(30 days)
Not Found
No
The description focuses on electrical stimulation and motion sensing for gait detection, with no mention of AI or ML algorithms for data analysis, decision-making, or adaptation.
Yes
The device is intended to treat foot drop or muscle weakness, facilitate muscle re-education, prevent disuse atrophy, maintain/increase joint range of motion, and increase local blood flow, all of which are therapeutic purposes.
No
The L100 Go System is intended for therapeutic purposes, such as providing ankle dorsiflexion and improving gait, through electrical stimulation. It does not perform any diagnostic functions like measuring, analyzing, or interpreting biological data to identify a disease, condition, or risk.
No
The device description explicitly lists multiple hardware components, including an External Pulse Generator, Lower Leg Cuff, Power supply, Tester, and Electrodes. While it includes software components (Clinician Application and Optional Mobile Application), it is not solely software.
Based on the provided information, the L100 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 (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The L100 Go System does not interact with or analyze any biological specimens.
- The L100 Go System is a therapeutic device. Its intended use is to provide ankle dorsiflexion through electrical stimulation 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 delivers electrical stimulation to the lower leg muscles for therapeutic purposes, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The L100 Go System is intended to provide ankle dorsiflexion in adults with foot drop or muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to the spinal cord). The L100 Go System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot; thus, it also may improve the adult's gait.
The L100 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 L100 Go System is designed to improve gait in adults suffering from foot drop or muscle weakness. The L100 Go System can also deliver transcutaneous stimulation to the muscles in the lower leg to facilitate muscle re-education, prevent/retard disuse atrophy, maintain or increase joint range of motion, and/or increase local blood flow.
The L100 Go system consists of the following L300 Go components/accessories with the exception of a modified lower leg cuff:
- External Pulse Generator (EPG), which can be plugged into Lower Leg Cuff. EPG contains user interface including control and indications. EPG also contains integrated motion sensors enabling detecting gait events.
- Lower Leg Cuff, including cradle for the EPG. This is the only L300 Go component modified for the L100 Go.
- Clinician Application (CAPP), installed on tablet PC. CAPP is used by a trained clinician during configuration of the system for optimal fitting to the patient.
- Power supply (charger) with two USB ports and a proprietary cable to charge the EPG.
- Tester, which is used for trouble shooting to confirm that stimulation is being delivered.
- Optional Mobile Application (MAPP), based on the iOS and Android SmartPhone platform enabling the patients to wirelessly control the EPG(s) and retrieve and monitor their daily activity.
- Electrode and electrode bases which are attached to the inner side of the lower leg cuff.
The L100 Go System can be operated in one of the following modes:
- Gait Mode
- Training Mode
- Clinician Mode
Gait Mode is used for walking, and it can be selected by the clinician and also by the patient. Training Mode is used to train muscles when patients are not walking (for example, sitting or lying down), and it can be selected by either the clinician or the patient. Clinician Mode allows the clinician to apply enhanced training and is only available to the clinicians.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Affected leg (lower leg)
Indicated Patient Age Range
Adults
Intended User / Care Setting
Prescription Use
Kits are provided to clinicians, and they configure the system for optimal fitting to the patient. Patients can use the system at home for walking (Gait Mode) or muscle training (Training Mode).
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)
The modified cuff design was subjected to verification testing to ensure no loss of mechanical strength and functionality.
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.
L300 Go System, K190285
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
March 4, 2020
Bioness Inc. Shanna Hu Regulatory Affairs Manager, FES Technology 25103 Rye Canyon Loop Valencia, California 91355
Re: K200262
Trade/Device Name: L100 Go System Regulation Number: 21 CFR 882.5810 Regulation Name: External Functional Neuromuscular Stimulator Regulatory Class: Class II Product Code: GZI, IPF Dated: January 31, 2020 Received: February 3, 2020
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
1
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,
For Vivek Pinto, Ph.D. Director 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
2
Indications for Use
510(k) Number (if known)
Device Name L100 Go System
Indications for Use (Describe)
The L100 Go System is intended to provide ankle dorsiflexion in adults with foot drop or muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to the spinal cord). The L100 Go System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot; thus, it also may improve the adult's gait.
