NARKOMED GS ANESTHESIA SYSTEM

K963994 · Draeger Medical, Inc. · BSZ · Mar 19, 1997 · Anesthesiology

Device Facts

• Record ID: K963994
• Device Name: NARKOMED GS ANESTHESIA SYSTEM
• Applicant: Draeger Medical, Inc.
• Product Code: BSZ · Anesthesiology
• Decision Date: Mar 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5160
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NMGS may be used for spontaneous, manually assisted, or automatic ventilation, and delivery of gases and anesthetic vapor. The NMGS can monitor oxygen concentration, breathing pressure, and respiratory volume.

Device Story

Narkomed GS (NMGS) is a continuous flow gas anesthesia system; provides spontaneous, manually assisted, or automatic ventilation; delivers anesthetic gases and vapors. Integrated monitors track oxygen concentration, breathing pressure, and respiratory volume. Used in clinical settings (OR) by anesthesia providers. Incorporates AV2+ anesthesia ventilator as integral subassembly. Features optional two or three vaporizer configurations. Includes serial interface (Vitalink protocol) for communication with external monitors (Vitalert 2000/3000). Supports clinical decision-making by providing real-time respiratory and gas delivery data to the clinician.

Clinical Evidence

Bench testing only. Qualification included hazard analysis, software verification, environmental testing, and electromagnetic compatibility testing.

Technological Characteristics

Continuous flow gas anesthesia system. Integrated monitors for O2, pressure, and volume. Serial interface (Vitalink protocol). Optional two or three vaporizer configurations. Software-controlled ventilation via AV2+ subassembly.

Indications for Use

Indicated for patients requiring spontaneous, manually assisted, or automatic ventilation and delivery of anesthetic gases/vapors during anesthesia procedures.

Regulatory Classification

Identification

A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).

Predicate Devices

• Narkomed 2C Anesthesia System (K930351/A)
• Narkomed AV2+ Anesthesia Ventilator (K953228)

Reference Devices

• Vitalert 2000 monitor
• Vitalert 3000 monitor

Submission Summary (Full Text)

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K963994

MAR 19 1997

# Summary of Safety and Effectiveness Data Relating to Substantial Equivalence

Proprietary Name: Narkomed GS Anesthesia System

Classification Name: Gas-Machine, Anesthesia 73BSZ

Device Class: Class II

Manufacturer: North American Dräger
3135 Quarry Road
Telford, Pennsylvania 18969

Establishment Registration Number: 2517967

Devices to which substantial equivalence is claimed:
- Narkomed 2C Anesthesia System K930351/A
- Narkomed AV2+ Anesthesia Ventilator K953228

## Device Description:

The NMGS is a continuous flow gas anesthesia system.

## Intended Use:

The NMGS may be used for spontaneous, manually assisted, or automatic ventilation, and delivery of gases and anesthetic vapor. The NMGS can monitor oxygen concentration, breathing pressure, and respiratory volume.

## Substantial Equivalence:

The NMGS is substantially equivalent to the Narkomed 2C (NM2C) and the AV2+ Anesthesia Ventilator (AV2+).

The NMGS, like the NM2C is an anesthesia system with integrated monitors for oxygen concentration, breathing pressure and respiratory volume. The gas delivery system, absorber and scavenger of the NMGS are the same design that is used on the NM2C. The NMGS uses the AV2+ anesthesia ventilator. The AV2+ is marketed as an integral subassembly of North American Dräger anesthesia systems, including the NM2C.

The NMGS like the NM2C is available with a serial interface for communication via the Vitalink serial link protocol to devices such as NAD's Vitalert 2000 and 3000 monitors.

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The NMGS differs from the NM2C by offering an optional two vaporizer configuration of the system as well as the three vaporizer configuration.

The NMGS and the NM2C have the same intended use and principal of operation and are substantially equivalent.

Qualification of the NMGS included hazard analysis, software verification, and qualification testing, environmental testing, and electromagnetic compatibility testing.