OHMEDA EXCEL DRAW-OVER MILITARY VAPORIZER SYSTEM

K946127 · Ohmeda Medical · BSZ · Oct 8, 1996 · Anesthesiology

Device Facts

• Record ID: K946127
• Device Name: OHMEDA EXCEL DRAW-OVER MILITARY VAPORIZER SYSTEM
• Applicant: Ohmeda Medical
• Product Code: BSZ · Anesthesiology
• Decision Date: Oct 8, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5160
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Ohmeda Excel Draw-Over Military Vaporizer System is specifically designed for use with the Ohmeda Single-Agent Draw-Over Vaporizer. It consists of an Excel 210 system with an attached draw-over vaporizer. The purpose is to provide a platform for the delivery of inhalation anesthetic agents using the draw-over vaporizer and supplemental gas supply.

Device Story

System provides platform for inhalation anesthetic delivery; utilizes Ohmeda Excel 210 base modified with kit for Ohmeda Single-Agent Draw-Over Vaporizer. Kit includes mounting attachments, O2 flush cover, monitoring ports, scavenging interconnection, and extended oxygen enrichment tube. Operated by clinicians in military environments. Device facilitates draw-over anesthesia technique; allows supplemental gas supply. Benefits include portable, adaptable anesthesia delivery in field or specialized military contexts.

Clinical Evidence

Bench testing only. Compliance with ASTM F1161-1988 and MIL-STD-1472B standards documented.

Technological Characteristics

Anesthesia delivery system; includes draw-over vaporizer, mounting attachments, O2 flush cover, monitoring ports, scavenging interconnection, oxygen enrichment tube. Complies with ASTM F1161-1988 and MIL-STD-1472B. Mechanical/pneumatic operation; no software or electronic sensing/actuation described.

Indications for Use

Indicated for delivery of inhalation anesthetic agents in military settings requiring draw-over anesthesia delivery systems.

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

• Ohmeda 'B' Series Gas Delivery System (K863207)
• Ohmeda PAC Portable Anesthesia Machine (K850648A)
• Ohmeda Universal PAC Portable Anesthesia Machine (K901117A)

Submission Summary (Full Text)

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FROM :

15:12 434 0.24/05

# OHMEDA

K946127

OFF THE BOC GROUP

Ohmeda Inc
Ohmeda Drive
PO Box 7550
Madison WI 53707-7550
608 221 1551

October 2, 1996

Subject: 510(k) Summary of Safety and Effectiveness Information for the Ohmeda Excel Draw-Over Military Vaporizer System

Proprietary: Ohmeda Excel Draw-Over Military Vaporizer System

Common: Anesthesia Machine

Classification: Primary: Gas Machine for Anesthesia Class II 21CFR868.5160 - 73BSZ
Secondary: Anesthetic Vaporizer (non heated) Class II 21CFR868.5880 - 73CAD
Breathing Gas Mixer Class II 21CFR868.5330 - 73BZR
Uncompensated Thorpe Tube Flowmeter Class II 21CFR868.2320 - 73CCN

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 1992.

The Ohmeda Excel Draw-Over Military Vaporizer System is substantially equivalent to the following currently marketed Ohmeda devices:

1. Ohmeda 'B' Series Gas Delivery System (currently known as the Ohmeda Excel Anesthesia System) which was the subject of a cleared 510(k) premarket notification on 10/30/86 with FDA log number K863207.
2. Ohmeda PAC Portable Anesthesia Machine that was the subject of a cleared 510(k) premarket notification on 7/1/85 with FDA log number K850648A.
3. Ohmeda Universal PAC Portable Anesthesia Machine that was the subject of a cleared 510(k) premarket notification on 9/7/90 with FDA log number K901117A.

The Ohmeda Excel Draw-Over Military Vaporizer System is specifically designed for use with the Ohmeda Single-Agent Draw-Over Vaporizer. It consists of an Excel 210 system with an attached draw-over vaporizer. The purpose is to provide a platform for the delivery of inhalation anesthetic agents using the draw-over vaporizer and supplemental gas supply.

The Ohmeda Excel Draw-Over Military Vaporizer System is a modification of the Ohmeda Excel 210 that has been made to facilitate the Ohmeda Single-Agent Draw-Over Vaporizer and the militaries needs. The system consists of an Ohmeda Single Agent Draw Over Vaporizer and a kit that allows the vaporizer to be used with an Ohmeda Excel system. The kit consists of mounting attachments, O2 flush cover, monitoring ports, scavenging interconnection, and an extended length oxygen enrichment tube.

The Ohmeda Excel Draw-Over Military Vaporizer System was designed to comply with the applicable portions of the following voluntary standards:

1. ASTM F1161-1988 - "Standard Specification for Minimum Performance and Safety Requirements for Components and Systems of Continuous Flow Anesthesia Machines".
2. MIL-STD-1472B - "Human Engineering Design Criteria for Military Systems, Equipment and Facilities".

Standards agencies, such as U.L. and E.T.L., do not provide specific certification services for this type of device.

The Ohmeda Excel Draw-Over Military Vaporizer System and the currently marketed devices are substantially equivalent in technological characteristics, theory of operation, and use of accessories.