L360 Thigh System

K191587 · Bioness, Inc. · GZI · Sep 12, 2019 · Neurology

Device Facts

• Record ID: K191587
• Device Name: L360 Thigh System
• Applicant: Bioness, Inc.
• Product Code: GZI · Neurology
• Decision Date: Sep 12, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The L360 Thigh System is intended 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 L360 Thigh System electrically stimulates muscles in the affected leg to provide knee flexion or extension; thus, it also may improve the individual's gait. The L360 Thigh System may also: Facilitate muscle re-education Prevent/retard disuse atrophy Maintain or increase joint range of motion Increase local blood flow Provide early post-surgical quadricep and hamstring strengthening Improve post-surgical knee stability secondary to quadricep and hamstring strengthening Relax muscle spasms

Device Story

L360 Thigh System is a functional neuromuscular stimulator for adult patients with upper motor neuron injury. Device consists of thigh stimulation cuffs with surface electrodes, a central external pulse generator (EPG), an optional control unit, an optional gait sensor, and a clinician programming system. EPG delivers electrical stimulation to muscles to facilitate knee flexion/extension. Gait sensor uses motion-based algorithms to detect heel events and synchronize stimulation. Clinician configures system for optimal fit. Patients may use an optional mobile app to control EPG and monitor activity. Device is used in clinical or home settings. Output is electrical stimulation; healthcare providers use device to improve gait, strengthen muscles, and manage post-surgical recovery. Benefits include improved mobility, muscle re-education, and atrophy prevention.

Clinical Evidence

Bench testing only. Performance data from the predicate L300 Go System (lifetime, reliability, mechanical durability, environmental, functional/software verification and validation, electrical safety, and EMC) is applied to the L360 Thigh System. Biocompatibility (cytotoxicity, sensitization, irritation) is based on identical materials to the predicate.

Technological Characteristics

External functional neuromuscular stimulator. Materials: Bay State Polymer PA-2000RX (Control Unit/EPG), TPU (Thigh Cuff), ABS (Foot Sensor). Energy: 3.7V, 1000mAh Li-ion battery. Waveform: Pulsed, biphasic, rectangular with interphase interval. Connectivity: Wireless control unit/mobile app. Standards: IEC 60601-1, 60601-1-2, 60601-1-6, 60601-1-8, 60601-1-11, 60601-2-10, IEC 62304, ISO 14971, ISO 10993. Software: Rule-based/firmware.

Indications for Use

Indicated for adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, spinal cord injury) to assist knee flexion/extension and improve gait. Also indicated for muscle re-education, prevention/retardation of disuse atrophy, maintenance/increase of joint range of motion, increased local blood flow, early post-surgical quadricep/hamstring strengthening, improved post-surgical knee stability, and relaxation of muscle spasms.

Regulatory Classification

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.

Predicate Devices

• L300 Go System (K190285)
• Kneehab XP, Type 412/421 (K110350)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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.

September 12, 2019

Bioness Inc. Shanna Hu Sr. Regulatory Affairs Specialist 25103 Rye Canyon Loop Valencia, California 91355

Re: K191587

Trade/Device Name: L360 Thigh System Regulation Number: 21 CFR 882.5810 Regulation Name: External Functional Neuromuscular Stimulator Regulatory Class: Class II Product Code: GZI, IPF Dated: June 11, 2019 Received: June 14, 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 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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Vivek Pinto. PhD Director (Acting) 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

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## Indications for Use

510(k) Number (if known) K191587

Device Name L360 Thigh System

Indications for Use (Describe)

The L360 Thigh System is intended 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 L360 Thigh System electrically stimulates muscles in the affected leg to provide knee flexion or extension; thus, it also may improve the individual's gait.

