(66 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on mechanical and motorized components controlled by a computer and user interface, without mentioning adaptive or learning capabilities.
Yes
The device is described as assisting in rehabilitation for individuals with specific neurological conditions, aiming to improve ambulatory functions. The studies presented demonstrate its efficacy in improving various metrics related to rehabilitation, such as TUG scores and 6-minute walk test distances.
No
The EksoNR is described as a powered motorized orthosis intended to perform ambulatory functions in rehabilitation. Its function is to assist in movement and rehabilitation, not to diagnose medical conditions or provide diagnostic information.
No
The device description explicitly states it is a "powered motorized orthosis" consisting of a "fitted metal brace," "battery powered motors," and an "integrated solid torso containing the computer and power supply." This clearly indicates the presence of significant hardware components beyond just software.
Based on the provided information, the EksoNR™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- EksoNR™ Function: The EksoNR™ is a powered motorized orthosis designed to assist with ambulatory functions (walking) in rehabilitation settings. It is worn externally on the body and directly interacts with the user's physical movement.
- Intended Use: The intended use clearly describes a physical rehabilitation tool for individuals with specific neurological conditions, focusing on enabling gait and improving mobility. It does not involve the analysis of biological specimens.
The description of the device, its intended use, and the performance studies all point to a physical rehabilitation device, not a diagnostic tool that analyzes samples.
N/A
Intended Use / Indications for Use
The EksoNR is intended to perform ambulatory functions in rehabilitations under the supervision of a trained physical therapist for the following populations:
• Individuals with multiple sclerosis (upper extremity motor function of at least one arm).
• Individuals with acquired brain injury, including traumatic brain injury and stroke (upper extremity motor function of at least 4/5 in at least one arm).
• Individuals with spinal cord injuries at levels T4 to L5 (upper extremity motor function of at least 4/5 in both arms).
• Individuals with spinal cord injuries at levels of C7 to T3 (ASIA D with upper extremity motor function of at least 4/5 in both arms).
The therapist must complete a training program prior to use of the devices are not intended for sports or stair climbing
Product codes (comma separated list FDA assigned to the subject device)
PHL
Device Description
The Ekso is a powered motorized orthosis. It consists of a fitted metal brace that supports the legs, feet, and torso. It is worn via straps on the body, legs, and feet. Battery powered motors drive knee and hip joints. It has an integrated solid torso containing the computer and power supply. It has a hand-held user interface to specify settings and initiate steps. The Ekso is used with a cane, crutch, or walker.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
legs, feet, and torso
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physical therapist for the following populations:
• Individuals with multiple sclerosis
• Individuals with acquired brain injury, including traumatic brain injury and stroke
• Individuals with spinal cord injuries at levels T4 to L5
• Individuals with spinal cord injuries at levels of C7 to T3 (ASIA D with upper extremity motor function of at least 4/5 in both arms).
Rehabilitation institutions under the supervision of a trained physical therapist.
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)
-
Study Type: Single center, prospective parallel-assignment, single-blinded, randomized controlled study of patients with multiple sclerosis.
-
Sample Size: 18 subjects total used the Ekso.
-
Key Results:
- TUG scores improved significantly from 24s at baseline to 20.61s at completion of all Ekso sessions (n=17).
- Average walking speed was maintained throughout the intervention from 0.69m/s at baseline to 0.66m/s at completion of all Ekso sessions (n=18).
- Average cognitive MOCA scores improved slightly from 25.39 at baseline to 26.06 at completion of all Ekso sessions (n=18).
- No falls or other adverse events reported.
-
Study Type: Single center, randomized study of patients with multiple sclerosis.
-
Sample Size: 9 subjects total used the Ekso.
-
Key Results:
- TUG scores improved significantly from 16.99s at baseline to 14.15s at completion of all Ekso sessions (n=8).
- Average walking speed was maintained throughout the intervention from 10.37s at baseline to 10.63s at completion of all Ekso sessions (n=8).
- Symbol digit modalities test measuring cognition improved from baseline scores of 39.38 to post scores of 45.63.
- 6 minute walk test (6MWT) distance increased from 279.65m to 294.69m.
