(408 days)
Not Found
No
The document does not mention AI, ML, or any related technologies in the device description or performance studies. The operation is described as being under the supervision of a trained physical therapist.
Yes.
The device's intended use is for rehabilitation, specifically to perform ambulatory functions for individuals with spinal cord injuries, indicating a therapeutic purpose.
No
The device is described as an exoskeleton intended for rehabilitation, specifically to perform ambulatory functions for individuals with spinal cord injuries. There is no indication that it is used for diagnosing medical conditions.
No
The device description explicitly states that the ExoAtlet-II includes a "battery powered exoskeleton" and an "ExoCrutch," which are hardware components.
Based on the provided information, the ExoAtlet-II is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- ExoAtlet-II Function: The ExoAtlet-II is a robotic exoskeleton designed to assist individuals with spinal cord injuries in performing ambulatory functions (walking) during rehabilitation. It is a physical device that interacts with the user's body externally.
- Intended Use: The intended use clearly states it's for "ambulatory functions in rehabilitation" and focuses on physical movement and support.
- Device Description: The description details a battery-powered exoskeleton, crutches, and a tablet PC, all components of a physical rehabilitation aid, not a diagnostic tool that analyzes biological samples.
Therefore, the ExoAtlet-II falls under the category of a rehabilitation device or assistive technology, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ExoAtlet-II is intended to perform ambulatory functions in rehabilitation under the supervision of a trained physical therapist for the following population with upper extremity motor function at least 4/5 in both arms:
- Individuals with spinal cord injuries at levels T4 to L5
- Individuals with spinal cord injuries at levels of C7 to T3 (ASIA D)
The therapist must complete a training program prior to use of the device.
The device is not intended for sports or stair climbing.
Product codes (comma separated list FDA assigned to the subject device)
PHL
Device Description
The ExoAtlet-II is intended to perform ambulatory functions in rehabilitation institutions, hospitals, or similar institutions under the supervision of a healthcare professional (HCP) such as a trained physical therapist. The ExoAtlet-II is indicated for individuals with spinal cord injuries at levels T4-L5 and individuals with spinal cord injuries at levels of C7-T3. All users must have upper extremity motor function of at least 4/5 in both arms. The ExoAtlet-II is intended for multiple users in a clinical setting (i.e., gait lab or rehabilitation center) under supervision. The ExoAtlet-II includes a battery powered exoskeleton, an ExoCrutch, and a Tablet PC.
ExoAtlet-II is designed to be operated with a trained physical therapist who has received preliminary training on the Exoskeleton operation. This therapist will be familiar with the rules of the use and operational documentation. Training is conducted in a designated medical facility that is representative of the indicated environments (e.g., hospital, outpatient physical therapy clinic or similar). The training identifies safe environments of device use and uses all of the safety features found in the subject device. The training manual will be provided with the user manual along with a trainee itinerary and a trainee certification exam. The trainee needs to pass 80% of the exam questions to obtain certification.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
legs and upper body
Indicated Patient Age Range
18 years and older
Intended User / Care Setting
trained physical therapist in rehabilitation institutions, hospitals, or similar institutions (clinical setting, gait lab, or rehabilitation center)
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)
SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for the ExoAtlet-II.
Bench Testing: The elbow crutches provided in the ExoAtlet-II were testing in compliance to:
- ISO 11334-1:2007 Assistive products for walking manipulated by one arm -Requirements and test methods — Part 1: Elbow crutches
Software Verification: The software development and testing were executed in compliance to:
- IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1: 2012 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
- IEC 62304:2006 Medical device software Software life cycle processes
Electromagnetic Compatibility and Electrical Safety: The subject device was tested in compliance to:
- IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1: 2012 Medical electrical equipment -. Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2: 2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-6:11 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- CISPR 11: 2015 (Class A, Group 1) Industrial, scientific and medical equipment - Radiofrequency disturbance characteristics - Limits and methods of measurement
- IEC 61000-3-2: 2014 Electromagnetic compatibility (EMC) – Part 3-2: Limits – Limits for harmonic current emissions (equipment input current ≤ 16 A per phase)
- IEC 61000-3-3: 2013 Amendment 1 - Electromagnetic compatibility (EMC) - Part 3-3: Limits - Limitation of voltage changes, voltage fluctuations and flicker in public lowvoltage supply systems, for equipment with rated current ≤ 16 A per phase and not subject to conditional connection
- IEC 62368-1: 2014 (Second Edition) Audio/video, information and communication technology equipment - Part 1: Safety requirements
- IEC 62133: 2012 (Second Edition) Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable application – Part 2: Lithium systems
SUMMARY OF CLINICAL TESTING
Study type: open label, non-randomized clinical study
Sample size: 20 subjects (18 years and older) with spinal cord injuries in the T4-L5 or C7-T4 range and type D neurological disorders according to the ASIA scale.
