(191 days)
No
The summary describes a standard multi-gas and pulse oximetry monitor without any mention of AI or ML capabilities. The performance studies listed are typical for such devices and do not suggest the use of AI/ML.
No.
The device is a monitor that measures gas concentrations, not a device that treats or ameliorates a condition.
No
The device measures and monitors physiological parameters (CO2, SpO2, pulse rate) and gas concentrations (N2O, anesthetic agents) during medical procedures, rather than diagnosing a disease or condition. Its purpose is to provide real-time information for patient management during anesthesia, not to identify a medical problem.
No
The device description explicitly states it is an "integrated monitoring system" and mentions "multiple gas analysis" and "pulse oximetry," which strongly implies the presence of hardware components for sensing and measurement. The performance studies also include "environmental, and electromagnetic compatibility testing," which are typically associated with hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as measuring and monitoring gases and physiological parameters (CO2, O2 saturation, pulse rate, anesthetic gases). This is done directly on the patient or their exhaled breath, not on a sample taken from the body.
- Device Description: The description confirms it's an integrated monitoring system for gas analysis and pulse oximetry. This aligns with patient monitoring, not laboratory testing of samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples to provide diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease. This device operates by monitoring gases and physiological signs directly from the patient.
N/A
Intended Use / Indications for Use
The Vamos Variable Anesthetic Gas Monitor is indicated for measuring and monitoring the CO2 concentration, functional oxygen saturation SpO2, pulse rate and the concentrations of N20, Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane. Federal law restricts this device to sale by or on the order of a physician.
Product codes
73 CCK, 73 CBR, 73 CBQ, 73 CBS, 74 DQA
Device Description
The Vamos is an integrated monitoring system used for multiple gas analysis (CO2, N2O, and anesthetic agent concentrations). Pulse oximetry may also be included as an option.
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
Qualification of the Vamos included hazard analysis, functional, communication, environmental, and electromagnetic compatibility testing.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).
0
JAN 1 7 2002
K012/39
SUMMARY OF SAFETY AND EFFECTIVENESS DATA RELATING TO SUBSTANTIAL EQUIVALENCE
| Proprietary Name: | Vamos Anesthetic Gas Monitor |
|---|---|
| Classification Name: | Analyzer, Gas, Carbon-Dioxide, Gaseous Phase - 73 CCK |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase - 73 CBR | |
| Analyzer, Gas, Enflurane, Gaseous Phase - 73 CBQ | |
| Analyzer, Gas, Halothane, Gaseous Phase - 73 CBS | |
| Oximeter - 74 DQA | |
| Device Class: | Class II |
| Manufacturer: | Dräger Medizintechnik GmbH |
| 53/55 Moislinger Allee | |
| Lübeck, Germany 23558 | |
| Establishment Registration No.: | 9611500 |
| Devices to which substantial | |
| equivalence is claimed: | Vitalert 3000 Monitoring System - K913995 |
| NPB4000 Pulse Oximeter - K962424 |
Device Description:
The Vamos is an integrated monitoring system used for multiple gas analysis (CO2, N2O, and anesthetic agent concentrations). Pulse oximetry may also be included as an option.
Intended Use:
The Vamos may be used for measuring and monitoring the functional oxygen saturation (SpO2), pulse rate and the concentrations of CO2, N2O and the following anesthestic agents; Halothane, Enflurane, Isoflurane, Sevoflurane, and Desflurane.
Substantial Equivalence:
Like the Vitalert 3000 (VA3000), the Vamos is an integrated monitoring system used for multiple gas analysis (CO2, N2O, and anesthetic agent concentrations) and Pulse oximetry. The VA3000 offers Non-Invasive Blood Pressure (NIBP) monitoring as an option while the Vamos does not.
The Vamos and VA3000 integrate the function of the electronic monitors. Measurement data, a real time CO2 waveform, and alarms are displayed. Both use an electro- luminescent display.
The Vamos and VA3000 use a combination of a keypad and incremental encoder to control screen formats and settings.
The Vamos offers an optional battery backup system, which is automatically enabled in the event of power failure and provides a one hour minimum power reserve time from full charge. The VA3000 does not have a battery backup system.
1
The Vamos uses the same pulse oximetry module as the NPB4000 Pulse Oximeter (K962424).
The gas analyzer used in the Vamos is similar to that used in the VA3000 in that both utilize infrared absorption technology.
The Vamos and the VA3000 incorporate an RS-232 serial communication port.
Qualification of the Vamos included hazard analysis, functional, communication, environmental, and electromagnetic compatibility testing.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with a single snake winding around a staff.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 7 2002
Mr. Michael A. Kelhart Draeger Medical Inc. 3135 Quarry Road Telford, PA 18969
K012139 Re:
Vamos Anesthetic Gas Monitor Vallos Anesthere Gas Monton
Regulation Number: 868.1400, 868.1700, 868.1500, 868.1620, and 870.2700 Regulation Name: 6001-000, 00017700, 00017700, 00011900, Oxide Gas Analyzer, Enflurane Gas Analyzer, Halothane Gas Analyzer, and Oximeter Regulatory Class: II (two) Regulatory Class: 11 (1.10)
Product Code: 73 CCK, CBR, CBQ, CBS, NHO, NHP, NHQ, and 74 DQA Dated: October 23, 2001 Received: October 24, 2001
Dear Mr. Kelhart:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications felerenced above and have actions. In the enclicate devices marketed in interstate for use stated in the encreations) it regard) and entirent date of the Medical Device Amendments, or to connineres prior to May 20, 1978, as excordance with the provisions of the Federal Food, Drug, devices that have been received in assee approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, therefore, market the Act include requirements for annual registration, listing of general controls provisions of the rice, 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 olassined (600 as 100 strols. Existing major regulations affecting your device can may or subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Michael A. Kelhart
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc advised that I Dris issualites vour device complies with other requirements of the Act that I DA has made a acterimiations administered by other Federal agencies. You must of any irederal statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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) This iciticition. The FDA finding of substantial equivalence of your device to a legally premarket notincation: "The PPA miams of casification 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 If you desire specific ad 100 for in vitro diagnostic devices), please contact the Office of additionally 21 CHC Far 807.10 For questions on the promotion and advertising of Compliance at (301) 597-1810. I first of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Tegulation Chitica, "Misoranang of responsibilities under the Act may be obtained from the Outcl general information on your versational 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,
Qada Till
ram D. Zuckerman, M.D Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| Page | | 1
ot | |
|------|---------------------------------------------------|---------|---|
| | A Market Pro and Collection Company of Concession | | - |
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _ Vamos Anesthetic Gas Monitor
Indications for Use:
STAKI NUmbe
The Vamos Variable Anesthetic Gas Monitor is indicated for measuring and monitoring the CO2 concentration, functional oxygen saturation SpO2, pulse rate and the concentrations of N20, Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane. 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 | |
|---|---|
| ---------------------- | -- |
(Optional Format 1-2-96)