(261 days)
Not Found
No
The description focuses on manual control and pre-programmed sequences, with no mention of AI or ML algorithms for adapting stimulation or analyzing patient data.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for the following uses: Functional Electrical Stimulation (FES)... NeuroMuscular Electrical Stimulation (NMES)" for various therapeutic purposes, such as improving hand function, maintaining range of motion, preventing atrophy, and relaxing muscle spasms. Furthermore, the "Intended User / Care Setting" mentions its use for "therapy session only in a professional healthcare facility."
No
The device is an electrical stimulation device intended for therapeutic uses such as improving hand function, maintaining range of motion, preventing atrophy, increasing blood circulation, relaxing muscle spasms, and muscle re-education. It does not perform any diagnostic function.
No
The device description explicitly details hardware components including a voltage-controlled generating source, disposable electrodes, flexible patches with solid-state relay technology, and LED indicators. It also mentions compliance testing for hardware safety and performance standards (e.g., IEC 60601 series).
Based on the provided text, the NeuStim NN-01 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes the device as an electrical stimulation device for therapeutic purposes (improving hand function, maintaining range of motion, preventing atrophy, etc.) by applying electrical pulses to the patient's body. This is a direct interaction with the patient's body for treatment.
- Device Description: The description details how the device generates electrical pulses and delivers them through electrodes worn on the patient's skin to evoke muscle contractions. This is a physical intervention.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The NeuStim NN-01 does not perform any such analysis of biological specimens.
The NeuStim NN-01 is a therapeutic medical device that applies electrical stimulation to the body.
N/A
Intended Use / Indications for Use
The NeuStim NN-01 is an electrical stimulation device indicated for the following uses:
Functional Electrical Stimulation (FES):
Improvement of hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord injury.
NeuroMuscular Electrical Stimulation (NMES):
- · Maintaining or increasing hand range of motion;
- · Prevention or retardation of disuse atrophy;
- · Increasing local blood circulation;
- · Relaxation of muscle spasms; and
- · Muscle re-education.
The NeuStim NN-01 is intended for use on the right arm/right hand only.
Product codes (comma separated list FDA assigned to the subject device)
GZI, IPF
Device Description
The NeuStim Model NN-01 (herein Device) consists of a voltage-controlled generating source that connects to disposable electrodes that are worn by the patient on the anterior and posterior forearm and around the thumb, these are named the Flexor, Extensor and Thumb Disposable Electrodes respectively. The disposable electrodes consist of multiple contacts that can stimulate the muscles in different areas of the forearm and thumb with 10kHz voltage pulses generated by the NeuStim voltage-controlled stimulator.
The Device is classified as a Functional Stimulation (FES) and NeuroMuscular Electrical Stimulation (NMES) device. The Device uses galvanic electrical energy to evoke muscle contractions.
The Device has 181 addressable electrode contacts enabling fine spatial resolution of stimulation to the patient. The Device allows manual electrode scanning to facilitate rapid mapping of effective stimulation points, which can be stored for use in future sessions. This rapid scanning capability is enabled through the use of solid-state relay technology embedded in the flexible patches that mate directly with the disposable electrodes. The motion of the user's (i.e. licensed healthcare professional) finger on the screen of the NeuStim" Tablet electronically steers the stimulation point through the use of a solid-state relay matrix in each patch and thumb dongle, while lighting LED indicators on the back of the patch/dongle under control. This allows immediate, dynamic visual indication of the stimulation location which facilitates rapid mapping (i.e. user can quickly find and return to useful stimulation points). When the user observes desired muscle activations and associated wrist, hand, or finger movements, the related stimulation locations can be stored as a pattern. Up to three of these stored patterns can then be combined into a compound move where the stimulator will continuously time multiplex between them to allow for compound motion. Finally, up to three compound moves or patterns can be combined into a sequence where each of the selected compound moves or patterns are applied for a user configurable number of seconds.
The Device uses a stimulation pulse repetition rate of 50 Hz. The stimulation pulse is comprised of a multiphasic (5 cycle) waveform with a total duration of 0.5 ms. The stimulation output (peak) voltage is less than 65V (500 Ohm load) and less than 120V (10,000 Ohm load). The stimulation output power will not exceed 0.25 W/cm^2 (averaged over one second) into a 500 Ohm Load.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
The NeuStim NN-01 is intended for use on the right arm/right hand only.
