(98 days)
Not Found
No
The description mentions a "dynamic gait tracking algorithm" but does not provide any details suggesting it uses AI or ML. The focus is on electrical stimulation and basic sensor data processing.
Yes
The device is intended to provide ankle dorsiflexion, assist knee flexion or extension, facilitate muscle re-education, prevent/retard disuse atrophy, maintain or increase joint range of motion, and increase local blood flow, all of which are therapeutic effects for individuals with muscle weakness or foot drop.
No
The L300 Go System is a therapeutic device that stimulates muscles to provide ankle dorsiflexion and assist knee flexion or extension, which may improve gait. It is not designed to diagnose medical conditions, but rather to treat symptoms.
No
The device description explicitly lists multiple hardware components, including an External Pulse Generator, Functional Stimulation Cuffs, a power supply, and optional hardware like a Control Unit and Foot Sensor. While it includes software components (Clinician Application and Mobile Application), it is not solely software.
Based on the provided information, the L300 Go System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for providing ankle dorsiflexion and/or assisting knee flexion or extension in individuals with muscle weakness. This involves directly interacting with the patient's body through electrical stimulation to improve gait and muscle function.
- Device Description: The description details components like an External Pulse Generator, Functional Stimulation Cuffs, and software for configuration and monitoring. These are all external components used for applying electrical stimulation to the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The L300 Go System does not involve the analysis of any biological specimens.
The L300 Go System is a therapeutic device that uses electrical stimulation to treat a physical condition (foot drop and muscle weakness).
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 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 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).
-
- Optional Foot Sensor, which uses a dynamic gait tracking algorithm to detect heel events and wirelessly synchronizes stimulation.
-
- Optional Mobile Application (MAPP), based on the SmartPhone platform enabling the patients to wirelessly retrieve and monitor their daily activity. At the time of clearance of K162407, the MAPP did not include any control feature, but control features like those of the Optional Control Unit have been added to the MAPP and are part of this submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Affected leg (ankle, knee)
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)
Software changes were subjected to verification testing to include regression testing to ensure no loss of original functionality. In the version change from MAPP 1.0 to MAPP 2.0, new functions were introduced, and those new functions were subjected to both verification testing (including regression testing) and validation testing. Electrical safety and electromagnetic compatibility testing, including coexistence with common wireless emitters, was completed under the predicate submission and evaluated for applicability to the design modifications proposed under the current submission.
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 9, 2018
Bioness. Inc. Mary Dadone, Ph.D. 25103 Rye Canyon Loop Valencia, California 91355
Re: K173682
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: November 30, 2017 Received: December 1, 2017
Dear Dr. Dadone:
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
1
801); medical device reporting of medical device-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.
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.
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,
Vivek J. Pinto -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) K173682
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 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) | Residential Use (Part 1, CFR 201, Subpart D) On-Site Construction (Part 1, CFR 201, Subpart C) | Residential Use (Part 1, CFR 201, Subpart D) | On-Site Construction (Part 1, CFR 201, Subpart C) |
|---|---|---|---|
| Residential Use (Part 1, CFR 201, Subpart D) | |||
| On-Site Construction (Part 1, CFR 201, Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary Bioness Inc. L300 Go System
510(k) Summary: L300 Go System
| Applicant Name: | Bioness Inc. |
|---|---|
| Contact Person(s): | Mary Dadone, Ph.D. |
| Regulatory Consultant to Bioness Inc. | |
| Office Number: (661) 714-0701 | |
| Email: mary.dadone@bioness.com | |
| Mercedes Bayani | |
| Global Director, Regulatory Affairs, Bioness Inc. | |
| Office Number: (661) 902-5324 | |
| Fax Number: (661) 362-4851 | |
| Email: mercedes.bayani@bioness.com | |
| 25103 Rye Canyon Loop | |
| Valencia, CA 91355, U.S.A | |
| Date Prepared: | March 8, 2018 |
| 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:Traditional 510(k)
Predicate Device:
Company: Bioness, Inc. Device: L300 Go System K162407
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Purpose of this Traditional 510(k):
This Traditional 510(k) is submitted to clear several minor modifications and to address an upgrade in the Mobile Application (MAPP) for the L300 Go System. 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 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 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).
-
- Optional Foot Sensor, which uses a dynamic gait tracking algorithm to detect heel events and wirelessly synchronizes stimulation.
-
- Optional Mobile Application (MAPP), based on the SmartPhone platform enabling the patients to wirelessly retrieve and monitor their daily activity. At the time of clearance of K162407, the MAPP did not include any control feature, but control features like those of the Optional Control Unit have been added to the MAPP and are part of this submission.
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.
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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 Traditional 510(k)
This Traditional 510(k) addresses the following modifications:
- Change in the External Pulse Generator (EPG) cover material .
- . Firmware/Electrical Changes
- . Changes in the Clinician Application (CAPP) software
- Changes in the Mobile Application (MAPP) software
- Labeling Changes
- Packaging Changes ●
Summary of Technological Characteristics
Table 1 below summarizes the technological characteristics of new device in comparison to those of the predicate device. Summary Comparison Table
| L300 Go System (K162407) | L300 Go System after Design Modifications | |
|---|---|---|
| Manufacturer | Bioness Inc. | Bioness Inc. |
| 510(k) number | K162407 | K173682 |
| Product code | GZI & IPF | GZI & IPF |
| L300 Go System (K162407) | L300 Go System after Design | |
| Modifications | ||
| 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
• Clinician mode |
| Regulated
Current or
Regulated
Voltage | Current | Current |
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| | L300 Go System (K162407) | L300 Go System after Design
Modifications | | |
|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | 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 | | |
| 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) |
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| | L300 Go System (K162407) | 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 |
| | L300 Go System (K162407) | L300 Go System after Design Modifications |
| User Control | Using hand-held Control Unit 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; 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; 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 |
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Table 1 ends here
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Summary of Nonclinical Tests Submitted
Because of a modification in the assembly process for the optional Control Unit (CU), the CU was retested for Environmental Ingress Protection by Minnetronix Inc. (Bioness development vendor) using a validated test method. The modified CU successfully passed the Environmental Ingress Protection testing.
Because of a change in the Electrical Pulse Generator (EPG) housing material, the EPG was retested for Mechanical Vibration and Shock using a validated Minnetronix test method. The modified EPG successfully passed the Mechanical Vibration and Shock testing.
Packaging and shipping tests were performed to address the new packaging system. These tests included Initial Manual Handling, Vehicle Stacking, Loose Load Vibration, Low Pressure, Vehicle Vibration, Concentrated Impact, and Final Manual Handling (ASTM D5276-98, Schedule A, Level III). All packaging passed all tests.
Software changes were subjected to verification testing to include regression testing to ensure no loss of original functionality. In the version change from MAPP 1.0 to MAPP 2.0, new functions were introduced, and those new functions were subjected to both verification testing (including regression testing) and validation testing. Electrical safety and electromagnetic compatibility testing, including coexistence with common wireless emitters, was completed under the predicate submission and evaluated for applicability to the design modifications proposed under the current submission.
Conclusion:
The L300 Go System has been verified and validated successfully for its intended use through the combination of original bench testing, additional bench testing, engineering analysis, and thorough verification and validation testing of all software changes. Based on the results of the nonclinical testing, Bioness concludes that the device is substantially equivalent to the predicate L300 Go System.