Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or related terms, nor does it describe any features or performance metrics typically associated with AI/ML algorithms (e.g., training data, test data, specific algorithm types). The device description focuses on mechanical and control system components.

Therapeutic

Yes
The device is intended to enable individuals with spinal cord injury to perform ambulatory functions in rehabilitation institutions, which aligns with the definition of a therapeutic device designed to restore or improve physiological function.

Diagnostic

No

The device is a powered exoskeleton intended to assist individuals with spinal cord injury perform ambulatory functions; it does not diagnose any condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "wearable, powered exoskeleton" consisting of motorized leg braces, a torso module, battery pack, main controller unit, and a wireless user interface, in addition to control software and a mobile app. This clearly indicates it is a hardware device with integrated software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is for enabling individuals with spinal cord injury to perform ambulatory functions. This is a therapeutic and rehabilitative purpose, not a diagnostic one.
Device Description: The description details a wearable, powered exoskeleton that assists with physical movement (sitting, standing, walking, turning). This is a physical device interacting with the user's body for functional assistance.
Lack of Diagnostic Elements: There is no mention of the device analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a disease or condition.
Clinical Study Focus: The clinical study evaluates the device's performance in terms of mobility and functional independence (walking tests, FIM scores, etc.), which are measures of physical function, not diagnostic accuracy.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

PHL

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

lower limbs and trunk

Indicated Patient Age Range

Adults over age of 18

Intended User / Care Setting

trained user, rehabilitation institutions

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)

A clinical study was performed with the investigational product, the Phoenix™, for assessing the mobility of persons with Spinal Cord Injury (SCI) while using the device. The study was conducted to evaluate the Phoenix device for safety and effectiveness in allowing persons with SCI who are non-ambulatory to poorly ambulatory to stand up and walk under a variety of conditions. The study was performed in compliance with Good Clinical Practices (GCP) with subjects enrolled in an IRB approved study that were consented for participation according to the intended use of the device, defined inclusion criteria, and defined exclusion criteria; with the purpose of meeting the study objectives.
The study objectives were defined as the following:

. Demonstrate that the Phoenix device is both safe and effective for the intended use for patients with SCI who are non-ambulatory or poorly ambulatory to stand up and walk under a variety of conditions.
Participants with SCI Level T4 to L5 can safely complete transitional movements (stand up, turn, sit down) and walk using Phoenix with minimal contact assistance or Functional Independence Measure (FIM).
. Participants with SCI level T4 to L5 are able to achieve walking during the 10 Meter Walk Test (10MWT) and 6 Minute Walk Test (6MWT).

The clinical study was planned for and completed with 40 (forty) subjects. The subjects were required to complete a series of 20 (twenty) study sessions that included screening, fitting, evaluation, training with the device, as well as assessment from each session and outcome measurements. Assessments were conducted throughout the total number of sessions with final outcome measurements recorded at the completion of the study.

The outcomes measurements for the clinical study are summarized as follows:

The mean FIM for the 10 Meter Walk Test (10MWT) was 4.6 (±0.50). Participants completed the 10MWT in 61.9 seconds (±34.64) on average with a mean speed of 0.12 m/s (±0.06). All participants were able to complete the 10MWT.
The mean FIM for the 6-minute walk test was 4.37 (±0.49), indicating an acceptable level of functional independence during this assessment.
. The Timed Up-and-Go (TUG) Test measured the ability of the subject to perform transitional motions beyond just walking, i.e. standing up, sitting down, and turning. Of the 40 (forty) subjects that completed the study, 39 (thirty-nine) subjects were able to complete with minimal contact assistance (FIM score of 4 or higher) and one (1) subject was able to complete with moderate contact assistance (FIM score of 3).
. Level of assistance was measured according to WISC-II and FIM scores during the study to provide a view of task-specific level of assistance needed while performing movements using the Phoenix device. The WISC-II scores for all subjects averaged mean scores of 8.60 (±2.19) for the final assessment during the study. The FIM scores as noted previously support that subjects were capable of managing all scenarios presented, which included using the device on concrete and carpet.
. Study participants were requested to complete multiple questionnaires during the study trial including a Modified Borg Rating of Perceived Exertion to capture the effort subjects felt to achieve basic level-ground walking. The averaged results of the assessment for indoor level ground walking at the end of their sessions was 3.3, which corresponds to an exertion level just above "moderate."
Adverse Events (AE) reported during the study included minor instances of bruising. The causes attributed to these reported incidents were related to improper fitting or improper padding. These subjects were able to safely complete the study. There were no Unanticipated Adverse Events (UAE). The clinical study concluded that the Phoenix device is safe and effective for its intended use and the outcomes of the study met the stated objectives. The clinical trial supports the indication for use for enabling 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Mean FIM for 10MWT: 4.6 (±0.50)
Time for 10MWT: 61.9 seconds (±34.64)
Mean speed for 10MWT: 0.12 m/s (±0.06)
Mean FIM for 6-minute walk test: 4.37 (±0.49)
FIM score for TUG test: 39 subjects with FIM score of 4 or higher; 1 subject with FIM score of 3.
Mean WISC-II scores: 8.60 (±2.19)
Averaged Modified Borg Rating of Perceived Exertion: 3.3

Predicate Device(s)

K152416

Reference Device(s)

EKSO (K161443), REWALK (K160987)

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 890.3480 Powered lower extremity exoskeleton.

(a)
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.(b)
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).

Summary

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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 info@suitx.com

1.3 Submission Contact

Official Contact Kelly Mettler Director of Regulatory Affairs and Quality Assurance Regulatory@suitx.com

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 info@acknowledge-rs.com 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
Exoskeleton	Indego®
510(k) Number	K183152	K152416	N/A
Product Code	PHL	PHL	Same
Regulation
Number	890.3480	890.3480	Same
Regulation
Name	Powered Exoskeleton	Powered Exoskeleton	Same
Indications for
Use	The Phoenix Medical
Exoskeleton orthotically
fits to the lower limbs and
the 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.	The Indego® orthotically
fits to the lower limbs and
the trunk; the device is
intended to enable
individuals with spinal cord
injury at levels T7 to L5 to
perform ambulatory
functions with supervision
of a specially trained
companion in accordance
with the user assessment
and training certification
program. The device is also
intended to enable
individuals with spinal cord
injury at levels T4 to T6 to
perform ambulatory
functions in rehabilitation
institutions in accordance
with the user assessment
and training certification
program. The Indego is not
intended for sports or stair
climbing.	Similar; the Phoenix
indications for use are
the same as the
predicate device when
used in rehabilitation
institutions.
Manufacturer	SuitX	Parker Hannifin	Significant Differences
Trade Name	Phoenix Medical
Exoskeleton	Indego®
Body Coverage	Worn over legs and around
hips and lower torso;
shoulder straps for
additional stability	Worn over legs and around
hips and lower torso	Similar; the components
are worn around the
legs and torso with the
control unit of the
device integrated into
the hip segment. A rigid
back is connected to the
hip segment and worn
in a similar fashion as a
backpack. The rigid back
of the torso module of
the Phoenix is similar to
other FDA cleared
exoskeletons including
the EKSO (K161443) and
REWALK (K160987). No
additional safety or
efficacy concern as the
component
configuration is similar
for the legs, hip, and
torso of the patient.
Size of
Components	Modular Adjustable
Medium, and Large upper
leg, lower leg; and
adjustable torso
components; control unit
integrated in torso unit	Modular Small, Medium,
and Large upper leg, lower
leg, and hip components;
control unit integrated in
hip unit	Similar; adjustability
provided by manually
adjusting the length of
hard components.
Control unit is
integrated in hip unit.
No additional safety or
efficacy concern as the
component
configuration is similar
for the legs, hip, and
torso of the patient.
Mobility Aid	Crutches or walkers	Crutches or walkers	Same
Ability of User
Mobility	Sit, stand, walk, and turn	Sit, stand, walk, and turn	Same
Walking Speed	~ 2 km/hr.	~ 2 km/hr.	Same
Grade
Inclination	5 degrees	5 degrees	Same
Manufacturer
Trade Name	SuitX
Phoenix Medical
Exoskeleton	Parker Hannifin
Indego®	Significant Differences
Type of
Surface	Smooth, cement, carpet	Smooth, grass, cement,
carpet, transitions,
thresholds	Similar; the Phoenix
surface types are the
same as the predicate
device when used in
rehabilitation
institutions.
Patient
Population	Adults over age of 18 with
Spinal Cord Injury (SCI)
from T4 to L5	Adults over age of 18 with
Spinal Cord Injury (SCI)
from T4 to L5	Same
Height of
Patient	61" to 75" (1.55 to 1.91m)	61" to 75" (1.55 to 1.91m)	Same
Weight of
Patient	Up to 200 lbs. (90.7 kg)	Up to 250 lbs. (113 kg)	Similar; the device
accommodates lighter
weight patients and
does not present any
additional safety or
efficacy concerns.
Control
Method	Remote control on the
walker or crutch to trigger
all transitions	Uses postural cues to
trigger all transitions	Similar; the remote
control provides the
trained user direct
control over the device
operation. Additionally,
the remote control is
used to trigger sit-to-
stand and stand-to-sit.
No additional safety or
efficacy concerns have
been identified.
Range of
Motion	Hip: 140° flexion to 38°
extension
Knees: 110° flexion to 5°
extension	Hip: 110° flexion to 30°
extension
Knees: 110° flexion to
10° extension	Similar; there is a larger
range of motion for the
Phoenix device to allow
easier sit-to-stand
transitions. No
additional safety or
efficacy concerns as
clinical data supports
the safe use of the
device for ambulation
and sitting/standing
transitions.
Manufacturer
Trade Name	SuitX
Phoenix Medical
Exoskeleton	Parker Hannifin
Indego®	Significant Differences
Weight	33 lbs. (15kg)	26 lbs. (12kg)	Similar; the device
weighs more than the
predicate device but
within predicate range
of exoskeleton devices
(26 lbs. - 66 lbs.).
Rechargeable
Battery	Rechargeable lithium ion.
51.8 V, 10A peak current,
10A continuous current,
113Wh fully charged; 4
hours of continuous
walking per charge	Rechargeable lithium
ion. 33.3V, 36A peak
current, 12A continuous
current. 159Wh fully
charged; 1.5 hours of
continuous walking per
charge	Similar; the phoenix
battery is slightly
smaller but provides the
necessary power for the
operation of the device.
No additional safety or
efficacy concerns.
Battery Charge
Time	Maximum of 2 hours	Maximum of 4 hours	Similar; the Phoenix
battery is able to be
charged in a slightly
faster period of time.
No additional safety or
efficacy concerns.
Expected
Useable Life	5 years	5 years	Same
Training
Program	Yes	Yes	Same
Certification
Program	Yes	Yes	Same
User Feedback	Provides auditory feedback
and LED indicators on top
of hip unit, visible to the
wearer	Provides vibratory
feedback and LED
indicators on top of hip
unit, visible to the wearer	Similar; auditory
feedback provides the
user with critical safety
information; both
devices provide LED
indicators to
communicate
information to the user.
No additional safety or
efficacy concerns.
Manufacturer	SuitX	Parker Hannifin
Trade Name	Phoenix Medical	Indego®	Significant Differences
	Exoskeleton
Fall Detection
and Mitigation	Detects posture and
prevents user from
standing up if improper
posture is detected.
Automatic User Interface
timeout reduces the risk of
falling due to accidental
user inputs. Fall protection
is provided by the
Healthcare
Professional/Physical
Therapist (PT). Device does
not have fall detection
features.	Detects forward, backward,
and sideways falling as it is
happening; the device
makes adjustments during
the course of the fall to
position the user for
minimal risk of injury	Different; the Phoenix
device will notify the
user after detecting
improper positioning to
prevent the risk of
injury during standup.
While standing or
walking, fall protection
and mitigation is
provided by the
Healthcare Professional/
Physical Therapist (PT).
No additional safety or
efficacy concerns have
been identified as both
devices require a
spotter to guard against
Failsafe
Feature	In the event of power
failure – knees become
locked and hips free
(similar to typical passive
leg braces)	In event of power failure -
knees become locked and
hips free (similar to typical
passive leg braces)	falls.
Same
Operating
Temperature	32°F to 88°F (0°C to 31°C)	32°F to 88°F (0°C to 31°C)	Same
Operating
Humidity	30% to 75% RH	30% to 75% RH	Same
Electrical
Safety Testing	Passed IEC 60601-1:2005
(3rd Edition) + CORR.
1:2006 + CORR. 2:2007 +
A1:2012 (or IEC 60601-1:
2012 reprint)	Passed ANSI/AAMI
ES60601-
1:2005/(R)2012	Similar; tested to
newest version of the
standard
Electromagnetic
Compatibility
Testing	Passed IEC 60601-1-2:2014
(4TH Edition)	Passed IEC 60601-1-
2:2007	Similar; tested to
newest version of the
standard
Technical Area	Test Completed	Results
Electrical Safety
Testing	IEC 60601-1:2005 (3rd Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012
(or IEC 60601-1: 2012 reprint)	PASS
Electromagnetic
Compatibility Testing	IEC 60601-1-2:2014 (4th Edition)
AAMI/TIR69:2017 - Medical Devices - Risk Management of Radio-
Frequency Wireless Coexistence	PASS
Battery Safety Testing	UN 38.3, ISO 62133	PASS
Thermal	IEC 60601-1:2005 (R2012)	PASS
Software Verification
and Validation
Testing	Software verification and validation testing per FDA Guidance and IEC 62304:
Conformance of software development life cycle for the Phoenix software systemCompliance to the requirements of the FDA guidance document for software contained in a medical device.	PASS
Maximum Torque
Testing	Testing to verify the maximum continuous and peak torques that are applied at the knees and hips measured in Nm against defined specifications.	PASS
Cleaning Testing	Testing to verify the device can be cleaned using alcohol-based solution.	PASS
Component Lifecycle
Testing	Verification that the device meets the requirements for the major mechanical subsystems to perform safely during the expected use between routine servicing in simulated normal use	PASS
Durability Testing	Performance testing designed to verify the device meets factors of safety defined in design input requirements
Cyclic torque testing was conducted on various subsections of the device (e.g. hip, knee, spine).
Cyclic impact fatigue loading of the device construct was completed.	PASS
Battery Life Cycle
Testing	Testing performed for the batteries being cycled through normal use including measuring the full charge amount, capacity of battery, and cycle life over defined periods, according to the battery specifications	PASS
Storage and
Transport Testing	Completed testing to support that the device is protected and not damaged during normal, routine shipping according to ISTA Standards for drop, compression, and vibration	PASS

