(270 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found". While the device performs complex physiological monitoring and data processing, there is no indication of AI or ML being used in the provided summary.
No
The "Intended Use / Indications for Use" section explicitly states "Not therapeutic devices."
Yes
Explanation: 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)." This directly indicates a diagnostic capability.
No
The device description explicitly states that the device is a "Patient Monitor" which "acquire[s] multiple physiological patient signals, display[s] measurement values, waves and trends, generate[s] physiological and technical alarms, provide[s] data recording and support patient data management." It also mentions operating with "external Measurement Modules" and a "4-Slot Module Rack FMX-4". These are all hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The description clearly states that this device is a patient monitor that acquires and displays physiological signals directly from the patient's body (ECG, SpO2, blood pressure, temperature, etc.). It does not process specimens taken from the body.
- Intended Use: The intended use is for monitoring physiological parameters of patients, generating alarms, and providing data recording and management. While some measurements might be used to aid in diagnosis or treatment decisions, the device itself is not performing the diagnostic test on a specimen.
The device is a patient monitoring system, which falls under a different regulatory category than IVDs.
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 intended to be used for monitoring of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neontors are intended for use by trained healthcare professionals in a hospital environment.
The monitors are only for use on one patient at a time. They are not intended for use in transport situations. They are not intended for home use. 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 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 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
February 3, 2023
Philips Medizin Systeme Böblingen GmbH Stefan Breuer Senior Regulatory Affairs Engineer Hewlett-Packard Str. 2 Böblingen, BW 71034 Germany
Re: K221348
Trade/Device Name: IntelliVue Patient Monitor MX750 (866471); IntelliVue Patient Monitor MX850 (866470) 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 Dated: May 12, 2022 Received: January 4, 2023
Dear Stefan Breuer:
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.
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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-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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.
Shruti N. Mistry -S
for
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
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Indications for Use
510(k) Number (if known) K221348
Device Name
IntelliVue Patient Monitor MX750 (866471); IntelliVue Patient Monitor MX850 (866470)
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 intended to be used for monitoring of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neontors are intended for use by trained healthcare professionals in a hospital environment.
The monitors are only for use on one patient at a time. They are not intended for use in transport situations. They are not intended for home use. 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 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 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 a bold, sans-serif font. The word is written in a bright blue color. The letters are evenly spaced and the overall appearance is clean and modern.
510(k) Summary
| 510(k) Summary | ||||
|---|---|---|---|---|
| 1.1 Submitter | ||||
| Date Prepared | April 27, 2022 | |||
| Submitter/Owner | Philips Medizin Systeme Böblingen GmbH | |||
| FDA Establishment Number 9610816 | ||||
| Hewlett-Packard-Str. 2 | ||||
| 71034 Böblingen | ||||
| Germany | ||||
| Phone: +49 151 1961 5514 | ||||
| Fax: +49 7031 463 2442 | ||||
| Key Contact | Stefan Breuer | |||
| Senior Regulatory Affairs Engineer | ||||
| Stefan.Breuer@philips.com | ||||
| 510(k) Submission Type | This is a traditional 510(k). | |||
| 1.2 Device | ||||
| Trade Name | IntelliVue Patient Monitor MX750 | |||
| IntelliVue Patient Monitor MX850 | ||||
| Common Name | Multiparameter Patient Monitor | |||
| Classification Name | Panel & Name: Cardiovascular Devices | |||
| Subpart & Division: 21 CFR §870.1025 | ||||
| Regulatory Class: II | ||||
| Product Code: MHX | ||||
| 1.3 Predicate Device | ||||
| 510(k) No. | Company | Device Name | Product Code | |
| Primary Predicate Device | K210906 | Philips | IntelliVue Patient Monitor MX750 | |
| IntelliVue Patient Monitor MX850 | MHX | |||
| Reference Devices | K162603 | Masimo | O3 Regional Oximeter System | MUD |
| K123043 | Masimo | Infrared Mainstream (IRMA) CO2 Gas Analyzer | CCK | |
| K171121 | Masimo | Infrared Sidestream (ISA) CO2 Gas Analyzer | CCK | |
| K172890 | Masimo | SedLine Sedation Monitor | OLW |
Image /page/4/Picture/5 description: The image shows the Philips logo. The logo is a blue shield with the word "PHILIPS" in white at the top. Below the word, there are two wavy lines and two stars. The stars are four-pointed and have a plus sign in the center.
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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 white, providing a strong contrast that makes the word stand out.
The subject devices are substantially equivalent to the legally marketed predicate devices.
1.4 Device Description
IntelliVue Patient Monitors MX750 and MX850 – description of the device per 21 CFR 807.92(a) (4)
The IntelliVue Patient Monitors MX750 and MX850 acquire multiple physiological patient signals, display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management. They operate with the external Measurement Modules and the IntelliVue 4-Slot Module Rack FMX-4, which establishes the connection between the individual plug-in measurement modules and the MX750 and MX850 monitors.
The monitors support multiple non-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 in the patient vicinity at the bedside. These devices have a color display with a touch-screen as a primary input device. They also support keyboard and pointing devices such as a mouse.
The monitor models MX750 and MX850 differ mainly in size. While MX750 has a 19" flat panel display, MX850 has a 22″ display.
1.5 Indication for Use
Intended Use as required per 21 CFR 807.92(a)(5)
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 intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment.
The monitors are only for use on one patient at a time. They are not intended for use in transport situations. They are not intended for home use. 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.
Image /page/5/Picture/17 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, there is a white circle with two wavy lines across the middle. There are also two four-pointed stars, one on the upper left and one on the lower right of the circle. Above the shield, the word "PHILIPS" is written in blue.
6
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 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 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 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