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 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

Device Description

The L300 Go System is intended to provide ankle dorsiflexion in adult and pediatric individuals with foot drop and/or assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, spinal cord injury) or other disability. 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).
1. Optional Foot Sensor, which uses a dynamic gait tracking algorithm to detect heel events and wirelessly synchronizes stimulation.
1. Optional Mobile Application (MAPP), based on the SmartPhone platform enabling the patients to wirelessly retrieve and monitor their daily activity. At the time of clearance of K162407, the MAPP did not include any control feature, but control features like those of the Optional Control Unit have been added to the MAPP and are part of this submission.

AI/ML Overview

This document is a 510(k) summary for the Bioness L300 Go System, focusing on modifications made to a previously cleared device (K162407). It does not contain acceptance criteria for device performance or a study demonstrating the device meets such criteria in terms of clinical effectiveness. Instead, it describes non-clinical testing performed to demonstrate that the modifications to the device do not alter its substantial equivalence to the predicate device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria for clinical performance or reported device performance in terms of efficacy metrics (e.g., gait improvement percentages, dorsiflexion angles). It focuses on non-clinical testing to ensure that modifications to the device (e.g., changes in material, software updates) do not negatively impact its safety and functionality compared to the predicate device.

For the non-clinical tests mentioned, the "acceptance criteria" can be inferred as "successfully passed the testing," indicating that the device's performance post-modification remained within acceptable limits for the specific tests conducted.

Test Type	Acceptance Criteria (Inferred)	Reported Device Performance
Environmental Ingress Protection (CU)	Successfully passed the testing	The modified CU successfully passed the Environmental Ingress Protection testing.
Mechanical Vibration and Shock (EPG)	Successfully passed the testing	The modified EPG successfully passed the Mechanical Vibration and Shock testing.
Packaging and Shipping Tests (ASTM D5276-98, Schedule A, Level III)	All tests passed	All packaging passed all tests.
Software Verification Testing (MAPP)	No loss of original functionality	Software changes were subjected to verification testing to include regression testing to ensure no loss of original functionality.
Software Validation Testing (New MAPP Functions)	New functions perform as intended	New functions were subjected to both verification testing (including regression testing) and validation testing.
Electrical Safety and Electromagnetic Compatibility	Maintained compliance from predicate	Evaluated for applicability to the design modifications. (Implies continued compliance based on predicate)

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

The document describes non-clinical engineering and software testing. It does not refer to a "test set" in the context of clinical data or patient samples.

Sample Size for non-clinical tests: Not explicitly stated as a number of units, but common for such tests to involve one or a small number of physical units for destructive or environmental testing.
Data Provenance: The testing was conducted internally by Bioness or by Minnetronix Inc. (a Bioness development vendor), indicating it is internal, likely prospective, engineering bench testing. There is no mention of country of origin regarding clinical data.

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

This information is not applicable. The document describes non-clinical hardware and software testing, not clinical studies requiring expert ground truth for patient outcomes.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods (e.g., 2+1) are typically used in clinical studies for interpreting ambiguous results or establishing ground truth from expert readings. The tests described are engineering and software tests with defined pass/fail criteria.

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

No MRMC study was conducted or is mentioned in this document. The submission focuses on demonstrating substantial equivalence for minor device modifications and software upgrades through non-clinical testing, not on clinical effectiveness studies.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This concept is less applicable to a functional neuromuscular stimulator that inherently requires human interaction and application by a clinician/user. The document describes software verification and validation, including for the Mobile Application (MAPP) which has user interaction, but not a "standalone algorithm" performance in the sense of an AI diagnostic tool.

7. Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is typically defined by engineering specifications, validated test methods, and industry standards (e.g., ASTM standards for packaging, internal design requirements for software functionality). Not pathology, outcomes data, or expert consensus in a clinical sense.

8. Sample Size for the Training Set:

This information is not applicable. The text describes verification and validation of modified hardware and software, not the development of a machine learning model that would require a "training set."

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

This information is not applicable, as there is no "training set" for a machine learning model mentioned.