Key Results:
- 19 of 20 subjects successfully completed the 10 Meter Walk Test and the six-minute walk test (6 MWT). One subject was unable to complete the 6 MWT due to insufficient physical fitness.
- Surveys found that all subjects were able to use the device.
- 18 of 20 subjects rated their comfort from eight out of ten to a ten out of ten. Two subjects rated their comfort a six out of ten.
- None of the skin assessments found any adverse events related to biocompatibility such as abrasions, dry flaky skin, cut, eschar, or rash before, during, or after use of the ExoAtlet-II.
Conclusion: Based on the testing performed, including clinical testing, software validation, and electrical safety testing, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate devices.
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency's name in a lighter shade of blue.
July 16, 2021
ExoAtlet Asia Co. Ltd. Allison Komiyama, PhD Principal Consultant AcKnowledge Regulatory Strategies, LLC 2251 San Diego Ave. Suite B-257 San Diego, California 92110
Re: K201473
Trade/Device Name: ExoAtlet-II Regulation Number: 21 CFR 890.3480 Regulation Name: Powered Lower Extremity Exoskeleton Regulatory Class: Class II Product Code: PHL Dated: June 16, 2021 Received: June 16, 2021
Dear Dr. 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.
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
1
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 (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 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,
Image /page/1/Picture/5 description: The image shows the name "Tushar Bansal -S" in a large, sans-serif font. The text is black and appears to be centered on a white background. The letters are evenly spaced, and the overall impression is clean and legible.
For 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201473
Device Name ExoAtlet-II
Indications for Use (Describe)
The ExoAtlet-II is intended to perform ambulatory functions in rehabilitation under the supervision of a trained physical therapist for the following population with upper extremity motor function at least 4/5 in both arms:
· Individuals with spinal cord injuries at levels T4 to L5
- · Individuals with spinal cord injuries at levels of C7 to T3 (ASIA D)
The therapist must complete a training program prior to use of the device.
The device is not intended for sports or stair climbing.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for EXOATLET. The logo is in a sans-serif font, with the "EXO" portion in a bright blue color and the "ATLET" portion in black. The letters are all capitalized and have a modern, clean design.
DATE PREPARED
July 16, 2021
MANUFACTURER AND 510(k) OWNER
ExoAtlet Asia Co. Ltd. 4582 S. Ulster Street, Suite 205 Denver, CO 80237 Telephone: Official Contact: Bret Bostock, CEO ExoAtlet US
REPRESENTATIVE/CONSULTANT
Allison C. Komiyama, Ph.D., R.A.C. Michelle Rubin-Onur, Ph.D. AcKnowledge Regulatory Strategies, LLC +1 (619) 458-9547 Telephone: Email: akomiyama@acknowledge-rs.com, mrubin@acknowledge-rs.com Website: https://www.acknowledge-rs.com/
DEVICE INFORMATION
| Proprietary Name/Trade Name: | ExoAtlet-II |
|---|---|
| Common Name: | Powered Exoskeleton |
| Regulation Number: | 21 CFR 890.3480 |
| Class: | Class II |
| Product Code: | PHL |
| Premarket Review: | Neurology |
| Review Panel: | Neuromodulation and Physical Medicine Devices (DHT5B) |
PREDICATE DEVICE IDENTIFICATION
The ExoAtlet-II is substantially equivalent to the following predicates:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---|---|---|
| K143690 | Ekso™ (version 1.1) and Ekso GT™ (version 1.2) / | |
| Ekso Bionics, Inc. | ✓ |
The predicate devices have not been subject to a design related recall.
4
Image /page/4/Picture/1 description: The image shows the logo for EXOATLET. The logo is written in a sans-serif font, with the first three letters, "EXO," in blue. The remaining letters, "ATLET," are in gray. The logo is simple and modern.
DEVICE DESCRIPTION
The ExoAtlet-II is intended to perform ambulatory functions in rehabilitation institutions, hospitals, or similar institutions under the supervision of a healthcare professional (HCP) such as a trained physical therapist. The ExoAtlet-II is indicated for individuals with spinal cord injuries at levels T4-L5 and individuals with spinal cord injuries at levels of C7-T3. All users must have upper extremity motor function of at least 4/5 in both arms. The ExoAtlet-II is intended for multiple users in a clinical setting (i.e., gait lab or rehabilitation center) under supervision. The ExoAtlet-II includes a battery powered exoskeleton, an ExoCrutch, and a Tablet PC.
