(95 days)
Not Found
No
The summary describes a device that adds physiological measurements and processes basic signals. There is no mention of AI, ML, image processing, or complex data analysis that would typically indicate the use of such technologies. The Integrated Pulmonary Index (IPI) is mentioned, but the description does not suggest it uses AI/ML; it's more likely a calculated index based on standard physiological parameters.
No.
The device is a measurement extension that adds physiological measurements such as CO2, temperature, and blood pressure, which are diagnostic or monitoring functions, not therapeutic.
Yes
The device adds "physiological measurements" such as CO2, temperature, invasive blood pressure, and cardiac output, which are used to assess a patient's medical condition. The Integrated Pulmonary Index (IPI) mentioned also indicates a diagnostic purpose, even as an adjunct to vital sign monitoring.
No
The device description explicitly states that the devices are "compact measuring devices without display and control elements" and are "connected to a dedicated host device." This indicates they are hardware components that perform measurements and transmit data, not purely software.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality.
- Device Function: The description clearly states that these devices are "measurement extensions" that add "physiological measurements" like CO2, temperature, invasive blood pressure, and cardiac output. These measurements are taken directly from the patient (e.g., CO2 from breath, blood pressure from a catheter).
- Lack of Specimen Analysis: There is no mention of analyzing any specimens (blood, tissue, etc.) derived from the human body. The measurements are direct physiological readings.
- Intended Use: The intended use is for monitoring physiological parameters in patients, not for analyzing samples in a lab setting.
Therefore, the IntelliVue Capnography Extension 867040 and Microstream Extension 867041 are considered patient monitoring devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Indications for Use statement for the Capnography Extension 867040:
The measurement extension adds physiological measurements (Mainstream / Sidestream CO2 and optionally temperature, invasive blood pressure, cardiac output) to a dedicated host device. It is intended for use by trained healthcare professionals for adult, pediatric, and neonatal patients in a hospital environment and for transport inside hospitals.
The measurement extension can only function when it is connected to a dedicated host device.
Indications for Use statement for the Microstream Extension 867041:
The measurement extension adds physiological measurements (Microstream CO2 and optionally temperature and invasive blood pressure) to a dedicated host device. It is intended for use by trained healthcare professionals for adult, pediatric, and neonatal patients in a hospital environment and for transport inside hospitals.
The measurement extension can only function when it is connected to a dedicated host device.
The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.
Product codes (comma separated list FDA assigned to the subject device)
CCK, BZQ, DXG, DRQ, FLL
Device Description
The new IntelliVue Capnography Extension 867040 and Microstream Extension 867041 are modifications of the legally marketed Philips Capnography Extension M3014A and Microstream Extension M3015B, respectively.
IntelliVue Capnography Extension 867040 and Microstream Extension 867041 are compact measuring devices without display and control elements that, in combination with dedicated host devices, add the following measurement parameters:
867040: Capnography (Mainstream / Sidestream CO2) and optionally temperature, invasive blood pressure, and cardiac output (C.O.)
867041: Microstream CO2 and optionally temperature and invasive blood pressure. IntelliVue Capnography Extension 867040 and Microstream Extension 867041 use settings and power of the connected host device. Trend data and measurement settings from the measurements in the extensions are stored in the connected host device. The measurement extensions send processed waves, numerics and basic alerts to the host device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric, and neonatal patients
The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only.
Intended User / Care Setting
trained healthcare professionals for adult, pediatric, and neonatal patients in a hospital environment and for transport inside hospitals.
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)
The new IntelliVue Capnography Extension 867040 and Microstream Extension 867041 have been subject of a series of V&V activities:
- Compliance with relevant recognized consensus standards:
- . IEC 60601-1-2: 2007 (Ed. 3) (Electromagnetic Compatibility)
- AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012 (Ed. 3.1) (Basic safety and ● essential performance)
- IEC 60601-2-34: 2011 (Ed. 3) (Invasive blood pressure monitoring equipment)
- ISO 80601-2-55: 2011 (Ed. 1) (Respiratory gas monitors)
- ISO 80601-2-56: 2009 (Ed. 1) (Clinical thermometers) ●
- AAMI ANSI IEC 62304:2006 (Ed. 1) (Software life cycle processes) All applicable requirements have been met.
- Testing as required by the Hazard Analysis.
All specified pass/fail criteria have been met. The test results have confirmed the effectiveness of the implemented design risk mitigation measures.
