IRMA C02 MODEL 200101; IRMA AX 200601 by PHASEIN AB

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.

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.

AI/ML Overview

The provided 510(k) summary for the IRMA - Infrared Mainstream Gas Analyzer (K123043) describes the device, its intended use, and comparison to predicate devices, but it does not explicitly list quantitative acceptance criteria or a detailed study proving the device meets specific performance metrics.

However, based on the information provided, we can infer the acceptance criteria and the nature of the study:

Inferred Acceptance Criteria and Reported Device Performance:

The primary acceptance criterion is substantial equivalence to the predicate devices (ISA - Infrared Sidestream Gas Analyzer, K103604, and VEO Multigas Monitor for Pocket PC, K081601) in terms of performance, safety, and effectiveness. The reported device performance is that it met or exceeded these criteria.

Acceptance Criteria (Inferred)	Reported Device Performance
Performance equivalent or superior to predicate devices (ISA, VEO Multigas Monitor) throughout the operating range for gas measurement capabilities (CO2, N2O, anesthetic agents).	"The IRMA, models 200101 and 200601 demonstrated performance, safety and effectiveness equivalent or superior to its predicates in all characteristics."
Safety equivalent or superior to predicate devices.	"The IRMA, models 200101 and 200601 demonstrated performance, safety and effectiveness equivalent or superior to its predicates in all characteristics."
Effectiveness equivalent or superior to predicate devices.	"The IRMA, models 200101 and 200601 demonstrated performance, safety and effectiveness equivalent or superior to its predicates in all characteristics."
Same basic technology concepts as predicate devices.	"The IRMA uses the same basic technology concepts used in the predicate devices."
Same intended use as predicate devices.	"The intended use of the IRMA and its predicates are the same."
Equivalent electric power consumption.	"All the devices consume equivalent amounts of electric power."
Utilization of single-patient-use connections to interface with gases in the breathing circuit.	"All the devices...utilize single-patient-use connections to interface with gases in the breathing circuit."
Equivalent labeling and materials.	"Labeling and materials used are equivalent."

1. A table of acceptance criteria and the reported device performance:

(See table above)

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated. The document mentions "calibrated gas samples" and "legally marketed anesthesia and ventilation devices," but no specific number of samples or devices is provided.
Data Provenance: Not explicitly stated. The testing was described as "in direct comparison to predicates," suggesting laboratory or simulated use environments rather than clinical patient data. There is no mention of country of origin or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not specified.
Qualifications of Experts: Not specified. It's likely that the "ground truth" for gas concentrations was established by the calibrated gas samples themselves rather than human experts, and the performance with anesthesia/ventilation devices was assessed against their known specifications.

4. Adjudication method for the test set:

Adjudication method: Not described. Given the nature of objective gas measurement, it's unlikely that human adjudication (e.g., 2+1, 3+1) was used for establishing ground truth regarding gas concentrations. The comparison would be against known reference values from calibrated samples.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a gas analyzer, not an AI-assisted diagnostic tool that requires human interpretation of images or other data.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Standalone Performance: Yes, implicitly. The device itself performs the gas analysis. The "testing in direct comparison to predicates throughout the operating range was conducted using calibrated gas samples and legally marketed anesthesia and ventilation devices." This implies evaluating the device's ability to accurately measure gases against a known standard (calibrated gases) and its functional compatibility with other medical equipment, without direct human intervention in the measurement process itself. The IRMA is a sensor that interfaces with a "medical backboard device for display of respiratory parameters," indicating its standalone measurement capability.

7. The type of ground truth used:

Type of Ground Truth: The ground truth for gas concentration measurements was established using calibrated gas samples. For compatibility and functional testing, the "legally marketed anesthesia and ventilation devices" would serve as a benchmark for expected performance and integration.

8. The sample size for the training set:

Sample Size for Training Set: Not applicable or not specified. This device is an infrared gas analyzer, a sensor technology, not a machine learning or AI-based system that typically uses a "training set" in the conventional sense. Its "training" would be inherent in its design, calibration, and manufacturing process based on physics and spectroscopy principles, rather than a data-driven model.

9. How the ground truth for the training set was established:

Ground Truth for Training Set: Not applicable in the context of an AI/ML training set. For a physical device like this, the "ground truth" for its development would be based on established scientific principles of infrared spectroscopy and gas analysis, validated through rigorous engineering design, component selection, and manufacturing quality control.

Summary

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510(k) SUMMARY K 123043

1. 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
1. 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)
1. Substantially equivalent to:

ISA (Infrared Sidestream Gas Analyzer, K103604) VEO Multigas Monitor for Pocket PC (K081601)

1. 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.
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.

1. 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.

ﮯ ﺗ

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Note: An IRMA mainstream gas analyzer shall only be connected to medical backboard devices approved by PHASEIN.

1. 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.
1. 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.
1. Conclusions from testing: The IRMA, models 200101 and 200601 demonstrated performance, safety and effectiveness equivalent or superior to its predicates in all characteristics.

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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.

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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:

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:

Regulation Number and Section

§ 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).