Phoenix

K183152 · Us Bionics, Inc. (Dba Suitx) · PHL · Apr 17, 2019 · Physical Medicine

Device Facts

• Record ID: K183152
• Device Name: Phoenix
• Applicant: Us Bionics, Inc. (Dba Suitx)
• Product Code: PHL · Physical Medicine
• Decision Date: Apr 17, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3480
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Phoenix orthotically fits to the lower limbs and trunk. The device is intended to enable individuals with spinal cord injury at levels T4 to L5 to perform ambulatory functions in rehabilitation institutions in accordance with the user assessment and training certification program. This device is not intended for sports or stair climbing.

Device Story

Phoenix is a wearable, powered exoskeleton assisting trained users with SCI (T4-L5) to sit, stand, walk, and turn in rehabilitation institutions. System comprises motorized leg braces, torso module, lithium-ion battery, main controller, and wireless user interface (crutch/walker-mounted) paired with an Android tablet app. Clinicians operate the device, adjusting modular components (spine, hip, femur, tibia, footplate) and soft-good straps to fit patients. Device provides auditory feedback and LED indicators to the wearer. In power failure, knees lock and hips remain free. System requires mandatory clinician-led training and certification. Output enables patient ambulation, potentially improving mobility and functional independence. Safety is maintained by a required spotter/therapist during use.

Clinical Evidence

Prospective clinical study of 40 subjects with SCI (T4-L5). Primary endpoints: safety and effectiveness for transitional movements and walking. Results: 10MWT mean speed 0.12 m/s (±0.06); mean FIM 4.6 (±0.50). 6MWT mean FIM 4.37 (±0.49). TUG test: 39/40 subjects completed with minimal assistance, 1 with moderate assistance. Adverse events limited to minor bruising from improper fit; no unanticipated adverse events. Study confirms safety and effectiveness for intended use.

Technological Characteristics

Powered exoskeleton; modular adjustable aluminum/mechanical frame; lithium-ion battery (51.8V, 113Wh); motorized hip/knee actuators. Connectivity: wireless interface to Android tablet. Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), UN 38.3/ISO 62133 (battery). Software: control system for gait/transitions. Cleaning: alcohol-based solution compatible.

Indications for Use

Indicated for adults over 18 with spinal cord injury (SCI) at levels T4 to L5 to perform ambulatory functions in rehabilitation institutions. Contraindicated for sports or stair climbing.

Regulatory Classification

Identification

A powered lower extremity exoskeleton is a prescription device that is composed of an external, powered, motorized orthosis that is placed over a person's paralyzed or weakened limbs for medical purposes.

Special Controls

In combination with the general controls of the FD&C Act, the Powered Exoskeleton is subject to the following special controls:

