(151 days)
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 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
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 qait.
The L300 Go System consists of:
-
- One or two Functional Stimulation Cuffs (L300 Lower Leg and Thigh), that include surface electrodes.
-
- External Pulse Generator (EPG) for the lower leg and EPG for thigh. Both EPG's deliver stimulation to their respective cuffs, and have user interface, including visual, audio, and tactile feedback. Lower EPG can use motion sensor based algorithm to detect heel events.
-
- A Control Unit that allows simple wireless remote control of the EPG's while displaying real-time information regarding the system's status.
-
- An optional Gait Sensor, which uses a dynamic gait tracking algorithm to detect heel events and wirelessly synchronizes stimulation.
-
- 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.
-
- A power supply with two USB outputs and a proprietary cable to charge the EPG.
This document is a 510(k) Summary for the Bioness L300 Go System, a medical device intended to provide ankle dorsiflexion and/or assist knee flexion/extension. The primary purpose of this document is to demonstrate substantial equivalence to previously cleared predicate devices, not to present a comprehensive study proving device performance against acceptance criteria. Therefore, most of the requested information regarding study details, sample sizes, expert involvement, and ground truth establishment is not available in the provided text.
Based on the available information, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for the L300 Go System in terms of performance metrics like accuracy, sensitivity, or specificity. Instead, it demonstrates an equivalence to predicate devices in various technical specifications and functional aspects. The tables (Table 1.0, Table 2a, Table 2b) primarily compare the technical output specifications and basic unit characteristics of the L300 Go System with its predicate devices.
| Feature / Criteria (Derived from comparison to predicates) | L300 Go System Reported Performance |
|---|---|
| Output Waveform | Biphasic Symmetrical / Asymmetrical |
| Shape | Rectangular |
| Max Output Voltage (@500Ω) | Lower leg: 50V, Thigh: 50V |
| Max Output Current (@500Ω) | Lower leg: 100mA, Thigh: 100mA |
| Pulse Width (Biphasic Symmetrical) | 100, 150, 200, 250, 300 µs |
| Frequency | 10-45 Hz |
| Net Charge per pulse (@500Ω) | 0 µC (using inverted balanced phases) |
| Max Phase Charge (@500Ω) | Lower leg: 30 µC, Thigh: 30 µC |
| Max Current Density (@500Ω) | Varies by cuff size (e.g., Lower leg small cuff: 1.63 mA/cm² (rms)) |
| Max Power Density (@500Ω) | Varies by cuff size (e.g., Lower leg small cuff: 13.4 mW/cm²) |
| Burst Mode Functionality | Yes (heel off/contact triggered, timer/complementary event terminated) |
| ON Time (Training mode) | 4-20 sec |
| OFF Time (Training mode) | 4-20 sec |
| Compliance with Standards | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, FCC part 15 subpart C and B1, 21 CFR 898 (Yes) |
| Wireless Communication Technology | Industry-standard Bluetooth (low energy) |
| User Interface | Expanded User Interface (via Remote Control or Stimulator) |
| Clinician Programmer | Tablet/PC-based Clinician Programmer |
| Number of Stimulation Channels | One or two (lower leg), one (thigh) |
| Tilt Sensor for Gait Trigger | Yes (similar to WalkAide) |
The document asserts that the L300 Go System "does not introduce any new issues of safety or efficacy" relative to its predicate devices, implying that its performance is equivalent in these aspects.
2. Sample size used for the test set and the data provenance
Not provided. The document outlines a substantial equivalence argument rather than a dedicated performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not provided. There is no mention of a test set or ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not provided. There is no mention of an adjudication method.
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 an external functional neuromuscular stimulator, not an AI-assisted diagnostic or imaging device that would typically involve human "readers" or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question generally applies to AI-driven diagnostic systems. The L300 Go System includes algorithms (e.g., motion sensor-based algorithm to detect heel events, dynamic gait tracking algorithm), but the device itself is a functional electrical stimulator, not an algorithm-only device. Its functionality inherently involves interaction with the human body to achieve a therapeutic effect. The document focuses on the technical specifications and equivalency to previously cleared devices.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not provided. The document focuses on technical specifications and functional equivalence rather than clinical ground truth for a diagnostic outcome.
8. The sample size for the training set
Not applicable. This device is not an AI/ML model that would be "trained" in the traditional sense on a dataset. The document discusses "software" and "firmware" but not a machine learning training process.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 27, 2017
Bioness Inc. % Evan L. Rosenfeld, M.D., J.D. Regulatory Consultant MDJD Consulting 5905 Warm Mist Ln. Dallas. Texas 75248
Re: K162407
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: December 16, 2016 Received: December 21, 2016
Dear Evan L. Rosenfeld, M.D., J.D.:
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 801); medical device reporting (reporting of medical device
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Page 2 - Evan L. Rosenfeld, M.D., J.D.
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Carlos L. Pena -S
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) K162407
Device Name L300 Go System
Indications for Use (Describe)
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 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
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Exportation (to Part 370.2(a) Subject to the EAR)
On-Site Consumption (to 370.2(a) Subject to the EAR)
|× | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary Bioness Inc. L300 Go System
510(k) Summary: L300 Go System
Company name: Bioness Inc.
