(30 days)
The NeuroMetrix UNIVERSAL Electrodes are intended for use with electrodiagnostic equipment for the recording of electrophysiological activity from peripheral nerves and muscles, and for peripheral nerve electrical stimulation UNIVERSAL Electrodes are non-sterile and are for single patient use only
Surface electrodes are the interface medium between neurodiagnostic equipment and the patient When used for detection, they transduce broelectric signals into electronic signals for measurement of bioelectrical phenomena in the body, such as peripheral nerve or muscle responses When used in conjunction with stimulation circuitry in neurodiagnostic devices. they provide the interface necessary to stimulate perspheral nerves Surface electrodes are used in the performance of nerve conduction studies (NCS) They are provided non-stertle and are designed and intended to be for single patient use only and are disposable
- 트 UNIVERSAL Multi-Electrode Set A (UE-004)
- 0 UNIVERSAL Multi-Electrode Set B (UE-005)
These individually placed electrodes are not configured for specific nerves. limbs, or clinical applications They may be repositioned on the same patient up to four times Both of the Multi-Electrode Sets include two surface electrodes in a bar configuration for perspheral nerve stumulation, two pars of recording electrodes for measurement of broelectrical potentials, and a reference electrode The par of recording surface electrodes in Multi-Electrode set A (UE-004) are distinct with one arranged as ring electrodes In Multi-Electrode Set B (UE-005), three surface electrodes are used to create two recording pars by sharing of one of the electrodes All of the surface electrodes in the Multi-Electrode Sets are individually placed by The UNIVERSAL Electrodes include an embedded digital thermometer for the user measurement of skin-surface temperature, and a ruler (as part of the graphics layers) for the measurement of inter-electrode distances that are used for calculating conduction velocities
The provided document is a 510(k) summary for the NeuroMetrix UNIVERSAL Electrodes, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone study proving the device meets specific acceptance criteria based on performance data. Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not explicitly stated in this type of regulatory submission.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the 510(k) summary. A 510(k) submission for electrodes typically focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through material comparisons, intended use alignment, and technological characteristics, rather than through detailed performance metrics against specific quantitative acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. The submission does not detail any specific clinical or performance test sets used to generate data for this 510(k). The focus is on substantial equivalence to existing devices rather than a new performance study.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not provided. As no specific performance study with a test set is described, there's no mention of ground truth establishment by experts.
4. Adjudication Method for the Test Set
This information is not provided. No test set or adjudication process is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This information is not provided. An MRMC study is not mentioned. The 510(k) focuses on the device itself (electrodes), not a diagnostic algorithm that would typically be evaluated in an MRMC study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study Was Done
This information is not provided. The device is an electrode, not an algorithm. Therefore, a standalone algorithm performance study would not be applicable.
7. The Type of Ground Truth Used
This information is not provided. No ground truth is described as there's no performance study detailed.
8. The Sample Size for the Training Set
This information is not provided. The document describes an electrode, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. (See reason for #8).
Summary of the 510(k) Document's Approach to Meeting Regulatory Requirements:
The NeuroMetrix UNIVERSAL Electrodes 510(k) relies on demonstrating substantial equivalence to predicate devices. This means that instead of conducting a new study to prove specific performance metrics, the manufacturer asserts that the new electrodes are as safe and effective as previously cleared devices because they share the same:
- Intended Use: For use with electrodiagnostic equipment for recording electrophysiological activity from peripheral nerves and muscles, and for peripheral nerve electrical stimulation.
- Clinical Applications.
- Technological Characteristics:
- Surface electrodes that transduce bioelectric signals or provide an interface for stimulation.
- Non-sterile, single-patient use, and disposable.
- Inclusion of multi-electrode sets with various configurations (bar, ring) for stimulation and recording.
- Embedded digital thermometer and ruler for inter-electrode distance measurement.
- Materials, Manufacturing Process, and Packaging: Stated to be the same as NeuroMetrix Biosensors (K060584).
The predicate devices mentioned are:
The FDA's letter confirms that they reviewed the submission and determined that the device is substantially equivalent to the legally marketed predicate devices. This determination allows the device to be marketed without requiring a new Pre-Market Approval (PMA) application.
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).