The L100 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)
Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) Summary: | L100 Go System |
|---|---|
| Applicant Name: | Bioness Inc. |
| Contact Person(s): | Shanna Hu |
| Regulatory Affairs Manager, FES Technology | |
| Bioness Inc. | |
| 25103 Rye Canyon Loop | |
| Valencia, CA 91355, U.S.A | |
| Office Number: (661) 362-6694 | |
| Email: shanna.hu@bioness.com | |
| Mercedes Bayani | |
| Global Vice-President, Clinical & Regulatory Affairs | |
| Bioness Inc. | |
| Office Number: (661) 902-5324 | |
| Fax Number: (661) 362-4851 | |
| Email: mercedes.bayani@bioness.com | |
| Date Prepared: | March 4, 2020 |
| Trade Name: | L100 Go System |
| Classification: | Name: External functional neuromuscular stimulator |
| Product Code: GZI and IPF | |
| Regulation No: 21 CFR § 882.5810, § 890.5850 | |
| Class: II | |
| Classification Panel: Neurology |
Establishment Registration No.: 3004553866
Reason for Submission: Device Modifications
Type of Submission: Special 510(k)Type of Submission:Special 510(k)
Predicate Device:
Company: Bioness, Inc. Device: L300 Go System, K190285
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Image /page/4/Picture/1 description: The image shows the logo for Bioness. The logo consists of an orange sun-like symbol on the left, followed by the word "Bioness" in gray, and the words "LiveOn" in a smaller gray font below the word "Bioness". The sun-like symbol has eight orange rays, each made up of two lines that curve inward.
Purpose of this Special 510(k):
This Special 510(k) is submitted for a system called L100 Go System which is the same device as the Lower Leg configuration of the predicate L300 Go System with modified cuff design. None of the modifications affect the intended use of the device nor do they alfer the fundamental scientific technology of the device.
Device Description:
The L100 Go System is designed to improve gait in adults suffering from foot drop or muscle weakness. The L100 Go System can also deliver transcutaneous stimulation to the muscles in the lower leg to facilitate muscle re-education, prevent/retard disuse atrophy, maintain or increase joint range of motion, and/or increase local blood flow.
The L100 Go system consists of the following L300 Go components/accessories with the exception of a modified lower leg cuff:
-
- External Pulse Generator (EPG), which can be plugged into Lower Leg Cuff. EPG contains user interface including control and indications. EPG also contains integrated motion sensors enabling detecting gait events.
-
- Lower Leg Cuff, including cradle for the EPG. This is the only L300 Go component modified for the L100 Go.
-
- Clinician Application (CAPP), installed on tablet PC. CAPP is used by a trained clinician during configuration of the system for optimal fitting to the patient.
-
- Power supply (charger) with two USB ports and a proprietary cable to charge the EPG.
-
- Tester, which is used for trouble shooting to confirm that stimulation is being delivered.
-
- Optional Mobile Application (MAPP), based on the iOS and Android SmartPhone platform enabling the patients to wirelessly control the EPG(s) and retrieve and monitor their daily activity.
-
- Electrode and electrode bases which are attached to the inner side of the lower leg cuff.
The L100 Go System can be operated in one of the following modes:
- Gait Mode
- Training Mode •
- . Clinician Mode
Gait Mode is used for walking, and it can be selected by the clinician and also by the patient. Training Mode is used to train muscles when patients are not walking (for example, sitting or lying down), and it can be selected by either the clinician or the patient. Clinician Mode allows the clinician to apply enhanced training and is only available to the clinicians.
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Indications for Use:
The L100 Go System is intended to provide ankle dorsiflexion in adults with foot drop or muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to pathways to the spinal cord). The L100 Go System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot; thus, it also may improve the adult's gait.
