(86 days)
Not Found
No
The description focuses on mechanical and physical compensation mechanisms (temperature, flow, pressure) and does not mention any computational or learning-based technologies.
Yes
The device is used for the metered delivery of anesthetic agents for continuous flow techniques of inhalation anesthesia, which is a therapeutic intervention.
No
Explanation: The device is described as a vaporizer for delivering anesthetic agents during inhalation anesthesia, which is a treatment modality, not a diagnostic one.
No
The device description clearly describes a hardware device (vaporizer) for delivering anesthetic agents, not a software-only product.
Based on the provided text, the Datex-Ohmeda Tec 7 vaporizer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the "metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia." This describes a device used directly on a patient during a medical procedure, not a device used to examine specimens taken from the body.
- Device Description: The description reinforces its function in delivering anesthetic agents during anesthesia.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
Therefore, the Datex-Ohmeda Tec 7 vaporizer is a medical device used in the delivery of anesthesia, 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, 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.
Product codes (comma separated list FDA assigned to the subject device)
73 CAD
Device Description
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.
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 (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.
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
Image /page/0/Picture/0 description: The image shows a black circle with a white "D" inside it, along with the text "K031027" written diagonally. The text appears to be handwritten and is oriented at an angle relative to the circle. The circle is positioned in the upper-left portion of the image, while the text extends downwards and to the right.
JUN 2 6 2003
Summary of Safety and Effectiveness
April 1, 2003
| Subject: | 510(k) Summary of Safety and Effectiveness Information for the
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;
-
- EN 740 Anesthetic Work Stations
-
- ISO 5358 Anesthetic Gas Machines
-
- 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 608-221-1551 Toll Free 800-345-2700 Facsimile 608-222-9147
Datav. Ohmods
1
| Device Name | |
|---|---|
| Device Name: Proprietary | Datex-Ohmeda Tec 7 (enflurane) |
| 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 | |
| (isoflurane, halothane, sevoflurane, enflurane) | 510(k)s K942091 and K892057 |
| Datex-Ohmeda Tec 7 Anesthesia Vaporizer | |
| (isoflurane, halothane, sevoflurane) | 510(k) K012924 |
| 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 | |
| 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:
.
2
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.
3
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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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
4
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
General Hospital.
510(k) Number: K031027
Prescription Use
(Per 21CFR801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
(