Atalante

K221859 · Wandercraft SAS · PHL · Dec 29, 2022 · Physical Medicine

Device Facts

• Record ID: K221859
• Device Name: Atalante
• Applicant: Wandercraft SAS
• Product Code: PHL · Physical Medicine
• Decision Date: Dec 29, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3480
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Atalante exoskeleton is intended to enable individuals with hemiplegia due to cerebrovascular accident (CVA) to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator. The operator must complete a training program prior to use of the device. The Atalante system is intended to be used on adolescents of 18 years and older and adults, able to tolerate a stand-up position. The device is not intended for sports or stair climbing.

Device Story

Atalante is a fully powered, self-balancing hip-knee-ankle lower body exoskeleton; 12 actuated degrees of freedom. Device enables hands-free ambulatory functions and mobility exercises for hemiplegic patients in rehabilitation centers. Operated by trained clinicians; requires mandatory certification training. System utilizes dynamic-walking control for natural gait and power efficiency. Input includes patient physical parameters; output provides mechanical assistance for sit, stand, walk, turn, and exercise. Feedback provided via handheld controller, physio interface, and auditory signals. Device must be used with safety rails. Benefits include improved functional ambulation and balance during early rehabilitation.

Clinical Evidence

Two clinical studies involving 43 patients with CVA due to stroke; all subjects completed performance outcome measures. Real-world evidence from >250 patients. Five non-serious adverse events reported. Results indicate safe and effective use, with improvements in functional ambulation and balance during early rehabilitation.

Technological Characteristics

Powered lower extremity exoskeleton; 12 actuated degrees of freedom. Rechargeable lithium-ion battery (46.8 V, 9 Ah). Materials biocompatibility per ISO 10993-5/10. Electrical safety per ANSI/AAMI ES60601-1; EMI per IEC 60601-1-2. Software validated per IEC 62304. Features dynamic-walking control algorithm. Dimensions include adjustable upper/lower leg components.

Indications for Use

Indicated for adolescents (18+) and adults with hemiplegia due to cerebrovascular accident (CVA) capable of tolerating a stand-up position. Not indicated 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® (K173530)

Reference Devices

• Ekso™ (v.1.1) (K143690)
• Ekso GT™ (v.1.2) (K143690)

Submission Summary (Full Text)

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December 29, 2022

Wandercraft SAS % Andre Kindsvater Senior Consultant Emergo Global Consulting. LLC 2500 Bee Cave Road Building 1 Suite 300 Austin, Texas 78746

Re: K221859

Trade/Device Name: Atalante Regulation Number: 21 CFR 890.3480 Regulation Name: Powered Lower Extremity Exoskeleton Regulatory Class: Class II Product Code: PHL Dated: June 22, 2022 Received: June 27, 2022

Dear Andre Kindsvater:

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Heather L. Dean -S

Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K221859

Device Name Atalante

Indications for Use (Describe)

The Atalante exoskeleton is intended to enable individuals with hemiplegia due to cerebrovascular accident (CVA) to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation under the supervision of a trained operator. The operator must complete a training program prior to use of the device.

The Atalante system is intended to be used on adolescents of 18 years and older and adults, able to tolerate a stand-up position.

The device is not intended for sports or stair climbing.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) Summary Atalante

#### 1. Submission Sponsor

Wandercraft SAS 88 rue de Rivoli 75004 Paris France

Contact: Matthieu Masselin Title: Chief Executive Officer

#### 2. Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: [phone] Email: [e-mail]

Contact: André Kindsvater Title: Senior Consultant RA & QA

#### 3. Date Prepared

June 22nd, 2022

#### 4. Device Identification

| Trade/Proprietary Name: | Atalante |
|-------------------------|---------------------------------------------------|
| Common/Usual Name: | Powered Exoskeleton |
| Classification Name: | Powered lower extremity exoskeleton |
| Regulation Number: | 890.3480 |
| Product Code: | PHL |
| Class: | II |
| Classification Panel: | Neurological and Physical Medicine Devices (OHT5) |

#### 5. Legally Marketed Predicate Devices

| | Primary Predicate | Reference Device |
|---------------|-------------------|-----------------------------------------|
| Device name | Indego® | EksoTM (v.1.1) and<br>Ekso GTTM (v.1.2) |
| 510(K) number | K173530 | K143690 |

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| Regulation Number | 21 CFR 890.3480 | 21 CFR 890.3480 |
|-------------------|----------------------|---------------------|
| Regulation Name | Powered Exoskeleton | Powered Exoskeleton |
| Product code | PHL | PHL |
| Review Panel: | Neurology | Neurology |
| Manufacturer | Parker Hannifin Corp | Ekso Bionics Inc. |

#### 6. Indication for Use Statement

The Atalante exoskeleton is intended to enable individuals with hemiplegia due to cerebrovascular accident (CVA) to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator must complete a training program prior to use of the device.

The Atalante system is intended to be used on adolescents of 18 years and older and adults, able to tolerate a stand-up position.

The device is not intended for sports or stair climbing.

#### 7. Device Description

The Atalante is a completely self-balancing walking system for people with mobility disabilities. It is a fully powered hip-knee-ankle lower body exoskeleton with 12 actuated degrees of freedom. Atalante is self-balancing and includes dynamic-walking control. Dynamic-walking allows the Atalante to consume significantly less power and have a more natural gait.

#### 8. Substantial Equivalence Discussion

The following table compares the Atalante to the predicate devices with respect to indications for use, principles of operation, technological characteristics, materials, and performance, and forms the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device.

