(126 days)
Not Found
No
The summary describes a standard electrical muscle stimulation (EMS) device with pre-programmed training programs. There is no mention of AI, ML, or any adaptive or learning capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device's intended use explicitly states it "is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind" and "must be used only on healthy muscles, not for rehabilitation purposes."
No
This device is intended to stimulate healthy muscles to improve or facilitate muscle performance, not for diagnosis. The text explicitly states it "is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind" and "is not designed for rehabilitation purposes."
No
The device description explicitly states that the "Genesis EMS Plus System includes the stimulator device, EMS suit with integrated electrodes, electrode wiring, specific underwear, stimulator charger (Off-the-shelf USB-C PD 3.0) and control device (Off-the-shelf Android Tablet with custom application)". This indicates the system includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Gnesis EMS Plus Function: The Gnesis EMS Plus is an electro-medical device that stimulates healthy muscles externally using electrical impulses. It does not analyze any specimens taken from the body.
- Intended Use: The intended use is to "stimulate healthy muscles in order to improve or facilitate muscle performance," not to diagnose or monitor medical conditions through the analysis of biological samples.
Therefore, the Gnesis EMS Plus falls under the category of an external medical device, specifically an electrical muscle stimulator, and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Gnesis EMS Plus is intended to stimulate healthy muscles in order to improve or facilitate muscle performance, is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.
None of Gnesis EMS Plus training programs is designed for injured or ailing muscles and its use on such cases is contraindicated.
Each of Gnesis EMS Plus training programs, depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), is designed for a specific type of exercise.
Gnesis EMS Plus is a device for electronic muscle stimulation based on EMS technology. Gnesis EMS Plus is specifically designed as an addition to other sports and for training muscles. It must be used only on healthy muscles, not for rehabilitation purposes.
Product codes
NGX
Device Description
Gnesis EMS Plus is an electro-medical device intended for stimulating healthy muscles in order to improve or facilitate muscle performance. It is designed for personal training.
None of Gnesis EMS Plus training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. It must be used only on healthy muscles and patients, it is not designed for rehabilitation purposes.
The device must be worn over the underwear provided by the system manufacturer, ensuring that the electrodes do not come into direct contact with the patient's skin.
Gnesis EMS Plus System cannot be used while the user is performing demanding tasks, such as jumping or lifting weights, any exercise must be approved by a qualified trainer.
Genesis EMS Plus System includes the stimulator device, EMS suit with integrated electrodes, electrode wiring, specific underwear, stimulator charger (Off-the-shelf USB-C PD 3.0) and control device (Off-the-shelf Android Tablet with custom application)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Electrodes can be applied to multiple anatomical sites.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Use in athletic training facilities. Not for use outdoors.
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
Non-clinical testing:
-Internal laboratory tests for waveform quality, responsiveness of controls, parameter regulation accuracy, battery life and reliability.
-EMC testing according to the procedures defined in IEC 60601-1-2 by external certification authority.
-Safety testing according to IEC 60601-1 and IEC 60601-2-10 by external certification authority.
Clinical testing:
Gnesis EMS Plus System implements Electrical Muscle Stimulation technology, which is a very well known and proved technology.
The system implements no significant differences form the clinical point of view, therefore no additional clinical testing was necessary to prove the performance of the device, apart from performance and safety testing.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains 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.
June 6, 2023
Creative Fitness Developments S.L. Jose Luis Delgado Official Correspondent Alfahuir 40. Valencia 46020, Spain
Re: K230261
Trade/Device Name: Gnesis EMS Plus Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: October 30, 2022 Received: January 31, 2023
Dear Jose Luis Delgado:
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.
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
1
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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Gnesis EMS Plus
Indications for Use (Describe)
Gnesis EMS Plus is intended to stimulate healthy muscles in order to improve or facilitate muscle performance, is not intended to be used in coniunction with therapy or treatment of medical diseases or medical conditions of any kind.
None of Gnesis EMS Plus training programs is designed for injured or ailing muscles and its use on such cases is contraindicated.
Each of Gnesis EMS Plus training programs, depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), is designed for a specific type of exercise.
Gnesis EMS Plus is a device for electronic muscle stimulation based on EMS technology. Gnesis EMS Plus is specifically designed as an addition to other sports and for
training muscles. It must be used only on healthy muscles, not for rehabilitation purposes.
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."