Summary

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March 9, 2018

Bioness. Inc. Mary Dadone, Ph.D. 25103 Rye Canyon Loop Valencia, California 91355

Re: K173682

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: November 30, 2017 Received: December 1, 2017

Dear Dr. Dadone:

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Vivek J. Pinto -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) K173682

Device Name L300 Go System

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)	Residential Use (Part 1, CFR 201, Subpart D) On-Site Construction (Part 1, CFR 201, Subpart C)	Residential Use (Part 1, CFR 201, Subpart D)	On-Site Construction (Part 1, CFR 201, Subpart C)
Residential Use (Part 1, CFR 201, Subpart D)
On-Site Construction (Part 1, CFR 201, Subpart C)

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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Image /page/3/Picture/0 description: The image contains the logo for "Bioness LiveOn". The logo consists of an abstract sun-like symbol on the left, with the word "Bioness" in bold, gray letters to the right. Below "Bioness" is the word "LiveOn" in a smaller, lighter font. The sun-like symbol is orange and has eight radiating arms.

510(k) Summary Bioness Inc. L300 Go System

510(k) Summary: L300 Go System

Applicant Name:	Bioness Inc.
Contact Person(s):	Mary Dadone, Ph.D.Regulatory Consultant to Bioness Inc.Office Number: (661) 714-0701Email: mary.dadone@bioness.com
	Mercedes BayaniGlobal Director, Regulatory Affairs, Bioness Inc.Office Number: (661) 902-5324Fax Number: (661) 362-4851Email: mercedes.bayani@bioness.com25103 Rye Canyon LoopValencia, CA 91355, U.S.A
Date Prepared:	March 8, 2018
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:Traditional 510(k)

Predicate Device:

Company: Bioness, Inc. Device: L300 Go System K162407

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Image /page/4/Picture/0 description: The image contains the logo for Bioness. The logo consists of an abstract sun-like symbol on the left, with the word "Bioness" in gray to the right of it. Below "Bioness" is the text "LiveOn" in a smaller font size. The sun-like symbol is made up of several orange lines arranged in a circular pattern.

Purpose of this Traditional 510(k):

This Traditional 510(k) is submitted to clear several minor modifications and to address an upgrade in the Mobile Application (MAPP) for the L300 Go System. 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 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).
1. Optional Foot Sensor, which uses a dynamic gait tracking algorithm to detect heel events and wirelessly synchronizes stimulation.
1. Optional Mobile Application (MAPP), based on the SmartPhone platform enabling the patients to wirelessly retrieve and monitor their daily activity. At the time of clearance of K162407, the MAPP did not include any control feature, but control features like those of the Optional Control Unit have been added to the MAPP and are part of this submission.

Indications for Use:

The L300 Go System is intended to provide ankle dorsiflexion in adult and pediatric individuals with foot drop and/or 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.

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Image /page/5/Picture/1 description: The image shows the logo for Bioness. The logo features a stylized sun-like symbol in orange on the left, followed by the word "Bioness" in gray, with a small orange dot above the "i". Below "Bioness" is the text "LiveOn" in a smaller, lighter gray font.

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 Traditional 510(k)

This Traditional 510(k) addresses the following modifications:

Change in the External Pulse Generator (EPG) cover material .
. Firmware/Electrical Changes
. Changes in the Clinician Application (CAPP) software
Changes in the Mobile Application (MAPP) software
Labeling Changes
Packaging Changes ●

Summary of Technological Characteristics

Table 1 below summarizes the technological characteristics of new device in comparison to those of the predicate device. Summary Comparison Table

	L300 Go System (K162407)	L300 Go System after Design Modifications
Manufacturer	Bioness Inc.	Bioness Inc.
510(k) number	K162407	K173682
Product code	GZI & IPF	GZI & IPF
	L300 Go System (K162407)	L300 Go System after DesignModifications
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• Clinician mode
RegulatedCurrent orRegulatedVoltage	Current	Current

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Image /page/6/Picture/0 description: The image shows the logo for Bioness LiveOn. The logo consists of a stylized sunburst symbol in orange on the left, followed by the word "Bioness" in gray, with a small orange dot above the "i". Below "Bioness" is the word "LiveOn" in a smaller, lighter gray font. The overall design is clean and modern.

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	L300 Go System (K162407)	L300 Go System after DesignModifications
Power Source	Control Unit: Li Coin Cell, CR2032,3 V, 240 mAhEPG: Rechargeable, Li-Ion,Prismatic, 3.7 V, 1000 mAhFoot Sensor: Li Coin Cell,CR2032, 3 V, 240 mAh	Control Unit: Li Coin Cell, CR2032,3 V, 240 mAhEPG: Rechargeable, Li-Ion,Prismatic, 3.7 V, 1000 mAhFoot Sensor: Li Coin Cell,CR2032, 3 V, 240 mAh
Microprocessor-Controlled	Yes	Yes
Max OutputCurrent(± 10%)	Thigh FSC:100 mA @ 500Ohm loadL300 Lower LegFSC: 100 mA @500 Ohm load	Thigh FSC:100 mA @ 500Ohm loadL300 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)

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Image /page/8/Picture/0 description: The image contains the logo for Bioness. The logo consists of an orange sun-like symbol on the left, followed by the word "Bioness" in gray, and the words "LiveOn" in a smaller font below it. The logo is clean and modern, with a focus on the company name.

