(66 days)
The Neuro20 PRO System is intended to stimulate muscles in order to improve or facilitate muscle performance.
Other indications for use include:
- · Re-educating muscles
- · Increasing local blood circulation
- · Maintaining or increasing range of motion
- · Relaxation of muscle spasm
- · Retarding or preventing disuse atrophy
The Neuro20 PRO System is a powered muscle stimulator designed for individual or group rehabilitation and recovery. The Neuro20 PRO System is a transcutaneous electrical muscle stimulation (EMS) device which stimulates motor nerves by means of electrical impulses transmitted by electrodes. The system utilizes electrical stimulation to create an involuntary contractions of motor neurons are transmitted to the muscle fibers where they stimulate a muscular response.
Depending on the parameters of the electrical impulses (pulse intensity, pulse duration, pulse width, pulse rise, pause time, total session duration), different types of muscle work can be imposed on the stimulated muscles. The involuntary muscle activation can be voluntarily over-ridden through intentional exercise. Individual intensity levels can be modulated for each muscle group. One to ten patients may be treated within a session.
The Neuro20 PRO System is comprised of three major components: the Control Box with battery (the muscle stimulator), Smart Suit (the wearable suit with electrodes covering the muscles), and Operating Tablet with software which allows the medical professional to adjust the parameters for the patient. Users may be actively engaged within a variety of training modes while the clinician/operator controls the software. The Neuro20 PRO System accessories are a battery charger, protective case, and Smart Suit packaging.
The Neuro20 Control Box connects to the suit and is powered by a battery. It is controlled by the medical practitioner operating the software. The Smart Suit applies the electrodes to the upper body, arms, legs, and buttocks. The Control Unit is connected to the Operating Tablet wirelessly.
The Neuro20 PRO System is a powered muscle stimulator intended to improve or facilitate muscle performance, re-educate muscles, increase local blood circulation, maintain or increase range of motion, relax muscle spasm, and retard or prevent disuse atrophy.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Standard) | Reported Device Performance (Test Results) |
|---|---|
| IEC60601-2-10:2012+AMD1:2016 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators | Passed IEC60601-2-10 Standard Testing. |
| IEC 60601-1-2:Edition 4.1, 2020-09; Consolidated Version: Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests; FCC/CFR 47:Part 15B | Passed IEC 60601-1-2 Standard Testing. |
| IEC60601-1:2005+A1:2012 – Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | Passed IEC 60601-1 Standard Testing. |
| IEC 60601-1-11:Edition 2.1, 2020-07, Consolidated Edition:Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment | Passed IEC 60601-1-11 Testing. |
| IEC 62304:2006+AMD1:2015 Medical Device Software - Software life-cycle processes | Checklist of Compliance IEC 62304 accepted. |
| EN ISO 14971:2019 Medical devices - Application of risk management to medical devices | Risk Management per ISO 14971 performed. |
| IEC 62366-1:2015+AMD1:2020 Medical Devices – Part 1: Application of usability engineering to medical devices | Passed IEC 62366-1 Standard Testing. |
| ISO10993-1:2018 – Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process | ISO 10993-1 Evaluation Performed. |
| ISO 10993-5:2009 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Biological Evaluation 10993-5 performed. |
| ISO10993-10:2010 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Passed ISO-10993-10 Standard Testing. |
| IEC60601-1-6:2010+AMD2:2020 – Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | Passed IEC 60601-6 Standard Testing. (Also listed as Passed IEC 62366-1 Standard Testing.) |
| IEC 62133-2:2017 – 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 | Passed IEC 62133-2 Standard Testing. |
Study Proving Device Meets Acceptance Criteria:
The device's compliance with the acceptance criteria is demonstrated through a series of non-clinical performance tests evaluating its safety, essential performance, and functionality according to recognized international and national standards.
