(152 days)
Not Found
No
The description focuses on mechanical and physical compensation mechanisms (temperature, flow, pressure) and does not mention any AI or ML terms or functionalities.
Yes.
The device is designed for the metered delivery of inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia, which is a therapeutic intervention.
No
The device is an anesthesia vaporizer designed for delivering specific inhalation anesthetic agents, not for diagnosing medical conditions.
No
The device description clearly describes a physical anesthesia vaporizer with mechanical components for metering, temperature, flow, and pressure compensation, and designed to be mounted on manifolds. This is a hardware device, not software-only.
Based on the provided information, the Datex-Ohmeda Tec 7 vaporizer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is designed for the "metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia." This is a device used on a patient during a medical procedure, not for testing samples from a patient.
- Lack of IVD Indicators: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples, providing diagnostic information based on those samples, or being used in a laboratory setting for testing.
Therefore, the Datex-Ohmeda Tec 7 vaporizer is a medical device used in anesthesia delivery, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
73 CAD
Device Description
The Datex-Ohmeda Tec 7 Anesthesia 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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).
Not Found
§ 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).
0
JAN 3 0 2002
Datex-Ohmeda Ohmeda Drive P.O. Box 7550 Madison, WI 53707-7550
Telephone: 608-221-1551 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;
-
- EN 740 Anesthetic Work Stations
-
- ISO 5358 Anesthetic Gas Machines
-
- 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
1
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 608-223-2496 facsimile
Establishment Registration and Owner/Operator Numbers Establishment Registration Number: 2112667 Owner/Operator Number 8030853
2
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.
3
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 (301) 594-4646. 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" (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 (800) 638-2041 or (301) 443-6597 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
4
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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)