(151 days)
Not Found
No
The description mentions a "motion sensor based algorithm" and a "dynamic gait tracking algorithm," but these are not explicitly described as AI or ML algorithms. The document also explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The device is intended to treat foot drop and assist knee flexion/extension by electrically stimulating muscles, and it also aims to facilitate muscle re-education, prevent disuse atrophy, maintain/increase joint range of motion, and increase local blood flow. These uses clearly indicate a therapeutic purpose.
No
The L300 Go System is intended to provide ankle dorsiflexion and/or assist knee flexion or extension by electrically stimulating muscles. Its functions are therapeutic (facilitating muscle re-education, preventing disuse atrophy, maintaining or increasing joint range of motion, increasing local blood flow) rather than diagnostic. It does not identify or characterize diseases or conditions.
No
The device description explicitly lists multiple hardware components including Functional Stimulation Cuffs, External Pulse Generators, a Control Unit, an optional Gait Sensor, and a power supply. While it includes software for programming, it is not a software-only device.
No, the L300 Go System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This includes things like blood, urine, tissue, etc., to provide information about a physiological state, health, disease, or congenital abnormality.
- The L300 Go System is a therapeutic device. Its intended use is to provide electrical stimulation to muscles in the leg to improve gait and address muscle weakness. It directly interacts with the patient's body to provide a physical effect.
The description clearly outlines a system that applies electrical stimulation externally to the patient's leg, not a device that analyzes biological samples.
N/A
Intended Use / 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 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
Product codes (comma separated list FDA assigned to the subject device)
GZI, IPF
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.
-
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Affected leg (ankle, knee, lower leg, thigh)
Indicated Patient Age Range
Adult and pediatric individuals
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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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
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
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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
4
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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.
5
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-
- 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
6
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Substantial Equivalence:
Table 1.0 Basic Unit Characteristics
| | Current
submission
L300 Go System | Predicate
L300 Plus System | Predicate
L300 System | Predicate
WalkAide
System |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. 510(k)
Number and
Indication for
Use | K162407
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
individuals with
muscle weakness
related to upper
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 may also
improve individual's
gait. | K103343
The Ness L300 Plus
System is intended
to provide ankle
dorsiflexion and
knee flexion or
extension in
individuals with foot
drop and thigh
muscle weakness,
following an upper
motor neuron injury
or disease. During
gait, the L300 Plus
System electrically
stimulates muscles
in the affected leg to
provide dorsiflexion
of the foot and
flexion or extension,
thus it may improve
the individual's gait. | K122784
The Ness L300
Foot Drop System
is intended to
provide ankle
dorsiflexion in
individuals ( adult
and pediatrics)
who have foot drop
following an upper
motor neuron injury
or disease. During
the swing phase of
gait, the Ness
L300 electrically
stimulates muscles
in the affected leg
to provide
dorsiflexion of the
foot . | K140886
The Innovative
Neurotronics
WalkAide
System is
intended to
address the lack
of ankle
dorsiflexion in
patients who
have sustained
damage to upper
motor neurons or
pathways to the
spinal cord.
During the swing
phase of
walking, the
WalkAide
electrically
stimulates the
appropriate
muscles that
cause ankle
dorsiflexion and
may thus
improve the gait
in patients with
chronic stroke.
walking ability. |
| | The L300 Go
System may also:
facilitate muscle reeducation, prevent/retard disuse atrophy, maintain or increase joint range of motion increase local blood flow | The L300 Plus
System may also:
facilitate muscle reeducation prevent/retard disuse atrophy, maintain or increase joint range of motion increase local blood flow. | The Ness 300 may
improve :
gait, facilitate muscle reeducation, prevent/retard disuse atrophy, maintain or increase joint range of motion increase local blood flow. | Medical benefits
of Functional
Electrical
Stimulation
(FES) may
include:
prevent /retardation of disuse atrophy increased local blood flow, muscle reeducation, and maintained or increased joint range of motion |
| 2. Device
Name, Model | L300 Go | L300 Plus | L300 | WalkAide |
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| 3.
Manufacturer | Bioness Inc.