2. Sample Size for the Test Set and Data Provenance:
The provided document does not specify a "test set" in the context of clinical data for performance evaluation. All performance data is based on non-clinical testing against relevant standards. Therefore, information regarding sample size and data provenance (e.g., country of origin, retrospective/prospective) for a test set of data is not applicable for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable, as no clinical test set requiring expert-established ground truth was used for this submission. The evaluation was based on non-clinical engineering and safety standards.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set requiring adjudication was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was conducted or referenced in the provided document. The submission explicitly states: "The determination of substantial equivalence using clinical performance data is not applicable because such data is not required to determine the substantial equivalence of the Neuro20 PRO System to the cited predicate devices." Therefore, no effect size of human readers improving with or without AI assistance is provided.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. The Neuro20 PRO System is an electrical muscle stimulator, not an AI or algorithm-based diagnostic/therapeutic device that would typically undergo standalone algorithm performance studies. The compliance is demonstrated via adherence to safety and performance standards for muscle stimulators.
7. Type of Ground Truth Used:
The "ground truth" for demonstrating the device meets its acceptance criteria is based on adherence to established international and national performance and safety standards for medical electrical equipment, particularly for nerve and muscle stimulators. This includes standards related to electrical safety, electromagnetic compatibility, software lifecycle processes, risk management, usability engineering, and biological evaluation of medical devices.
8. Sample Size for the Training Set:
Not applicable, as this is related to clinical data for algorithm training, which was not part of this 510(k) submission for a powered muscle stimulator.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set requiring ground truth establishment for an algorithm was used.
{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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 23, 2023
Neuro20 Technologies % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K223797
Trade/Device Name: Neuro20 Pro System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: NGX, IPF Dated: January 25, 2023 Received: February 6, 2023
Dear Dave Yungvirt:
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 (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 located 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.
{1}------------------------------------------------
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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.
Tushar Bansal -S
Tushar Bansal, PhD Acting Assistant Director, Acute Injury Devices Team 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K223797
Device Name Neuro20 PRO System
Indications for Use (Describe)
The Neuro20 PRO System is intended to stimulate muscles in order to improve or facilitate muscle performance.
Other indications for use include:
- · Re-educating muscles
- · Increasing local blood circulation
- · Maintaining or increasing range of motion
- · Relaxation of muscle spasm
- · Retarding or preventing disuse atrophy
Type of Use (Select one or both, as applicable)
X 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."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for Neuro20 Efficient Health. The word "NEURO" is in a bold, sans-serif font, with the "20" in a smaller, lighter font to the right. There is a graphic of connected dots to the left of the "20". Below the word "NEURO" is the phrase "EFFICIENT HEALTH" in a smaller, lighter font.
510(k) Summary
| 510(k) Submitter: | Dennis SchmittNeuro20 Technologies, Corp.3802 Spectrum BlvdSuite 116ETampa, FL 33612(917) 503 NURO (6876)dj@neuro20.com |
|---|---|
| Primary Correspondent: | Dennis SchmittNeuro20 Technologies, Corp.3802 Spectrum BlvdSuite 116ETampa, FL 33612(917) 503 NURO (6876)dj@neuro20.com |
| Date 510(k) Summary Prepared | 15-July-2022 |
| Trade Name of Device:Common Name:Model Identification:Product codes:Classification Name: | Neuro20 PRO SystemNeuro20 PRON20PRO-SYSNGX, IPFStimulator, Muscle, Powered, For Muscle Conditioning(21CFR 890.5850, Product Code NGX)Stimulator, Muscle(21CFR 890.5850, Product Code IPF) |
| Review Panel | 89 Physical Medicine |
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for Neuro20. The word "NEURO" is in a bold, sans-serif font, with the "20" in a lighter, sans-serif font to the right. To the left of the "20" is a graphic of connected dots. Below the word "NEURO" is the phrase "EFFICIENT HEALTH" in a smaller, sans-serif font.
Predicate devices
| Primary Predicate Device: | miha bodytec II |
|---|---|
| 510(k) Number: | K201975 |
| Product Classification: | II |
| Classification Name: | Powered Muscle Stimulator (21CFR 890.5850, Product Code NGX, IPF) |
| Secondary Predicate Device: | Compex® Rehab |
| 510(k) Number: | K090632 |
| Product Classification: | II |
| Classification Name: | Powered Muscle Stimulator (21CFR 890.5850, Product Code IPF) |
Device Description:
The Neuro20 PRO System is a powered muscle stimulator designed for individual or group rehabilitation and recovery. The Neuro20 PRO System is a transcutaneous electrical muscle stimulation (EMS) device which stimulates motor nerves by means of electrical impulses transmitted by electrodes. The system utilizes electrical stimulation to create an involuntary contractions of motor neurons are transmitted to the muscle fibers where they stimulate a muscular response.