Table 1. Technological SE Comparison between Phoenix and Predicate

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Non-Clinical Performance Data 8

suitX completed a number of non-clinical tests to demonstrate the safety and effectiveness of the Phoenix™ and to establish substantial equivalence to the predicate device of this 510(k) submission. The Phoenix met all requirements for design characteristics, non-clinical performance testing, electrical safety and EMC/EMI testing, to confirm that the Phoenix device met the design inputs and specifications for the device.

The Phoenix passed all non-clinical testing in accordance with internal suitX requirements, national and international standards shown in Table 2 below to support substantial equivalence to the predicate device.

Table 2. Performance Testing by Technical Area

The Phoenix device passed all testing stated above as shown by the acceptable results obtained.

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Clinical Performance Data 9

A clinical study was performed with the investigational product, the Phoenix™, for assessing the mobility of persons with Spinal Cord Injury (SCI) while using the device. The study was conducted to evaluate the Phoenix device for safety and effectiveness in allowing persons with SCI who are non-ambulatory to poorly ambulatory to stand up and walk under a variety of conditions. The study was performed in compliance with Good Clinical Practices (GCP) with subjects enrolled in an IRB approved study that were consented for participation according to the intended use of the device, defined inclusion criteria, and defined exclusion criteria; with the purpose of meeting the study objectives.