- Average functional reach test distance increased from baseline of 9.61cm to 10.46cm at completion of all Ekso sessions.
- No falls or other adverse events reported.
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 9, 2022
Ekso Bionics, Inc. Michael Glover Global Director of Clinical Experience 1414 Harbour Way South, Suite 1201 Richmond, California 94804
Re: K220988
Trade/Device Name: EksoNR Regulation Number: 21 CFR 890.3480 Regulation Name: Powered Lower Extremity Exoskeleton Regulatory Class: Class II Product Code: PHL Dated: March 31, 2022 Received: April 4, 2022
Dear Michael Glover:
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,
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
2
Indications for Use
510(k) Number (if known) K220988
Device Name EksoNR
Indications for Use (Describe)
The EksoNR™ is intended to perform ambulatory functions in rehabilitations under the supervision of a trained physical therapist for the following populations:
· Individuals with multiple sclerosis (upper extremity motor function of at least one arm).
• Individuals with acquired brain injury, including traumatic brain injury and stroke (upper extremity motor function of at least 4/5 in at least one arm).
· Individuals with spinal cord injuries at levels T4 to L5 (upper extremity motor function of at least 4/5 in both arms).
· Individuals with spinal cord injuries at levels of C7 to T3 (ASIA D with upper extremity motor function of at least 4/5 in both arms).
The therapist must complete a training program prior to use of the devices are 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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3
510(k) Summary as required by 21 CFR 807.92(c)
| Device name | Ekso |
|---|---|
| Submitters name & | |
| contact info | Ekso Bionics® Inc. |
| 1414 Harbour Way South | |
| Suite 1201 | |
| Richmond, CA 94804 | |
| Contact Details: | |
| Scott Davis | |
| President and COO | |
| Tel: +1 603-831-2980 | |
| Email: sdavis@eksobionics.com | |
| Ekso Bionics Tel: +1 (510) 984-1761 | |
| Ekso Bionics Fax: +1 (510) 927-2647 | |
| Preparation Date | March 29, 2022 |
| Device Name & | |
| Classification | Trade Name: EksoNR™ |
| Common Name: Exoskeleton | |
| Classification Name: Powered Exoskeleton | |
| Device Classification: Class II, 21 CFR 890.3480 | |
| Product Code: PHL | |
| Legally Marketed | |
| Predicate Device | K200574, EksoNR, Ekso Bionics, Inc. |
| Device Description | The Ekso is a powered motorized orthosis. It consists of a fitted metal |
| brace that supports the legs, feet, and torso. It is worn via straps on the | |
| body, legs, and feet. Battery powered motors drive knee and hip joints. It | |
| has an integrated solid torso containing the computer and power supply. It | |
| has a hand-held user interface to specify settings and initiate steps. The | |
| Ekso is used with a cane, crutch, or walker. | |
| Indication for Use | |
| Statement | The EksoNR™ is intended to perform ambulatory functions in rehabilitation |
| institutions under the supervision of a trained physical therapist for the | |
| following populations: | |
| • Individuals with multiple sclerosis (upper extremity motor function | |
| of at least 4/5 in at least one arm) | |
| • Individuals with acquired brain injury, including traumatic brain | |
| injury and stroke (upper extremity motor function of at least 4/5 in | |
| at least one arm). | |
| • Individuals with spinal cord injuries at levels T4 to L5 (upper | |
| extremity motor function of at least 4/5 in both arms). | |
| • Individuals with spinal cord injuries at levels of C7 to T3 (ASIA D | |
| with upper extremity motor function of at least 4/5 in both arms). | |
| The therapist must complete a training program prior to use of the device. | |
| The devices are not intended for sports or stair climbing. | |
| Substantial | |
| Equivalence | |
| Discussion | This device and the previously cleared (predicate) device (K200574) are |
| essentially the same products. | |
| Differences in Indications for Use | |
| The purpose of this 510(k) is to update the indications for use. The | |
| indications for use are identical to that of the predicate device, with the | |
| addition of the following: | |
| ● Individuals with multiple sclerosis (upper extremity motor function | |
| of at least 4/5 in at least one arm) | |
| The change noted above expands the existing indications to include | |
| individuals with multiple sclerosis (MS). The intended use of the device is | |
| unchanged. For the purposes of this intended use (ambulatory | |
| rehabilitation), patients with MS present similarly, are screened for device | |
| safety requirements, and are treated in the same way as patients with ABI | |
| or SCI. As such, gait ambulation effectiveness of the device is no different | |
| when used on patients with MS. When used as instructed, the device is as | |
| safe to use with a broader population of patients with neurological | |
| conditions to include the already cleared ABI and SCI population and this | |
| new MS population. |
4
Technical Characteristics
The device is essentially unchanged from the current (predicate) device. All changes since the previous submission fall below the threshold requiring a 510(k) per the FDA's October 25, 2017, " Guidance for Industry and FDA Staff: Deciding When to Submit a 510(k) for a Change to an Existing Device". Even though there is no change, for completeness, the technical characteristics of the device are compared with the current device below.
