BionicGym is intended to stimulate healthy muscles in order to exercise, improve or facilitate muscle performance. It is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the training programs or operational parameters are designed to target injured or ailing muscles.

Device Description

The BionicGym Powered Muscle Stimulator is a home use, wearable device in the form of a double thigh wrap garment. The electronics are housed in a control unit that is fitted into a pocket on the right thigh garment. The control unit generates electrical pulses which are distributed to hydrogel electrodes positioned within the thigh garments and in contact with the user's thighs. The control unit delivers pulses to the muscles via the electrodes in defined patterns, which cause controlled contractions of the legs. The program characteristics determine the leg muscle contractions, which may be tetanic or sub-tetanic, the latter of which can induce cardiovascular and aerobic demand, thus the user receives an exercise workout. The intensity of the workout can be selected from a suite available via a smart device (e.g. phone) based application ('App'). The workout can be paused or stopped from either the App or the control unit.

The principle of operation of the BionicGym Powered Muscle Stimulator is that the pulse pattern delivered to the thigh electrodes is a composite of pulses shared between the electrode array. Repeating the pulse pattern induces contractions of the large muscle groups in the legs (quadriceps, hamstrings, gluteal and calf muscles), exercising the legs and raising the user's heart rate.

AI/ML Overview

The provided document is a 510(k) summary for the BionicGym Powered Muscle Stimulator. It outlines the device's technical specifications and compares it to a predicate device, focusing on non-clinical performance testing. However, it does not include data from a clinical study with acceptance criteria and reported device performance. The information is limited to non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance based on a clinical study from this document, nor can I answer questions related to sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, type of ground truth used from a clinical study, or training set details. This information would typically be found in a clinical study report, which is not part of this 510(k) summary.

The document focuses on non-clinical testing to demonstrate that the device meets safety and performance standards comparable to an existing device, rather than proving effectiveness against specific clinical acceptance criteria.

Here's what can be extracted regarding the device's testing and a comparison to its predicate:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):

The document details compliance with various international standards for electrical safety, electromagnetic compatibility, and biocompatibility, as well as software verification and validation. These standards serve as the "acceptance criteria" for non-clinical performance. The "reported device performance" is a statement of compliance.

Acceptance Criteria (Non-Clinical Standards)	Description / Reported Device Performance
Electrical Safety
IEC 60601-1:2005+AMD1:2012	Complies
IEC 60601-1-11:2015	Complies
IEC 60601-2-10:2012+AMD1:2016	Complies
Electromagnetic Compatibility
IEC 60601-1-2:2012	Complies
Biocompatibility
ISO 10993-5:2009	Complies (for surface devices, prolonged contact with intact skin)
ISO 10993-10:2010	Complies (for surface devices, prolonged contact with intact skin)
Software Verification & Validation
FDA Guidance: "Content of Premarket Submissions for Software Contained in Medical Devices", etc.	Developed, verified, validated, and documented in accordance with FDA guidance. (Moderate level of concern for Firmware & App, Minor for Web App)
Bench Tests
Control Unit Assembly and Test	Performed
PSU and Dock Assembly and Test	Performed
Control Unit Free Fall and Impact Tests	Performed
Garment Impact Tests	Performed
Simulated Transport Tests	Performed
Battery Charging Tests	Performed
Aging Tests	Performed
Reusability Tests	Performed (electrodes reusable up to 25 sessions)
Maximum Power Density Test	Performed

Regarding the other points, the document states:

2. Sample size used for the test set and the data provenance: Not applicable. This document describes non-clinical performance testing and comparison to a predicate device, not a clinical study with a test set of patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth and expert consensus are typically associated with clinical validations of diagnostic or prognostic devices. This device is a muscle stimulator.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a muscle stimulator, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical muscle stimulator, with software controlling its function. Its "performance" is its ability to stimulate muscles according to its programmed parameters, which is assessed through bench testing and compliance with standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the traditional sense for a diagnostic device. For the non-clinical tests, the "ground truth" is defined by the objective pass/fail criteria of the international standards (e.g., specific current leakage limits, biocompatibility results) and engineering specifications for bench tests.

8. The sample size for the training set: Not applicable. This document does not describe a machine learning algorithm or a training set. The software mentioned is traditional control software.

9. How the ground truth for the training set was established: Not applicable.

Summary

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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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

July 18, 2019

Medical Currents Ltd % Roger Gray VP Quality and Regulatory Donawa Lifescience Consulting Srl Piazza Albania 10 Rome, 00153 It

Re: K182794

Trade/Device Name: BionicGym Powered Muscle Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: June 14, 2019 Received: June 19, 2019

Dear Roger Gray:

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.

