non-cytotoxic), ISO 10993-10 (no skin sensitization), and ISO 10993-23 (nonirritant).
- Packaging, shelf life, and transit simulation testing: Shipment simulation (ASTM D4332-14 and ASTM D4169-16) and accelerated aging for 1 year (ASTM F1980-16) were performed. Device performance was verified after aging.
- Device performance: Tested prior to and post environmental and aging testing, including Mechanical (device assembly), Electrical, Functional, and Usability aspects, performing according to design specifications for at least 1 year.
- Software verification and validation testing: Tested for safe and secure use, including Bluetooth connection, stimulation parameter identification, and cybersecurity protection. Device functions performed as expected.
- Electrical safety and EMC testing: Tested according to EN60601-1 & IEC60601-1-2 standards and passed. Complies with FCC regulation 47CRF15, Section 15.247.
Key Metrics
Not Found
Predicate Device(s)
Shenzhen XFT-2000 (K193275)
Reference Device(s)
K071137, K220994, K153224, K210938
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 shows 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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).
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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.
3
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.
4
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5
510K Summary
Submitter:
| Submitter's Name | NeuroTrigger LTD |
|---|---|
| Address: | Nirim 3, Tel Aviv 67060, Israel |
| Phone | +972-52-296-3130 |
| Contact Person Name: | Nikolai Kunicher, PhD |
| Title: | CEO |
| Phone Number: | +972-522963130 |
| 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:
6
- 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
7
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.
8
Predicate Comparison Tables
Table 1: Basic Unit Characteristics (comparison with predicate device)
| Device Name | NeuroTriggerBasic
(Device Under
Review) | Shenzhen XFT-2000
(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
number | 21 CFR 890.5850 | 21 CFR 890.5850 | Same |
| Intended Use | A powered muscle stimulator intended
for medical purposes that repeatedly
contracts muscles by passing
electrical currents through electrodes
contacting the affect body area. | A powered muscle stimulator
intended for medical purposes that
repeatedly contracts muscles by
passing electrical currents through
electrodes contacting the affect body
area. | Same |
| Device Name | NeuroTriggerBasic
(Device Under
Review) | Shenzhen XFT-2000
(Predicate Device) | Comparison |
| 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. | XFT-2000 is intended for the
following use:
- Relaxation of muscle spasms
- Prevention or retardation of
disuse atrophy - Increasing local blood circulation
- Muscle re-education
- Immediate post-surgical stimulation
of calf muscles to prevent venous
thrombosis - Maintaining or increasing range
of motion - Adjunctive treatment in the
management of post-surgical
and post-traumatic acute pain. | Substantially equivalent |
| Technology | Electrical Muscle Stimulation (EMS) | Electrical Muscle Stimulation
(EMS) | Same |
| Power Source - method of line current isolation | N/A (battery operated) | N/A (battery operated) | Same |
| Battery | One rechargeable Lithium, Prismatic,
4.2V (3.7 nominal), 120 milliampere
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
(Device Under
Review) | Shenzhen XFT-2000
(Predicate Device) | Comparison |
| - Patient leakage current - Normal condition
- Single fault condition | 1 Alon G., Kantor G., Ho. H. Effects of electrode size on basic excitatory responses and on skeletal stimulus parameters. Journal of Orthopaedic & Sports Physical Therapy. Volume 20 Number 1 July 1994.
2 Li P., Chai G., Zhu K., Lan N., Sui X. Effects of electrode size and spacing on sensory modalities in the phantom thumb perception area for the forearm amputees. Annu Int Conf IEEE Eng Med Biol Soc, 2015:3383-6.
21
underwent accelerated aging for 1 year following the ASTM F1980-16 standard.
- Device performance: NTB was tested after passing the 1 yr accelerated aging o period and performed according to device requirements. Device is safe and effective for patient use after 1 year aging.
- -Performance testing, NTB device was tested prior and post environmental and aging testing to ensure that the device performs according to its design specifications and is safe and effective for use post shelving for at least 1 year. The performance testing can be divided into the following categories:
- Mechanical (including device assembly) O
- Electrical o
- Functional; and O
- Usability O
- -Software verification and validation testing was conducted to test for the safe and secure use of the software with the NTB device, which included Bluetooth connection, stimulation parameter identification, and cybersecurity protection. Device function performs as expected and according to software requirements.
- -Electrical safety and EMC testing. The NTB device was tested according to the EN60601-1 & IEC60601-1-2 standards for EMC and electrical safety and passed. Furthermore, the device complies with FCC regulation 47CRF15, Section 15.247. The device is safe for patient use.
CONCLUSION:
The NeuroTrigger Basic device is substantially equivalent to the predicate device Shenzhen XFT-2000 (K193275). Both the subject device and the predicate device use electrodes to deliver stimulation to patients' muscles.
The stimulation parameters of NTB are similar to the predicate device. The comparison of the device under review, and the predicate device can be seen in the tables above (Table 1 and Table 2). The NTB device is designed to comply with relevant safety recognized consensus standards. Detailed and strictly controlled testing has been carried out.
Furthermore, tests results and risk analysis show that the NeuroTrigger Basic is a safe for the intended use, and differences between the NTB and the predicate device do not raise any new questions of safety or effectiveness.
These data support that the NeuroTrigger Basic device is substantially equivalent to the predicate device.