The L360 Thigh System may also:

- · Facilitate muscle re-education
- · Prevent/retard disuse atrophy
- · Maintain or increase joint range of motion
- · Increase local blood flow
- · Provide early post-surgical quadricep and hamstring strengthening
- · Improve post-surgical knee stability secondary to quadricep and hamstring strengthening
- Relax muscle spasms

| 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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Image /page/3/Picture/0 description: The image contains the logo for "Bioness LiveOn". The logo consists of an abstract sun-like symbol on the left, with the word "Bioness" in a bold, sans-serif font to the right of it. Below "Bioness" is the word "LiveOn" in a smaller, lighter font. The sun-like symbol is orange, while the text is gray.

# 510(k) Summary

| 510(k) Summary: | L360 Thigh 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: [phone]<br>Email: [e-mail]<br>Mercedes Bayani<br>Global Director, Clinical & Regulatory Affairs<br>Bioness Inc.<br>Office Number: [phone]<br>Fax Number: [phone]<br>Email: [e-mail] |
| Date prepared: | September 12, 2019 |
| Device Trade Name: | L360 Thigh 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: Expansion of the Indication for Use

Type of Submission: Traditional 510(k)

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Image /page/4/Picture/0 description: The image contains the logo for "Bioness LiveOn". The logo consists of an orange sun-like symbol with several rays emanating from a central point. To the right of the symbol is the word "Bioness" in a bold, gray sans-serif font. Below "Bioness" is the word "LiveOn" in a smaller, lighter font, also in gray. A registered trademark symbol is present to the right of the word "Bioness".

#### Predicate devices:

- 1. Company: Bioness Inc. Device: L300 Go System (K190285)
- 2. Company: Bio-Medical Research, Ltd. Device: Kneehab XP, Type 412/421 (K110350)

## Purpose of the traditional 510(k) notice:

The L360 Thigh System is the Thigh Standalone configuration of its predicate device, the L300 Go System, with expanded indication for use. The L360 Thigh System is substantially equivalent to its own superset device, the L300 Go System, and the Bio-Medical Research Ltd. Kneehab XP, Type 412/421(hereinafter referred to as Kneehab XP).

### Device description:

The L360 Thigh System is intended to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damaqe to pathways to the spinal cord). The L360 Thigh System electrically stimulates muscles in the affected leg to provide knee flexion or extension; thus, it also may improve the individual's gait.

The L360 Thigh System consists of:

- 1. One or two Thigh Functional Stimulation Cuffs (Thigh Cuff) that include surface electrodes.
- 2. Central External Pulse Generator (EPG). The EPG delivers stimulation to their respective cuffs, and have user interface, including visual, audio, and tactile feedback. The EPG can use motion sensor based algorithm to detect heel events.
- 3. An optional Control Unit that allows simple wireless remote control of the EPG's while displaying real-time information regarding the system's status.

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Image /page/5/Picture/0 description: The image contains the logo for "Bioness LiveOn". The logo features an abstract sun-like symbol on the left, composed of interconnected orange lines. To the right of the symbol is the word "Bioness" in a bold, gray sans-serif font. Below "Bioness" is the word "LiveOn" in a smaller, lighter gray font, with a trademark symbol next to it.

- 4. An optional Gait Sensor, which uses a dynamic gait tracking algorithm to detect heel events and wirelessly synchronizes stimulation.
- 5. A Clinician's Programming System with software, which is used for system programming by a trained clinician during configuration of the system for optimal fitting to the patient.
- 6. An optional Mobile Application (MAPP) enabling the patients to wirelessly control the EPG(s) and retrieve and monitor their daily activity.
- 7. A power supply with two USB outputs and a proprietary cable to charge the EPG(s).

### Indications for use:

The L360 Thigh System is intended 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 L360 Thigh System electrically stimulates muscles in the affected leg to provide knee flexion or extension; thus, it also may improve the individual's gait.

The L360 Thigh System may also:

- Facilitate muscle re-education
- Prevent/retard disuse atrophy
- · Maintain or increase joint range of motion
- Increase local blood flow
- · Provide early post-surgical quadricep and hamstring strengthening
- · Improve post-surgical knee stability secondary to quadricep and hamstring strengthening
- Relax muscle spasms

#### Substantial Equivalence:

The table on next page summarize the indication for use and technological characteristics of the new device in comparison to those of the predicate devices.