*Classification.* Class II (special controls). The special controls for this device are:(1) Elements of the device materials that may contact the patient must be demonstrated to be biocompatible. (2) Appropriate analysis/testing must validate electromagnetic compatibility/interference (EMC/EMI), electrical safety, thermal safety, mechanical safety, battery performance and safety, and wireless performance, if applicable. (3) Appropriate software verification, validation, and hazard analysis must be performed. (4) Design characteristics must ensure geometry and materials composition are consistent with intended use. (5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing must include: (i) Mechanical bench testing (including durability testing) to demonstrate that the device will withstand forces, conditions, and environments encountered during use; (ii) Simulated use testing ( *i.e.,* cyclic loading testing) to demonstrate performance of device commands and safeguard under worst case conditions and after durability testing;(iii) Verification and validation of manual override controls are necessary, if present; (iv) The accuracy of device features and safeguards; and (v) Device functionality in terms of flame retardant materials, liquid/particle ingress prevention, sensor and actuator performance, and motor performance. (6) Clinical testing must demonstrate a reasonable assurance of safe and effective use and capture any adverse events observed during clinical use when used under the proposed conditions of use, which must include considerations for: (i) Level of supervision necessary, and (ii) Environment of use ( *e.g.,* indoors and/or outdoors) including obstacles and terrain representative of the intended use environment.(7) A training program must be included with sufficient educational elements so that upon completion of training program, the clinician, user, and companion can: (i) Identify the safe environments for device use, (ii) Use all safety features of device, and (iii) Operate the device in simulated or actual use environments representative of indicated environments and use. (8) Labeling for the Physician and User must include the following: (i) Appropriate instructions, warning, cautions, limitations, and information related to the necessary safeguards of the device, including warning against activities and environments that may put the user at greater risk. (ii) Specific instructions and the clinical training needed for the safe use of the device, which includes: (A) Instructions on assembling the device in all available configurations; (B) Instructions on fitting the patient; (C) Instructions and explanations of all available programs and how to program the device; (D) Instructions and explanation of all controls, input, and outputs; (E) Instructions on all available modes or states of the device; (F) Instructions on all safety features of the device; and (G) Instructions for properly maintaining the device. (iii) Information on the patient population for which the device has been demonstrated to have a reasonable assurance of safety and effectiveness. (iv) Pertinent non-clinical testing information ( *e.g.,* EMC, battery longevity).(v) A detailed summary of the clinical testing including: (A) Adverse events encountered under use conditions, (B) Summary of study outcomes and endpoints, and (C) Information pertinent to use of the device including the conditions under which the device was studied ( *e.g.,* level of supervision or assistance, and environment of use (*e.g.,* indoors and/or outdoors) including obstacles and terrain).

Predicate Devices

• Indego® (K152416)

Reference Devices

• EKSO (K161443)
• REWALK (K160987)

Submission Summary (Full Text)

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## 510(k) Summary as required by 21 CFR 807.92 K183152

#### Submission Information ਹ

### 1.1 Device Name

Phoenix™

### 1.2 Submission Sponsor

US Bionics, Inc. (DBA suitX) 4512 Hollis Street Emeryville, CA 94608

Homayoon Kazerooni, PhD Founder & CEO 1.510.610.2188 [e-mail]

### 1.3 Submission Contact

Official Contact Kelly Mettler Director of Regulatory Affairs and Quality Assurance [e-mail]

### Representative/Consultant

Allison C. Komiyama, Ph.D., R.A.C. AcKnowledge Regulatory Strategies, LLC Principal Consultant 2251 San Diego Avenue, Suite B-257 San Diego, CA 92110, USA 1.619.458.9547 [e-mail] https://www.acknowledge-rs.com

### 1.4 Submission Preparation Date

K183152 – 15 April 2019

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#### 2 Device Identification

| Trade Name: | Phoenix™ |
|------------------------|------------------------------|
| Common Name: | Powered Exoskeleton |
| Manufacturer: | US Bionics, Inc. (DBA suitX) |
| Classification Name: | Powered Exoskeleton |
| Device Classification: | Class II, 21 CFR 890.3480 |
| Product Code: | PHL |

#### Legally Marketed Predicate Device 3

| Trade Name: | Indego® |
|----------------------|-----------------------------------------------|
| Manufacturer: | Parker Hannifin Corporation (Parker Hannifin) |
| Classification Name: | Powered Exoskeleton |
| 510k Number: | K152416 |
| Submission Date: | 2/26/2016 |

#### Device Description 4

The Phoenix™ is a wearable, powered exoskeleton that assists a trained user to sit, stand, walk, and turn. The Phoenix consists of a pair of motorized leg braces coupled to a torso module, a lithium-ion battery pack, a main controller unit, and a wireless user interface attached to the handle of an assistive device (such as a crutch, walker, or parallel bars), control software, and mobile Android tablet hosting a mobile app. The Phoenix dimensions, such as spine length, torso hip width, femur length, femur bracket, tibia length, tibia bracket, and foot plate length can be adjusted individually. The Phoenix is coupled to the user via soft-good components (i.e. shoulder straps, waist pads, thigh straps, and shin pads), which can be adjusted to accommodate various users' dimensions.

