(172 days)
No
The document describes a "propriety signal processing algorithm" and different control modes (CVC, CAC, CIC) based on bioelectrical signals and sensor data, but it does not explicitly mention or describe the use of AI or ML techniques. The control logic appears to be based on pre-defined algorithms and parameters adjusted by a trained professional, rather than learning from data.
Yes
The device is described as a "gait training device intended to temporarily help improve ambulation upon completion of the HAL gait training intervention" and is used to treat various medical conditions affecting mobility, such as spinal cord injury and post-stroke paresis.
No.
The Medical HAL Lower Limb Type is a gait training device intended to temporarily help improve ambulation. While it uses bioelectrical signals, these are for control and biofeedback training, not for diagnosing medical conditions.
No
The device description explicitly states it is a "battery powered bi-lateral lower extremity exoskeleton" and describes physical components like a controller, main unit, sensor shoes, and electrodes. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a "battery powered bi-lateral lower extremity exoskeleton" used for "gait training." It provides "assistive torque at the knee and hip joints." While it uses surface electromyography (EMG) signals, these are used to control the device and provide biofeedback, not to diagnose or detect a disease or condition from a sample.
- Intended Use: The intended use is focused on improving ambulation and gait training for individuals with specific neurological conditions. It does not mention any diagnostic purpose.
Therefore, the Medical HAL Lower Limb Type is a therapeutic and assistive device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Medical HAL Lower Limb Type orthotically fits to the lower limbs and trunk; HAL is a gait training device intended to temporarily help improve ambulation upon completion of the HAL gait training intervention. HAL must be used with a Body Weight Support system. HAL is not intended for sports or stair climbing. HAL gait training is intended to be used in conjunction with regular physiotherapy.
The device is intended for individuals with:
-
spinal cord iniurv at levels C4 to L5 (ASIA C. ASIA D) and T11 to L5 (ASIA A with Zones of Partial Preservation, ASIA B);
-
post stroke paresis
-
paraplegia due to progressive neuromuscular diseases (spinal muscular atrophy, spinal and bulbar muscular atrophy, amyotrophic lateral sclerosis, Charcot-Marie-Tooth disease, distal muscular dystrophy, inclusion body myositis, congenital myopathy, muscular dystrophy)
-cerebral palsy and are 12 years or older
-spastic paraplegia caused by either HTLV-1 Associated Myelopathy (HAM) or hereditary spastic paraplegia (HSP)
who exhibit sufficient residual motor and movement-related functions of the hip and knee to trigger and control HAL.
In preparation for HAL gait training, the controller can be used while the exoskeleton is not donned to provide biofeedback training through the visualization of surface electromyography bioelectrical signals recorded.
HAL is intended to be used inside healthcare facilities while under trained medical supervision in accordance with the user assessment and training certification program.
Product codes (comma separated list FDA assigned to the subject device)
PHL, HCC
Device Description
Medical HAL Lower Limb Type is a battery powered bi-lateral ower extremity exoskeleton that provides assistive torque at the knee and hip joints for gait training. HAL is comprised of a controller, a main unit, and sensor shoes in 30 size variations (variation same as predicate: 3 different leg lengths, 2 different leg lengths, 2 different waist widths >> total 24. New size variation: 3 different leg configurations, 1 leg lengths, 2 different waist widths >> total 6) and weighs ~9.5 kg (21 lbs). The main difference between the Model ML05 and ML07 is the leglengths. ML05 has S.M, L, XL sizes, while ML07 has 2S sizes. The device uses legally marketed electrodes (up to 18 electrodes) to record surface electromyography bioelectrical signals that are processed using a propriety signal processing algorithm. The propriety processing algorithm allows the detect surface electromyography bioelectrical signals to control the HAL device in CVC mode and provide visualization of the surface electromyography bioelectrical signals during biofeedback training. The assistive torque can be adjusted using three parameters: sensitivity level, torque tuner, and balance tuner. The device can also provide two additional modes: Cybernic Autonomous Control (CAC) mode and Cybernic Impedance Control (ClC) mode. CAC mode provides assistive torque leg trajectories based on postural cues and sensor shoe measurements. CC mode provides torque to compensate for frictional resistance of the motor based on joint motion. CIC mode does not provide torque assistance for dictating joint trajectories. A trained medical professional (i.e., physical therapist, etc.) can configure, operate, and monitor the device during gait training to make adjustments as needed.
