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 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.

AI/ML Overview

The provided document describes the Phoenix™ powered exoskeleton and its regulatory submission (K183152). It outlines performance data to demonstrate its safety and effectiveness and its substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative manner as pass/fail thresholds for specific metrics before the study. Instead, the study objectives and the results achieved are presented as evidence that the device meets its intended purpose. The table below synthesizes the implicit acceptance criteria from the study objectives and the reported performance.

Acceptance Criterion (Implied from Study Objective)	Reported Device Performance (Result)
Safe and effective for intended use (SCI T4-L5 non-ambulatory to poorly ambulatory to stand up and walk under various conditions)	Safety: "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... There were no Unanticipated Adverse Events (UAE)." "The clinical study concluded that the Phoenix device is safe and effective for its intended use..." Effectiveness: All detailed performance metrics below support effectiveness.
Participants with SCI T4-L5 can safely complete transitional movements (stand up, turn, sit down) and walk using Phoenix with minimal contact assistance or Functional Independence Measure (FIM)	Transitional Movements (TUG Test): 39 out of 40 subjects completed with minimal contact assistance (FIM score of 4 or higher); 1 subject completed with moderate contact assistance (FIM score of 3). Level of Assistance (WISC-II): Averaged mean scores of 8.60 (±2.19) for the final assessment. Level of Assistance (FIM): "FIM scores as noted previously support that subjects were capable of managing all scenarios presented..."
Participants with SCI T4-L5 are able to achieve walking during the 10 Meter Walk Test (10MWT) and 6 Minute Walk Test (6MWT).	10MWT: All participants (40/40) were able to complete the 10MWT. Mean FIM was 4.6 (±0.50). Average completion time was 61.9 seconds (±34.64), with a mean speed of 0.12 m/s (±0.06). 6MWT: Mean FIM was 4.37 (±0.49), "indicating an acceptable level of functional independence."
User exertion for basic level-ground walking (Modified Borg Rating of Perceived Exertion)	Averaged results of 3.3 for indoor level-ground walking at the end of sessions, corresponding to an exertion level just above "moderate."

2. Sample size used for the test set and the data provenance

Sample Size: 40 subjects.
Data Provenance: The document does not specify the country of origin of the data. It states, "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..." This implies a prospective clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of diagnostic accuracy studies (e.g., radiologists interpreting images). Instead, the study evaluates the functional performance and safety of the exoskeleton in human subjects. The outcome measures (FIM, WISC-II, 10MWT, 6MWT, TUG Test, Modified Borg) are objective measures or standardized assessments commonly used in rehabilitation, performed by trained clinicians/investigators within the study protocol. The "ground truth" here is the direct, observed performance of the subjects using the device.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

The concept of an adjudication method (like 2+1 for conflicting interpretations) is not applicable here as this is a functional performance and safety study, not a diagnostic study requiring interpretation of outcomes by multiple experts. The clinical outcomes were directly measured or observed by the study staff.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This study is a clinical trial assessing the performance of a medical device (exoskeleton), not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is irrelevant to this document.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm-only performance study was not done. The Phoenix™ is a physical medical device (exoskeleton) intended for use by individuals with spinal cord injury in rehabilitation settings. Its entire purpose involves human-in-the-loop performance (the user wearing and operating the device under clinician supervision).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For this functional performance study, the "ground truth" consists of observed clinical outcomes data and standardized functional assessment scores collected directly from the subjects using the Phoenix™ device in a controlled clinical setting. These include:

Functional Independence Measure (FIM) scores
WISC-II scores (likely a typo for WISCI II - Walking Index for Spinal Cord Injury)
10 Meter Walk Test (10MWT) results (time, speed)
6 Minute Walk Test (6MWT) results (implied distance/FIM score)
Timed Up-and-Go (TUG) Test results
Modified Borg Rating of Perceived Exertion scores
Adverse Event (AE) reporting.

8. The sample size for the training set

The document mentions "training with the device" for the 40 subjects enrolled in the clinical study as part of their 20 sessions. This training is for the actual users (patients) and clinicians to learn how to operate the device, not an algorithm's training data.

The document does not refer to a "training set" in the context of machine learning or AI algorithms. The Phoenix™ is a powered exoskeleton, not an AI diagnostic tool that requires a separate training data set for model development.

