The M1026B Anesthesia Gas Module is intended to measure and monitor anesthesia gas and to provide this data to health care contents in the volunation varially varialy 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 The device is intriculour of assiric and neonate patient anesthesia gas monitoring.

Device Description

The name of this device is the PhilipsM1026B Anesthetic Gas Monitor for use with the Philips IntelliVue Family of Patient Monitors MP40/50/60/70/90, the Anesthesia Component Monitoring System M1176A and the Philips Viridia 24 System. The common name is the Philips Anesthesia Gas Monitor.

AI/ML Overview

This document is a 510(k) summary for the Philips M1026B Anesthetic Gas Monitor. It describes the device, its intended use, and its substantial equivalence to previously marketed devices. However, it does not contain the acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) summary identifies the device as being substantially equivalent to the Philips M1026A, which was cleared under K951127, K982619, and K994188. This means the manufacturer is asserting that the new device performs as safely and effectively as the predicate devices. The FDA's letter (APR 29 2004) confirms this determination of substantial equivalence.

Therefore, I cannot provide the requested information, which includes:

A table of acceptance criteria and the reported device performance
Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and their qualifications
Adjudication method for the test set
If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
If a standalone performance study was done
The type of ground truth used
The sample size for the training set
How the ground truth for the training set was established

This type of detailed performance data is typically found in the full 510(k) submission, not in the summary document. The summary focuses on substantiating equivalence, not on detailing a new performance study against specific acceptance criteria.

Summary

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510(k) Summary 7

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 Philips Medizin Systeme Böblingen GmbH Patient Monitoring Division Cardiac Monitoring Solution Group Hewlett Packard Str. 2 71120 Boeblingen Germany Phone: (+49) 7031 463 1734 (+49) 7031 463 2442 Fax: e-mail: Herbert.van dyk@philips.com

The summary was prepared on April 06 , 2004.

1. The name of this device is the PhilipsM1026B Anesthetic Gas Monitor for use with the Philips IntelliVue Family of Patient Monitors MP40/50/60/70/90, the Anesthesia Component Monitoring System M1176A and the Philips Viridia 24 System. The common name is the Philips 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 M1026B AGM 510(k) no. K951127 and K982619

1. The above device is substantially equivalent to the PhilipsM1026A marketed pursuant to K951127, K982619, and K994188.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 2004

Mr. Herbert van Dyk Quality and Regulatory Sensior Engineer Philips Medizin Systeme Böeblingen GmbH Cardiac Monitoring Solutions Group Hewlett-Packard Str.2 71120 Böeblingen GERMANY

Re: K040917

Trade/Device Name: Philips Anesthesia Gas Monitor, Model M1026B Regulation Number: 21 CFR 868.1500 and 21 CFR 868.1620 Regulation Name: Halothane Gas Analyzer, Enflurane Gas Analyzer Regulatory Class: II Product Code: CBQ, CBS Dated: April 6, 2004 Reccived: April 8, 2004

Dear Mr. van Dyk:

We have reviewed your Scction 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 promatket 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 cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Fxisting 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 - Mr. van Dyk

Please be advised that FDA's issuance of a substantial equivalence determination does 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 and ifoung (s as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirents as electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Scction 510(k) rins reter notification. The FDA finding of substantial equivalence of your device to a premarketed 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 (301) 594-4646. 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 maj donall Manufacturers, International 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,

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: Philips M1026B Anesthesia Gas Monitor

Indications for Use:

The M1026B Anesthesia Gas Module is intended to measure and monitor anesthesia gas THE MT02019 Anosthosia Gus Houaf and to provide this data to health care contents in the volunation varially varialy 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 The device is intriculour of assiric and neonate patient anesthesia gas monitoring.

MRI Compatibility Statemcnt: The M1026B is not intended for use in a MRI magnetic field

Yes Prescription Use (part 21 CFR 801 Subpart D) AND / OR

Over-The-Counter Use No (part 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)

(Division Sign-Off)
Division of Anesthesiology, General Hospital (Optional Format 3-10-98)
(Posted November 13, 2003) Infection Control, Dental Devices
510(k) Number:	K040917

Regulation Number and Section

§ 868.1500 Enflurane gas analyzer.

(a)
Identification. An enflurane gas analyzer is a device intended to measure the concentration of enflurane anesthetic in a gas mixture.(b)
Classification. Class II (performance standards).