25103 Rye Canyon
Loop, Valencia, CA
91355 | Bioness
Neuromodulation, a
Bioness Inc.
company
8 Hanagar Street,
Hod Hasharon,
4501309 Israel | Bioness
Neuromodulation, a
Bioness Inc.
company
8 Hanagar Street,
Hod Hasharon,
4501309 Israel | Innovative
Neurotronics
4999 Aircenter
Cir #103, Reno,
NV 89502 | |
|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-----------------|
| 4. Power
Source(s) | Battery operated | Battery operated | Battery operated | Battery operated | |
| - Method of
Line Current
Isolation | N/A
(Battery operated) | N/A
(Battery operated) | N/A
(Battery operated) | N/A
(Battery
operated) | |
| - Patient
Leakage
current | As required by IEC
60601-1 | As required by IEC
60601-1 | As required by IEC
60601-1 | Information is not
available | |
| o Normal
condition | Less than 1.0 µA | Less than 1.3 µA | Less than 1.3 µA | Information is not
available | |
| o Single
fault
condition | 3.0 µA | 9.5 µA | 9.5 µA | Information is not
available | |
| 5. Number of
output modes | Two modes:
Biphasic Symmetric
and Biphasic
Asymmetric. | Two modes:
Biphasic Symmetric
and Biphasic
Asymmetric. | Two modes:
Biphasic Symmetric
and Biphasic
Asymmetric. | One Mode:
Biphasic
Asymmetric. | |
| | Applicable to both
lower leg and thigh
position of the
device. | Applicable to both
lower leg (L300
RFS) and thigh
(Thigh RFS)
position of the
device. | Applicable to lower
leg only. | Applicable to
lower leg only. | |
| 6. Number of
output
channels | Lower leg small cuff
– 1 channel | Lower leg small cuff
– 1 channel (L300
RFS) | Lower leg small cuff
– 1 channel (L300
RFS) | Lower leg cuff –
1 channel | |
| | Lower leg regular
cuff – 1 or 2
channels (in 2
channel
configuration, both
channels function
as a single channel
with separately
adjustable medial / | Lower leg regular
cuff – 1 channel | Lower leg regular
cuff – 1 channel | Lower leg
regular cuff – 1
channel | |
| | lateral stimulation
intensity)
Thigh cuff – 1
channel | Thigh cuff – 1
channel (Thigh
RFS) | N/A | N/A | |
| - Synchronous
or
Alternating? | Alternating (at one
time only one
channel is
activated) | N/A | N/A | N/A | |
| - Method of
Channel
Isolation | Isolation between
lower leg and thigh
cuff stimulators:
Thigh and Lower
cuffs are stimulated
by different battery
operated EPG's
without galvanic
connection between
them. | Isolation between
lower leg and thigh
cuff stimulators:
Thigh and Lower
cuffs are stimulated
by different battery
operated RFS units
without galvanic
connection between
them. | N/A | N/A | |
| | Isolation between
channels within the
same stimulator:
channels in the
same EPG are
switched using high
voltage FET
switches. | N/A | N/A | N/A | |
| 7. Regulated
current or
regulated
voltage? | Current | Current | Current | Voltage | |
| 8. Software /
Firmware /
Microprocessor
Control? | Yes | Yes | Yes | Yes | |
| 9. Automatic
Overload Trip? | Yes | Yes | Yes | No | |
| 10. Automatic
No-Load Trip | Yes | Yes | Yes | No | |
| 11. Automatic
Shut off? | Yes | Yes | Yes | No | |
| 12. Patient
Override
Control? | Yes | Yes | Yes | Yes | |
| 13. Indication
Display | Yes | Yes | Yes | Yes | |
| -
On/Off
Status | Yes | Yes | Yes | Yes | |
| -
Low
battery | Yes | Yes | Yes | Yes | |
| -
Voltage /
Current
Level? | Yes | Yes | Yes | Yes | |
| 14. Timer
range
(minutes) | Gait mode: 1-10
seconds
Max stimulation
duration (clinician
selectable)
Training mode: 5-60
minutes | Gait mode: 2-10
seconds
Max stimulation
duration (clinician
selectable)
Training mode: 5-60
minutes | Gait mode: 2-10
seconds
Max stimulation
duration (clinician
selectable)
Training mode: 5-
60 minutes | Gait mode: 0.2-3
seconds
Max stimulation
duration
(clinician
selectable)
Exercise mode:
1-30 minutes | |
| 15.
