VAMOS ANESTHETIC GAS MONITOR

K012139 · Draeger Medical, Inc. · CCK · Jan 17, 2002 · Anesthesiology

Device Facts

• Record ID: K012139
• Device Name: VAMOS ANESTHETIC GAS MONITOR
• Applicant: Draeger Medical, Inc.
• Product Code: CCK · Anesthesiology
• Decision Date: Jan 17, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.1400
• Device Class: Class 2

Intended 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.

Device Story

Vamos is an integrated monitoring system for anesthetic gas analysis (CO2, N2O, Halothane, Enflurane, Isoflurane, Sevoflurane, Desflurane) and pulse oximetry. It utilizes infrared absorption technology for gas analysis and an integrated pulse oximetry module. The device displays real-time CO2 waveforms, gas concentrations, SpO2, pulse rate, and alarms on an electroluminescent screen. Users control settings via a keypad and incremental encoder. It includes an optional battery backup providing one hour of reserve power. The device is intended for clinical use by healthcare professionals to monitor patient physiological status during anesthesia, aiding in clinical decision-making through continuous monitoring of gas and oxygenation levels.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, including hazard analysis, functional, communication, environmental, and electromagnetic compatibility testing.

Technological Characteristics

Integrated monitoring system using infrared absorption technology for gas analysis. Features an electroluminescent display, keypad, and incremental encoder interface. Includes an optional battery backup system. Connectivity provided via RS-232 serial port. Pulse oximetry module is identical to the NPB4000. Sterilization method not specified.

Indications for Use

Indicated for measuring and monitoring CO2, N2O, and anesthetic agents (Halothane, Enflurane, Isoflurane, Sevoflurane, Desflurane), functional oxygen saturation (SpO2), and pulse rate in patients requiring anesthetic gas and pulse oximetry monitoring. Prescription use only.

Regulatory Classification

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.

Predicate Devices

• Vitalert 3000 Monitoring System (K913995)
• NPB4000 Pulse Oximeter (K962424)

Submission Summary (Full Text)

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# 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<br>Analyzer, Gas, Nitrous-Oxide, Gaseous Phase - 73 CBR<br>Analyzer, Gas, Enflurane, Gaseous Phase - 73 CBQ<br>Analyzer, Gas, Halothane, Gaseous Phase - 73 CBS<br>Oximeter - 74 DQA |
| Device Class: | Class II |
| Manufacturer: | Dräger Medizintechnik GmbH<br>53/55 Moislinger Allee<br>Lübeck, Germany 23558 |
| Establishment Registration No.: | 9611500 |
| Devices to which substantial<br>equivalence is claimed: | Vitalert 3000 Monitoring System - K913995<br>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.

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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.

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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.

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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 [phone]. I first of Compliance at [phone]. 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 [phone] or [phone] 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<br>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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | <div>✓</div> |
|---------------------------------------|--------------|
|---------------------------------------|--------------|

OR

| Over-The-Counter-Use | |
|----------------------|--|
|----------------------|--|

(Optional Format 1-2-96)