Contact person:
Mercedes Bayani Global Director, Regulatory Affairs Bioness Inc. Office Number: (661) 902-5324 Fax Number: (661) 362-4852 Email: mercedes.bayani@bioness.com 25103 Rye Canyon Loop Valencia, CA 91355, U.S.A.
Application Correspondent:
Evan L. Rosenfeld, M.D., J.D. Regulatory Consultant for Bioness Inc. MDJD Consulting Office Number: (972) 239-7021 Fax Number: (972) 239-7021 Email: evanrosenfeld2@sbcglobal.net
Date prepared: January 27, 2017
Trade Name: L300 Go System
Classification name: External functional neuromuscular stimulator
Class: Il
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Panel Identification: Neurology
Product code: GZI and IPF
Regulation number:
21 CFR § 882.5810 External functional neuromuscular stimulators
21 CFR § 890.5850 Powered muscle stimulators
Predicate devices:
-
- Company: Bioness Neuromodulation Ltd. Device: NESS L300 Plus System (K103343)
-
- Company: Bioness Neuromodulation Ltd. Device: NESS L300 System (K122784)
-
- Company: Innovative Neurotronics, Inc. Device: WalkAide System (K140886)
Purpose of the traditional 510(k) notice:
The L300 Go System is a new device that is substantially equivalent to its own prior generation devices, the NESS L300 Plus System, the NESS L300 System and the Innovative Neurotronics, Inc. WalkAide System.
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 qait.
The L300 Go System consists of:
-
- One or two Functional Stimulation Cuffs (L300 Lower Leg and Thigh), that include surface electrodes.
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Image /page/5/Picture/1 description: The image contains the logo for Bioness. The logo consists of an orange star-like symbol on the left, followed by the word "Bioness" in gray. Below "Bioness" is the text "LiveOn" in a smaller font size. The logo is simple and modern, with a focus on the company name.
-
- External Pulse Generator (EPG) for the lower leg and EPG for thigh. Both EPG's deliver stimulation to their respective cuffs, and have user interface, including visual, audio, and tactile feedback. Lower EPG can use motion sensor based algorithm to detect heel events.
-
- A Control Unit that allows simple wireless remote control of the EPG's while displaying real-time information regarding the system's status.
-
- An optional Gait Sensor, which uses a dynamic gait tracking algorithm to detect heel events and wirelessly synchronizes stimulation.
-
- 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.
-
- A power supply with two USB outputs and a proprietary cable to charge the EPG.
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.
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
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Substantial Equivalence:
Table 1.0 Basic Unit Characteristics
| CurrentsubmissionL300 Go System | PredicateL300 Plus System | PredicateL300 System | PredicateWalkAideSystem | |
|---|---|---|---|---|
| 1. 510(k)Number andIndication forUse | K162407The L300 GoSystem is intendedto provide ankledorsiflexion in adultand pediatricindividuals with footdrop and/or toassist knee flexionor extension inindividuals withmuscle weaknessrelated to upperneurondisease/injury (e.g.,stroke, damage topathways to thespinal cord). TheL300 Go Systemelectricallystimulates musclesin the affected leg toprovide ankledorsiflexion of thefoot and/or kneeflexion or extension;thus, it may alsoimprove individual'sgait. | K103343The Ness L300 PlusSystem is intendedto provide ankledorsiflexion andknee flexion orextension inindividuals with footdrop and thighmuscle weakness,following an uppermotor neuron injuryor disease. Duringgait, the L300 PlusSystem electricallystimulates musclesin the affected leg toprovide dorsiflexionof the foot andflexion or extension,thus it may improvethe individual's gait. | K122784The Ness L300Foot Drop Systemis intended toprovide ankledorsiflexion inindividuals ( adultand pediatrics)who have foot dropfollowing an uppermotor neuron injuryor disease. Duringthe swing phase ofgait, the NessL300 electricallystimulates musclesin the affected legto providedorsiflexion of thefoot . | K140886The InnovativeNeurotronicsWalkAideSystem isintended toaddress the lackof ankledorsiflexion inpatients whohave sustaineddamage to uppermotor neurons orpathways to thespinal cord.During the swingphase ofwalking, theWalkAideelectricallystimulates theappropriatemuscles thatcause ankledorsiflexion andmay thusimprove the gaitin patients withchronic stroke.walking ability. |
