The L360 Thigh System is intended 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 L360 Thigh System electrically stimulates muscles in the affected leg to provide knee flexion or extension; thus, it also may improve the individual's gait.

The L360 Thigh System may also:

Facilitate muscle re-education
Prevent/retard disuse atrophy
Maintain or increase joint range of motion
Increase local blood flow
Provide early post-surgical quadricep and hamstring strengthening
Improve post-surgical knee stability secondary to quadricep and hamstring strengthening
Relax muscle spasms

Device Description

The L360 Thigh System is intended to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damaqe to pathways to the spinal cord). The L360 Thigh System electrically stimulates muscles in the affected leg to provide knee flexion or extension; thus, it also may improve the individual's gait.

The L360 Thigh System consists of:

1. One or two Thigh Functional Stimulation Cuffs (Thigh Cuff) that include surface electrodes.
1. Central External Pulse Generator (EPG). The EPG delivers stimulation to their respective cuffs, and have user interface, including visual, audio, and tactile feedback. The EPG can use motion sensor based algorithm to detect heel events.
1. An optional Control Unit that allows simple wireless remote control of the EPG's while displaying real-time information regarding the system's status.
1. An optional Gait Sensor, which uses a dynamic gait tracking algorithm to detect heel events and wirelessly synchronizes stimulation.
1. A Clinician's Programming System with software, which is used for system programming by a trained clinician during configuration of the system for optimal fitting to the patient.
1. An optional Mobile Application (MAPP) enabling the patients to wirelessly control the EPG(s) and retrieve and monitor their daily activity.
1. A power supply with two USB outputs and a proprietary cable to charge the EPG(s).

AI/ML Overview

This document is a 510(k) Premarket Notification for the Bioness L360 Thigh System, seeking to expand its indications for use. Based on the provided text, the acceptance criteria are primarily demonstrated through a showing of substantial equivalence to existing predicate devices, rather than through a a new clinical study with explicitly defined performance metrics the device needs to meet.

Here's an analysis of the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance.

The document does not provide a traditional table of acceptance criteria with specific performance metrics (e.g., accuracy, sensitivity, specificity, or improvement in a clinical outcome that the device must achieve).

Instead, the acceptance criteria for this 510(k) submission are based on demonstrating substantial equivalence to two predicate devices: the Bioness L300 Go System (K190285) and the Bio-Medical Research Ltd. Kneehab XP (K110350). The performance reported is that the device "is performing as intended" and "is substantially equivalent to the predicate devices."

The submission argues that the L360 Thigh System is essentially the "Thigh Standalone configuration" of the L300 Go System, with the only difference being an expansion of indications. Therefore, the performance tests conducted on the L300 Go System are considered applicable.

Acceptance Criterion (Implicit)	Reported Device Performance (L360 Thigh System / L300 Go System)
Technological Characteristics Substantial Equivalence	"The L360 Thigh System, subject of this submission is exactly the same device in all aspect to the Thigh Standalone configuration of its predicate device, the L300 Go System, cleared for marketing under K190285."
Expanded Indication Justification	"The only difference between the devices is the expansion of the indication to provide relaxation of muscle spasms and post-surgical muscle strengthening and knee stability. The proposed indication for use is supported by its substantial equivalence to that of the Predicate Device #1, the L300 Go System (K190285) and Predicate Device #2, the Kneehab XP (K110350) with regards to its use as a neuromuscular electronic stimulator (NMES), and additionally supported by scientific literature, the principle of the NMES, and the standard indication for use for Powered Muscle Stimulators classified under 21 CFR 890.5850 (product code: IPF) per FDA Guidance Document for Powered Muscle Stimulator 510(k)s issued on June 9, 1999."
Electrical Safety	Meets IEC 60601-1, IEC 60601-2-10, and related standards. Patient Leakage Current: Normal condition: Less than 1.0µA; Single fault condition: 3.0µA.
Electromagnetic Compatibility (EMC)	Meets IEC 60601-1-2.
Software Verification and Validation	Completed. Meets IEC 62304.
Mechanical Durability	Completed.
Lifetime Test	Completed.
Environmental Conditions	Completed.
Biocompatibility	New testing not run as it uses the same materials as the predicate. Predicate underwent Cytotoxicity, Sensitization, Irritation testing in accordance with ISO 10993.
Functional Verification and Validation	Completed.
Overall Performance & Intended Use	"The conclusions drawn from the performance tests demonstrate that the device is performing as intended, and is substantially equivalent to the predicate devices."