3
510(k) Summary
Creative Fitness Developments S.L. Gnesis EMS Plus K230261
1. SUBMITTER
| Manufacturer Name: | Creative Fitness Developments S.L. |
|---|---|
| Av. Alfahuir 40 | |
| 46020 Valencia (Spain) | |
| +34.628.09.96.67 | |
| Official Contact: | José Miguel Requena García |
| Av. Alfahuir 40 | |
| 46020 Valencia (Spain) | |
| +34.628.09.96.67 | |
| support@gnesisofficial.com | |
| 510(k) Summary | 01 June 2023 |
| Preparation Date: | |
| 510(k) Number: | K230261 |
2. DEVICE
| Trade/Proprietary Name: | Gnesis EMS Plus |
|---|---|
| Common name: | Powered muscle stimulator |
| Regulation Number: | 21 CFR 890.5850 |
| Regulation Name: | Powered muscle stimulator |
| Regulatory Class: | Class II |
| Product Code: | NGX |
4
3. PREDICATE DEVICE
WIEMSpro, K181955 Name & 510(k) Number:
I-MOTION, K212413
Medical Cables S.L. Manufacturer Name:
l-Motion Group Global Iberica S.L
4. DEVICE DESCRIPTION
Gnesis EMS Plus is an electro-medical device intended for stimulating healthy muscles in order to improve or facilitate muscle performance. It is designed for personal training.
None of Gnesis EMS Plus training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. It must be used only on healthy muscles and patients, it is not designed for rehabilitation purposes.
The device must be worn over the underwear provided by the system manufacturer, ensuring that the electrodes do not come into direct contact with the patient's skin.
Gnesis EMS Plus System cannot be used while the user is performing demanding tasks, such as jumping or lifting weights, any exercise must be approved by a qualified trainer.
Genesis EMS Plus System includes the stimulator device, EMS suit with integrated electrodes, electrode wiring, specific underwear, stimulator charger (Off-the-shelf USB-C PD 3.0) and control device (Off-the-shelf Android Tablet with custom application)
5. INDICATION FOR USE
Gnesis EMS Plus is intended to stimulate healthy muscles in order to improve or facilitate muscle performance, is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.
None of Gnesis EMS Plus training programs is designed for injured or ailing muscles and its use on such cases is contraindicated.
Each of Gnesis EMS Plus training programs, depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), is designed for a specific type of exercise.
Gnesis EMS Plus is a device for electronic muscle stimulation based on EMS technology.
Gnesis EMS Plus is specifically designed as an addition to other sports and for training muscles. It must be used only on healthy muscles, not for rehabilitation purposes.
6. SUMMARY OF COMPARISON WITH PREDICATE DEVICE
In the establishment of substantial equivalence, the Gnesis EMS Plus device is compared with the following previously cleared devices:
5
Comparison of the proposed device with the predicate devices is summarized in the following table:
| COMPARISON OF TECHNOLOGICAL CHARACTERISTICS | ||||
|---|---|---|---|---|
| Characteristic / | ||||
| Feature | Proposed device | |||
| Gnesis EMS Plus | Predicate device 1 | |||
| WIEMSPRO | Predicate device 2 | |||
| I-Motion | Comparison | |||
| GENERAL COMPARISON | ||||
| Classification | ||||
| name | Powered muscle | |||
| stimulator | Powered muscle | |||
| stimulator | Powered muscle | |||
| stimulator | Same | |||
| Product code | NGX | NGX | NGX | Same |
| Regulation | ||||
| number | 21 CFR 890.5850 | 21 CFR 890.5850 | 21 CFR 890.5850 | Same |
| Panel | Physical Medicine | Physical Medicine | Physical Medicine | Same |
| Class | Class II | Class II | Class II | Same |
| 510(K) Number | K230261 | K181955 | K212413 | |
| INTENDED USE | ||||
| Intended Use | Must be used for only | |||
| healthy muscles and client. | ||||