The study objectives were defined as the following:

. Demonstrate that the Phoenix device is both safe and effective for the intended use for patients with SCI who are non-ambulatory or poorly ambulatory to stand up and walk under a variety of conditions.
Participants with SCI Level T4 to L5 can safely complete transitional movements (stand up, turn, sit down) and walk using Phoenix with minimal contact assistance or Functional Independence Measure (FIM).
. Participants with SCI level T4 to L5 are able to achieve walking during the 10 Meter Walk Test (10MWT) and 6 Minute Walk Test (6MWT).

The clinical study was planned for and completed with 40 (forty) subjects. The subjects were required to complete a series of 20 (twenty) study sessions that included screening, fitting, evaluation, training with the device, as well as assessment from each session and outcome measurements. Assessments were conducted throughout the total number of sessions with final outcome measurements recorded at the completion of the study.

The outcomes measurements for the clinical study are summarized as follows:

The mean FIM for the 10 Meter Walk Test (10MWT) was 4.6 (±0.50). Participants completed the 10MWT in 61.9 seconds (±34.64) on average with a mean speed of 0.12 m/s (±0.06). All participants were able to complete the 10MWT.
The mean FIM for the 6-minute walk test was 4.37 (±0.49), indicating an acceptable level of functional independence during this assessment.
. The Timed Up-and-Go (TUG) Test measured the ability of the subject to perform transitional motions beyond just walking, i.e. standing up, sitting down, and turning. Of the 40 (forty) subjects that completed the study, 39 (thirty-nine) subjects were able to

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Image /page/11/Picture/0 description: The image shows the logo for SuitX. The logo is in black, except for the X, which is in red. The logo is simple and modern, and it is likely used to represent a company that specializes in exoskeletons and other wearable technologies.

complete with minimal contact assistance (FIM score of 4 or higher) and one (1) subject was able to complete with moderate contact assistance (FIM score of 3).

. Level of assistance was measured according to WISC-II and FIM scores during the study to provide a view of task-specific level of assistance needed while performing movements using the Phoenix device. The WISC-II scores for all subjects averaged mean scores of 8.60 (±2.19) for the final assessment during the study. The FIM scores as noted previously support that subjects were capable of managing all scenarios presented, which included using the device on concrete and carpet.
. Study participants were requested to complete multiple questionnaires during the study trial including a Modified Borg Rating of Perceived Exertion to capture the effort subjects felt to achieve basic level-ground walking. The averaged results of the assessment for indoor level ground walking at the end of their sessions was 3.3, which corresponds to an exertion level just above "moderate."
Adverse Events (AE) reported during the study included minor instances of bruising. The causes attributed to these reported incidents were related to improper fitting or improper padding. These subjects were able to safely complete the study. There were no Unanticipated Adverse Events (UAE). The clinical study concluded that the Phoenix device is safe and effective for its intended use and the outcomes of the study met the stated objectives. The clinical trial supports the indication for use for enabling 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.

10 Conclusion

The non-clinical and clinical testing information contained herein demonstrates the Phoenix™ performs according to its intended use. U.S. Bionics, Inc. (DBA suitX) considers the Phoenix (subject device) to be substantially equivalent to the legally marketed predicate device (K152416) noted herein and is safe and effective for its labeled intended use.

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Image /page/12/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.

April 17, 2019

US Bionics, Inc. (DBA suitX) % Allison Komivama Principal Consultant AcKnowledge Regulatory Strategies, LLC 2251 San Diego Avenue, Suite B-257 San Diego, California 92110

Re: K183152

Trade/Device Name: Phoenix Regulation Number: 21 CFR 890.3480 Regulation Name: Powered Lower Extremity Exoskeleton Regulatory Class: Class II Product Code: PHL Dated: March 15, 2019 Received: March 18, 2019

Dear Allison Komiyama:

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.

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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 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.htm); 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,

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