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective).

The document does not describe a new clinical "test set" in the context of typical AI/ML performance evaluation (e.g., a set of patient cases used to evaluate an algorithm's diagnostic accuracy). Instead, it refers to performance tests (electrical, mechanical, functional, software V&V, EMC, biocompatibility) conducted on the L300 Go System (the predicate device). These are engineering and system-level tests, not typically clinical trials involving patient samples.

Sample Size for Test Set: Not applicable in the context of patient data samples for algorithm performance. The "test set" refers to the device itself being subjected to various engineering and regulatory conformance tests.
Data Provenance (Country of Origin, Retrospective/Prospective): Not applicable for the type of testing described. The "data" here are results from engineering and biocompatibility tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience).

This question is not applicable to the type of device and submission described. This is a functional neuromuscular stimulator, not an AI/ML diagnostic or image analysis device that requires expert ground truth labeling for a test set. The validation relies on engineering and biological safety tests, and a showing of substantial equivalence to predicate devices, supported by scientific literature on the principle of NMES.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set.

Not applicable. There is no clinical test set requiring expert adjudication for ground truth, as this is not an AI/ML diagnostic device.

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 submission is for a functional electrical stimulation device, not an AI-assisted diagnostic or image interpretation tool. Therefore, an MRMC study comparing human reader performance with or without AI assistance is not relevant to this device or its regulatory pathway.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.

Not applicable. While the device has software and algorithms for stimulus delivery and gait detection, it is a hardware medical device with specific physical and electrical outputs for therapeutic purposes. Its "performance" is in stimulating muscles as intended, not in autonomously interpreting data or making diagnostic decisions without human involvement in setting up or managing the therapy. The performance tests mentioned (functional, software V&V) implicitly cover standalone algorithm functioning within the device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).

For the specific type of device and submission (510(k) for an expanded indication based on substantial equivalence), "ground truth" as typically understood in AI/ML validation (e.g., definitive diagnosis) is not explicitly mentioned or relied upon. The ground truth for proving substantial equivalence relies on:

Technical Specifications Comparison: Direct comparison of electrical, mechanical, and software characteristics to predicates.
Engineering Test Results: Pass/fail criteria for electrical safety, EMC, reliability, etc., as per recognized standards (e.g., IEC 60601 series, ISO 14971, ISO 10993).
Prior Regulatory Clearances: The fact that the predicate devices were previously cleared by the FDA establishes their safety and effectiveness characteristics as a benchmark.
Scientific Literature and Principle of NMES: Supporting the general safety and effectiveness of Neuromuscular Electrical Stimulation for the stated indications.

8. The sample size for the training set.

Not applicable. This document describes a traditional medical device, not an AI/ML product developed using large training datasets. The "training" for such devices typically refers to the engineering design and development process, informed by established medical principles and device standards.

9. How the ground truth for the training set was established.

Not applicable. As above, there is no AI/ML training set as such. The "ground truth" for the device's design and functionality comes from established engineering principles, international standards, and existing regulatory clearances of similar predicate devices.

Summary

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September 12, 2019

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

Re: K191587

Trade/Device Name: L360 Thigh System Regulation Number: 21 CFR 882.5810 Regulation Name: External Functional Neuromuscular Stimulator Regulatory Class: Class II Product Code: GZI, IPF Dated: June 11, 2019 Received: June 14, 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 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

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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 (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 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,

Vivek Pinto. PhD Director (Acting) 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

510(k) Number (if known) K191587

Device Name L360 Thigh System

Indications for Use (Describe)

The L360 Thigh System may also:

· Facilitate muscle re-education
· Prevent/retard disuse atrophy
· Maintain or increase joint range of motion
· Increase local blood flow
· Provide early post-surgical quadricep and hamstring strengthening
· Improve post-surgical knee stability secondary to quadricep and hamstring strengthening
Relax muscle spasms

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 contains the logo for "Bioness LiveOn". The logo consists of an abstract sun-like symbol on the left, with the word "Bioness" in a bold, sans-serif font to the right of it. Below "Bioness" is the word "LiveOn" in a smaller, lighter font. The sun-like symbol is orange, while the text is gray.

