(206 days)
Not Found
No
The description focuses on electrical stimulation triggered by a heel sensor and configured by a clinician, with no mention of AI or ML technologies.
Yes
The device is intended to provide ankle dorsiflexion, improve gait, facilitate muscle reeducation, prevent disuse atrophy, maintain/increase joint range of motion, and increase local blood flow in individuals with drop foot, all of which are therapeutic purposes.
No
The device description focuses on providing electrical stimulation to improve gait and muscle function, not on detecting, diagnosing, or monitoring a disease or condition. The PDA is used for configuring the device, not for diagnostic purposes.
No
The device description clearly outlines multiple hardware components including a heel sensor, control unit, below the knee orthosis with electrodes and stimulation unit, and a PDA. This is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
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).
- NESS L300 Function: The NESS L300 is a neuroprosthesis that directly stimulates muscles in the leg to improve gait. It interacts with the body in vivo (within the living organism).
- Lack of Specimen Analysis: The description of the NESS L300 does not mention any analysis of biological specimens. Its function is based on electrical stimulation and sensing of physical movement (heel contact).
Therefore, based on the provided information, the NESS L300 is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NESS L300 is intended to provide ankle dorsiflexion in individuals with drop foot following an upper motor neuron injury or disease. During the swing phase of gait, the NESS L300 electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot; thus, it may improve the individual's gait. The NESS L300 may also facilitate muscle reeducation, prevent/retard disuse atrophy, maintain or increase joint range of motion and increase local blood flow.
Product codes
GZI and IPF
Device Description
The NESS L300 neuroprosthesis device consisting of a heel sensor, control unit (waist mounted or neck strap or in pocket) and below the knee orthosis containing electrodes and a controlled stimulation unit.
The heel sensor detects "heel off" and "heel contact" events during gait. It transmits signals to the stimulator, which initiates/ pauses the stimulation accordingly, thus activating the foot Dorsiflexors to ensure proper foot clearance during the swing phase, and proper foot placement during the stance phase.
The NESS L300 comprises of 4 main parts:
-
- A lower leg orthosis with integrated stimulation unit (stimulator) and electrodes, RF communication and rechargeable battery.
-
- A waist mounted (or in-pocket) control unit (CU), including a PDA interface, RF communication and AAA rechargeable battery.
-
- Foot sensor, with RF communication and non-rechargeable coin battery.
-
- PDA HP iPAQ hx4700 Pocket PC. The PDA is intended to be used by the clinician for configuring the control unit with the functional parameters as appropriate for every patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle, lower leg, foot
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician (for configuring the control unit)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
NESS
510(k) Summary:
JUL - 7 2006
NESS L300
Company Name:
NESS-Neuromuscular Electrical Stimulation Systems Ltd.
Contact Person: Amit Dar R&D and Clinical Manager
Telephone: +972-9-748-5738 Fax: +972-9-748-5740 E-mail: amit@ness.co.il
Authorized US Agent:
Daniel J. Doyle Daniel J. Doyle Associates 45 Beavers St. High Bridge, NJ 08829
Phone: (908) 638-5347 Fax: (908) 638-4711 E-mail: dandoyle@blast.net
Date prepared: May 5, 2006
Trade Name: NESS L300
Classification name: External functional neuromuscular stimulator
Class: II
Panel identification: Neurological devices
Product code: GZI and IPF
1
Image /page/1/Picture/0 description: The image shows the word "NESS" in a stylized, rounded font. The letters are thick and black, with rounded edges. The letters are connected to each other, giving the word a continuous appearance.
Regulation number: 882.5810
Predicate Devices: ODFS Dropped Foot Stimulator from Department of Medical Physics and Biomedical Engineering, Salisbury District Hospital, Salisbury, United Kingdom cleared under 510(k) no. K050991 and WalkAide, NeuroMotion Inc in Edmonton, Alberta, Canada, cleared under 510(k) no. K974514
Device description:
The NESS L300 neuroprosthesis device consisting of a heel sensor, control unit (waist mounted or neck strap or in pocket) and below the knee orthosis containing electrodes and a controlled stimulation unit.
The heel sensor detects "heel off" and "heel contact" events during gait. It transmits signals to the stimulator, which initiates/ pauses the stimulation accordingly, thus activating the foot Dorsiflexors to ensure proper foot clearance during the swing phase, and proper foot placement during the stance phase.
The NESS L300 comprises of 4 main parts:
-
- A lower leg orthosis with integrated stimulation unit (stimulator) and electrodes, RF communication and rechargeable battery.
-
- A waist mounted (or in-pocket) control unit (CU), including a PDA interface, RF communication and AAA rechargeable battery.
-
- Foot sensor, with RF communication and non-rechargeable coin battery.
-
- PDA HP iPAQ hx4700 Pocket PC. The PDA is intended to be used by the clinician for configuring the control unit with the functional parameters as appropriate for every patient.
Indications for Use:
The NESS L300 is intended to provide ankle dorsiflexion in individuals with drop foot following an upper motor neuron injury or disease. During the swing phase of gait, the NESS L300 electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot; thus, it may improve the individual's gait. The NESS L300 may also facilitate muscle reeducation, prevent/retard disuse atrophy, maintain or increase joint range of motion and increase local blood flow.
2
Image /page/2/Picture/0 description: The image shows the word "NESS" in a stylized, bold font. The letters are connected and have rounded edges, giving the word a modern and sleek appearance. The color of the letters is black, and the background is white, creating a high contrast. The overall design is simple yet eye-catching.
Substantial Equivalence:
The NESS L300 device has the same intended use and the same principle of operation as the ODFS Dropped Foot Stimulator from Department of Medical Physics and Biomedical Engineering, Salisbury District Hospital, Salisbury, United Kingdom cleared under 510(k) no. K050991 and WalkAide, NeuroMotion Inc in Edmonton, Alberta, Canada, cleared under 510(k) no. K974514. The main technological difference between NESS L300 and the predicate devices is the RF wireless communication between the components versus the wired communication in the predicate devices. The NESS L300 was successfully tested for electromagnetic compatibility (EMC).
Conclusion:
The evaluation of the NESS L300 does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to the predicate device.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services, USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird's head, body, and wings. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 7 2006
NESS Neuromuscular Electrical Stimulation Systems % Hogan and Hartson LLP Mr. Jonathan S. Kahn 555 13th Street, N.W. Washington, District of Columbia 20004-1109
Re: K053468 Trade/Device Name: NESS L300 Regulation Number: 21 CFR 882.5810 Regulation Name: External functional neuromuscular stimulator Regulatory Class: Class II Product Code: GZI Dated: July 5, 2006 Received: July 5, 2006
Dear Mr. Kahn:
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.
4
Page 2 - Mr. Jonathan S. Kahn
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Herbert Leunens
Mark N. Melkerson Director, Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Attachment 4
Indications for Use
510(k) Number (if known): K053468
Device Name: NESS L300
Indications for Use:
The NESS L300 is intended to provide ankle dorsiflexion in individuals with drop foot following an upper motor neuron injury or disease. During the swing phase of gait, the NESS L300 electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot; thus, it may improve the individual's gait. The NESS L300 may also facilitate muscle re-education, prevent/retard disuse atrophy, maintain or increase joint range of motion and increase local blood flow.
Over-The-Counter Use Prescription Use _ X Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Division of General, Restorative,
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| 510(k) Number | K053468 |