(116 days)
Not Found
No
The document describes a mechanical vaporizer and does not mention any AI or ML components or functionalities.
No.
The device is described as a vaporizer that enriches fresh gas flow with anesthetic vapor in an anesthesia delivery system, which assists in administering anesthesia but does not directly treat a disease or condition itself.
No
Explanation: The device is a vaporizer used to deliver anesthetic vapor, not to diagnose a medical condition. Its function is to enrich gas flow with anesthetic agents, not to identify or monitor diseases.
No
The device description clearly states it is a "non-heated calibrated vaporizer" and a "concentration calibrated non-heated vaporizer for vaporizing liquid anesthetic agents," indicating it is a physical hardware device.
Based on the provided information, the Dräger-Vapor 2000 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed to "enrich the fresh gas flow of an anesthesia delivery system with a controlled amount of anesthetic vapor." This is a function related to delivering medication to a patient during anesthesia, not performing tests on samples taken from the body (which is the core of IVD).
- Device Description: The description reinforces this by stating it's a "concentration calibrated non-heated vaporizer for vaporizing liquid anesthetic agents." Again, this describes a device used in the process of administering anesthesia.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, the Dräger-Vapor 2000 falls under the category of a medical device used in the delivery of anesthesia, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Vapor 2000 is intended for vaporization and delivery of a controlled amount of liquid anesthetic agent. The Vapor 2000 is designed and labeled accordingly for use with Enflurane, Isoflurane, Halothane, and Sevoflurane,
The Dräger-Vapor 2000 (Vapor 2000) is a non-heated calibrated vaporizer designed to enrich the fresh gas flow of an ancsthesia delivery system with a controlled amount of anesthetic vapor. Separate models of the single-agent vaporizer are intended for use with one of the following agents: isoflurane, halothane, cofluranc, or sevofiuranc. The vaporizer is not intended for use with desflurane, or for use within an anesthetic breathing system. Federal law restricts this device to sale by or on the order of a physician.
Product codes (comma separated list FDA assigned to the subject device)
73 CAD
Device Description
The Dräger-Vapor 2000 (Vapor 2000) is a concentration calibrated non-heated vaporizer for vaporizing liquid anesthetic agents.
The Vapor 2000 (Vapor 2000) is a non-heated calibrated vaporizer designed to enrich the fresh gas flow of an ancsthesia delivery system with a controlled amount of anesthetic vapor. Separate models of the single-agent vaporizer are intended for use with one of the following agents: isoflurane, halothane, cofluranc, or sevofiuranc. The vaporizer is not intended for use with desflurane, or for use within an anesthetic breathing system.
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)
Qualification of the Vapor 2000 included testing to demonstrate compliance with ASTM Standard F 1161-88, and the effect of temperature, gas flow, duration of use, tilting, and back pressure on concentration output.
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
K71923
SEP 1 6 1997
Summary of Safety and Effectiveness Data Relating to Substantial Equivalence
Proprietary Name: Dräger-Vapor® 2000
Classification Name: Vaporizer, Anesthesia, Non-heated
Device Class: Class II
-
Initial Distributor: North American Dräger 3135 Quarry Road Telford, Pennsylvania 18969
Establishment Registration Number: 2517967 -
Manufacturer: Drägerwerk AG Lübeck, Germany
Establishment Registration Number: 2517967
Device to which substantial equivalence is claimed: Dräger-Vapor® 19.1 K940255
Device Description:
The Dräger-Vapor 2000 (Vapor 2000) is a concentration calibrated non-heated vaporizer for vaporizing liquid anesthetic agents.
Intended Use:
The Vapor 2000 is intended for vaporization and delivery of a controlled amount of liquid anesthetic agent. The Vapor 2000 is designed and labeled accordingly for use with Enflurane, Isoflurane, Halothane, and Sevoflurane,
Substantial Equivalence:
The Vapor 2000 is substantially equivalent to the Dräger-Vapor 19.1 (Vapor 19.1). Both are concentration calibrated, non-heated vaporizers for vaporizing liquid anestheiic agents with a vaporizing chamber bypass. Both the Vapor 2000 and Vapor 19.1 are available with attached funnel or key-index filling systems. The Vapor 2000 will also be available with the Quik-Fill™ filling system.
The Vapor 2000 differs slightly from the Vapor 19.1 in that the Vapor 2000 has a transport mode which secures the vaporizer from spillage of liquid agent, leakage of anesthetic vapor, and closes off the vaporizing chamber isolating liquid agent or vapors from the rest of the vaporizer.
1
The Vapor 2000 has a larger reservoir than the Vapor 19.1.
The Vapor 2000 and the Vapor 19.1 have the same intended use and principal of operation and are substantially equivalent.
Qualification of the Vapor 2000 included testing to demonstrate compliance with ASTM Standard F 1161-88, and the effect of temperature, gas flow, duration of use, tilting, and back pressure on concentration output.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
SEP 1 6 1997
Mr. James J. Brennan North American Drager 3135 Quarry Road 18869 Telford, Pennsylvania
к971923 Re: Dräger-Vapor® 2000 Regulatory Class: II (two) Product Code: 73 CAD August 5, 1997 Dated: Received: August 5, 1997
Dear Mr. Brennan:
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 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 assumptions. Failure to comply with the GMP regulation 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.
3
Page 2 - Mr. James J. Brennan
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 requlation (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 requlation 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/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
4
Page 1
510(k) Number (if known): K971923
Device Name: Drager-Vapor& 2000
Indications for Use:
The Dräger-Vapor 2000 (Vapor 2000) is a non-heated calibrated vaporizer designed to enrich the fresh gas flow of an ancsthesia delivery system with a controlled amount of anesthetic vapor. Separate models of the single-agent vaporizer are intended for use with one of the following agents: isoflurane, halothane, cofluranc, or sevofiuranc. The vaporizer is not intended for use with desflurane, or for use within an anesthetic breathing 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 CDRII, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
. Bazant
OR
Over-The-Counter Use_
Afl. A. Ciall.
(Optional Format 1-2-96)
(Division Sign-Off) (Division Sign-Oit)
Division of Cardiovascular, Respiratory, Division of Occal Devices
510(k) Number _