L300 Go System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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. 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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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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<br>Sr. Regulatory Affairs Specialist<br>Bioness Inc.<br>25103 Rye Canyon Loop<br>Valencia, CA 91355, U.S.A<br>Office Number: (661) 362-6694<br>Email: shanna.hu@bioness.com<br><br>Mercedes Bayani<br>Global Director, Clinical & Regulatory Affairs<br>Bioness Inc.<br>Office Number: (661) 902-5324<br>Fax Number: (661) 362-4851<br>Email: mercedes.bayani@bioness.com | | Date Prepared: | February 7, 2019 | | Trade Name: | L300 Go System | | Classification: | Name: External functional neuromuscular stimulator<br>Product Code: GZI and IPF<br>Regulation No: 21 CFR § 882.5810, § 890.5850<br>Class: II<br>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}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for "Bioness LiveOn". The logo features a stylized sun-like symbol on the left, composed of several orange lines radiating outward from a central point. To the right of the symbol is the word "Bioness" in gray, with a smaller "LiveOn" underneath it, also in gray. The logo appears to be for a company or product related to health or wellness. ## 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: - 1) 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. - 2) Lower leg FSC, including cradle for the EPG. - 3) Upper leg FSC, including cradle for the EPG. - 4) 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. - 5) Power supply (charger) with two USB ports and a proprietary cable to charge the EPG. - 6) L300 Go Tester. - 7) 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. - 8) Optional Foot Sensor, which uses a dynamic gait tracking algorithm to detect heel events and wirelessly synchronizes stimulation. - 9) 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: {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for Bioness LiveOn. The logo consists of an orange sun-like symbol on the left, followed by the word "Bioness" in gray, and the word "LiveOn" in a smaller font below "Bioness". The sun-like symbol has eight arms, each made of four lines. - 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). . {6}------------------------------------------------ ### 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<br>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<br>to provide ankle dorsiflexion in<br>adult and pediatric individuals with<br>foot drop and/or to assist knee<br>flexion or extension in adult<br>individuals with muscle weakness<br>related to upper motor neuron<br>disease/injury (e.g., stroke,<br>damage to pathways to the spinal<br>cord). The L300 Go System<br>electrically stimulates muscles in<br>the affected leg to provide ankle<br>dorsiflexion of the foot and/or knee<br>flexion or extension; thus, it also<br>may improve the individual's gait.<br><br>The L300 Go System may also:<br>• Facilitate muscle re-education<br>• Prevent/retard disuse atrophy<br>• Maintain or increase joint range<br>of motion<br>• Increase local blood flow | The L300 Go System is intended<br>to provide ankle dorsiflexion in<br>adult and pediatric individuals with<br>foot drop and/or to assist knee<br>flexion or extension in adult<br>individuals with muscle weakness<br>related to upper motor neuron<br>disease/injury (e.g., stroke,<br>damage to pathways to the spinal<br>cord). The L300 Go System<br>electrically stimulates muscles in<br>the affected leg to provide ankle<br>dorsiflexion of the foot and/or knee<br>flexion or extension; thus, it also<br>may improve the individual's gait.<br><br>The L300 Go System may also:<br>• Facilitate muscle re-education<br>• Prevent/retard disuse atrophy<br>• Maintain or increase joint range<br>of motion<br>• Increase local blood flow | | Number of<br>Output Modes | 2 modes: Biphasic Asymmetric<br>and Symmetric | 2 modes: Biphasic Asymmetric<br>and Symmetric | | Number of<br>Programs | • Gait<br>• Training/Exercise<br>• Clinician mode | • Gait<br>• Training/Exercise<br>• Cycle Training Mode<br>• Clinician mode | | Regulated<br>Current or<br>Regulated<br>Voltage | Current | Current | {7}------------------------------------------------ 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<br>Modifications | | |-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Control Unit: Li Coin Cell, CR2032,<br>3 V, 240 mAh | | Control Unit: Li Coin Cell, CR2032,<br>3 V, 240 mAh | | | Power Source | EPG: Rechargeable, Li-Ion,<br>Prismatic, 3.7 V, 1000 mAh | | EPG: Rechargeable, Li-Ion,<br>Prismatic, 3.7 V, 1000 mAh | | | | Foot Sensor: Li Coin Cell,<br>CR2032, 3 V, 240 mAh | | Foot Sensor: Li Coin Cell,<br>CR2032, 3 V, 240 mAh | | | Microprocessor<br>-Controlled | Yes | | Yes | | | Max Output<br>Current<br>(± 10%) | Thigh FSC:<br>100 mA @ 500<br>Ohm