#### 5 Indication for Use

The Phoenix orthotically fits to the lower limbs and trunk. The device is intended to enable individuals with spinal cord injury at levels T4 to L5 to perform ambulatory functions in rehabilitation institutions in accordance with the user assessment and training certification program. This device is not intended for sports or stair climbing.

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#### б Training

Training is a critical and required component of using the Phoenix™ exoskeleton. Patients and Clinicians must undergo training developed by suitX to learn proper use of the Phoenix device. The four-phase training program described in this guide is designed for training clinicians on the proper use and fit of the Phoenix. Refer to Table 1 below for the training sequence.

Table 1 Clinical Certification Training 4 Phase Training Program

- Device Overview
- Demonstration of ExoControl App Use
- Patient Measurement
- Tibia Length O
- Femur Length O
- Torso Width O
- Torso Height O
- Adjustment of Phoenix to fit Patient
- Leg Adjustment O
- Torso Adjustment (Width and Height)
- Footplate Adjustment O
- Safeguard Patient during maneuvers
- Standing Up O
- Walking O
- 0 Turning
- Sitting down O
- Documentation of settings, measurements, ● and outcomes (patient's maneuvers).

- Practice setting up and conducting an entire test session
- Review of phase 1 and 2 training ●
-
- Review of phase 1 training ●
- Session preparation and procedure ●
- Practice donning the device ●
- Practice resting while standing ●
- . Review of fail-safe sitting procedure
- Review of what to do in case of fall ●
- Demonstrate storage of device .
- Review troubleshooting of device

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- Review of any outstanding questions from phase 1-3
- . Certification

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### Substantial Equivalence (SE) Discussion 7

The following table compares the Phoenix™ to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The technological similarities between the subject device and the predicate device are substantially equivalent. The subject device does not raise any new issues of safety or effectiveness. Table 1, below, provides a summary comparison of the technological characteristics.

