Atalante X

K232077 · Wandercraft SAS · PHL · Dec 13, 2023 · Physical Medicine

Device Facts

• Record ID: K232077
• Device Name: Atalante X
• Applicant: Wandercraft SAS
• Product Code: PHL · Physical Medicine
• Decision Date: Dec 13, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3480
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator for the following populations: - Individuals with hemiplegia due to cerebrovascular accident (CVA) - Individuals with spinal cord injuries at levels T5 to L5 (SCI) The operator must complete a training program prior to use of the device. Atalante X 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 X is a self-balancing, powered lower-body exoskeleton (hip-knee-ankle) with 12 actuated degrees of freedom. It enables hands-free ambulatory functions and mobility exercises (sit, stand, walk, turn, squat, weight shift) for patients with mobility disabilities. Operated by a trained clinician in rehabilitation institutions, the device utilizes dynamic-walking control to achieve a natural gait with reduced power consumption. The operator monitors the system via a handheld controller and interface, receiving visual and auditory feedback. By providing hands-free mobility, the device allows patients to potentially engage in additional tasks during therapy, facilitating rehabilitation and improving patient mobility outcomes.

Clinical Evidence

Clinical evidence includes two studies with 21 SCI patients and real-world evidence from 481 patients (including 40 SCI patients, 560 sessions). Results show ambulatory function with speed comparable to predicates while allowing hands-free operation. 24 adverse events reported (mostly minor skin lesions, one nausea, one incontinence); no serious adverse events. Data supports safety and effectiveness for SCI levels T5-L5.

Technological Characteristics

Powered lower-extremity exoskeleton; 12 actuated degrees of freedom; self-balancing dynamic-walking control. Rechargeable 46.8V, 6.4Ah Li-ion battery. Materials biocompatibility per ISO 10993-5/10. Electrical safety per ANSI/AAMI ES60601-1; EMC per IEC 60601-1-2. Software validated per IEC 62304.

Indications for Use

Indicated for adolescents 18+ and adults with hemiplegia due to CVA or spinal cord injuries (T5-L5) requiring rehabilitation in clinical settings. Contraindicated for sports or stair climbing.

Regulatory Classification

Identification

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

Special Controls

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

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

Predicate Devices

• Atalante (K221859)
• Indego® (K173530)

Submission Summary (Full Text)

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December 13, 2023

Wandercraft SAS Maria Iacono, PhD Director of Regulatory and Quality Affairs 88 rue de Rivoli Paris, Ile-de-France 75004 France

Re: K232077

Trade/Device Name: Atalante X Regulation Number: 21 CFR 890.3480 Regulation Name: Powered Lower Extremity Exoskeleton Regulatory Class: Class II Product Code: PHL Dated: November 24, 2023 Received: November 24, 2023

Dear Dr. Iacono:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

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

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

Sincerely.

# Heather L. Dean -S

Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological

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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) K232077

Device Name Atalante X

#### Indications for Use (Describe)

Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitations under the supervision of a trained operator for the following populations:

- Individuals with hemiplegia due to cerebrovascular accident (CVA).

- Individuals with spinal cord injuries at levels T5 to L5 (SCI).

The operator must complete a training program prior to use of the device.

Atalante X 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 X

#### 1. Submission Sponsor

Wandercraft SAS 88 rue de Rivoli 75004 Paris, France

Contact: Matthieu Masselin Title: Chief Executive Officer

#### 2. Submission Correspondent

Wandercraft SAS 88 rue de Rivoli 75004 Paris, France Email: [e-mail]

Contact: Maria Ida Iacono, PhD Title: Chief of Regulatory, Quality, and Clinical Affairs – Global

#### 3. Date Prepared

July 13th, 2023

#### 4. Device Identification

| Trade/Proprietary Name: | Atalante X |
|-------------------------|---------------------------------------------------|
| 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) |

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#### 5. Legally Marketed Predicate Devices

