(265 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found". While the device processes various physiological signals and provides derived measurements and clinical decision support tools (like the SSC Sepsis Protocol and Integrated Pulmonary Index), the summary does not indicate that these functions utilize AI or ML algorithms. The description focuses on standard physiological monitoring and data processing.
No
The "Intended Use / Indications for Use" section explicitly states, "The monitors are not therapeutic devices."
Yes
The "Intended Use / Indications for Use" section explicitly states, "The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC11)." Additionally, the device monitors various physiological parameters and provides data that can be used by healthcare professionals for diagnosis.
No
The device description explicitly states that the monitors "acquire multiple physiological patient signals" and have a "color display with touchscreen as a primary input device," indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the monitors are for "monitoring the physiological parameters of patients." This involves measuring signals directly from the patient's body (ECG, SpO2, blood pressure, temperature, etc.).
- Device Description: The device description details the acquisition of "multiple physiological patient signals" and the display of "measurement values, waves and trends." These are all related to in-vivo measurements.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not process or analyze such specimens.
The device is a patient monitor, which is a type of medical device used for continuous or intermittent monitoring of a patient's vital signs and other physiological parameters. This is distinct from an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
The monitors are only for use on one patient at a time. The monitors are not therapeutic devices. The monitors are for prescription use only.
The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC11).
ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.
BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.
The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only. 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 derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients.
The Intelli Vue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients.
The Masimo rainbow SET measurement is indicated for the nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRac). The Masimo rainbow SET measurement is indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused.
The noninvasive Masimo O3 Regional Oximeter System and accessories are intended for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥40 kg and on pediatrics ≥5 kg and
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 22, 2023
Philips Medizin Systeme Boeblingen GmbH Siegfried Breitling Regulatory Affairs Specialist Hewlett-Packard-Strasse 2 Boeblingen, BW 71034 Germany
Re: K223574
Trade/Device Name: IntelliVue Patient Monitor MX400 (866060), Intelli Vue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066) Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MHX, MLD, DSJ, DSK, DXN, DRT, DPS, DQA, DSF, MSX, CCK, CBQ, NHO, NHP, NHQ, CBS, CBR, CCL, BZC, BZQ, LKD, KLK, KOI, GWQ, GWS, FLL Dated: November 29, 2022 Received: November 30, 2022
Dear Siegfried Breitling:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jennifer W. Shih -S
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223574
Device Name
IntelliVue Patient Monitor MX400 (866060); IntelliVue Patient Monitor MX450 (866062); IntelliVue Patient Monitor MX500 (866064); IntelliVue Patient Monitor MX550 (866066)
Indications for Use (Describe)
The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
The monitors are only for use on one patient at a time.
The monitors are not therapeutic devices.
The monitors are for prescription use only.
The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC11).
ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.
BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.
The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only. 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 derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients.
The Intelli Vue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients.
The Masimo rainbow SET measurement is indicated for the nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRac). The Masimo rainbow SET measurement is indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused.
The noninvasive Masimo O3 Regional Oximeter System and accessories are intended for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥40 kg and on pediatrics ≥5 kg and Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/4/Picture/0 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 centered and takes up most of the frame.