| Manufacturer | SuitX | Parker Hannifin | Significant Differences |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Phoenix Medical<br>Exoskeleton | Indego® | |
| 510(k) Number | K183152 | K152416 | N/A |
| Product Code | PHL | PHL | Same |
| Regulation<br>Number | 890.3480 | 890.3480 | Same |
| Regulation<br>Name | Powered Exoskeleton | Powered Exoskeleton | Same |
| Indications for<br>Use | The Phoenix Medical<br>Exoskeleton orthotically<br>fits to the lower limbs and<br>the trunk; the device is<br>intended to enable<br>individuals with spinal cord<br>injury at levels T4 to L5 to<br>perform ambulatory<br>functions in rehabilitation<br>institutions in accordance<br>with the user assessment<br>and training certification<br>program. This device is not<br>intended for sports or stair<br>climbing. | The Indego® orthotically<br>fits to the lower limbs and<br>the trunk; the device is<br>intended to enable<br>individuals with spinal cord<br>injury at levels T7 to L5 to<br>perform ambulatory<br>functions with supervision<br>of a specially trained<br>companion in accordance<br>with the user assessment<br>and training certification<br>program. The device is also<br>intended to enable<br>individuals with spinal cord<br>injury at levels T4 to T6 to<br>perform ambulatory<br>functions in rehabilitation<br>institutions in accordance<br>with the user assessment<br>and training certification<br>program. The Indego is not<br>intended for sports or stair<br>climbing. | Similar; the Phoenix<br>indications for use are<br>the same as the<br>predicate device when<br>used in rehabilitation<br>institutions. |
| Manufacturer | SuitX | Parker Hannifin | Significant Differences |
| Trade Name | Phoenix Medical<br>Exoskeleton | Indego® | |
| Body Coverage | Worn over legs and around<br>hips and lower torso;<br>shoulder straps for<br>additional stability | Worn over legs and around<br>hips and lower torso | Similar; the components<br>are worn around the<br>legs and torso with the<br>control unit of the<br>device integrated into<br>the hip segment. A rigid<br>back is connected to the<br>hip segment and worn<br>in a similar fashion as a<br>backpack. The rigid back<br>of the torso module of<br>the Phoenix is similar to<br>other FDA cleared<br>exoskeletons including<br>the EKSO (K161443) and<br>REWALK (K160987). No<br>additional safety or<br>efficacy concern as the<br>component<br>configuration is similar<br>for the legs, hip, and<br>torso of the patient. |
| Size of<br>Components | Modular Adjustable<br>Medium, and Large upper<br>leg, lower leg; and<br>adjustable torso<br>components; control unit<br>integrated in torso unit | Modular Small, Medium,<br>and Large upper leg, lower<br>leg, and hip components;<br>control unit integrated in<br>hip unit | Similar; adjustability<br>provided by manually<br>adjusting the length of<br>hard components.<br>Control unit is<br>integrated in hip unit.<br>No additional safety or<br>efficacy concern as the<br>component<br>configuration is similar<br>for the legs, hip, and<br>torso of the patient. |
| Mobility Aid | Crutches or walkers | Crutches or walkers | Same |
| Ability of User<br>Mobility | Sit, stand, walk, and turn | Sit, stand, walk, and turn | Same |
| Walking Speed | ~ 2 km/hr. | ~ 2 km/hr. | Same |
| Grade<br>Inclination | 5 degrees | 5 degrees | Same |
| Manufacturer<br>Trade Name | SuitX<br>Phoenix Medical<br>Exoskeleton | Parker Hannifin<br>Indego® | Significant Differences |
| Type of<br>Surface | Smooth, cement, carpet | Smooth, grass, cement,<br>carpet, transitions,<br>thresholds | Similar; the Phoenix<br>surface types are the<br>same as the predicate<br>device when used in<br>rehabilitation<br>institutions. |
| Patient<br>Population | Adults over age of 18 with<br>Spinal Cord Injury (SCI)<br>from T4 to L5 | Adults over age of 18 with<br>Spinal Cord Injury (SCI)<br>from T4 to L5 | Same |
| Height of<br>Patient | 61" to 75" (1.55 to 1.91m) | 61" to 75" (1.55 to 1.91m) | Same |
| Weight of<br>Patient | Up to 200 lbs. (90.7 kg) | Up to 250 lbs. (113 kg) | Similar; the device<br>accommodates lighter<br>weight patients and<br>does not present any<br>additional safety or<br>efficacy concerns. |
| Control<br>Method | Remote control on the<br>walker or crutch to trigger<br>all transitions | Uses postural cues to<br>trigger all transitions | Similar; the remote<br>control provides the<br>trained user direct<br>control over the device<br>operation. Additionally,<br>the remote control is<br>used to trigger sit-to-<br>stand and stand-to-sit.<br>No additional safety or<br>efficacy concerns have<br>been identified. |
