(31 days)
Not Found
No
The document describes a functional electrical stimulation system with motion sensors and a dynamic gait tracking algorithm, but it does not mention the use of AI or ML technologies. The performance studies focus on verification and validation of software changes and physical modifications, not on the performance of an AI/ML algorithm.
Yes
The device is described as 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," and also to "facilitate muscle re-education, prevent/retard disuse atrophy, maintain or increase joint range of motion, and increase local blood flow." These are all therapeutic actions, directly addressing and improving a health condition or its symptoms.
No
The device is intended to provide ankle dorsiflexion and/or assist knee flexion/extension by electrically stimulating muscles to improve gait, facilitate muscle re-education, prevent disuse atrophy, maintain/increase joint range of motion, and increase local blood flow. Its functions are therapeutic and rehabilitative, not diagnostic.
No
The device description explicitly lists multiple hardware components including an External Pulse Generator, Functional Stimulation Cuffs, a power supply, and an optional Foot Sensor. While it includes software components (Clinician Application and Mobile Application), it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- L300 Go System Function: The L300 Go System works by applying electrical stimulation to muscles in the affected leg to improve gait and address muscle weakness. It directly interacts with the patient's body and does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes a therapeutic and rehabilitative purpose (providing ankle dorsiflexion, assisting knee movement, improving gait, muscle re-education, etc.), not diagnostic testing of biological samples.
- Device Description: The components and operation of the system involve external stimulation and control, not laboratory analysis of specimens.
Therefore, the L300 Go System falls under the category of a therapeutic or rehabilitative medical device, not an In Vitro Diagnostic device.
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 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
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 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 consists of the following components:
-
- External Pulse Generator (EPG), which can be plugged into lower leg Functional Stimulation Cuff (FSC) or thigh FSC or into both cuffs. EPG contain user interface including control and indications. EPG also contains integrated motion sensors enabling detecting gait events.
-
- Lower leg FSC, including cradle for the EPG.
-
- Upper leg FSC, including cradle for the EPG.
-
- Clinician Application (CAPP), based on tablet PC. CAPP will be used by a trained clinician during configuration of the system for optimal fitting to the patient.
-
- Power supply (charger) with two USB ports and a proprietary cable to charge the EPG.
-
- L300 Go Tester.
-
- Optional Control Unit that allows simple control of the EPG(s) such as selecting mode of operation (gait/training) or fine-tune the stimulation intensity for each EPG individually.
-
- Optional Foot Sensor, which uses a dynamic gait tracking algorithm to detect heel events and wirelessly synchronizes stimulation.
-
- Optional Mobile Application (MAPP), which can be downloaded on a smartphone and offers the same control functions as the optional Control Unit, as well as enabling the patients to retrieve and monitor their daily activity. At the time of clearance of K173682, the MAPP was only an iOS-based application. In this submission, Bioness is adding an Android-based MAPP. The software features, user interface, and wireless communication protocol of the Android version are the same as the iOS version, the only difference is the operating system.
The L300 Go System can be operated in one of the following modes:
- Gait Mode
- Training Mode
- Cycle 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. Cycle Training Mode is used to train muscles while the patient is using a stationary exercise bicycle, 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 (ankle, knee, foot, lower leg, thigh)
Indicated Patient Age Range
Adult and pediatric individuals
Intended User / Care Setting
Clinician, patient. Not specified if for home or clinical settings.
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)
Software and Firmware changes were subject to verification testing to ensure no loss of original functionality. Software changes related to the addition of Cyclic Training Mode were subjected to both verification testing and validation testing.
Because of a modification in the bottom enclosure of the External Pulse Generator (EPG), The EPG was retested for Environmental Ingress Protection. The modified EPG successfully passed the test and continue to meet the safety requirements and classification requirement of IP42.
Transportation test were performed to address the new packaging of the Clinician's Kit. The new packaging passed all tests.
Key results: The L300 Go System has been verified and validated successfully for its intended use through the combination of original bench testing and thorough verification and validation testing of all software and hardware changes.