9. How the ground truth for the training set was established

As there is no mention of a "training set" for an algorithm in this context, this question is not applicable to the provided document. The device itself is "trained" in terms of its parameters and control mechanisms during its engineering and development phase, but this is distinct from "ground truth for a training set" in AI/ML performance studies.

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

5 Indication for Use

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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 MedicalExoskeleton	Indego®
510(k) Number	K183152	K152416	N/A
Product Code	PHL	PHL	Same
RegulationNumber	890.3480	890.3480	Same
RegulationName	Powered Exoskeleton	Powered Exoskeleton	Same
Indications forUse	The Phoenix MedicalExoskeleton orthoticallyfits to the lower limbs andthe trunk; the device isintended to enableindividuals with spinal cordinjury at levels T4 to L5 toperform ambulatoryfunctions in rehabilitationinstitutions in accordancewith the user assessmentand training certificationprogram. This device is notintended for sports or stairclimbing.	The Indego® orthoticallyfits to the lower limbs andthe trunk; the device isintended to enableindividuals with spinal cordinjury at levels T7 to L5 toperform ambulatoryfunctions with supervisionof a specially trainedcompanion in accordancewith the user assessmentand training certificationprogram. The device is alsointended to enableindividuals with spinal cordinjury at levels T4 to T6 toperform ambulatoryfunctions in rehabilitationinstitutions in accordancewith the user assessmentand training certificationprogram. The Indego is notintended for sports or stairclimbing.	Similar; the Phoenixindications for use arethe same as thepredicate device whenused in rehabilitationinstitutions.
Manufacturer	SuitX	Parker Hannifin	Significant Differences
Trade Name	Phoenix MedicalExoskeleton	Indego®
Body Coverage	Worn over legs and aroundhips and lower torso;shoulder straps foradditional stability	Worn over legs and aroundhips and lower torso	Similar; the componentsare worn around thelegs and torso with thecontrol unit of thedevice integrated intothe hip segment. A rigidback is connected to thehip segment and wornin a similar fashion as abackpack. The rigid backof the torso module ofthe Phoenix is similar toother FDA clearedexoskeletons includingthe EKSO (K161443) andREWALK (K160987). Noadditional safety orefficacy concern as thecomponentconfiguration is similarfor the legs, hip, andtorso of the patient.
Size ofComponents	Modular AdjustableMedium, and Large upperleg, lower leg; andadjustable torsocomponents; control unitintegrated in torso unit	Modular Small, Medium,and Large upper leg, lowerleg, and hip components;control unit integrated inhip unit	Similar; adjustabilityprovided by manuallyadjusting the length ofhard components.Control unit isintegrated in hip unit.No additional safety orefficacy concern as thecomponentconfiguration is similarfor the legs, hip, andtorso of the patient.
Mobility Aid	Crutches or walkers	Crutches or walkers	Same
Ability of UserMobility	Sit, stand, walk, and turn	Sit, stand, walk, and turn	Same
Walking Speed	~ 2 km/hr.	~ 2 km/hr.	Same
GradeInclination	5 degrees	5 degrees	Same
ManufacturerTrade Name	SuitXPhoenix MedicalExoskeleton	Parker HannifinIndego®	Significant Differences
Type ofSurface	Smooth, cement, carpet	Smooth, grass, cement,carpet, transitions,thresholds	Similar; the Phoenixsurface types are thesame as the predicatedevice when used inrehabilitationinstitutions.
PatientPopulation	Adults over age of 18 withSpinal Cord Injury (SCI)from T4 to L5	Adults over age of 18 withSpinal Cord Injury (SCI)from T4 to L5	Same
Height ofPatient	61" to 75" (1.55 to 1.91m)	61" to 75" (1.55 to 1.91m)	Same
Weight ofPatient	Up to 200 lbs. (90.7 kg)	Up to 250 lbs. (113 kg)	Similar; the deviceaccommodates lighterweight patients anddoes not present anyadditional safety orefficacy concerns.
ControlMethod	Remote control on thewalker or crutch to triggerall transitions	Uses postural cues totrigger all transitions	Similar; the remotecontrol provides thetrained user directcontrol over the deviceoperation. Additionally,the remote control isused to trigger sit-to-stand and stand-to-sit.No additional safety orefficacy concerns havebeen identified.