The L100 Go System may also:
- Facilitate muscle re-education .
- Prevent/retard disuse atrophy .
- Maintain or increase joint range of motion ●
- Increase local blood flow ●
Modifications Addressed in this Special 510(k)
This Special 510(k) addresses the new L100 Go Cuff which is a modification of the predicate L300 Go lower leg cuffs. The L100 Go Cuff combines the design elements of both the L300 Go lower leg Reqular and Small cuffs.
Summary of Technological Characteristics
The Table below summarizes the technological characteristics of the subject device in comparison to those of the predicate device, specifically, the lower leg configuration of the predicate device.
| | L300 Go System
(K190285) | L100 Go System (this
submission) | Equivalency
Assessment |
|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Bioness Inc. | Bioness Inc. | Same |
| 510(k) number | K190285 | To be assigned | N/A |
| Product code | GZI & IPF | GZI & IPF | Same |
| | L300 Go System
(K190285) | L100 Go System (this
submission) | Equivalency
Assessment |
| Intended use | The L300 Go System is
intended to provide ankle
dorsiflexion in adult and
pediatric individuals with
foot drop and/or to assist
knee flexion or extension in
adult individuals with
muscle weakness related to
upper motor neuron
disease/injury (e.g., stroke,
damage to pathways to the
spinal cord). The L300 Go
System electrically
stimulates muscles in the
affected leg to provide
ankle dorsiflexion of the
foot and/or knee flexion or
extension; thus, it also may
improve the individual's
gait.
The L300 Go System may
also:
• Facilitate muscle re-
education
• Prevent/retard disuse
atrophy
• Maintain or increase joint
range of motion
• Increase local blood flow | The L100 Go System is
intended to provide ankle
dorsiflexion in adults with
foot drop or muscle
weakness related to upper
motor neuron disease/injury
(e.g., stroke, damage to
pathways to the spinal cord).
The L100 Go System
electrically stimulates
muscles in the affected leg
to provide ankle dorsiflexion
of the foot; thus, it also may
improve the adult's gait.
The L100 Go System may
also:
• Facilitate muscle re-
education
• Prevent/retard disuse
atrophy
• Maintain or increase joint
range of motion
• Increase local blood flow | Same
(The intended use of
L100 Go System is a
subset of the
predicate device.
The L100 Go System
is a lower leg cuff
only system,
therefore, it does not
assist knee flexion or
extension) |
| Number of
Output Modes | 2 modes: Biphasic
Asymmetric and Symmetric | 2 modes: Biphasic
Asymmetric and Symmetric | Same |
| Number of
Programs | • Gait
• Training/Exercise
• Cycle Training Mode
• Clinician mode | • Gait
• Training/Exercise
• Clinician mode | Different
(Cycle Training Mode
is disabled for the
L100 Go System) |
| Regulated
Current or
Regulated
Voltage | Current | Current | Same |
| | L300 Go System
(K190285) | L100 Go System (This
submission) | Equivalency
Assessment |
| Power Source | Control Unit: Li Coin Cell,
CR2032, 3 V, 240 mAh
EPG: Rechargeable, Li-Ion,
Prismatic, 3.7 V, 1000 mAh
Foot Sensor: Li Coin Cell,
CR2032, 3 V, 240 mAh | EPG: Rechargeable, Li-Ion,
Prismatic, 3.7 V, 1000 mAh | Same
(optional Control Unit
and Foot Sensor are
not offered with the
L100 Go System) |
| Method of Line
Current
Isolation | N/A (Battery operated) | N/A (Battery operated) | Same |
| Patient
Leakage
Current,
Normal
condition [μA] | Less than 1.0 (IEC 60601-
-
| Less than 1.0 (IEC 60601-1) | Same |
| Patient
Leakage
Current, Single
fault condition
[μA] | 3.0 (IEC 60601-1) | 3.0 (IEC 60601-1) | Same |
| Number of
Output Modes | Two: Symmetric &
Asymmetric | Two: Symmetric &
Asymmetric | Same |
| Number of
Output
Channels | Small lower leg cuff: 1
Regular lower leg cuff: 1 or
2
Thigh cuff: 1 | Lower leg cuff: 1 | Same
(The L100 Go lower
leg cuff has the same
output channel as
the L300 Go small
lower leg cuff) |
| Synchronous
or Alternating? | Alternating (at one time
only one channel is
activated) | N/A (only one channel will
be activated) | Same
(L100 Go cuff is
single channeled.
This is the same as
L300 Go small lower
leg cuff) |
| 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 channels
within the regular lower cuff | Isolation between channels
with the lower leg cuff
stimulator: N/A
(Only one channel will be
activated) | Same
(The isolation
between channels is
not applicable to
L100 Go lower leg
cuff stimulator, this is
the same as L300
Go small lower leg
cuff stimulator) |
| | L300 Go System
(K190285) | L100 Go System (This
submission) | Equivalency
Assessment |
| | same EPG are switched
using high voltage FET
switches. | | |
| | Isolation between channels
within the small lower cuff
stimulator: N/A (only one
channel will be activated) | | |
| | Isolation between channels
within the Thigh cuff
stimulator: N/A (only one
channel will be activated) | | |
| Regulated
Current or
Regulated
Voltage? | Current | Current | Same |
| Software/Firmw
are/Microproce
ssor-Controlled | Yes | Yes | Same |
| Automatic
Overload Trip? | Yes | Yes | Same |
| Automatic No-
Load Trip? | Yes | Yes | Same |
| Automatic Shut
Off? | Yes | Yes | Same |
| Patient
Override
Control? | Yes | Yes | Same |
| Indicator
Display:
• On/Off
Status?
• Low Battery?
•Voltage/Current Level? | Yes
Yes
Yes | Yes
Yes
Yes | Same |
| Timer Range
[minutes] | No | No | Same |
| | L300 Go System
(K190285) | L100 Go System (This
submission) | Equivalency
Assessment |
| Max Output
Current
(± 10%) | Lower leg cuffs:
100 mA @ 500 Ohm
Thigh cuff:
100 mA @ 500 Ohm | Lower leg cuff:
100 mA @ 500 Ohm | Same
(L100 Go lower leg
cuff has the same
maximum output
current as the L300
Go lower leg cuff.
Thigh cuff is not
available in the L100
Go System) |
| Max Average
Current Density
[mARMS/cm2]
[Over smallest
electrode] | Lower leg EPG:
small cuff, small round
electrodes (36mm)
$1.27 \text{ mA}{\text{RMS}}/\text{cm}^{2}$ (500 Ω,
Irms=13.0 mA, electrode
area of 10.2 cm2)
Thigh EPG: $0.18 \text{mA}{\text{RMS}}/\text{cm}^{2}$
(500 Ω, Irms=13.0 mA,
electrode area of 74 cm2) | Lower leg EPG:
Lower leg cuff, regular round
electrodes (45mm)
$0.82 \text{mA}_{\text{RMS}}/\text{cm}^{2}$ (500 Ω,
Irms=13.0 mA, electrode area
of 15.9 cm2) | Different
(since L100 Go cuff
only comes in the
size same as the
predicate regular
cuff, the calculation
is based on the
electrode of the
regular cuff. Thigh
cuff is not available
in the L100 Go
System) |
| Max Average
Power Density,
(mW/cm2) | Lower leg EPG:
small cuff, small round
electrodes (36mm)
$8.3 \text{ mW}/\text{cm}^{2}$ (500 Ω,
Irms=13.0 mA, electrode
area of 10.2 cm2)
regular cuff, regular round
electrodes (45mm)
$5.3 \text{ mW}/\text{cm}^{2}$ (500 Ω,
Irms=13.0 mA, electrode
area of 15.9 cm2)
Thigh EPG:
$1.1 \text{mW}/\text{cm}^{2}$ (500 Ω,
Irms=13.0mA, electrode area
of 74 cm2) | Lower Leg EPG:
Lower leg cuff, regular round
electrodes (45mm)
$5.3 \text{ mW}/\text{cm}^{2}$ (500 Ω,
Irms=13.0 mA, electrode area
of 15.9 cm2) | Same
(L100 Go cuff only
comes in regular
size) |
| | L300 Go System
(K190285) | L100 Go System (This
submission) | Equivalency
Assessment |
| Stimulation
Channels | Regular Cuff: 1 or 2 (In 2-
channel
mode, both function as a
single channel but with
separately
adjustable medial/ lateral
stimulation
intensity)
Small Cuff: 1
Thigh Cuff: 1 | Lower leg cuff: 1 | Same
(L100 Go has one
stimulation channel
which is identical to
channel #1 of L300
Go Regular Cuff) |
| Frequency/
Phase duration | Frequency: 10, 15, 20, 25,
30, 35, 40, 45 Hz
Symmetric and Asymmetric
positive: 100, 150, 200,
250, 300μs;
Asymmetric Negative: 300,
450, 600, 750, 900μs; | Frequency: 10, 15, 20, 25,