| Current Device | Current Device | ||
|---|---|---|---|
| Manufacturer | Ekso Bionics®, Inc. | Ekso Bionics®, Inc. | |
| Trade Name | EksoNR™ | EksoNR™ | Differences |
| 510(k) Number | K220988 | K200574 | N/A |
| Product Code | PHL | PHL | Same |
| Regulation Number | 890.3480 | 890.3480 | Same |
| Regulation Name | Powered Exoskeleton | Powered Exoskeleton | Same |
| Body Coverage | Worn over legs and upper | ||
| body with rigid torso | Worn over legs and upper | ||
| body with rigid torso | Same | ||
| Size of Components | Adjustable upper leg, lower | ||
| leg, and hip width; control | |||
| unit integrated into the | |||
| torso | Adjustable upper leg, lower | ||
| leg, and hip width; control | |||
| unit integrated into the | |||
| torso | Same | ||
| Comparison of Technical Characteristics | |||
| Current Device | Current Device | ||
| Manufacturer | Ekso Bionics®, Inc. | Ekso Bionics®, Inc. | |
| Trade Name | EksoNR™ | EksoNR™ | Differences |
| Mobility Aid | Walker, Crutches, Cane | Walker, Crutches, Cane | Same |
| Ability of User Mobility | Sit, stand, walk, and | ||
| Turn | Sit, stand, walk, and | ||
| Turn | Same | ||
| Walking Speed | ~2 km/hr | ~2 km/hr | Same |
| Grade of Inclination | 1.15 deg | 1.15 deg | Same |
| Type of Surface | Smooth, cement, carpet | Smooth, cement, carpet | Same |
| Height of Patient | ~62″ to 74″ (1.58 m to 1.88 | ||
| m) | ~62″ to 74″ (1.58 m to 1.88 | ||
| m) | Same | ||
| Weight of Patient | Up to 220 lbs (100kg) | Up to 220 lbs (100kg) | Same |
| Control Method | Handheld interface for PT; | ||
| weight shift to initiate steps | Handheld interface for PT; | ||
| weight shift to initiate | |||
| steps | Same | ||
| Range of Motion | Hips: 135° flexion to 20° | ||
| extension | |||
| Knees: 130° flexion to 0° | |||
| extension | |||
| Ankles: 10° flexion to 10° | |||
| extension | Hips: 135° flexion to 20° | ||
| extension | |||
| Knees: 130° flexion to 0° | |||
| extension | |||
| Ankles: 10° flexion to 10° | |||
| extension | Same | ||
| Device Weight | 50 lbs (23 kg) | 50 lbs (23 kg) | Same |
| Rechargeable Battery | Rechargeable lithium ion | ||
| batteries 48.1V, 30A peak | |||
| current, 1 hour of | |||
| continuous usage per | |||
| charge | Rechargeable lithium ion | ||
| batteries 48.1V, 30A peak | |||
| current, 1 hour of | |||
| continuous usage per | |||
| charge | Same | ||
| Battery Charge Time | 1 hour | 1 hour | Same |
| Expected Useable Life | 4 years | 4 years | Same |
| Training Program | Yes | Yes | Same |
| Certification Program | Yes | Yes | Same |
| User Feedback | Provides visual feedback on | ||
| the handheld controller and | |||
| auditory feedback | Provides visual feedback on | ||
| the handheld controller | |||
| and auditory feedback | Same | ||
| Fall Detection and | |||
| Mitigation | None | None | Same |
| Failsafe Feature | In event of power failure- | ||
| knees become locked and | |||
| hips free (similar to typical | |||
| passive leg braces) | In event of power failure- | ||
| knees become locked and | |||
| hips free (similar to typical | |||
| passive leg braces) | Same | ||
| Current Device | Current Device | ||
| Manufacturer | Ekso Bionics®, Inc. | Ekso Bionics®, Inc. | |
| Trade Name | EksoNR™ | EksoNR™ | Differences |
| Operating Temperature | 10° to 95°F (-12° to -35° C) | 10° to 95°F (-12° to -35° C) | Same |
| Operating Humidity | Not available | Not available | Same |
| Electrical Safety Testing | IEC 60601-1:2005 with US deviations | IEC 60601-1:2005 with US deviations | Same |