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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.

Vivek Pinto, PhD Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation 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

510(k) Number (if known) K182794

Device Name BionicGym Powered Muscle Stimulator

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

| | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Medical Currents LTD and Bionic Gym. The text "MEDICAL CURRENTS LTD" is in black, all-caps font. Below that is the logo for Bionic Gym, with the word "bionic" in orange and the word "GYM" in black.

510(k) Summary

I. General Information on Submitter

Submitter/Address:	Medical Currents Ltd8 Cuffe LaneDublin 2D02W840Ireland
Contact person:	Dr. Louis Crowe
Phone:	+353 87 239 3473
Correspondent:	Mr. Roger GrayVP, Quality and RegulatoryDonawa Lifescience Consulting SrlPiazza Albania 1000153 RomeItaly
Phone:	+39 06 578 2665
Fax:	+39 06 574 3786
Email:	rgray@donawa.com

II. Date Prepared 17 July 2019

III. General Information on Device

Device Name:	BionicGym Powered Muscle Stimulator
Common Name:	Powered Muscle Stimulator
Regulation Number:	21 CFR 890.5850
Regulation Name:	Stimulator, muscle, powered, for muscle conditioning
Product Code:	NGX
Regulatory Class:	II

IV. Predicate Devices

PowerDot® PD-01 Muscle Stimulator (K150078). The predicate device has not been subject to any design related recalls.

V. Device Description

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MEDICAL CURREN

Image /page/4/Picture/1 description: The image shows the logo for Bionic Gym. The word "bionic" is in orange, and the word "GYM" is in black. There are three horizontal lines underneath the words. The logo is tilted slightly to the right.

BionicGym can run a variety of training programs. However, there is a hard-limit in the firmware of 140 V and 200 mA maximum pulse amplitude, and the electrodes are large (≥150 x100 mm), so the pulse/current density is always low and the maximum amplitudes are always within allowable limits.

Wireless communication is used to control the workout programs, utilizing Bluetooth for communications between the control unit, thigh wrap electrodes, and Smartphone App. The Smartphone App is available for both Android and iPhone operating systems.

VI. Indications for Use

BionicGym is intended to stimulate healthy muscles in order to exercise, improve or facilitate muscle performance. It is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the training programs or operational parameters are designed to target injured or ailing muscles.

VII. Comparison of Intended Use and Technological Characteristics of the Subject and Predicate Devices

The Indications for Use for BionicGym are very similar to those for the predicate device. While the predicate device is intended to be applied to a number of muscle groups, BionicGym is intended for application to the wearer's thighs.

Both the subject and predicate devices are controlled via a Smartphone App, which communicates with the unit controller via low energy Bluetooth. Both subject and predicate devices use electronic pulses to stimulate the muscles to which they are applied, with a number of programmable variants.

Differences exist between the subject and predicate device in relation to the nature, strength and duration of the stimulation pulses, but these differences are not significant in relation to the safety and effectiveness of the devices.

