DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE)

K031027 · Datex-Ohmeda, Inc. · CAD · Jun 26, 2003 · Anesthesiology

Device Facts

• Record ID: K031027
• Device Name: DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE)
• Applicant: Datex-Ohmeda, Inc.
• Product Code: CAD · Anesthesiology
• Decision Date: Jun 26, 2003
• 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, sevoflurane and enflurane 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 (enflurane) is an agent-specific anesthesia vaporizer; it receives continuous flow of carrier gas as input. The device utilizes internal mechanisms to provide temperature, flow, and pressure compensation, ensuring constant anesthetic output despite evaporative cooling or fluctuating inlet conditions. It is designed for mounting on Selectatec series manifolds within anesthesia workstations. Operated by clinicians (anesthesiologists/nurse anesthetists) in clinical settings like operating rooms, the device provides metered delivery of enflurane to the patient. The output is used to maintain anesthesia levels during surgical procedures, directly affecting patient sedation and pain management. The device benefits patients by providing precise, stable delivery of inhalation anesthetics.

Clinical Evidence

Bench testing only. No clinical data provided. Validation testing supported compliance with EN 740, ISO 5358, and ASTM F1161 standards.

Technological Characteristics

Non-heated, agent-specific anesthesia vaporizer. Features temperature, flow, and pressure compensation mechanisms. 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 (enflurane) for use in continuous flow techniques of inhalation anesthesia in patients requiring general 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

• Datex-Ohmeda Tec 5 Anesthesia Vaporizer (K942091, K892057)
• Datex-Ohmeda Tec 7 Anesthesia Vaporizer (K012924)

Submission Summary (Full Text)

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JUN 2 6 2003

Summary of Safety and Effectiveness

April 1, 2003

| Subject: | 510(k) Summary of Safety and Effectiveness Information for the<br>Datex-Ohmeda Tec 7 (enflurane) Anesthesia Vaporizer |
|-----------------|-----------------------------------------------------------------------------------------------------------------------|
| Proprietary: | Datex-Ohmeda Tec 7 (enflurane) 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 (enflurane) Anesthesia Vaporizer is substantially equivalent to the currently marketed Datex-Ohmeda Tec 7 (isoflurane, halothane, sevoflurane) and Datex-Ohmeda Tec 5 Anesthesia Vaporizers (isoflurane, halothane, sevoflurane, enflurane), which were the subject of cleared 510(k) premarket notifications K012924, 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, sevoflurane and enflurane 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 (enflurane) 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 (enflurane) Anesthesia Vaporizer and the currently marketed Datex-Ohmeda Tec 7 (isoflurane, halothane, sevoflurane) and Datex-Ohmeda Tec 5 Anesthesia Vaporizers (isoflurane, halothane, sevoflurane), substantially equivalent in uses, design concepts, technologies and materials. The Datex-Ohmeda Tec 7 (enflurane) 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: William E. Exner Vice President, Regulatory and Quality Affairs

Datex-Ohmeda, Inc P.O. Box 7550 Madison, WI 5370" ww.dates of mach as a Telephone [phone] Toll Free 800-345-2700 Facsimile 608-222-9147

Datav. Ohmods

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| Device Name | |
|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Device Name: Proprietary | Datex-Ohmeda Tec 7 (enflurane)<br>Anesthesia Vaporizer |
| Device Name: Common | Anesthesia Vaporizer |
| Device Name: Classification | Vaporizer, Anesthesia, Non-heated |
| Device Classification and Panel | |
| Device Classification: | 73CAD - 21CFR868.5880 - Class II |
| Device Panel: | Anesthesiology |
| Predicate Devices | |
| Datex-Ohmeda Tec 5 Anesthesia Vaporizer<br>(isoflurane, halothane, sevoflurane, enflurane) | 510(k)s K942091 and K892057 |
| Datex-Ohmeda Tec 7 Anesthesia Vaporizer<br>(isoflurane, halothane, sevoflurane) | 510(k) K012924 |
| Performance Standards Information | |
| To the best knowledge of Datex-Ohmeda, performance standards have not been<br>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 | |
| USA | |
| Telephone | 608-221-1551 |
| Facsimile | 608-223-2496 |
| Establishment Registration and Owner/Operator Numbers | |
| Datex-Ohmeda Establishment Registration Number: | 2112667 |

2112667
8030853 Datex-Ohmeda Owner/Operator Number:

.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.

Rockville MD 20850

Mr. William E. Exner Vice President, Regulatory and Quality Affairs Datex-Ohmeda, Incorporated P.O. Box 7550 Madison, WI 53707

Re: K031027

Datex-Ohmeda Tec 7 Anesthesia Vaporizer (Enflurane) Regulation Number: 868.5880 Regulation Name: Vaporizer, Anesthesia, Non-heated Regulatory Class: Class II (two) Product Code: 73 CAD Dated: May 27, 2003 Received: May 28, 2003

Dear Mr. Exner:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally 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) that do not require approval of a premarket approval application (PMA). 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

JUN 2 6 2002

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. William E. Exner

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with 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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation 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 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division 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,

Sura Runser

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K031027 510(k) Number (if known):

Datex-Ohmeda Tec 7 (enflurane) Anesthesia Vaporizer Device Name:

Indications For 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, sevoflurane and enflurane 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.

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General Hospital.

510(k) Number: K031027

Prescription Use
(Per 21CFR801.109)

OR

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

(