Predicate Devices

I'm sorry, but without text stating the K/DEN numbers, I cannot answer the question. The provided text indicates "Not Found" for "Predicate Device(s)".

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard physiological patient monitor and does not mention any AI or ML capabilities in its intended use, device description, or performance studies.

Therapeutic

No.
The "Intended Use / Indications for Use" section explicitly states: "The monitor is not a therapeutic device."

Diagnostic

No

The primary purpose of the device is for monitoring and recording physiological parameters, generating alarms, and providing data to healthcare professionals. While it does mention "diagnostic recording of rhythm and detailed morphology of complex cardiac complexes" for ECG, the overall intended use and device description point to a monitoring device rather than a primary diagnostic tool.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Multi-Measurement Module X3 and the IntelliVue Patient Monitor MX100" which are described as compact, rugged, lightweight monitors with built-in invasive and non-invasive measurements, indicating they are hardware devices.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use: The intended use clearly states the device is for "monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates." This involves measuring physiological signals directly from the patient's body (e.g., ECG, respiration, SpO2, NBP, pressure, temperature, CO2).
IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Description: The device description reinforces that it "acquire multiple physiological patient signals" and displays "measurement values, waves and trends." This aligns with direct physiological monitoring, not testing of samples.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or performing laboratory-style tests.

Therefore, this device falls under the category of a patient monitor, which is a type of medical device used for direct physiological measurement, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Intended Use:

The monitor is intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.

Indication for Use:

The monitor is indicated for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients.

The monitor is only for use on one patient at a time.

The monitor is not a therapeutic device.

Caution: The monitor is 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.

The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only.

Warning: 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 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 monitor is intended for use by trained healthcare professionals in a hospital environment. The monitor is also intended for use during patient transport inside the hospital environment. It is not intended for home use.

Warning: The monitor is not intended for use in an MRI environment or in an oxygen-enriched environment (for example, hyperbaric chambers).

Contraindications: There are no known contraindications for the IntelliVue MX100/X3 Patient Monitor/Multi-Measurement Module.

Product codes

MHX, DOA, DRT, DSI, DSJ, DXN, FLL, MLD

Device Description

The Multi-Measurement Module X3 and the IntelliVue Patient Monitor MX100, 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 devices offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They can be located in the patient vicinity at the bedside or can be used mobile, during patient transport inside hospitals. The X3 and MX100 can interact with the Central Station via LAN or wireless link.

The Multi-Measurement Module X3 and IntelliVue Patient Monitor MX100 are compact, rugged, lightweight monitors with built-in invasive and non-invasive measurements, namely ECG (including arrhythmia and ST), respiration, SpO2, NBP, dual invasive pressure, temperature, and CO2. It can further extend the measurement capabilities when connecting to the legally marketed IntelliVue Multi-Measurement Extensions

The X3 can be used in two ways: as a multi-measurement module for the Philips IntelliVue family of patient monitors and as a stand-alone monitor.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

adults, pediatrics, and neonates.
ST segment monitoring 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 PPV measurement has been validated only for adult patients.

Intended User / Care Setting

healthcare professionals, hospital environment, patient transport inside the hospital environment.

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)

Non-Clinical Tests – Harmonized Standards
The subject devices have passed all safety tests for demonstrated compliance with the recognized standards below.
Non-clinical Bench Tests
No new issues of safety or effectiveness as compared to the predicate are introduced because of using this device.
Clinical Studies
The subject devices, like the primary predicate devices, did not require clinical trials.
Compliance to the FDA Quality System Regulations, FDA recognized standards, FDA guidance documents, harmonized standards, verification and validation, software validation, usability validation, and risk management activities have taken place for the subject devices.
Based upon the design, intended use, indications for use, classification, usability and safety testing, the subject devices are substantially equivalent to the listed predicate devices.
No new issues of substantial equivalence are introduced as a result of using this device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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November 22, 2023

Philips Medizin Systeme Boeblingen GmbH Monica Da Silva Principal Regulatory Affairs Specialist Hewlett-Packard-Strasse 2 Boeblingen, BW 71034 Germany

Re: K230604

Trade/Device Name: Intelli Vue Patient Monitor MX100 (867033), Intelli Vue Multi-Measurement Module X3 (867030) 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, DOA, DRT, DSI, DSJ, DXN, FLL, MLD Dated: October 27, 2023 Received: October 27, 2023

Dear Monica Da Silva:

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/cdrb/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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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 (OS) 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 (QS) 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 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).

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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)

K230604

Device Name

IntelliVue Patient Monitor MX100 (867033) IntelliVue Multi-Measurement Module X3 (867030)

Indications for Use (Describe)