DATEX-OHMEDA ANESTHESIA VAPORIZER, MODEL D-TEC

K990132 · Datex-Ohmeda, Inc. · CAD · Jan 21, 1999 · Anesthesiology

Device Facts

• Record ID: K990132
• Device Name: DATEX-OHMEDA ANESTHESIA VAPORIZER, MODEL D-TEC
• Applicant: Datex-Ohmeda, Inc.
• Product Code: CAD · Anesthesiology
• Decision Date: Jan 21, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Datex-Ohmeda D-Tec is an electronic vaporizer which delivers the anesthetic agent desflurane. It heats desflurane to maintain temperature and vapor pressure for consistent output. For added convenience and safety, the vaporizer has an LED display which indicates vaporizer status - no output, low agent, warm-up, operational and alarm battery low. The D-Tec attaches to the Dragerwerk interlocking manifold which allows the user to change vaporizer arrangement from case to case or move vaporizers from suite to suite without the need for tools.

Device Story

Electronic vaporizer for desflurane delivery; heats agent to maintain temperature/vapor pressure for consistent output. Features LED status display (no output, low agent, warm-up, operational, low battery). Designed for use with Dragerwerk anesthesia systems via interlocking manifold; allows tool-free mounting/rearrangement. Operated by clinicians in surgical settings. Benefits patient by ensuring precise, consistent anesthetic concentration delivery.

Clinical Evidence

Bench testing only. Compliance with EN 740, EN 60601-1, EN 60601-1-2, ISO 5358, and ASTM F1161 standards.

Technological Characteristics

Electronic vaporizer; heating element for desflurane temperature/vapor pressure control. LED status display. Interlocking manifold mounting system. Complies with EN 740, EN 60601-1, EN 60601-1-2, ISO 5358, and ASTM F1161.

Indications for Use

Indicated for the delivery of desflurane anesthetic agent to a flow of medical gases through an anesthesia machine for patients requiring anesthesia.

Regulatory Classification

Identification

An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.

Predicate Devices

• Ohmeda Tec 6 vaporizer (K990132)
• Ohmeda Tec vaporizer NAD variant (K990132)

Submission Summary (Full Text)

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## K990132

Summary of Safety and Effectiveness

Madison, WI 53707-7550

Telephone [phone]

Facsimile 608-222-9147

Customer Service 800-345-2700

Product Support 800-345-2755

Website www.datex-ohmeda.com January 13, 1999

510(k) Summary of Safety and Effectiveness Information for the Datex-Subject: Ohmeda D-Tec Anesthesia Vaporizer Datex-Ohmeda D-Tec Anesthesia Vaporizer Proprietary: Common: Vaporizer, Anesthesia Anesthesiology, 73CAD, 21CFR868.5880 Classification:

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

The Datex-OhmedaD-Tec anesthesia vaporzier is substantially equivalent to the following currently marketed device:

- Ohmeda Tec 6 vaporizer Class II 21CFR868.5880 73CAD 1.
- Ohmeda Tec vaporizer NAD variant Class II CFR868.5880 73CAD 2.

The Datex-Ohmeda D-Tec anesthesia vaporizer is device that delivers physician selected concentrations of desflurane anesthetic agent to a flow of medical gases through an anesthesia machine, and to the patient. The spacing of the port valves, helps ensure that the Datex-Ohmeda D-Tec anesthesia vaporizer can only be mounted on Dragerwerk anesthesia systems with a Dragerwerk interlocking manifold.

The Datex-Ohmeda D-Tec anesthesia vaporizer was designed to comply with the applicable portions of the following voluntary standards;

- 1. EN 740 Anesthetic Work Stations
- 2. EN 60601 1, 150 601-1: 1988 Medical Electrical Equipment
- 4. EN 60601-1-2, IEC 601-1-2: 1998 Medical Electrical Equipment Electromagnetic Compatability
- 5. ISO 5358 Anesthetic Gas Machines
- 6. ASTM F1161 Specifications for Anesthetic Gas Machines

The Datex-Ohmeda D-Tec anesthesia vaporizer and the currently marketed devices are substantially equivalent in design concepts, technologies and materials. The Datex-Ohmeda D-Tec anesthesia vaporizer has been validated through rigorous testing that, in part, support the compliance of the Datex-Ohmeda D-Tec anesthesia vaporizer to the above mentioned standards.

## Datex-Ohmeda

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 1 1999

Mr. Daniel Kosednar Datex-Ohmeda Ohmeda Drive P.O. Box 7550 Madison, WI 53707-7550

Re: K990132 Datex-Ohmeda Anesthesia Vaporizer, Model D-TEC Regulatory Class: II (two) Product Code: 73 CAD Dated: January 13, 1999 Received: January 14, 1999

Dear Mr. Kosednar:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Daniel Kosednar

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Čallahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K 990132

Device Name: Datex-Ohmeda D-Tec Anesthesia Vaporizer

Indications For Use:

The Datex-Ohmeda D-Tec is an electronic vaporizer which delivers the anesthetic agent desflurane. It heats desflurane to maintain temperature and vapor pressure for consistent output. For added convenience and safety, the vaporizer has an LED display which indicates vaporizer status - no output, low agent, warm-up, operational and alarm battery low. The D-Tec attaches to the Dragerwerk interlocking manifold which allows the user to change vaporizer arrangement from case to case or move vaporizers from suite to suite without the need for tools.

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Mark Kramer
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and
Neurological Devices

| 510(k) Number: | k990132 |
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Over-The-Counter Use
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1.109)Concurrence of CDRH, Office of Device Evaluation (ODE)

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