| Range of<br>Motion | Hip: 140° flexion to 38°<br>extension<br>Knees: 110° flexion to 5°<br>extension | Hip: 110° flexion to 30°<br>extension<br>Knees: 110° flexion to<br>10° extension | Similar; there is a larger<br>range of motion for the<br>Phoenix device to allow<br>easier sit-to-stand<br>transitions. No<br>additional safety or<br>efficacy concerns as<br>clinical data supports<br>the safe use of the<br>device for ambulation<br>and sitting/standing<br>transitions. |
| Manufacturer<br>Trade Name | SuitX<br>Phoenix Medical<br>Exoskeleton | Parker Hannifin<br>Indego® | Significant Differences |
| Weight | 33 lbs. (15kg) | 26 lbs. (12kg) | Similar; the device<br>weighs more than the<br>predicate device but<br>within predicate range<br>of exoskeleton devices<br>(26 lbs. - 66 lbs.). |
| Rechargeable<br>Battery | Rechargeable lithium ion.<br>51.8 V, 10A peak current,<br>10A continuous current,<br>113Wh fully charged; 4<br>hours of continuous<br>walking per charge | Rechargeable lithium<br>ion. 33.3V, 36A peak<br>current, 12A continuous<br>current. 159Wh fully<br>charged; 1.5 hours of<br>continuous walking per<br>charge | Similar; the phoenix<br>battery is slightly<br>smaller but provides the<br>necessary power for the<br>operation of the device.<br>No additional safety or<br>efficacy concerns. |
| Battery Charge<br>Time | Maximum of 2 hours | Maximum of 4 hours | Similar; the Phoenix<br>battery is able to be<br>charged in a slightly<br>faster period of time.<br>No additional safety or<br>efficacy concerns. |
| Expected<br>Useable Life | 5 years | 5 years | Same |
| Training<br>Program | Yes | Yes | Same |
| Certification<br>Program | Yes | Yes | Same |
| User Feedback | Provides auditory feedback<br>and LED indicators on top<br>of hip unit, visible to the<br>wearer | Provides vibratory<br>feedback and LED<br>indicators on top of hip<br>unit, visible to the wearer | Similar; auditory<br>feedback provides the<br>user with critical safety<br>information; both<br>devices provide LED<br>indicators to<br>communicate<br>information to the user.<br>No additional safety or<br>efficacy concerns. |
| Manufacturer | SuitX | Parker Hannifin | |
| Trade Name | Phoenix Medical | Indego® | Significant Differences |
| | Exoskeleton | | |
| Fall Detection<br>and Mitigation | Detects posture and<br>prevents user from<br>standing up if improper<br>posture is detected.<br>Automatic User Interface<br>timeout reduces the risk of<br>falling due to accidental<br>user inputs. Fall protection<br>is provided by the<br>Healthcare<br>Professional/Physical<br>Therapist (PT). Device does<br>not have fall detection<br>features. | Detects forward, backward,<br>and sideways falling as it is<br>happening; the device<br>makes adjustments during<br>the course of the fall to<br>position the user for<br>minimal risk of injury | Different; the Phoenix<br>device will notify the<br>user after detecting<br>improper positioning to<br>prevent the risk of<br>injury during standup.<br>While standing or<br>walking, fall protection<br>and mitigation is<br>provided by the<br>Healthcare Professional/<br>Physical Therapist (PT).<br>No additional safety or<br>efficacy concerns have<br>been identified as both<br>devices require a<br>spotter to guard against |
| Failsafe<br>Feature | In the event of power<br>failure – knees become<br>locked and hips free<br>(similar to typical passive<br>leg braces) | In event of power failure -<br>knees become locked and<br>hips free (similar to typical<br>passive leg braces) | falls.<br>Same |
| Operating<br>Temperature | 32°F to 88°F (0°C to 31°C) | 32°F to 88°F (0°C to 31°C) | Same |
| Operating<br>Humidity | 30% to 75% RH | 30% to 75% RH | Same |
| Electrical<br>Safety Testing | Passed IEC 60601-1:2005<br>(3rd Edition) + CORR.<br>1:2006 + CORR. 2:2007 +<br>A1:2012 (or IEC 60601-1:<br>2012 reprint) | Passed ANSI/AAMI<br>ES60601-<br>1:2005/(R)2012 | Similar; tested to<br>newest version of the<br>standard |
| Electromagnetic<br>Compatibility<br>Testing | Passed IEC 60601-1-2:2014<br>(4TH Edition) | Passed IEC 60601-1-<br>2:2007 | Similar; tested to<br>newest version of the<br>standard |
| Technical Area | Test Completed | Results | |
| Electrical Safety<br>Testing | IEC 60601-1:2005 (3rd Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012<br>(or IEC 60601-1: 2012 reprint) | PASS | |
| Electromagnetic<br>Compatibility Testing | IEC 60601-1-2:2014 (4th Edition)<br>AAMI/TIR69:2017 - Medical Devices - Risk Management of Radio-<br>Frequency Wireless Coexistence | PASS | |
| Battery Safety Testing | UN 38.3, ISO 62133 | PASS…