(27 days)
Not Found
No
The document describes a gas analyzer based on infrared spectrometry with automatic agent identification, but there is no mention of AI or ML in the device description, intended use, or performance studies. The technology described is based on established physical principles (infrared gas spectrometry).
No.
The device is for monitoring breath rate and breathing gases, not for therapy.
No
The device monitors breath rate and breathing gases (CO2, N2O, anesthetic agents) during anesthesia, recovery, and respiratory care. Its purpose is monitoring, not diagnosing a medical condition.
No
The device description clearly states it is a "mainstream respiratory gas analyzer based on infrared gas spectrometry" and connects to a patient breathing circuit via an "Airway Adapter," indicating it is a hardware device that measures gases.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The IRMA mainstream gas analyzer monitors gases in the patient's breath within the breathing circuit. This is a measurement of gases exhaled by the patient, not a test performed on a sample taken from the patient's body.
- Intended Use: The intended use clearly states monitoring of breath rate and breathing gases during anesthesia, recovery, and respiratory care. This is a real-time monitoring function, not a diagnostic test on a biological sample.
Therefore, the IRMA mainstream gas analyzer falls under the category of a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The IRMA mainstream gas analyzer is intended to be connected to other medical devices for monitoring of breath rate and the breathing gases CO2, N2O and the anesthetic agents Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane. It is intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit and patient room for adult, pediatric and infant patients. IRMA CO2 may also be used in the emergency medical services environment and road ambulances. Note: An IRMA mainstream gas analyzer shall only be connected to medical backboard devices approved by PHASEIN.
Product codes (comma separated list FDA assigned to the subject device)
CCK, CBR, CBS, CBQ, NHQ, NHP, NHO
Device Description
IRMA is a mainstream respiratory gas analyzer based on infrared gas spectrometry. It is intended to be connected to another medical backboard device for display of respiratory parameters. IRMA is connected to the patient breathing circuit via the Airway Adapter. This premarket submission adds the M80 device as a host backboard display to IRMA. There are no changes to the previously cleared sensor technology. The following IRMA models are available: a) IRMA CO2 (model/catalogue number 200101), measurement of CO2. b) IRMA AX+ (model/catalogue number 200601), measurement of CO2, N2O and anesthetic agents with automatic agent identification The IRMA product family also includes the adult and pediatric/infant Airway Adapter. A modura holder and velcro holder are offered as optional accessories.
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 infant patients
Intended User / Care Setting
operating suite, intensive care unit and patient room, emergency medical services environment and road ambulances
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
Testing in direct comparison to predicates throughout the operating range was conducted using calibrated gas samples and legally marketed anesthesia and ventilation devices.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The IRMA, models 200101 and 200601 demonstrated performance, safety and effectiveness equivalent or superior to its predicates in all characteristics.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
§ 868.1400 Carbon dioxide gas analyzer.
(a)
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.(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY K 123043
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- 510(k) Owner Name and Address: PHASEIN AB Svärdvägen 15 182 33 Danderyd Sweden Telephone: 46-8-544-98-150 Fax: 46-8-544-98-169 PHASEIN is a subsidiary of Masimo Corporation
- Contact Person: 2. David Weissburg Weissburg Associates 808 Williamson St., Suite 402 Madison, Wisconsin, 53703 USA
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- Date prepared: 28 September, 2012
- Trade Name: Infrared Mainstream Gas Analyzer (IRMA), model/catalogue numbers 4. 200101 and 200601
- Common Name: Multigas Monitor 5.
- Classification Names: Carbon-dioxide gas analyzer (21 CFR 868.1400, Product Code 6. CCK)
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- Substantially equivalent to:
ISA (Infrared Sidestream Gas Analyzer, K103604) VEO Multigas Monitor for Pocket PC (K081601)
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- Device Description: IRMA is a mainstream respiratory gas analyzer based on infrared gas spectrometry. It is intended to be connected to another medical backboard device for display of respiratory parameters. IRMA is connected to the patient breathing circuit via the Airway Adapter. This premarket submission adds the M80 device as a host backboard display to IRMA. There are no changes to the previously cleared sensor technology.
The following IRMA models are available:
- Device Description: IRMA is a mainstream respiratory gas analyzer based on infrared gas spectrometry. It is intended to be connected to another medical backboard device for display of respiratory parameters. IRMA is connected to the patient breathing circuit via the Airway Adapter. This premarket submission adds the M80 device as a host backboard display to IRMA. There are no changes to the previously cleared sensor technology.
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a) IRMA CO2 (model/catalogue number 200101), measurement of CO2.
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IRMA AX+ (model/catalogue number 200601), measurement of CO2, N2O and 5 b) anesthetic agents with automatic agent identification
The IRMA product family also includes the adult and pediatric/infant Airway Adapter. A modura holder and velcro holder are offered as optional accessories.
-
- Indications for Use:
The IRMA mainstream gas analyzer is intended to be connected to other medical devices for monitoring of breath rate and the breathing gases CO2, N20 and the anesthetic agents Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane.
- Indications for Use:
It is intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit and patient room for adult, pediatric and infant patients. IRMA CO2 may also be used in the emergency medical services environment and road ambulances.
ﮯ ﺗ
1
Note: An IRMA mainstream gas analyzer shall only be connected to medical backboard devices approved by PHASEIN.
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- Comparison to predicates: The IRMA model/catalogue numbers 200101 and 200601 have the same gas measurement capabilities as its predicate devices. The IRMA uses the same basic technology concepts used in the predicate devices. The intended use of the IRMA and its predicates are the same. All the devices consume equivalent amounts of electric power and utilize single-patient-use connections to interface with gases in the breathing circuit. Labeling and materials used are equivalent.
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- Testing vs. predicates: Testing in direct comparison to predicates throughout the operating range was conducted using calibrated gas samples and legally marketed anesthesia and ventilation devices.
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- Conclusions from testing: The IRMA, models 200101 and 200601 demonstrated performance, safety and effectiveness equivalent or superior to its predicates in all characteristics.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Phasein AB
C/O Weissburg Associates
Mr. David Weissburg
Principal
808 Williamson Street, Suite 402
Madison, Wisconsin 53703
OCT 25 2012
Re: K123043
Trade/Device Name: IRMA - Infrared Mainstream Gas Analyzer Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK, CBR, CBS, CBQ, NHQ, NHP, NHO Dated: September 19, 2012 Received: September 28, 2012
Dear Mr. Weissburg:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
3
Page 2- Mr. Weissburg
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
ph for
Anthony D. Watson, B.S., M.S., M.B.A. 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 Statement
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: IRMA - Infrared Mainstream Gas Analyzer.
Indications for Use:
The IRMA mainstream gas analyzer is intended to be connected to other medical devices for monitoring of breath rate and the breathing gases CO2, N2O and the anesthetic agents Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane.
It is intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit and patient room for adult, pediatric and infant patients. IRMA CO2 may also be used in the emergency medical services environment and road ambulances.
Note: An IRMA mainstream gas analyzer shall only be connected to medical backboard devices approved by PHASEIN.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
Page 1 of 1
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: