(261 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Neuvotion NeuStim (NN-01) device:
1. Table of Acceptance Criteria and Reported Device Performance
The provided FDA 510(k) summary does not explicitly detail a table of acceptance criteria with specific quantitative thresholds. Instead, it references compliance with various national and international standards. The "Results" column consistently states "Passed" for each test, indicating that the device met the requirements of these standards.
| Purpose | Testing | Reported Device Performance (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 |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not include information about the sample size used for a test set, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective). The studies listed are primarily non-clinical, focusing on device safety, performance, and compliance with standards. There is a "Summary of Clinical Testing: Not Applicable" statement, which further confirms the absence of a test set derived from human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since "clinical testing is not applicable" and no human test set is described, there is no information provided regarding experts used to establish ground truth or their qualifications. The ground truth for the non-clinical tests is established by meeting the requirements of the specific engineering and safety standards referenced.
4. Adjudication Method for the Test Set
As there is no described test set involving human subjects and clinical outcomes, an adjudication method is not applicable and not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The submission explicitly states "Summary of Clinical Testing: Not Applicable," indicating that no clinical studies (which would include MRMC studies) were performed for this 510(k). The comparison provided is between the subject device's technical specifications and the predicate device's general characteristics, not a clinical effectiveness study.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
The Neuvotion NeuStim (NN-01) is an external functional neuromuscular stimulator, a physical device that delivers electrical stimulation. It leverages software/firmware control for its operation but is not an AI algorithm that makes diagnostic or treatment decisions in a standalone manner without human interaction. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" as typically applied to AI/ML devices is not directly applicable here. The software verification and validation are part of the overall device performance, which is intrinsically human-controlled (by a licensed healthcare professional).
7. Type of Ground Truth Used
The ground truth used for the reported studies is primarily compliance with established regulatory standards and engineering specifications. For example:
- Safety and Essential Performance: Defined by standards like ANSI/AAMI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10.
- Biocompatibility: Defined by ISO 10993-1 (specifically Parts 5 and 10).
- Battery Safety: Defined by IEC 62133-2.
- Software Requirements: Defined by the software verification and validation process against predefined requirements.
- User Needs, Device Requirements, Coexistence, Shelf-Life, Adhesive Performance, Current Distribution/Electrode Impedance: These are validated against internal design specifications, user requirements, and relevant standards (e.g., IEEE/ANSI C63.27 for coexistence).
8. Sample Size for the Training Set
There is no mention of a training set sample size. Training sets are typically associated with machine learning or AI models. The NeuStim NN-01, while having software, is not described as an AI/ML device that requires a data training set in the context of this 510(k) submission. Its functionality relies on pre-programmed parameters and user-defined stimulation patterns.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set mentioned, there is no information on how its ground truth was established.
{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 | ComparisonResults |
|---|---|---|---|
| Indications for Use 21CFR807.92(a)(5) | |||
| 1. Indications forUse | 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 | EquivalentSubject 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 | ComparisonResults | ||||
|---|---|---|---|---|---|---|---|
