The L300 Go System is intended to provide ankle dorsiflexion in adult and pediatric individuals with foot drop and/or to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g. stroke, damage to pathways to the spinal cord). The L300 Go System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot and/or knee flexion or extension: thus, it also may improve the individual's gait.

The L300 Go System may also:

o Facilitate muscle re-education
o Prevent/retard disuse atrophy
o Maintain or increase joint range of motion
o Increase local blood flow

Device Description

The L300 Go System is intended to provide ankle dorsiflexion in adult and pediatric individuals with foot drop and/or to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to pathways to the spinal cord). The L300 Go System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot and/or knee flexion or extension; thus, it also may improve the individual's gait.

The L300 Go system consists of the following components:

1. External Pulse Generator (EPG), which can be plugged into lower leg Functional Stimulation Cuff (FSC) or thigh FSC or into both cuffs. EPG contain user interface including control and indications. EPG also contains integrated motion sensors enabling detecting gait events.
1. Lower leg FSC, including cradle for the EPG.
1. Upper leg FSC, including cradle for the EPG.
1. Clinician Application (CAPP), based on tablet PC. CAPP will be used by a trained clinician during configuration of the system for optimal fitting to the patient.
1. Power supply (charger) with two USB ports and a proprietary cable to charge the EPG.
1. L300 Go Tester.
1. Optional Control Unit that allows simple control of the EPG(s) such as selecting mode of operation (gait/training) or fine-tune the stimulation intensity for each EPG individually.
1. Optional Foot Sensor, which uses a dynamic gait tracking algorithm to detect heel events and wirelessly synchronizes stimulation.
1. Optional Mobile Application (MAPP), which can be downloaded on a smartphone and offers the same control functions as the optional Control Unit, as well as enabling the patients to retrieve and monitor their daily activity. At the time of clearance of K173682, the MAPP was only an iOS-based application. In this submission, Bioness is adding an Android-based MAPP. The software features, user interface, and wireless communication protocol of the Android version are the same as the iOS version, the only difference is the operating system.

The L300 Go System can be operated in one of the following modes:

Gait Mode
Training Mode ●
. Cycle Training Mode
. Clinician Mode

Gait Mode is used for walking, and it can be selected by the clinician and also by the patient. Training Mode is used to train muscles when patients are not walking (for example, sitting or lying down), and it can be selected by either the clinician or the patient. Cycle Training Mode is used to train muscles while the patient is using a stationary exercise bicycle, and it can be selected by either the clinician or the patient. Clinician Mode allows the clinician to apply enhanced training and is only available to the clinicians.

AI/ML Overview

The provided text describes a Special 510(k) submission for the Bioness L300 Go System, primarily focused on device modifications including software changes and the addition of an Android version Mobile Application. The submission asserts that these changes do not affect the intended use or fundamental scientific technology of the device.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria in a quantitative table for this specific Special 510(k) submission. Instead, the submission focuses on demonstrating that the modified device maintains the safety and efficacy previously established for its predicate device (K173682) through verification and validation testing of the changes.

The reported device performance, in this context, refers to the successful completion of these tests:

Acceptance Criteria (Implied)	Reported Device Performance
No loss of original software/firmware functionality	Software and firmware changes subject to verification testing for original functionality; successfully passed.
Software changes for Cyclic Training Mode function correctly	Subjected to verification and validation testing; successfully passed.
Modified External Pulse Generator (EPG) meets Environmental Ingress Protection (IP42) requirements	EPG retested and successfully passed IP42 classification.
New Clinician's Kit packaging withstands transportation	New packaging passed all transportation tests.
Overall safety and effectiveness is maintained post-modification	Bioness concludes substantial equivalence to predicate.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify sample sizes used for the "verification testing" or "validation testing" mentioned for software/firmware/cyclic training mode. It also does not provide information on the provenance of data (e.g., country of origin, retrospective/prospective). These details would typically be found in more comprehensive study reports, which are not included in this FDA 510(k) summary.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This document does not describe any study involving human experts establishing ground truth for a test set. The testing described appears to be engineering or performance testing against predefined technical specifications and standards.

