(126 days)
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.
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)
Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text.
The Gnesis EMS Plus device is a Powered Muscle Stimulator. The provided FDA 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical performance and safety testing against recognized electrical and medical device standards. There is no information about an AI component or a study involving human readers or comparative effectiveness in the traditional sense of AI system evaluation. The "acceptance criteria" here relate to meeting established safety and performance standards for powered muscle stimulators and demonstrating similar technological characteristics and intended use as predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Standards Adhered to) | Reported Device Performance / Compliance |
|---|---|---|
| General Characteristics | Classified as "Powered muscle stimulator" (NGX) | Same as Predicates |
| Regulation Number: 21 CFR 890.5850 | Same as Predicates | |
| Regulatory Class: Class II | Same as Predicates | |
| Panel: Physical Medicine | Same as Predicates | |
| Intended Use | Must be used for healthy muscles; not for therapy or treatment of medical diseases/conditions. Not for injured/ailing muscles. Designed for improving/facilitating muscle performance. | Same as Predicates, all devices designed for improving healthy muscle training. |
| Use Environment | Use in athletic training facilities; not outdoors. | Same as Predicates |
| Anatomical Sites | Electrodes can be applied to multiple anatomical sites. | Same as Predicates |
| Power Source | Battery operated (Lithium) | Battery operated (Lithium). Higher input voltage than one predicate (WIEMPro) and similar to another (I-Motion). Deemed similar and does not affect safety/performance. |
| Method of Line Current Isolation | N/A (battery operated device) | N/A (battery operated device) |
| Patient Leakage Current | N/A (battery operated device) | N/A (battery operated device) |
| Number of Output Modes | One output mode with varying stimulation frequency and duty cycle ranges. | Same as Predicates |
| Number of Output Channels | 1 Channel, Alternating | Same as Predicates |
| Independent Channels with Possibility to Regulate Current | All channels conforming to regulations | 12 Channels (Predicates have 10). Two extra channels are identical and conform to regulations. |
| Regulated Current and/or Voltage | Regulated current | Same as Predicates |
| Software/Firmware/Microprocessor Control | Yes | Same as Predicates |
| Automatic Overload Trip | Yes | Same as Predicates |
| Automatic No-load Trip | Yes | Same as Predicates |
| Automatic Shut Off | On/Off switch, Power-save timer | Adds power-save timer when device is not connected to control App and not delivering treatment. |
| Patient Override Control | Yes, push on On/Off button directly pauses program. | Same as Predicates |
| Indicator Display | Yes | Same as Predicates |
| Housing Material | Safety tested for leakage currents and impact resistance. | Aluminum (Predicates are plastic). Safety tested according to IEC 60601-2-10. |
| Device Weight | Not a specific criterion, but compared. | 500g (Predicates 300g). Heavier due to aluminum construction. |
| Dimensions | Not a specific criterion, but compared. | Similar to Predicates |
| Waveform | Symmetrical bi-phasic (all programs) | Same as Predicates |
| Current/Voltage | Higher current than one predicate (I-Motion), similar to another (WIEMPro). | Higher current than i-motion, similar to WIEMSPRO. |
| Maximum Power Density | Included in risk management file according to IEC 60601-2-10 clause 201.4.2. | Higher than Predicates. Included in risk management, due to higher frequencies/duty cycle, not used in practice. |
| Maximum Current Density | Not a specific criterion, but compared. | Similar to Predicates (2 mA/cm2 vs 1.92/1.87 mA/cm2). |
| Pulse Duration (Width) | Allows for lower pulse durations, lower energy density, complies with IEC 60601-2-10 accuracy limits. | 25-400 µs (Predicates 150-450 µs). |
| Frequency | Allows for higher frequencies, complies with IEC 60601-2-10 limits. | 1-150 Hz (Predicates 1-100 Hz). |
| Time Range (Minutes) | Maximum program: 90 minutes | More restrictive than Predicates (unlimited). |
| Reusable Pads | Yes | Same as Predicates |
| Compliance with Voluntary Standards / LAB tests performed | IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-10, IEC 62304, ISO 14971. | Full compliance with these standards by accredited laboratory. |
2. Sample Size for the Test Set and Data Provenance
The provided document describes non-clinical testing in a laboratory setting. There is no "test set" in terms of patient data or clinical imaging. The "test set" for this device would refer to the physical device and its components undergoing engineering and electrical testing.
- Sample Size: Not applicable in the context of clinical or AI performance data. The device itself (Gnesis EMS Plus) was the "sample" for the non-clinical tests.