| The L300 GoSystem may also:facilitate muscle reeducation, prevent/retard disuse atrophy, maintain or increase joint range of motion increase local blood flow | The L300 PlusSystem may also:facilitate muscle reeducation prevent/retard disuse atrophy, maintain or increase joint range of motion increase local blood flow. | The Ness 300 mayimprove :gait, facilitate muscle reeducation, prevent/retard disuse atrophy, maintain or increase joint range of motion increase local blood flow. | Medical benefitsof FunctionalElectricalStimulation(FES) mayinclude:prevent /retardation of disuse atrophy increased local blood flow, muscle reeducation, and maintained or increased joint range of motion | |
| 2. DeviceName, Model | L300 Go | L300 Plus | L300 | WalkAide |
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| 3.Manufacturer | Bioness Inc.25103 Rye CanyonLoop, Valencia, CA91355 | BionessNeuromodulation, aBioness Inc.company8 Hanagar Street,Hod Hasharon,4501309 Israel | BionessNeuromodulation, aBioness Inc.company8 Hanagar Street,Hod Hasharon,4501309 Israel | InnovativeNeurotronics4999 AircenterCir #103, Reno,NV 89502 | |
|---|---|---|---|---|---|
| 4. PowerSource(s) | Battery operated | Battery operated | Battery operated | Battery operated | |
| - Method ofLine CurrentIsolation | N/A(Battery operated) | N/A(Battery operated) | N/A(Battery operated) | N/A(Batteryoperated) | |
| - PatientLeakagecurrent | As required by IEC60601-1 | As required by IEC60601-1 | As required by IEC60601-1 | Information is notavailable | |
| o Normalcondition | Less than 1.0 µA | Less than 1.3 µA | Less than 1.3 µA | Information is notavailable | |
| o Singlefaultcondition | 3.0 µA | 9.5 µA | 9.5 µA | Information is notavailable | |
| 5. Number ofoutput modes | Two modes:Biphasic Symmetricand BiphasicAsymmetric. | Two modes:Biphasic Symmetricand BiphasicAsymmetric. | Two modes:Biphasic Symmetricand BiphasicAsymmetric. | One Mode:BiphasicAsymmetric. | |
| Applicable to bothlower leg and thighposition of thedevice. | Applicable to bothlower leg (L300RFS) and thigh(Thigh RFS)position of thedevice. | Applicable to lowerleg only. | Applicable tolower leg only. | ||
| 6. Number ofoutputchannels | Lower leg small cuff– 1 channel | Lower leg small cuff– 1 channel (L300RFS) | Lower leg small cuff– 1 channel (L300RFS) | Lower leg cuff –1 channel | |
| Lower leg regularcuff – 1 or 2channels (in 2channelconfiguration, bothchannels functionas a single channelwith separatelyadjustable medial / | Lower leg regularcuff – 1 channel | Lower leg regularcuff – 1 channel | Lower legregular cuff – 1channel | ||
| lateral stimulationintensity)Thigh cuff – 1channel | Thigh cuff – 1channel (ThighRFS) | N/A | N/A | ||
| - SynchronousorAlternating? | Alternating (at onetime only onechannel isactivated) | N/A | N/A | N/A | |
| - Method ofChannelIsolation | Isolation betweenlower leg and thighcuff stimulators:Thigh and Lowercuffs are stimulatedby different batteryoperated EPG'swithout galvanicconnection betweenthem. | Isolation betweenlower leg and thighcuff stimulators:Thigh and Lowercuffs are stimulatedby different batteryoperated RFS unitswithout galvanicconnection betweenthem. | N/A | N/A | |
| Isolation betweenchannels within thesame stimulator:channels in thesame EPG areswitched using highvoltage FETswitches. | N/A | N/A | N/A | ||
| 7. Regulatedcurrent orregulatedvoltage? | Current | Current | Current | Voltage | |
| 8. Software /Firmware /MicroprocessorControl? | Yes | Yes | Yes | Yes | |
| 9. AutomaticOverload Trip? | Yes | Yes | Yes | No | |
| 10. AutomaticNo-Load Trip | Yes | Yes | Yes | No | |
| 11. AutomaticShut off? | Yes | Yes | Yes | No | |
| 12. PatientOverrideControl? | Yes | Yes | Yes | Yes | |
| 13. IndicationDisplay | Yes | Yes | Yes | Yes | |
| -On/OffStatus | Yes | Yes | Yes | Yes | |
| -Lowbattery | Yes | Yes | Yes | Yes | |
| -Voltage /CurrentLevel? | Yes | Yes | Yes | Yes | |