The NeuStim NN-01 stimulates the following muscles:
- Extensor Digitorum, Extensor Pollicis Brevis and Longus
- Thenar Muscle Group
- Flexor Digitorum Superficialis, Flexor Pollicis Longus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used for therapy session only in a professional healthcare facility by a licensed practitioner
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)
| Purpose | Testing | Results |
|---|---|---|
| Verify compliance with ANSI/AAMI ES60601-1 and IEC 60601-1 requirements for basic safety and essential performance | Battery powered device, Type BF Applied Parts | Passed |
| Verify compliance with IEC 60601-1-2 requirements for basic safety and essential performance Electromagnetic Disturbances | Battery powered device; radiated emissions, radiated field immunity, proximity filed immunity, magnetic field immunity, electrostatic discharge immunity | Passed |
| Verify compliance with IEC 60601-2-10 requirements for the safety and essential performance of nerve and muscle stimulators | Battery powered muscle stimulator, Type BF Applied Parts, normal and single-fault, energy and power limits | Passed |
| Verify compliance with ISO 10993-1 Biologic Evaluation of Medical Devices | Part 5: Tests for in vitro cytotoxicity; Part 10: Tests for irritation and skin sensitization | Passed |
| Verify compliance with IEC 62133-2 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems | Battery individual cells and packs certified via third party testing | Passed |
| Verify software meets requirements | Software Verification and Validation | Passed |
| Verify user needs are met | System Design Validation | Passed |
| Verify device meets requirements | Design Verification | Passed |
| Verify device meets IEEE/ANSI C63.27 Coexistence Testing | Tier 2 | Passed |
| Verify device meets labeled Shelf-Life. | Shelf-Life Validation Study | Passed |
| Verify device meets Adhesive Performance Criteria | Adhesive Performance Validation Study | Passed |
| Verify device meets Current Distribution (Dispersion) and Electrode Impedance Criteria | Power and Current Density Validation Study | Passed |
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.
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
§ 882.5810 External functional neuromuscular stimulator.
(a)
Identification. An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.(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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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.
November 22, 2024
Neuvotion Inc. Chad Bouton President and CEO 165 Club Rd Stamford, Connecticut 06905
Re: K240632
Trade/Device Name: Neuvotion NeuStim (NN-01) Regulation Number: 21 CFR 882.5810 Regulation Name: External Functional Neuromuscular Stimulator Regulatory Class: Class II Product Code: GZI, IPF Dated: October 31, 2024 Received: November 1, 2024
Dear Chad Bouton:
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"
1
(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).
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 OS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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).
2
Sincerely,
Amber T. Ballard -S
Amber Ballard, PhD 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
3
Indications for Use
510(k) Number (if known) K240632
Device Name Neuvotion NeuStim NN-01
Indications for Use (Describe)
The NeuStim NN-01 is an electrical stimulation device indicated for the following uses:
Functional Electrical Stimulation (FES):
Improvement of hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord injury.
NeuroMuscular Electrical Stimulation (NMES):
- · Maintaining or increasing hand range of motion;
- · Prevention or retardation of disuse atrophy;
- · Increasing local blood circulation;
- · Relaxation of muscle spasms; and
- · Muscle re-education.
The NeuStim NN-01 is intended for use on the right arm/right hand only.
| 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."
4
510(k) Summary
Contact Details 21 CFR 807.92(a)(1):
Neuvotion Inc. 165 Club Rd. Stamford, CT 06905
Mr. Chad Bouton Email: boutonce@neuvotion-inc.com Tel: 614.561.1140
Date Prepared: November 22, 2024
Device Name 21 CFR 807.92(a)(2):
Device Trade Name: Neuvotion NeuStim NN-01 Common Name: External functional neuromuscular stimulator Classification Name: Stimulator, Neuromuscular, External Functional Regulation Number: 882.5810 Product Codes: GZI, IPF
Legally Marketed Predicate Devices 21 CFR 807.92(a)(3):
K123636, Bioness NESS H200 Wireless Hand Rehabilitation System Product Codes GZI, IPF
Device Description Summary 21 CFR 807.92(a)(4):
The NeuStim Model NN-01 (herein Device) consists of a voltage-controlled generating source that connects to disposable electrodes that are worn by the patient on the anterior and posterior forearm and around the thumb, these are named the Flexor, Extensor and Thumb Disposable Electrodes respectively. The disposable electrodes consist of multiple contacts that can stimulate the muscles in different areas of the forearm and thumb with 10kHz voltage pulses generated by the NeuStim voltage-controlled stimulator.
