(27 days)
Not Found
No
The document describes a functional electrical stimulator that uses electrical stimulation based on the gait cycle. There is no mention of AI, ML, or any learning algorithms used for decision-making or adaptation.
Yes
The device is intended to address a lack of ankle dorsiflexion and improve gait using electrical stimulation, which are therapeutic interventions.
No
The device is an electrical stimulator designed to improve patient gait and provide other medical benefits by stimulating ankle dorsiflexion, rather than diagnosing a condition.
No
The device description explicitly states it is an "external functional electrical stimulator" and "a small device that attaches to the leg," indicating it is a hardware device that delivers electrical stimulation.
Based on the provided information, the Innovative Neurotronics WalkAide System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The WalkAide System is an external functional electrical stimulator that is applied to the leg to stimulate muscles and improve gait. It does not involve the analysis of any biological specimens.
The description clearly indicates it's a therapeutic device used to address a physical condition (lack of ankle dorsiflexion) through electrical stimulation.
N/A
Intended Use / Indications for Use
The Innovative Neurotronics WalkAide System is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of gait, the WalkAide electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the patient's gait. Medical benefits of Functional Electrical Stimulation (FES) may include prevention/retardation of disuse atrophy, increased local blood flow, muscle re-education, and maintained or increased joint range of motion.
Product codes (comma separated list FDA assigned to the subject device)
GZI
Device Description
The WalkAide is an external functional electrical stimulator. It is a small device that attaches to the leg just below the knee, near the head of the fibula. During a gait cycle, the WalkAide stimulates the common peroneal nerve, which innervates the tibialis anterior and other muscles that cause dorsiflexion of the ankle. The WalkAide System consists of the WalkAide Patient Kit and the WalkAide Clinician Kit . The WalkAide Patient Kit comprises of all the components and accessories that the patient will take home and use. The Clinician System comprises the accessories that a clinician (i.e., orthotic specialist, physiotherapist, occupational therapist, etc.) will use to set up a patient's WalkAide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
leg just below the knee, near the head of the fibula; ankle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
patient, clinician (i.e., orthotic specialist, physiotherapist, occupational therapist, etc.)
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)
Applicable performance and safety testing was performed to verify technological and functional characteristics including any design modification. Any design modifications do not raise any safety or effectiveness issues.
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
§ 882.5810 External functional neuromuscular stimulator.
(a)
Identification. An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.(b)
Classification. Class II (performance standards).
0
510(k) Summary for the Innovative Neurotronics, Inc. WalkAide System
SPONSOR 1.
Innovative Neurotronics, Inc. Two Bethesda Metro Center, Suite 1200 Bethesda, Maryland
| Contact Person: | Fayyaz Memon – Director of Quality and Manufacturing |
|---|---|
| Telephone: | 1-888-884-6462 ext. 1005 |
August 25, 2005 Date Prepared:
DEVICE NAME 2.
| Proprietary Name: | WalkAide |
|---|---|
| Common/Usual Name: | External Neuromuscular Functional Stimulator |
| Classification Names: | External Neuromuscular Functional Stimulator |
| Classification Number: | 21 CFR 882.5810 |
| Product Code: | GZI |
PREDICATE DEVICES 3.
Neuromotion WalkAide System-K974514
INTENDED USE 4.
The Innovative Neurotronics WalkAide System is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of gait, the WalkAide electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the patient's gait. Medical benefits of Functional Electrical Stimulation (FES) may include prevention/retardation of disuse atrophy, increased local blood flow, muscle re-education, and maintained or increased joint range of motion.
1
DEVICE DESCRIPTION ડ.
The WalkAide is an external functional electrical stimulator. It is a small device that attaches to the leg just below the knee, near the head of the fibula. During a gait cycle, the WalkAide stimulates the common peroneal nerve, which innervates the tibialis anterior and other muscles that cause dorsiflexion of the ankle. The WalkAide System consists of the WalkAide Patient Kit and the WalkAide Clinician Kit . The WalkAide Patient Kit comprises of all the components and accessories that the patient will take home and use. The Clinician System comprises the accessories that a clinician (i.e., orthotic specialist, physiotherapist, occupational therapist, etc.) will use to set up a patient's WalkAide.
BASIS FOR SUBSTANTIAL EQUIVALENCE 6.
The intended use and technological characteristics such as pulse shape, pulse width, pulse intensity, stimulation trigger mechanism, and other characteristics of the proposed WalkAide are either identical or substantially equivalent to the parent WalkAide devices.
Applicable performance and safety testing was performed to verify technological and functional characteristics including any design modification. Any design modifications do not raise any safety or effectiveness issues.
CONCLUSIONS 7.
Based on the information provided in this premarket notification, Innovative Neurotronics believes that the proposed WalkAide is substantially equivalent to the parent Walk-Aide.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
SEP 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Fayyaz Memon Director of Quality and Manufacturing Innovative Neurotronics, Inc. Two Bethesda Metro Center, Suite 1200 Bethesda, Maryland 20814
Re: K052329
Trade/Device Name: Walk Aide External Dunctional Neuromuscular Stimulator Regulation Number: 21 CFR 882.5810 Regulation Name: External functional neuromuscular stimulator Regulatory Class: II Product Code: GZI Dated: August 25, 2005 Received: August 25, 2005
Dear Mr. Memon:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Fayyaz Memon
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter with a finding of substantial equivalence of your device of your device to a legally promatics notineted in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Signature
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number : _ _ (1)53337
Device Name: Innovative Neurotronics, Inc., WalkAide External Functional Neuromuscular Stimulator
Indications for Use:
The Innovative Neurotronics WalkAide External Functional Neuromuscular Stimulator (WalkAide System) is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of gait, the WalkAide System electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the patient's gait. Medical benefits of Functional Electrical Stimulation (FES) may include prevention/ retardation of disuse atrophy, increased local blood flow, muscle re-education, and maintained or increased joint range of motion.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K052329
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