(7 days)
Ohmeda Tec 6 vaporizer Class II 21CFR868.5880 73CAD 1., Ohmeda Tec vaporizer NAD variant Class II CFR868.5880 73CAD 2.
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No
The description focuses on electronic control, heating, and status display, with no mention of AI or ML terms or functionalities.
Yes
The device is used to deliver an anesthetic agent to a patient, which is a therapeutic intervention.
No
The device is an electronic vaporizer designed to deliver desflurane anesthetic agent. Its function is therapeutic (delivery of medication) rather than diagnostic (identifying a disease or condition).
No
The device description clearly states it is an "electronic vaporizer" and describes physical components like an LED display and attachment mechanisms, indicating it is a hardware device.
Based on the provided text, the Datex-Ohmeda D-Tec is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use/Indications for Use: The description clearly states its purpose is to deliver anesthetic agent (desflurane) to a patient during anesthesia. This is a direct interaction with the patient's respiratory system, not an in vitro test of a biological sample.
- Device Description: It describes a device that delivers a substance to a patient via an anesthesia machine. This is consistent with a therapeutic or life support device, not a diagnostic one.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition based on in vitro analysis.
The device's function is to deliver a drug (desflurane) to a patient, which falls under the category of a medical device used in patient care, not an in vitro diagnostic test.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
73 CAD
Device Description
The Datex-Ohmeda D-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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
physician
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Ohmeda Tec 6 vaporizer Class II 21CFR868.5880 73CAD 1., Ohmeda Tec vaporizer NAD variant Class II CFR868.5880 73CAD 2.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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Image /page/0/Picture/0 description: The image is a black and white logo. The logo consists of a large circle with a smaller square in the upper right corner. Inside the circle is a white shape that resembles the letter 'D'.
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;
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- EN 740 Anesthetic Work Stations
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- EN 60601 1, 150 601-1: 1988 Medical Electrical Equipment
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- EN 60601-1-2, IEC 601-1-2: 1998 Medical Electrical Equipment Electromagnetic Compatability
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- ISO 5358 Anesthetic Gas Machines
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- 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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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol that resembles three abstract human figures or a triple helix design. The logo is black and white.
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:
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.
(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 |
|---|---|
| ---------------- | --------- |
OR
Over-The-Counter Use
(Optional Format 1-2-96)
se
1.109)Concurrence of CDRH, Office of Device Evaluation (ODE)
Drecerinting I le (Per 21CFR801
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