The Device is classified as a Functional Stimulation (FES) and NeuroMuscular Electrical Stimulation (NMES) device. The Device uses galvanic electrical energy to evoke muscle contractions.
The Device has 181 addressable electrode contacts enabling fine spatial resolution of stimulation to the patient. The Device allows manual electrode scanning to facilitate rapid mapping of effective stimulation points, which can be stored for use in future sessions. This rapid scanning capability is enabled through the use of solid-state relay technology embedded in the flexible patches that mate directly with the disposable electrodes. The motion of the user's (i.e. licensed healthcare professional) finger on the screen of the NeuStim" Tablet electronically steers the stimulation point through the use of a solid-state relay matrix in each patch and thumb dongle, while lighting LED indicators on the back of the patch/dongle under control. This allows immediate, dynamic visual indication of the stimulation location which facilitates rapid mapping (i.e. user can quickly find and return to useful stimulation points). When the user observes desired muscle activations and associated wrist, hand, or finger movements, the related stimulation locations can be stored as a pattern. Up to three of these stored patterns can then be combined into a compound move where the stimulator will continuously time multiplex between them to allow for
5
compound motion. Finally, up to three compound moves or patterns can be combined into a sequence where each of the selected compound moves or patterns are applied for a user configurable number of seconds.
The Device uses a stimulation pulse repetition rate of 50 Hz. The stimulation pulse is comprised of a multiphasic (5 cycle) waveform with a total duration of 0.5 ms. The stimulation output (peak) voltage is less than 65V (500 Ohm load) and less than 120V (10,000 Ohm load). The stimulation output power will not exceed 0.25 W/cm^2 (averaged over one second) into a 500 Ohm Load.
Indications for Use 21 CFR 807.92(a)(5):
The NeuStim NN-01 is an electrical stimulation device indicated for the following uses:
Functional Electrical Stimulator (FES):
Improvement of hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord injury.
NeuroMuscular Electrical Stimulation (NMES):
- -Maintenance and/or increase of hand range of motion;
- -Prevention or retardation of disuse atrophy;
- -Increasing local blood circulation;
- -Relaxation of muscle spasms; and
- -Muscle re-education
The NeuStim NN-01 is intended for use on the right arm/right hand only.
| Device/
Characteristic | NESS H200 Wireless (K123636)
Predicate Device | NeuStim Model NN-01 (K240632)
Subject Device | Comparison
Results |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| | Indications for Use 21CFR807.92(a)(5) | | |
| 1. Indications for
Use | Functional Electrical Stimulation (FES):
- Improvement of hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord injury.
NeuroMuscular Electrical Stimulation (NMES):
- Maintenance and/or increase of hand range of motion
- Prevention and/or retardation of disuse atrophy
- Increase in local blood circulation | Functional Electrical Stimulation (FES):
- Improvement of hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord injury.