Compliance
with Voluntary
Standards | IEC 60601-1, IEC
60601-1-2, IEC
60601-2-10, FCC
part 15 subpart C
and B1 | IEC 60601-1, IEC
60601-1-1, IEC
60601-1-2, IEC
60601-2-10, FCC
part 15 subpart C
and B1 | IEC 60601-1, IEC
60601-1-1, IEC
60601-1-2, IEC
60601-2-10, FCC
part 15 subpart C
and B1 | IEC 60601-1,
IEC 60601-1-2,
IEC 60601-2-10 | |
| 16.
Compliance
with 21 CFR
898? | Yes | Yes | Yes | Yes | |
| 17. Weight | Control Unit: 60 g
EPG: 60 g | Control Unit: 45 g
L300 RFS: 50 g
Thigh RFS: 50 g | Control Unit: 45 g
L300 RFS: 50 g | Control Module:
88 g | |
| | Lower leg
FSC: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 mm
Thigh RFS:
74x43x15 mm | L300 RFS:
74x43x15 mm | | |
| | Lower leg FSC:
160x100x125 mm
Thigh FSC:
Length: 200 mm
Circumference
(min):
Proximal panel:
270 mm
Distal panel
(regular): 310 mm
Foot Sensor
(dimensions of the
Transmitter):
65x50x10: mm | L300 FSC:
160x100x125 mm
Thigh FSC:
Length: 170-260
mm
Circumference
(min):
Proximal panel:
240 mm
Distal panel
(regular): 300 mm
Gait Sensor
(dimensions of the | L300 FSC:
160x100x125 mm
Gait Sensor
(dimensions of the
Transmitter):
80x50x10 mm | | |
| | | Transmitter):
80x50x10 mm | | | |
| 19. Housing
Materials and
Construction | Remote Control:
Bay State Polymer
PA-2000RX | Control Unit:
PC-ABS | Control Unit:
PC-ABS | Control Module:
ABS | |
| | EPG: Bay State
Polymer PA-
2000RX
(Polycarbonate +
ABS) | L300 RFS:
polyamide 12
with 30% glass
fibers
reinforcement +
Transparent
ABS
Thigh RFS: PC-
ABS | L300 RFS:
polyamide 12
with 30% glass
fibers
reinforcement +
Transparent
ABS | | |
| | Lower Leg FSC:
Biocompatible fabric
over plastic (POM
Hi) skeleton
Thigh FSC: TPU | L300 FSC:
Biocompatible
fabric over
plastic (POM Hi)
skeleton. | L300 FSC:
Biocompatible
fabric over
plastic (POM Hi)
skeleton. | | |
| | Foot Sensor: ABS
(Sensor housing),
Bay state Polymer
PA-2000RX
(Electronics
housing) | Thigh FSC: TPU
Foot Sensor: ABS | Foot Sensor: ABS | | |
8
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Section 5 Section 5
510(k) Summary
9
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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 –
BIPHASIC
SYMMETRICAL | Current
submission
L300 Go System | Predicate
L300 Plus System | Predicate
L300 System | Predicate
WalkAide
System |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| 1. Waveform | Biphasic
Symmetrical | Biphasic
Symmetrical | Biphasic
Symmetrical | Biphasic
Asymmetrical
only |
| 2. Shape | Rectangular | Rectangular | Rectangular | N/A |
| 3. Maximum
Output Voltage
(+/- 10%) | Lower leg: 50V @
500 Ω
Thigh:
50V @
500 Ω | Lower leg: 40V @
500 Ω
Thigh:
50V @
500 Ω | Lower leg: 40V
@ 500 Ω
Thigh: N/A | N/A |
| | Lower leg: 130V @
2 kΩ
Thigh:
130V @
2 kΩ | Lower leg: 120V @
2 kΩ
Thigh:
120V @
2 kΩ | Lower leg:
120V @ 2 kΩ
Thigh: N/A | N/A |
| | Lower leg: 130V @
10 kΩ
Thigh:
130V @
10 kΩ | Lower leg: 120V @
10 kΩ
Thigh:
120V @
10 kΩ | Lower leg:
120V @ 10 kΩ
Thigh: N/A | N/A |
| 4. Maximum
Output Current
(+/- 10%) | Lower leg: 100mA
@ 500 Ω
Thigh:
100mA
@ 500 Ω | Lower leg: 80mA
@ 500 Ω
Thigh:
100mA
@ 500 Ω | Lower leg:
80mA @ 500Ω
Thigh: N/A | N/A |