| | Primary Predicate | Secondary Predicate | |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | Atalante | Indego® | |
| 510(K) number | K221859 | K173530 | |
| 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 | Wandercraft SAS | Parker Hannifin Corp. | |
| FEATURE | Subject Device<br>Atalante X | Primary Predicate<br>Atalante | Secondary Predicate<br>Indego® |
| 510(k) Number | TBD | K221859 | K173530 |
| Manufacturer | Wandercraft SAS | Wandercraft SAS | Parker Hannifin Corp. |
| Product Code | PHL | PHL | PHL |
| Regulation | 890.3480 | 890.3480 | 890.3480 |
| Regulation<br>Name | Powered Exoskeleton | Powered Exoskeleton | Powered Exoskeleton |
| Indications for<br>Use | Atalante X is intended to perform<br>ambulatory functions and<br>mobility exercises, hands-free, in<br>rehabilitation institutions under<br>the supervision of a trained<br>operator for the following<br>populations:<br>- Individuals with hemiplegia due<br>to cerebrovascular accident<br>(CVA)<br>- Individuals with spinal cord<br>injuries at levels T5 to L5 (SCI)<br>The operator must complete a<br>training program prior to use of<br>the device.<br>Atalante X is intended to be used<br>on adolescents of 18 years and<br>older, and adults able to tolerate<br>a stand-up position.<br>The device is not intended for<br>sports or stair climbing. | The Atalante exoskeleton is<br>intended to enable individuals<br>with hemiplegia due to<br>cerebrovascular accident (CVA)<br>to perform ambulatory functions<br>and mobility exercises, hands-<br>free, in rehabilitation institutions<br>under the supervision of a trained<br>operator.<br>The operator must complete a<br>training program prior to use of<br>the device.<br>The Atalante system is intended<br>to be used on adolescents of 18<br>years and older and adults, able<br>to tolerate a stand-up position.<br>The device is not intended for<br>sports or stair climbing. | The Indego® orthotically fits to<br>the lower limbs and the trunk; the<br>device is intended to enable<br>individuals with spinal cord injury<br>at levels T3 to L5 to perform<br>ambulatory functions with<br>supervision of a specially trained<br>companion in accordance with<br>the user assessment and training<br>certification program. The device<br>is also intended to enable<br>individuals with SCI at levels C7 to<br>L5 to perform ambulatory<br>functions in rehabilitation<br>institutions in accordance with<br>the user assessment and training<br>certification program. Finally, the<br>Indego® is also intended to<br>enable individuals with<br>hemiplegia (with motor function<br>of 4/5 in least one upper<br>extremity) due to<br>cerebrovascular accident (CVA)<br>to perform ambulatory functions<br>in rehabilitation institutions in<br>accordance with the user<br>assessment and training<br>certification program.<br>The Indego is not intended for<br>sports or stair climbing. |
| Population | Adolescents of 18 years and<br>older, and adults | Adolescents of 18 years and<br>older, and adults | Adults over age of 18 |
| Environment | Rehabilitation institutions | Rehabilitation Institutions | Rehabilitation Institutions |
| Body Coverage | Worn over legs and upper body<br>with rigid torso | Worn over legs and upper body<br>with rigid torso | Worn over legs and around hips<br>with lower torso |
| Size of<br>Components | Adjustable upper leg, lower leg.<br>Non-adjustable hip width; | Adjustable upper leg, lower leg.<br>Non-adjustable hip width; | Modular Small, Medium and<br>Large upper leg, lower leg and hip<br>components; |
| Mobility Aid | None | None | Walker, Crutches, Cane |
| FEATURE | Subject Device<br>Atalante X | Primary Predicate<br>Atalante | Secondary Predicate<br>Indego® |
| User Mobility | Sit, stand, walk, turn, exercise<br>(weight shift, squat),<br>repositioning | Sit, stand, walk, turn, exercise<br>(weight shift, squat),<br>repositioning | Sit, stand, walk, and turn |
| Walking Speed | ~2km/hr | ~2km/hr | ~2 km/hr |
| Type of<br>Surface | Smooth | Smooth | Smooth, cement, carpet |
| Range of<br>Motion | Hip: 90° flexion,<br>5° extension;<br>17° abduction,<br>10° adduction;<br>10° medial rotation,<br>20° lateral rotation<br>Knees: 110° Flexion;<br>-5°Extension:<br>Ankle: 0 dorsiflexion,<br>9° plantar flexion,<br>18° pronation and supination | Hip: 90° flexion,<br>5° extension;<br>17° abduction,<br>10° adduction;<br>10° medial rotation,<br>20° lateral rotation<br>Knees: 110° Flexion;<br>-5°Extension:<br>Ankle: 0 dorsiflexion,<br>9° plantar flexion,<br>18° pronation and supination | Hips: 110° flexion to 30° extension<br>Knees: 110° flexion to 10°<br>extension |
| Rechargeable<br>Battery | Rechargeable Lithium-ion battery<br>46.8 V, 6,4Ah<br>Usage duration: 2h of continuous<br>usage per charge | Rechargeable Lithium-ion battery<br>46.8 V, 9 Ah<br>Usage duration: 2h of continuous<br>usage per charge | Rechargeable lithium ion.<br>33.3 V, 36A peak current, 12A<br>continuous current. 159Wh fully<br>charged;<br>Usage duration: 1.5h of<br>continuous usage per charge |
| Battery Charge<br>Time | 2h 30min | 4h | 4h |
| Training<br>Program | Yes | Yes | Yes |
| Certification<br>Program | Yes | Yes | Yes |
| User Feedback | Provides visual feedback on the<br>handheld controller and physio<br>interface, and auditory feedback | Provides visual feedback on the<br>handheld controller and operator<br>interface, and auditory feedback | Provides vibratory feedback and<br>LED indicators on top of hip unit,<br>visible to wearer |
| Fall Detection<br>and Mitigation | Must be used in combination with<br>safety rail | Must be used in combination with<br>safety rail | Detects forward, backward and<br>sideways falling as it is happening;<br>the device makes adjustments<br>during the course of the fall to<br>position the user for minimal risk<br>of injury or allow the user to<br>attempt to recover unassisted…