NeuroMuscular Electrical Stimulation (NMES):
- Maintenance and/or increase of hand range of motion
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Relaxation of muscle spasms
- Muscle re-education | Equivalent
Subject Device is identical with a subset of Predicate Device, i.e. right arm/right hand |
6
| Device/
Characteristic | NESS H200 Wireless (K123636)
Predicate Device | NeuStim Model NN-01 (K240632)
Subject Device | Comparison
Results | | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | - Re-education of muscles | The NeuStim NN-01 is intended for use on the right arm/right hand only. | | | | | |
| 2. Intended Use
Environment | Used both for therapy session in a professional healthcare facility and for patient to take home | Used for therapy session only in a professional healthcare facility by a licensed practitioner | Equivalent
Subject Device is identical with a subset of Predicate Device | | | | |
| 3. Prescription or
OTC? | Prescription | Prescription | Identical | | | | |
| 4. Target
Population | Patients with hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord injury | Patients with hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord injury | Identical | | | | |
| 5. Anatomical Site | Not publicly available | The NeuStim NN-01 stimulates the following muscles:
- Extensor Digitorum, Extensor Pollicis Brevis and Longus
- Thenar Muscle Group
- Flexor Digitorum Superficialis, Flexor Pollicis Longus | Identical | | | | |
| | Device/
Characteristic | NESS H200 Wireless (K123636)
Predicate Device | NeuStim Model NN-01 (K240632)
Subject Device | Comparison
Results | | | |
| Basic Unit Characteristics Summary (Guidance Document for Powered Muscle Stimulators, Attachment II, Section 2) | | | | | | | |
| 1. | 510(k) Number | K123636 | K240632 | N/A | | | |
| 2. | Device Name,
Model | NESS H200 Wireless | NeuStim NN-01 | N/A | | | |
| 3. | Manufacturer | Bioness | Neuvotion Inc. | N/A | | | |
| 4. | Power Source(s) | Rechargeable battery | Internally powered (secondary
Lithium Ion battery) | Identical | | | |
| - | Method of Line
Current Isolation | Not publicly available | Wireless (inductive) charging | Equivalent | | | |
| - | Method of Line
Current Isolation | Not publicly available | n/a | n/a | | | |
| - | Patient Leakage
Current Normal
Condition | Not publicly available | Meets 60601-1 Clause 8.7 limits | Identical | | | |
| - | Patient Leakage
Current Single
Fault Condition | Not publicly available | Meets 60601-1 Clause 8.7 limits | Identical | | | |
| 5. | Number of
Output Modes | Not publicly available | One (1) | Identical | | | |
| 6. | Number of
Output Channels | Not publicly available | Two (2) | Different | | | |
| - | Synchronous or
Alternating? | Not publicly available | Synchronous | Indeterminate | | | |
| - | Method of
Channel
Isolation | Not publicly available | Transformer | Indeterminate | | | |
| 7. | Regulated
Current or
Regulated
Voltage? | Not publicly available | Regulated Voltage | Different
Subject Device
safe by design
since current
limiting
hardware
circuitry
employed | | | |
| 8. | Software/
Firmware/
Microprocessor
Control? | Not publicly available | Yes | Identical | | | |
| 9. | Automatic
Overload Trip? | Not publicly available | Yes | Identical | | | |
| 10. | Automatic No-
Load Trip? | Not publicly available | No | Different | | | |
| Device/
Characteristic | NESS H200 Wireless (K123636)
Predicate Device | NeuStim Model NN-01 (K240632)
Subject Device | Comparison
Results | | | | |
| 11. Automatic Shut
Off? | Not publicly available | No | Subject Device
safe by design
since voltage
mode is used
and current-
limiting
hardware
circuitry
employed
Different | | | | |
| 12. Patient Override
Control? | Not publicly available | Yes | Subject Device
safe since used
under clinical
staff direct
supervision
Identical | | | | |
| 13. Indicator Display
– On/Off Status? | Not publicly available | Yes | Identical | | | | |
| – Low Battery? | Not publicly available | Yes | Identical | | | | |
| – Voltage/Current
Level | Not publicly available | Yes | Identical | | | | |
| 14. Timer Range
(minutes) | Not publicly available | n/a | Different | | | | |
| 15. Compliance with
Voluntary
Standards | Yes
IEC 60601-1, IEC 60601-1-2 | Yes
IEC 60601-1, IEC 60601-1-2, IEC
60601-2-10, ES60601-1, ISO 10993-
5, ISO 10993-10, IEC 62133-2, IEEE
ANSI C63.27-2017. AAMI TIR69:2017 | Subject Device
safe since used
under clinical
staff direct
supervision
Equivalent
Subject device
conforms to
additional safety
and performance
standards | | | | |
| 16. Compliance with
21 CFR 898 | Not publicly available | Yes | Identical | | | | |
| 17. Weight | Not publicly available | 55g | N/A | | | | |
| 18. Dimensions (in.)
