INTELLIVUE PATIENT MONITOR by PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN

The Philips MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors are intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP2, X2, MP5, MP20, MP30, MP40, and MP50 are additionally intended for use in transport situations within hospital environments. The MP5 is also intended for use during patient transport outside of a hospital environment. The monitors are not intended for home use. They are intended for use by health care professionals.

AI/ML Overview

The provided 510(k) summary (K093268) is for the Philips IntelliVue Patient Monitors, specifically for the introduction of software release G.08 which includes "enhancements in the Respiration algorithm." However, the document does not provide specific acceptance criteria or a detailed study proving the device meets those criteria for the respiration algorithm enhancement.

Instead, it states:

"Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified devices 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 IntelliVue Patient Monitors meet all reliability requirements and performance claims."

This generic statement indicates that the new software release G.08 was evaluated against the existing specifications and performance claims of the predicate devices. It does not offer a new study with specific acceptance criteria, sample sizes, ground truth methodologies, or expert qualifications for the enhanced Respiration algorithm.

Therefore, many of the requested details cannot be extracted from this specific 510(k) summary. I will answer what is available and explicitly state when information is not present in the document.

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided document. The document states "Pass/Fail criteria were based on the specifications cleared for the predicate devices," but it does not specify what those criteria are for the enhanced respiration algorithm or report specific performance metrics against them.

2. Sample Size Used for the Test Set and Data Provenance

Not available in the provided document. The summary mentions "system level and regression tests" but does not provide details on the sample size or the nature of the test data (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable/available. This 510(k) summary does not describe a study involving expert-established ground truth for the enhanced respiration algorithm. The testing described is against existing predicate device specifications.

4. Adjudication Method for the Test Set

Not applicable/available. No information on an adjudication method is provided, as no expert review or medical decision-making process is described in the testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document does not describe a multi-reader, multi-case comparative effectiveness study involving human readers with and without AI assistance. The enhancement is to a "Respiration algorithm," which is typically a standalone calculation, not an AI-assisted interpretation for human readers in the context of this document.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, implicitly. The testing described ("system level and regression tests") would inherently evaluate the standalone performance of the algorithm against its specifications. However, specific details of a standalone study or its results are not provided in this summary. The statement "The results demonstrate that the Philips IntelliVue Patient Monitors meet all reliability requirements and performance claims" implies standalone testing for the algorithm's function.

7. Type of Ground Truth Used

Implicitly, engineering specifications/clinical standards of the predicate device. The document states "Pass/Fail criteria were based on the specifications cleared for the predicate devices." This suggests that the "ground truth" for evaluating the enhanced respiration algorithm would be its adherence to established performance parameters and accuracy benchmarks relevant to those predicate device specifications, rather than new pathology, expert consensus, or outcomes data.

8. Sample Size for the Training Set

Not applicable/available. As this document concerns a software enhancement to an existing device, and the testing is described as against predicate specifications, there is no mention of a "training set" in the context of, for example, a machine learning algorithm being developed from scratch. If the "enhancements" included adaptive or machine learning components (which is not stated), details about a training set would typically be provided.

9. How the Ground Truth for the Training Set Was Established

Not applicable/available. See point 8.

Summary

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K093268

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.

1. The submitter of this premarket notification is:
  Andreas Suchi Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Tel: ++49 7031 463-1291 e-mail: andreas.suchi@philips.com

Fax: ++49 7031 463-2442

This summary was prepared on May 10, 2010.

1. The names of the devices are the Philips MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors 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 (witharrhythmia detection or alarms)
	§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 Signal Conditioner,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, Lead SwitchingAdapter
	§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 Pressure Transducer
	§870.2900, I	DSA	Cable, Transducer and Electrode, incl.Patient Connector
	-	MSX	System, Network and Communication,Physiological Monitors

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Device Panel	Classification	ProCode	Description
	§870.2910, II	DRG	Transmitters and Receivers, PhysiologicalSignal, Radiofrequency
AnesthesiologyDevices	§868.1400, II	CCK	Analyzer, Gas, Carbon Dioxide, Gaseous-Phase
	§868.1500, II	CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase(Anesthetic Concentration)
	§868.1500, II	NHO	Analyzer, Gas, Desflurane, Gaseous-Phase(Anesthetic Concentration)
	§868.1500, II	NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
	§868.1500, II	NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase(Anesthetic Concentration)
	§868.1620, II	CBS	Analyzer, Gas, Halothane, Gaseous-Phase(Anesthetic Concentration)
	§868.1700, II	CBR	Analyzer, Gas, Nitrous Oxide, Gaseous-Phase (Anesthetic Concentration)
	§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, for Infantnot under Gas Anesthesia
General Hospital andPersonal Use Devices	§880.2910, II	FLL	Thermometer, Electronic, Clinical
Neurological Devices	§882.1400, II	GWR	Electroencephalograph
	§882.1420, II	GWS	Analyzer, Spectrum,Electroencephalogram Signal

1. The modified devices are substantially equivalent to previously cleared Philips IntelliVue Patient Monitors marketed pursuant to K021778, K030038, K032858, K033444, K033513, K040304, K040357, K041235, K042845, K050762, K051106, K052801, K053522, K060221, K060541, K061052, K061610, K062283, K063315, K062392, K063725, K71426, K72020.
1. The modification is the introduction of software release G.08 for the entire IntelliVue Patient Monitors family, models MP2, X2, MP5, MP20, MP30, MP30, MP60, MP70, MP80, and MP90 including enhancements in the Respiration algorithm.
1. The modified devices have the same intended use as the legally marketed predicate devices. The Philips MP2, X2, MP5, MP20, MP30, MP40, MP50, MP70, MP80, and MP90 IntelliVue Patient Monitors are intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP2, X2, MP5, MP20, MP30, MP40, and MP50 are additionally intended for use in transport situations within hospital environments. The MP5 is also intended for use during patient transport outside of a hospital environment. The monitors are not intended for home use. They are intended for use by health care professionals.
1. The modified devices have the same technological characteristics as the legally marketed predicate device.

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1. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified devices 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 IntelliVue Patient Monitors meet 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

Philips Medizin Systeme Boeblingen GmbH c/o Mr. Andreas Suchi Senior Regulatory Affairs Engineer Hewlett-Packard Str. 2 D-71034 Boeblingen Germany

MAY 1 1 2010

Re: K093268

Trade/Device Name: Philips Intellivue Patient Monitor Models MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Regulatory Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II (Two) Product Code: MHX Dated: May 4, 2010 Received: May 5, 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/ReportaProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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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Indications for Use

K093268 510(k) Number (if known):

Philips MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, Device Name: MP70, MP80, and MP90 IntelliVue Patient Monitors, Software Revision G.08.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number 5/11/10

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.