INTELLIVUE PATIENT MONITOR by PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN

The Philips MP75 IntelliVue patient monitor is intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The monitor is not intended for home use. It is intended for use by health care professionals.

AI/ML Overview

Here's an analysis of the provided text regarding the Philips MP75 IntelliVue patient monitor's acceptance criteria and study information:

Based on the provided 510(k) summary, the device is a patient monitor, and the submission is for a modification to an existing cleared device, not a new device. Therefore, the description focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo clinical study with specific performance metrics against predefined acceptance criteria for a novel algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide specific quantitative acceptance criteria or reported device performance metrics in the format of a table as would be expected for an AI/algorithm-based diagnostic device where performance metrics like sensitivity, specificity, or AUC are typically defined.

Instead, the submission states:

"Pass/Fail criteria were based on the specifications cleared for the predicate devices"
"test results showed substantial equivalence."
"The results demonstrate that the Philips MP75 IntelliVue patient monitor meets all reliability requirements and performance claims."

This indicates that the "acceptance criteria" were broadly defined as meeting the established specifications and performance of the predicate devices. The "reported device performance" is essentially that it met these criteria, thus achieving substantial equivalence. No specific numerical performance values (e.g., accuracy, sensitivity for arrhythmia detection) are provided in this summary.

2. Sample size used for the test set and the data provenance

The document does not specify a sample size for a test set or data provenance (country of origin, retrospective/prospective). The testing involved "system level and regression tests as well as testing from the hazard analysis." This suggests engineering and functional testing rather than a clinical study with a patient data test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. As this appears to be more of an engineering/functional validation rather than a clinical performance study, the concept of "ground truth" as established by medical experts for a diagnostic algorithm is not explicitly addressed.

4. Adjudication method for the test set

This information is not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no indication of an MRMC comparative effectiveness study being performed. The device is a patient monitor, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This submission pertains to a patient monitor (a hardware device with integrated software), not a standalone algorithm. The "test results showed substantial equivalence" for the modified device (the patient monitor with the new application module) compared to the predicate device. Therefore, the testing described would inherently be of the integrated system.

7. The type of ground truth used

The document does not explicitly state the type of ground truth used. Given the nature of the device (a multi-parameter patient monitor) and the testing described (verification, validation, system-level, regression, hazard analysis), the "ground truth" would likely be derived from:

Established specifications and technical standards: For signal acquisition, processing, and display accuracy.
Simulated physiological signals: For testing various parameter measurements (e.g., ECG, blood pressure, SpO2).
Benchmarking against predicate devices: Directly comparing outputs or performance to already cleared devices.

8. The sample size for the training set

This information is not applicable/not provided. The device is a patient monitor, and the submission describes a modification to an existing device. It does not refer to a new AI model that would require a "training set" in the context of machine learning. The "specifications cleared for the predicate devices" served as the baseline for the modification.

9. How the ground truth for the training set was established

This information is not applicable/not provided, as there is no mention of a training set for an AI model.

Summary

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510 (k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92.

The submitter of this premarket notification is:

JUN 1 8 2010

Andreas Suchi Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Tel: ++49 7031 463-1291 Fax: ++49 7031 463-2442 e-mail: andreas.suchi@philips.com

This summary was prepared on May 20, 2010.