[W x H x D] | Not publicly available | Length: 2.34in
Width: 1.87in
Depth: .91in | N/A | | | | |
| 19. Housing
Materials and
Construction | Not publicly available | Polymer Housing,
Silicone Rubber,
Volero Straps | Identical | | | | |
| Device/
Characteristic | NESS H200 Wireless (K123636)
Predicate Device | NeuStim Model NN-01 (K240632)
Subject Device | Comparison
Results | | | | |
| | | | Subject Device
safe per ISO
10993 testing
and per FDA
Biocompatibility
Guidance
Attachment G,
Section B | | | | |
| | Output Specifications (Guidance Document for Powered Muscle Stimulators, Attachment II, Section 3) | | | | | | |
| | Waveform (e.g.,
pulsed monophasic,
biphasic) | Not publicly available | Multiphasic | | | | |
| | | Shape (e.g.,
rectangular, spike,
rectified sinusoidal) | Not publicly available | Sinusoidal | Different
Subject Device
uses voltage
mode, but safe
by design since
charge-balanced
and maximum
power density
level is below
limit of
0.25W/cm² to
prevent excess
tissue heating | | |
| | | | Maximum Output
Voltage (volts) (+/-
%) at 500 Ohms,
2k Ohms and 10k
Ohms | Not publicly available | 55.9 @ 500Ω
87.4V @ 2000Ω
105.5V @ 10000Ω | Different
Subject Device
uses voltage
mode, but safe
by design. The
maximum voltage
and current
values are | |
| | | | | Device/Characteristic | NESS H200 Wireless (K123636)
Predicate Device | NeuStim Model NN-01 (K240632)
Subject Device | Comparison Results |
| | | | | Maximum Output
Current (specify
units) (+/- __%) at
500 ohms, 2k Ohms
and 10k Ohms | Not publicly available | 111.9 mA @ 500Ω
43.7 mA @ 2000Ω
10.6 mA @ 10000Ω | instantaneous maximum value
for a high- frequency (very
short phase duration)
stimulation waveform. Since
the phase duration is
significantly lower (0.05ms vs.
the predicate durations of 0.1,
0.2, 0.3 ms). Therefore the
resulting maximum phase
charge is substantially
equivalent to the Predicate Device.
Different
Subject Device uses voltage
mode, but safe by design. The
maximum voltage and current
values are instantaneous
maximum values for a high-
frequency (very short phase
duration) stimulation
waveform. Since the phase
duration is significantly
lower (0.05ms vs. the predicate
durations of 0.1, 0.2, 0.3 ms).
Therefore the resulting
maximum phase charge is |
| | | | | Device/
Characteristic | NESS H200 Wireless (K123636)
Predicate Device | NeuStim Model NN-01 (K240632)
Subject Device | Comparison
Results |
| Pulse width (specify
units) | Not publicly available | | | 0.5 milliseconds | equivalent to the
Predicate Device. | | |
| Frequency | Not publicly available | 50 Hz | | Equivalent | | | |
| Symmetrical
phases? (yes/no) | Not publicly available | Yes | Identical | | | | |
| Phase Duration
(include units),
(state range, if
applicable), (both
phases, if
asymmetrical) | Not publicly available | 0.05 milliseconds | Equivalent
The shorter
phase duration of
the Subject
Device results in
decreased
apparent tissue
impedance
thereby allowing
increased current
delivery for a
given voltage
level resulting in
effective muscle
contractions. | | | | |
| Net Charge (uC per
pulse) (If zero, state
method of achieving
zero net charge) | Not publicly available | 0, Balanced Waveform | Identical | | | | |
| Maximum Phase
Charge (mC) | Not publicly available | 0.00408 mC | Equivalent | | | | |
| Maximum Current
Density (RMS)
(mA/cm²) | Not publicly available | 1.78 mA/cm²
(500 Ohm Load) | Different
Subject Device
safe by design as
maximum
current density
level is below
limit of 2
mA/cm² per IEC
60601-2-10 to
prevent excess
tissue heating | | | | |
| Maximum Power
Density, (W/cm²),
(using smallest
electrode
conductive
surface area) | Not publicly available | 0.0563 W/cm²
(500 Ohm Load) | Different
Subject Device
safe by design as
maximum power | | | | |
| Device/
Characteristic | NESS H200 Wireless (K123636)
Predicate Device | NeuStim Model NN-01 (K240632)
Subject Device | Comparison
Results | | | | |
| | | | below limit of
0.25W/cm² to
prevent excess
tissue heating | | | | |
| Burst Mode (i.e.