510(k) Summary

510(k) Summary:	L360 Thigh 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:	September 12, 2019
Device Trade Name:	L360 Thigh 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: Expansion of the Indication for Use

Type of Submission: Traditional 510(k)

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Predicate devices:

1. Company: Bioness Inc. Device: L300 Go System (K190285)
1. Company: Bio-Medical Research, Ltd. Device: Kneehab XP, Type 412/421 (K110350)

Purpose of the traditional 510(k) notice:

The L360 Thigh System is the Thigh Standalone configuration of its predicate device, the L300 Go System, with expanded indication for use. The L360 Thigh System is substantially equivalent to its own superset device, the L300 Go System, and the Bio-Medical Research Ltd. Kneehab XP, Type 412/421(hereinafter referred to as Kneehab XP).

Device description:

The L360 Thigh System is intended to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damaqe to pathways to the spinal cord). The L360 Thigh System electrically stimulates muscles in the affected leg to provide knee flexion or extension; thus, it also may improve the individual's gait.

The L360 Thigh System consists of:

1. One or two Thigh Functional Stimulation Cuffs (Thigh Cuff) that include surface electrodes.
1. Central External Pulse Generator (EPG). The EPG delivers stimulation to their respective cuffs, and have user interface, including visual, audio, and tactile feedback. The EPG can use motion sensor based algorithm to detect heel events.
1. An optional Control Unit that allows simple wireless remote control of the EPG's while displaying real-time information regarding the system's status.

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Image /page/5/Picture/0 description: The image contains the logo for "Bioness LiveOn". The logo features an abstract sun-like symbol on the left, composed of interconnected orange lines. To the right of the symbol is the word "Bioness" in a bold, gray sans-serif font. Below "Bioness" is the word "LiveOn" in a smaller, lighter gray font, with a trademark symbol next to it.

1. An optional Gait Sensor, which uses a dynamic gait tracking algorithm to detect heel events and wirelessly synchronizes stimulation.
1. A Clinician's Programming System with software, which is used for system programming by a trained clinician during configuration of the system for optimal fitting to the patient.
1. An optional Mobile Application (MAPP) enabling the patients to wirelessly control the EPG(s) and retrieve and monitor their daily activity.
1. A power supply with two USB outputs and a proprietary cable to charge the EPG(s).

Indications for use:

The L360 Thigh System may also:

Facilitate muscle re-education
Prevent/retard disuse atrophy
· Maintain or increase joint range of motion
Increase local blood flow
· Provide early post-surgical quadricep and hamstring strengthening
· Improve post-surgical knee stability secondary to quadricep and hamstring strengthening
Relax muscle spasms

Substantial Equivalence:

The table on next page summarize the indication for use and technological characteristics of the new device in comparison to those of the predicate devices.