#### Table 5A - Comparison of Characteristics preliminary

| | Subject Device | Predicate | Reference Device |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FEATURE | Atalante | Indego® | Ekso<br>Ekso™ (v.1.1) and<br>Ekso GT™ (v.1.2) |
| 510(k) Number | K221859 | K173530 | K143690 |
| Manufacturer | Wandercraft SAS | Parker Hannifin Corp. | Ekso Bionics Inc. |
| Product Code | PHL | PHL | PHL |
| Regulation | 890.3480 | 890.3480 | 890.3480 |
| Regulation Name | Powered Exoskeleton | Powered Exoskeleton | Powered Exoskeleton |
| | Subject Device | Predicate | Reference Device |
| FEATURE | Atalante | Indego® | Ekso<br>Ekso™ (v.1.1) and<br>Ekso GT™ (v.1.2) |
| Indications for Use | The Atalante exoskeleton is<br>intended to enable<br>individuals with hemiplegia<br>due to cerebrovascular<br>accident (CVA) to perform<br>ambulatory functions and<br>mobility exercises, hands-<br>free, in rehabilitation<br>institutions under the<br>supervision of a trained<br>operator.<br>The operator must<br>complete a training program<br>prior to use of the device.<br>The Atalante system is<br>intended to be used on<br>adolescents of 18 years<br>and older and adults able to<br>tolerate a stand-up position.<br>The device is not intended<br>for sports or stair climbing. | The Indego® orthotically fits<br>to the lower limbs and the<br>trunk; the device is intended<br>to enable individuals with<br>spinal cord injury at levels<br>T3 to L5 to perform<br>ambulatory functions with<br>supervision of a specially<br>trained companion in<br>accordance with the user<br>assessment and training<br>certification program. The<br>device is also intended to<br>enable individuals with<br>spinal cord injury at levels<br>C7 to L5 to perform<br>ambulatory functions in<br>rehabilitation institutions in<br>accordance with the user<br>assessment and training<br>certification program.<br>Finally, the Indego® is also<br>intended to enable<br>individuals with hemiplegia<br>(with motor function of 4/5<br>in least one upper<br>extremity) due to<br>cerebrovascular accident<br>(CVA) to perform<br>ambulatory functions in<br>rehabilitation institutions in<br>accordance with the user<br>assessment and training<br>certification program. The<br>Indego is not intended for<br>sports or stair climbing. | The Ekso™ (version 1.1)<br>and Ekso GT™ (version<br>1.2) are intended to perform<br>ambulatory functions in<br>rehabilitation institutions<br>under the supervision of a<br>trained physical therapist<br>for the following population<br>with upper extremity motor<br>function of at least 4/5 in<br>both arms:<br>Individuals with hemiplegia<br>due to stroke,<br>Individuals with spinal cord<br>injuries at levels T4 to L5,<br>and Individuals with spinal<br>cord injuries at levels of C7<br>to T3 (ASIA D).<br>The therapist must<br>complete a training program<br>prior to use of the device.<br>The devices are not<br>intended for sports or stair<br>climbing. |
| | Subject Device | Predicate | Reference Device |
| FEATURE | Atalante | Indego® | Ekso<br>Ekso™ (v.1.1) and<br>Ekso GT™ (v.1.2) |
| Population | Adolescents of 18 years<br>and older, and adults | Adults over age of 18 | Adults over age of 18 |
| Environment | Rehabilitation centers | CVA population cleared<br>only for use in<br>Rehabilitation centers | Rehabilitation centers |
| Body Coverage | Worn over legs and upper<br>body with rigid torso | Worn over legs and around<br>hips with lower torso | Worn over legs and upper<br>body with rigid torso |
| Size of Components | Adjustable upper leg, lower<br>leg. Non adjustable hip<br>width; | Modular Small, Medium and<br>Large upper leg, lower leg<br>and hip components; | Adjustable upper leg, lower<br>leg, and hip width; |
| Mobility Aid | None | Walker, Crutches, Cane | Walker, Crutches, Cane |
| User Mobility | Sit, stand, walk, turn,<br>exercise (weight shift,<br>squat), repositioning | Sit, stand, walk, and turn | Sit, stand, walk, exercises<br>(weight shift) and turn |
| Walking Speed | ~2km/hr | ~2 km/hr | ~2 km/hr |
| Type of Surface | Smooth | Smooth, cement, carpet | Smooth, cement,carpet |
| Range of Motion | Hip: 90° flexion,<br>5° extension;<br>17° abduction,<br>10° adduction;<br>10° medial rotation,<br>20° lateral rotation | Hips: 110° flexion<br>to 30° extension | Hips: 135° flexion<br>to 20° extension |
| | Knee: 110° flexion<br>to -5° extension<br>(flexum). | Knees: 110° flexion<br>to 10° extension | |
| | Ankle: 0 dorsiflexion,<br>9° plantar flexion,<br>18° pronation and<br>supination | | Ankles: 0° dorsiflexion<br>to 25° plantar extension |
| Rechargeable<br>Battery | Rechargeable lithium-ion<br>battery 46.8 V, 9 Ah | Rechargeable lithium ion.<br>33.3 V, 36A peak current,<br>12A continuous current. | Rechargeable lithium<br>ion batteries 48.1V,<br>30A peak current, |
| | Usage duration: 2 hours of<br>continuous usage per<br>charge | 159Wh fully charged; | |
| | | Usage duration: 1.5 hours<br>of continuous usage per<br>charge | 1 hour of continuous<br>usage per charge |
| Battery Charge<br>Time | 4 hours | 4 hours | 1 hour |
| Training Program | Yes | Yes | Yes |
| | Subject Device | Predicate | Reference Device |
| FEATURE | Atalante | Indego®…