1. The name of the device is the Philips MP75 IntelliVue patient monitor
  Classification names are as follows:

Device Panel	Classification	ProCode	Description
CardiovascularDevices	§870.1025, II	DSI	Detector and alarm, arrhythmia
	§870.1025, II	MLD	Monitor, ST Segment with Alarm
	§870.1025, II	MHX	Monitor, Physiological, Patient(with arrhythmia detection oralarms)
	§870.1100, II	DSJ	Alarm, Blood Pressure
	§870.1110, II	DSK	Computer, Blood Pressure
	§870.1130, II	DXN	System, Measurement, Blood-Pressure, Non-Invasive
	§870.1435, II	DXG	Computer, Diagnostic, Pre-Programmed, Single-Function
	§870.1915, II	KRB	Probe, Thermodilution
	§870.2060, II	DRQ	Amplifier and SignalConditioner, Transducer Signal
	§870.2300, II	DRT	Monitor, Cardiac (incl.Cardiotachometer & Rate Alarm)
	§870.2340, II	DPS	Electrocardiograph
	§870.2340, II	MLC	Monitor, ST Segment
	§870.2350, II	DRW	Electrocardiograph, LeadSwitching Adapter
	§870.2370, II	KRC	Tester, Electrode, Surface,Electrocardiograph
	§870.2600, I	DRJ	System, Signal Isolation
	§870.2700, II	DQA	Oximeter
	§870.2770, II	DSB	Plethysmograph, Impedance
	§870.2800, II	DSH	Recorder, Magnetic tape,Medical
	§870.2810, I	DSF	Recorder, Paper Chart
	§870.2850, II	DRS	Extravascular Blood PressureTransducer
	§870.2900, I	DSA	Cable, Transducer andElectrode, incl. PatientConnector
Device Panel	Classification	ProCode	Description
	-	MSX	System, Network andCommunication, PhysiologicalMonitors
	§870.2910, II	DRG	Transmitters and Receivers,Physiological Signal,Radiofrequency
AnesthesiologyDevices	§868.1400, II	CCK	Analyzer, Gas, Carbon Dioxide,Gaseous-Phase
	§868.1500, II	CBQ	Analyzer, Gas, Enflurane,Gaseous-Phase (AnestheticConcentration)
	§868.1500, II	NHO	Analyzer, Gas, Desflurane,Gaseous-Phase (AnestheticConcentration)
	§868.1500, II	NHP	Analyzer, Gas, Sevoflurane,Gaseous-Phase (AnestheticConcentration)
	§868.1500, II	NHQ	Analyzer, Gas, Isoflurane,Gaseous-Phase (AnestheticConcentration)
	§868.1620, II	CBS	Analyzer, Gas, Halothane,Gaseous-Phase (AnestheticConcentration)
	§868.1700, II	CBR	Analyzer, Gas, Nitrous Oxide,Gaseous-Phase (AnestheticConcentration)
	§868.1720, II	CCL	Analyzer, Gas, Oxygen, Gaseous-Phase
	§868.1880, II	BZC	Data calculator Pulmonary-function
	§868.2375, II	BZQ	Monitor, Breathing Frequency
	§868.2480, II	LKD	Monitor, Carbon Dioxide,Cutaneous
	§868.2500, II	KLK	Monitor, Oxygen, Cutaneous, forInfant not under Gas Anesthesia
General Hospitaland Personal UseDevices	§880.2910, II	FLL	Thermometer, Electronic,Clinical
NeurologicalDevices	§882.1400, II	GWR	Electroencephalograph
	§882.1420, I	GWS	Analyzer, Spectrum,Electroencephalogram Signal

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1. The modified device is substantially equivalent to previously cleared Philips IntelliVue patient monitors marketed pursuant to K021778 and K100939.
1. The modification is the introduction and support of a standard application module for the IntelliVue MP75 patient monitor.
- 1. The modified device has the same intended use as the leqally marketed predicate device. The Philips MP75 IntelliVue patient monitor is intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The monitor is not intended for home use. It is intended for use by health care professionals.

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1. The modified device has the same technological characteristics as the legally marketed predicate device.
1. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified device with respect to the predicate. Testing involved system level and regression tests as well as testing from the hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence. The results demonstrate that the Philips MP75 IntelliVue patient monitor meets all reliability requirements and performance claims.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 1 8 2010

Philips Medizin Systeme Böblingen GmbH c/o Mr. Andreas Suchi Senior Regulatory Affairs Engineer - Patient Monitoring Hewlett-Packard-Str. 2 Böblingen GERMANY 71034

K101449 Re:

Trade/Device Name: Philips MP75 IntelliVue Patient Monitor (software revision H.01) Regulatory Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: MHX Dated: May 20, 2010 Received: May 24, 2010

Dear Mr. Suchi:

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. 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.

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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Page 2 - Mr. Andreas Suchi

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

C. Brem D. Zuckerman, M.D.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K101444

Indications for Use

510 (k) Number (if known) :

Philips MP75 IntelliVue patient monitor, software Device Name: revision H.01.

Indications for Use: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

Prescription Use Over-The-Counter Use Yes No AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE

OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

W.W.W.

510(k) N

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.