	L300 Go System (K162407)	L300 Go System after DesignModifications
StimulationChannels	Thigh EPG: 1Lower Leg EPG:2 (functioning asa single channelwith separately-adjustablemedial / lateralstimulationintensity)	Thigh EPG: 1Lower 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
	L300 Go System (K162407)	L300 Go System after Design Modifications
User Control	Using hand-held Control Unit or the EPG-based interface, the user can:Turn system On/Off (via EPG only) and Start/Stop stimulation Select Gait/Training program Fine-tune stimulation intensity around working point set by the clinician Test L300 Lower Leg EPG & Thigh EPG stimulation before starting to ambulate	Using hand-held Control Unit, the mobile application (MAPP), or the EPG-based interface, the user can:Turn system On/Off (via EPG only) and Start/Stop stimulation Select Gait/Training program Fine-tune stimulation intensity around working point set by the clinician Test L300 Lower Leg EPG & Thigh EPG stimulation before starting to ambulate
Stimulationtrigger source(when used forgait)	In gait mode, stimulation is triggered by:(1) the motion sensor embedded in the EPG; or(2) Foot Sensor that detects Heel On & Heel Contact events during gait and transmits them wirelessly to the lower and thigh EPGs.	In gait mode, stimulation is triggered by:(1) the motion sensor embedded in the EPG; or(2) Foot Sensor that detects Heel On & Heel Contact events during gait and transmits them wirelessly to the lower and thigh EPGs.
Communicationmethod	Control Unit – Lower Leg /Thigh EPG: wireless Bluetooth (Low Energy) communication protocolGait Sensor – Lower Leg/Thigh EPG: wireless Bluetooth (Low Energy) communication protocolClinician Programmer – EPG: wireless Bluetooth (Low Energy) communication protocolMAPP – Lower Leg /Thigh EPG: wireless Bluetooth (Low Energy) communication protocol	Control Unit – Lower Leg /Thigh EPG: wireless Bluetooth (Low Energy) communication protocolGait Sensor – Lower Leg/Thigh EPG: wireless Bluetooth (Low Energy) communication protocolClinician Programmer – EPG: wireless Bluetooth (Low Energy) communication protocolMAPP – Lower Leg /Thigh EPG: wireless Bluetooth (Low Energy) communication protocol

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Image /page/9/Picture/0 description: The image shows the logo for Bioness. The logo consists of an orange sun-like symbol on the left, followed by the word "Bioness" in gray, with a small orange dot above the "i". 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 and tagline.

Table 1 ends here

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Summary of Nonclinical Tests Submitted

Because of a modification in the assembly process for the optional Control Unit (CU), the CU was retested for Environmental Ingress Protection by Minnetronix Inc. (Bioness development vendor) using a validated test method. The modified CU successfully passed the Environmental Ingress Protection testing.

Because of a change in the Electrical Pulse Generator (EPG) housing material, the EPG was retested for Mechanical Vibration and Shock using a validated Minnetronix test method. The modified EPG successfully passed the Mechanical Vibration and Shock testing.

Packaging and shipping tests were performed to address the new packaging system. These tests included Initial Manual Handling, Vehicle Stacking, Loose Load Vibration, Low Pressure, Vehicle Vibration, Concentrated Impact, and Final Manual Handling (ASTM D5276-98, Schedule A, Level III). All packaging passed all tests.

Software changes were subjected to verification testing to include regression testing to ensure no loss of original functionality. In the version change from MAPP 1.0 to MAPP 2.0, new functions were introduced, and those new functions were subjected to both verification testing (including regression testing) and validation testing. Electrical safety and electromagnetic compatibility testing, including coexistence with common wireless emitters, was completed under the predicate submission and evaluated for applicability to the design modifications proposed under the current submission.

Conclusion:

The L300 Go System has been verified and validated successfully for its intended use through the combination of original bench testing, additional bench testing, engineering analysis, and thorough verification and validation testing of all software changes. Based on the results 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).