(153 days)
Not Found
No
The summary mentions "dynamic-walking control" for a "self-balancing walking system," which suggests advanced control algorithms, but it does not explicitly mention or describe the use of AI or ML technologies. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is intended for rehabilitation and mobility exercises for individuals with specific medical conditions (hemiplegia due to CVA, spinal cord injuries), which indicates a therapeutic purpose.
No
The device description and intended use indicate that Atalante X is a walking assistance system for rehabilitation, not a device used to diagnose medical conditions or diseases.
No
The device description explicitly states that Atalante X is a "fully powered hip-knee-ankle lower body exoskeleton with 12 actuated degrees of freedom," indicating it is a physical hardware device, not software only.
Based on the provided information, the Atalante X device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Atalante X Function: The Atalante X is a robotic exoskeleton designed to assist with mobility and rehabilitation exercises for individuals with specific neurological conditions. It directly interacts with the patient's body to facilitate movement.
- Lack of Specimen Analysis: The description of the Atalante X does not mention any analysis of biological specimens. Its function is purely mechanical and related to physical therapy and mobility assistance.
Therefore, the Atalante X falls under the category of a physical rehabilitation device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
PHL
Device Description
Atalante X 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 X is selfbalancing and includes dynamic-walking control. Dynamic-walking allows the Atalante X to consume significantly less power and have a more natural gait.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower body, hip-knee-ankle
Indicated Patient Age Range
adolescents of 18 years and older, and adults
Intended User / Care Setting
trained operator / 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)
Two clinical studies with a total of 21 patients with spinal cord injury (SCI) were undertaken. The device could ensure ambulatory functions with comparable speed to that of the predicates while leaving upper limbs free potentially for additional tasks. The findings are supported by real world evidence of use by over 481 patients which performed 3 sessions or more, including 40 SCI patients at levels C3-L3 who performed a total of 560 sessions.
There were altogether 24 adverse events in both clinical studies, majority of which were minor skin lesions, one occurrence of nausea and one of incontinence. None of them was serious.
Clinical data demonstrate that patients with SCI at levels T5-L5 can use Atalante X safely and effectively.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text.
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"
1
(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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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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4
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: reglementaire@wandercraft.eu
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) |
5
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 | ||
| Atalante X | Primary Predicate | ||
| Atalante | Secondary Predicate | ||
| 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 | |||
| Name | Powered Exoskeleton | Powered Exoskeleton | Powered Exoskeleton |
| 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. | 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. | The Indego® orthotically fits to
the lower limbs and the trunk; the
device is intended to enable
individuals with spinal cord injury
at levels T3 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 SCI at levels C7 to
L5 to perform ambulatory
functions in rehabilitation
institutions in accordance with
the user assessment and training
certification program. Finally, the
Indego® is also intended to
enable individuals with
hemiplegia (with motor function
of 4/5 in least one upper
extremity) due to
cerebrovascular accident (CVA)
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. |
| Population | Adolescents of 18 years and
older, and adults | Adolescents of 18 years and
older, and adults | Adults over age of 18 |
| Environment | Rehabilitation institutions | Rehabilitation Institutions | Rehabilitation Institutions |
| Body Coverage | Worn over legs and upper body
with rigid torso | Worn over legs and upper body
with rigid torso | Worn over legs and around hips
with lower torso |
| Size of
Components | Adjustable upper leg, lower leg.
Non-adjustable hip width; | Adjustable upper leg, lower leg.
Non-adjustable hip width; | Modular Small, Medium and
Large upper leg, lower leg and hip
components; |
| Mobility Aid | None | None | Walker, Crutches, Cane |
| FEATURE | Subject Device
Atalante X | Primary Predicate
Atalante | Secondary Predicate
Indego® |
| User Mobility | Sit, stand, walk, turn, exercise
(weight shift, squat),
repositioning | Sit, stand, walk, turn, exercise
(weight shift, squat),
repositioning | Sit, stand, walk, and turn |
| Walking Speed | ~2km/hr | ~2km/hr | ~2 km/hr |
| Type of
Surface | Smooth | Smooth | Smooth, cement, carpet |
| Range of
Motion | Hip: 90° flexion,
5° extension;
17° abduction,
10° adduction;
10° medial rotation,
20° lateral rotation
Knees: 110° Flexion;
-5°Extension:
Ankle: 0 dorsiflexion,
9° plantar flexion,
18° pronation and supination | Hip: 90° flexion,
5° extension;
17° abduction,
10° adduction;
10° medial rotation,
20° lateral rotation
Knees: 110° Flexion;
-5°Extension:
Ankle: 0 dorsiflexion,
9° plantar flexion,
18° pronation and supination | Hips: 110° flexion to 30° extension
Knees: 110° flexion to 10°
extension |
| Rechargeable
Battery | Rechargeable Lithium-ion battery
46.8 V, 6,4Ah
Usage duration: 2h of continuous
usage per charge | Rechargeable Lithium-ion battery
46.8 V, 9 Ah
Usage duration: 2h of continuous
usage per charge | Rechargeable lithium ion.