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	L360 Thigh System(This submission)	L300 Go System(K190285)	Kneehab XP(K110350)
Manufacturer	Bioness Inc.	Bioness Inc.	Bio-Medical Research Ltd.
510(k) number	To be assigned	K190285	K110350
Product Code	GZI & IPF	GZI & IPF	IPF, GZJ, NYN
PrescriptionUse	Yes	Yes	Yes
Indicationfor UseStatement	The L360 Thigh Systemis intended to assist kneeflexion or extension inadult individuals withmuscle weakness relatedto upper motor neurondisease/injury (e.g.,stroke, damage topathways to the spinalcord). The L360 ThighSystem electricallystimulates muscles in theaffected leg to provideknee flexion or extension;thus, it also may improvethe individual's gait.The L360 Thigh Systemmay also:Facilitate muscle re-education Prevent/retard disuse atrophy Maintain or increase joint range of motion Increase local blood flow Provide early post-surgical quadriceps andhamstring strengthening Improve post-surgical knee stability secondaryto quadriceps and hamstring strengthening Relax muscle spasms	The L300 Go System isintended to provideankle dorsiflexion inadult and pediatricindividuals with foot dropand/or to assist kneeflexion or extension inadult individuals withmuscle weaknessrelated to upper motorneuron disease/injury(e.g. stroke, damage topathways to the spinalcord). The L300 GoSystem electricallystimulates muscles inthe affected leg toprovide ankledorsiflexion of the footand/or knee flexion orextension; thus, it alsomay improve theindividual's gait.The L300 Go Systemmay also:Facilitate muscle re-education Prevent/retard disuse atrophy Maintain or increase joint range of motion Increase local blood flow	In NMES mode (Programs1-6) the Kneehab XP isintended to:Maintain or increase the range of motion Prevention or retardation of disuse atrophy Re-educate muscles Early post-surgical quadriceps strengtheningand improved post surgical knee stabilitysecondary to quadriceps strengthening Relax muscle spasms Increase blood circulationIn TENS Mode (Programs7-9) the Kneehab XP isintended to:Provide symptomatic relief and management ofchronic, intractable pain Provide an adjunctive treatment in themanagement of acute, post-surgical or post-traumatic pain Provide symptomatic relief and management ofintractable pain and relief of pain associated witharthritis Provide an adjunctive therapy in reducing the levelof pain and symptoms associated withosteoarthritis of the knee
Energysource	3.7V, 1000mAh Lithiumion rechargeableprismatic battery	3.7V, 1000mAh Lithiumion rechargeableprismatic battery	3.6V NiMH rechargeablebattery pack
	L360 Thigh System(This submission)	L300 Go System(K190285)	Kneehab XP(K110350)
HousingMaterialandConstruction	Control Unit: Bay StatePolymer PA-2000RX	Control Unit: Bay StatePolymer PA-2000RX	Control Unit: ABS-PA-757)
	EPG: Bay State PolymerPA-2000RX	EPG: Bay State PolymerPA-2000RX	Garment: ContainsEEPROM(A
	Thigh FSC: TPU	Thigh FSC: TPU	Outer fabric: 100% NylonInner fabric: 70%
	Foot Sensor: ABS(Sensor housing),Bay state Polymer PA-2000RX (Electronicshousing)	Foot Sensor: ABS(Sensor housing),Bay state Polymer PA-2000RX (Electronicshousing)	Polychloroprene & 30%PolyurethaneBinding: 82% Nylon & 18%ElastaneFastening: 100 Nylon
Electrode	Two non-woven cloth	Two non-woven cloth	Four gel pad electrodes
	electrodes, oval(Proximal 130x75mm,91.1 $cm^2$ and Distal120x63mm, 72 $cm^2$ )	electrodes, oval(Proximal 130x75mm,91.1 $cm^2$ and Distal120x63mm, 72 $cm^2$ )	Electrode A: 194 $cm^2$Electrode B: 74 $cm^2$Electrode C: 83 $cm^2$Electrode D: 66 $cm^2$
	Constructed from non-conductive plastic back,stainless steel mesh, andcloth facing towards theleg.	Constructed from non-conductive plastic back,stainless steel mesh,and cloth facing towardsthe leg.
Lead wires	Wires embedded in thecuff	Wires embedded in thecuff	Over-molded SATAconnector splitting to 5leads / studs embedded inthe garment
StimulationSite	Quadriceps orHamstring	Quadriceps orHamstring	Quadriceps
Standards Met	IEC 60601-1IEC 60601-1-6IEC 60601-1-8IEC 60601-1-11IEC 60601-1-2IEC 60601-2-10IEC 62304ISO 14971ISO 10993-1ISO 10993-5ISO 10993-1021 CFR 80121 CFR 898	IEC 60601-1IEC 60601-1-6IEC 60601-1-8IEC 60601-1-11IEC 60601-1-2IEC 60601-2-10IEC 62304ISO 14971ISO 10993-1ISO 10993-5ISO 10993-1021 CFR 80121 CFR 898	IEC 60601-1IEC 60601-2-10IEC 60601-1-2ISO 14971ISO 10993-1ISO 10993-5ISO 10993-1021 CFR 89821 CFR 801
Method of lineisolation	N/A (battery operated)	N/A (battery operated)	No line connection (batteryoperated)
PatientLeakagecurrent	Normal condition:Less than 1.0µA (asrequired by IEC 60601- 1)Single fault	Normal condition:Less than 1.0µA (asrequired by IEC 60601-1)	Information is not available
	condition:3.0µA (as requiredby IEC 60601-1)	Single fault condition:3.0µA (as required byIEC 60601-1)
	L360 Thigh System(This submission)	L300 Go System(K190285)	Kneehab XP(K110350)
StimulationModes	- Gait- Training- Cycle Training- Clinician	- Gait- Training- Cycle Training- Clinician	NMES (Programs 1-6)TENS (Programs 7-10)
Waveform/shape	Pulsed, Biphasic,Rectangular withinterphase interval	Pulsed, Biphasic,Rectangular withinterphase interval	Pulsed, Biphasic,Rectangular with interphaseinterval
Number ofoutputchannels	1 channel(EPG has 2channels, but only 1channel isconnected to thethigh cuff electrodes)	Thigh cuff:1 channel(EPG has 2 channels,but only 1 channel isconnected to the thighcuff electrodes)	2
SynchronousorAlternating?	N/A, only one outputchannel	N/A, only one outputchannel for thigh cuff	Synchronous (multiplexed)
Method ofChannelIsolation	N/A, only one outputchannel	N/A, only one outputchannel for thigh cuff	Transistor
Regulatedcurrent orvoltage	Current	Current	Current
Software /Firmware /Microprocessor Control?	Yes	Yes	Yes
Automaticoverload trip?	Yes	Yes	Yes, current limited,indefinite short circuitallowed
Automatic No-load trip?	Yes	Yes	Yes
Automaticshut off?	Yes	Yes	Yes
Patientoverridecontrol?	Yes	Yes	Yes, pause button
Indicator Display:
On/OffStatus?	Yes	Yes	Yes
LowerBattery?	Yes	Yes	Yes
Voltage/CurrentLevel?	Yes	Yes	Yes
	L360 Thigh System(This submission)	L300 Go System(K190285)	Kneehab XP(K110350)
Timer range	Gait mode: N/A,stimulation timing isdetermined by heel on /heel off eventsCycle Training Mode:N/A, stimulation timingis determined byposition of the pedalsTraining mode: 5-60minutes	Gait mode: N/A,stimulation timing isdetermined by heel on /heel off eventsCycle Training Mode:N/A, stimulation timing isdetermined by positionof the pedalsTraining mode: 5-60minutes	20 min > - open
Compliancewith 21 CFR898?	Yes	Yes	Yes
Weight	EPG: 60gThigh cuff: 300g	EPG: 60gThigh cuff: 300g	Control Unit: 116g (inc.batteries)
Dimensions(W x H x D)	EPG: 82x47x15mmThigh cuff:- Length: 200mm- Circumference (min)- Proximal panel:270mm- Distal panel: 310mm	EPG: 82x47x15mmThigh cuff:- Length: 200mm- Circumference (min)- Proximal panel:270mm- Distal panel: 310mm	Control Unit: 60x32x115mm
Frequency /Phaseduration	Frequency: 10, 15,20, 25, 30, 35, 40, 45 HzSymmetric andAsymmetric positive:100, 150, 200, 250,300 $μ$ sAsymmetric Negative:300, 450, 600, 750,900 $μ$ s	Frequency: 10, 15, 20,25, 30, 35, 40, 45 HzSymmetric andAsymmetric positive:100, 150, 200, 250,300 $μ$ sAsymmetric Negative:300, 450, 600, 750, 900$μ$ s	300 $μ$ sNMES Programs:P1: 50 Hz, 300 - 400 $μ$ sP2: 50 Hz, 300 - 400 $μ$ sP3: 50 Hz, 300 - 400 $μ$ sP4: 50 Hz, 300 - 400 $μ$ sP5: 35 Hz, 300 - 400 $μ$ sP6: 70 Hz, 300 - 400 $μ$ s
Baseline topeak current(+/-10%)	100mA @ 500 Ohm65mA @ 2k Ohm13mA @ 10k Ohm	100mA @ 500 Ohm65mA @ 2k Ohm13mA @ 10k Ohm	80mA @ 500 Ohm28mA @ 2k Ohm3.9mA @ 10k Ohm
Baseline topeak outputvoltage (+/-10%)	50V @ 500 Ohm130V @ 2k Ohm130V @ 10k Ohm	50V @ 500 Ohm130V @ 2k Ohm130V @ 10k Ohm	40.0V @ 500 Ohm55.6V @ 2k Ohm39.3V @ 10k Ohm
MaximumRMS outputvoltage (+/-10%) Vrms	8.2V @ 500 Ohm21.3V @ 2 kOhm21.3 @ 10 kOhm	8.2V @ 500 Ohm21.3V @ 2 kOhm21.3 @ 10 kOhm	9.3V @ 500 Ohm17.1V @ 2kOhm14.1V @ 10kOhm
MaximumRMS outputcurrent (+/-10%) Irms	Symmetric:16.4mA @ 500 Ohm10.7mA @ 2 kOhm2.1mA @ 10 kOhm	Symmetric:16.4mA @ 500 Ohm10.7mA @ 2 kOhm2.1mA @ 10 kOhm	18.6 mA @ 500 Ohm8.6mA @ 2k Ohm1.42mA @ 10k Ohm
	L360 Thigh System(This submission)	L300 Go System(K190285)	Kneehab XP(K110350)
Pulse width	Positive phase: 100,150, 200, 250,300µs(positive phase)	Positive phase: 100,150, 200, 250,300µs(positive phase)	640 µs - sum of bothphases 300 µs + 40 µsinterphase interval
	Interphase interval:20, 50, 200 µs	Interphase interval:20, 50, 200 µs	(There is a discrepancybetween the 510K summaryof the device and the
	Total pulse durationfor symmetricwaveform (for 50 µsinterphaseinterval): 250, 350,450, 550, 650 µs	Total pulse durationfor symmetricwaveform (for 50 µsinterphaseinterval): 250, 350,450, 550, 650 µs	device's IFU).
	Total pulse durationfor asymmetricwaveform(for 50 µs interphaseinterval): 450, 650,850, 1050, 1250 µs	Total pulse durationfor asymmetricwaveform(for 50 µs interphaseinterval): 450, 650,850, 1050, 1250 µs
Net charge(µC per pulse)	0 µC @ 500 Ohm	0 µC @ 500 Ohm	0 µC @ 500 Ohm
Maximumphase charge@ 500 Ohm(+/-20%)	30 µC @ 500 Ohm(300 µs * 100mA)	30 µC @ 500 Ohm(300 µs * 100mA)	24 µC @ 500 Ohm
Maximumcurrentdensity @ 500Ohm (mA/cm²)	0.228 mA/cm²(calculated as 16.4mA/72cm²)	Thigh:0.228 mA/cm²(calculated as 16.4mA/72cm²)	0.224 mA/cm²(calculated as 18.6mA/83cm²)
Maximumpower density@ 500 Ohmusing smallestelectrode	1.87 mW/cm² (500Ohm, electrode areaof 74cm²)	1.87 mW/cm² (500Ohm, electrode areaof 74cm²)	2.1mW/cm² @ 500 Ohm
conductivesurface area

