(106 days)
The EksoNR™ is intended to perform ambulatory functions in rehabilitations under the supervision of a trained physical therapist for the following populations:
- · 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 star climbing.
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.
The provided text is a 510(k) Summary for the EksoNR™ exoskeleton, a medical device for rehabilitation. It details the device's indications for use, its technical characteristics, and non-clinical and clinical performance data to support its substantial equivalence to a predicate device.
However, the information provided does not contain details about an AI/algorithm-driven device, nor does it specify acceptance criteria in terms of quantitative performance metrics (like sensitivity, specificity, or AUC) that would be typically found for such a device. The document focuses on showing the device's safety and effectiveness for an expanded patient population in rehabilitation based on clinical studies, rather than the performance of an algorithm.
Therefore, I cannot extract the information required to populate the requested table or answer questions related to AI/algorithm performance, ground truth establishment for a test set, expert adjudication, or MRMC studies.
The document indicates "Software - Verification, Validation, and hazard analysis" was performed, but it does not describe a study involving a test set, ground truth experts, or performance metrics relevant to an AI/algorithm's diagnostic or predictive capabilities. It primarily discusses the exoskeleton's performance in facilitating gait ambulation and safety for patients, not an AI's performance in, for example, image analysis or diagnostic prediction.
To answer your request thoroughly, I would need a document describing an AI/algorithm-driven medical device and its performance evaluation against defined acceptance criteria.
{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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 15, 2020
Ekso Bionics, Inc. Jack Peurach CEO 1414 Harbour Way South, Suite 1201 Richmond, CA 94804
Re: K200574
Trade/Device Name: EksoNRTM Regulation Number: 21 CFR 890.3480 Regulation Name: Powered Lower Extremity Exoskeleton Regulatory Class: Class II Product Code: PHL Dated: February 27, 2020 Received: March 5, 2020
Dear Mr. Peurach:
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 Acting Assistant Director, Acute Injury Devices DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K200574 Device Name EksoNR™M
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 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 star 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{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 SouthSuite 1201Richmond, CA 94804 |
| Contact Details:Jack PeurachCEO | |
| Tel: +1 510-260-7610Email: jack@eksobionics.com | |
| Ekso Bionics Tel: +1 (510) 984-1761Ekso Bionics Fax: +1 (510) 927-2647 | |
| Preparation Date | February 27, 2020 |
| Device Name &Classification | Trade Name: EksoNR™Common Name: ExoskeletonClassification Name: Powered ExoskeletonDevice Classification: Class II, 21 CFR 890.3480Product Code: PHL |
| Legally Marketed | K161443, Ekso, Ekso Bionics, Inc. |
| Device Description | The Ekso is a powered motorized orthosis. It consists of a fitted metal brace thatsupports 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 torsocontaining the computer and power supply. It has a hand-held user interface tospecify settings and initiate steps. The Ekso is used with a cane, crutch, or walker. |
| Indication for UseStatement | The EksoNR™ is intended to perform ambulatory functions in rehabilitationinstitutions under the supervision of a trained physical therapist for the followingpopulations:• Individuals with acquired brain injury, including traumatic brain injury andstroke (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 extremitymotor function of at least 4/5 in both arms).• Individuals with spinal cord injuries at levels of C7 to T3 (ASIA D with upperextremity motor function of at least 4/5 in both arms).The therapist must complete a training program prior to use of the device. Thedevices are not intended for sports or stair climbing. |
| Substantial EquivalenceDiscussion | This device and the previously cleared (predicate) device (K161443) are essentially the same products. |
| Differences in Indications for Use | |
| The purpose of this 510(k) is to update the indications for use relative to the predicate device. The indications for use are identical to that of the predicate device, other than the following (changed wording is bolded ): | |
| Individuals with hemiplegia due to stroke (upper extremity motor function of at least 4/5 in at least one arm) | |
| has been updated to: | |
| Individuals with an acquired brain injury, including traumatic brain injury and stroke (upper extremity motor function of at least 4/5 in at least one arm) | |
| The change noted above expands the existing stroke indication to the broader acquired brain injury (ABI) population. The intended use of the device is unchanged. For the purposes of this intended use (ambulatory rehabilitation), ABI patients present similarly, are screened for device safety requirements including sufficient cognitive ability to follow instructions and safely use the device, and are treated in the same way as stroke patients (a subset of ABI). As such, gait ambulation effectiveness of the device is no different when used on the general ABI population. When used as instructed, the device is as safe to use with the general ABI population as the already cleared stroke 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.