30, 35, 40, 45 Hz
Symmetric and Asymmetric
positive: 100, 150, 200, 250,
300μs;
Asymmetric Negative: 300,
450, 600, 750, 900μs; | Same |
| Electrodes
used in the
system | Lower Leg Cuffs:
• 2 Hydro-Gel electrodes
assembled on
electrode bases, or
• 2 non-woven cloth
electrodes assembled
on electrode bases, or
• 2 non-woven cloth
electrodes attached
with snaps (also called
"QuickFit" electrodes),
or
• 3 non-woven cloth
electrodes attached
with snaps (segmented
electrodes [also called
"steering" electrodes],
using common anode
to allow separate
adjustment of medial
and lateral stimulation.
This electrode is only
used for regular cuff)
Thigh Cuff:
• 2 single, non-woven
cloth electrodes
attached with snaps | Lower leg Cuff:
• 2 Hydro-Gel electrodes
assembled on electrode
bases, or
• 2 non-woven cloth
electrodes assembled
on electrode bases, or
• 2 non-woven cloth
electrodes attached
with snaps (also called
"QuickFit" electrodes) | Different
(L100 Go does not
use steering
electrodes) |
| | L300 Go System
(K190285) | L100 Go System (This
submission) | Equivalency
Assessment |
| Clinician
Control/
Programming | Clinician uses the Clinician
Programmer (CAPP) to set
stimulation energy and
temporal parameters
related to the functional
stimulation performance for
dorsiflexion control | Clinician uses the Clinician
Programmer (CAPP) to set
stimulation energy and
temporal parameters related
to the functional stimulation
performance for dorsiflexion
control | Same |
| Clinician
Programmer
(CAPP)
Platform | Tablet PC | Tablet PC | Same |
| User Control | Using hand-held Control
Unit, the mobile application
(MAPP), or the EPG-based
interface, the user can:
Turn system On/Off
(EPG only)Start/Stop stimulationSelect Gait/Training
programFine-tune stimulation
intensity around
working point set by
the clinicianTest L300 Lower Leg
EPG & Thigh EPG
stimulation before
starting to ambulate | Using the mobile application
(MAPP), or the EPG-based
interface, the user can:
Turn system On/Off
(EPG only)Start/Stop stimulationSelect Gait/Training
programFine-tune stimulation
intensity around
working point set by
the clinicianTest L100 Lower Leg
EPG stimulation before
starting to ambulate | Same
(Control Unit is
optional, and is not
offered with the L100
Go System) |
| Stimulation
trigger source
(when used for
gait) | In gait mode, stimulation is
triggered by:
(1) the motion sensor
embedded in the EPG
(two-dimension tilt); or
(2) Foot Sensor that
detects Heel On &
Heel Contact events
during gait and
transmits them
wirelessly to the lower
and thigh EPGs. | In gait mode, stimulation is
triggered by:
(1) the motion sensor
embedded in the EPG
(two-dimension tilt). | Same
(Foot Sensor is
optional, and is not
offered with the L100
Go System) |
| | L300 Go System (190285) | L100 Go System (This
submission) | Equivalency
Assessment |
| Communicatio
n method | Control Unit - Lower Leg
/Thigh EPG: wireless
Bluetooth (Low Energy)
communication protocol
Gait Sensor - Lower
Leg/Thigh EPG: wireless
Bluetooth (Low Energy)
communication protocol
Clinician Programmer -
EPG:
wireless Bluetooth (Low
Energy) communication
protocol
MAPP – Lower Leg /Thigh
EPG: wireless Bluetooth
(Low Energy)
communication protocol | Clinician Programmer -
EPG:
wireless Bluetooth (Low
Energy) communication
protocol
MAPP – Lower Leg /Thigh
EPG: wireless Bluetooth
(Low Energy)
communication protocol | Same
(Control Unit and
Foot Sensor are
optional, and are not
offered with the L300
Go System) |
| Compliance
with Voluntary
Standards | Yes.
