INTELLIVUE GAS MODULES, MODELS G5 M1019A AND G1 M1013A

K053204 · Draeger Medical AG & Co. Kgaa · CCK · Feb 3, 2006 · Anesthesiology

Device Facts

• Record ID: K053204
• Device Name: INTELLIVUE GAS MODULES, MODELS G5 M1019A AND G1 M1013A
• Applicant: Draeger Medical AG & Co. Kgaa
• Product Code: CCK · Anesthesiology
• Decision Date: Feb 3, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.1400
• Device Class: Class 2

Intended Use

The IntelliVue gas modules are indicated for measuring and monitoring CO2 concentration and the concentrations of N2O, O2, Halothane, Enflurane, Sevoflurane and Desflurane. Federal Law restricts this device to sale by or on the order of a physician.

Device Story

IntelliVue G5 M1019A/G1 M1013A are anesthetic gas modules for ventilated patients; used in clinical settings during anesthesia induction, maintenance, and emergence. Inputs: airway gas samples. Principle: nondispersive infrared measurement for respiratory/anesthetic gases; paramagnetic measurement for O2 (Fast O2). Outputs: display waves for O2, CO2, N2O, anesthetic agents; numerics for inspired/end-tidal values and airway respiration rate. Features: automatic identification of up to two anesthetic agents; optional sample gas return to breathing circuit. Operation: connects to Philips IntelliVue monitors via RS232 digital interface. Automatic zero calibration maintains accuracy. Clinicians use output to monitor patient gas concentrations and adjust anesthesia delivery, potentially improving patient safety during ventilation.

Clinical Evidence

Bench testing only. Verification and validation performed in accordance with FDA regulations and company internal standards to confirm device meets specifications and is safe and effective for intended use.

Technological Characteristics

Nondispersive infrared (NDIR) sensor for respiratory/anesthetic gases; paramagnetic sensor for O2. Digital RS232 interface for connectivity with Philips IntelliVue monitors. Automatic zero calibration. Optional sample gas return. Form factor: gas module.

Indications for Use

Indicated for measuring and monitoring CO2, N2O, O2, and anesthetic agents (Halothane, Enflurane, Isoflurane, Sevoflurane, Desflurane) in ventilated patients during anesthesia induction, maintenance, and emergence. 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 (K012139, K040847)
• SCIO (with Infinity Patient Monitors) (K031340, K051628)
• Philips M1026B Anesthetic Gas Monitor (K040917)
• EGM - Essential Gas Monitor (K041956)

Submission Summary (Full Text)

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**Dräger**medical

A Dräger and Siemens Company

K053204

510(k) Summary (Section 10)

ਗੁਰੂਰ re Bour

## Summary of Safety and Effectiveness

## Applicants Name and Address

Draeger Medical AG & Co. KGaA Moislinger Allee 53-55 D-23542 Luebeck Germany

## Applicants Contact Person

Dr. Karin Luebbers Senior Manager Regulatory Affairs

| Tel. No.: | 011 49 [phone] |
|-----------|-------------------------|
| Fax No.: | 011 49 (451) 882-7-5367 |

#### Applicants US Contact Person

Ms Monica Ferrante Director of Regulatory Affairs

| Tel. No .: | [phone] |
|------------|----------------|
| Fax No.: | [phone] |

### Date the Summary was prepared

October 31, 2005

#### Device Name

a

| Trade Name: | IntelliVue G5 M1019A / IntelliVue G1 M1013A |
|--------------|---------------------------------------------|
| Common Name: | Anesthetic Multi Gas Monitor |

#### Classification

| Regulation No. | Device | Product Code |
|----------------|----------------------------------------------|--------------|
| 868.1400 | Analyzer, Gas, Carbon Dioxide, Gaseous Phase | (73CCK) |
| 868.1700 | Analyzer, Gas, Nitrous Oxide, Gaseous Phase | (73CBR) |
| 868.1500 | Analyzer, Gas, Enflurane, Gaseous Phase | (73CBQ) |
| 868.1620 | Analyzer, Gas, Halothane, Gaseous Phase | (73CBS) |
| 868.1500 | Analyzer, Gas, Desflurane, Gaseous Phase | (73NHO) |
| 868.1500 | Analyzer, Gas, Sevoflurane, Gaseous Phase | (73NHP) |
| 868.1500 | Analyzer, Gas, Isoflurane, Gaseous Phase | (73NHQ) |
| 868.1720 | Analyzer, Gas, Oxygen, Gaseous-Phase | (73CCL) |

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## Legally marketed device to which Substantial Equivalence is claimed

VAMOS (K012139, K040847) Manufactured by Draeger Medical AG & Co. KGaA; Germany Distributed in the United States by Draeger Medical Inc.

