Who is the manufacturer of NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR?

The Magstim Company , Ltd. filed the 510(k) submission for NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR (K964869).

What is the FDA product code for NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR?

ETN. It is classified under 21 CFR 874.1820 as a Class 2 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR?

510(k) clearance (submission type: Traditional).

What are the predicate devices for NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR?

Neurosign 100 (The Magstim Company); Brackmann II (WR Medical); NIM-2XL Nerve Integrity Monitor (Xomed).

Who can help prepare an FDA 510(k) submission like NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR

K964869 · The Magstim Company , Ltd. · ETN · May 14, 1997 · Ear, Nose, Throat

Device Facts

Record ID	K964869
Device Name	NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR
Applicant	The Magstim Company , Ltd.
Product Code	ETN · Ear, Nose, Throat
Decision Date	May 14, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.1820
Device Class	Class 2

Intended Use

The Neurosign 800 is intended to monitor and to stimulate cranial motor nerves. The motor nerves are monitored by detecting EMG activity in the muscles they innervate.

Device Story

Neurosign 800; EMG machine and nerve stimulator. Inputs: EMG signals via intramuscular or surface electrodes; electrical current via stimulating probe. Operation: Central control unit processes EMG activity from innervated muscles; stimulator pod delivers current to nerve tissue. Output: Visual/auditory EMG monitoring; nerve stimulation. Usage: Clinical setting; operated by surgeons/clinicians. Benefit: Facilitates nerve identification and preservation during surgery.

Clinical Evidence

No clinical data provided. Safety and effectiveness established via history of similar predicate devices and internal company clinical evaluations.

Technological Characteristics

EMG machine and nerve stimulator; central control unit with pre-amplifier pod and stimulator pod. Uses intramuscular or surface electrodes for EMG recording and stimulating probes for nerve tissue. Materials and manufacturing methods identical to Neurosign 100.

Indications for Use

Indicated for monitoring and stimulation of cranial motor nerves in patients undergoing surgical procedures where nerve identification and preservation are required.

Regulatory Classification

Identification

A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.

Predicate Devices

Neurosign 100 (The Magstim Company)
Brackmann II (WR Medical)
NIM-2XL Nerve Integrity Monitor (Xomed)

Related Devices

K991583 — NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR · The Magstim Company , Ltd. · May 19, 1999
K110140 — NEUROVISION NERVE LOCATOR MONITOR · Neurovision Medical Products, Inc. · Sep 30, 2011
K223254 — C2 Xplore · Inomed Medizintechnik GmbH · Jan 27, 2023
K982595 — NIM4 · Xomed, Inc. · Sep 4, 1998
K111647 — C2 NERVEMONITOR SYSTEM WITH ACCESSORIES · Inomed Medizintechnik GmbH · Oct 6, 2011

Submission Summary (Full Text)

{0} Neurosign 800 Motor Nerve Monitor 510(k) K96 4869 MAY 14 1997 # Neurosign 800 Motor Nerve Monitor The Neurosign 800 is an EMG machine and nerve stimulator. The machine consists of a central control unit to which a pre-amplifier pod and intramuscular or surface electrodes are attached for EMG recordings. Additionally connected to the main unit is a stimulator pod to which a stimulating probe which delivers current to nerve tissue may be connected. The Neurosign 800 is intended to monitor and to stimulate cranial motor nerves. The motor nerves are monitored by detecting EMG activity in the muscles they innervate. The Neurosign 800 is similar to the following products which are currently in commercial distribution: a) Neurosign 100, The Magstim Company b) Brackmann II, WR Medical c) NIM-2XL Nerve Integrity Monitor, Xomed The safety and effectiveness of the Neurosign 800 has been established through various techniques. The history of the similar products listed above lacks complaints related to safety and effectiveness, and as far as we are aware there have been no reports of adverse effects or reportable incidents connected with them, or in any published papers on nerve monitoring. The Magstim Company performs extensive in-house and on-site clinical evaluation of all its products both prior to and after product release for distribution. Our methods and procedures for acceptance of products as well as our techniques for clinical evaluation are performed using team participation. Team members include, but are not limited to, Marketing, Manufacturing, Engineering, Clinical Engineering, Manufacturing Engineering and Quality Assurance. The Neurosign 800 has met all specifications and expectations for its intended use based on the evaluations conducted thus far. The materials and methods used to manufacture the Neurosign 800 do not vary from the current materials and methods used by The Magstim Company in the manufacture of the Neurosign 100. We will incorporate new proven technologies as they become available; however, these improvements support product performance through greater reliability. The Magstim Company concludes that the Neurosign 800 is safe and effective for its intended use. The Magstim Company Limited