| Electromagnetic Compatibility Testing | Passed IEC 60601-1-2: 2014 | Passed IEC 60601-1-2: 2014 | Same |
Comparison of Technical Characteristics
5
6
Clinical Performance Summary
The current device utilized 7 different studies to demonstrate safety and efficacy of the current indications for use (K200574). This submission builds from those 7 studies with 2 additional clinical studies (summarized below) focusing on the specific population added by the expanded indication for use in this submission. These studies demonstrate the device effectively enables gait ambulation, and there were no reported adverse events indicating the device is safe to use with this expanded population.
7
| Study | Description |
|---|---|
| ADEMBI MS | Single center, prospective parallel-assignment, single-blinded, randomized controlled |
| study of patients with multiple sclerosis. Only patients who were randomized to | |
| utilize Ekso were included in this submission. | |
| Duration of Intervention | |
| • Ambulation during a mean of 18.4 sessions per patient (range 13 to 20) | |
| 18 subjects total used the Ekso | |
| • Mean time since MS diagnosis: $12.94\pm8.11$ years | |
| • 3 were diagnosed with primary progressive MS | |
| • 8 were diagnosed with secondary progressive MS | |
| • 7 were diagnosed with relapsing remitting MS | |
| Results: | |
| For those participants who completed pre and post testing (n=17 for TUG, n=18 for | |
| others) | |
| • TUG scores improved significantly from 24s at baseline to 20.61s at | |
| completion of all Ekso sessions | |
| • Average walking speed was maintained throughout the intervention from | |
| 0.69m/s at baseline to 0.66m/s at completion of all Ekso sessions | |
| • Average cognitive MOCA scores improved slightly from 25.39 at baseline to | |
| 26.06 at completion of all Ekso sessions | |
| • There were no falls or other adverse events reported |
8
Single center, randomized study of patients with multiple sclerosis. Only patients who Kessler MS were randomized to utilize Ekso were included in this submission.
Duration of Intervention
-
Ambulation during a mean of 7.78 sessions per patient (range 6 to 8) ●
9 subjects total used the Ekso -
1 was diagnosed with secondary progressive MS
-
. 8 were diagnosed with relapsing remitting MS
Results:
For those participants who completed pre and post testing (n=8)
- . TUG scores improved significantly from 16.99s at baseline to 14.15s at completion of all Ekso sessions
- Average walking speed was maintained throughout the intervention from 10.37s at baseline to 10.63s at completion of all Ekso sessions
- Symbol digit modalities test measuring cognition improved from baseline scores of 39.38 to post scores of 45.63
- 6 minute walk test (6MWT) distance increased from 279.65m to 294.69m
- Average functional reach test distance increased from baseline of 9.61cm to 10.46cm at completion of all Ekso sessions
- There were no falls or other adverse events reported
Substantial Equivalence Conclusion
This device is substantially equivalent to the current device has technical characteristics and intended uses listed above to facilitate gait ambulation. The supporting clinical data demonstrating the use of the product with patients with multiple sclerosis (MS), show that the device effectively facilitates gait ambulation in the expanded patient population. The clinical data reported no adverse events demonstrating the device is safe on this patient population when used in accordance with existing labeling.