Patients must exhibit sufficient residual motor and movement-related functions of the hip and knee to trigger and control HAL. The patient must be supported by a Body Weight Support (BWS) system before and during device use. The BWS must not be detached from the patient before doffing this device. HAL is not intended to provide sit-stand or stand-sit movements. HAL is capable of gait speeds up to approximately 2 km/hour on level ground. HAL is not intended for sports or stairclimbing.
In preparation to using HAL, the controller can be used while the exoskeleton is not donned to provide biofeedback training through the visualization of surface electromyography bioelectrical signals recorded. HAL is intended to be used in conjunction with regular physiotherapy. HAL is intended to be used inside a medical facility under the supervision of trained medical professionals who have successfully completed the HAL training program.
It is thought that one of the causes of the brain, nerves, and muscles lies in an abnormality of the signal transmission loop of the brain/nervous system between the brain and the peripherals that normally allows the body to function appropriately.
All Medical Cybernic Systems, including HAL, are designed to detect and adjust the patient's neurological information in a way that allows the device to assist with the appropriate function of the body. Through repeated activity that is synchronized with the brain's neural signal of motor intent, the patient's physical function gradually improves.
More specifically, in order to allow the body to appropriately function even if the signal detected at the periphery is too faint to elicit actual muscle movement, an MD can intervene by tuning the parameters embedical Cybernic System. This intervention enables the Medical Cybernic System to realize the movement in place of the patient's muscles. Even if the muscles barely function, repetition of neurologically-controlled voluntary movement and walking treatment has been shown to improve ambulation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower limbs and trunk; hip and knee joints
Indicated Patient Age Range
12 years or older
Intended User / Care Setting
trained medical professional (i.e., physical therapist, etc.); healthcare facilities / medical facility
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)
The following nonclinical test were newly submitted for the additional size variation device. FDA quidance documents and recognized consensus standards were not used/referenced.
-Maximum angle velocity
-Torque output
-Angle measurement performance
-Trunk absolute angle measurement performance
-Plantar force measurement performance
-BES input impedance
-BES measurement performance (CMRR)
-BES measurement performance (Frequency characteristics)
The safety and effectiveness of the subject device is demonstrated through the following clinical evaluation procedure for each of the 5 indication groups (A: spinal cord injury (K171909 cleared, and included in K201559), B: cerebrovascular disease (K201559 cleared), C: progressive neuromuscular disease (K201559 cleared), D: cerebral palsy (new) and E: spastic paraplegia (new)). After evaluating the results for the 5 groups, we conclude that:
A. The device is sufficiently safe when used under general and special controls described in this submission; and
B. The evaluation results are sufficient to support the claims identified in the Indications for Use for this submission.
The nonclinical and clinical tests submitted demonstrate that the device is as safe and as effective, and performs as well as the legally marketed device cleared as K201559.
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.
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 of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The logo is simple and professional, and it is easily recognizable.
May 7, 2024
Cyberdyne Inc. Yohei Suzuki Official Correspondent 2-2-1 Gakuen-Minami Tsukuba, Ibaraki 305-0818 Japan
Re: K233695
Trade/Device Name: Medical HAL Lower Limb Type (HAL-ML) Regulation Number: 21 CFR 890.3480 Regulation Name: Powered Lower Extremity Exoskeleton Regulatory Class: Class II Product Code: PHL, HCC Dated: April 9, 2024 Received: April 9, 2024
Dear Yohei Suzuki:
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
2
(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.
Tushar Bansal -S
for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
3
Indications for Use
Submission Number (if known)
Device Name
Medical HAL Lower Limb Type (HAL-ML)
Indications for Use (Describe)
Medical HAL Lower Limb Type orthotically fits to the lower limbs and trunk; HAL is a gait training device intended to temporarily help improve ambulation upon completion of the HAL gait training intervention. HAL must be used with a Body Weight Support system. HAL is not intended for sports or stair climbing. HAL gait training is intended to be used in conjunction with regular physiotherapy.
The device is intended for individuals with:
-
spinal cord iniurv at levels C4 to L5 (ASIA C. ASIA D) and T11 to L5 (ASIA A with Zones of Partial Preservation, ASIA B);
-
post stroke paresis
-
paraplegia due to progressive neuromuscular diseases (spinal muscular atrophy, spinal and bulbar muscular atrophy, amyotrophic lateral sclerosis, Charcot-Marie-Tooth disease, distal muscular dystrophy, inclusion body myositis, congenital myopathy, muscular dystrophy)
-cerebral palsy and are 12 years or older
-spastic paraplegia caused by either HTLV-1 Associated Myelopathy (HAM) or hereditary spastic paraplegia (HSP)
who exhibit sufficient residual motor and movement-related functions of the hip and knee to trigger and control HAL.
