(165 days)
The NESS L300 Plus System is intended to provide ankle dorsiflexion and knee flexion or extension in individuals with foot drop and thigh muscle weakness, following an upper motor neuron injury or disease. During gait the L300 Plus System electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot and knee flexion or extension, thus it may improve the individual's gait. The L300 Plus System may also:
- Facilitate Muscle re-education
- Prevent/retard disuse atrophy
- Maintain or increase joint range of motion
- Increase local blood flow
The NESS L300 Plus System is intended to provide ankle dorsiflexion and knee flexion or extension in individuals with foot drop and thigh muscle weakness, following an upper motor neuron injury or disease. The NESS L300 Plus System is a combination of its two predicate devices of its two predicate devices, the NESS L300 (K080219) and the NESS System (K022776).
The NESS L300 Plus System consists of:
- A Control Unit that allows simple operation while displaying real time information regarding the system's status.
- Two Functional Stimulation Cuffs (L300 and Thigh, figures 11-2, 11-3 respectively), that include two surface electrodes and an integrated configurable Radio Frequency Stimulation unit each.
- A Gait Sensor, which uses a dynamic gait tracking algorithm to detect heel events and wirelessly synchronizes stimulation.
- A Clinician's Programming System with software, which is used for system programming by a trained clinician during configuration of the system for optimal fitting to the patient.
- A L300 Tester. The L300 Tester is utilized for checking the RFSs and FSCs for functionality.
- A power supply with a 3-way splitter cable to charge the Control Unit and both Radio Frequency Stimulation units.
This 510(k) summary for the NESS L300 Plus System does not contain the specific information requested regarding acceptance criteria, study details, or performance data.
Here's what is available from the document:
- Device Name: NESS L300 Plus System
- Intended Use Statement: "The NESS L300 Plus System is intended to provide ankle dorsiflexion and knee flexion or extension in individuals with foot drop and thigh muscle weakness, following an upper motor neuron injury or disease. During gait, the L300 Plus System electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot and knee flexion or extension, thus it may improve the individual's gait. The L300 Plus System may also: facilitate muscle re-education, prevent/retard disuse atrophy, maintain or increase joint range of motion, and increase local blood flow."
- Predicate Devices: NESS L300 (K080219) and NESS system (K022776).
- Purpose of 510(k): "The NESS L300 Plus is a new device based on the NESS L300 and on the NESS system." It is a combination of these two predicate devices.
- Conclusion: Bioness Neuromodulation believes the NESS L300 Plus is substantially equivalent to its predicate devices "without raising any new safety and effectiveness concerns."
Missing Information:
The document focuses on establishing substantial equivalence to predicate devices, which is common for 510(k) submissions. It does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set, data provenance, or details of a study proving the device meets acceptance criteria.
- Number of experts, their qualifications, or adjudication methods for ground truth establishment.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect sizes.
- Details of a standalone algorithm performance study.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample size for a training set.
- How ground truth for a training set was established.
This is a substantial equivalence (510(k)) submission, which typically relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring new clinical trials to establish de novo performance criteria against specific acceptance thresholds. Therefore, the details requested for a study proving the device meets defined acceptance criteria are not present in this type of submission.
§ 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).