ExoAtlet-II is designed to be operated with a trained physical therapist who has received preliminary training on the Exoskeleton operation. This therapist will be familiar with the rules of the use and operational documentation. Training is conducted in a designated medical facility that is representative of the indicated environments (e.g., hospital, outpatient physical therapy clinic or similar). The training identifies safe environments of device use and uses all of the safety features found in the subject device. The training manual will be provided with the user manual along with a trainee itinerary and a trainee certification exam. The trainee needs to pass 80% of the exam questions to obtain certification.
INDICATIONS FOR USE
The ExoAtlet-II is intended to perform ambulatory functions in rehabilitation under the supervision of a trained physical therapist for the following population with upper extremity motor function at least 4/5 in both arms:
- Individuals with spinal cord injuries at levels T4 to L5
- Individuals with spinal cord injuries at levels of C7 to T3 (ASIA D)
The therapist must successfully complete a training program prior to use of the device. The device is not intended for sports or stair climbing.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
ExoAtlet believes that the ExoAtlet-II is substantially equivalent to the predicate devices based on the information summarized here:
The subject device has a similar design and dimensions as the devices cleared in K143690. The subject device has the same intended use and similar technological characteristics (i.e., energy source, maximum user weight, and type of surface the device can function on) to the devices cleared in K143690. The ExoAtlet-II has undergone testing to ensure that any differences in technological characteristics (i.e., ability of user mobility, walking speed, grade of inclination, and range of motion) do not affect safety and effectiveness when compared to the predicate devices.
5
EXOATLET
| Subject Device | Predicate Device | ||
|---|---|---|---|
| ExoAtlet Asia Co. Ltd. | Ekso Bionics, Inc. | Statement of | |
| Equivalence | |||
| ExoAtlet-II | Ekso™ (version 1.1) and Ekso GT™ (version 1.2) | ||
| K201473 | K143690 | ||
| Indications for | The ExoAtlet-II is intended to perform ambulatory functions in | The Ekso™ (version 1.1) and Ekso GT™ (version 1.2) are intended | Different to the |
| Use | rehabilitation institutions under the supervision of a trained | to perform ambulatory functions in rehabilitation institutions | predicate. The subject |
| physical therapist for the following population with upper | under the supervision of a trained physical therapist for the | device is not intended to | |
| extremity motor function at least 4/5 in both arms: | following population with upper extremity motor function of at | be used by individuals | |
| Individuals with spinal cord injuries at | least 4/5 in both arms: | with hemiplegia whereas | |
| levels T4 to L5 | ● Individuals with hemiplegia due to stroke | the predicate device is. | |
| Individuals with spinal cord injuries at | ● Individuals with spinal cord injuries at levels T4 to | Both the subject and | |
| levels of C7 to T3 (ASIA D) | L5 | predicate device include | |
| a training program prior | |||
| The therapist must successfully complete a training program | ● Individuals with spinal cord injuries at levels of | ||
| C7 to T3 (ASIA D). | to use of the device. | ||
| prior to use of the device. The device is not intended for sports | The therapist must complete a training program prior to use of | Both devices are not | |
| or stair climbing. | the device. The devices are not intended for sports or stair | intended for sports or | |
| climbing. | stair climbing. | ||
| Product Codes / | PHL / 21 CFR 890.3480 | PHL / 21 CFR 890.3480 | Identical to the |
| Regulation | predicate. No impact on | ||
| Number | safety or effectiveness. | ||
| Regulation | Powered lower extremity exoskeleton | Powered lower extremity exoskeleton | Identical to the |
| Description | predicate. No impact on | ||
| safety and effectiveness. | |||
| Technical Characteristics | |||
| Components | Exoskeleton | ||
| ExoCrutch | |||
| Tablet PC | ● Exoskeleton | ||
| ● Mobile application | Different to the | ||
| predicate device. Clinical | |||
| evidence demonstrates | |||
| that there is no impact | |||
| on safety and | |||
| effectiveness. | |||
| Exoskeleton | 25 kg | 23 kg | Different to the |
| Weight | predicate device. | ||
| Performance and clinical | |||
| testing demonstrate that | |||
| there is no impact on | |||
| safety and effectiveness. | |||
| Body Coverage | Worn over legs and upper body with rigid torso | Worn over legs and upper body with rigid torso | Identical to the |
| predicate device. No | |||
| impact on safety and | |||
| effectiveness. | |||
| Size of | Adjustable upper leg, lower leg, and hip width | Adjustable upper leg, lower leg, and hip width , control unit | Identical to the |
| Components | integrated into the torso | predicate device. No | |
| impact on safety and | |||
| effectiveness. | |||
| Ability of User | |||
| Mobility | |||
| SitStandWalk | SitStandWalkTurn | Different from the | |
| predicate device. The | |||
| ExoAtlet-II does not | |||
