(89 days)
The SafeOp 2: Neural Informatix System is intended for use in monitoring neurological status by recording somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NMJ). Neuromonitoring procedures include intracranial, intratemporal, extratemporal, neck dissections, upper and lower extremities, spinal degenerative treatments, pedicle screw fixation, intervertebral fusion cages, rhizotomy, orthopedic surgery, open/percutaneous, lumbar, thoracic, and cervical surgical procedures.
The SafeOp™ 2: Neural Informatix System (SafeOp 2 System), formerly known as EPAD 2 (K182542), consists of the SafeOp head unit with power supply and IV pole mount, the Alpha Informatix Tablet with docking station and power supply and a data transfer USB cable. Associated disposable accessories consists of an electrode harness, surface and/or subdermal needle electrodes, and stimulating probe or clip contained in various kits. The SafeOp 2 System head unit contains a complete data acquisition system that has builtin stimulators, amplifiers, relays, A/D Converters, Digital Signal Processors, CPUs, and storage devices. The head unit interfaces with other equipment through communication ports and serves as the patient-contacting portion of the system where it is close to the surgical field. The head unit hardware contains an eight acquisition (input) channel and six-output channel Evoked Potential Stimulator that is used in the operating room to display nerve and muscle responses. The user can use these responses to diagnose insults to the peripheral or central nerves and to determine relative nerve location, proximity, and integrity data. The SafeOp 2 System application provides the primary graphical user interface and controls for the SafeOp 2 System. The application runs on a touchscreen tablet mobile device which connects to the head unit either via wired USB cable or wireless via Wi-Fi, enabling both user input (e.g., patient and procedure information, adjustment of stimulus and acquisition parameters) and display of output (e.g., display of acquired waveforms, data, messages and alerts to the clinician).
The provided text is a 510(k) summary for the SafeOp 2: Neural Informatix System. It primarily focuses on demonstrating substantial equivalence to a predicate device (EPAD™ 2 System, K182542) rather than presenting a detailed study proving the device meets specific acceptance criteria based on clinical performance.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" and "reported device performance" in the typical sense of a clinical study measuring diagnostic accuracy or treatment efficacy. Instead, it demonstrates "substantial equivalence" to a predicate device by comparing various specifications. The "acceptance criteria" for this submission would broadly be that the device's specifications and performance are comparable to the predicate, with any differences not introducing new safety or effectiveness concerns.
| Specification/Property | Predicate Device (EPAD™ 2 System, K182542) | Subject Device (SafeOp™ 2 System) | Performance/Rationale |
|---|---|---|---|
| Intended Use/Indications for Use | Identical | Identical | Identical |
| Device Class | II | II | Identical |
| Product Code | GWF, GXY, GXZ, IKN, PDQ, ETN | GWF, GXY, GXZ, IKN, PDQ, ETN | Identical |
| Regulation Number | §882.1870, §882.1320, §882.1350, §890.1375, §874.1820, §874.1820 | §882.1870, §882.1320, §882.1350, §890.1375, §874.1820, §874.1820 | Identical |
| Device Classification Name | Stimulator, Electrical, Evoked Response | Stimulator, Electrical, Evoked Response | Identical |
| Monitoring Modalities | EMG, SSEP, NMJ | EMG, SSEP, NMJ | Identical |
| Head Unit Power Supply | 100 to 240 VAC, 50-60 Hz (input); 15 VDC, 2.5A (output) | 100 to 240 VAC, 50-60 Hz (input); 12 VDC, 2.5A (output) | Head unit power supply does not impact device performance when compared to the predicate. The change in power does not introduce new risks, or impact existing risks. Therefore, this difference does not affect device safety or effectiveness. |
| Mode of Operation | Continuous | Continuous | Identical |
| Dimensions | 12"W x 8"H x 2"D | 12"W x 8"H x 2"D | Identical |
| Weight | 50 MΩ (at DC) | > 50 MΩ (at DC) | Identical |
| Low Frequency Filter | 10 Hz (SSEP), 30 Hz (EMG) | 10 Hz (SSEP), 30 Hz (EMG) | Identical |
| High Frequency Filter | 2.7 kHz (SSEP & EMG) | 2.7 kHz (SSEP & EMG) | Identical |
| Notch Filter | 50 or 60 Hz | 50 or 60 Hz | Identical |
| AlphaInformatix (AIX) Tablet OS | Android powered tablet | Windows 10 powered tablet | Completed V&V testing successfully demonstrates that the differences in the Operating Systems (OS) have no impact on device performance when compared to the predicate. The OS change does not introduce new risks, or impact existing risks. Therefore, this difference does not affect device safety or effectiveness. |
| Remote Access | No | No | Identical |
| Surface Electrode Anatomical Sites | SSEP: Upper/lower limbs and head/neck | SSEP: Upper/lower limbs and head/neck | Identical |
| Surface Electrode Type | Customer cutaneous electrodes for use with SafeOp only. Single, double and triple electrodes. | Customer cutaneous electrodes for use with SafeOp only. Single, double and triple electrodes. | Identical |
| Conductive Surface Area | 20x25mm | 25.4x25.4mm (1x1in.) | Completed V&V testing successfully demonstrates that the differences in the surface area has no impact on device performance when compared to the predicate. The change does not introduce new risks, or impact existing risks. Therefore, this difference does not affect device safety or effectiveness. |
| Conductive Gel | Wet gel | Solid gel | Completed V&V testing successfully demonstrates that the differences in the conductive gel has no impact on device performance when compared to the predicate. The change does not introduce new risks, or impact existing risks. Therefore, this difference does not affect device safety or effectiveness. |
| Connectors | Nicomatic three pin | Nicomatic three pin | Identical |
| Current Density |
§ 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).