DATEX-OHMEDA ANESTHESIA VAPORIZER, MODEL D-TEC by DATEX-OHMEDA, INC.

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 Description

The Datex-OhmedaD-Tec anesthesia vaporzier 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.

AI/ML Overview

This document is a 510(k) summary for the Datex-Ohmeda D-Tec Anesthesia Vaporizer. It outlines the safety and effectiveness of the device by establishing substantial equivalence to previously marketed devices and compliance with voluntary standards.

Here's the breakdown of the requested information based on the provided text, noting that much of the information typically found in acceptance criteria studies for AI/software devices (like sample sizes, ground truth establishment, MRMC studies) is not applicable to a hardware device like an anesthesia vaporizer:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Voluntary Standards)	Reported Device Performance
EN 740 Anesthetic Work Stations	Complies
EN 60601-1, ISO 601-1: 1988 Medical Electrical Equipment	Complies
EN 60601-1-2, IEC 601-1-2: 1998 Medical Electrical Equipment Electromagnetic Compatability	Complies
ISO 5358 Anesthetic Gas Machines	Complies
ASTM F1161 Specifications for Anesthetic Gas Machines	Complies

Explanation: The document states that "The Datex-Ohmeda D-Tec anesthesia vaporizer was designed to comply with the applicable portions of the following voluntary standards" and "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." This implies that meeting these standards serves as the acceptance criteria and the rigorous testing demonstrated compliance.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not applicable as this is a hardware medical device (anesthesia vaporizer), not a software or AI-based device that relies on a "test set" of data in the same way. The testing would be laboratory-based and engineering validation, not data-driven.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable. Ground truth, in the context of expert consensus, is typically for diagnostic imaging or similar scenarios where human interpretation is a primary component. For an anesthesia vaporizer, "ground truth" would be the device's physical performance against established engineering and medical device standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable for the same reasons as #2 and #3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable as this is a hardware device. MRMC studies are used to evaluate the impact of AI on human reader performance, which isn't relevant for an anesthesia vaporizer.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as this is a hardware device. "Standalone" performance as an algorithm is not a concept for an anesthesia vaporizer. Its "performance" is its ability to deliver anesthetic agent as specified, which is evaluated through engineering tests, not an algorithm's output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device would be established by the voluntary standards themselves (EN 740, EN 60601-1, etc.) and validated through engineering and laboratory testing. The device's performance (e.g., accuracy of anesthetic agent delivery, temperature control, safety features) is measured against the specifications and requirements outlined in these standards.

8. The sample size for the training set

This information is not applicable as this is a hardware device and does not involve training data for an algorithm.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as #8.

Summary

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K990132

Summary of Safety and Effectiveness

Madison, WI 53707-7550

Telephone 608-221-1551

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
1. EN 60601 1, 150 601-1: 1988 Medical Electrical Equipment
1. EN 60601-1-2, IEC 601-1-2: 1998 Medical Electrical Equipment Electromagnetic Compatability
1. ISO 5358 Anesthetic Gas Machines
1. 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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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

510(k) Number:	K990132
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OR
Over-The-Counter Use
(Optional Format 1-2-96)
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1.109)Concurrence of CDRH, Office of Device Evaluation (ODE)

Drecerinting I le (Per 21CFR801

Regulation Number and Section

§ 868.5880 Anesthetic vaporizer.

(a)
Identification. An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.(b)
Classification. Class II (performance standards).