(274 days)
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Unknown
The device description mentions "software that drives a linear actuator" based on brain signals, but it does not explicitly state whether this software utilizes AI or ML algorithms for signal processing or translation. The absence of mentions of AI, DNN, or ML, and the lack of details on training/test sets, make it impossible to definitively confirm the presence of AI/ML.
Yes
The device is indicated for use in chronic stroke patients to facilitate muscle re-education and for maintaining or increasing range of motion in the upper extremity, which are therapeutic goals. It also is described as allowing the patient to perform therapeutic exercises.
No
Explanation: The device is described as a rehabilitation system intended to facilitate muscle re-education and increase range of motion, not to diagnose a medical condition. It detects brain activity to enable therapeutic exercises but does not provide diagnostic information about the patient's neurological state beyond what is needed for its operational control.
No
The device description explicitly states that the system consists of a Handpiece (motor-driven orthosis), a Tablet computer, and a Biometric Headset (containing EEG sensors). These are physical hardware components, not solely software.
Based on the provided information, the Neurolutions IpsiHand Upper Extremity Rehabilitation System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Neurolutions System Function: The Neurolutions System works by detecting brain activity (EEG signals) and translating those signals into physical movement of a hand orthosis. It is a rehabilitation device designed to facilitate muscle re-education and improve range of motion.
- No Specimen Analysis: The device does not analyze any biological specimens taken from the patient. It interacts with the patient's brain signals and provides physical assistance to their hand.
Therefore, the Neurolutions IpsiHand Upper Extremity Rehabilitation System falls under the category of a rehabilitation device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Neurolutions IpsiHand Upper Extremity Rehabilitation System is indicated for use in chronic stroke patients (≥ 6 months post-stroke) age 18 or older undergoing stroke rehabilitation, to facilitate muscle re-education and for maintaining or increasing range of motion in the upper extremity.
Product codes
QOL
Device Description
The Neurolutions IpsiHand Upper Extremity Rehabilitation System (a.k.a. Neurolutions System or IpsiHand System) detects goal-oriented brain activity using non-invasive EEG electrodes to allow a stroke patient to perform therapeutic exercises that they would otherwise not be able to perform, due to their impairment.
The Neurolutions System consists of the Neurolutions Handpiece, a Tablet computer, and a Biometric Headset. Using a standard Windows Tablet as the patient interface, the System translates brain signals from the Biometric Headset into movement of the motor-driven Handpiece worn over the patient's hand and wrist. The motion of the Handpiece, in turn, opens and closes the patient's impaired hand. The combined action of these System components allows the stroke patient to perform physical therapy exercises that they would otherwise not be able to perform, due to their impairment. The Biometric Headset, which contains dry electroencephalographic (EEG) sensors, receives electrical signals from the motor or pre-motor cortex, predominantly of the unaffected hemisphere of the patient's brain, and in so doing, detects the patient's intentions to move their affected hand. These intentions to move are translated into motor movements of the Handpiece using software that drives a linear actuator contained inside of the Handpiece. The Handpiece opens and closes the hand using a 3-finger pincer grip mechanism designed to emulate the movement of grasping an object using the two forefingers and thumb in a grasping motion (one degree of freedom).
The device functions as powered exercise equipment for the patient's hand using three separate modes: the main mode of therapy is referred to as the brain-computer interface (BCI) or 'thought' mode in which the patient's hand is opened or closed by the powered orthosis based on brain signals received from the Biometric headset; the second mode is referred to as a 'volitional' mode in which a patient actively opens and closes their hand with the System enabling independent range of motion; the third is a continuous passive motion (CPM) mode in which the System simply moves the patient's hand passively through a comfortable range of motion in a repetitive fashion.
The Neurolutions System is designed for use in clinic or home settings as part of prescribed rehabilitation therapy.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
EEG
Anatomical Site
Upper extremity (hand and wrist)
Indicated Patient Age Range
18 or older
Intended User / Care Setting
Prescription use in accordance with 21 CFR 801.109. Used in clinic or home settings as part of prescribed rehabilitation therapy.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A. Treatment of Chronic Stroke with IpsiHand, Clinical Study (ORS-0008)
- Study type: Prospective, non-randomized, self-controlled feasibility study.
- Sample size: Ten chronic (≥ 6 months) hemiparetic stroke survivors.