| Comparison of Technical Characteristics | |||
|---|---|---|---|
| Current Device | |||
| Manufacturer | Ekso Bionics®, Inc. | Ekso Bionics®, Inc. | |
| Trade Name | EksoNR™ | Ekso GT® and EksoNR™ | Differences |
| 510(k) Number | K161443 | 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 upperbody with rigid torso | Worn over legs and upperbody with rigid torso | Same |
| Size of Components | Adjustable upper leg, lowerleg, and hip width; control unitintegrated into the torso | Adjustable upper leg, lowerleg, and hip width; control unitintegrated into the torso | Same |
| Mobility Aid | Walker, Crutches, Cane | Walker, Crutches, Cane | Same |
| Comparison of Technical Characteristics | |||
| Current Device | |||
| Manufacturer | Ekso Bionics®, Inc. | Ekso Bionics®, Inc. | |
| Trade Name | EksoNR™ | Ekso GT® and EksoNR™ | Differences |
| Ability of User Mobility | Sit, stand, walk, andturn | Sit, stand, walk, andTurn | 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°extensionKnees: 130° flexion to 0°extensionAnkles: 10° flexion to 10°extension | Hips: 135° flexion to 20°extensionKnees: 130° flexion to 0°extensionAnkles: 10° flexion to 10°extension | Same |
| Device Weight | 50 lbs (23 kg) | 50 lbs (23 kg) | Same |
| Rechargeable Battery | Rechargeable lithium ionbatteries 48.1V, 30A peakcurrent, 1 hour of continuoususage per charge | Rechargeable lithium ionbatteries 48.1V, 30A peakcurrent, 1 hour of continuoususage 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 thehandheld controller andauditory feedback | Provides visual feedback on thehandheld controller andauditory feedback | Same |
| Fall Detection andMitigation | None | None | Same |
| Failsafe Feature | In event of power failure-knees become locked and hipsfree (similar to typical passiveleg braces) | In event of power failure-knees become locked and hipsfree (similar to typical passiveleg braces) | Same |
| 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 USdeviations | IEC 60601-1:2005 with USdeviations | Same |
| ElectromagneticCompatibility Testing | Passed IEC 60601-1-2: 2014 | Passed IEC 60601-1-2: 2007 | Same, newerversion |
Comparison of Technical Characteristics
{5}------------------------------------------------
Comparison of Technical Characteristics
{6}------------------------------------------------
Non-clinical Performance Summary
| Technical Area | Tests Completed |
|---|---|
| Electrical Safety andElectromagnetic Compatibility | IEC 60601-1:2005, IEC 60601-1-2:2014, low battery testing, IEC 62133, IEC 61960 parts 7.4 and 7.5, UN 38.3, UN Manual (ST/SG/AC. 10/11/Rev.5/Amend.1), battery life cycle testing |
| Durability | Worst case loading of knee and hip joints beyond service life, worst case loading of structure beyond service life, ankle spring durability, component strength testing |
| Thermal | IEC 60601-1:2005 (ISO 7176 not required; batteries on the Ekso are mounted to the aluminum Torso frame, enclosed in an aluminum case, and not near any flammable material. The testing conducted per IEC 60601 -1 in terms of flame retardant evaluations is sufficient to support the device functionality in terms of flame retardant materials.) |
| Software | Verification, Validation, and hazard analysis |
| Bench Testing | IEC 60601-1:2005 sec. 15.3 (IP22 not required) |
Clinical Performance Summary
The current device utilized 5 different studies to demonstrate safety and efficacy of the current indications for use (K161443). This submission builds from those 5 studies with 2 additional clinical studies (summarized below) focusing on the specific populations 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.
| Study | Description |
|---|---|
| Kessler ABI | Single center, open-label, non-comparative, non-randomized, prospective study of patients with acquired brain injury (only non-stroke patients included in this submission). |
| Duration of Intervention | |
| Ambulation during a mean of 5.8 sessions (range 1 to 20) | |
| 24 subjects total used the Ekso | |
| Mean time since injury 92.2 days (range of 10 to 835 days) 6 closed TBI 1 TBI unspecified 3 non-TBI anoxic 2 non-TBI neoplasm NOS 2 non-TBI malignant neoplasm 3 non-TBI benign neoplasm of meninges 1 non-TBI non traumatic hemorrhage | |
| Results | |
| Mean Motor FIM scores pre and post-training were 20.4 and 54.2, respectively |
- Mean Cognitive FIM scores pre and post-training were 12.2 and 23.0, respectively ●
- There were no falls or other adverse events reported ●
{7}------------------------------------------------
Kessler TBI Single center, open-label, non-comparative, non-randomized, prospective study of patients with traumatic brain injury.
Duration of Intervention
-
Ambulation during a mean of 4.9 sessions (range 2 to 5) .
25 subjects total used the Ekso -
Mean time since injury 3540 days (range of 603 to 21360 days) ●
-
. All were unspecified TBI
Results
- . Mean 10MWT pre and post-training were 17 and 18 seconds, respectively
- Mean 2MWT pre and post-training were 126 and 128 meters, respectively
- Mean TUG scores pre and post-training were 19.3 and 21.7, respectively
- There were no falls or other adverse events reported ●
Substantial Equivalence Conclusion
This device is substantially equivalent to the current devices have the same technical characteristics and the same intended uses, to facilitate gait ambulation. The supporting clinical data demonstrating the use of the product with patients with Acquired Brain Injury (ABI), including both Traumatic Brain Injury (TBI) and non-Traumatic Brain Injury (non-TBI), 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.
§ 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).