DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER

K012924 · Datex-Ohmeda, Inc. · CAD · Jan 30, 2002 · Anesthesiology

Device Facts

• Record ID: K012924
• Device Name: DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER
• Applicant: Datex-Ohmeda, Inc.
• Product Code: CAD · Anesthesiology
• Decision Date: Jan 30, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Datex-Ohmeda Tec 7 vaporizer is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia. It is available in halothane, isoflurane and sevoflurane variants. Each vaporizer is agent specific and is clearly labeled with the name of the anesthetic agent that it is designed for. The vaporizer is temperature, flow and pressure compensated so that its output remains relatively constant despite cooling due to evaporation, variations in inlet flow and fluctuating pressures. The vaporizer is designed to be used on Selectatec series mounted manifolds.

Device Story

The Datex-Ohmeda Tec 7 is a non-heated, agent-specific anesthesia vaporizer. It receives continuous flow of carrier gas as input; utilizes internal temperature, flow, and pressure compensation mechanisms to ensure stable anesthetic output despite evaporative cooling or pressure fluctuations; and delivers precise concentrations of anesthetic vapor. Designed for use on Selectatec series mounted manifolds within anesthesia workstations. Operated by clinicians (anesthesiologists/anesthetists) in clinical settings. Output is used to maintain patient anesthesia; benefits include consistent, controlled delivery of inhalation agents.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance with EN 740, ISO 5358, and ASTM F1161 standards was validated through bench testing.

Technological Characteristics

Non-heated, agent-specific vaporizer. Features temperature, flow, and pressure compensation. Designed for Selectatec series manifold mounting. Complies with EN 740, ISO 5358, and ASTM F1161. Mechanical operation; no software or electronic components.

Indications for Use

Indicated for the metered delivery of specific inhalation anesthetic agents (halothane, isoflurane, or sevoflurane) during continuous flow inhalation anesthesia. For prescription use only.

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

• Datex-Ohmeda Tec 5 Anesthesia Vaporizer (K942091, K892057)

Submission Summary (Full Text)

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### JAN 3 0 2002

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

Telephone: [phone] Customer Service: 800-345-2700 Product Support: 800-345-2755

Website: www.datex-ohmeda.com

Summary of Safety and Effectiveness

August 30, 2001

| Subject: | 510(k) Summary of Safety and Effectiveness Information for the |
|-----------------|----------------------------------------------------------------|
| | Datex-Ohmeda Tec 7 Anesthesia Vaporizer |
| Proprietary: | Datex-Ohmeda Tec 7 Anesthesia Vaporizer |
| Common: | Vaporizer, Anesthesia |
| Classification: | Anesthesiology, 73CAD, 21CFR868.5880, Class II |

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

The Datex-Ohmeda Tec 7 Anesthesia Vaporizer is substantially equivalent to the currently marketed Datex-Ohmeda Tec 5 anesthesia Vaporizer, which was the subject of 510(k)s K942091 and K892057.

The Datex-Ohmeda Tec 7 vaporizer is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia. It is available in halothane, isoflurane and sevoflurane variants. Each vaporizer is agent specific and is clearly labeled with the name of the anesthetic agent that it is designed for. The vaporizer is temperature, flow and pressure compensated so that its output remains relatively constant despite cooling due to evaporation, variations in inlet flow and fluctuating pressures. The vaporizer is designed to be used on Selectatec series mounted manifolds.

The Datex-Ohmeda Tec 7 Anesthesia Vaporizer was designed to comply with the applicable portions of the following voluntary standards;

- 1. EN 740 Anesthetic Work Stations
- 2. ISO 5358 Anesthetic Gas Machines
- 3. ASTM F1161 Specifications for Anesthetic Gas Machines

The Datex-Ohmeda Tec 7 Anesthesia Vaporizer and the currently marketed Tec 5 are substantially equivalent in uses, design concepts, technologies and materials. The Datex-Ohmeda Tec 7 Anesthesia Vaporizers have been validated through testing that, in part, support the compliance of the current and predicate device to the above mentioned standards.

#### Contact: Bill Exner

Vice President, Quality Assurance and Regulatory Affairs

# Datex-Ohmeda

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Device Name

Device Name: Proprietary Device Name: Common Device Name: Classification

Device Classification and Panel Device Classification: Device Panel:

Datex-Ohmeda Tec 7 Anesthesia Vaporizer Anesthesia Vaporizer Vaporizer, Anesthesia, Non-heated

73CAD – 21CFR868.5880 – Class II Anesthesiology

Predicate Devices

Datex-Ohmeda Tec 5 Anesthesia Vaporizer: 510(k) K942091 and 510(k) 892057

#### Performance Standards Information

To the best knowledge of Datex-Ohmeda, performance standards have not been promulgated by the FDA for this device.

Device Manufacturing Facility Information

Datex-Ohmeda, Inc. Anesthesia, Drug Delivery and Ventilation Business Unit Ohmeda Drive P.O. Box 7550 Madison, WI 53707-7550 608-221-1551 telephone [phone] facsimile

Establishment Registration and Owner/Operator Numbers Establishment Registration Number: 2112667 Owner/Operator Number 8030853

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three heads facing to the right. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### JAN 3 0 2002

Mr. Bill Exner Datex-Ohmeda, Inc. Anesthesia and Drug Delivery Business Unit P.O. Box 7550 Madison, WI 53707-7550

Re: K012924

Datex-Ohmeda Tec 7 Anesthesia Vaporizer Regulation Number: 868.5880 Regulation Name: Vaporizer, Anesthesia, Non-heated Regulatory Class: Class II (two) Product Code: 73 CAD Dated: January 2, 2002 Received: January 3, 2002

Dear Mr. Exner:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We nave reviewed your Section 9 ro(x) premained is substantially equivalent (for the indications felerenced and nave determined is marketed predicate devices marketed in interstate for use stated in the encrosule for regally manated povice Amendments, or to commerce prof to May 20, 1776, the encordance with the provisions of the Federal Food, Drug, devices that have been reclassified in accerative was a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval appl and Cosment Act (Act) that to hot require approvial controls provisions of the Act. The Act. The You may, therefore, market the device, obly of courements for annual registration, listing of general controls provisions of the rict labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (SCC above) the exist on a or regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller "Entroling and be found in the Code of Peachar 2015 ming your device in the Federal Register.

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#### Page 2 - Mr. Bill Exner

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I rease or acreased a determination that your device complies with other requirements of the Act that I Dri has intatutes and regulations administered by other Federal agencies. You must or any I vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OFF in the quality systems (21 CFR Part 820); and if applicable, the electronic roral in also quinn control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premaince nevice 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oivision of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

K. Dork Tille

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KO12924 510(k) Number (if known): Datex-Ohmeda Tec 7 Anesthesia Vaporizer Device Name:

Indications For Use:

The Datex-Ohmeda Tec 7 vaporizer is designed for the metered delivery of specific inhalation The Datex-Onmeda Tec 7 Vaportzer is designed for the of inhalation ansthesia. It is arailable in anesthetic agents for use in continuous now toolizer is agent specific and is clearly labeled halothane, Isollurane and sevonutalis. Laon vapor. The vapor. The vaporsite is temperature, flow and with the name of the allestiled agent that it is acceptively consent despite cooling due to evaporation, pressure compensated so that its output remains lead resy comments of the used on Selectatec series mounted manifolds.

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Concurrence of CDRH Office of Device Evaluation (ODE)

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

Kolz924 510(k) Number: .

Prescription Use . (Per 21CFR801.109) OR

Over-The-Counter Use-(Optional Format 1-2-96)