(47 days)
No
The description focuses on a mechanical vaporizer and does not mention any AI/ML components or functionalities.
No.
The device enriches fresh gas flow with anesthetic agent vapor but does not directly treat a medical condition or disease.
No
The device enriches fresh gas flow with anesthetic vapor in an anesthesia delivery system, which indicates it is a therapeutic or delivery device, not one used for diagnosis.
No
The device description clearly states it is a "concentration calibrated non-heated vaporizer for vaporizing liquid anesthetic agents, designed in a vaporizer chamber bypass arrangement," indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to enrich the fresh gas flow of an anesthesia delivery system with anesthetic agent vapor. This is a therapeutic function, directly related to patient care during surgery or other procedures requiring anesthesia.
- Device Description: The description confirms it's a vaporizer for liquid anesthetic agents, used within an anesthesia delivery system.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are used for diagnosis, monitoring, or screening, which is not the function of this device.
The device is clearly a component of an anesthesia delivery system, which is a medical device used for patient treatment.
N/A
Intended Use / Indications for Use
The Vapor 19.3 is intended for vaporization and delivery of a controlled amount of liquid anesthetic agent. The Vapor 19.3 is labeled and calibrated for sevoflurane, isoflurane, and enflurane.
The Drager-Vapor 19.3 is a non-heated calibrated vaporizer to enrich the fresh gas flow of an anesthesia delivery system with a controlled anesthetic agent vapor. The Vapor 19.3 is indicated for use with enflurane, halothane, isoflurane, and sevoflurane. The Vapor 19.3 is not indicated for use with desflurane or in the breathing circuit of an anesthesia delivery system. Federal law restricts this device to sale by or on the order of a physician.
Product codes
73 CAD
Device Description
The Drager-Vapor 19.3 (Vapor 19.3) is a concentration calibrated non-heated vaporizer for vaporizing liquid anesthetic agents, designed in a vaporizer chamber bypass arrangement.
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
physician
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)
Qualification of the Vapor 19.3 was limited to component qualification testing on those differences to demonstrate complicable clauses of ASTM Standard F1161-88, Sections 8 and 12.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Dräger-Vapor® 19 (K771899), Drager-Vapor® 19 for Sevoflurane (K942055)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
୧ 1638 JUL
SUMMARY OF SAFETY AND EFFECTIVENESS DATA RELATING TO SUBSTANTIAL EQUIVALENCE
| Proprietary Name: | Dräger-Vapor® 19.3 |
|---|---|
| Classification Name: | Vaporizer, Anesthesia, Non-heated |
| Device Class: | Class II |
| Initial Distributor: | North American Dräger |
| 3135 Quarry Road | |
| Telford, Pennsylvania 18969 USA | |
| Establishment Registration No .: | 2517967 |
| Manufacturer: | Dräger Medizintechnik GmbH |
| Lübeck, Germany | |
| Establishment Registration No .: | 9611500 |
| Predicate Devices: | Dräger-Vapor® 19 (K771899) |
| Drager-Vapor® 19 for Sevoflurane (K942055) |
Device Description
The Drager-Vapor 19.3 (Vapor 19.3) is a concentration calibrated non-heated vaporizer for vaporizing liquid anesthetic agents, designed in a vaporizer chamber bypass arrangement.
Intended Use
The Vapor 19.3 is intended for vaporization and delivery of a controlled amount of liquid anesthetic agent. The Vapor 19.3 is labeled and calibrated for sevoflurane, isoflurane, and enflurane.
Substantial Equivalence
The Vapor 19.3 is substantially equivalent to the currently distributed Dräger-Vapor 19.1 (Vapor 19.1) vaporizers (K771899 and K942055). The Vapor 19.1 are identical except for the way they are interfaced with the anesthesia machine.
Like the Vapor 19.1, the Vapor 19.3 will be labeled and calibrated for use with sevoflurane, halothane, isoflurane, or enflurane. The dosing of the anesthetic agents remains the same, as does the body of the vaporizer. Both the Vapor 19,3 and 19.1 are available with a permanently attached Key-Index Fill System, or funnel filling device.
The Vapor 19.3 differs from the Vapor 19.1 in the way that the vaporizer may be mounted to the anesthesia machine. The Vapor 19.3 offers a plug-in system which provides for simple installation/
1
removal of the vaporizer for another. The Vapor 19.3 provides a permanently mounted plug-in adapter which is placed into the mounting pins on the anesthesia machine. The connection to the anesthesia machine is secured by turning its right-angle locking lever until secured in place. The Vapor 19.3 then cannot be removed until actuating the locking lever. This feature is similar to that on the Dräger-Vapor 19.1 with Plug System S Plus (K981472) for connection of the Vapor 19.1 to Selectatec Series Mounting Manifolds.
The exclusion system for the Vapor 19.3 differs from that of the currently distributed Vapor 19.1 in that the Vapor 19.3 is designed for attachment to an anesthesia system with two-position vaporizer mounting and which encompasses an interlock system that prevents more than one vaporizer from being ON at a time. To accomplish this, the cap to the Vapor 19.3 handwheel has been designed with openings (holes) on the sides in which the pin of the interlock mechanism may slide. When the pin is moved to allow one vaporizer to be ON, it prevents the rotation of the handwheel of the second vaporizer, thus preventing two vaporizers from being ON at the same time.
The Vapor 19.3 is intended for the same use and has the same principle of operation as the Vapor 19.1.
Except for different mounting connections and interlock/exclusion systems, the Vapor 19,3 is identical to the Vapor 19.1. Therefore, qualification of the Vapor 19.3 was limited to component qualification testing on those differences to demonstrate complicable clauses of ASTM Standard F1161-88, Sections 8 and 12.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL C 1898
Ms. J. Teresa Dorriety North American Dräger 3135 Quarry Road Telford, PA 18969
K981773 Re: Dräger-Vapor 19.3 Regulatory Class: II (two) Product Code: 73 CAD Dated: May 19, 1998 Received: May 20, 1998
Dear Ms. Dorriety:
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 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). 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 Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. 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 - Ms. J. Teresa Dorriety
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. Callahan, 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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Page _ 1 _ of __ l
K981773 510(k) Number (if known):_
Device Name: _ Drager-Vapor 19.3 (Vapor 19.3)
Indications for Use:
The Drager-Vapor 19.3 is a non-heated calibrated vaporizer to enrich the fresh gas flow of an anesthesia delivery system with a controlled anesthetic agent vapor. The Vapor 19.3 is indicated for use with enflurane, halothane, isoflurane, and sevoflurane. The Vapor 19.3 is not indicated for use with desflurane or in the breathing circuit of an anesthesia delivery system. Federal law restricts this device to sale by or on the order of a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
Marle Kramer
(Optional Format 1-2-96)
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number