In preparation for HAL gait training, the controller can be used while the exoskeleton is not donned to provide biofeedback training through the visualization of surface electromyography bioelectrical signals recorded.
HAL is intended to be used inside healthcare facilities while under trained medical supervision in accordance with the user assessment and training certification program.
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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4
| 510(k) #: K233695 | 510(k) Summary | Prepared on: 2024-04-29 |
|---|---|---|
| ------------------- | ---------------- | ------------------------- |
Contact Details
| Applicant Name | CYBERDYNE Inc. |
|---|---|
| Applicant Address | 2-2-1 Gakuen-minami Tsukuba Ibaraki 305-0818 Japan |
| Applicant Contact Telephone | +81298698453 |
| Applicant Contact | Mr. Yohei Suzuki |
| Applicant Contact Email | suzuki_yohei@cyberdyne.jp |
Device Name
| Device Trade Name | Medical HAL Lower Limb Type (HAL-ML) |
|---|---|
| Common Name | Powered lower extremity exoskeleton |
| Classification Name | Powered Exoskeleton |
| Regulation Number | 890.3480 |
| Product Code | PHL |
Legally Marketed Predicate Devices
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K201559 | HAL for Medical Use (Lower Limb Type) | PHL |
Device Description Summary
| 21 CFR 807.92(a)(1) |
|---|
| --------------------- |
| 21 CFR 807.92(a)(2) |
|---|
| --------------------- |
| 21 CFR 807.92(a)(3) |
|---|
| --------------------- |
| 21 CFR 807.92(a)(4) |
|---|
| --------------------- |
Medical HAL Lower Limb Type is a battery powered bi-lateral ower extremity exoskeleton that provides assistive torque at the knee and hip joints for gait training. HAL is comprised of a controller, a main unit, and sensor shoes in 30 size variations (variation same as predicate: 3 different leg lengths, 2 different leg lengths, 2 different waist widths >> total 24. New size variation: 3 different leg configurations, 1 leg lengths, 2 different waist widths >> total 6) and weighs ~9.5 kg (21 lbs). The main difference between the Model ML05 and ML07 is the leglengths. ML05 has S.M, L, XL sizes, while ML07 has 2S sizes. The device uses legally marketed electrodes (up to 18 electrodes) to record surface electromyography bioelectrical signals that are processed using a propriety signal processing algorithm. The propriety processing algorithm allows the detect surface electromyography bioelectrical signals to control the HAL device in CVC mode and provide visualization of the surface electromyography bioelectrical signals during biofeedback training. The assistive torque can be adjusted using three parameters: sensitivity level, torque tuner, and balance tuner. The device can also provide two additional modes: Cybernic Autonomous Control (CAC) mode and Cybernic Impedance Control (ClC) mode. CAC mode provides assistive torque leg trajectories based on postural cues and sensor shoe measurements. CC mode provides torque to compensate for frictional resistance of the motor based on joint motion. CIC mode does not provide torque assistance for dictating joint trajectories. A trained medical professional (i.e., physical therapist, etc.) can configure, operate, and monitor the device during gait training to make adjustments as needed.
Patients must exhibit sufficient residual motor and movement-related functions of the hip and knee to trigger and control HAL. The patient must be supported by a Body Weight Support (BWS) system before and during device use. The BWS must not be detached from the patient before doffing this device. HAL is not intended to provide sit-stand or stand-sit movements. HAL is capable of gait speeds up to approximately 2 km/hour on level ground. HAL is not intended for sports or stairclimbing.
In preparation to using HAL, the controller can be used while the exoskeleton is not donned to provide biofeedback training through the visualization of surface electromyography bioelectrical signals recorded. HAL is intended to be used in conjunction with regular physiotherapy. HAL is intended to be used inside a medical facility under the
5
supervision of trained medical professionals who have successfully completed the HAL training program.
It is thought that one of the causes of the brain, nerves, and muscles lies in an abnormality of the signal transmission loop of the brain/nervous system between the brain and the peripherals that normally allows the body to function appropriately.
All Medical Cybernic Systems, including HAL, are designed to detect and adjust the patient's neurological information in a way that allows the device to assist with the appropriate function of the body. Through repeated activity that is synchronized with the brain's neural signal of motor intent, the patient's physical function gradually improves.