Depending on the parameters of the electrical impulses (pulse intensity, pulse duration, pulse width, pulse rise, pause time, total session duration), different types of muscle work can be imposed on the stimulated muscles. The involuntary muscle activation can be voluntarily over-ridden through intentional exercise. Individual intensity levels can be modulated for each muscle group. One to ten patients may be treated within a session.
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image is a logo for Neuro20 Efficient Health. The logo has the word "NEURO" in bold, black letters. To the right of the word "NEURO" is the number "20" in a light blue color. There are also some light blue and black dots and lines that connect the word "NEURO" to the number "20". Below the word "NEURO" is the phrase "EFFICIENT HEALTH" in light blue letters.
Device Description (continued)
The Neuro20 PRO System is comprised of three major components: the Control Box with battery (the muscle stimulator), Smart Suit (the wearable suit with electrodes covering the muscles), and Operating Tablet with software which allows the medical professional to adjust the parameters for the patient. Users may be actively engaged within a variety of training modes while the clinician/operator controls the software. The Neuro20 PRO System accessories are a battery charger, protective case, and Smart Suit packaging.
The Neuro20 Control Box connects to the suit and is powered by a battery. It is controlled by the medical practitioner operating the software. The Smart Suit applies the electrodes to the upper body, arms, legs, and buttocks. The Control Unit is connected to the Operating Tablet wirelessly.
The Neuro20 PRO System is to be used in a professional setting such as physicians' office, physical therapist, professional sports setting, and nursing homes as well as in the home healthcare environment. The device must be operated by a trainer who has received full training from the manufacturer. Prior to a training session the correct suit size is selected for the patient in order to ensure proper placement of the electrodes. The trainer can choose between pre-set training programs on the software. The intensity can be adjusted by the trainer at the UI of the Operating Tablet separately for each channel. Complete body training which addresses all muscle groups is possible with up to 10 pairs of electrodes. Once the training is started, the control unit generates and transmits the electrical signals to the electrodes via Bluetooth. During pulse application, the trainer instructs the patient on specific exercises to perform. The training can be stopped anytime by pressing the multi-function / stop button, pause button on the software, or on the Control Box connected to the Suit.
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image is a logo for Neuro20. The logo has the word "NEUR" in black, with the "20" in blue and a graphic of connected dots to the left of the "20". Below the logo is the phrase "EFFICIENT HEALTH" in blue.
Indications for Use of the Device:
The Neuro20 PRO System is intended to stimulate muscles in order to improve or facilitate muscle performance.
Other indications for use include:
- Re-educating muscles
- Increasing local blood circulation
- Maintaining or increasing range of motion
- Relaxation of muscle spasm
- Retarding or preventing disuse atrophy
The following table compares the indications for use of the proposed device against those of the primary predicate device and the secondary predicate device.
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image is a logo for Neuro20 Efficient Health. The word "NEURO" is in large, bold, black letters. To the right of the word "NEURO" is a graphic of blue and black dots and lines, followed by the number "20" in blue. Below the word "NEURO" is the phrase "EFFICIENT HEALTH" in smaller, blue letters.
Technological Characteristics Comparison with Predicates:
The design and material differences between the Neuro20 PRO System, the primary predicate and secondary predicate is that the Neuro20 PRO System design is a complete body suit made of flexible spandex with electrodes that do not contain accessible plugs or cables but does contain a battery pack with rechargeable Bluetooth technology. The miha bodytec II uses external power supply to operate and involves the use of an ibody® electrode polyurethane vest worn by the patient, with electrodes worn over under garments and a control unit mounted on a stand, connected with the control unit via cables. The Compex® Rehab is a battery-powered hand-held stimulator which connects to cutaneous electrodes, placed manually on the body part being targeted (including the same body parts as those targeted by the Neuro20 PRO System and miha bodytec II).