| 14. Timerrange(minutes) | Gait mode: 1-10secondsMax stimulationduration (clinicianselectable)Training mode: 5-60minutes | Gait mode: 2-10secondsMax stimulationduration (clinicianselectable)Training mode: 5-60minutes | Gait mode: 2-10secondsMax stimulationduration (clinicianselectable)Training mode: 5-60 minutes | Gait mode: 0.2-3secondsMax stimulationduration(clinicianselectable)Exercise mode:1-30 minutes | |
| 15.Compliancewith VoluntaryStandards | IEC 60601-1, IEC60601-1-2, IEC60601-2-10, FCCpart 15 subpart Cand B1 | IEC 60601-1, IEC60601-1-1, IEC60601-1-2, IEC60601-2-10, FCCpart 15 subpart Cand B1 | IEC 60601-1, IEC60601-1-1, IEC60601-1-2, IEC60601-2-10, FCCpart 15 subpart Cand B1 | IEC 60601-1,IEC 60601-1-2,IEC 60601-2-10 | |
| 16.Compliancewith 21 CFR898? | Yes | Yes | Yes | Yes | |
| 17. Weight | Control Unit: 60 gEPG: 60 g | Control Unit: 45 gL300 RFS: 50 gThigh RFS: 50 g | Control Unit: 45 gL300 RFS: 50 g | Control Module:88 g | |
| Lower legFSC:150 | L300 FSC: 150 g | L300 FSC: 150 g | N/A | ||
| g | Thigh FSC: 330 g | Gait Sensor: 30 g | Gait Sensor: 30 g | Control Module: | |
| Thigh cuff: 300 g | |||||
| Foot Sensor: 25 g | |||||
| 18. Dimensions[W x H x D] | Control Unit:75x40x17 mm | Control Unit:73x46x18 mm | Control Unit:73x46x18 mm | Control Module:82x61x21 mm | |
| EPG: 82x47x15 mm | L300 RFS:74x43x15 mmThigh RFS:74x43x15 mm | L300 RFS:74x43x15 mm | |||
| Lower leg FSC:160x100x125 mmThigh FSC:Length: 200 mmCircumference(min):Proximal panel:270 mmDistal panel(regular): 310 mmFoot Sensor(dimensions of theTransmitter):65x50x10: mm | L300 FSC:160x100x125 mmThigh FSC:Length: 170-260mmCircumference(min):Proximal panel:240 mmDistal panel(regular): 300 mmGait Sensor(dimensions of the | L300 FSC:160x100x125 mmGait Sensor(dimensions of theTransmitter):80x50x10 mm | |||
| Transmitter):80x50x10 mm | |||||
| 19. HousingMaterials andConstruction | Remote Control:Bay State PolymerPA-2000RX | Control Unit:PC-ABS | Control Unit:PC-ABS | Control Module:ABS | |
| EPG: Bay StatePolymer PA-2000RX(Polycarbonate +ABS) | L300 RFS:polyamide 12with 30% glassfibersreinforcement +TransparentABSThigh RFS: PC-ABS | L300 RFS:polyamide 12with 30% glassfibersreinforcement +TransparentABS | |||
| Lower Leg FSC:Biocompatible fabricover plastic (POMHi) skeletonThigh FSC: TPU | L300 FSC:Biocompatiblefabric overplastic (POM Hi)skeleton. | L300 FSC:Biocompatiblefabric overplastic (POM Hi)skeleton. | |||
| Foot Sensor: ABS(Sensor housing),Bay state PolymerPA-2000RX(Electronicshousing) | Thigh FSC: TPUFoot Sensor: ABS | Foot Sensor: ABS |
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Section 5 Section 5
510(k) Summary
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Section 5 Section 5
510(k) Summary
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Table 2a. Output Specifications (Mode 1 – biphasic symmetrical output)
| MODE 1 –BIPHASICSYMMETRICAL | CurrentsubmissionL300 Go System | PredicateL300 Plus System | PredicateL300 System | PredicateWalkAideSystem |
|---|---|---|---|---|
| 1. Waveform | BiphasicSymmetrical | BiphasicSymmetrical | BiphasicSymmetrical | BiphasicAsymmetricalonly |
| 2. Shape | Rectangular | Rectangular | Rectangular | N/A |
| 3. MaximumOutput Voltage(+/- 10%) | Lower leg: 50V @500 ΩThigh:50V @500 Ω | Lower leg: 40V @500 ΩThigh:50V @500 Ω | Lower leg: 40V@ 500 ΩThigh: N/A | N/A |
| Lower leg: 130V @2 kΩThigh:130V @2 kΩ | Lower leg: 120V @2 kΩThigh:120V @2 kΩ | Lower leg:120V @ 2 kΩThigh: N/A | N/A | |
| Lower leg: 130V @10 kΩThigh:130V @10 kΩ | Lower leg: 120V @10 kΩThigh:120V @10 kΩ | Lower leg:120V @ 10 kΩThigh: N/A | N/A | |
| 4. MaximumOutput Current(+/- 10%) | Lower leg: 100mA@ 500 ΩThigh:100mA@ 500 Ω | Lower leg: 80mA@ 500 ΩThigh:100mA@ 500 Ω | Lower leg:80mA @ 500ΩThigh: N/A | N/A |
| Lower leg: 65mA@ 2 kΩThigh:65mA@ 2 kΩ | Lower leg: 60mA@ 2 kΩThigh:60mA@ 2 kΩ | Lower leg:60mA @ 2 kΩThigh: N/A | N/A | |
| Lower leg: 13mA@ 10 kΩThigh:13mA@ 10 kΩ | Lower leg: 12mA@ 10 kΩThigh:12mA@ 10 kΩ | Lower leg:12mA @ 10kΩThigh: N/A | N/A | |
| 5. Pulse width | 100, 150, 200, 250,300 µs (each:positive and phase) | 100, 200, 300 µs(each: positive andphase) | 100, 200, 300µs (each:positive andphase) | N/A |
