← Product Code [GWQ](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWQ) · K962157 # MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM (K962157) _Physiometrix, Inc. · GWQ · Nov 25, 1996 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWQ/K962157 ## Device Facts - **Applicant:** Physiometrix, Inc. - **Product Code:** [GWQ](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWQ.md) - **Decision Date:** Nov 25, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.1400 - **Device Class:** Class 2 - **Review Panel:** Neurology ## Indications for Use The NeuroLink NeuroMonitoring System has the same intended use as the predicate device, the HydroDot NeuroMonitoring System. Both are designed to locate EEG electrodes according the 10-20 International System and present electrical signal sensed by the electrodes from the skin to existing EEG recording, analysis and archiving equipment. ## Device Story NeuroLink NeuroMonitoring System (Model 1310) acquires EEG signals via biosensor electrodes and headpiece; transmits signals through patient module and fiber optic cable to DSP interface card; interfaces with existing digital EEG recording/analysis equipment. Used in clinical settings; operated by clinicians. Fiber optic cable ensures patient isolation. System supports remote/local self-test, calibration, and impedance testing. LCD display provides status/impedance feedback. Facilitates standardized 10-20 electrode placement and signal archiving. ## Clinical Evidence No clinical data provided; substantial equivalence based on technological characteristics and bench testing of signal acquisition/transmission components. ## Technological Characteristics System components: biosensor electrodes, headpiece, battery-powered patient module, fiber optic cable, DSP interface card. Signal acquisition via cutaneous electrodes; fiber optic isolation. Connectivity: interfaces with host digital EEG computer. Impedance testing and calibration features included. Class II device (21 CFR 882.1320, 882.1835). ## Regulatory Identification An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head. ## Predicate Devices - HydroDot NeuroMonitoring System ([K930080](/device/K930080.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} NOV 25 1996 K962157 Physiometrix, Inc. 510(k), Premarket Notification NeuroLink NeuroMonitoring System, Model 1310 # SUMMARY OF SAFETY AND EFFECTIVENESS Date: June 3, 1996 Company: Physiometrix, Inc. Five Billerica Park 101 Billerica Avenue N. Billerica, MA 01862 Contact: Dawn E. Frazer Director, Regulatory Affairs & Quality Assurance (508) 670-2422 (800) 474-9746 Subject Device: Model 1310, NeuroLink NeuroMonitoring System Predicate Device: K930080, HydroDot NeuroMonitoring System Classification: Class II, CFR 21 Part 882.1320, Cutaneous Electrodes Class II, 21 CFR Part 882.1835, Physiological Signal Amplifier Description: The e-Net NeuroMonitoring System consists of a set of components that work together to acquire and present EEG signal to any existing EEG recording and analysis equipment. The components in the original submission included Biosensor electrodes, e-Net headpiece, Patient Module, fiber optic interface, Monitor Module, AC power supply, and EEG Adapter Cable. The components of this submission include Biosensor electrodes, e-Net headpiece, Patient Module, fiber optic interface, and DSP Interface Card (replaces Monitor Module). The AC power supply and EEG Adapter Cable have been eliminated. The modified system discussed in this submission uses the same electrodes and headpiece for signal acquisition but has changes in the modules used to transmit signals to the existing EEG recording and analysis equipment. The Patient Module is a small battery powered unit attached to the patient. Power is enabled when the Patient Module is plugged into the DSP Card via the fiber optic cable, the host digital EEG computer is in the powered state and the Patient Module is enabled by pressing the control button located on the Patient Module. A five meter fiber optic cable is standard. The fiber optic cable provides outstanding patient isolation and flexible patient EEG Record Station placement options. A connector located at the top end of the module attaches to our standard e-Net headpiece or optionally a mini-jack for interface to standard cup electrodes. Self test, calibration and impedance tests are - page 6 - {1} Physiometrix, Inc. 510(k), Premarket Notification NeuroLink NeuroMonitoring System, Model 1310 remotely activated from the host Digital EEG Machine through the DSP Interface Card or locally by depressing the appropriate test button on the Patient Module. A visual indication of control button function, system status and out of range impedance can be provided on the LCD display as controlled from the host Digital EEG Machine. Intended Use: The NeuroLink NeuroMonitoring System has the same intended use as the predicate device, the HydroDot NeuroMonitoring System. Both are designed to locate EEG electrodes according the 10-20 International System and present electrical signal sensed by the electrodes from the skin to existing EEG recording, analysis and archiving equipment. - page 7 - --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWQ/K962157](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWQ/K962157) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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