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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March 14, 2019
Bioness Inc. Shanna Hu Sr. Regulatory Affairs Specialist 25103 Rye Canyon Loop Valencia, California 91355
Re: K190285
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: February 8, 2019 Received: February 11, 2019
Dear Shanna Hu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You mav, 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 avare 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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Kelliann T. Wachrathit -S
For Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190285
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 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:
- o Facilitate muscle re-education
- o Prevent/retard disuse atrophy
- o Maintain or increase joint range of motion
o Increase local blood flow
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the logo for Bioness. The logo consists of an orange starburst-like symbol on the left, followed by the word "Bioness" in gray, and the words "LiveOn" in a smaller font below the word "Bioness". The logo is simple and modern, and the colors are bright and eye-catching.
| 510(k) Summary: | L300 Go System |
|---|---|
| Applicant Name: | Bioness Inc. |
| Contact Person(s): | Shanna Hu |
| Sr. Regulatory Affairs Specialist | |
| 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 Director, Clinical & Regulatory Affairs
Bioness Inc.
Office Number: (661) 902-5324
Fax Number: (661) 362-4851
Email: mercedes.bayani@bioness.com |
| Date Prepared: | February 7, 2019 |
| Trade Name: | L300 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) |
Predicate Device:
Company: Bioness, Inc. Device: L300 Go System, K173682
4
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Purpose of this Special 510(k):
This Special 510(k) is submitted to add an Android version Mobile Application to the L300 Go System as well as to include minor modifications made to the device since the clearance of the last 510K. K173682. None of these changes affect the intended use of the device nor do they alter the fundamental scientific technology of the device.
Device Description:
The L300 Go System 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 consists of the following components:
-
- External Pulse Generator (EPG), which can be plugged into lower leg Functional Stimulation Cuff (FSC) or thigh FSC or into both cuffs. EPG contain user interface including control and indications. EPG also contains integrated motion sensors enabling detecting gait events.
-
- Lower leg FSC, including cradle for the EPG.
-
- Upper leg FSC, including cradle for the EPG.
-
- Clinician Application (CAPP), based on tablet PC. CAPP will be used by a trained clinician during configuration of the system for optimal fitting to the patient.
-
- Power supply (charger) with two USB ports and a proprietary cable to charge the EPG.
-
- L300 Go Tester.
-
- Optional Control Unit that allows simple control of the EPG(s) such as selecting mode of operation (gait/training) or fine-tune the stimulation intensity for each EPG individually.
-
- Optional Foot Sensor, which uses a dynamic gait tracking algorithm to detect heel events and wirelessly synchronizes stimulation.
-
- Optional Mobile Application (MAPP), which can be downloaded on a smartphone and offers the same control functions as the optional Control Unit, as well as enabling the patients to retrieve and monitor their daily activity. At the time of clearance of K173682, the MAPP was only an iOS-based application. In this submission, Bioness is adding an Android-based MAPP. The software features, user interface, and wireless communication protocol of the Android version are the same as the iOS version, the only difference is the operating system.
The L300 Go System can be operated in one of the following modes:
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- Gait Mode
- Training Mode ●
- . Cycle 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. Cycle Training Mode is used to train muscles while the patient is using a stationary exercise bicycle, 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.
Indications for 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 ●
Modifications Addressed in this Special 510(k)
This Special 510(k) addresses the following modifications:
- Changes in the External Pulse Generator (EPG) software and Firmware.
- Changes in the Mobile Application (MAPP) iOS software.
- Changes in the Clinician Application (CAPP) software.
- Addition of the cycle training mode (software changes only).
- Changes in the EPG bottom enclosure.
- Clinician Kit Packaging Change. ●
- Labeling Changes. ●
- Addition of an Android version Mobile Application (MAPP). .
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Section 5 510(k) Summary
Image /page/6/Picture/1 description: The image contains the logo for Bioness. The logo consists of a stylized sun-like symbol on the left, with the word "Bioness" in a bold, gray sans-serif font to the right of the symbol. Below "Bioness" is the text "LiveOn" in a smaller font size.