| Interphase periodµs: 50, 100, 200Total pulseduration:250, 350, 450, 550,650 µs(for interphase | Interphase periodµs: 50Total pulseduration:250, 450, 650 µs | Interphaseperiod µs: 50Total pulseduration:250, 450, 650 µs | ||
| 6. Frequency | interval of 50 µs)10, 15, 20, 25, 30,35, 40, 45 Hz | 20, 25, 30, 35, 40,45 Hz | 20, 25, 30, 35,40, 45 Hz | N/A |
| 7. Forinterferentialmodes only: BeatFrequency. | N/A | N/A | N/A | N/A |
| 8. For multiphasicwaveforms only: | Yes | Yes | Yes | N/A |
| -Symmetricalphases? | Yes | Yes | Yes | N/A |
| - Phase Duration | Positive phase:100, 150, 200, 250,300 µsNegative phase:100, 150, 200, 250,300 µs | Positive phase:100, 200, 300 µsNegative phase:100, 200, 300 µs | Positivephase:100, 200, 300µsNegativephase:100, 200, 300µs | N/A |
| 9. Net Charge(µC per pulse) @500 Ω | 0 µC, usinginverted balancedphases | 0 µC, usinginverted balancedphases | 0 µC, usinginvertedbalancedphases | N/A |
| 10. MaximumPhase Charge(µC) @ 500 Ω | Lower leg:$300 \text{ µs } * 100 \text{ mA } =$30 µCThigh:$300 \text{ µs } * 100 \text{ mA } =$30 µC | Lower leg:$300 \text{ µs } * 80 \text{ mA } =$24 µCThigh:$300 \text{ µs } * 100 \text{ mA } =$30 µC | Lower leg:$300 \text{ µs } * 80$$\text{mA } = 24 \text{ µC}$Thigh: N/A | N/A |
| 11. MaximumCurrent Density@ 500 Ω | Maximum currentlevels are:Lower leg: 16.43mA (rms)Thigh:16.43mA (rms)Maximum currentdensity is:Lower leg (smallcuff):1.63 mA/cm² (rms),for smallestelectrodes area of10.1 cm²Lower leg (regularcuff):1.04 mA/cm² (rms),for smallestelectrodes area of15.8 cm²Thigh: 0.23mA/cm² (rms), forsmallest electrodesarea of 72 cm² | Maximum currentlevels are:Lower leg: 13.15mA (rms)Thigh:16.43mA (rms)Maximum currentdensity is:Lower leg (smallcuff):1.30 mA/cm² (rms),for smallestelectrodes area of10.1 cm²Lower leg (regularcuff):0.83 mA/cm² (rms),for smallestelectrodes area of15.8 cm²Thigh: 0.23mA/cm² (rms), forsmallest electrodesarea of 72 cm² | Maximumcurrent levelsare:Lower leg:13.15 mA(rms)Thigh: N/AMaximumcurrent densityis:Lower leg(small cuff):1.30 mA/cm²(rms), forsmallestelectrodesarea of 10.1cm²Lower leg(regular cuff):0.83 mA/cm²(rms), forsmallestelectrodesarea of 15.8cm²Thigh: N/A | N/A |
| 12. MaximumPower Density @500 Ω | Lower leg (smallcuff):13.4 mW/cm², forsmallest electrodesarea of 10.1 cm²Lower leg (regularcuff): | Lower leg (smallcuff):8.6 mW/cm², forsmallest electrodesarea of 10.1 cm²Lower leg (regularcuff): | Lower leg(small cuff):8.6 mW/cm²,for smallestelectrodesarea of 10.1cm²Lower leg | N/A |
| smallest electrodesarea of 15.8 cm2 | smallest electrodesarea of 15.8 cm2 | (regular cuff):5.5 mW/cm2, for smallest electrodesarea of 15.8 cm2 | ||
| Thigh: 1.9 mW/cm2, forsmallest electrodesarea of 72 cm2 | Thigh: 1.9 mW/cm2, forsmallest electrodesarea of 72 cm2 | Thigh: N/A | ||
| 13. Burst Mode | Lower leg: Pulse bursts are triggeredby 'heel off' and terminated by 'heelcontact' events during gait cycle. IfFoot Sensor is on the contralateralleg, pulse bursts are triggered by'heel contact' and are terminated by'heel off'. | Lower leg: Pulse bursts are triggeredby 'heel off' and terminated by 'heelcontact' events during gait cycle.Thigh: Pulse bursts can be triggeredeither by 'heel off' or 'heel contact'events (or both). Burst terminated bytimer or the complementary event. | Lower leg:Pulse bursts are triggeredby 'heel off' and terminated by 'heelcontact' events during gait cycle.Thigh: N/A | N/A |
| a. Pulses perburst | Pulses per burst =$Burst duration * Pulse frequency$ | Pulses per burst =$Burst duration * Pulse frequency$ | Pulses per burst =$Burst duration * Pulse frequency$ | N/A |
| b. Bursts persecond | Lower leg:Bursts per second =Strides per secondThigh:Bursts per second =$2 * Strides per second$ | Lower leg:Bursts per second =Strides per secondThigh:Bursts per second =$2 * Strides per second$ | Lower leg:Bursts per second =Strides per secondThigh: N/A | N/A |
| c. Burstduration | Lower leg:Burst duration =Swing durationThigh:Burst duration ≈$40%Swing duration (typically 60% of stride duration) + 60%Stance duration (typically 40% of stride duration)$Total =$0.40.6+0.60.4$ | Lower leg:Burst duration =Swing durationThigh:Burst duration ≈$40%Swing duration (typically 60% of stride duration) + 60%Stance duration (typically 40% of stride duration)$Total =$0.40.6+0.60.4$ | Lower leg:Burst duration =Swing durationThigh: N/A | N/A |