-
-Additional environmental testing (temperature, humidity) and mechanical testing (mechanical classes 7M1 and 7M3 and chemical resistance against disinfecting and cleaning agents)
All specified test requirements have been met. The tests have confirmed that the new devices work according to their specifications and indicated claims during tests simulating general hospital conditions, handling and transport in hospital environments, disinfection, and storage. -
-Performance bench testing of C.O. signal acquisition All specified test requirements have been met. The new devices perform according to the specified criteria that are the same as those for the predicate devices.
-
Unit level tests, functional system level tests, and regression system level tests. -The new devices perform according to the specified criteria. All specified test requirements have been met. The test results demonstrate that modified and previously available device functions work correctly according to the specifications and labeling claims.
Key results:
Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new devices with respect to the predicates. Testing comprised electrical and mechanical tests, EMC tests, environmental tests, performance tests, functional and regression tests.
Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence.
The results demonstrate that the new devices meet all defined reliability requirements and performance claims.
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
§ 868.1400 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 26, 2017
Philips Medizin Systeme Boeblingen GmbH Markus Stacha Sr. Regulatory Affairs Engineer Hewlett-Packard-Str. 2 Boeblingen, D-71034 GERMANY
Re: K172904
Trade/Device Name: IntelliVue Capnography Extension 867040, IntelliVue Microstream Extension 867041 Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK, BZQ, DXG, DRQ, FLL Dated: October 25, 2017 Received: October 27, 2017
Dear Markus Stacha:
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.
1
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 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tina Kiang
-s
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below
Indications for Use
510(k) Number: K172904
Device Name: IntelliVue Capnography Extension 867040 and Microstream Extension 867041 Indications for Use (Describe)
Indications for Use statement for the Capnography Extension 867040:
The measurement extension adds physiological measurements (Mainstream / Sidestream CO2 and optionally temperature, invasive blood pressure, cardiac output) to a dedicated host device. It is intended for use by trained healthcare professionals for adult, pediatric, and neonatal patients in a hospital environment and for transport inside hospitals.
The measurement extension can only function when it is connected to a dedicated host device.
Indications for Use statement for the Microstream Extension 867041:
The measurement extension adds physiological measurements (Microstream CO2 and optionally temperature and invasive blood pressure) to a dedicated host device. It is intended for use by trained healthcare professionals for adult, pediatric, and neonatal patients in a hospital environment and for transport inside hospitals.
The measurement extension can only function when it is connected to a dedicated host device.
The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (8/14)
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Image /page/3/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, providing a strong contrast that makes the word stand out.
510(k) Summary
This summary of 510(k) information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92.
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- Submitter of this premarket notification
Markus Stacha Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Tel: +49 7031 463-2840 Fax: +49 7031 463-2442 e-mail: markus.stacha@philips.com
- Submitter of this premarket notification
This summary was prepared on Dec 22, 2017.
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- The name and classification of the device
Trade name: IntelliVue Capnography Extension 867040 and Microstream Extension 867041 Common name: Multifunction Patient Monitor Module.
- The name and classification of the device
Primary regulation and classification: CFR Title 21 Part 868 - Anesthesiology Devices, Section 868.1400 'Carbon dioxide gas analyzer'. Device Class II. Product Code: CCK. Secondary Product Codes: BZQ, DXG, DRQ, DSA, FLL.
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- The new Philips IntelliVue Capnography Extension 867040 is substantially equivalent to the previously cleared Philips Capnography Extension M3014A marketed pursuant to K050762. The new Philips IntelliVue Microstream Extension 867041 is substantially equivalent to the previously cleared Philips Microstream Extension M3015B marketed pursuant to K993383 and K113441.
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- Description of the device
The new IntelliVue Capnography Extension 867040 and Microstream Extension 867041 are modifications of the legally marketed Philips Capnography Extension M3014A and Microstream Extension M3015B, respectively.
IntelliVue Capnography Extension 867040 and Microstream Extension 867041 are compact measuring devices without display and control elements that, in combination with dedicated host devices, add the following measurement parameters:
867040: Capnography (Mainstream / Sidestream CO2) and optionally temperature, invasive blood pressure, and cardiac output (C.O.)
867041: Microstream CO2 and optionally temperature and invasive blood pressure. IntelliVue Capnography Extension 867040 and Microstream Extension 867041 use settings and power of the connected host device. Trend data and measurement settings from the measurements in the extensions are stored in the connected host device. The measurement extensions send processed waves, numerics and basic alerts to the host device.