4. Adjudication Method for the Test Set

Not applicable, as there's no mention of a ground truth established by human experts or a test set requiring adjudication in the context of this document. The testing described is primarily technical verification and validation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned in this document. The device is a functional neuromuscular stimulator, not an imaging or diagnostic AI tool that would typically involve human readers interpreting cases.

6. Standalone (Algorithm Only) Performance Study

While the document describes rigorous testing of the device's software and hardware (including the algorithms within the EPG and mobile applications), it doesn't present this as a "standalone" performance study in the context of a comparative effectiveness study against a human baseline or a widely accepted clinical standard for an AI diagnostic algorithm. The aim here is to confirm the device's functional integrity after modifications.

7. Type of Ground Truth Used

The "ground truth" for the tests described appears to be:

Technical Specifications and Requirements: For software/firmware functionality and the cyclic training mode.
Industry Standards: For environmental ingress protection (IP42) and transportation testing.
Predicate Device Performance: The primary "ground truth" is that the modified device should perform equally safely and effectively as the previously cleared predicate device (K173682).

8. Sample Size for the Training Set

The document does not describe any "training set" in the context of machine learning or AI models being trained. The "software and firmware changes" likely refer to updates in control logic, user interface, or functional modes, which are verified and validated rather than trained on data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set for an AI model is mentioned or implied.

Summary

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March 14, 2019

Bioness Inc. Shanna Hu Sr. Regulatory Affairs Specialist 25103 Rye Canyon Loop Valencia, California 91355

Re: K190285

Trade/Device Name: L300 Go System Regulation Number: 21 CFR 882.5810 Regulation Name: External Functional Neuromuscular Stimulator Regulatory Class: Class II Product Code: GZI, IPF Dated: February 8, 2019 Received: February 11, 2019

Dear Shanna Hu:

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 mav, 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 avare 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

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requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Kelliann T. Wachrathit -S

For Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190285

Device Name L300 Go System

Indications for Use (Describe)

The L300 Go System may also:

o Facilitate muscle re-education
o Prevent/retard disuse atrophy
o Maintain or increase joint range of motion

o Increase local blood flow

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for Bioness. The logo consists of an orange starburst-like symbol on the left, followed by the word "Bioness" in gray, and the words "LiveOn" in a smaller font below the word "Bioness". The logo is simple and modern, and the colors are bright and eye-catching.

510(k) Summary:	L300 Go System
Applicant Name:	Bioness Inc.
Contact Person(s):	Shanna HuSr. Regulatory Affairs SpecialistBioness Inc.25103 Rye Canyon LoopValencia, CA 91355, U.S.AOffice Number: (661) 362-6694Email: shanna.hu@bioness.comMercedes BayaniGlobal Director, Clinical & Regulatory AffairsBioness Inc.Office Number: (661) 902-5324Fax Number: (661) 362-4851Email: mercedes.bayani@bioness.com
Date Prepared:	February 7, 2019
Trade Name:	L300 Go System
Classification:	Name: External functional neuromuscular stimulatorProduct Code: GZI and IPFRegulation No: 21 CFR § 882.5810, § 890.5850Class: IIClassification Panel: Neurology
Establishment Registration No.:	3004553866
Reason for Submission:	Device Modifications
Type of Submission:	Special 510(k)

Predicate Device:

Company: Bioness, Inc. Device: L300 Go System, K173682

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Purpose of this Special 510(k):

This Special 510(k) is submitted to add an Android version Mobile Application to the L300 Go System as well as to include minor modifications made to the device since the clearance of the last 510K. K173682. None of these changes affect the intended use of the device nor do they alter the fundamental scientific technology of the device.

Device Description:

The L300 Go System is intended to provide ankle dorsiflexion in adult and pediatric individuals with foot drop and/or to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to pathways to the spinal cord). The L300 Go System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot and/or knee flexion or extension; thus, it also may improve the individual's gait.

