(23 days)
The CareFusion Nicolet EDX is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems including Nerve Conduction (NCS), Electromyography (EMG), Evoked Potentials (EP), Autonomic Responses and Intra-Operative Monitoring including Electroencephalography (EEG).
Evoked Potential (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP), Electroretinography (ERG), Electrooculography (EOG), P300, Motor Evoked Potentials (MEP) and Contingent Negative Variation (CNV). The Nicolet EDX with Synergy Software may be used to determine autonomic responses to physiologic stimuli by measuring the change in electrical resistance between two electrodes (Galvanic Skin Response and Sympathetic Skin Response). Autonomic testing also includes assessment of RR Interval variability. The Nicolet EDX with Synergy Software is used to detect the physiologic function of the nervous system, for the location of neural structures during surgery, and to support the diagnosis of neuromuscular disease or condition.
The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the nerve; Electromyography measures the electrical activity of the muscle and Evoked Potentials measure electrical activity from the Central Nervous System.
The Nicolet EDX with Synergy Software is intended to be used by a qualified healthcare provider.
The CareFusion Nicolet EDX system with Synergy Software (Synergy EDX) is designed for the acquisition, display, analysis, reporting, and management of electrophysiological information from the human nervous and muscular systems. The system is designed to perform nerve conduction studies (NCS), needle electromyography (EMG) testing, evoked potential (EP) testing, and intra-operative monitoring (IOM). Synergy EDX provides a variety of tests spanning the various modalities.
The Synergy EDX consists of the following major components:
- Nicolet EDX console base unit;
- Synergy control panel:
- Nicolet amplifier (there are two types available: 2 channel (AT2) with two non-switched amplifier channels and an 8 channel (AT2 + 6) amplifier with two non-switched and six switched amplifier channels;
- Desktop or laptop computer with a keyboard and mouse;
- Display monitor; and
- Synergy Software
The Synergy EDX optional accessories/components consists of the following:
- Nicolet HB6 or HB7 Head Box
- Stimulator probes (RS 10 probe, WR 50 Probe, S403 probe)
- SP1/SP2 electrical stimulator switching units
- Footswitches (single and triple)
- LED goggles
- Patient response button
- Photic strobe
- Headphones or other auditory transducers
- Cart
- Isolation transformer
- Printer
This document is a 510(k) Summary for the CareFusion Nicolet EDX with Synergy Software. It primarily serves to demonstrate substantial equivalence to previously cleared predicate devices, rather than presenting a performance study with detailed acceptance criteria and results from a clinical trial or a structured validation study as one might expect for a novel AI/ML device.
Here's an analysis based on the provided text, addressing your points:
The Device: The CareFusion Nicolet EDX with Synergy Software is a diagnostic electromyograph system designed for acquiring, displaying, analyzing, reporting, and managing electrophysiological information from human nervous and muscular systems. It performs nerve conduction studies (NCS), needle electromyography (EMG), evoked potential (EP) testing, and intra-operative monitoring (IOM).
Overview of Acceptance Criteria and Performance (Based on Substantial Equivalence):
This submission is a 510(k) for substantial equivalence, not a new de novo device with specific clinical performance acceptance criteria against a ground truth. The acceptance criteria essentially revolve around demonstrating that the new device has the same technological characteristics, indications for use, and safety/effectiveness as its predicate devices, or that any differences do not raise new questions of safety or effectiveness.
The document primarily shows that the CareFusion Nicolet EDX with Synergy Software is "Identical" or "Similar" to its predicate device, the CareFusion Nicolet EDX with Viking software (K112052), with one minor addition (CNV test to EP modality) and one minor difference in auditory tone frequency that doesn't change indications for use or safety/effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a substantial equivalence submission relying on comparison to a predicate, the "acceptance criteria" are implied by the similarity to the predicate, and "performance" is demonstrated by showing these similarities through technical specifications, rather than new quantitative performance metrics.
| Characteristic | Acceptance Criteria (Implied by Predicate K112052) | Reported Device Performance (CareFusion Nicolet EDX with Synergy Software) | Discussion of Differences (from Predicate) |
|---|---|---|---|
| 1.1 Indications For Use | Same as CareFusion Nicolet EDX with Viking (K112052): Acquisition, display, analysis, storage, reporting, and management of electrophysiological information from human nervous and muscular systems (NCS, EMG, EP, Autonomic Responses, IOM incl. EEG). EP includes VEP, AEP, SEP, ERG, EOG, P300, MEP. Autonomic testing includes GSR, SSR, RR Interval variability. Used to detect physiologic function of nervous system, locate neural structures during surgery, and support diagnosis of neuromuscular disease or condition. | Same as described for acceptance criteria. | Identical to the Nicolet EDX with Viking software, with the minor addition of the CNV test being a part of the Evoked Potential Modality. |
| 1.2 Warnings | Items related to off-label use or misuse. | Identical. | Identical to the Nicolet EDX with Viking software. |
| 1.3 Contra-indications | Items related to design and indicated use limitations (e.g., not for use in flammable anesthetics or with defibrillation). | Identical. | Identical to the Nicolet EDX with Viking software. |
| 2.1 General systems approach | Computer-based equipment with dedicated hardware peripherals/components. | Identical. | Identical to the Nicolet EDX with Viking software. |
| 2.2 User input device | Window mouse/keyboard driven graphic interface with dedicated control panel. | Window mouse/keyboard driven graphic interface with dedicated control panel. | Identical to the Nicolet EDX with Viking software. (Footnote 1 states Synergy control panel is functionally equivalent but differs in number of controls, which is deemed acceptable). |
| 2.12 Safety Standards | Compliance with IEC 60601-1:1998 + A1:1991+A2:1995, IEC 60601-1-1:2000, EN/IEC 60601-1-2: Ed. 2.0+A1:2004, IEC 60601-2-40: 1998, UL 60601-1: 2003-04-25 ED1 Rev:2003/06/30, CAN/CSA-C22.2 no. 601.1-M90. | Compliance demonstrated through testing. | Identical to the Nicolet EDX with Viking software (as implied by compliance with same standards). |
| 3.1 Number of channels | 2 to 8 | 2 to 8 | Identical to the Nicolet EDX with Viking software. |
| 3.2 CMMR | > 110 dB | > 110 dB | Identical to the Nicolet EDX with Viking software. |
| 3.3 Noise |
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).