| | Lower leg: 65mA
@ 2 kΩ
Thigh:
65mA
@ 2 kΩ | Lower leg: 60mA
@ 2 kΩ
Thigh:
60mA
@ 2 kΩ | Lower leg:
60mA @ 2 kΩ
Thigh: N/A | N/A |
| | Lower leg: 13mA
@ 10 kΩ
Thigh:
13mA
@ 10 kΩ | Lower leg: 12mA
@ 10 kΩ
Thigh:
12mA
@ 10 kΩ | Lower leg:
12mA @ 10
kΩ
Thigh: N/A | N/A |
| 5. Pulse width | 100, 150, 200, 250,
300 µs (each:
positive and phase) | 100, 200, 300 µs
(each: positive and
phase) | 100, 200, 300
µs (each:
positive and
phase) | N/A |
| | Interphase period
µs: 50, 100, 200
Total pulse
duration:
250, 350, 450, 550,
650 µs
(for interphase | Interphase period
µs: 50
Total pulse
duration:
250, 450, 650 µs | Interphase
period µs: 50
Total pulse
duration:
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. For
interferential
modes only: Beat
Frequency. | N/A | N/A | N/A | N/A |
| 8. For multiphasic
waveforms only: | Yes | Yes | Yes | N/A |
| -
Symmetrical
phases? | Yes | Yes | Yes | N/A |
| - Phase Duration | Positive phase:
100, 150, 200, 250,
300 µs
Negative phase:
100, 150, 200, 250,
300 µs | Positive phase:
100, 200, 300 µs
Negative phase:
100, 200, 300 µs | Positive
phase:
100, 200, 300
µs
Negative
phase:
100, 200, 300
µs | N/A |
| 9. Net Charge
(µC per pulse) @
500 Ω | 0 µC, using
inverted balanced
phases | 0 µC, using
inverted balanced
phases | 0 µC, using
inverted
balanced
phases | N/A |
| 10. Maximum
Phase Charge
(µC) @ 500 Ω | Lower leg:
$300 \text{ µs } * 100 \text{ mA } =$
30 µC
Thigh:
$300 \text{ µs } * 100 \text{ mA } =$
30 µC | Lower leg:
$300 \text{ µs } * 80 \text{ mA } =$
24 µC
Thigh:
$300 \text{ µs } * 100 \text{ mA } =$
30 µC | Lower leg:
$300 \text{ µs } * 80$
$\text{mA } = 24 \text{ µC}$
Thigh: N/A | N/A |
| 11. Maximum
Current Density
@ 500 Ω | Maximum current
levels are:
Lower leg: 16.43
mA (rms)
Thigh:
16.43
mA (rms)
Maximum current
density is:
Lower leg (small
cuff):
1.63 mA/cm² (rms),
for smallest
electrodes area of
10.1 cm²
Lower leg (regular
cuff):
1.04 mA/cm² (rms),
for smallest
electrodes area of
15.8 cm²
Thigh: 0.23
mA/cm² (rms), for
smallest electrodes
area of 72 cm² | Maximum current
levels are:
Lower leg: 13.15
mA (rms)
Thigh:
16.43
mA (rms)
Maximum current
density is:
Lower leg (small
cuff):
1.30 mA/cm² (rms),
for smallest
electrodes area of
10.1 cm²
Lower leg (regular
cuff):
0.83 mA/cm² (rms),
for smallest
electrodes area of
15.8 cm²
Thigh: 0.23
mA/cm² (rms), for
smallest electrodes
area of 72 cm² | Maximum
current levels
are:
Lower leg:
13.15 mA
(rms)
Thigh: N/A
Maximum
current density
is:
Lower leg
(small cuff):
1.30 mA/cm²
(rms), for
smallest
electrodes
area of 10.1
cm²
Lower leg
(regular cuff):
0.83 mA/cm²
(rms), for
smallest
electrodes
area of 15.8
cm²
Thigh: N/A | N/A |
| 12. Maximum
Power Density @
500 Ω | Lower leg (small
cuff):
13.4 mW/cm², for
smallest electrodes
area of 10.1 cm²
Lower leg (regular
cuff): | Lower leg (small
cuff):
8.6 mW/cm², for
smallest electrodes
area of 10.1 cm²
Lower leg (regular
cuff): | Lower leg
(small cuff):
8.6 mW/cm²,
for smallest
electrodes
area of 10.1
cm²
Lower leg | N/A |
| | | | | |
| | smallest electrodes
area of 15.8 cm2 | smallest electrodes
area of 15.8 cm2 | (regular cuff):