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Image /page/6/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 words "LiveOn" in a smaller font below "Bioness". The sun-like symbol is made up of several orange lines that converge at the center.

| | L360 Thigh System<br>(This submission) | L300 Go System<br>(K190285) | Kneehab XP<br>(K110350) |
|----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Bioness Inc. | Bioness Inc. | Bio-Medical Research Ltd. |
| 510(k) number | To be assigned | K190285 | K110350 |
| Product Code | GZI & IPF | GZI & IPF | IPF, GZJ, NYN |
| Prescription<br>Use | Yes | Yes | Yes |
| Indication<br>for Use<br>Statement | The L360 Thigh System<br>is intended to assist knee<br>flexion or extension in<br>adult individuals with<br>muscle weakness related<br>to upper motor neuron<br>disease/injury (e.g.,<br>stroke, damage to<br>pathways to the spinal<br>cord). The L360 Thigh<br>System electrically<br>stimulates muscles in the<br>affected leg to provide<br>knee flexion or extension;<br>thus, it also may improve<br>the individual's gait.<br><br>The L360 Thigh System<br>may also:<br>Facilitate muscle re-education Prevent/retard disuse atrophy Maintain or increase joint range of motion Increase local blood flow Provide early post-surgical quadriceps and<br>hamstring strengthening Improve post-surgical knee stability secondary<br>to quadriceps and hamstring strengthening Relax muscle spasms | The L300 Go System is<br>intended to provide<br>ankle dorsiflexion in<br>adult and pediatric<br>individuals with foot drop<br>and/or to assist knee<br>flexion or extension in<br>adult individuals with<br>muscle weakness<br>related to upper motor<br>neuron disease/injury<br>(e.g. stroke, damage to<br>pathways to the spinal<br>cord). The L300 Go<br>System electrically<br>stimulates muscles in<br>the affected leg to<br>provide ankle<br>dorsiflexion of the foot<br>and/or knee flexion or<br>extension; thus, it also<br>may improve the<br>individual's gait.<br><br>The L300 Go System<br>may also:<br>Facilitate muscle re-education Prevent/retard disuse atrophy Maintain or increase joint range of motion Increase local blood flow | In NMES mode (Programs<br>1-6) the Kneehab XP is<br>intended to:<br>Maintain or increase the range of motion Prevention or retardation of disuse atrophy Re-educate muscles Early post-surgical quadriceps strengthening<br>and improved post surgical knee stability<br>secondary to quadriceps strengthening Relax muscle spasms Increase blood circulation<br>In TENS Mode (Programs<br>7-9) the Kneehab XP is<br>intended to:<br>Provide symptomatic relief and management of<br>chronic, intractable pain Provide an adjunctive treatment in the<br>management of acute, post-surgical or post-<br>traumatic pain Provide symptomatic relief and management of<br>intractable pain and relief of pain associated with<br>arthritis Provide an adjunctive therapy in reducing the level<br>of pain and symptoms associated with<br>osteoarthritis of the knee |
| Energy<br>source | 3.7V, 1000mAh Lithium<br>ion rechargeable<br>prismatic battery | 3.7V, 1000mAh Lithium<br>ion rechargeable<br>prismatic battery | 3.6V NiMH rechargeable<br>battery pack |
| | L360 Thigh System<br>(This submission) | L300 Go System<br>(K190285) | Kneehab XP<br>(K110350) |
| Housing<br>Material<br>and<br>Construction | Control Unit: Bay State<br>Polymer PA-2000RX | Control Unit: Bay State<br>Polymer PA-2000RX | Control Unit: ABS-PA-757) |