- Key results: Subjects had a statistically significant improvement in the Action Research Arm Test (ARAT) of a mean 660 points. Six of the 10 subjects showed a difference exceeding the ARAT Minimal Clinically Important Difference (MCID). Secondary outcome measures including Canadian Occupational Performance Measure (COPM), Motricity Index, and grip strength also significantly improved. No patient injury or adverse events reported, only minor fatigue in one subject.
B. IpsiHand Device Use in Stroke Patients to Assess Functional Motor Outcomes, Clinical Study (ORS-0012)
- Study type: Prospective, non-randomized, self-controlled study.
- Sample size: 31 enrolled subjects (24 progressed to Phase 2). 17 subjects completed the study protocol, and 12 completed the 6-month durability visit.
- Key results: From baseline to 12 weeks, patients (n=17) demonstrated a mean improvement of (b) (9) with a standard deviation (SD) of (b) (4) (two sided, one-sample t-test, p-value
§ 890.5420 Electroencephalography (EEG)-driven upper extremity powered exerciser.
(a)
Identification. An EEG-driven upper extremity powered exerciser is a non-invasive prescription device intended for rehabilitation by driving movement or exercise of an impaired upper extremity in response to the detection of purpose oriented electrical activity produced by the patient's brain.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must capture any adverse events observed during clinical use and must demonstrate that the EEG signal can be translated into intended motion.
(2) Software verification, validation, and hazard analysis must be performed.
(3) Performance data must demonstrate the electromagnetic compatibility, electrical safety, battery safety, and wireless compatibility of the device.
(4) The device components that contact the patient must be demonstrated to be biocompatible.
(5) Performance data must validate the reprocessing instructions for the reusable components of the device.
(6) Labeling must include:
(i) Instructions on fitting the device to the patient;
(ii) Information on how the device operates and the typical sensations experienced during treatment; and
(iii) Reprocessing instructions.
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DE NOVO CLASSIFICATION REQUEST FOR NEUROLUTIONS IPSIHAND UPPER EXTREMITY REHABILITATION SYSTEM
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Electroencephalography (EEG)-driven upper extremity powered exerciser. An EEG-driven upper extremity powered exerciser is a non-invasive prescription device intended for rehabilitation by driving movement or exercise of an impaired upper extremity in response to the detection of purpose oriented electrical activity produced by the patient's brain.
NEW REGULATION NUMBER: 21 CFR 890.5420
CLASSIFICATION: Class II
PRODUCT CODE: QOL
BACKGROUND
DEVICE NAME: Neurolutions IpsiHand Upper Extremity Rehabilitation System
SUBMISSION NUMBER: DEN200046
DATE DE NOVO RECEIVED: July 23, 2020
SPONSOR INFORMATION:
Neurolutions, Inc. 1101 Pacific Ave, Suite 300 San Cruz, California 95060
INDICATIONS FOR USE
The Neurolutions IpsiHand Upper Extremity Rehabilitation System is indicated as follows:
The Neurolutions IpsiHand Upper Extremity Rehabilitation System is indicated for use in chronic stroke patients (≥ 6 months post-stroke) age 18 or older undergoing stroke rehabilitation, to facilitate muscle re-education and for maintaining or increasing range of motion in the upper extremity.
LIMITATIONS
The sale, distribution, and use of the Neurolutions System are restricted to prescription use in accordance with 21 CFR 801.109.
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The Neurolutions System is contraindicated for use in patients having any of the following conditions:
- . Severe spasticity or rigid contractures in the wrist and/or digits that would prevent the Neurolutions Handpiece from being properly fit or positioned for use.
- . Skull defects due to craniotomy or craniectomy.
The safety and effectiveness of Neurolutions System therapy has not been evaluated in the following patient populations:
- Patients with Dementia, or who are too cognitively impaired to understand tasks
- Patients with severe, receptive aphasia who have difficulty understanding written or spoken language, or who are unable to follow written instructions
- Patients with severe unilateral visual inattention (neglect) that would visually limit use of the Tablet
The Neurolutions System should be used with caution in patients with nerve or sensory impairment that may limit or interfere with the patient's ability to sense pain in response to potential pressure points on the Neurolutions Handpiece.
As with use of any medical device, there are risks associated with treatment using the Neurolutions System. Some patients may experience any of the following adverse events during use of the device.
