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510(k) Data Aggregation
(376 days)
NeuroTrigger Basic is indicated for the prevention of disuse atrophy, muscle re-education, and for maintaining or increasing range of motion.
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
The NeuroTrigger Basic (NTB) Device has the following acceptance criteria and device performance:
1. A table of acceptance criteria and the reported device performance:
| Feature/Parameter | Acceptance Criteria (Predicate: Shenzhen XFT-2000) | Reported Device Performance (NeuroTrigger Basic) |
|---|---|---|
| Basic Unit Characteristics | ||
| Product Code | IPF, GZJ | IPF |
| Regulation Number | 21 CFR 890.5850 | 21 CFR 890.5850 |
| 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. |
| Indications for Use | 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. | NeuroTrigger Basic is indicated for the prevention or retardation of disuse atrophy and muscle re-education to maintain or increase range of motion. |
| Technology | Electrical Muscle Stimulation (EMS) | Electrical Muscle Stimulation (EMS) |
| Power Source | N/A (battery operated) | N/A (battery operated) |
| Battery | 3 AAA batteries | One rechargeable Lithium, Prismatic, 4.2V (3.7 nominal), 120 milliampere hour (mAh) |
| Average DC current through electrodes when device is on but no pulses are being applied | 0 µA | 0 µA |
| Number of Output Modes | 1 mode for NMES, 1 mode for transcutaneous electrical nerve stimulation (TENS) | 1 mode for neuromuscular stimulation (NMES) |
| Programs | - 10 pre-set NMES programs - 3 pre-set TENS programs - User can create and save custom programs - Frequency, pulse duration, amplitude, treatment time, and time on/off can be adjusted | - Unlimited number of programs can be created by the user - Frequency, pulse duration, amplitude, ramp up time, and time on/off can be adjusted |
| Number of Output Channels | 2 channels | 1 channel |
| Regulated current or voltage | Regulated current | Constant current (also referred to as regulated current) |
| Software / Firmware / Microprocessor Control? | Yes | Yes, software and firmware |
| Automatic overload trip? | Yes | Yes, if a zero load is connected, current shuts off |
| Automatic no-load trip? | Yes | Yes, if no load is connected, current shuts off |
| Automatic shut off | Yes | Yes |
| User override control? | Yes, pause button | Yes |
| Indicator Display: On / Off Status | Yes | Yes |
| Low Battery? | Yes | Yes |
| Voltage / Current Level? | Yes | Yes |
| Timer Range (min) (NMES mode) | 60 min | Open Stimulation period (with a caution statement for max duration of 120 minutes) |
| Compliance with voluntary standards? | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10 | IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-10, ISO 10993-1 Part 1 |
| Compliance with 21 CFR 898? | Yes | Yes |
| Weight | 96 g | 11.9 g |
| Dimensions (mm) | 114 x 66 x 20 | 65 x 60 x 13 |
| Housing material | Silicone & ABS | ABS, injection molding |
| Stimulation Output Specifications | ||
| Waveform and shape | Pulsed, symmetric, balanced Biphasic, Rectangular | Pulsed, symmetric, balance biphasic, rectangular, with interphase interval |
| Area of electrode(s) | 19.6 cm² | 1.5 cm² |
| Dimensions of electrode(s) | 5 cm diameter (round) | 1.4 cm diameter (round) |
| Maximum output voltage @ 500 Ω ± 10% | 29.7 V | 12.5 V |
| Maximum output voltage @ 2 kΩ ± 10 % | 89.1 V | 50 V |
| Maximum output voltage @ 10 kΩ ± 10% | 125 V | 90 V (maximum voltage remains constant at a load larger than 3.6 kΩ) |
| Maximum output current @ 500 Ω ± 10 % | 59.4 mA | 25 mA |
| Maximum output current @ 2 kΩ ± 10% | 44.5 mA | 25 mA |
| Maximum output current @ 10 kΩ ± 10% | 12.5 mA | 9 mA |
| Maximum Phase Charge @ 500 Ω | 10.8 µC | 15.0 µC |
| Maximum Phase Charge @ 2 kΩ | 15.6 µC | 15.0 µC |
| Maximum Phase Charge @ 10KΩ | 4.4 µC | 5.4 µC |
| Pulse (phase) width | 100 - 350 µs | 80 - 600 µs |
| Frequency (Hz) | 100-350 Hz | 10 - 300 Hz |
| Net Charge (µC per pulse) | Zero (Biphasic, charge balanced stimulation) | Zero (Biphasic, charge balanced stimulation) |
| Maximum Power Density, (W/cm²) (using smallest electrode conductive surface area) | 8.9 mW/cm² @ 500Ohm | 19.1 mW/cm² @ 500Ohm |
| Max current (RMS) (mA) @ 500 Ω | 16.9 | 7.57 |
| Burst Mode - Pulses per burst | 1 - 625 pulses | 10 - 300 pulses |