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	L360 Thigh System(This submission)	L300 Go System(K190285)	Kneehab XP(K110350)
Burst mode	YesBursts can betriggered by threedifferent sources:	YesBursts can betriggered by threedifferent sources:	YesBursts are triggered byon/off settings of the timer,per selected NMESprogram.
	Gait mode:Bursts triggeredeither by 'heel off' or'heel contact' events(or both).	Gait mode:Bursts triggeredeither by 'heel off' or'heel contact' events(or both).
	Cycle TrainingMode:Bursts triggered byposition of the pedalsduring pedaling cycle.	Cycle TrainingMode:Bursts triggered byposition of the pedalsduring pedaling cycle.
	Training mode:Bursts triggered byon/off settings of thetimer.	Training mode:Bursts triggered byon/off settings of thetimer.
Pulse perburst	Pulses per burst =Burst$duration*Frequency$	Pulses per burst =Burst$duration*Frequency$	Pulses per burst = Burst$duration*Frequency$
Bursts persecond	Gait mode:Bursts per second =$2*Strides per second$	Gait mode:Bursts per second =$2*Strides per second$	Average number of burstsper second = $1 / (time on + time off)$
	Cycle Training mode:Burst per second =revolutions per second	Cycle Training mode:Burst per second =revolutions per second
	Training mode:Average number ofbursts per second =$1 / (time on + time off)$	Training mode:Average number ofbursts per second =$1 / (time on + time off)$