In summary for energy comparison between the Neuro20 PRO System, the primary predicate and secondary predicate, and miha bodytec II, the Neuro20 PRO has less maximum output voltage, output current, power density and phase charge than the primary predicate and secondary predicate miha bodytec II. The Neuro20 PRO system is within the pulse width, pulse frequency, and pulse duration range of the primary predicate and secondary predicate. miha bodytec II . The waveforms of the Neuro20 PRO System, the primary predicate and secondary predicate and the miha bodytec II are similar. The Neuro20 PRO System has more safety options then the primary predicate and secondary predicate miha bodytec II in that the Neuro20 PRO System connector layout is designed to prevent misconnection, current regulation, no charging of the device is possible while training (removal of accumulator), fuses and lock bits against manipulation, battery, voltage, and output current monitoring.
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for Neuro20. The logo has the word "NEURO" in black, with the number "20" in blue and black to the right of the word. Below the word "NEURO" is the phrase "EFFICIENT HEALTH" in blue.
Technological Characteristics Comparison with Predicates: (continued)
| Characteristic | Neuro20 PRO SystemProposed device | miha bodytec IIPrimary predicate | Compex® RehabSecondary predicate |
|---|---|---|---|
| 1. 510(k) Number | K223797 | K201975 | K090632 |
| 2. Device Name, Model | Neuro20 PRO System | miha bodytec II | Compex® Rehab |
| 3. Manufacturer | Neuro20 Technologies, Corp. | miha bodytec GmbH | Chattanooga Group |
| 4. Power Source(s) | Rechargeable Li-ion battery 7.4V Types LP-E5, 2 Cells each UL listed: MH60905. Pack certified to IEC62133-2:2017 (5.6 watts (756 mA Max @ 7.4 V). | Control Unit: 15V – 19V; External power supply (100-240V ~ 50-60 Hz). | 4.8 V (2000 mAh) NiMH rechargeable battery |
| - Method of Line Current Isolation | N/A – Neuro20 PRO System is a battery-operated device in accordance with 60601-1-1 | Power Supply in accordance with IEC 60601-1-1 | N/A (battery operated device) |
| - Patient Leakage-- Normal Condition-- Single Fault Condition | N/A – Neuro20 PRO System is a battery-operated device in accordance with 60601-1-1 | < 100 μΑ | N/A (battery operated device) |
| 5. Number of Output Modes | 4 output modes | One (symmetric biphasic) with 6 training programs. | One (symmetric biphasic) |
| 6. Number of Output Channels | 10 channels selective stimulation. | 10 channels, selective stimulation. Maximum one channel is active at any time. | Four independent and individually adjustable channels that are electrically isolated from each other |
| - Synchronous or Alternating | Synchronous, but never two channels activated at the same time. | Alternating. | For 2-channel configuration, channels 1 and 2 alternate. For 4-channel configuration, channels 1+2 alternate with channels 3+4. |
| - Method of Channel Isolating | Multiplexed by Control Box | Multiplexed by control unit. | Not publicly available |
| 7. Regulated Current or Regulated Voltage? | Constant current control | Regulated voltage (all channels) | Regulated current (all channels) |
| Characteristic | Neuro20 PRO SystemProposed device | miha bodytec IIPrimary predicate | Compex® RehabSecondary predicate |
| 8. Software/Firmware/MicroprocessorControl | Yes | Yes | Yes |
| 9. AutomaticOverload Trip | Yes, no load and shortcircuit conditions arehandled | Yes, no load and shortcircuit conditions arehandled | Not publicly available |
| 10. AutomaticNo Load Trip | Yes, no load and shortcircuit conditions arehandled. | Yes, no load and shortcircuit conditions arehandled. | Not publicly available |
