(194 days)
Not Found
No
The document describes software updates that introduce new features like alarm sounds, a visual patient avatar, and configurable alarm management. While the visual patient feature involves displaying vital signs in an animated avatar, there is no mention of AI or ML being used for analysis, interpretation, or prediction of patient data. The performance studies listed are standard electrical safety, EMC, software integration, and usability tests, not studies typically associated with validating AI/ML algorithms.
No.
The "Indications for Use" section explicitly states, "The monitors are not therapeutic devices."
Yes
The device is intended for monitoring and recording physiological parameters, and specifically states that the "ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes". Additionally, the BIS and SedLine monitors are described as aids in monitoring the effects of anesthetic agents and the state of the brain, suggesting diagnostic applications.
No
The device description explicitly states that the modifications are for "IntelliVue Patient Monitors MX750/MX850 and IntelliVue 4-Slot Module Rack FMX-4," which are hardware devices. The submission describes a new software version for these existing hardware monitors, not a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use and Indications for Use: The primary purpose of this device is to monitor and record physiological parameters of patients (adults, pediatrics, and neonates). This involves measuring things like ECG, BIS, NMT, SpO2, pulse rate, SpCO, SpMet, SpHb, RRac, rSO2, and EEG signals. These are all measurements taken from the patient's body, not on samples of bodily fluids or tissues in vitro (outside the body).
- Device Description: The description focuses on software updates and features related to displaying and managing patient vital signs and alarms. There is no mention of analyzing biological samples.
- Lack of IVD Characteristics: An IVD device typically involves the examination of specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis.
The device is clearly a patient monitor, which is a type of medical device used to track physiological signs directly from a living patient.
N/A
Intended Use / Indications for Use
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. 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 EC 11). 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 quide 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 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 noninvasive monitoring 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 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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December 19, 2023
Philips Medizin Systeme Boeblingen GmbH Siegfried Breitling Regulatory Affairs Specialist Hewlett-Packard-Strasse 2 Boeblingen, BW 71034 Germany
Re: K231671
Trade/Device Name: IntelliVue Patient Monitor MX750 (866471), Intelli Vue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468) 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, BZC, BZQ, CBQ, CBR, CBS, CCK, CCL, DPS, DQA, DRT, DSF, DSJ, DSK, DXN, FLL, GWQ, GWS, KLK, KOI, LKD, MLD, MSX, NHO, NHP, NHQ Dated: November 17, 2023 Received: November 17, 2023
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
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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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
K231671
Device Name IntelliVue Patient Monitor MX750 (866471); IntelliVue Patient Monitor MX850 (866470);
IntelliVue 4-Slot Module Rack FMX-4 (866468)
Indications for Use (Describe)
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.
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 EC 11). 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 quide 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 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 noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO),
4
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 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K231671 510(k) Summary
| Submitter/Owner | Philips Medizin Systeme Böblingen GmbH
FDA Establishment Number 9610816
Hewlett-Packard-Str. 2
71034 Böblingen
Germany | | | |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|---------|-------------------------------------------------------------------------------------------------------------|-----------------|
| | Phone: +49 151 40903561 | | | |
| Trade Name | IntelliVue Patient Monitor MX750
IntelliVue Patient Monitor MX850
IntelliVue 4-Slot Module Rack FMX-4 | | | |
| Common Name | Multiparameter Patient Monitor | | | |
| Classification Name | Panel & Name: Cardiovascular Devices
Subpart & Division: 21 CFR §870.1025
Regulatory Class: II
Product Code: MHX | | | |
| Predicate Device | 510(k) No. | Company | Device Name | Product
Code |
| K221348 is the primary
predicate device. | K221348 | Philips | IntelliVue Patient Monitor MX750
IntelliVue Patient Monitor MX850
IntelliVue 4-Slot Module Rack FMX-4 | MHX |
| Intended Use and
| Indications for Use | Intended Use: |
|---|---|
| The modified IntelliVue | |
| Patient Monitors MX750 | |
| and MX850 have the same | |
| intended use and | |
| indications as the legally | |
| marketed predicate device. | 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. | |
| 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 EC 11). | |
| 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 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 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 noninvasive | |
| monitoring 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 |