Table 1: Predicate device comparison table
Item	Subject device	Predicate Device (PD)	Similarity
Device name	BionicGym Powered MuscleStimulator	PowerDot® PD-01 MuscleStimulator	N/A
510(k) Sponsor	Medical Currents Ltd, Ireland	Smartmissimo Technologies Pte Ltd,Singapore	N/A
510(k) Reference	Not yet assigned	K150078	N/A
FDA Product Code	NGX	NGX	Same
FDA ClassificationName	Stimulator, muscle, powered, formuscle conditioning	Stimulator, muscle, powered, formuscle conditioning	Same
FDA RegulationNumber	21 CFR 890.5850	21 CFR 890.5850	Same
Device description	A wearable device in the form of atwo thigh wraps. The electronics arehoused in a control unit whichgenerates electrical pulses whichare distributed to hydrogelelectrodes positioned within thethigh garments. Designed to beused with the BionicGym MobileApp.	The PD-01 Muscle Stimulator is abattery-powered neuromuscularstimulator intended to be used withthe PowerDot® Mobile Application.PowerDot® electrodes can beapplied to multiple anatomical sites.	SubstantiallyEquivalent
Table 1: Predicate device comparison table
Item	Subject device	Predicate Device (PD)	Similarity
Indications for Use	BionicGym is intended to stimulatehealthy muscles in order to exercise,improve or facilitate muscleperformance. It is not intended to beused in conjunction with therapy ortreatment of medical diseases ormedical conditions of any kind. Noneof the training programs oroperational parameters aredesigned to target injured or ailingmuscles.	The PowerDot PD-01 device, usedwith PowerDot Mobile Application, isintended for the stimulation ofhealthy muscles in order to improveor facilitate muscle performance.The PowerDot PD-01 device andPowerDot Mobile Application are notintended to be used in conjunctionwith therapy or treatment diseasesof medical or medical conditions ofany kind.	SubstantiallyEquivalent
Rx / OTC?	ОТС	ОТС	Same
Electrical safety	Complies with:IEC 60601-1IEC 60601-1-11IEC 60601-2-10	Complies with:IEC 60601-1IEC 60601-1-11IEC 60601-2-10	Same
Electromagneticcompatibility	Complies with:IEC 60601-1-2	Complies with:IEC 60601-1-2	Same
Anatomical sites	Thighs	Multiple	Different
Power Source	2 x Battery, Li-Po, rechargeable.Not replaceable by user.	Battery, Li-Po, rechargeable.Not replaceable by user.	Same
Method of Line CurrentIsolation	N/A	N/A	Same
Patient LeakageCurrent	Normal: < 25 µASingle fault: < 25 µA	Normal: < 25 µASingle fault: < 25 µA	Same
Average DC currentthrough electrodeswhen device is on butno pulses are beingapplied	0 µA	0 µA	Same
Number of outputmodes	One output mode, but with varyingstimulation parameters	One output mode, but with varyingstimulationfrequency, pulse width andduty cycle ranges	SubstantiallyEquivalent
Number of outputchannels	Any combination of 8 electrodes canform a channel (synchronous)	2 channels Synchronous (withasynchronous support)	Different
Method of channelisolation	Galvanic	Galvanic	Same
Regulated current orvoltage	Regulated current within allowablevoltage range	Regulated voltage	Different
Microprocessorcontrolled	Yes	Yes	Same
Automatic overload trip	Yes	Yes	Same
Automatic no-load trip	Yes	Yes	Same
Automatic shut-off	Yes	Yes	Same
User over-ride control	Yes	Yes	Same
Indicator display:- On/Off status-Low battery- Voltage/ current level	YesYesYes (as 'intensity')	YesYesYes	Same
Timer range	0 - 120 mins max	0 - 60 mins max	Different
Compliance with 21CFR 898	Yes	Yes	Same
Table 1: Predicate device comparison table
Item	Subject device	Predicate Device (PD)	Similarity
Waveform	Biphasic rectangular symmetricalwith charge balancing secondphase, Zero net DC	Biphasic, close to rectangular,asymmetrical, withcharge balancing secondphase, zero net DC	Different
Maximum OutputVoltage (+/- 15 %)	140 V @ 500 Ω140 V @ 2 kΩ140 V @ 10 kΩ	90 V @ 500 Ω122 V @ 2 kΩ138 V @ 10 kΩ	SubstantiallyEquivalent
Maximum OutputCurrent (+/- 15 %)	At pulse width of 400 µs:200 mA @ 500 Ω70 mA @ 2 kΩ14 mA @ 10 kΩ	At pulse width of 400 µs:136 mA @ 500 Ω50 mA @ 2 kΩ12.4 mA @ 10 kΩ	SubstantiallyEquivalent
Pulse width	10 μs to 400 μs	150-400 µs (for mainphase)	SubstantiallyEquivalent
Frequency	1 - 99 Hz per channel	1 - 120 Hz	Different
For interferential modesonly:- Beat Frequency (Hz)	N/A	N/A	Same
For multiphasicwaveforms only:- Symmetrical phases- Phase duration(s)	Yes1 μs to 400 μs for positive phase,same for negative phase	No150-400 μs for positive phase, samefor negative phase	SubstantiallyEquivalent
Net chargeHow achieved	0 µC at 500 ΩSymmetrical pulses	0 µC at 500 ΩCapacitor coupling	Different
Maximum phase charge(@ 500 Ω), μC perpulse	80 μC	34.4 μC	SubstantiallyEquivalent
Maximum currentdensity (@ 500 Ω),mA/cm² (rms)	0.50 mA/cm²	1.27 mA/cm²	Different
Maximum averagecurrent, mA (@ 500 Ω)(average absolutevalue)	9.9 mA	2.7 mA	Different
Maximum averagepower density, W/cm²(@ 500 Ω)	0.0100 W/cm²	0.0177 W/cm²	Different
Burst mode:a) Pulses per secondb) Bursts per secondc) Burst durationd) Duty Cycle:= (b) x (c)	N/A	a) 2b) 120c) 150-400 μsd) 2-12 x 2-60	Different
ON Time	Continuous or 0.1 to 24 sec	Continuous or 2-12 sec	SubstantiallyEquivalent
OFF Time	0-120 sec	0-60 sec	SubstantiallyEquivalent
Electrode type	Self adhesive	Self adhesive	Same
Electrode dimensions	168 x 112 x 2.4 mm	8 x 4 cm and 4.5 cm diameter	Different
Electrode weight	57 g	Unknown	Different
Electrode conductivesurface area	175 cm²	Approx 30 cm² and 15 cm²	Different
Table 1: Predicate device comparison table
ltem	Subject device	Predicate Device (PD)	Similarity
Electrodes in use duringexercise session	2 - 8	1 or 2	Different
Electrode materials	· Silicone-coated PET release liner· Hydrogel reference G607· Conductive carbon film· Printed silver pattern on the carbonfilm	• MultiStick® MG-1500 hydrogel• Other materials unknown	Different
Incorporatedelectroconductivemedia?	Yes	Yes	Same
Electrode hydrogel pH	5.3 to 5.5	Unknown	Probablyequivalent
Hydrogel formulation	Glycerine 60%Polyacrylic acid 20%Water 19%Salt 1%	Unknown	Probablyequivalent
Skin-to-electrodeImpedance Range	310 to 451 Ω	Unknown	Unknown
Maximum duration ofelectrode use	25 workout sessions	Single workout session	Different
Secondary electrodesupport?	Yes - thigh wraps	No	Different
Wrap dimensions	Large – R Leg 647 x 376 x 20 mmLarge – L Leg 647 x 376 x 16 mmSmall - R Leg 567 x 347 x 20 mmSmall – L Leg 567 x 347 x 16 mmExtension 225 x 130 x 1.5 mm	N/A	N/A
Wrap weight	Large - R Leg 284 gLarge - L Leg 266 gSmall - R Leg 242 gSmall - L Leg 234 gExtension 67 g	N/A	N/A
Wrap material	Neoprene and nylon/spandex blend	N/A	N/A
Smartphone App?	Yes	Yes	Same