| - Re-education of muscles | The NeuStim NN-01 is intended for use on the right arm/right hand only. | ||||||
| 2. Intended UseEnvironment | 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 | EquivalentSubject Device is identical with a subset of Predicate Device | ||||
| 3. Prescription orOTC? | Prescription | Prescription | Identical | ||||
| 4. TargetPopulation | 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 | ComparisonResults | ||||
| 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 (secondaryLithium Ion battery) | Identical | |||
| - | Method of LineCurrent Isolation | Not publicly available | Wireless (inductive) charging | Equivalent | |||
| - | Method of LineCurrent Isolation | Not publicly available | n/a | n/a | |||
| - | Patient LeakageCurrent NormalCondition | Not publicly available | Meets 60601-1 Clause 8.7 limits | Identical | |||
| - | Patient LeakageCurrent SingleFault Condition | Not publicly available | Meets 60601-1 Clause 8.7 limits | Identical | |||
| 5. | Number ofOutput Modes | Not publicly available | One (1) | Identical | |||
| 6. | Number ofOutput Channels | Not publicly available | Two (2) | Different | |||
| - | Synchronous orAlternating? | Not publicly available | Synchronous | Indeterminate | |||
| - | Method ofChannelIsolation | Not publicly available | Transformer | Indeterminate | |||
| 7. | RegulatedCurrent orRegulatedVoltage? | Not publicly available | Regulated Voltage | DifferentSubject Devicesafe by designsince currentlimitinghardwarecircuitryemployed | |||
| 8. | Software/Firmware/MicroprocessorControl? | Not publicly available | Yes | Identical | |||
| 9. | AutomaticOverload 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 | ComparisonResults | ||||
| 11. Automatic ShutOff? | Not publicly available | No | Subject Devicesafe by designsince voltagemode is usedand current-limitinghardwarecircuitryemployedDifferent | ||||
| 12. Patient OverrideControl? | Not publicly available | Yes | Subject Devicesafe since usedunder clinicalstaff directsupervisionIdentical | ||||
| 13. Indicator Display– On/Off Status? | Not publicly available | Yes | Identical | ||||
| – Low Battery? | Not publicly available | Yes | Identical | ||||
| – Voltage/CurrentLevel | Not publicly available | Yes | Identical | ||||
| 14. Timer Range(minutes) | Not publicly available | n/a | Different | ||||
| 15. Compliance withVoluntaryStandards | YesIEC 60601-1, IEC 60601-1-2 | YesIEC 60601-1, IEC 60601-1-2, IEC60601-2-10, ES60601-1, ISO 10993-5, ISO 10993-10, IEC 62133-2, IEEEANSI C63.27-2017. AAMI TIR69:2017 | Subject Devicesafe since usedunder clinicalstaff directsupervisionEquivalentSubject deviceconforms toadditional safetyand performancestandards | ||||
| 16. Compliance with21 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: 2.34inWidth: 1.87inDepth: .91in | N/A | ||||
| 19. HousingMaterials andConstruction | 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 | ComparisonResults | ||||
| Subject Devicesafe per ISO10993 testingand per FDABiocompatibilityGuidanceAttachment 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 | DifferentSubject Deviceuses voltagemode, but safeby design sincecharge-balancedand maximumpower densitylevel is belowlimit of0.25W/cm² toprevent excesstissue heating | ||||
| Maximum OutputVoltage (volts) (+/-%) at 500 Ohms,2k Ohms and 10kOhms | Not publicly available | 55.9 @ 500Ω87.4V @ 2000Ω105.5V @ 10000Ω | DifferentSubject Deviceuses voltagemode, but safeby design. Themaximum voltageand currentvalues are | ||||
| Device/Characteristic | NESS H200 Wireless (K123636)Predicate Device | NeuStim Model NN-01 (K240632)Subject Device | Comparison Results | ||||
| Maximum OutputCurrent (specifyunits) (+/- __%) at500 ohms, 2k Ohmsand 10k Ohms | Not publicly available | 111.9 mA @ 500Ω43.7 mA @ 2000Ω10.6 mA @ 10000Ω | instantaneous maximum valuefor a high- frequency (veryshort phase duration)stimulation waveform. Sincethe phase duration issignificantly lower (0.05ms vs.the predicate durations of 0.1,0.2, 0.3 ms). Therefore theresulting maximum phasecharge is substantiallyequivalent to the Predicate Device.DifferentSubject Device uses voltagemode, but safe by design. Themaximum voltage and currentvalues are instantaneousmaximum values for a high-frequency (very short phaseduration) stimulationwaveform. Since the phaseduration is significantlylower (0.05ms vs. the predicatedurations of 0.1, 0.2, 0.3 ms).Therefore the resultingmaximum phase charge is | ||||