• IEC 60601-1
• IEC 60601-2-10
• IEC 60950-1
• IEC 60601-1-11
• IEC 60601-1-2
FCC part 15:2007 Federal
Communications
Commission (FCC)
regulations Subpart C,
15.247 | Yes.
• IEC 60601-1
• IEC 60601-2-10
• IEC 60950-1
• IEC 60601-1-11
• IEC 60601-1-2
FCC part 15:2007 Federal
Communications
Commission (FCC)
regulations Subpart C,
15.247 | Same |
| Compliance
with 21 CFR
898? | Yes | Yes | Same |
| Weight | EPG: 60 [gram]
Lower leg regular Cuff: 150
[gram]
Lower leg small Cuff: 104
[gram] | EPG: 60 [gram]
Lower Leg Cuff: 127 [gram] | Different
(The L100 Go Cuff is
lighter compared to
the L300 Go lower
regular cuff, this is
because the L100
Go cuff does not
have the TPU frame) |
| | L300 Go System (190285) | L100 Go System (This
submission) | Equivalency
Assessment |
| Dimensions
[mm] (WxHxD) | EPG: 82x47x15 [mm]
Lower leg regular Cuff:
160x100x125 [mm]
Lower leg small Cuff:
110x80x100 [mm] | EPG: 82x47x15 [mm]
Lower Leg Cuff:
160x100x125 [mm] | Same
(The L100 Go cuff
has the same
dimension as the
L300 Go lower
regular Cuff) |
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10
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Image /page/12/Picture/0 description: The image shows the logo for Bioness. The logo consists of a stylized sun-like symbol on the left, with the word "Bioness" in gray, bold letters to the right of the symbol. Below "Bioness" is the phrase "LiveOn" in a smaller, lighter font. The sun-like symbol is made up of several orange lines arranged in a circular pattern.
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Table ends here
The difference between the predicate device and the device in this submission is in the number of programs offered, the availability of the optional Control Unit and Foot Sensor, the number of available electrodes, and the weight of the subject device is a simpler system, therefore, the Cycle Training Mode feature is disabled. For the same reason, the optional Control Unit and Foot Sensor that are offered with the predicate device is not offered with the subject device. Furthermore, the subject device, the L100 Go System, is a single channel system, therefore, the steering electrode which is used for 2 channel stimulation is not applicable. These technological differences do not affect the safety and effectiveness of the subject device.
Summary of Nonclinical Tests Submitted
The modified cuff design was subjected to verification testing to ensure no loss of mechanical strength and functionality.
Conclusion:
The L100 Go System has been verified and validated successfully for its intended use through the combination of predicate device bench testing and thorough verification and validation testing of all changes. Based on the result of the nonclinical testing, Bioness concludes that the device is substantially equivalent to the predicate L300 Go System.