Table 1 includes a detailed comparison between the subject and predicate devices.

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MEDICAL CURRENTS LTD

Image /page/5/Picture/1 description: The image shows the logo for Bionic Gym. The word "bionic" is in orange, and the word "GYM" is in black. There are three orange lines underneath the words. The logo is slightly blurry.

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MEDICAL CURRENTS LTD

Image /page/6/Picture/1 description: The image shows the logo for Bionic Gym. The word "bionic" is in orange, and the word "GYM" is in black. There are three horizontal lines underneath the word "GYM".

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MEDICAL CURRENTS

Image /page/7/Picture/1 description: The image shows the logo for Bionic Gym. The word "bionic" is in orange, and the word "GYM" is in black. There are three horizontal lines underneath the word "GYM".

The subject device and the predicate devices have many identical or similar properties or features. The differences that exist with respect to device functionality are:

. BionicGym includes thigh wraps with predefined electrode positions, whereas the predicate device electrodes can be placed in many different locations.
The BionicGym electrodes are much larger, resulting in lower current density at maximum output.
. BionicGym incorporates an electrode check in the software to ensure all active electrodes are in appropriate contact with the skin; no such check is present in the predicate device.
. BionicGym has known electrode positions and does not allow the user to determine relative channel intensities and/or positions. The user picks from a suite of known and tested programs with predetermined channels and relative channel intensities.
BionicGym pulses are symmetrical biphasic, as opposed to asymmetrical biphasic in the predicate).
The user can choose a program lasting up to two hours, (as opposed to one hour in the predicate).
. BionicGym uses thigh wraps to allow correct positioning and support of the electrodes, whereas the predicate has no secondary means of support for the electrodes.

With regard to these differences, the following paragraphs provide additional explanations:

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MEDICAL CURRENTS

Image /page/8/Picture/1 description: The image shows the logo for Bionic Gym. The word "bionic" is in orange, and the word "GYM" is in black. There are three horizontal lines underneath the words.

Anatomical sites: BionicGym can be used only on the thigh wraps cannot be fitted around the head, neck or torso, thus the possibility of inadvertent transcerebral, carotid sinus or transthoracic stimulation pathways is avoided by design.

Number of output channels: The predicate device has only two channels, which limits the muscles it can target. For instance, from the website for the predicate, it appears the device can target only the quadriceps OR hamstring of only one leg at a time. By using more channels, BionicGym allows each muscle group to receive similar and balanced contractions and overall exercise times.

Timer range: It is often the case that exercise sessions last for longer than an hour, as allowed by the predicate device. BionicGym allows sessions to last up to two hours, which is not significant in safety terms, because the current densities through the skin are low when compared with the predicate device.

