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510(k) Data Aggregation
(135 days)
SmartEP is an evoked response testing and diagnostic device, that is capable of eliciting, acquiring, and measuring auditory, somatosensory, and visual evoked potential data, as well as providing nerve stimulation and monitoring.
The intended use of the SmartEP device is to objectively record evoked responses from patients of all ages upon the presentation of sensory stimuli. The product is indicated for use as a diagnostic aid and adjunctive tool in sensory related disorders (i.e., auditory, somatosensory, visual) and in surgical procedures for inter-operative nerve monitoring.
SmartEP is an evoked response system that is capable of eliciting, acquiring, and measuring auditory, somatosensory, and visual evoked potential data, as well as providing nerve stimulation/monitoring.
The feature modifications described in this 510(k) are to incorporate additional/expanded indications to the SmartEP device for somatosensory evoked potential, visual evoked potential, and nerve stimulation testing to the previously FDA cleared indications for auditory evoked potential testing. Specifically, additional hardware and software features have been added to the original SmartEP device system to objectively acquire somatosensory/visual evoked potentials upon the presentation of a somatosensory/visual stimulus, and to provide nerve stimulation/monitoring functionality.
The provided text describes a 510(k) premarket notification for the SmartEP device, seeking expanded indications for Somatosensory Evoked Potential (SEP), Visual Evoked Potential (VEP), and Nerve Stimulation/Monitoring. The core of the information regarding acceptance criteria and supporting studies is based on demonstrating substantial equivalence to predicate devices.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the equivalence of key specifications and intended use to legally marketed predicate devices. The "reported device performance" is a demonstration that the SmartEP's characteristics meet or are comparable to those of the predicate devices. The tables provided (Table E-1 and Table E-2) serve as the primary evidence for this.
Table 1: Acceptance Criteria and Reported Device Performance for SEP & VEP (Summarized from Table E-1)
| Parameter | Acceptance Criteria (Predicate Device: Nicolet Viking II K890495) | Reported SmartEP Performance (Device Under Review) |
|---|---|---|
| Intended Use | SEP: Stimulate, record, and process somatosensory evoked potentials. VEP: Stimulate, record, and process visual evoked potentials. | Same |
| Indications for Use | Recording and analysis of physiological data necessary for the diagnosis of somatosensory and visual related disorders. | Same |
| Target Population | All Ages | Same |
| Design | External box housing circuitry connected to CPU via RS232 connection. | External box housing circuitry connected to personal computer via a USB connection. (Note: This is a design difference, but implied functionally equivalent). |
| Materials | Assorted electrical components, circuit boards, SEP electrical stimulation box, SEP electrical stimulator probe, video monitor, and electrodes. | Assorted electrical components, circuit boards, SEP electrical stimulation box, SEP electrical stimulator probe, visual stimulation LED array, and electrodes. |
| Sterility | None Required | Same |
| Biocompatibility | Completely Biocompatible | Same (specifically for SEP Stimulator Probe: Type-302 stainless steel, meets ISO-10993) |
| Anatomical Sites | SEP: Upper/lower limbs and head. VEP: Scalp. | Same |
| Energy Delivery | SEP: Stimulation of upper or lower limbs with surface electrical signals. VEP: Stimulation of eyes with visual light patterns. | Same |
| Where Used | Clinical Setting | Same |
| Safety | Conforms to UL544 & IEC 60601-1 | Meets EN 60601-1 |
| Patient Isolation | Type BF (IEC 60601-1) (for data), Fiber Optic Signal Link. | Type BF (IEC 60601-1) (for data), Fiber Optic Signal Link (for amp), Medical-grade power supplies, 4000Vdc, 10 MegaOhms (for power), 3500Vdc, 10 TeraOhms (for probe), Isolation transformers, Isolation amplifiers. |
| Somatosensory Stimuli - Type | Constant Current or Voltage | Constant Current |
| Somatosensory Stimuli - Current Levels | 0 - 100 mA, 0 - 400V (into 4000 Ohms load) | 0 - 100 mA (400 Volt maximum) (into 4000 Ohms load) |
| Visual Stimuli - Output Illumination | None Specified | Red LED Light (Class I AEL Level), Peak Wavelength: 625 nm, Max Accessible Power: |
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