| It is not intended to be | ||||
| used in conjunction with | ||||
| therapy or treatment of | ||||
| medical diseases or | ||||
| medical | ||||
| conditions of any kind. | Must be used for only | |||
| healthy muscles and | ||||
| client. It is not intended | ||||
| to be used in | ||||
| conjunction with therapy | ||||
| or treatment of medical | ||||
| diseases or medical | ||||
| conditions of any kind. | Must be used for only | |||
| healthy muscles and | ||||
| client. It is not intended | ||||
| to be used in conjunction | ||||
| with therapy or | ||||
| treatment of medical | ||||
| diseases or medical | ||||
| conditions of any kind. | Same | |||
| Indication for | ||||
| use | Gnesis EMS Plus is | |||
| intended to stimulate | ||||
| healthy muscles in order | ||||
| to improve or facilitate | ||||
| muscle performance, is | ||||
| not intended to be used in | ||||
| conjunction with therapy | ||||
| or treatment of medical | ||||
| diseases or medical | ||||
| conditions of any kind. | ||||
| None of Gnesis EMS Plus | ||||
| training programs is | ||||
| designed for injured or | ||||
| ailing muscles and its use | WIEMSPRO is intended | |||
| to stimulate healthy | ||||
| muscles in | ||||
| order to improve or | ||||
| facilitate muscle | ||||
| performance. The | ||||
| WIEMSPRO is not | ||||
| intended to be used in | ||||
| conjunction with | ||||
| therapy or treatment of | ||||
| medical diseases or | ||||
| medical conditions | ||||
| of any kind. None of | ||||
| WIEMSPRO training | I-MOTION intended to | |||
| stimulate healthy | ||||
| muscles in order to | ||||
| improve or facilitate | ||||
| muscle performance. The | ||||
| I-MOTION is not intended | ||||
| to be used in conjunction | ||||
| with therapy or | ||||
| treatment of medical | ||||
| diseases or medical | ||||
| conditions of any kind. | ||||
| None of the I-MOTION | ||||
| training programs is | ||||
| designed for injured or | Similar. | |||
| All three devices | ||||
| are designed for | ||||
| improving | ||||
| healthy muscle | ||||
| training. |
6
7
| Use environment | Use in athletic training
facilities. Not for use
outdoors. | Use in athletic training
facilities. Not for use
outdoors. | Use in athletic training
facilities. Not for use
outdoors. | Same |
|--------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Anatomical sites | Electrodes can be applied
to multiple anatomical
sites. | Electrodes can be
applied to multiple
anatomical sites. | Electrodes can be applied
to multiple anatomical
sites. | Same |
| TECHNOLOGICAL CHARACTERISTICS AND PERFORMANCE | | | | |
| Powered
Muscle
Stimulator | YES | YES | YES | Same |
| Power source | Battery:3 x 3.6 V= 10,8V -
3,20AH (Lithium) | Battery:3.7V-2,4AH (Li
Po) | Battery:2 x 3.7 V= 7,4V -
3,4AH (Lithium) | Similar
Higher input
voltage to
improve
efficiency and
battery life.
Doesn't affect
safety,
performance/
functionality of
the device. |
| Method of line
current
isolation | N/A (battery operated
device) | N/A (battery operated
device) | N/A (battery operated
device) | Same |
| Patient leakage
Same
current
-Normal
condition
-Single fault
condition | N/A (battery operated
device) | N/A (battery operated
device) | N/A (battery operated
device) | Same |
| Battery operated | YES, Lithium polymer cell
rechargeable | YES, Lithium polymer cell
rechargeable | YES, Lithium polymer cell
rechargeable | Same |
| Number of
Output modes | One output mode, but
with varying stimulation
frequency and duty cycle
ranges | One output mode, but
with varying stimulation
frequency and duty cycle
ranges | One output mode, but
with varying stimulation
frequency and duty cycle
ranges | Same |
| Number of
Output channels
- Synchronous or
Alternating?