Pulse trains):
– Pulses per burst
– Bursts per
second
– Burst duration
(seconds)
– Duty Cycle: Line
(b) x Line (c) | Not publicly available | N/A | N/A | | | | |
| ON Time (seconds) | Not publicly available | Variable | Identical | | | | |
| OFF Time (seconds) | Not publicly available | Variable | Identical | | | | |
| Additional Features
(if applicable) | – Intelli-Connect Earpiece Trigger
Device | n/a | N/A | | | | |
| Description of Accessories (Guidance Document for Powered Muscle Stimulators, Attachment II, Section 4)
Section 4 applies to only to the Subject Device. | | | | | | | |
| Description of Software/Firmware/Microprocessor Control (Guidance Document for Powered Muscle Stimulators,
Attachment II, Section 5) | | | | | | | |
| 1. Determination
of the level of
concern | Not publicly available | Basic Documentation Level | Subject device
complies with
current
regulations and
FDA Guidance | | | | |
| 2. Description of all
device functions
controlled by
the software | Not publicly available | Start / Stop Stimulation
Stimulation Amplitude
Stimulation Location
Stimulation Pattern
LED Indicators
Pairing with Control Device
Monitor and Display Battery Levels
Entering Sleep Mode | Equivalent | | | | |
7
8
9
10
11
12
13
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b):
| Purpose | Testing | Results |
|---|---|---|
| Verify compliance with | ||
| ANSI/AAMI ES60601-1 and IEC | ||
| 60601-1 requirements for | ||
| basic safety and essential | ||
| performance | Battery powered device, Type | |
| BF Applied Parts | Passed | |
| Verify compliance with IEC | ||
| 60601-1-2 requirements for | ||
| basic safety and essential | ||
| performance Electromagnetic | ||
| Disturbances | Battery powered device; | |
| radiated emissions, radiated | ||
| field immunity, proximity filed | ||
| immunity, magnetic field | ||
| immunity, electrostatic | ||
| discharge immunity | Passed | |
| Verify compliance with IEC | ||
| 60601-2-10 requirements for | ||
| the safety and essential | ||
| performance of nerve and | ||
| muscle stimulators | Battery powered muscle | |
| stimulator, Type BF Applied | ||
| Parts, normal and single-fault, | ||
| energy and power limits | Passed | |
| Verify compliance with ISO | ||
| 10993-1 Biologic Evaluation of | ||
| Medical Devices | Part 5: Tests for in vitro | |
| cytotoxicity; | ||
| Part 10: Tests for irritation and | ||
| skin sensitization | Passed | |
| Verify compliance with IEC | ||
| 62133-2 Secondary cells | ||
| and batteries containing | ||
| alkaline or other non-acid | ||
| electrolytes - Safety | ||
| requirements for portable | ||
| sealed secondary cells, and | ||
| for batteries made from | ||
| them, for use in portable | ||
| applications - Part 2: | ||
| Lithium systems | Battery individual cells and | |
| packs certified via third party | ||
| testing | Passed | |
| Verify software meets | ||
| requirements | Software Verification and | |
| Validation | Passed | |
| Verify user needs are met | System Design Validation | Passed |
| Verify device meets | ||
| requirements | Design Verification | Passed |
| Verify device meets | ||
| IEEE/ANSI C63.27 | ||
| Coexistence Testing | Tier 2 | Passed |
| Verify device meets labeled | ||
| Shelf-Life. | Shelf-Life Validation Study | Passed |
| Verify device meets | ||
| Adhesive Performance | ||
| Criteria | Adhesive Performance | |
| Validation Study | Passed | |
| Verify device meets Current | ||
| Distribution (Dispersion) | ||
| and Electrode Impedance | ||
| Criteria | Power and Current Density | |
| Validation Study | Passed |
14
Summary of Clinical Testing:
Not Applicable
Conclusion: The NeuStim NN-01 Device has the same intended use, does not raise any different questions of safety and effectiveness, and the provided performance data demonstrate substantial equivalence to the cleared Bioness Ness H200 System (K123636).