| Burst Mode - Bursts per second | 0.05 - 0.5 Hz | 0.09 - 0.32 Hz |
| Burst Mode - Burst duration (s) | 1 - 5 s | 0.1 - 1.0 s |
| Burst Mode - Duty Cycle | Not available | 0.9% - 32% |
| Connectivity | N/A | Bluetooth Low Energy (BLE 5.2) connectivity to Android platform-based app |
Study Proving Acceptance Criteria:
The NeuroTrigger Basic (NTB) device's acceptance criteria are primarily met through performance testing that demonstrates its substantial equivalence to the predicate device, Shenzhen XFT-2000 (K193275), and compliance with relevant safety and performance standards. The provided document details a comprehensive set of non-clinical, bench tests to establish this.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a separate "test set" in terms of patient data or clinical trials. The evaluation relies on bench testing of the NeuroTrigger Basic device samples. The number of device units tested for each non-clinical test (e.g., biocompatibility, environmental, performance) is not explicitly stated, but it's implied that sufficient samples were used to meet testing standards.
- Data Provenance: The data provenance is from non-clinical, bench testing conducted on the NeuroTrigger Basic device. There is no indication of retrospective or prospective clinical data from human subjects in this 510(k) summary. All testing appears to be laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this 510(k) submission. The "ground truth" for the non-clinical bench testing is defined by the recognized consensus standards (e.g., ISO, IEC, ASTM, FCC) that the device must comply with and the specified design performance parameters. The evaluation is based on whether the device's measured performance meets these established technical specifications and passes the standard-specific criteria, rather than expert interpretation of patient data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as the evaluation is based on objective, quantifiable measurements from bench testing against predefined standards and specifications, rather than subjective interpretation of clinical data requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. The NeuroTrigger Basic is a powered muscle stimulator, not an AI-powered diagnostic or assistive device that would involve "human readers" or AI assistance in interpretation. No MRMC comparative effectiveness study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable in the context of an "algorithm only" performance study. The NeuroTrigger Basic contains embedded software that controls stimulation signals and communicates with a mobile app. The performance of this software is assessed as part of the overall device performance in the bench testing (e.g., "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."). However, this is not a standalone "algorithm-only" performance study in the typical sense of AI-driven diagnostic tools.
7. The type of ground truth used:
The ground truth for evaluating the NeuroTrigger Basic device is based on:
- Engineering design specifications: The device was tested to ensure conformance to its own design specifications.
- Recognized consensus standards: Compliance with various international standards for medical electrical equipment (IEC 60601 series), biocompatibility (ISO 10993 series), and packaging/shelf-life (ASTM standards) serves as a primary ground truth.
- Performance relative to a legally marketed predicate device: The concept of "substantial equivalence" means the device must perform similarly to or better than the predicate device without raising new questions of safety or effectiveness. The detailed comparison table and discussion of differences against the Shenzhen XFT-2000 serve as an indirect "ground truth" for functional equivalency.
8. The sample size for the training set:
This information is not applicable as there is no indication of a "training set" in the context of machine learning or AI algorithm development for this device. The software embedded in the device controls the stimulation signals and user interface, but it's not described as a learning algorithm requiring training data.
9. How the ground truth for the training set was established:
This information is not applicable as there is no training set described for this device.
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