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	L360 Thigh System(This submission)	L300 Go System(K190285)	Kneehab XP(K110350)
Duty Cycle(Bursts persecond * burstduration)	Gait mode:For example, forpace of one strideper second, Duty Cycle =0.48 sec * 1 (stride/sec) 100% = 48%Cycle Trainingmode:For example, for onerevolution per second,Duty cycle = 0.3 sec 1rps * 100% = 30%Training mode:On time: 4 – 20 secOff time: 4 – 20 secMin Duty Cycle = 4sec * (1/40)(1/sec) 100% = 10%Max Duty Cycle = 20sec (1/24)(1/sec) *100% = 83%	Gait mode:For example, forpace of one strideper second, Duty Cycle=0.48 sec * 1 (stride/sec)100% = 48%Cycle Trainingmode:For example, for onerevolution per second,Duty cycle = 0.3 sec 1rps * 100% = 30%Training mode:On time: 4 – 20 secOff time: 4 – 20 secMin Duty Cycle = 4sec * (1/40)(1/sec) 100% = 10%Max Duty Cycle = 20sec (1/24)(1/sec) *100% = 83%	NMES mode:P1 Duty Cycle = 5 sec (1/15)(1/sec) 100% =33%P2 Duty Cycle = 10 sec (1/20)(1/sec) 100% =50%P3 Duty Cycle = 10 sec (1/30)(1/sec) 100% =33%P4 Duty Cycle = 10 sec (1/40)(1/sec) 100% =25%P5 Duty Cycle = 5 sec (1/10)(1/sec) 100% =33%P6 Duty Cycle = 10 sec (1/60)(1/sec) 100% = 17%
Pulsefrequency	10, 15, 20, 25, 30,35, 40, 45 Hz	10, 15, 20, 25, 30,35, 40, 45 Hz	NMES mode:35, 50, 70Hz
Ramp up time	0-2 sec (0.5 secstep)	0-2 sec (0.5 secstep)	NMES mode: 0.5 sec
Ramp downtime	0-2 sec (0.5 secstep)	0-2 sec (0.5 secstep)	NMES mode: 0.5 sec
On time(contractiontime)	4 – 20 sec (1 secstep)	4 – 20 sec (1 secstep)	NMES mode:5 sec or 10 sec
Off time(relaxationtime)	4 – 20 sec (1 secstep)	4 – 20 sec (1 secstep)	NMES mode:5, 10, 20, 30, or 50 sec