| Device/Characteristic | NESS H200 Wireless (K123636)Predicate Device | NeuStim Model NN-01 (K240632)Subject Device | ComparisonResults | ||||
| Pulse width (specifyunits) | Not publicly available | 0.5 milliseconds | equivalent to thePredicate Device. | ||||
| Frequency | Not publicly available | 50 Hz | Equivalent | ||||
| Symmetricalphases? (yes/no) | Not publicly available | Yes | Identical | ||||
| Phase Duration(include units),(state range, ifapplicable), (bothphases, ifasymmetrical) | Not publicly available | 0.05 milliseconds | EquivalentThe shorterphase duration ofthe SubjectDevice results indecreasedapparent tissueimpedancethereby allowingincreased currentdelivery for agiven voltagelevel resulting ineffective musclecontractions. | ||||
| Net Charge (uC perpulse) (If zero, statemethod of achievingzero net charge) | Not publicly available | 0, Balanced Waveform | Identical | ||||
| Maximum PhaseCharge (mC) | Not publicly available | 0.00408 mC | Equivalent | ||||
| Maximum CurrentDensity (RMS)(mA/cm²) | Not publicly available | 1.78 mA/cm²(500 Ohm Load) | DifferentSubject Devicesafe by design asmaximumcurrent densitylevel is belowlimit of 2mA/cm² per IEC60601-2-10 toprevent excesstissue heating | ||||
| Maximum PowerDensity, (W/cm²),(using smallestelectrodeconductivesurface area) | Not publicly available | 0.0563 W/cm²(500 Ohm Load) | DifferentSubject Devicesafe by design asmaximum power | ||||
| Device/Characteristic | NESS H200 Wireless (K123636)Predicate Device | NeuStim Model NN-01 (K240632)Subject Device | ComparisonResults | ||||
| below limit of0.25W/cm² toprevent excesstissue heating | |||||||
| Burst Mode (i.e.Pulse trains):– Pulses per burst– Bursts persecond– 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 TriggerDevice | 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. Determinationof the level ofconcern | Not publicly available | Basic Documentation Level | Subject devicecomplies withcurrentregulations andFDA Guidance | ||||
| 2. Description of alldevice functionscontrolled bythe software | Not publicly available | Start / Stop StimulationStimulation AmplitudeStimulation LocationStimulation PatternLED IndicatorsPairing with Control DeviceMonitor and Display Battery LevelsEntering 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 withANSI/AAMI ES60601-1 and IEC60601-1 requirements forbasic safety and essentialperformance | Battery powered device, TypeBF Applied Parts | Passed |
| Verify compliance with IEC60601-1-2 requirements forbasic safety and essentialperformance ElectromagneticDisturbances | Battery powered device;radiated emissions, radiatedfield immunity, proximity filedimmunity, magnetic fieldimmunity, electrostaticdischarge immunity | Passed |
| Verify compliance with IEC60601-2-10 requirements forthe safety and essentialperformance of nerve andmuscle stimulators | Battery powered musclestimulator, Type BF AppliedParts, normal and single-fault,energy and power limits | Passed |
| Verify compliance with ISO10993-1 Biologic Evaluation ofMedical Devices | Part 5: Tests for in vitrocytotoxicity;Part 10: Tests for irritation andskin sensitization | Passed |
| Verify compliance with IEC62133-2 Secondary cellsand batteries containingalkaline or other non-acidelectrolytes - Safetyrequirements for portablesealed secondary cells, andfor batteries made fromthem, for use in portableapplications - Part 2:Lithium systems | Battery individual cells andpacks certified via third partytesting | Passed |
| Verify software meetsrequirements | Software Verification andValidation | Passed |
| Verify user needs are met | System Design Validation | Passed |
| Verify device meetsrequirements | Design Verification | Passed |
| Verify device meetsIEEE/ANSI C63.27Coexistence Testing | Tier 2 | Passed |
| Verify device meets labeledShelf-Life. | Shelf-Life Validation Study | Passed |
| Verify device meetsAdhesive PerformanceCriteria | Adhesive PerformanceValidation Study | Passed |
| Verify device meets CurrentDistribution (Dispersion)and Electrode ImpedanceCriteria | Power and Current DensityValidation 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).
§ 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).