- · Fatigue, discomfort and/or headache associated with device use
- · Skin redness or pressure point(s) associated with the mechanical hand exerciser
Durability testing has not been completed beyond 6-months, persistence of benefits beyond 6-months post device use are currently unknown.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
The Neurolutions IpsiHand Upper Extremity Rehabilitation System (a.k.a. Neurolutions System or IpsiHand System) detects goal-oriented brain activity using non-invasive EEG electrodes to allow a stroke patient to perform therapeutic exercises that they would otherwise not be able to perform, due to their impairment.
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The Neurolutions System shown in the figure below, consists of the Neurolutions Handpiece, a Tablet computer, and a Biometric Headset.
Image /page/2/Picture/1 description: A person is wearing a hand rehabilitation device. The device is blue and black and is attached to the person's hand and wrist with straps. The device appears to be designed to help the person move their fingers and hand. The person's hand is resting on a black surface.
Neurolutions Handpiece
Image /page/2/Picture/3 description: The image shows a white tablet with a Windows operating system displayed on the screen. The tablet is positioned at a slight angle, showcasing the screen and the thin profile of the device. The Windows interface is visible, featuring the start menu and various application icons, suggesting the tablet is in active use or standby mode.
Tablet
Image /page/2/Picture/5 description: The image shows a black headset with multiple sensors attached to it, placed on a transparent head model. The headset has a central circular pad on top, with several smaller circular sensors extending outwards and downwards. The sensors appear to be positioned to make contact with the head. The transparent head model is featureless, allowing the headset and sensors to be clearly visible.
Biometric Headset
Using a standard Windows Tablet as the patient interface, the System translates brain signals from the Biometric Headset into movement of the motor-driven Handpiece worn over the patient's hand and wrist. The motion of the Handpiece, in turn, opens and closes the patient's impaired hand. The combined action of these System components allows the stroke patient to perform physical therapy exercises that they would otherwise not be able to perform, due to their impairment. The Biometric Headset, which contains dry electroencephalographic (EEG) sensors, receives electrical signals from the motor or pre-motor cortex, predominantly of the unaffected hemisphere of the patient's brain, and in doing so, detects the patient's intentions to move their affected hand. These intentions to move are translated into motor movements of the Handpiece using software that drives a linear actuator contained inside of the Handpiece. The Handpiece opens and closes the hand using a 3-finger pincer grip mechanism designed to emulate the movement of grasping an object using the two forefingers and thumb in a grasping motion (one degree of freedom).
The device functions as powered exercise equipment for the patient's hand using three separate modes: the main mode of therapy is referred to as the brain-computer interface (BCI) or 'thought' mode in which the patient's hand is opened or closed by the powered orthosis based on brain signals received from the Biometric headset; the second mode is referred to as a 'volitional' mode in which a patient actively opens and closes their hand with the System enabling independent range of motion; the third is a continuous passive motion (CPM) mode in which the System simply moves the patient's hand passively through a comfortable range of motion in a repetitive fashion.
The Neurolutions System is designed for use in clinic or home settings as part of prescribed rehabilitation therapy.
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
Only the Biometric Headset and Neurolutions System Handpiece are considered patientcontacting components of the System. The sponsor tested (6) samples each of the loop
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straps, orthosis padding, headset top foam padding and headset ear pad covers, which are patient-contacting throughout the therapy. However, the orthosis housing, EEG electrode components, plastic components of the finger tray and thumb rest, chargers, and the polycarbonate components of the biometric headset were not tested, as these components are in contact with the skin for a brief period and represent a low risk. The tablet was also not tested for biocompatibility, as it is an off-the-shelf consumer electronics device that is in contact with the patient only when initiating or updating the therapy program, thus posing a low risk for biocompatibility issues.
The biocompatibility evaluation for the Biometric Headset and Neurolutions System Handpiece was conducted in accordance with the International Standard ISO 10993-1: 2009 "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing Within a Risk Management Process". The Biometric Headset and Neurolutions System Handpiece are categorized as a surface device in limited ( 6 months post-stroke) age 18 or older undergoing stroke rehabilitation, to facilitate muscle re-education and for maintaining or increasing range of motion in the upper extremity.
The probable benefits outweigh the probable risks for the Neurolutions IpsiHand Upper Extremity Rehabilitation System. The device provides benefits and the risks can be mitigated by the use of general controls and the identified special controls.
CONCLUSION
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The De Novo request for the Neurolutions IpsiHand Upper Extremity Rehabilitation System is granted and the device is classified as follows:
Product Code: QOL Device Type: Electroencephalography (EEG)-driven upper extremity powered exerciser Regulation Number: 21 CFR 890.5420 Class: II