| turn. Effectiveness of the | |||
| sit, stand, and walk | |||
| functions were | |||
| evaluated through | |||
| clinical testing. | |||
| Mobility Aid | Crutch, Walker | Crutch, Walker | Identical to the |
| predicate device. No | |||
| impact on safety and | |||
| effectiveness. | |||
| Energy Source | Rechargeable lithium batteries 25.55V, 5700mAh, 4 hours of | ||
| continuous usage per charge | Rechargeable lithium batteries 48.1V, 30A peak current, 1 hour of | ||
| continuous usage per charge | Different from the | ||
| predicate device. The | |||
| battery of the ExoAtlet-II | |||
| can be charged for | |||
| longer. Safety concerns | |||
| regarding battery safety | |||
| were evaluated through | |||
| electrical safety and | |||
| EMC testing. | |||
| Maximum User | |||
| Weight | 100 kg (220 lbs) | 100 kg (220 lbs) | Identical to the |
| predicate device. No | |||
| impact on safety and | |||
| effectiveness. | |||
| User Height | 1.60-1.90 m | 1.58-1.88 m | Different to the |
| predicate device. | |||
| Performance and clinical | |||
| testing demonstrate that | |||
| there is no impact on | |||
| safety and effectiveness. | |||
| Walking Speed | 1.5 km/hr | ~ 2 km/hr | Different from the |
| predicate device. The | |||
| ExoAtlet-II speed is | |||
| slightly slower and does | |||
| not pose an increased | |||
| safety risk; the reduced | |||
| speed of the device was | |||
| evaluated through | |||
| clinical testing. | |||
| Grade of | |||
| Inclination | 0-5º | 1.15º | Different from the |
| predicate device. The | |||
| ExoAtlet-II can handle a | |||
| greater grade of | |||
| inclination. Safety | |||
| concerns regarding the | |||
| increased inclination | |||
| was evaluated through | |||
| clinical testing. | |||
| Type of Surface | Smooth, cement, carpet | Smooth, cement, carpet | Identical to the |
| predicate device. No | |||
| impact on safety and | |||
| effectiveness. | |||
| Range of Motion | Hips: 108º flexion to 21º extension Knees: 112º flexion to 2º extension Ankles: 15º flexion to 0-15º extension | Hips: 135º flexion to 20º extension Knees: 130º flexion to 0º extension Ankles: 10º flexion to 10º extension | Different from the |
| predicate device. The | |||
| ExoAtlet-II has a larger | |||
| range of motion in the | |||
| hips, knees, and ankles. | |||
| Safety and effectiveness | |||
| were evaluated through | |||
| clinical testing. | |||
| Fall Detection | |||
| and Mitigation | None | None | Identical to the |
| predicate device. No | |||
| impact on safety and | |||
| effectiveness. | |||
| Failsafe Feature | Yes, in the event of a failure-knees and pelvis become locked | Yes, in the event of a failure-knees become locked and hips free | Different from the |
| predicate device. The | |||
| ExoAtlet-II locks the | |||
| knees and pelvis. Safety | |||
| concerns regarding this | |||
| locking were evaluated | |||
| through clinical testing. | |||
| The therapist training | |||
| program also educates | |||
| the therapist on what to | |||
| do under this | |||
| circumstance | |||
| Operating | |||
| temperature | 0°C to 35°C | -12°C to 40°C | Different from the |
| predicate device. The | |||
| ExoAtlet-II can be | |||
| operated at a | |||
| temperature that is | |||
| within the predicate's | |||
| operating range. Any | |||
| possible effect on device | |||
| function was evaluated | |||
| through electrical safety | |||
| and EMC testing, as well | |||
| as performance testing. | |||
| Battery Charge | |||
| Time | 4 hours | 1 hour | Different from the |
| predicate device. The | |||
| ExoAtlet-II can remain | |||
| charged for longer. | |||
| Battery safety and | |||
| effectiveness were | |||
| evaluated through | |||
| electrical safety and | |||
| EMC testing, and clinical | |||
| testing. | |||
| Expected useable | |||
| life | 5 years | 4 years | Different from the |
| predicate device. The | |||
| ExoAtlet-II has a slightly | |||
| longer shelf life. The | |||
| difference in shelf life | |||
| was evaluated through | |||
| durability testing. | |||
| Testing | |||
| Performance | |||
| Testing | Software Electrical safety and electromagnetic compatibility Durability Clinical | Software Electrical safety and electromagnetic compatibility Durability Clinical | Identical to the |
| predicate device. No | |||
| impact on safety and | |||
| effectiveness. | |||
| Electrical safety | |||
| Testing | IEC 60601-1 | IEC 60601-1 | Identical to the |
| predicate device. No | |||
| impact on safety and | |||
| effectiveness. | |||
| EMC | |||
| Compatibility | |||
| testing | IEC 60601-1-2 | IEC 60601-1-2 | Identical to the |
| predicate device. No | |||
| impact on safety and | |||
| effectiveness. | |||
| Clinical | Yes | Yes | Identical to the |
| predicate device. No | |||
| impact on safety and | |||
| effectiveness. | |||
| Training Program | Yes | Yes | Identical to the predicate device. No impact on safety and effectiveness. |
| Certification Program | Yes | Yes | Identical to the predicate device. No impact on safety and effectiveness. |
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Image /page/7/Picture/0 description: The image shows the logo for EXOATLET. The logo is in a sans-serif font. The letters "EXO" are in blue, while the letters "ATLET" are in black.