-Method of
Channel
Isolation | 1 CHANNEL
Alternating | 1 CHANNEL
Alternating | 1 CHANNEL
Alternating | Same |
| Independent
channels with
possibility to
regulate the
current | 12 CHANNELS | 10 CHANNELS | 10 CHANNELS | Two extra
channels, all
channels are
identical and
conforming to |
8
| individually | regulations | |||
|---|---|---|---|---|
| Regulated | ||||
| current and / or | ||||
| voltage | Regulated current | Regulated current | Regulated current | Same |
| Software/Firmw | ||||
| are/Microproces | ||||
| sor | ||||
| Control? | Yes | Yes | Yes | Same |
| Automatic | ||||
| overload Trip? | Yes | Yes | Yes | Same |
| Automatic No- | ||||
| load trip? | Yes | Yes | Yes | Same |
| Automatic Shut | ||||
| Off? | On/Off switch | |||
| Power-save timer | On/Off switch | On/Off switch | Adds power | |
| save timer, | ||||
| active only | ||||
| when device is | ||||
| not connected | ||||
| to control App | ||||
| and not | ||||
| delivering | ||||
| treatment. | ||||
| Patient Override | ||||
| Control? | Yes, push on On/Off | |||
| button directly pause the | ||||
| program | Yes, push on On/Off | |||
| button directly pause the | ||||
| program | Yes, push on On/Off | |||
| button directly pause the | ||||
| program | Same | |||
| Indicator | ||||
| Display? | Yes | Yes | Yes | Same |
| Plastic Housing | ||||
| materials | No, aluminum | Plastic | Plastic | Different |
| material, safety | ||||
| tested according | ||||
| to IEC 60601-2- | ||||
| 10 for leakage | ||||
| currents | ||||
| Device weight | 500 g | 300 g | 300 g | Heavier because |
| of aluminum | ||||
| construction | ||||
| Dimensions | [5,5 X 4 X 1,2] in | [6,66 x 3,27 x 1,18] in | [5,3 X 2,7 X 1,7] in | Similar |
| Waveform (e.g., | ||||
| pulsed | ||||
| mono-phasic, | ||||
| bi-phasic) | ||||
| (program per | ||||
| program) | Symmetrical bi-phasic (all | |||
| programs | Symmetrical bi-phasic | |||
| (all | ||||
| programs | Symmetrical bi-phasic (all | |||
| programs | Same |
9
| definition | ||||
|---|---|---|---|---|
| Current/ | ||||
| Voltage | 120mA/85V | 125mA/170V | 90mA/110V | Higher current |
| than i-motion, | ||||
| similar to | ||||
| WIEMSPRO | ||||
| Maximum power | ||||
| density | 14,4mW/cm2@500ohm | 9,61mW/cm2@500ohm | 9mW/cm2@500ohm | Higher power |
| density, | ||||
| included in risk | ||||
| management | ||||
| file according to | ||||
| IEC 60601-2-10 | ||||
| clause 201.4.2 | ||||
| This is due to | ||||
| higher | ||||
| frequencies | ||||
| available, | ||||
| resulting in | ||||
| higher duty | ||||
| cycle, not used | ||||
| in practice. | ||||
| Maximum | ||||
| current density | 2 mA/cm2 | |||
| Smallest electrode size: 60 | 1,92mA/cm2 | |||
| Smallest electrode size: | 1,87mA/cm2 | |||
| Smallest electrode size: | Similar | |||
| cm2 | 65 cm2 | 48cm2 | ||
| Pulse duration | ||||
| (width) | 25-400 µs | 150-450 µs | 150-450 µs | Allows for lower |
| pulse durations, | ||||
| doesn't | ||||
| introduce any | ||||
| risk as in this | ||||
| case energy | ||||
| density is lower, | ||||
| complies with | ||||
| IEC 60601-2-10 | ||||
| accuracy limits | ||||
| Frequency | 1 -150 Hz | 1 -100 Hz | 1 -100 Hz | Allows for |
| higher | ||||
| frequencies, | ||||
| complies with | ||||
| IEC 60601-2-10 | ||||
| limits | ||||
| Time range | ||||
| (minutes) | Maximum program: 90 | |||
| minutes | Maximum program: | |||
| unlimited | Maximum program: | |||
| unlimited | More restrictive | |||
| Reusable pads | Yes | Yes | Yes | Same |
| Compliance with | ||||
| voluntary | ||||
| standards / LAB | ||||
| tests performed | IEC 60601-1:2005 + | |||
| COR1:2006 + COR2:2007 + | ||||
| AMD1:2012 | ||||
| IEC 60601-1-2:2014 | ||||
| IEC 60601-1-6:2010 | IEC 60601-1-2:2007 | |||
| IEC 60601-1-6:2010 | ||||
| IEC 60601-2-10:2012 | ||||
| FCC 47 CFR Part 15 | ||||
| IEC 62304:2006 | IEC 60601-1:2005 (ed. | |||
| 3.0) +corrigendum 2006+ | ||||
| corrigendum 2007 + | ||||
| interpretation sheet 2008 | ||||
| +interpretation sheet | Similar | |||
| IEC 60601-2-10:2012 | 2009 |
10
| IEC 62304:2006
ISO 14971:2007 | ANSI/AAMI ES60601-1:
2005 / A2:2010 | IEC 60601-1-6:2010
(ed.3.0) + A1:2013
IEC 60601-1-2:2014
IEC 60601-2-10:2012 +
A1:2016
IEC 62304:2006
ISO 14971:2019 |
| ---------------------------------- | ---------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------- |
|---|
11
7. NON-CLINICAL TESTING
During the development of the Gnesis EMS Plus System the following non-clinical tests have been performed to validate the adequate performance of the system and equivalence to other systems in the market.