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| d. Duty cycle[Line (b) x Line(c)] | Lower leg:Duty cycle of 50-70% (swing ratio ina typical subject)Thigh:Duty cycle: ≈ 48%(0.40.6+0.60.4) | Lower leg:Duty cycle of 50-70% (swing ratio ina typical subject)Thigh:Duty cycle: ≈ 48%(0.40.6+0.60.4) | Lower leg:Duty cycle of50-70% (swingratio in atypical subject)Thigh: N/A | N/A |
|---|---|---|---|---|
| 14. ON Time | Training mode: 4-20 secGait mode: 1-10sec (themax stimulationdurationafter triggeringevent isdetected) | Training mode: 4-20 secGait mode: 2-10sec (themax stimulationdurationafter triggeringevent isdetected) | Training mode:4-20 secGait mode: 2-10 sec (themaxstimulationdurationafter triggeringevent isdetected) | N/A |
| 15. OFF Time | Training mode: 4-20 secGait mode: notlimited | Training mode: 4-60 secGait mode: notlimited | Training mode:4-60 secGait mode: notlimited | N/A |
Table 2b. Output Specifications (Mode 2 – biphasic asymmetrical output)
| MODE 1 -BIPHASICASYMMETRICAL | CurrentsubmissionL300 Go System | PredicateL300 PlusSystem | PredicateL300 System | PredicateWalkAideSystem |
|---|---|---|---|---|
| 1. Waveform | BiphasicAsymmetrical | BiphasicAsymmetrical | BiphasicAsymmetrical | BiphasicAsymmetrical |
| 2. Shape | Rectangular | Rectangular | Rectangular | Rectangular |
| 3. MaximumOutput Voltage(+/- 10%) | Lower leg: 50V @500 ΩThigh:50V @500 Ω | Lower leg: 40V @500 ΩThigh:50V @500 Ω | Lower leg: 40V@ 500 ΩThigh:N/A | Lower leg:101V @ 500 ΩThigh:N/A |
| Lower leg: 130V@ 2 kΩThigh:130V @2 kΩ | Lower leg: 120V@ 2 kΩThigh:120V @2 kΩ | Lower leg:120V @ 2 kΩThigh:N/A | Lower leg:134V @ 2 kΩThigh:N/A | |
| Lower leg: 130V@ 10 kΩThigh:130V @10 kΩ | Lower leg: 120V@ 10 kΩThigh:120V @10 kΩ | Lower leg:120V @ 10 kΩThigh:N/A | Lower leg:146V @ 10 kΩThigh:N/A | |
| 4. MaximumOutput Current(+/- 10%) | Lower leg: 100mA@ 500 ΩThigh:100mA@ 500 Ω | Lower leg: 80mA@ 500 ΩThigh:100mA@ 500 Ω | Lower leg:80mA @ 500 ΩThigh:N/A | Lower leg: 202mA @ 500 ΩThigh:N/A |
| Lower leg: 65mA@ 2 kΩThigh:65mA@ 2 kΩ | Lower leg: 60mA@ 2 kΩThigh:60mA@ 2 kΩ | Lower leg:60mA @ 2 kΩThigh:N/A | Lower leg: 67mA @ 2 kΩThigh:N/A | |
| Lower leg: 13mA@ 10 kΩThigh:13mA@ 10 kΩ | Lower leg: 12mA@ 10 kΩThigh:12mA@ 10 kΩ | Lower leg:12mA @ 10 kΩThigh:N/A | Lower leg: 15mA @ 10 kΩThigh:N/A | |
| @ 10 kΩThigh:13mA@ 10 kΩ | @ 10 kΩThigh:12mA@ 10 kΩ | 12mA @ 10 kΩThigh:N/A | mA @ 10 kΩThigh:N/A | |
| 5. Pulse width | Positive phase:100, 150, 200,250, 300 μsNegative phase:300, 450, 600,750, 900 μsInterphase period:50, 100, 200 μsTotal pulseduration:600, 800, 1000,1200, 1400 μs(for interphaseinterval of 200 μs) | Positive phase:100, 200, 300 μsNegative phase:400, 800, 1200 μsInterphase period:0 μsTotal pulseduration:500, 1000, 1500μs | Positive phase:100, 200, 300μsNegativephase:400, 800, 1200μsInterphaseperiod: 0 μsTotal pulseduration:500, 1000,1500 μs | 15, 50, 100,150, 200, 250,300 μs |
| 6. Frequency | 10, 15, 20, 25, 30,35, 40, 45 Hz | 20, 25, 30, 35, 40,45 Hz | 20, 25, 30, 35,40, 45 Hz | 16.7, 20.0,25.0, 33.3 Hz |
| 7. Forinterferentialmodes only: BeatFrequency. | N/A | N/A | N/A | N/A |
| 8. For multiphasicwaveforms only: | Yes | Yes | Yes | Yes |
| -Symmetricalphases? | No | No | No | No |
| -Phase Duration | Positive phase:100, 150, 200,250, 300 μsNegative phase:300, 450, 600,750, 900 μs | Positive phase:100, 200, 300 μsNegative phase:400, 800, 1200μs | Positivephase:100, 200, 300μsNegativephase:400, 800,1200 μs | Information isnot available |
| 9. Net Charge (μCper pulse) @ 500Ω | 0 μC, usinginverted balancedphases | 0 μC, usinginverted balancedphases | 0 μC, usinginvertedbalancedphases | Information isnot available |
| 10. MaximumPhase Charge(μC) @ 500 Ω | Lower leg:$300 \text{ μs} * 100 \text{ mA} =30 \text{ μC}$ | Lower leg:$300 \text{ μs} * 80 \text{ mA} =24 \text{ μC}$ | Lower leg:$300 \text{ μs} * 80 \text{ mA} = 24 \text{ μC}$ | Lower leg: 50μC |
| Thigh:$300 \text{ μs} * 100 \text{ mA} =30 \text{ μC}$ | Thigh:$300 \text{ μs} * 100 \text{ mA} =30 \text{ μC}$ | Thigh: N/A | Thigh: N/A | |