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Image /page/8/Picture/1 description: The image shows the word "EXOATLET" in a stylized font. The "EXO" portion of the word is in a light blue color, while the "ATLET" portion is in black. The font is sans-serif and has a modern, minimalist look.
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Image /page/9/Picture/0 description: The image shows the word "EXOATLET" in a stylized font. The "EXO" portion of the word is in a bright blue color, while the "ATLET" portion is in a light gray color. The font is modern and sleek, with sharp angles and clean lines. The logo appears to be for a sports or fitness-related company.
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SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for the ExoAtlet-II.
Bench Testing: The elbow crutches provided in the ExoAtlet-II were testing in compliance to:
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. ISO 11334-1:2007 Assistive products for walking manipulated by one arm -Requirements and test methods — Part 1: Elbow crutches
Software Verification: The software development and testing were executed in compliance to: -
. IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1: 2012 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
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IEC 62304:2006 Medical device software Software life cycle processes ●
Electromagnetic Compatibility and Electrical Safety: The subject device was tested in compliance to:
- IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1: 2012 Medical electrical equipment -. Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2: 2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- . IEC 60601-1-6:11 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- CISPR 11: 2015 (Class A, Group 1) Industrial, scientific and medical equipment - Radiofrequency disturbance characteristics - Limits and methods of measurement
- . IEC 61000-3-2: 2014 Electromagnetic compatibility (EMC) – Part 3-2: Limits – Limits for harmonic current emissions (equipment input current ≤ 16 A per phase)
- . IEC 61000-3-3: 2013 Amendment 1 - Electromagnetic compatibility (EMC) - Part 3-3: Limits - Limitation of voltage changes, voltage fluctuations and flicker in public lowvoltage supply systems, for equipment with rated current ≤ 16 A per phase and not subject to conditional connection
- IEC 62368-1: 2014 (Second Edition) Audio/video, information and communication technology equipment - Part 1: Safety requirements
- IEC 62133: 2012 (Second Edition) Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable application – Part 2: Lithium systems
SUMMARY OF CLINICAL TESTING
ExoAtlet conducted an open label, non-randomized clinical study to assess the safety and effectiveness of the ExoAtlet-II in subjects, 18 years and older, with spinal cord injuries in the T4-L5 or C7-T4 range and type D neurological disorders according to the ASIA scale (n=20).
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Image /page/11/Picture/1 description: The image shows the word "EXOATLET" in a stylized font. The "EXO" portion of the word is in a bright blue color, while the "ATLET" portion is in a dark gray color. The font is sans-serif and appears to be custom-designed, with unique shapes for some of the letters.
19 of the 20 subjects successfully completed the 10 Meter Walk Test and the six-minute walk test (6 MWT). One subject was unable to complete the 6 MWT due to insufficient physical fitness. The surveys found that all of the subjects were able to use the subject device and on a scale from 1-10 (worst to best), 18 of the 20 subjects rated their comfort from eight out of ten to a ten out of ten. Two subjects rated their comfort a six out of ten. Additionally, none of the skin assessments found any adverse events related to biocompatibility such as abrasions, dry flaky skin, cut, eschar, or rash before, during, or after use of the ExoAtlet-II.
CONCLUSION
Based on the testing performed, including clinical testing, software validation, and electrical safety testing, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed ExoAtlet-II are assessed to be substantially equivalent to the predicate devices.