510(k) Summary
| 510(k) Summary | |
|---|---|
| 1.1 Submitter | |
| Date Prepared | November 29, 2022 |
| Submitter/Owner | Philips Medizin Systeme Böblingen GmbH |
| FDA Establishment Number 9610816 | |
| Hewlett-Packard-Str. 2 | |
| 71034 Böblingen | |
| Germany | |
| Key Contact | Siegfried Breitling |
| Regulatory Affairs Specialist | |
| siegfried.breitling@philips.com | |
| Phone: +49 151 200 443 77 | |
| 510(k) Submission Type | This is a traditional 510(k). |
| 1.2 Device | |
| Trade Name | IntelliVue Patient Monitor MX400 |
| IntelliVue Patient Monitor MX450 | |
| IntelliVue Patient Monitor MX500 | |
| IntelliVue Patient Monitor MX550 | |
| Common Name | Multiparameter Patient Monitor |
| Classification Name | Panel & Name: Cardiovascular Devices |
| Subpart & Division: 21 CFR §870.1025 | |
| Regulatory Class: II | |
| Classification Product Code: MHX | |
| Subsequent Product Codes: MLD, DSJ, DSK, DXN, DRT, DPS, DQA, DSF, | |
| MSX, CCK, CBQ, NHO, NHP, NHQ, CBS, CBR, CCL, BZC, BZQ, LKD, KLK, KOI, | |
| GWQ, GWS, FLL | |
| 1.3 Predicate Device |
| 510(k) No. | Company | Device Name | Product Code | |
|---|---|---|---|---|
| Predicate Device | K182979 | Philips | IntelliVue Patient Monitor MX400 | |
| IntelliVue Patient Monitor MX450 | ||||
| IntelliVue Patient Monitor MX500 | ||||
| IntelliVue Patient Monitor MX550 | MHX | |||
| DRT, DSI, DSJ, DSK, DXN, MLD, MSX |
Image /page/4/Picture/6 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, the word "PHILIPS" is written in white at the top. Below the text, there are two wavy lines and four stars, also in white. The overall design is simple and recognizable, representing the brand's identity.
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Image /page/5/Picture/0 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 plain white, which makes the blue letters stand out.
| K172890 | Masimo | SedLine Sedation Monitor | OLW | |
|---|---|---|---|---|
| GXY, OLT, OMC, ORT | ||||
| The subject devices are substantially equivalent to the legally marketed predicate devices. | ||||
| 1.4 | Device Description | |||
| IntelliVue Patient Monitors MX400, MX450, MX500 and MX550 - description of the device per 21 | ||||
| CFR 807.92(a) (4) | ||||
| The IntelliVue Patient Monitors MX400, MX450, MX500 and MX550 acquire multiple physiological | ||||
| patient signals, display measurement values, waves and trends, generate physiological and | ||||
| technical alarms, provide data recording and support patient data management. | ||||
| The monitors support multiple non-invasive and invasive measurements such as ECG, arrhythmia, | ||||
| ST, QT, SpO2, respiration rate, pulse rate, heart rate, invasive and non-invasive blood pressure, | ||||
| temperature, CO2, tcpO2/ tcpCO2, C.O., CCO, intravascular SO2, SvO2, ScvO2, EEG, BIS, NMT, and | ||||
| gas analysis. | ||||
| The monitors offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal | ||||
| care environments. They are located at the patient bedside vicinity and can also be used during | ||||
| patient transport inside hospitals. The monitors have a color display with touchscreen as a primary | ||||
| input device. They also support a specialized remote control, keyboard and pointing devices such as | ||||
| a mouse. External displays can be connected to a built-in video port to provide an adaptive | ||||
| duplicate image of the primary display. The monitors can interact with several compatible external | ||||
| measuring and auxiliary devices locally at the bedside or in transport situations and with the Central | ||||
| Station via LAN or wireless link. |
Intended Use and Indication for Use 1.5
Intended Use as required per 21 CFR 807.92(a)(5)
Intended Use:
The devices are intended to be used for monitoring and recording of, and to generate alarms for multiple physiological parameters of adults, pediatrics, and neonates.
Indications for Use:
The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
The monitors are only for use on one patient at a time.
Image /page/5/Picture/11 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, there are two wavy lines that resemble water or sound waves. Above and below the waves are four-pointed star shapes. Above the shield, the word "PHILIPS" is written in a sans-serif font, also in blue.
6
The monitors are not therapeutic devices. The monitors are for prescription use only.
The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC11).
ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.
BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.
The SSC Sepsis Protocol, in the Protocol Watch clinical decision support tool, is intended for use with adult patients only.
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 derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients.
The IntelliVue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients.
The Masimo rainbow SET measurement is indicated for the nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRac). The Masimo rainbow SET measurement is indicated for use during both no motion conditions, and for patients who are well or poorly perfused.
The noninvasive Masimo O3 Regional Oximeter System and accessories are intended for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥40 kg and on pediatrics ≥5 kg and