MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5

K994188 · Agilent Technologies, GmbH · CBQ · May 19, 2000 · Anesthesiology

Device Facts

• Record ID: K994188
• Device Name: MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5
• Applicant: Agilent Technologies, GmbH
• Product Code: CBQ · Anesthesiology
• Decision Date: May 19, 2000
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.1500
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The M1026A Anesthesia gas Module is intended to measure and monitor anesthesia gas contents in the ventilation circuitry of a patient and to provide this data to health care professionals in form readings, waves and alarms, via the Component Monitoring System, for the support of clinical decision making.

Device Story

The Agilent M1026A Anesthesia Gas Monitor (AGM) integrates with the M1166A Component Monitoring System (CMS) and Viridia 24 (Model 1204A) via RS232 digital interface. It measures respiratory gases and anesthetic agents in ventilated patients. Principle of operation: non-dispersive infrared analysis (Andros Inc. Model 4700 MGM) for gas concentrations; paramagnetic transduction (Servomex PM1111 D/E) for fast O2 measurement. The device displays real-time readings, waveforms, and physiological alarms; it documents deviations when preset limits are exceeded. It triggers INOP alarms for malfunctions, apnea, or power loss. Used by healthcare professionals in clinical anesthesia environments during induction, maintenance, and emergence. Provides data to support clinical decision-making.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and performance similarities to the predicate device.

Technological Characteristics

Non-dispersive infrared (NDIR) gas analysis (Andros Inc. Model 4700 MGM); paramagnetic O2 transduction (Servomex PM1111 D/E). Digital interface (RS232) for integration with CMS. Monitors CO2, Enflurane, Halothane, N2O, O2, Desflurane, Isoflurane, and Sevoflurane. Form factor: module for Component Monitoring System.

Indications for Use

Indicated for adult, pediatric, and neonate patients requiring anesthesia gas monitoring in health care facilities. Not intended for use in MRI magnetic fields.

Regulatory Classification

Identification

An enflurane gas analyzer is a device intended to measure the concentration of enflurane anesthetic in a gas mixture.

Predicate Devices

• Agilent Technologies M1026A (K951127)
• Agilent Technologies M1026A (K982619)

Submission Summary (Full Text)

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5. 510(K) SUMMARY

# MAY 1 9 2000

K994188

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. § 807.92.

- 1. The submitter of this premarket notification is :
Herbert van Dyk Quality and Regulatory Senior Engineer Agilent Technologies Deutschland GmbH Patient Monitoring Division Health Care Solution Group Herrenbergerstr. 130 71120 Boeblingen Germany Phone: [phone] Fax: [phone] e-mail: [e-mail]

The summary was prepared on December 6, 1999.

- 2. The name of this device is the Agilent Technologies M1026A Anesthetic Gas Monitor Option C05 for use with the Agilent Technologies Model M1166A Component Monitoring System (CMS) and Viridia 24 Agilent Technologies Model 1204A. The common name is the Agilent Technologies Anesthesia Gas Monitor. Classification names are as follows:

| Regulation number | Classification name |
|-------------------|-----------------------------|
| 868.1400 | Carbon dioxide gas analyzer |
| 868.1500 | Enflurane gas analyzer |
| 868.1620 | Halothane gas analyzer |
| 868.1700 | Nitrous oxide gas analyzer |
| 868.1720 | Oxygen gas analyzer |
| 868.2375 | Breathing frequency monitor |
| Unclassified | Desflurane gas analyzer |
| Unclassified | Isoflurane gas analyzer |
| Unclassified | Sevoflurane gas analyzer |

The unclassified gas analyzers for desflurane, isoflurane and sevoflurane are similar to the gases classified under 868.1500, enflurane, and 868.1620, halothane. Analysis of these gases has been cleared under the original M1026A AGM 510(k) no. K951127 and K982619

- 3. The above device is substantially equivalent to the Agilent Technologies M1026A marketed pursuant to K951127 and K982619.

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- 4. The above device operates with Agilent Technologies Anesthesia Component Monitoring System (ACMS) and the Viridia 24 Agilent Technologies Model 1204A through a digital interface (RS232). The monitoring system is known as the Model M1166A Component Monitoring System (CMS). When coupled with the above ACMS, the device will measure and display respiratory gases and anesthetic agents of ventilated patients. The device will signal physiological alarms and document deviations when preset limits are exceeded. An INOP ("inoperative") alarm is triggered and a message is displayed in the event of malfunction, lack of detectable breath, power disconnects, and other inoperative states.
- 5. The device has the same intended use as the legally marketed predicate device. When connected to the ACMS, it is the intended for measuring the airway gases of ventilated patients within the anesthesia environment during the induction and maintenance of, and emergence from, anesthesia.
- 6. The technological characteristics are the same or similar to those found with the predicate device. Using the Andros Inc. Model 4700 MGM Multi Gas Module, the concentration of respiratory and anesthetic gases is calculated for patients under anesthesia by non-dispersive infrared analysis. Fast O2 measurement is done using the Servomex PM1111 D/E paramagnetic transducer.

| Special 510{k} M1026A 5Agld<br>Tifle: |
|---------------------------------------|
|---------------------------------------|

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#### Public Health Service

MAY 1 9 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Herbert van Dyk Quality and Regulatory Senior Engineer Agilent Technologies, GMBH Healthcare Solution Group Herrenberger Straße 130 - 71034 Böblingen Germany

K994188 Re: Anesthesia Gas Monitor M1026A Regulatory Class: II (two) Product Code: CBQ, CBS Dated: April 18, 2000 Received: April 20, 2000

Dear Mr. Van Dyk:

We have reviewed your Section 510(k) notification of intent to market we nave reviews from and we have determined the device is che device forcerenced and for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in encrobare, co regally in to May 28, 1976, the enactment date of the Incercato ocaments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and In accordante with a You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls che general conclude 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 Regulation (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 Failure to comply with the GMP regulation may result in assumptions. aegulatory 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 obrigation you might .Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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### Page 2 - Mr. Herbert van Dyk

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The Finding of substantial in your 310(x) premarket notification marketed predicate device equivalence of your device co a royal device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling II you desire specific advice for for for for for in vitro regulation (21 CFN fare over and act the Office of Compliance at diagnostic devices) productions on the promotion and [phone]. Addrefonally, 2017-10-11 the Office of Compliance at advertising of your doviee, provettion entitled, [phone]. AISO) premarket notification" (21 CFR 807.97).
"Misbranding by reference to premarket notification" (21 may "Misbranding by reference to promaticilities under the Act may Ocher general information of Small Manufacturers Assistance at its be obtained from the Britison.
toll-free number [phone] or [phone], ar at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of

9941888 510(k) Number (if known):

Device Name: Agilent Technologies M1026A Anesthesia Gas Monitor

#### Indications for Use:

The M1026A Anesthesia gas Module is intended to measure and monitor anesthesia gas contents in the ventilation circuitry of a patient and to provide this data to health care professionals in form readings, waves and alarms, via the Component Monitoring System, for the support of clinical decision making.

The device is indicated for use in health care facilities by health care professionals whenever there is a need for adult, pediatric and neonate patient anesthesia gas monitoring.

MRI Compatibility Statement: The M1026A is not intended for use in a MRI magnetic field

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Concurence of CDRH, Office of Device Evaulation (ODE)

for Mardi N. Mulhern

(Posted July 1, 1998)

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devic 510(k) Number

(Optional Format 3-10-98)