33.3 V, 36A peak current, 12A
continuous current. 159Wh fully
charged;
Usage duration: 1.5h of
continuous usage per charge |
| Battery Charge
Time | 2h 30min | 4h | 4h |
| Training
Program | Yes | Yes | Yes |
| Certification
Program | Yes | Yes | Yes |
| User Feedback | Provides visual feedback on the
handheld controller and physio
interface, and auditory feedback | Provides visual feedback on the
handheld controller and operator
interface, and auditory feedback | Provides vibratory feedback and
LED indicators on top of hip unit,
visible to wearer |
| Fall Detection
and Mitigation | Must be used in combination with
safety rail | Must be used in combination with
safety rail | 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 or allow the user to
attempt to recover unassisted |
| Failsafe
Feature | (use of safety rail) | (use of safety rail) | In the event of power failure
knees become locked and hips
free (similar to typical passive leg
braces) |
| Electrical
Testing | ANSI AAMI ES60601-
1:2005/(R)2012 AndA1:2012. | ANSI AAMI ES60601-
1:2005/(R)2012 And A1:2012 | ANSI/AAMI ES60601-
1:2005/(R)2012 |
| EMC Testing | IEC 60601-1-2 2020
AIM 7351731:2021 | IEC 60601- 1-2:2014
AIM 7351731:2021 | IEC 60601-1-2: 2014 |
6. Indication for Use Statement
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 standup position.
The device is not intended for sports or stair climbing.
7. Device Description
Atalante X 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 X is selfbalancing and includes dynamic-walking control. Dynamic-walking allows the Atalante X to consume significantly less power and have a more natural gait.
8. Substantial Equivalence Discussion
The following table compares Atalante X 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 devices.
6
Table 5A – Comparison of Characteristics
7
8
9. Non-Clinical Performance Data
To demonstrate safety and effectiveness of Atalante X and to show substantial equivalence to the predicate devices, Wandercraft SAS completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. Atalante X passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate devices:
- Cytotoxicity testing per ISO 10993-5: Passed
- . Irritation and Sensitization testing per ISO 10993-10: Passed
- Electrical safety testing per ANSI/AAMI 60601-1: Passed
- Electromagnetic Interreference (EMI) testing per IEC 60601-1-2: Passed
- Software verification and validation per IEC 62304 and FDA Guidance – the current version has been fully validated
- System (Device) Verification and Validation: Passed
- Electronics Sub-system Verification: Passed
- . Mechanics Sub-system Verification: Passed
- Cycling Testing: Passed
- Thermal Testing: Passed
- Useful Life Testing supports 5 years ●
- Transportation Testing per ASTM D4169 demonstrates package integrity is maintained: Passed ●
10. Clinical Performance Data
Two clinical studies with a total of 21 patients with spinal cord injury (SCI) were undertaken. The device could ensure ambulatory functions with comparable speed to that of the predicates while leaving upper limbs free potentially for additional tasks. The findings are supported by real world evidence of use by over 481 patients which performed 3 sessions or more, including 40 SCI patients at levels C3-L3 who performed a total of 560 sessions.
There were altogether 24 adverse events in both clinical studies, majority of which were minor skin lesions, one occurrence of nausea and one of incontinence. None of them was serious.
Clinical data demonstrate that patients with SCI at levels T5-L5 can use Atalante X safely and effectively.
11. Training
Prior to the first use of Atalante X, to ensure safe and effective operation of the device, the operator must complete a certification training. To optimize the integration of the clinical setting, such training is then followed by frequent visits by Wandercraft Customer Care to further support the operator with the exoskeleton. The training program is offered for as many operators as agreed in the contract signed with the customer.
Training is composed by a theoretical part including presentation and description of the whole system and its mode of operations and a hands-on practice. This latter will be performed both in pairs – with an operator in the role of "operator" and another operator in the role of a "patient" – and in individual
9
sessions. The double role allows the operators to understand the device from both the operator's and patient's perspectives.
An operator is considered certified, i.e., with proven competence to safely operate Atalante X alone with the patient, only after fulfilling all eligibility requirements and pass the certification evaluation.
12. Statement of Substantial Equivalence
Atalante X has the same intended use as the Atalante and Indego® predicate devices, and the same or similar technological characteristics. The differences in technological characteristics do not raise new or different questions of safety and effectiveness. Performance testing has demonstrated that Atalante X is as safe and effective as the predicate devices. Therefore, Atalante X is substantially equivalent to the predicate devices.