The L300 Go system consists of the following components:

1. External Pulse Generator (EPG), which can be plugged into lower leg Functional Stimulation Cuff (FSC) or thigh FSC or into both cuffs. EPG contain user interface including control and indications. EPG also contains integrated motion sensors enabling detecting gait events.
1. Lower leg FSC, including cradle for the EPG.
1. Upper leg FSC, including cradle for the EPG.
1. Clinician Application (CAPP), based on tablet PC. CAPP will be used by a trained clinician during configuration of the system for optimal fitting to the patient.
1. Power supply (charger) with two USB ports and a proprietary cable to charge the EPG.
1. L300 Go Tester.
1. Optional Control Unit that allows simple control of the EPG(s) such as selecting mode of operation (gait/training) or fine-tune the stimulation intensity for each EPG individually.
1. Optional Foot Sensor, which uses a dynamic gait tracking algorithm to detect heel events and wirelessly synchronizes stimulation.
1. Optional Mobile Application (MAPP), which can be downloaded on a smartphone and offers the same control functions as the optional Control Unit, as well as enabling the patients to retrieve and monitor their daily activity. At the time of clearance of K173682, the MAPP was only an iOS-based application. In this submission, Bioness is adding an Android-based MAPP. The software features, user interface, and wireless communication protocol of the Android version are the same as the iOS version, the only difference is the operating system.

The L300 Go System can be operated in one of the following modes:

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Gait Mode
Training Mode ●
. Cycle Training Mode
. Clinician Mode

Indications for Use:

The L300 Go System is intended to provide ankle dorsiflexion in adult and pediatric individuals with foot drop and/or to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to pathways to the spinal cord). The L300 Go System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot and/or knee flexion or extension; thus, it also may improve the individual's gait.

The L300 Go System may also:

Facilitate muscle re-education ●
Prevent/retard disuse atrophy ●
Maintain or increase joint range of motion ●
Increase local blood flow ●

Modifications Addressed in this Special 510(k)

This Special 510(k) addresses the following modifications:

Changes in the External Pulse Generator (EPG) software and Firmware.
Changes in the Mobile Application (MAPP) iOS software.
Changes in the Clinician Application (CAPP) software.
Addition of the cycle training mode (software changes only).
Changes in the EPG bottom enclosure.
Clinician Kit Packaging Change. ●
Labeling Changes. ●
Addition of an Android version Mobile Application (MAPP). .

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Section 5 510(k) Summary

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Summary of Technological Characteristics

The Table below summarizes the technological characteristics of new device in comparison to those of the predicate device.

	L300 Go System (K173682)	L300 Go System after DesignModifications
Manufacturer	Bioness Inc.	Bioness Inc.
510(k) number	K173682	K190285
Product code	GZI & IPF	GZI & IPF
Intended use	The L300 Go System is intendedto provide ankle dorsiflexion inadult and pediatric individuals withfoot drop and/or to assist kneeflexion or extension in adultindividuals with muscle weaknessrelated to upper motor neurondisease/injury (e.g., stroke,damage to pathways to the spinalcord). The L300 Go Systemelectrically stimulates muscles inthe affected leg to provide ankledorsiflexion of the foot and/or kneeflexion or extension; thus, it alsomay improve the individual's gait.The L300 Go System may also:• Facilitate muscle re-education• Prevent/retard disuse atrophy• Maintain or increase joint rangeof motion• Increase local blood flow	The L300 Go System is intendedto provide ankle dorsiflexion inadult and pediatric individuals withfoot drop and/or to assist kneeflexion or extension in adultindividuals with muscle weaknessrelated to upper motor neurondisease/injury (e.g., stroke,damage to pathways to the spinalcord). The L300 Go Systemelectrically stimulates muscles inthe affected leg to provide ankledorsiflexion of the foot and/or kneeflexion or extension; thus, it alsomay improve the individual's gait.The L300 Go System may also:• Facilitate muscle re-education• Prevent/retard disuse atrophy• Maintain or increase joint rangeof motion• Increase local blood flow
Number ofOutput Modes	2 modes: Biphasic Asymmetricand Symmetric	2 modes: Biphasic Asymmetricand Symmetric
Number ofPrograms	• Gait• Training/Exercise• Clinician mode	• Gait• Training/Exercise• Cycle Training Mode• Clinician mode
RegulatedCurrent orRegulatedVoltage	Current	Current