| 11. AutomaticShut Off | "On/Off" switch andautomatic shut off after 4minutes withoutcommunication, automaticstop of stimulation in caseof failure / malfunctiondetected | On/Off-Switch, stimulationstops after defined duration,automatic stop ofstimulation in case of failure/ malfunction detected. | On/Off button to interruptthe programmemomentarily, stimulationstops after defined duration,automatic stop ofstimulation in case of failure/ malfunction detectedthrough regular automaticperformance checks duringoperation. |
| 12. PatientOverrideControl | Yes, Stop button located onthe Neuro20 Control Box,patient has direct access. | Yes, while a program isactive the athlete/patient issupervised by a trainer andable to manipulate intensity(amplitude) and push thestop button. | Operation only byauthorized individuals.Choice of therapyparameters, programs andprotocols only byresponsible physician ortherapist. During trainingnot always supervised. Onlyif patients are unable tooperate the emergency stopfunction. |
| 13. IndicatorDisplay:- On/Off Status | Yes | Yes | Yes |
| - Low Battery | Yes | N/A - No Battery. | Yes |
| - Voltage/Current Level | Yes, displayed in form ofpercentage / value range. | Yes, displayed in form ofpercentage / value range. | Yes, displayed in form ofblack bar graphs |
| 14. TimerRange(in minutes) | 5 seconds – 1 hour. Screenshows remaining time inminutes and displays imageshowing time remaining. | Training should not exceed20 minutes; Screen showsremaining time in minutesand displays image showingtime remaining. | Maximum = 20 minutes (forthe programs referred to forsubstantial equivalencediscussion); Screen showsremaining time in horizontalbars |
| Characteristic | Neuro20 PRO System | miha bodytec II | Compex® Rehab |
| Proposed device | Primary predicate | Secondary predicate | |
| 15. Compliance | ISO 14971 :2019 | ISO 14971:2007 | IEC 60601-1 |
| with Voluntary | IEC 60601-1 2005 | AAMI ANSI ES 60601- | IEC 60601-1-2 |
| Standards | +A1 :2012 | 1 2005/®2012 And | IEC 60601-2-10 |
| EN 60601-1-2 : 2020-9 | A1:2012 | ||
| FCC/CFR 47 :Part 15B | IEC 60601-1-2:2014 | ||
| IEC60601-2- | IEC 60601-1-11:2015 | ||
| 10 :2012+AMD1 :2016 | IEC 60601-2-10:2016 | ||
| IEC | IEC 62304:2006 + A1:2015 | ||
| 62304 :2006+AMD1 :2015 | IEC 62366-1:2015 + | ||
| IEC 62366- | COR1:2016 | ||
| 1 :2015+AMD1 :2020 | ISO 10993-1:2009 | ||
| ISO 10993-1:2018 | ISO 10993-5:2009 | ||
| ISO 10993-10:2010 | ISO 10993-10:2010 | ||
| IEC 60601-1-6: 2010+AMD | ASTM F1980-16 | ||
| 2:2020 | |||
| ISO 15223-1:2016 | |||
| IEC 62133-2:2017 | |||
| IEC 60601-1-11: 2020-7 | |||
| ISO 10993-5: 2009 | |||
| 16. Compliance | Yes. | Yes. | Yes |
| with 21 CFR | |||
| 898 | |||
| 17. Weight | Neuro20 Control Box: 160g | Complete: 45.2 lb Control | Complete: N/A |
| with battery | unit: 10.3 lb i-body® with | Control unit: 0,66 lb | |
| Neuro20 Operating Tablet: | cable set: 3.3 lb i-body® | (battery included) | |
| Variable. | belt: 0.9 lb i-body® strap: | Accessory: N/A | |
| Neuro20 Smart Suit | 0.55 lb | ||
| Dependent on clothing size. | |||
| 18. Dimensions | Neuro20 Control Box: 126 | Control unit: 1.39 × 0.89 × | Control unit: 0.45 × 0.31 × |
| (in.) [WxDxH] | mm x 75.5 mm x 37.6 mm | 0.23 (W × D × H in ft) | 0.11 (W × D × H in ft) |
| Neuro20 Operating Tablet: | Complete: 1.77 × 1.69 × | ||
| Variable. | 3.89 (W × D × H in ft | ||
| Neuro20 Smart Suit: | |||
| Dependent on clothing size | |||
| 19. Housing | Control Box: ABS plastic | Control unit: Aluminum. | Control unit: plastic |
| Material and | housing. | ||
| Construction | |||
| Characteristic | Neuro20 PRO SystemProposed device | miha bodytec IIPrimary predicate | Compex® RehabSecondary predicate |
| Waveform(e.g., pulsedmonophasic,biphasic) | Symmetric biphasic | Symmetric biphasic. | Symmetricbiphasic |
| Shape (e.g.,rectangular,spike, rectifiedsinusoidal | Rectangular. | Rectangular. | Rectangular |
