MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR

K040847 · Draeger Medical, Inc. · CCK · Jun 17, 2004 · Anesthesiology

Device Facts

• Record ID: K040847
• Device Name: MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR
• Applicant: Draeger Medical, Inc.
• Product Code: CCK · Anesthesiology
• Decision Date: Jun 17, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.1400
• Device Class: Class 2

Intended Use

The Vamos Anesthetic Gas monitor is indicated for measuring and monitoring CO2 concentration, functional oxygen saturation (SPO2), pulse rate and the concentrations of N2O, Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane. Federal law restricts this device to sale by or on the order of a physician.

Device Story

Vamos Anesthetic Gas Monitor is an integrated system for monitoring respiratory gases (CO2, N2O) and anesthetic agents, with optional pulse oximetry (SPO2, pulse rate). Modified version introduces an option to return sampled gas to the breathing circuit instead of routing to a scavenger. Device used in clinical settings by healthcare professionals to monitor patient status during anesthesia. Output provides real-time concentration and physiological data to assist clinicians in managing patient ventilation and anesthesia delivery. Benefit includes continuous monitoring of gas levels and patient vitals, with the modification allowing for gas return to the circuit.

Clinical Evidence

Bench testing only. Testing performed to verify that the return of sample gas to the breathing circuit does not cause adverse effects to the patient.

Technological Characteristics

Integrated gas monitoring system for CO2, N2O, and anesthetic agents. Optional pulse oximetry module. Features a gas sampling system modified to allow return of sample gas to the breathing circuit.

Indications for Use

Indicated for measuring and monitoring CO2, SPO2, pulse rate, and concentrations of N2O and anesthetic agents (Halothane, Enflurane, Isoflurane, Sevoflurane, Desflurane) in patients. 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

• Vamos Anesthetic Gas Monitor (K012139)
• As/3 Anesthesia Delivery Unit (As/3Adu) (K973985)
• Capnomac Ultima Anesthesia Monitor (K932098)

Submission Summary (Full Text)

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### JUN 1 7 2004

K040847

#### Summary of Safety and Effectiveness Data Relating to Substantial Equivalence

Proprietary Name: Vamos Anesthetic Gas Monitor

Common Name: Analyzer, Gas

Classification Name: Analyzer Gas, Carbon-Dioxide, Gaseous Phase Analyzer, Gas, Nitrous-Oxide, Gaseous Phase Analyzer, Gas, Enflurane, Gaseous Analyzer, Gas, Halothane, Gaseous Oximeter

73 CCK, CBR, CBQ, CBS, NHO, NHP, NHQ, and 74 DQA Product Codes:

Device Class:Class II

Manufacturer: Draeger Medical AG & Co KGaA 53/55 Moislinger Allee Luebeck, Germany

Establishment Registration Number: 9611500

Devices to which substantial equivalence is claimed: Vamos Anesthetic Gas Monitor K012139 As/3 Anesthesia Delivery Unit (As/3Adu) K973985 Capnomac Ultima Anesthesia Monitor K932098

#### Device Description:

The modified Vamos is an integrated monitoring system used for the multiple gas analysis (CO2), N2O), and anesthetic agent concentrations). Pulse Oximetry may also be included as an option.

#### Intended Use:

The Vamos, is intended to be used for measuring and monitoring the functional oxygen saturation (SPO2), pulse rate and the concentrations of CO2, N2O), Enflurane, Desflurane, Isoflurane, Halothane, and Sevoflurane.

#### Substantial Equivalence:

Like the AS/3 ADU with the integrated Capnomac Ultima Anesthesia Monitor, the Vamos (K012139) is being modified to include the ability to use return sample gas to the breathing circuit as an option during gas analysis. Testing was performed to assure that there would be no adverse effects to the patient as a result of the sample gas passing through the Vamos and back to the breathing circuit instead of being routed to the scavenger.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 1 7 2004

Ms. Gale E. Winarsky, RAC Regulatory Affairs Project Manager Draeger Medical, Incorporated 3135 Quarry Road Telford, Pennsylvania 18969

Re: K040847

Trade/Device Name: Vamos Anesthesia Gas Monitor Regulation Number: 868.1400, 868.1700, 868.1500, 868.1620, 870.2700 Regulation Name: Carbon Dioxide Gas Analyzer, Nitrous Oxide Gas Analyzer, Enflurane Gas Analyzer, Halothane Gas Analyzer, Oximeter Regulatory Class: II Product Code: 73 CCK, CBR, CBQ, CBS, NHO, NHP, NHQ, and DQA Dated: May 28, 2004 Received: June 1, 2004

Dear Ms. Winarsky:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have to rowed your and have determined the device is substantially equivalent (for the referenced a o the national in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate comments, 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 the Federal F od; Drag, and Coou may, therefore, market the device, subject to the general approval upportions of the Act. The general controls provisions of the Act include controls provisions of a 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Wry, it may of subject to tax of Federal Regulations, 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 - Ms. Winarsky

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that 1 DA s issualled of that your device complies with other requirements Incall that IDA has made a actession regulations administered by other Federal agencies. of the Act of ally rederal statues and regarates. Including, but not limited to: registration You must comply with an the Piece brog (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 067), labeling (21 CFR Part 820); and if requirents as set form in the quality sjochly (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 letter will anow you to begin made ... ... ... ... ... ... ... ... ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . premarket notification. The PDF maing or 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), If you desire specific advice for your de at [phone]. 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 may obtain other generational 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,

Ous

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _ Vamos Anesthesia Gas Monitor_____

Indications for Use:

The Vamos Anesthetic Gas monitor is indicated for measuring and monitoring CO2 The Vallios Aliestifications oxygen saturation (SPO2), pulse rate and the concentrations of concentration, functional oxygen staturane and Desflurane and Desflurane. Federal law NEO, Italoniane, Broosale by or on the order of a physician.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Stan-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

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510(k) Number: K040847