Summary of Technological Characteristics
The Table below summarizes the technological characteristics of new device in comparison to those of the predicate device.
| | L300 Go System (K173682) | L300 Go System after Design
Modifications |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Bioness Inc. | Bioness Inc. |
| 510(k) number | K173682 | K190285 |
| Product code | GZI & IPF | GZI & IPF |
| 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 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 |
| Number of
Output Modes | 2 modes: Biphasic Asymmetric
and Symmetric | 2 modes: Biphasic Asymmetric
and Symmetric |
| Number of
Programs | • Gait
• Training/Exercise
• Clinician mode | • Gait
• Training/Exercise
• Cycle Training Mode
• Clinician mode |
| Regulated
Current or
Regulated
Voltage | Current | Current |
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Image /page/7/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 to the right of it. Below "Bioness" is the phrase "LiveOn" in a smaller font, also in gray. The logo is clean and modern, with a focus on the company name and tagline.
Table continues next page
| | L300 Go System (K173682) | | L300 Go System after Design
Modifications | |
|-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Control Unit: Li Coin Cell, CR2032,
3 V, 240 mAh | | Control Unit: Li Coin Cell, CR2032,
3 V, 240 mAh | |
| Power Source | EPG: Rechargeable, Li-Ion,
Prismatic, 3.7 V, 1000 mAh | | EPG: Rechargeable, Li-Ion,
Prismatic, 3.7 V, 1000 mAh | |
| | Foot Sensor: Li Coin Cell,
CR2032, 3 V, 240 mAh | | Foot Sensor: Li Coin Cell,
CR2032, 3 V, 240 mAh | |
| Microprocessor
-Controlled | Yes | | Yes | |
| Max Output
Current
(± 10%) | Thigh FSC:
100 mA @ 500
Ohm load | L300 Lower Leg
FSC: 100 mA @
500 Ohm load | Thigh FSC:
100 mA @ 500
Ohm load | L300 Lower Leg
FSC: 100 mA @
500 Ohm load |
| Max Average
Current Density
[mARMS/cm²]
[Over smallest
electrode] | Thigh EPG:
0.18 mARMS/cm²
(500 Ω, Irms=13.0
mA, electrode
area of 74 cm²) | Lower Leg EPG:
small cuff, gel
electrodes
1.27 mARMS/cm²
(500 Ω, Irms=13.0
mA, electrode
area of 10.2
cm²) | Thigh EPG:
0.18 mARMS/cm²
(500 Ω, Irms=13.0
mA, electrode
area of 74 cm²) | Lower Leg EPG:
small cuff, gel
electrodes
1.27 mARMS/cm²
(500 Ω, Irms=13.0
mA, electrode
area of 10.2
cm²) |
| Max Average
Power Density,
(mW/cm²) | Thigh EPG:
1.1 mW/cm²
(500 Ω, Irms=13.0
mA, electrode
area of 74 cm²) | Lower Leg EPG:
small cuff, gel
electrodes
8.3 mW/cm²
(500 Ω, Irms=13.0
mA, electrode
area of 10.2
cm²)
regular cuff, gel
electrodes
5.3 mW/cm²
(500 Ω, Irms=13.0
mA, electrode
area of 15.9
cm²) | Thigh EPG:
1.1 mW/cm²
(500 Ω, Irms=13.0
mA, electrode
area of 74 cm²) | Lower Leg EPG:
small cuff, gel
electrodes
8.3 mW/cm²
(500 Ω, Irms=13.0
mA, electrode
area of 10.2
cm²)
regular cuff, gel
electrodes
5.3 mW/cm²
(500 Ω, Irms=13.0
mA, electrode
area of 15.9
cm²) |
| | L300 Go System (K173682) | | L300 Go System after Design
Modifications | |
| Stimulation
Channels | Thigh EPG: 1 | Lower Leg EPG:
2 (functioning as
a single channel
with separately-
adjustable
medial / lateral
stimulation
intensity) | Thigh EPG: 1 | Lower Leg EPG:
2 (functioning as
a single channel
with separately-
adjustable
medial / lateral
stimulation
intensity) |
| Electrodes
used in the
system | Lower Leg FSC:
2 Hydro-Gel electrodes assembled on electrode bases, or 2 non-woven cloth electrodes assembled on electrode bases, or 2 non-woven cloth electrodes attached with snaps (also called "QuickFit" electrodes), or 3 non-woven cloth electrodes attached with snaps (segmented electrodes [also called "steering" electrodes], using common anode to allow separate adjustment of medial and lateral stimulation) Thigh FSC: 2 single, non-woven cloth electrodes attached with snaps | | Lower Leg FSC:
2 Hydro-Gel electrodes assembled on electrode bases, or 2 non-woven cloth electrodes assembled on electrode bases, or 2 non-woven cloth electrodes attached with snaps (also called "QuickFit" electrodes), or 3 non-woven cloth electrodes attached with snaps (segmented electrodes [also called "steering" electrodes], using common anode to allow separate adjustment of medial and lateral stimulation) Thigh FSC: 2 single, non-woven cloth electrodes attached with snaps | |
| 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 and/or knee weakness control | | Clinician uses the Clinician Programmer (CAPP) to set stimulation energy and temporal parameters related to the functional stimulation performance for dorsiflexion control and/or knee weakness control | |
| Clinician
Programmer
(CAPP)
Platform | Tablet PC | | Tablet PC | |
Table continues next page
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Image /page/8/Picture/0 description: The image shows the logo for Bioness. The logo consists of an orange starburst-like symbol on the left, followed by the word "Bioness" in gray, bold font. Below "Bioness" is the text "LiveOn" in a smaller, lighter gray font. The logo is simple and modern, with a focus on the company name.
Table continues next page
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Image /page/9/Picture/0 description: The image contains the logo for Bioness. The logo consists of an orange sun-like symbol on the left, followed by the word "Bioness" in gray, and the words "LiveOn" in a smaller font below "Bioness". The sun-like symbol is made up of several curved lines that radiate outward from a central point.
| | L300 Go System (K173682) | L300 Go System after Design
Modifications |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| User Control | Using hand-held Control Unit, the
mobile application (MAPP), or the
EPG-based interface, the user
can:
Turn system On/Off (via
EPG only) and Start/Stop
stimulation Select Gait/Training program Fine-tune stimulation
intensity around working
point set by the clinician Test L300 Lower Leg EPG &
Thigh EPG stimulation
before starting to ambulate | Using hand-held Control Unit, the
mobile application (MAPP), or the
EPG-based interface, the user
can:
Turn system On/Off (via EPG
only) and Start/Stop
stimulation Select Gait/Training program Fine-tune stimulation
intensity around working
point set by the clinician Test L300 Lower Leg EPG &
Thigh EPG stimulation
before starting to ambulate |
| 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)); or
(2) Foot Sensor that detects
Heel On & Heel Contact
events during gait and
transmits them wirelessly to
the lower and thigh EPGs. |
| Communication
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 | 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 |
Table ends here
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Summary of Nonclinical Tests Submitted
Software and Firmware changes were subject to verification testing to ensure no loss of original functionality. Software changes related to the addition of Cyclic Training Mode were subjected to both verification testing and validation testing.
Because of a modification in the bottom enclosure of the External Pulse Generator (EPG), The EPG was retested for Environmental Ingress Protection. The modified EPG successfully passed the test and continue to meet the safety requirements and classification requirement of IP42.
Transportation test were performed to address the new packaging of the Clinician's Kit. The new packaging passed all tests.
Conclusion:
The L300 Go System has been verified and validated successfully for its intended use through the combination of original bench testing and thorough verification and validation testing of all software and hardware changes. Based on the result of the nonclinical testing, Bioness concludes that the device is substantially equivalent to the predicate L300 Go System.