Range ofMotion	Hip: 140° flexion to 38°extensionKnees: 110° flexion to 5°extension	Hip: 110° flexion to 30°extensionKnees: 110° flexion to10° extension	Similar; there is a largerrange of motion for thePhoenix device to alloweasier sit-to-standtransitions. Noadditional safety orefficacy concerns asclinical data supportsthe safe use of thedevice for ambulationand sitting/standingtransitions.
ManufacturerTrade Name	SuitXPhoenix MedicalExoskeleton	Parker HannifinIndego®	Significant Differences
Weight	33 lbs. (15kg)	26 lbs. (12kg)	Similar; the deviceweighs more than thepredicate device butwithin predicate rangeof exoskeleton devices(26 lbs. - 66 lbs.).
RechargeableBattery	Rechargeable lithium ion.51.8 V, 10A peak current,10A continuous current,113Wh fully charged; 4hours of continuouswalking per charge	Rechargeable lithiumion. 33.3V, 36A peakcurrent, 12A continuouscurrent. 159Wh fullycharged; 1.5 hours ofcontinuous walking percharge	Similar; the phoenixbattery is slightlysmaller but provides thenecessary power for theoperation of the device.No additional safety orefficacy concerns.
Battery ChargeTime	Maximum of 2 hours	Maximum of 4 hours	Similar; the Phoenixbattery is able to becharged in a slightlyfaster period of time.No additional safety orefficacy concerns.
ExpectedUseable Life	5 years	5 years	Same
TrainingProgram	Yes	Yes	Same
CertificationProgram	Yes	Yes	Same
User Feedback	Provides auditory feedbackand LED indicators on topof hip unit, visible to thewearer	Provides vibratoryfeedback and LEDindicators on top of hipunit, visible to the wearer	Similar; auditoryfeedback provides theuser with critical safetyinformation; bothdevices provide LEDindicators tocommunicateinformation to the user.No additional safety orefficacy concerns.
Manufacturer	SuitX	Parker Hannifin
Trade Name	Phoenix Medical	Indego®	Significant Differences
	Exoskeleton
Fall Detectionand Mitigation	Detects posture andprevents user fromstanding up if improperposture is detected.Automatic User Interfacetimeout reduces the risk offalling due to accidentaluser inputs. Fall protectionis provided by theHealthcareProfessional/PhysicalTherapist (PT). Device doesnot have fall detectionfeatures.	Detects forward, backward,and sideways falling as it ishappening; the devicemakes adjustments duringthe course of the fall toposition the user forminimal risk of injury	Different; the Phoenixdevice will notify theuser after detectingimproper positioning toprevent the risk ofinjury during standup.While standing orwalking, fall protectionand mitigation isprovided by theHealthcare Professional/Physical Therapist (PT).No additional safety orefficacy concerns havebeen identified as bothdevices require aspotter to guard against
FailsafeFeature	In the event of powerfailure – knees becomelocked and hips free(similar to typical passiveleg braces)	In event of power failure -knees become locked andhips free (similar to typicalpassive leg braces)	falls.Same
OperatingTemperature	32°F to 88°F (0°C to 31°C)	32°F to 88°F (0°C to 31°C)	Same
OperatingHumidity	30% to 75% RH	30% to 75% RH	Same
ElectricalSafety Testing	Passed IEC 60601-1:2005(3rd Edition) + CORR.1:2006 + CORR. 2:2007 +A1:2012 (or IEC 60601-1:2012 reprint)	Passed ANSI/AAMIES60601-1:2005/(R)2012	Similar; tested tonewest version of thestandard
ElectromagneticCompatibilityTesting	Passed IEC 60601-1-2:2014(4TH Edition)	Passed IEC 60601-1-2:2007	Similar; tested tonewest version of thestandard
Technical Area	Test Completed	Results
Electrical SafetyTesting	IEC 60601-1:2005 (3rd Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012(or IEC 60601-1: 2012 reprint)	PASS
ElectromagneticCompatibility 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 Verificationand ValidationTesting	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 TorqueTesting	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 LifecycleTesting	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 requirementsCyclic 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 CycleTesting	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 andTransport 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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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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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

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).