Regulated current or voltage: With regulated current, as used in BionicGym, the exact pulse put into the user body is known, with an assurance of there being no net DC. Furthermore, the output is limited to 140 V (substantially less than the 500 V maximal permissible voltage).

Waveform: The BionicGym waveform is symmetrical, compared with the predicate device, which has an asymmetrical waveform. Having a symmetrical waveform helps ensure no net DC.

Net Charge: how achieved: Symmetrical biphasic pulses are used in BionicGym, whereas capacitive coupling is used in the predicate device. In BionicGym, each phase balances each other in shape as well as intensity and duration. As a further safety feature, each pulse is 'reversed' every second time it is qiven. E.g. if pulse 1 has electrode A positive and electrode B negative (in the first phase of the biphasic pulse) the next time it is delivered it will lead with A negative and B positive, etc. Thus, if there is any imbalance in a given pulse, the Net Charge would still be minimized when averaged over two of the pulses.

Maximum Current Density; Maximum Average Current; Maximum Average Power Density: These three parameters are closely related. BionicGym uses 8 electrodes that are each larger than the combined surface area of the 4 electrodes in the predicate device. This ensures that BionicGym delivers stimulation (up to the permissible level of 10 mA) while always maintaining a low current density and low power density.

Burst Mode: BionicGym does not have a burst mode, whereas the predicate device does.

Electrodes in use during exercise session: BionicGym has 8, while the predicate device has 4. BionicGym can contract both legs simultaneously, whereas the predicate can contract only a part of one leg at a time. Thus, BionicGym can achieve more balanced contractions, and both legs receive similar exercise levels and duration.

Thigh wraps: The BionicGym thigh wraps provide secondary support for the self adhesive electrodes, whereas the predicate relies on the self adhesive nature of the electrodes for conductivity. This secondary support in the BionicGym allows reuse of the electrodes up to 25 times, whereas the predicate device electrodes are intended for single use only.

None of the above-identified differences have any adverse effect on the safety or effectiveness of the subject device when compared with the predicate.

VIII. Summary of Non-Clinical Performance Testing

BionicGym has been subjected to non-clinical performance testing as follows:

Electrical safety:

IEC 60601-1:2005+AMD1:2012, 'Medical electrical equipment Part 1: General requirements for basic ● safety and essential performance'

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MEDICAL CURRENTS L

IEC 60601-1-2:2012, 'Medical electrical equipment Part 1-2: General requirements for basic safety . and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests'
IEC 60601-1-11:2015, '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'

Electromagnetic compatibility:

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'

Biocompatibility:

BionicGym components that contact the wearer are the thigh pad garments and the gel electrodes. Testing has demonstrated compliance with the following biocompatibility standards, based on these components being 'surface devices' with 'prolonged' contact with intact skin, in accordance with FDA guidance 'Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", and ISO 10993-1 'Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process':

ISO 10993-5: 2009, 'Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity' .
. ISO 10993-10:2010, 'Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization'

Software verification and validation testing:

The software has been developed, verified, validated and documented in accordance with FDA guidance, including:

'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices', 11 ● May 2005.
. 'General Principles of Software Validation; Final Guidance for Industry and FDA Staff, 11 January 2002.
'Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical ● Devices', 9 September 1999.
. 'Content of Premarket Submissions for Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff', October 2, 2014.
. 'Guidance for Industry - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software', 14 January 2005.
'Postmarket Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and ● Drug Administration Staff', 28 December 2016.

The software in BionicGym is in three parts:

BionicGym Firmware (control unit (MCU) and Bluetooth low energy system on chip (BLE SoC)) . (Moderate level of concern)
BionicGym Application (App) running on a Smartphone (Moderate level of concern)
. BionicGym Web Application (Minor level of concern)

Bench tests:

Control Unit Assembly and Test ●
PSU and Dock Assembly and Test ●
Control Unit Free Fall and Impact Tests
Garment Impact Tests
Simulated Transport Tests
Battery Charging Tests ●
Aging Tests ●
Reusability Tests ●

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Image /page/10/Picture/0 description: The image shows the logos for MEDICAL CURRENTS LTD and bionicGYM. The MEDICAL CURRENTS LTD logo is in black, while the bionicGYM logo is in orange and black. The bionicGYM logo also has a horizontal line underneath it.

Maximum Power Density Test .

IX. Conclusion

The subject and predicate devices have the same intended use and fundamental technological characteristics. The differences in technological characteristics between subject and predicate devices do not raise different questions of safety and effectiveness. The performance data demonstrate that the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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).