| MaximumOutput Voltage | 55V (@ 500Ω (+/- 10%)55V (@2kΩ (+/- 10%)55V (@ 10kΩ (+/- 10%) | <= 74Vp (@ 500Ω (54 - 74Vp)<= 152Vp @ 2kΩ (110152 Vp)<= 152Vp @ 10kΩ (130152 Vp) | 60V @ 500ΩInformation for 2kΩ and10kΩ not publicly available. |
| MaximumOutputCurrent | 120 mA @ (@, 500Ω30 mA @, 2kΩ6 mA @ 10kΩ | < 148mAp @ 500Ω(108-148mAp)< 76mAp @ 2kΩ (55-76mAp)< 15 mAp @ 10kΩ(13-15mAp) | 120mA (@, 500ΩInformation for 2kΩ and10kΩ not publicly available. |
| Pulse Width | 150 - 400 us | 50 - 400 us | 30 - 400 μs |
| Frequency | 7 - 100Hz (5% accuracy) | 2 - 150 Hz | 1 - 150 Hz |
| Forinterferentialmodes- Beat frequency | N/A - no interferentialmodes | Not publicly available | Not publicly available |
| MultiphasicWaveform:- SymmetricalPhases? | Yes | Yes | Yes |
| - Phase Duration | 75 - 200 us (10% accuracy) | 25 200 us | 15 200 us |
| Net Charge (ifzero, statemethod ofachieving zeronet charge). | 0μC @500Ω Excitationpulse fully Compensated | Not publicly available | Not publicly available |
| MaximumPhase Charge | 24 µC @500Ω | <32 μC @500Ω | 48 µC @ 500Ω |
| MaximumCurrentDensity | 0.46 mA/cm2 @ 500ΩRMS | 0.64 mA/cm² @ 500Ω | 1,18 mA/cm² @500Ω |
| MaximumPower Density | 4.7 mW/cm² @ 500Ω RMS | 0.82 mW/cm² @ 500Ω | Not publicly available |
| Burst Mode- Pulses perburst | N/A – no burst mode | Not publicly available | Not publicly available |
| - Burst persecond | N/A – no burst mode | Not publicly available | Not publicly available |
| - Burst duration(seconds) | N/A – no burst mode | Contraction time: 1 - 10 sRelaxation time: 0.0 - 10 s | Not publicly available |
| - Duty Cycle[Line (b) x Line(c)] | N/A – no burst mode | Not publicly available | Not publicly available |
| ON Time | 1-60 seconds | See Burst Mode | Not publicly available |
| OFF Time | 0-60 seconds | See Burst Mode | Not publicly available |
| Additionalfeatures: safetyCircuits | Short circuit protection, noload and overloadprotection, power button forimmediate shut-off,hardware error monitoring,firmware self- tests, securityconnection betweenNeuro20 Control Box andNeuro20 Smart Suit for animmediate cessation oftraining if wronglyconnected, connector layoutis designed to preventmisconnection, currentregulation, no charging ofdevice possible whiletraining (removal ofaccumulator), fuses and lockbits against manipulation,battery, voltage, and outputcurrent monitoring | Short circuit monitoring,watchdog monitoring, noload trip, on load trip,button for immediate shut-off, redundant hardwareerror monitoring,(emergency stop option).Firmware self -tests | Not publicly available |
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the logo for NEUR20 Efficient Health. The word "NEUR" is in black, and the number "20" is in blue with a graphic of connected dots. The words "EFFICIENT HEALTH" are in blue and are located below the word "NEUR".
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the logo for "NEURO 20" with the words "EFFICIENT HEALTH" underneath. The word "NEURO" is in a bold, sans-serif font, and the number "20" is in a lighter, sans-serif font with a series of dots and lines connecting the two. The words "EFFICIENT HEALTH" are in a light blue, sans-serif font and are centered below the word "NEURO".
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the logo for Neuro20 Efficient Health. The logo is in two lines, with the first line showing the word "NEURO" in a bold, sans-serif font, followed by a stylized image of a brain with the number "20" next to it. The second line shows the words "EFFICIENT HEALTH" in a smaller, sans-serif font.
Substantial Equivalence Discussion (continued)
Output Specifications:
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the logo for Neuro20 Efficient Health. The word "NEURO" is in bold, black letters. To the right of the word "NEURO" is a graphic of blue and black dots, followed by the number "20" in blue. Below the word "NEURO" is the phrase "EFFICIENT HEALTH" in light blue letters.