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Table continues next page

	L300 Go System (K173682)		L300 Go System after DesignModifications
	Control Unit: Li Coin Cell, CR2032,3 V, 240 mAh		Control Unit: Li Coin Cell, CR2032,3 V, 240 mAh
Power Source	EPG: Rechargeable, Li-Ion,Prismatic, 3.7 V, 1000 mAh		EPG: Rechargeable, Li-Ion,Prismatic, 3.7 V, 1000 mAh
	Foot Sensor: Li Coin Cell,CR2032, 3 V, 240 mAh		Foot Sensor: Li Coin Cell,CR2032, 3 V, 240 mAh
Microprocessor-Controlled	Yes		Yes
Max OutputCurrent(± 10%)	Thigh FSC:100 mA @ 500Ohm load	L300 Lower LegFSC: 100 mA @500 Ohm load	Thigh FSC:100 mA @ 500Ohm load	L300 Lower LegFSC: 100 mA @500 Ohm load
Max AverageCurrent Density[mARMS/cm²][Over smallestelectrode]	Thigh EPG:0.18 mARMS/cm²(500 Ω, Irms=13.0mA, electrodearea of 74 cm²)	Lower Leg EPG:small cuff, gelelectrodes1.27 mARMS/cm²(500 Ω, Irms=13.0mA, electrodearea of 10.2cm²)	Thigh EPG:0.18 mARMS/cm²(500 Ω, Irms=13.0mA, electrodearea of 74 cm²)	Lower Leg EPG:small cuff, gelelectrodes1.27 mARMS/cm²(500 Ω, Irms=13.0mA, electrodearea of 10.2cm²)
Max AveragePower Density,(mW/cm²)	Thigh EPG:1.1 mW/cm²(500 Ω, Irms=13.0mA, electrodearea of 74 cm²)	Lower Leg EPG:small cuff, gelelectrodes8.3 mW/cm²(500 Ω, Irms=13.0mA, electrodearea of 10.2cm²)regular cuff, gelelectrodes5.3 mW/cm²(500 Ω, Irms=13.0mA, electrodearea of 15.9cm²)	Thigh EPG:1.1 mW/cm²(500 Ω, Irms=13.0mA, electrodearea of 74 cm²)	Lower Leg EPG:small cuff, gelelectrodes8.3 mW/cm²(500 Ω, Irms=13.0mA, electrodearea of 10.2cm²)regular cuff, gelelectrodes5.3 mW/cm²(500 Ω, Irms=13.0mA, electrodearea of 15.9cm²)
	L300 Go System (K173682)		L300 Go System after DesignModifications
StimulationChannels	Thigh EPG: 1	Lower Leg EPG:2 (functioning asa single channelwith separately-adjustablemedial / lateralstimulationintensity)	Thigh EPG: 1	Lower Leg EPG:2 (functioning asa single channelwith separately-adjustablemedial / lateralstimulationintensity)
Electrodesused in thesystem	Lower Leg FSC:2 Hydro-Gel electrodes assembled on electrode bases, or 2 non-woven cloth electrodes assembled on electrode bases, or 2 non-woven cloth electrodes attached with snaps (also called "QuickFit" electrodes), or 3 non-woven cloth electrodes attached with snaps (segmented electrodes [also called "steering" electrodes], using common anode to allow separate adjustment of medial and lateral stimulation) Thigh FSC: 2 single, non-woven cloth electrodes attached with snaps		Lower Leg FSC:2 Hydro-Gel electrodes assembled on electrode bases, or 2 non-woven cloth electrodes assembled on electrode bases, or 2 non-woven cloth electrodes attached with snaps (also called "QuickFit" electrodes), or 3 non-woven cloth electrodes attached with snaps (segmented electrodes [also called "steering" electrodes], using common anode to allow separate adjustment of medial and lateral stimulation) Thigh FSC: 2 single, non-woven cloth electrodes attached with snaps
ClinicianControl/Programming	Clinician uses the Clinician Programmer (CAPP) to set stimulation energy and temporal parameters related to the functional stimulation performance for dorsiflexion control and/or knee weakness control		Clinician uses the Clinician Programmer (CAPP) to set stimulation energy and temporal parameters related to the functional stimulation performance for dorsiflexion control and/or knee weakness control
ClinicianProgrammer(CAPP)Platform	Tablet PC		Tablet PC