5.5 mW/cm2, for smallest electrodes
area of 15.8 cm2 | |
| | Thigh: 1.9 mW/cm2, for
smallest electrodes
area of 72 cm2 | Thigh: 1.9 mW/cm2, for
smallest electrodes
area of 72 cm2 | Thigh: N/A | |
| 13. Burst Mode | Lower leg: Pulse bursts are triggered
by 'heel off' and terminated by 'heel
contact' events during gait cycle. If
Foot Sensor is on the contralateral
leg, pulse bursts are triggered by
'heel contact' and are terminated by
'heel off'. | Lower leg: Pulse bursts are triggered
by 'heel off' and terminated by 'heel
contact' events during gait cycle.
Thigh: Pulse bursts can be triggered
either by 'heel off' or 'heel contact'
events (or both). Burst terminated by
timer or the complementary event. | Lower leg:
Pulse bursts are triggered
by 'heel off' and terminated by 'heel
contact' events during gait cycle.
Thigh: N/A | N/A |
| a. Pulses per
burst | Pulses per burst =
$Burst duration * Pulse frequency$ | Pulses per burst =
$Burst duration * Pulse frequency$ | Pulses per burst =
$Burst duration * Pulse frequency$ | N/A |
| b. Bursts per
second | Lower leg:
Bursts per second =
Strides per second
Thigh:
Bursts per second =
$2 * Strides per second$ | Lower leg:
Bursts per second =
Strides per second
Thigh:
Bursts per second =
$2 * Strides per second$ | Lower leg:
Bursts per second =
Strides per second
Thigh: N/A | N/A |
| c. Burst
duration | Lower leg:
Burst duration =
Swing duration
Thigh:
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 duration
Thigh:
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 duration
Thigh: N/A | N/A |
11
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| 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 | N/A |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----|
| 14. ON Time | Training mode: 4-
20 sec
Gait mode: 1-10
sec (the
max stimulation
duration
after triggering
event is
detected) | Training mode: 4-
20 sec
Gait mode: 2-10
sec (the
max stimulation
duration
after triggering
event is
detected) | Training mode:
4-20 sec
Gait mode: 2-
10 sec (the
max
stimulation
duration
after triggering
event is
detected) | N/A |
| 15. OFF Time | Training mode: 4-
20 sec
Gait mode: not
limited | Training mode: 4-
60 sec
Gait mode: not
limited | Training mode:
4-60 sec
Gait mode: not
limited | N/A |
Table 2b. Output Specifications (Mode 2 – biphasic asymmetrical output)
| MODE 1 -
BIPHASIC
ASYMMETRICAL | Current
submission
L300 Go System | Predicate
L300 Plus
System | Predicate
L300 System | Predicate
WalkAide
System |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| 1. Waveform | Biphasic
Asymmetrical | Biphasic
Asymmetrical | Biphasic
Asymmetrical | Biphasic
Asymmetrical |
| 2. Shape | Rectangular | Rectangular | Rectangular | Rectangular |
| 3. Maximum
Output Voltage
(+/- 10%) | Lower leg: 50V @
500 Ω
Thigh:
50V @
500 Ω | Lower leg: 40V @
500 Ω
Thigh:
50V @
500 Ω | Lower leg: 40V
@ 500 Ω
Thigh:
N/A | Lower leg:
101V @ 500 Ω
Thigh:
N/A |
| | Lower leg: 130V
@ 2 kΩ
Thigh:
130V @
2 kΩ | Lower leg: 120V
@ 2 kΩ
Thigh:
120V @
2 kΩ | Lower leg:
120V @ 2 kΩ
Thigh:
N/A | Lower leg:
134V @ 2 kΩ
Thigh:
N/A |
| | Lower leg: 130V
@ 10 kΩ
Thigh:
130V @
10 kΩ | Lower leg: 120V
@ 10 kΩ
Thigh:
120V @
10 kΩ | Lower leg:
120V @ 10 kΩ
Thigh:
N/A | Lower leg:
146V @ 10 kΩ
Thigh:
N/A |
| 4. Maximum
Output Current
(+/- 10%) | Lower leg: 100mA
@ 500 Ω
Thigh:
100mA
@ 500 Ω | Lower leg: 80mA
@ 500 Ω
Thigh:
100mA
@ 500 Ω | Lower leg:
80mA @ 500 Ω
Thigh:
N/A | Lower leg: 202
mA @ 500 Ω
Thigh:
N/A |
| | Lower leg: 65mA
@ 2 kΩ
Thigh:
65mA
@ 2 kΩ | Lower leg: 60mA
@ 2 kΩ
Thigh:
60mA
@ 2 kΩ | Lower leg:
60mA @ 2 kΩ
Thigh:
N/A | Lower leg: 67
mA @ 2 kΩ
Thigh:
N/A |
| | Lower leg: 13mA
@ 10 kΩ
Thigh:
13mA
@ 10 kΩ | Lower leg: 12mA
@ 10 kΩ
Thigh:
12mA
@ 10 kΩ | Lower leg:
12mA @ 10 kΩ
Thigh:
N/A | Lower leg: 15
mA @ 10 kΩ
Thigh:
N/A |
| | @ 10 kΩ
Thigh:
13mA
@ 10 kΩ | @ 10 kΩ
Thigh:
12mA
@ 10 kΩ | 12mA @ 10 kΩ
Thigh:
N/A | mA @ 10 kΩ
Thigh:
N/A |
| 5. Pulse width | Positive phase:
100, 150, 200,
250, 300 μs
Negative phase:
300, 450, 600,
750, 900 μs
Interphase period:
50, 100, 200 μs
Total pulse
duration:
600, 800, 1000,
1200, 1400 μs
(for interphase
interval of 200 μs) | Positive phase:
100, 200, 300 μs
Negative phase:
400, 800, 1200 μs
Interphase period:
0 μs
Total pulse
duration:
500, 1000, 1500
μs | Positive phase:
100, 200, 300
μs
Negative
phase:
400, 800, 1200
μs
Interphase
period: 0 μs
Total pulse
duration:
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. For
interferential
modes only: Beat
Frequency. | N/A | N/A | N/A | N/A |
| 8. For multiphasic
waveforms only: | Yes | Yes | Yes | Yes |
| -
Symmetrical
phases? | No | No | No | No |
| -
Phase Duration | Positive phase:
100, 150, 200,
250, 300 μs
Negative phase:
300, 450, 600,
750, 900 μs | Positive phase:
100, 200, 300 μs
Negative phase:
400, 800, 1200
μs | Positive
phase:
100, 200, 300
μs
Negative
phase:
400, 800,
1200 μs | Information is
not available |
| 9. Net Charge (μC
per pulse) @ 500
Ω | 0 μC, using
inverted balanced
phases | 0 μC, using
inverted balanced
phases | 0 μC, using
inverted
balanced
phases | Information is
not available |
| 10. Maximum
Phase 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: 50
μC |
| | 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. Maximum
Current Density @
500 Ω | Maximum current
levels are:
Lower leg: 13.42 | Maximum current
levels are:
Lower leg: 10.39 | Maximum
current levels
are: | Maximum
current levels
are: |
| | mA (rms)
Thigh:
13.42
mA (rms) | mA (rms)
Thigh:
13.0
mA (rms) | Lower leg:
10.39 mA (rms)
Thigh:
N/A | Lower leg:
20.7 mA (rms)
Thigh:
N/A |
| | Maximum current
density is: | Maximum current
density is: | Maximum
current density
is: | Maximum
current density
is: |
| | Lower leg (small
cuff):
$1.33 mA/cm^2$
(rms), for smallest
electrodes area of
$10.1 cm^2$ | Lower leg (small
cuff):
$1.03 mA/cm^2$
(rms), for smallest
electrodes area of
$10.1 cm^2$ | Lower leg
(small cuff):
$1.03 mA/cm^2$
(rms), for
smallest
electrodes area
of $10.1 cm^2$ | Lower leg:
$2.62 mA/cm^2$
(rms), for
smallest
electrodes area
of $7.9 cm^2$
(round, 3.175
cm diameter
electrodes) |
| | Lower leg (regular
cuff):
$0.85 mA/cm^2$
(rms), for smallest
electrodes area of
$15.8 cm^2$ | Lower leg (regular
cuff):
$0.66 mA/cm^2$
(rms), for smallest