- Data Provenance: The tests were conducted by an accredited laboratory (SGS Tecnos Spain) in accordance with international and European standards (e.g., IEC, ISO, UNE-EN). This is engineering and safety testing, not human data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable as the device is not an AI system being evaluated for diagnostic performance against a medical ground truth. The "ground truth" here is adherence to engineering and safety standards, verified by testing laboratories and the technical specifications of the device.
4. Adjudication Method for the Test Set
This is not applicable. There was no need for adjudication as the testing involved objective measurements against established technical standards, not subjective interpretations requiring expert consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done, and is not applicable to this device. This device is a powered muscle stimulator, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone algorithm-only performance study was not done, and is not applicable to this device. This device is a physical medical device, not a software algorithm or AI. The "performance" assessment was through non-clinical testing of its electrical and safety characteristics against recognized standards.
7. Type of Ground Truth Used
The "ground truth" for this device's acceptance is based on compliance with established international and European consensus standards for electrical medical equipment and powered muscle stimulators (e.g., IEC 60601 series, IEC 62304, ISO 14971). These standards define acceptable limits for electrical output, safety, EMC, software lifecycle, and risk management.
8. Sample Size for the Training Set
Not Applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set for an AI model, there is no ground truth established for one. The device's design and parameters were developed based on engineering principles and compliance with existing standards.
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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
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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
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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.
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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 |
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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:
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Comparison of the proposed device with the predicate devices is summarized in the following table:
| COMPARISON OF TECHNOLOGICAL CHARACTERISTICS | ||||
|---|---|---|---|---|
| Characteristic /Feature | Proposed deviceGnesis EMS Plus | Predicate device 1WIEMSPRO | Predicate device 2I-Motion | Comparison |
| GENERAL COMPARISON | ||||
| Classificationname | Powered musclestimulator | Powered musclestimulator | Powered musclestimulator | Same |
| Product code | NGX | NGX | NGX | Same |
| Regulationnumber | 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 onlyhealthy muscles and client.It is not intended to beused in conjunction withtherapy or treatment ofmedical diseases ormedicalconditions of any kind. | Must be used for onlyhealthy muscles andclient. It is not intendedto be used inconjunction with therapyor treatment of medicaldiseases or medicalconditions of any kind. | Must be used for onlyhealthy muscles andclient. It is not intendedto be used in conjunctionwith therapy ortreatment of medicaldiseases or medicalconditions of any kind. | Same |
| Indication foruse | Gnesis EMS Plus isintended to stimulatehealthy muscles in orderto improve or facilitatemuscle performance, isnot intended to be used inconjunction with therapyor treatment of medicaldiseases or medicalconditions of any kind.None of Gnesis EMS Plustraining programs isdesigned for injured orailing muscles and its use | WIEMSPRO is intendedto stimulate healthymuscles inorder to improve orfacilitate muscleperformance. TheWIEMSPRO is notintended to be used inconjunction withtherapy or treatment ofmedical diseases ormedical conditionsof any kind. None ofWIEMSPRO training | I-MOTION intended tostimulate healthymuscles in order toimprove or facilitatemuscle performance. TheI-MOTION is not intendedto be used in conjunctionwith therapy ortreatment of medicaldiseases or medicalconditions of any kind.None of the I-MOTIONtraining programs isdesigned for injured or | Similar.All three devicesare designed forimprovinghealthy muscletraining. |
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| Use environment | Use in athletic trainingfacilities. Not for useoutdoors. | Use in athletic trainingfacilities. Not for useoutdoors. | Use in athletic trainingfacilities. Not for useoutdoors. | Same |
|---|---|---|---|---|