| 11. MaximumCurrent Density @500 Ω | Maximum currentlevels are:Lower leg: 13.42 | Maximum currentlevels are:Lower leg: 10.39 | Maximumcurrent levelsare: | Maximumcurrent levelsare: |
| mA (rms)Thigh:13.42mA (rms) | mA (rms)Thigh:13.0mA (rms) | Lower leg:10.39 mA (rms)Thigh:N/A | Lower leg:20.7 mA (rms)Thigh:N/A | |
| Maximum currentdensity is: | Maximum currentdensity is: | Maximumcurrent densityis: | Maximumcurrent densityis: | |
| Lower leg (smallcuff):$1.33 mA/cm^2$(rms), for smallestelectrodes area of$10.1 cm^2$ | Lower leg (smallcuff):$1.03 mA/cm^2$(rms), for smallestelectrodes area of$10.1 cm^2$ | Lower leg(small cuff):$1.03 mA/cm^2$(rms), forsmallestelectrodes areaof $10.1 cm^2$ | Lower leg:$2.62 mA/cm^2$(rms), forsmallestelectrodes areaof $7.9 cm^2$(round, 3.175cm diameterelectrodes) | |
| Lower leg (regularcuff):$0.85 mA/cm^2$(rms), for smallestelectrodes area of$15.8 cm^2$ | Lower leg (regularcuff):$0.66 mA/cm^2$(rms), for smallestelectrodes area of$15.8 cm^2$ | Lower leg(regular cuff):$0.66 mA/cm^2$(rms), forsmallestelectrodes areaof $15.8 cm^2$ | Thigh: N/A | |
| Thigh: 0.19$mA/cm^2$ (rms), forsmallestelectrodes area of$72 cm^2$ | Thigh: 0.18$mA/cm^2$ (rms), forsmallestelectrodes area of$72 cm^2$ | Thigh: N/A | Thigh: N/A | |
| 12. MaximumPower Density @500 Ω | Lower leg (smallcuff):$8.9 mW/cm^2$ , forsmallestelectrodes area of$10.1 cm^2$ | Lower leg (smallcuff):$5.3 mW/cm^2$ , forsmallestelectrodes area of$10.1 cm^2$ | Lower leg(small cuff):$5.3 mW/cm^2$ ,for smallestelectrodes areaof $10.1 cm^2$ | Lower leg(small cuff):$27.6 mW/cm^2$ ,for smallestelectrodes areaof $7.9 cm^2$ |
| Lower leg (regularcuff):$5.7 mW/cm^2$ , forsmallestelectrodes area of$15.8 cm^2$ | Lower leg (regularcuff):$3.4 mW/cm^2$ , forsmallestelectrodes area of$15.8 cm^2$ | Lower leg(regular cuff):$3.4 mW/cm^2$ ,for smallestelectrodes areaof $15.8 cm^2$ | Thigh: N/A | |
| Thigh: 1.3$mW/cm^2$ , forsmallestelectrodes area of$72 cm^2$ | Thigh: 1.2$mW/cm^2$ , forsmallestelectrodes area of$72 cm^2$ | Thigh: N/A | ||
| 13. Burst Mode | Lower leg: Pulsebursts aretriggered by 'heeloff' and terminatedby 'heel contact'events during gaitcycle. If FootSensor is on thecontralateral leg,pulse bursts aretriggered by 'heelcontact' and areterminated by 'heeloff'. | Lower leg: Pulsebursts aretriggered by 'heeloff' and terminatedby 'heel contact'events during gaitcycle. | Lower leg:Pulse burstsare triggeredby 'heel off'and terminatedby 'heelcontact' eventsduring gaitcycle. | Lower leg:Pulse burstsare triggeredby 'heel off'and terminatedby 'heelcontact' eventsduring gaitcycle. |
| Thigh: Pulsebursts can betriggered either by'heel off' or 'heelcontact' events (or | Thigh: Pulsebursts can betriggered either by'heel off' or 'heelcontact' events (orboth). Burstterminated by | Thigh: N/A | Thigh: N/A | |
| both). Burst terminated by timer or the complementary event. | timer or the complementary event. | |||
| a. Pulses per burst | Pulses per burst = Burst duration * Pulse frequency | Pulses per burst = Burst duration * Pulse frequency | Pulses per burst = Burst duration * Pulse frequency | Pulses per burst = Burst duration * Pulse frequency |
| b. Bursts per second | Lower leg:Bursts per second = Strides per second | Lower leg:Bursts per second = Strides per second | Lower leg:Bursts per second = Strides per second | Lower leg:Bursts per second = Strides per second |
| Thigh:Bursts per second = 2 * Strides per second | Thigh:Bursts per second = 2 * Strides per second | Thigh: N/A | Thigh: N/A | |
| c. Burst duration | Lower leg:Burst duration = Swing durationThigh:Burst duration ≈ 40%Swing duration (typically 60% of stride duration) + 60%Stance duration (typically 40% of stride duration)Total = 0.40.6+0.60.4 ≈ 48% of stride duration | Lower leg:Burst duration = Swing durationThigh:Burst duration ≈ 40%Swing duration (typically 60% of stride duration) + 60%Stance duration (typically 40% of stride duration)Total = 0.40.6+0.60.4 ≈ 48% of stride duration | Lower leg:Burst duration = Swing durationThigh: N/A | Lower leg:Burst duration = Swing durationThigh: N/A |