electrodes area of
$15.8 cm^2$ | Lower leg
(regular cuff):
$0.66 mA/cm^2$
(rms), for
smallest
electrodes area
of $15.8 cm^2$ | Thigh: N/A |
| | Thigh: 0.19
$mA/cm^2$ (rms), for
smallest
electrodes area of
$72 cm^2$ | Thigh: 0.18
$mA/cm^2$ (rms), for
smallest
electrodes area of
$72 cm^2$ | Thigh: N/A | Thigh: N/A |
| 12. Maximum
Power Density @
500 Ω | Lower leg (small
cuff):
$8.9 mW/cm^2$ , for
smallest
electrodes area of
$10.1 cm^2$ | Lower leg (small
cuff):
$5.3 mW/cm^2$ , for
smallest
electrodes area of
$10.1 cm^2$ | Lower leg
(small cuff):
$5.3 mW/cm^2$ ,
for smallest
electrodes area
of $10.1 cm^2$ | Lower leg
(small cuff):
$27.6 mW/cm^2$ ,
for smallest
electrodes area
of $7.9 cm^2$ |
| | Lower leg (regular
cuff):
$5.7 mW/cm^2$ , for
smallest
electrodes area of
$15.8 cm^2$ | Lower leg (regular
cuff):
$3.4 mW/cm^2$ , for
smallest
electrodes area of
$15.8 cm^2$ | Lower leg
(regular cuff):
$3.4 mW/cm^2$ ,
for smallest
electrodes area
of $15.8 cm^2$ | Thigh: N/A |
| | Thigh: 1.3
$mW/cm^2$ , for
smallest
electrodes area of
$72 cm^2$ | Thigh: 1.2
$mW/cm^2$ , for
smallest
electrodes area of
$72 cm^2$ | Thigh: N/A | |
| 13. Burst Mode | Lower leg: Pulse
bursts are
triggered by 'heel
off' and terminated
by 'heel contact'
events during gait
cycle. If Foot
Sensor is on the
contralateral leg,
pulse bursts are
triggered by 'heel
contact' and are
terminated by 'heel
off'. | Lower leg: Pulse
bursts are
triggered by 'heel
off' and terminated
by 'heel contact'
events during gait
cycle. | Lower leg:
Pulse bursts
are triggered
by 'heel off'
and terminated
by 'heel
contact' events
during gait
cycle. | Lower leg:
Pulse bursts
are triggered
by 'heel off'
and terminated
by 'heel
contact' events
during gait
cycle. |
| | Thigh: Pulse
bursts can be
triggered either by
'heel off' or 'heel
contact' events (or | Thigh: Pulse
bursts can be
triggered either by
'heel off' or 'heel
contact' events (or
both). Burst
terminated 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 duration
Thigh:
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 duration
Thigh:
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 duration
Thigh: N/A | Lower leg:
Burst duration = Swing duration
Thigh: 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 sec
Gait mode: 1-10 sec (the max stimulation duration after triggering | Training mode: 4-20 sec
Gait mode: 2-10 sec (the max stimulation duration after triggering | Training mode: 4-20 sec
Gait mode: 2-10 sec (the max stimulation duration after triggering | Training mode: 1-5 sec
Gait mode: max 5 sec (the max stimulation duration |
| | detected) | detected) | detected) | event is
detected) |
| 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: not
limited | Gait mode: not
limited | Gait mode: not
limited | Gait mode: not
limited |
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Section 5 Section 5
510(k) Summary
15
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Section 5 510(k) Summary
16
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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
18
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.