| | EPG: Bay State Polymer<br>PA-2000RX | EPG: Bay State Polymer<br>PA-2000RX | Garment: Contains<br>EEPROM<br>(A |
| | Thigh FSC: TPU | Thigh FSC: TPU | Outer fabric: 100% Nylon<br>Inner fabric: 70% |
| | Foot Sensor: ABS<br>(Sensor housing),<br>Bay state Polymer PA-<br>2000RX (Electronics<br>housing) | Foot Sensor: ABS<br>(Sensor housing),<br>Bay state Polymer PA-<br>2000RX (Electronics<br>housing) | Polychloroprene & 30%<br>Polyurethane<br>Binding: 82% Nylon & 18%<br>Elastane<br>Fastening: 100 Nylon |
| Electrode | Two non-woven cloth | Two non-woven cloth | Four gel pad electrodes |
| | electrodes, oval<br>(Proximal 130x75mm,<br>91.1 $cm^2$ and Distal<br>120x63mm, 72 $cm^2$ ) | electrodes, oval<br>(Proximal 130x75mm,<br>91.1 $cm^2$ and Distal<br>120x63mm, 72 $cm^2$ ) | Electrode A: 194 $cm^2$<br>Electrode B: 74 $cm^2$<br>Electrode C: 83 $cm^2$<br>Electrode D: 66 $cm^2$ |
| | Constructed from non-<br>conductive plastic back,<br>stainless steel mesh, and<br>cloth facing towards the<br>leg. | Constructed from non-<br>conductive plastic back,<br>stainless steel mesh,<br>and cloth facing towards<br>the leg. | |
| Lead wires | Wires embedded in the<br>cuff | Wires embedded in the<br>cuff | Over-molded SATA<br>connector splitting to 5<br>leads / studs embedded in<br>the garment |
| Stimulation<br>Site | Quadriceps or<br>Hamstring | Quadriceps or<br>Hamstring | Quadriceps |
| Standards Met | IEC 60601-1<br>IEC 60601-1-6<br>IEC 60601-1-8<br>IEC 60601-1-11<br>IEC 60601-1-2<br>IEC 60601-2-10<br>IEC 62304<br>ISO 14971<br>ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10<br>21 CFR 801<br>21 CFR 898 | IEC 60601-1<br>IEC 60601-1-6<br>IEC 60601-1-8<br>IEC 60601-1-11<br>IEC 60601-1-2<br>IEC 60601-2-10<br>IEC 62304<br>ISO 14971<br>ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10<br>21 CFR 801<br>21 CFR 898 | IEC 60601-1<br>IEC 60601-2-10<br>IEC 60601-1-2<br>ISO 14971<br>ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10<br>21 CFR 898<br>21 CFR 801 |
| Method of line<br>isolation | N/A (battery operated) | N/A (battery operated) | No line connection (battery<br>operated) |
| Patient<br>Leakage<br>current | Normal condition:<br>Less than 1.0µA (as<br>required by IEC 60601- 1)<br>Single fault | Normal condition:<br>Less than 1.0µA (as<br>required by IEC 60601-<br>1) | Information is not available |
| | condition:<br>3.0µA (as required<br>by IEC 60601-1) | Single fault condition:<br>3.0µA (as required by<br>IEC 60601-1) | |
| | L360 Thigh System<br>(This submission) | L300 Go System<br>(K190285) | Kneehab XP<br>(K110350) |
| Stimulation<br>Modes | - Gait<br>- Training<br>- Cycle Training<br>- Clinician | - Gait<br>- Training<br>- Cycle Training<br>- Clinician | NMES (Programs 1-6)<br>TENS (Programs 7-10) |
| Waveform/<br>shape | Pulsed, Biphasic,<br>Rectangular with<br>interphase interval | Pulsed, Biphasic,<br>Rectangular with<br>interphase interval | Pulsed, Biphasic,<br>Rectangular with interphase<br>interval |
| Number of<br>output<br>channels | 1 channel<br>(EPG has 2<br>channels, but only 1<br>channel is<br>connected to the<br>thigh cuff electrodes) | Thigh cuff:<br>1 channel<br>(EPG has 2 channels,<br>but only 1 channel is<br>connected to the thigh<br>cuff electrodes) | 2 |
| Synchronous<br>or<br>Alternating? | N/A, only one output<br>channel | N/A, only one output<br>channel for thigh cuff | Synchronous (multiplexed) |
| Method of<br>Channel<br>Isolation | N/A, only one output<b…