| Anatomical sites | Electrodes can be appliedto multiple anatomicalsites. | Electrodes can beapplied to multipleanatomical sites. | Electrodes can be appliedto multiple anatomicalsites. | Same |
| TECHNOLOGICAL CHARACTERISTICS AND PERFORMANCE | ||||
| PoweredMuscleStimulator | YES | YES | YES | Same |
| Power source | Battery:3 x 3.6 V= 10,8V -3,20AH (Lithium) | Battery:3.7V-2,4AH (LiPo) | Battery:2 x 3.7 V= 7,4V -3,4AH (Lithium) | SimilarHigher inputvoltage toimproveefficiency andbattery life.Doesn't affectsafety,performance/functionality ofthe device. |
| Method of linecurrentisolation | N/A (battery operateddevice) | N/A (battery operateddevice) | N/A (battery operateddevice) | Same |
| Patient leakageSamecurrent-Normalcondition-Single faultcondition | N/A (battery operateddevice) | N/A (battery operateddevice) | N/A (battery operateddevice) | Same |
| Battery operated | YES, Lithium polymer cellrechargeable | YES, Lithium polymer cellrechargeable | YES, Lithium polymer cellrechargeable | Same |
| Number ofOutput modes | One output mode, butwith varying stimulationfrequency and duty cycleranges | One output mode, butwith varying stimulationfrequency and duty cycleranges | One output mode, butwith varying stimulationfrequency and duty cycleranges | Same |
| Number ofOutput channels- Synchronous orAlternating?-Method ofChannelIsolation | 1 CHANNELAlternating | 1 CHANNELAlternating | 1 CHANNELAlternating | Same |
| Independentchannels withpossibility toregulate thecurrent | 12 CHANNELS | 10 CHANNELS | 10 CHANNELS | Two extrachannels, allchannels areidentical andconforming to |
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| individually | regulations | |||
|---|---|---|---|---|
| Regulatedcurrent and / orvoltage | Regulated current | Regulated current | Regulated current | Same |
| Software/Firmware/MicroprocessorControl? | Yes | Yes | Yes | Same |
| Automaticoverload Trip? | Yes | Yes | Yes | Same |
| Automatic No-load trip? | Yes | Yes | Yes | Same |
| Automatic ShutOff? | On/Off switchPower-save timer | On/Off switch | On/Off switch | Adds powersave timer,active onlywhen device isnot connectedto control Appand notdeliveringtreatment. |
| Patient OverrideControl? | Yes, push on On/Offbutton directly pause theprogram | Yes, push on On/Offbutton directly pause theprogram | Yes, push on On/Offbutton directly pause theprogram | Same |
| IndicatorDisplay? | Yes | Yes | Yes | Same |
| Plastic Housingmaterials | No, aluminum | Plastic | Plastic | Differentmaterial, safetytested accordingto IEC 60601-2-10 for leakagecurrents |
| Device weight | 500 g | 300 g | 300 g | Heavier becauseof aluminumconstruction |
| 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.,pulsedmono-phasic,bi-phasic)(program perprogram) | Symmetrical bi-phasic (allprograms | Symmetrical bi-phasic(allprograms | Symmetrical bi-phasic (allprograms | Same |
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| definition | ||||
|---|---|---|---|---|
| Current/Voltage | 120mA/85V | 125mA/170V | 90mA/110V | Higher currentthan i-motion,similar toWIEMSPRO |
| Maximum powerdensity | 14,4mW/cm2@500ohm | 9,61mW/cm2@500ohm | 9mW/cm2@500ohm | Higher powerdensity,included in riskmanagementfile according toIEC 60601-2-10clause 201.4.2This is due tohigherfrequenciesavailable,resulting inhigher dutycycle, not usedin practice. |
| Maximumcurrent density | 2 mA/cm2Smallest electrode size: 60 | 1,92mA/cm2Smallest electrode size: | 1,87mA/cm2Smallest electrode size: | Similar |
| cm2 | 65 cm2 | 48cm2 | ||
| Pulse duration(width) | 25-400 µs | 150-450 µs | 150-450 µs | Allows for lowerpulse durations,doesn'tintroduce anyrisk as in thiscase energydensity is lower,complies withIEC 60601-2-10accuracy limits |
| Frequency | 1 -150 Hz | 1 -100 Hz | 1 -100 Hz | Allows forhigherfrequencies,complies withIEC 60601-2-10limits |
| Time range(minutes) | Maximum program: 90minutes | Maximum program:unlimited | Maximum program:unlimited | More restrictive |
| Reusable pads | Yes | Yes | Yes | Same |
| Compliance withvoluntarystandards / LABtests performed | IEC 60601-1:2005 +COR1:2006 + COR2:2007 +AMD1:2012IEC 60601-1-2:2014IEC 60601-1-6:2010 | IEC 60601-1-2:2007IEC 60601-1-6:2010IEC 60601-2-10:2012FCC 47 CFR Part 15IEC 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 |
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| IEC 62304:2006ISO 14971:2007 | ANSI/AAMI ES60601-1:2005 / A2:2010 | IEC 60601-1-6:2010(ed.3.0) + A1:2013IEC 60601-1-2:2014IEC 60601-2-10:2012 +A1:2016IEC 62304:2006ISO 14971:2019 |
|---|---|---|
| ---------------------------------- | ---------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------- |
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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.
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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.
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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/
§ 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).