(30 days)
Not Found
No
The device description focuses on sensor-based triggering of electrical stimulation based on gait events ("heel off" and "heel contact"). There is no mention of AI, ML, or any learning or adaptive algorithms.
Yes
The device is intended to provide specific therapeutic effects such as improving gait, facilitating muscle re-education, preventing disused atrophy, maintaining joint range of motion, and increasing local blood flow. These are all therapeutic outcomes.
No
The NESS L300 is described as a neuroprosthesis device intended to provide ankle dorsiflexion and improve gait in individuals with foot drop. Its functions include electrical stimulation of muscles to facilitate dorsiflexion, muscle re-education, preventing disuse atrophy, maintaining or increasing joint range of motion, and increasing local blood flow. These are all therapeutic actions, not diagnostic ones. The device detects "heel off" and "heel contact" events, but this detection serves to trigger therapeutic stimulation, not to diagnose a condition.
No
The device description explicitly lists multiple hardware components including a foot sensor, control unit, orthosis with electrodes and stimulation unit, and a clinician programmer handheld computer (PDA).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- NESS L300 Function: The NESS L300 is a neuroprosthesis device that uses electrical stimulation to directly interact with the human body to improve gait. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes a therapeutic intervention (providing ankle dorsiflexion, improving gait, muscle re-education, etc.) through electrical stimulation, not a diagnostic test performed on a sample.
- Device Description: The components described (foot sensor, control unit, orthosis with electrodes) are all designed for external application and direct interaction with the patient's leg and foot.
Therefore, the NESS L300 falls under the category of a therapeutic or rehabilitative medical 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 re-education, prevent/retard disused atrophy, maintain or increase joint range of motion and increase local blood flow.
Product codes
GZI, IPF
Device Description
This neuroprosthesis device consists of a RF foot sensor (Intelli-sense gait sensor), RF control unit (waist mounted / neck strap / in pocket), and a below the knee orthosis containing electrodes and a RF controlled stimulation unit (RF stim unit).
The Intelli-gait sensor detects "heel off" and "heel contact" events during gait and transmits signals to the RF stim unit. Accordingly, the RF stim unit initiates and pauses the stimulation, 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 RF stim unit and electrodes, RF communication, and rechargeable battery.
- A waist mounted (or in-pocket) Control Unit (CU), including a PDA (clinician programmer) interface, RF communication, and AAA rechargeable battery.
- Intelli-sense gait sensor with RF communication and non-rechargeable coin battery.
- Clinician Programmer Handheld computer (PDA)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ankle, foot, lower leg
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Per 21 C.F.R. 801.109)
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)
Performance data demonstrates that the modified NESS L300 is as safe and effective as the predicate device.
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
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510(k) SUMMARY
NESS, Ltd.'s NESS L300
510(k) Summary:
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:
Bioness, Inc. 25103 Rye Canyon Loop Valencia, CA 91355
Date prepared:
January 29, 2008
Trade Name:
NESS L300
Classification name:
External functional neuromuscular stimulator
Class: II
Panel identification: Neurological devices
Product code:
GZI and IPF
Regulation number:
882.5810 External functional neuromuscular stimulator 890.5850 Powered Muscle Stimulator
1
Predicate Devices:
Neuromuscular Electrical Stimulation Systems, Ltd.'s NESS L300 (K053468)
Purpose of the Special 510(k) notice.
The NESS L300 is a modification to the NESS L300 (K053468).
Device description:
This neuroprosthesis device consists of a RF foot sensor (Intelli-sense gait sensor), RF control unit (waist mounted / neck strap / in pocket), and a below the knee orthosis containing electrodes and a RF controlled stimulation unit (RF stim unit).
The Intelli-gait sensor detects "heel off" and "heel contact" events during gait and transmits signals to the RF stim unit. Accordingly, the RF stim unit initiates and pauses the stimulation, 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 RF stim unit and electrodes, RF communication, and rechargeable battery,
-
- A waist mounted (or in-pocket) Control Unit (CU), including a PDA (clinician programmer) interface, RF communication, and AAA rechargeable battery.
-
- Intelli-sense gait sensor with RF communication and non-rechargeable coin battery.
-
- Clinician Programmer Handheld computer (PDA)
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 disused atrophy, maintain or increase joint range of motion and increase local blood flow.
Substantial Equivalence:
The modified NESS L300 has the same intended use and similar indications, principles of operation, and technological characteristics as the original, cleared NESS L300. The minor differences in the embedded software, the Intelli-Gait (PDA) software, the hardware, and the accessories do not raise any new questions of safety or effectiveness. Performance data demonstrates that the modified NESS L300 is as safe and effective as the predicate device. Thus, the NESS L300 is substantially equivalent to its predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
FEB 28 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Neuromuscular Electrical Stimulation Systems % Dr. Evan Rosenfeld Bioness Incorporated 25103 Rye Canyon Loop Valencia, CA 91355
Re: K080219 Trade/Device Name: Modification to NESS L300 Regulation Number: 21 CFR 882.5810 Regulation Name: External functional neuromuscular stimulator Regulatory Class: Class II Product Code: GZI Dated: January 29, 2008 Received: January 29, 2008
Dear Dr. Rosenfeld:
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.
3
Page 2 - Dr. Evan Rosenfeld
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ K080219
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 disused atrophy, maintain or increase joint range of motion and increase local blood flow.
Prescription Use X (Per 21 C.F.R. 801.109)
AND/OR
Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark M. Millerson
Division of General, Restorative,
and i
K08021
510(k) Number