IntelliVue Capnography Extension, IntelliVue Microstream Extension
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K172904 FDA 510(k)
- FDA Product Code
- CCK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.1400 FDA 510(k)
- Regulation Number
- 868.1400 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The IntelliVue Capnography Extension and IntelliVue Microstream Extension are modular add-ons for patient monitoring systems, designed to measure end-tidal carbon dioxide (CO₂) via infrared absorption spectroscopy. These extensions provide real-time CO₂ waveform visualization, numeric CO₂ values, temperature readings, and two invasive pressure measurements, enhancing respiratory monitoring capabilities for critical care environments.
Both extensions are intended for use with compatible IntelliVue patient monitors and multi-measurement modules, offering flexible connectivity for continuous physiological data acquisition. Supplied as reusable medical devices, they comply with FDA 510(k) clearance and MDR regulations. The extensions require proper calibration and integration with host systems, adhering to standard clinical monitoring protocols.
Frequently asked questions
Are the IntelliVue Capnography Extension and IntelliVue Microstream Extension designed for single-use or can they be reused in clinical settings?
These extensions are reusable medical devices, as explicitly stated in the device description. They are intended for repeated use in clinical environments, provided they undergo proper cleaning, calibration, and maintenance per manufacturer guidelines to ensure accurate and reliable performance.
What types of physiological data can the IntelliVue Capnography Extension and IntelliVue Microstream Extension measure and display in real time?
Both extensions measure end-tidal carbon dioxide (CO₂) via infrared absorption spectroscopy, displaying a real-time CO₂ waveform and numeric CO₂ values. Additionally, they provide temperature readings and two invasive pressure measurements, enhancing respiratory monitoring for critical care patients.
How do these extensions connect to patient monitoring systems, and what systems are they compatible with?
The IntelliVue Capnography and Microstream Extensions are modular add-ons designed specifically for compatible IntelliVue patient monitors and multi-measurement modules. They offer flexible connectivity to enable continuous physiological data acquisition, ensuring seamless integration with existing monitoring infrastructure.
What regulatory pathways have these devices followed, and which advisory committee was involved in their review?
The devices were reviewed under the FDA 510(k) pathway with a Traditional clearance type, determined as Substantially Equivalent (SESE). The review was conducted by the Anesthesiology (AN) Advisory Committee, reflecting their specialized role in evaluating devices related to respiratory monitoring and anesthesia.
What is the primary purpose of these extensions in clinical settings, and how do they enhance patient monitoring?
The extensions are designed to enhance respiratory monitoring in critical care by providing real-time end-tidal CO₂ analysis, waveform visualization, and pressure measurements. This helps clinicians assess ventilation efficiency, detect issues like hypoventilation or hyperventilation, and improve patient outcomes during procedures such as anesthesia or mechanical ventilation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Capnography Extension - Philips, Microstream CO₂ Extension - Philips, Kapnographie-Erweiterung - Philips
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K172904 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Boeblingen GmbH
Sources (2)
- FDA 510(k) K172904 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026