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Image /page/4/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is the only element in the image and it is centered.
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- Intended Use
Indications for Use statement for the Capnography Extension 867040:
- Intended Use
The measurement extension adds physiological measurements (Mainstream / Sidestream CO2 and optionally temperature, invasive blood pressure, cardiac output) to a dedicated host device. It is intended for use by trained healthcare professionals for adult, pediatric, and neonatal patients in a hospital environment and for transport inside hospitals. The measurement extension can only function when it is connected to a dedicated host device.
Indications for Use statement for the Microstream Extension 867041:
The measurement extension adds physiological measurements (Microstream CO2 and optionally temperature and invasive blood pressure) to a dedicated host device. It is intended for use by trained healthcare professionals for adult, pediatric, and neonatal patients in a hospital environment and for transport inside hospitals.
The measurement extension can only function when it is connected to a dedicated host device.
The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.
The Intended Use and Indications for Use for the new Capnography Extension 867040 are the same as those for the predicate Capnography Extension M3014A. The only difference is the Continuous Cardiac Output (CCO) measurement option. Whereas the predicate measurement extension M3014A supports CCO measurement together with the dedicated host device, the new measurement extension does not support this measurement.
The Intended Use and Indications for Use for the new Microstream Extension 867041 are the same as those for the predicate Microstream Extension M3015B.
6. Technological Characteristics
The new IntelliVue Capnography Extension 867040 and Microstream Extension 867041 have the same relevant technological characteristics as the predicates M3014A and M3015B with regard to energy sources, portability, and robustness.
Compared to the predicates M3014A and M3015B, in the new 867040 and 867041 several electronic components were replaced by state-of-the-art components and the form factor was adapted to fit the new housing. The former common PCA for invasive pressure and temperature measurements was divided into two PCAs.
The plastic materials of the housings of the predicates M3014A and M3015B have been changed in the new 867040 and 867041 from ABS and PC-FR to PBT and PC, in order to enhance mechanical and chemical resistance.
Biocompatibility aspects are not affected because the devices do not have contact with patients.
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The fundamental scientific technology of the new IntelliVue Capnography Extension 867040 and Microstream Extension 867041 is the same as that of the predicates Capnography Extension M3014A and Microstream Extension M3015B.
The differences in technological characteristics between the new and the predicate devices do not raise different questions of safety or effectiveness.
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- Summary of V&V activities
The new IntelliVue Capnography Extension 867040 and Microstream Extension 867041 have been subject of a series of V&V activities:
- Summary of V&V activities
-
Compliance with relevant recognized consensus standards:
- . IEC 60601-1-2: 2007 (Ed. 3) (Electromagnetic Compatibility)
- AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012 (Ed. 3.1) (Basic safety and ● essential performance)
- IEC 60601-2-34: 2011 (Ed. 3) (Invasive blood pressure monitoring equipment)
- ISO 80601-2-55: 2011 (Ed. 1) (Respiratory gas monitors)
- ISO 80601-2-56: 2009 (Ed. 1) (Clinical thermometers) ●
- AAMI ANSI IEC 62304:2006 (Ed. 1) (Software life cycle processes) All applicable requirements have been met.
-
Testing as required by the Hazard Analysis.
All specified pass/fail criteria have been met. The test results have confirmed the effectiveness of the implemented design risk mitigation measures.
-
-Additional environmental testing (temperature, humidity) and mechanical testing (mechanical classes 7M1 and 7M3 and chemical resistance against disinfecting and cleaning agents)
All specified test requirements have been met. The tests have confirmed that the new devices work according to their specifications and indicated claims during tests simulating general hospital conditions, handling and transport in hospital environments, disinfection, and storage. -
-Performance bench testing of C.O. signal acquisition All specified test requirements have been met. The new devices perform according to the specified criteria that are the same as those for the predicate devices.
-
Unit level tests, functional system level tests, and regression system level tests. -The new devices perform according to the specified criteria. All specified test requirements have been met. The test results demonstrate that modified and previously available device functions work correctly according to the specifications and labeling claims.
-
- Conclusion
Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new devices with respect to the predicates. Testing comprised electrical and mechanical tests, EMC tests, environmental tests, performance tests, functional and regression tests.
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Image /page/6/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, which makes the blue letters stand out.
Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence.
The results demonstrate that the new devices meet all defined reliability requirements and performance claims.