SCIO (with Infinity Patient Monitors) (K031340, K051628) Manufactured by Draeger Medical AG & Co. KGaA; Germany Distributed in the United States by Draeger Medical Inc.

Philips M1026B Anesthetic Gas Monitor (with IntelliVue Patient Monitors) (K040917) Distributed in the United States by Philips Medical Systems

EGM - Essential Gas Monitor (K041956) Manufactured by Draeger Medical AG & Co. KGaA; Germany Distributed in the United States by Draeger Medical Inc.

## Description of the Device

The IntelliVue G5 M1019A / G1 M1013A gas modules provide a nondispersive infrared measurement of respiratory and anesthetic gases and a paramagnetic measurement of oxygen (Fast O2).

They are designed to work with Philips IntelliVue through a digital interface (RS232). They are intended for measuring the airway gases of ventilated patients during the induction of, maintenance of, and emergence from anesthesia.

The modules produce display waves for O2, CO2, N2O, and anesthetic agents, together with numerics for inspired and end-tidal values for O2, CO2, N2O, anesthetic agents, and airway respiration rate. Automatic identification of up to two anesthetic aqents and measurement of mixtures of up to two anesthetic agents are available as options. Return of the sample gas into the breathing circuit is available optional.

An automatic zero calibration is performed by the IntelliVue gas module as required to maintain measurement accuracy.

## Intended Use

The IntelliVue gas modules are indicated for measuring and monitoring CO2 concentration and the concentrations of N2O, O2, Halothane, Enflurane, Sevoflurane and Desflurane.

Federal Law restricts this device to sale by or on the order of a physician.

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## Substantial Equivalence

The intended use of IntelliVue gas modules is comparable by the referenced predicate devices

- Draeger Medical VAMOS Anesthetic Gas Monitor
- Draeger INFINITY Monitors with SCIO
- Philips M1026B Anesthetic Gas Monitor
- EGM Essential Gas Monitor

The technical characteristics of the IntelliVue gas modules do not raise new questions regarding safety or effectiveness. Furthermore the labeling of the IntelliVue gas module provides similar information as the predicate devices except for the subject of this submission.

Information provided in the 510(k) Premarket Notification supports the determination of substantial equivalence. Design, development, verification and validation of the device was performed in accordance with FDA regulations and guidance and company internal standards. The testing and analysis of results provide assurance that the devices meet their specifications and are safe and effective for their intended use.

In summary Draeger Medical AG & Co. KGaA has demonstrated that the IntelliVue gas modules are safe and effective. They are considered to be substantial equivalent to currently marketed predicate devices which have been previously cleared by the FDA.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a stylized eagle emblem. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Monica Ferrante Director, of Regulatory Affairs Draeger Medical AG & Company KG 3155 Quarry Road

Telford, Pennsylvania 18969

Re: K053204

Trade/Device Name: IntelliVue G5 M1019A / IntelliVue G1 M1013A Regulation Number: 868.1440 Regulation Name: Carbon Dioxide gas analyzer Regulatory Class: II Product Code: CCK Dated: January 24, 2006 Received: January 27, 2006

FEB 3

2006

Dear Mr. Ferrante:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

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### Page 2 - Ms. Ferrante

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions 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) 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), please contact the Office of Compliance 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-firee number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

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): K O53 このキ

Device Name: IntelliVue G5 M1019A / IntelliVue G1 M1013A

Indications for Use: The IntelliVue gas modules are indicated for measuring and monitoring CO2 concentration and the concentrations of N2O, O2, Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane.

Federal law restricts this device to sale by or on the order of a physician.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Auj Sabom

Division of Microbiology, General Hospital,
Infection Control, Dental Devices
K.05.3.2011

510(is) Number

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