| d. Duty cycle [Line (b) x Line (c)] | Lower leg:Duty cycle of 50-70% (swing ratio in a typical subject)Thigh:Duty cycle: ≈ 48% (0.40.6+0.60.4) | Lower leg:Duty cycle of 50-70% (swing ratio in a typical subject)Thigh:Duty cycle: ≈ 48% (0.40.6+0.60.4) | Lower leg:Duty cycle of 50-70% (swing ratio in a typical subject)Thigh: N/A | Lower leg:Duty cycle of 50-70% (swing ratio in a typical subject)Thigh: N/A |
| 14. ON Time | Training mode: 4-20 secGait mode: 1-10 sec (the max stimulation duration after triggering | Training mode: 4-20 secGait mode: 2-10 sec (the max stimulation duration after triggering | Training mode: 4-20 secGait mode: 2-10 sec (the max stimulation duration after triggering | Training mode: 1-5 secGait mode: max 5 sec (the max stimulation duration |
| detected) | detected) | detected) | event isdetected) | |
| 15. OFF Time | Training mode: 4-20 sec | Training mode: 4-60 sec | Training mode:4-60 sec | Training mode:1-10 sec |
| Gait mode: notlimited | Gait mode: notlimited | Gait mode: notlimited | Gait mode: notlimited |
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Section 5 Section 5
510(k) Summary
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Section 5 510(k) Summary
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The L300 Go System is substantially equivalent to a combination of both its own prior generation devices, the NESS L300 Plus System, cleared for marketing under K103343, the NESS L300 System, cleared for marketing under K122784, and the Innovative Neurotronics, Inc. WalkAide System, cleared for marketing under K140886. The L300 Go System does not introduce any new issues of safety or efficacy relative to either of these predicate devices.
The primary predicate device is the NESS L300 Plus, which is included in the L300 Go System almost in its entirety.
The L300 Go System incorporates all of the NESS L300 Plus components, including the following updates:
-
- Bioness-proprietary wireless communication technology is being replaced with industry-standard Bluetooth (low energy) wireless communication technology.
-
- Limited User Interface (i.e., used via Remote Control only) is being replaced with an expanded User Interface (that can be used either via or via Stimulatorbased interface).
-
- PDA-based Clinician Programmer is being replaced with and a Tablet/PCbased Clinician Programmer.
Thus, the L300 Go System incorporates all of the NESS L300 Plus components including a few other minor technological improvements listed above as compared to the predicate NESS L300 Plus.
One additional change in the L300 Go System is its design that now allows the clinician to use either one or two stimulation channels, rather than just the single channel available for use with the latter device (as is also the case with the WalkAide). However, this two-channel option in the L300 Go System simply allows the clinician to more precisely adjust foot eversion/inversion, does not introduce any new concerns of safety or efficacy, and is still operational just as a
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single-channel stimulator.
The L300 Go System also incorporates a tilt sensor very similar to that used in the WalkAide where (just as in the predicate device) that stimulation trigger mechanism can be used during gait, instead of a foot sensor as an alternative trigger source. However, both systems can also still employ the foot sensor with users for whom the tilt sensor cannot be used adequately.
Finally, the L300 Go System and both of its predicates can be used not only for improving gait but also for providing exercise functions. However, this feature is limited in the WalkAide device only to the lower leg, while it is available for use with the Bioness products for providing exercise functions in both the lower and upper leg.
Overall, then, the L300 Go System shares essentially the same intended use, technology, and stimulation methods and main components with its two predicate devices.
Conclusion:
Bioness believes that the L300 Go System is substantially equivalent to the NESS L300 Plus System (K103343), NESS L300 System (K122784) and the Innovation Neurotronics WalkAide System (K140886) predicate devices, and does not raise any new issues or concerns of safety or effectiveness.
§ 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).