End of table

The L360 Thigh System, subject of this submission is exactly the same device in all aspect to the Thigh Standalone configuration of its predicate device, the L300 Go System, cleared for marketing under K190285. The only difference between the devices is the expansion of the indication to provide relaxation of muscle spasms and post-surgical muscle strengthening and knee stability. The proposed indication for use is supported by its substantial equivalence to that of the Predicate Device #1, the L300 Go System (K190285) and Predicate Device #2, the Kneehab XP (K110350) with regards to its use as a neuromuscular electronic stimulator (NMES),

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and additionally supported by scientific literature, the principle of the NMES, and the standard indication for use for Powered Muscle Stimulators classified under 21 CFR 890.5850 (product code: IPF) per FDA Guidance Document for Powered Muscle Stimulator 510(k)s issued on June 9, 1999.

Performance Tests:

Since the L360 Thigh System is a subset and consists of the same components as the Thigh Standalone configuration of the predicate L300 Go System, there are no differences in the technological characteristics between the two devices. Therefore, the performance tests conducted on L300 Go System can also be applied to the L360 Thigh System.

The predicate L300 Go System was qualified through the following electrical, mechanical, and functional testing:

. Lifetime test
Reliability, mechanical durability ●
Environmental conditions testing
Functional Verification and Validation Tests .
Software Verification and Validation Tests
. Electrical Safety and Electromagnetic Compatibility (EMC)

The conclusions drawn from the performance tests demonstrate that the device is performing as intended, and is substantially equivalent to the predicate devices.

Biocompatibility:

The L360 Thigh System uses the exact same material and has the same type of skin contact as its predicate device, the L300 Go System, so new biocompatibility testing was not run. The predicate device underwent the following biocompatibility test evaluation in accordance with the FDA Good Laboratory Practice and requirements specified under ISO 10993.

. Cytotoxicity
Sensitization .
. Irritation

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Conclusion:

Bioness concludes that the L360 Thigh System is substantially equivalent to the company's own L300 Go System (K190285) and the Bio-Medical Research, Ltd.'s, Kneehab XP (K110350) predicate devices, and does not raise any new issues or concerns of safety or effectiveness.

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).