load | L300 Lower Leg<br>FSC: 100 mA @<br>500 Ohm load | Thigh FSC:<br>100 mA @ 500<br>Ohm load | L300 Lower Leg<br>FSC: 100 mA @<br>500 Ohm load | | Max Average<br>Current Density<br>[mARMS/cm²]<br>[Over smallest<br>electrode] | Thigh EPG:<br>0.18 mARMS/cm²<br>(500 Ω, Irms=13.0<br>mA, electrode<br>area of 74 cm²) | Lower Leg EPG:<br>small cuff, gel<br>electrodes<br>1.27 mARMS/cm²<br>(500 Ω, Irms=13.0<br>mA, electrode<br>area of 10.2<br>cm²) | Thigh EPG:<br>0.18 mARMS/cm²<br>(500 Ω, Irms=13.0<br>mA, electrode<br>area of 74 cm²) | Lower Leg EPG:<br>small cuff, gel<br>electrodes<br>1.27 mARMS/cm²<br>(500 Ω, Irms=13.0<br>mA, electrode<br>area of 10.2<br>cm²) | | Max Average<br>Power Density,<br>(mW/cm²) | Thigh EPG:<br>1.1 mW/cm²<br>(500 Ω, Irms=13.0<br>mA, electrode<br>area of 74 cm²) | Lower Leg EPG:<br>small cuff, gel<br>electrodes<br>8.3 mW/cm²<br>(500 Ω, Irms=13.0<br>mA, electrode<br>area of 10.2<br>cm²)<br>regular cuff, gel<br>electrodes<br>5.3 mW/cm²<br>(500 Ω, Irms=13.0<br>mA, electrode<br>area of 15.9<br>cm²) | Thigh EPG:<br>1.1 mW/cm²<br>(500 Ω, Irms=13.0<br>mA, electrode<br>area of 74 cm²) | Lower Leg EPG:<br>small cuff, gel<br>electrodes<br>8.3 mW/cm²<br>(500 Ω, Irms=13.0<br>mA, electrode<br>area of 10.2<br>cm²)<br>regular cuff, gel<br>electrodes<br>5.3 mW/cm²<br>(500 Ω, Irms=13.0<br>mA, electrode<br>area of 15.9<br>cm²) | | | L300 Go System (K173682) | | L300 Go System after Design<br>Modifications | | | Stimulation<br>Channels | Thigh EPG: 1 | Lower Leg EPG:<br>2 (functioning as<br>a single channel<br>with separately-<br>adjustable<br>medial / lateral<br>stimulation<br>intensity) | Thigh EPG: 1 | Lower Leg EPG:<br>2 (functioning as<br>a single channel<br>with separately-<br>adjustable<br>medial / lateral<br>stimulation<br>intensity) | | Electrodes<br>used in the<br>system | Lower Leg FSC:<br>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:<br>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<br>Control/<br>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<br>Programmer<br>(CAPP)<br>Platform | Tablet PC | | Tablet PC | | Table continues next page {8}------------------------------------------------ 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 {9}------------------------------------------------ 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<br>Modifications | |----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | User Control | Using hand-held Control Unit, the<br>mobile application (MAPP), or the<br>EPG-based interface, the user<br>can:<br>Turn system On/Off (via<br>EPG only) and Start/Stop<br>stimulation Select Gait/Training program Fine-tune stimulation<br>intensity around working<br>point set by the clinician Test L300 Lower Leg EPG &<br>Thigh EPG stimulation<br>before starting to ambulate | Using hand-held Control Unit, the<br>mobile application (MAPP), or the<br>EPG-based interface, the user<br>can:<br>Turn system On/Off (via EPG<br>only) and Start/Stop<br>stimulation Select Gait/Training program Fine-tune stimulation<br>intensity around working<br>point set by the clinician Test L300 Lower Leg EPG &<br>Thigh EPG stimulation<br>before starting to ambulate | | Stimulation<br>trigger source<br>(when used for<br>gait) | In gait mode, stimulation is<br>triggered by:<br>(1) the motion sensor embedded<br>in the EPG (two-dimension<br>tilt)); or<br>(2) Foot Sensor that detects<br>Heel On & Heel Contact<br>events during gait and<br>transmits them wirelessly to<br>the lower and thigh EPGs. | In gait mode, stimulation is<br>triggered by:<br>(1) the motion sensor embedded<br>in the EPG (two-dimension<br>tilt)); or<br>(2) Foot Sensor that detects<br>Heel On & Heel Contact<br>events during gait and<br>transmits them wirelessly to<br>the lower and thigh EPGs. | | Communication<br>method | Control Unit – Lower Leg /Thigh<br>EPG: wireless Bluetooth (Low<br>Energy) communication protocol<br><br>Gait Sensor – Lower Leg/Thigh<br>EPG: wireless Bluetooth (Low<br>Energy) communication protocol<br><br>Clinician Programmer – EPG:<br>wireless Bluetooth (Low Energy)<br>communication protocol<br><br>MAPP – Lower Leg /Thigh EPG:<br>wireless Bluetooth (Low Energy)<br>communication protocol | Control Unit – Lower Leg /Thigh<br>EPG: wireless Bluetooth (Low<br>Energy) communication protocol<br><br>Gait Sensor – Lower Leg/Thigh<br>EPG: wireless Bluetooth (Low<br>Energy) communication protocol<br><br>Clinician Programmer - EPG:<br>wireless Bluetooth (Low Energy)<br>communication protocol<br><br>MAPP – Lower Leg /Thigh EPG:<br>wireless Bluetooth (Low Energy)<br>communication protocol | Table ends here {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for Bioness. The logo features a stylized sun-like symbol in orange on the left. To the right of the symbol is the word "Bioness" in gray, with a smaller tagline "LiveOn" underneath, also in gray. The logo is simple and modern, with a focus on the company name and tagline. ## 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.