- Internal laboratory tests for waveform quality, responsiveness of controls, parameter . regulation accuracy, battery life and reliability.
- . EMC testing according to the procedures defined in IEC 60601-1-2 by external certification authority.
- . Safety testing according to IEC 60601-1 and IEC 60601-2-10 by external certification authority.
8. CLINICAL TESTING
Gnesis EMS Plus System implements Electrical Muscle Stimulation technology, which is a very well known and proved technology.
The system implements no significant differences form the clinical point of view, therefore no additional clinical testing was necessary to prove the performance of the device, apart from performance and safety testing.
12
9. CONCLUSIONS OF COMPARISON WITH PREDICATE DEVICES
The predicate devices: I-Motion and WIEMSPRO are currently marketed in US and approved by FDA with their respective 510(k) numbers.
Indications for use of Gnesis EMS Plus and WIEMSPRO are almost identical to those of I-Motion, as I-Motion is the main comparison device in both cases.
The above table shows Gnesis EMS Plus has equivalent technical characteristics, while observing the following minor differences:
- Gnesis EMS Plus uses a higher voltage battery, this affects power efficiency and battery life but has no effects on the treatment or battery safety. Cells comply with IEC 62133-2:2007 "Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems"
- . Gnesis EMS Plus has 12 channels. Wiempspro and I-Motion have 10. This allows for the treatment of more muscle groups, all channels have the same technical characteristics and comply with IEC 60601-2-10
- . Gnesis EMS Plus has on/off switch and Power-saver timer. Wiemspro and I-Motion have only on/off switch. Power-saver timer only works in case the device is disconnected from control application and treatment is not active.
- Gnesis EMS Plus is made of aluminum, Wiempspro and I-Motion of plastic. Safety tested according to IEC 60601-2-10 for leakage currents and impact resistance.
- . Gnesis EMS plus weights 500 gr.; Wiemspro and I-Motion weigh 300 gr.
- Gnesis EMS Plus has 10 programs customizable; Wiemspro has 10, I-Motion has none. All parameters are limited to the ranges mandated in IEC 60601-2-10
- Gnesis EMS Plus provides higher power and current densities and provides a wider range of adjustment of waveforms. All parameters are inside specified limits in IEC 60601-2-10
As these minor differences don't affect the basic safety of the device or create any significant deviation in performance from the predicate devices, and given that all three devices comply to the same main standards, Gnesis EMS Plus can be considered substantially equivalent to the predicate devices I-Motion and WIEMSPRO.
13
CONSENSUS STANDARDS 10.
In order to ensure adequate performance and safety of the Gnesis EMS Plus system, it has been tested by an accredited laboratory (SGS Tecnos Spain) according to the following standards:
- . Electromagnetic compatibility:
- UNE-EN 60601-1-2:2015, Spanish adopted version, identical to о IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- UNE-EN 60601-2-10:2015+A1:2016, Spanish adopted version, identical to o IEC 60601-2-10:2012+AMD1:2016 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
- Safety: ●
- UNE-EN 60601-1:2008 + Err.:2008 + Corr.:2010 + A1:2013 + A12:2015, Spanish o adopted version, identical to IEC 60601-1:2005 + COR1:2006 + COR2:2007 + AMD1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- UNE-EN 60601-1-6:2010 + A1:2015, Spanish adopted version, identical to o IEC 60601-1-6:2010+AMD1:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- UNE-EN 60601-2-10:2015+A1:2016, Spanish adopted version, identical to o IEC 60601-2-10:2012+AMD1:2016 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
- IEC 62304:2006+AMD1:2015 CSV Medical device software Software life cycle O processes
- ISO 14971:2019 Medical devices Application of risk management to medical O devices
Equivalence of UNE-EN and IEC standards can be checked in: https://www.en.une.org/