(21 days)
Not Found
No
The document describes a gas monitoring device and does not mention AI, ML, or related concepts.
No
The device is described as a monitor that measures and monitors anesthesia gas, providing data to support clinical decision making. It does not actively treat or restore health.
Yes
The device "measures and monitors anesthesia gas and ... provides this data ... for the support of clinical decision making." This indicates that it provides information that helps in diagnosing the patient's state under anesthesia.
No
The device description explicitly states it is a "PhilipsM1026B Anesthetic Gas Monitor" and is intended for use with other hardware components like "Philips IntelliVue Family of Patient Monitors" and "Anesthesia Component Monitoring System M1176A". This indicates it is a hardware device, not software-only.
Based on the provided text, the M1026B Anesthesia Gas Module is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "measure and monitor anesthesia gas" and provide this data to healthcare professionals for clinical decision making. This involves monitoring gases within the patient's respiratory system, which is an in vivo process (within a living organism).
- Device Description: The device is described as an "Anesthetic Gas Monitor" for use with patient monitors. This further reinforces its role in monitoring physiological parameters directly from the patient.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) outside of the body, which is the defining characteristic of an IVD.
Therefore, the M1026B Anesthesia Gas Module is a medical device used for in vivo monitoring of anesthesia gases in patients.
N/A
Intended Use / Indications for Use
The M1026B Anesthesia Gas Module is intended to measure and monitor anesthesia gas concentrations and respiratory gases and to provide this data to health care professionals in the operating room, recovery room and intensive care environment, especially when connected to the Philips IntelliVue Family of Patient Monitors MP40/50/60/70/90, or the Philips Viridia 24 System, or the Anesthesia 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 continuous measurement of adult, pediatric and neonate patient anesthesia gas monitoring is desired.
MRI Compatibility Statement: The M1026B is not intended for use in a MRI magnetic field
Product codes (comma separated list FDA assigned to the subject device)
CBQ, CBS
Device Description
ThePhilipsM1026B 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric and neonate
Intended User / Care Setting
health care professionals in the operating room, recovery room and intensive care environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the number K040917 written in black ink. The numbers are written diagonally from the bottom left to the upper right. The numbers are slightly distorted and not perfectly aligned.
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.
-
- 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 submitter of this premarket notification is :
The summary was prepared on April 06 , 2004.
-
- 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
| Tifle: | Married And States Comments of Children
Special 510(k) M10268 | Company confidential
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | page 115 of 162
I |
|--------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
would and the driver and the commend in a commend on a commended to compares of the comments of the comments of the comments of the comments of the comments of the contribute | |
1
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.
2
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
3
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 |