Who is the manufacturer of AS/3 NMT MODULE?

Datex Medical Instrumentation, Inc. filed the 510(k) submission for AS/3 NMT MODULE (K955026).

What is the FDA product code for AS/3 NMT MODULE?

KOI. It is classified under 21 CFR 868.2775 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for AS/3 NMT MODULE?

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

Who can help prepare an FDA 510(k) submission like AS/3 NMT MODULE?

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.

AS/3 NMT MODULE

K955026 · Datex Medical Instrumentation, Inc. · KOI · Apr 28, 1997 · Anesthesiology

Device Facts

Record ID	K955026
Device Name	AS/3 NMT MODULE
Applicant	Datex Medical Instrumentation, Inc.
Product Code	KOI · Anesthesiology
Decision Date	Apr 28, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.2775
Device Class	Class 2

Intended Use

The product is designed to be used for monitoring relaxation of patient during and after anesthesia and for regional block stimulation for nerve location. The intended environment of use is anesthesia department, including operation rooms (OR) and post-anesthesia care units (PACU) etc.

Device Story

AS/3 M-NMT module; component of AS/3 anesthesia monitoring system. Function: neuromuscular transmission monitoring and nerve location via regional block stimulation. Operation: module stimulates patient; measures response; transmits data to AS/3 anesthesia or compact monitor central unit. Central unit software calculates NMT values, displays data, manages trends, and provides monitoring features. Used in OR and PACU by anesthesia clinicians. Output assists in assessing patient relaxation levels and guiding nerve block procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Modular anesthesia monitoring component; hardware-based stimulation and response measurement; integrates with AS/3 anesthesia or compact monitor central unit; software-driven calculation and display.

Indications for Use

Indicated for monitoring neuromuscular relaxation in patients undergoing anesthesia and for regional block stimulation for nerve location in clinical settings including OR and PACU.

Regulatory Classification

Identification

An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.

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K212434 — Neuromuscular Transmission Monitor TOF3D · MIPM Mammendorfer Institut für Physik und Medizin GmbH · May 5, 2022
K042003 — INFINITY TRIDENT NMT POD · Draeger Medical Systems, Inc. · Sep 1, 2004
K213049 — STIMPOD NMS450 Nerve Stimulator · Xavant Technology (Pty), Ltd. · Oct 16, 2022
K023342 — NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE MAPPING PROBE, NEURO-TRACE III NERVE BG · Hdc Corp. · Mar 2, 2004

Submission Summary (Full Text)

{0} K955086 510(k) SUMMARY 23.02.96 APR 28 1997 Datex Division Instrumentarium Corp. P.O. Box 446 FIN-00101 Helsinki Finland Tel: +358 0 39411 Fax: +358 0 1463310 Contact person: Rauno Ruoho # PRODUCT NAMES Device name: $\mathrm{AS} / 3^{\mathrm{TM}}$ M-NMT Common name: Neuromuscular transmission Device # DESCRIPTION OF THE DEVICE The AS/3™ NMT Module is a part of the modular anesthesia monitoring system AS/3™. It provides relaxation measurement of patient. The product is designed to be used for monitoring relaxation of patient during and after anesthesia and for regional block stimulation for nerve location. The intended environment of use is anesthesia department, including operation rooms (OR) and post-anesthesia care units (PACU) etc. The NMT measurement hardware is in the NMT module. The NMT Module stimulates the patient controlled by the AS/3™ Anaesthesia or Compact Monitor central unit. Then the NMT Module measures the response of the stimulation and sends it to the AS/3™ Anaesthesia or Compact Monitor central unit. The AS/3™ monitor software receives the responses from the NMT module, calculates the NMT values, displays the NMT values, handles NMT trending and NMT monitor features.