More specifically, in order to allow the body to appropriately function even if the signal detected at the periphery is too faint to elicit actual muscle movement, an MD can intervene by tuning the parameters embedical Cybernic System. This intervention enables the Medical Cybernic System to realize the movement in place of the patient's muscles. Even if the muscles barely function, repetition of neurologically-controlled voluntary movement and walking treatment has been shown to improve ambulation.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
Medical HAL Lower Limb Type orthotically fits to the lower limbs and trunk;
HAL is a gait training device intended to temporarily help improve ambulation of the HAL gait training intervention. HAL must be used with a Body Weight Support system. HAL is not intended for sports or stair climbing. HAL gait training is intended to be used in conjunction with regular physiotherapy.
The device is intended for individuals with:
-
spinal cord injury at levels C4 to L5 (ASIA C, ASIA D) and T11 to L5 (ASIA A with Zones of Partial Preservation, ASIA B);
-
post stroke paresis
-
paraplegia due to progressive neuromuscular diseases (spinal and bulbar muscular atrophy, amyotrophic lateral sclerosis, Charcot-Marie-Tooth disease, distal muscular dody myositis, congenital myopathy, muscular dystrophy)
-cerebral palsy and are 12 years or older
-spastic paraplegia caused by either HTLV-1 Associated Myelopathy (HAM) or hereditary spastic paraplegia (HSP) who exhibit sufficient residual motor and movement-related functions of the hip and knee to trigger and control HAL.
In preparation for HAL gait training, the controller can be used while the exoskeleton is not donned to provide biofeedback training through the visualization of surface electromyography bioelectrical signals recorded.
HAL is intended to be used inside healthies while under trained medical supervision in accordance with the user assessment and training certification program.
Indications for Use Comparison
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
The device has additional diseases as target populations and consequently has different indications for use in comparison to the predicate device.
The additional diseases are "cerebral paraplegia caused by either HTLV-1 Associated Myelopathy (HAM) or hereditary spastic paraplegia (HSP).
The applicant has submitted clinical data to support the safety and efficacy of the treatment with these diseases. The level of evidence is equivalent to the other diseases aready reviewed in K201559. Therefore the difference does not raise new questions regarding the safety and effectiveness of the device and do not constitute a new intended use.
Technological Comparison
The subject device expands the indication for use (target disease) and expands the height range of intended patients enabling smaller patients to use the device. The comparison of target diseases and patient physique are listed below:
-
Spinal cord injury: Intended for both the subject and predicate devices
-
Post stroke paresis: Intended for both the subject and predicate devices
-
Progressive neuromuscular diseases: Intended for both the subject and predicate devices
-
Cerebral palsy: Newly intended for the subject device (Not intended for the predicate device)
-
Spastic paraplegia caused by either HTLV-1 Associated Myelopathy or hereditary spastic paraplegia: Newly intended for the subject device (Not intended for the predicate device)
6
- Weight: 15kg-100kg for the subject device, and 40kg-100kg for the predicate device. - Height(approx.): 100cm-190cm for the subject device, and 150cm-190cm for the predicate device.
The subject device adds a smaller variation to enable use by patients who were too small (short) to fit the predicate device. The additional variation is based on the same concept and is assembled using different parts that reflect the difference in device size.
Performance testing on electrical safety and EMC were newly conducted for the additional variation where different questions about safety may arise. The selection of the device size variation depends completely on the patient, and does not depend on the disease.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The following nonclinical test were newly submitted for the additional size variation device. FDA quidance documents and recognized consensus standards were not used/referenced.
-Maximum angle velocity
-Torque output
-Angle measurement performance
-Trunk absolute angle measurement performance
-Plantar force measurement performance
-BES input impedance
-BES measurement performance (CMRR)
-BES measurement performance (Frequency characteristics)
The safety and effectiveness of the subject device is demonstrated through the following clinical evaluation procedure for each of the 5 indication groups (A: spinal cord injury (K171909 cleared, and included in K201559), B: cerebrovascular disease (K201559 cleared), C: progressive neuromuscular disease (K201559 cleared), D: cerebral palsy (new) and E: spastic paraplegia (new)). After evaluating the results for the 5 groups, we conclude that:
A. The device is sufficiently safe when used under general and special controls described in this submission; and
B. The evaluation results are sufficient to support the claims identified in the Indications for Use for this submission.
The nonclinical and clinical tests submitted demonstrate that the device is as safe and as effective, and performs as well as the legally marketed device cleared as K201559.