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the logo for Neur20 Efficient Health. The logo has the word "NEUR" in large, bold, black letters. To the right of the word "NEUR" is a graphic of blue and black dots connected by lines, followed by the number "20" in blue. Below the word "NEUR" is the phrase "EFFICIENT HEALTH" in smaller, blue letters.
Determination of Substantial Equivalence:
Non-Clinical Performance Data:
The following non-clinical tests were performed on the Neuro20 PRO System:
| Performance Standard Neuro20 PRO System | Performance StandardTest Results |
|---|---|
| IEC60601-2-10:2012+AMD1:2016 Medical electrical equipment -Part 2-10: Particular requirements for the basic safety and essentialperformance of nerve and muscle stimulators | Passed IEC60601-2-10Standard Testing. |
| IEC 60601-1-2:Edition 4.1, 2020-09; Consolidated Version:Electrical Equipment - Part 1-2: General Requirements for BasicSafety and Essential Performance - Collateral Standard:Electromagnetic Disturbances - Requirements and TestsFCC/CFR 47:Part 15B | Passed IEC 60601-1-2Standard Testing. |
| IEC60601-1:2005+A1:2012 – Medical electrical equipment - Part 1:General requirements for basic safety and essential performance | Passed IEC 60601-1Standard Testing. |
| IEC 60601-1-11:Edition 2.1, 2020-07, ConsolidatedEdition :Medical electrical equipment - Part 1-11: Generalrequirements for basic safety and essential performance - CollateralStandard: Requirements for medical electrical equipment and medicalelectrical systems used in the home healthcare environment | Passed IEC 60601-1-11Testing: |
| IEC 62304:2006+AMD1:2015Medical Device Software - Software life-cycle processes | Checklist of ComplianceIEC 62304 accepted. |
| EN ISO 14971:2019Medical devices - Application of risk management to medical devices | Risk Management perISO 14971 performed. |
| IEC 62366-1:2015+AMD1:2020Medical Devices – Part 1: Application of usability engineering tomedical devices | Passed IEC 62366-1Standard Testing. |
| ISO10993-1:2018 – Biological evaluation of medical devices — Part1: Evaluation and testing within a risk management process | ISO 10993-1 EvaluationPerformed. |
| ISO 10993-5:2009 - Biological evaluation of medical devices - Part5: Tests for in vitro cytotoxicity | Biological Evaluation10993-5 performed. |
| ISO10993-10:2010 - Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization | Passed ISO-10993-10Standard Testing. |
| IEC60601-1-6:2010+AMD2:2020 – Medical electrical equipment –Part 1-6: General requirements for basic safety and essentialperformance - Collateral standard: Usability | Passed IEC 60601-6Standard Testing. |
| Passed IEC 62366-1Standard Testing. | |
| IEC 62133-2:2017 – Secondary cells and batteries containing alkalineor other non-acid electrolytes - Safety requirements for portablesealed secondary cells, and for batteries made from them, for use inportable applications - Part 2: Lithium systems | Passed IEC 62133-2Standard Testing. |
Determination of Substantial Equivalence: (continued)
{14}------------------------------------------------
Image /page/14/Picture/0 description: The image shows the logo for Neuro20. The logo has the word "NEURO" in bold, black font. To the right of the word is a graphic of blue and black dots connected by lines, followed by the number "20" in blue. Below the word "NEURO" is the phrase "EFFICIENT HEALTH" in a smaller, light blue font.
Non-Clinical Performance Data: (continued)
In summary, an evaluation of the results of the non-clinical testing performed on the Neuro20 PRO System demonstrates that the proposed device's safety, effectiveness, performance and functionality.
Clinical Performance Data:
The determination of substantial equivalence using clinical performance data is not applicable because such data is not required to determine the substantial equivalence of the Neuro20 PRO System to the cited predicate devices.
Conclusion
In conclusion, based on the nonclinical tests and the comparison offered in this 510(k) submission, it is demonstrated the Neuro20 PRO System is as safe, as effective, and performs as well as or better than the legally marketed devices identified in this submission.
§ 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).