Table continues next page

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Image /page/8/Picture/0 description: The image shows the logo for Bioness. The logo consists of an orange starburst-like symbol on the left, followed by the word "Bioness" in gray, bold font. Below "Bioness" is the text "LiveOn" in a smaller, lighter gray font. The logo is simple and modern, with a focus on the company name.

Table continues next page

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	L300 Go System (K173682)	L300 Go System after DesignModifications
User Control	Using hand-held Control Unit, themobile application (MAPP), or theEPG-based interface, the usercan:Turn system On/Off (viaEPG only) and Start/Stopstimulation Select Gait/Training program Fine-tune stimulationintensity around workingpoint set by the clinician Test L300 Lower Leg EPG &Thigh EPG stimulationbefore starting to ambulate	Using hand-held Control Unit, themobile application (MAPP), or theEPG-based interface, the usercan:Turn system On/Off (via EPGonly) and Start/Stopstimulation Select Gait/Training program Fine-tune stimulationintensity around workingpoint set by the clinician Test L300 Lower Leg EPG &Thigh EPG stimulationbefore starting to ambulate
Stimulationtrigger source(when used forgait)	In gait mode, stimulation istriggered by:(1) the motion sensor embeddedin the EPG (two-dimensiontilt)); or(2) Foot Sensor that detectsHeel On & Heel Contactevents during gait andtransmits them wirelessly tothe lower and thigh EPGs.	In gait mode, stimulation istriggered by:(1) the motion sensor embeddedin the EPG (two-dimensiontilt)); or(2) Foot Sensor that detectsHeel On & Heel Contactevents during gait andtransmits them wirelessly tothe lower and thigh EPGs.
Communicationmethod	Control Unit – Lower Leg /ThighEPG: wireless Bluetooth (LowEnergy) communication protocolGait Sensor – Lower Leg/ThighEPG: wireless Bluetooth (LowEnergy) communication protocolClinician Programmer – EPG:wireless Bluetooth (Low Energy)communication protocolMAPP – Lower Leg /Thigh EPG:wireless Bluetooth (Low Energy)communication protocol	Control Unit – Lower Leg /ThighEPG: wireless Bluetooth (LowEnergy) communication protocolGait Sensor – Lower Leg/ThighEPG: wireless Bluetooth (LowEnergy) communication protocolClinician Programmer - EPG:wireless Bluetooth (Low Energy)communication protocolMAPP – Lower Leg /Thigh EPG:wireless Bluetooth (Low Energy)communication protocol

Table ends here

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Summary of Nonclinical Tests Submitted

Software and Firmware changes were subject to verification testing to ensure no loss of original functionality. Software changes related to the addition of Cyclic Training Mode were subjected to both verification testing and validation testing.

Because of a modification in the bottom enclosure of the External Pulse Generator (EPG), The EPG was retested for Environmental Ingress Protection. The modified EPG successfully passed the test and continue to meet the safety requirements and classification requirement of IP42.

Transportation test were performed to address the new packaging of the Clinician's Kit. The new packaging passed all tests.

Conclusion:

The L300 Go System has been verified and validated successfully for its intended use through the combination of original bench testing and thorough verification and validation testing of all software and hardware changes. Based on the result of the nonclinical testing, Bioness concludes that the device is substantially equivalent to the predicate L300 Go System.

Regulation Number and Section

§ 882.5810 External functional neuromuscular stimulator.

(a)
Identification. An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.(b)
Classification. Class II (performance standards).