Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.

Device Description

Philips MP5 and MP5T IntelliVue Patient Monitors and Philips TRx4841A IntelliVue Telemetry System Transceiver. The modification is a change that adds wireless connection between the Philips MP5 and MP5T IntelliVue Patient Monitors and the Philips TRx4841A IntelliVue Telemetry System Transceiver as an alternative to the existing cable connection.

AI/ML Overview

The provided text describes a 510(k) summary for the Philips MP5 and MP5T IntelliVue Patient Monitors and the Philips TRx4841A IntelliVue Telemetry System Transceiver. The modification described is adding wireless connectivity as an alternative to existing cable connection.

However, the summary does not contain detailed information about specific acceptance criteria or an analytical study with quantitative results, sample sizes, expert involvement, or adjudication methods as typically found in comprehensive clinical validation reports for AI/CAD devices. The submission focuses on demonstrating substantial equivalence to previously cleared devices rather than a de novo validation of new performance claims for detection or diagnosis.

Here's a breakdown of what can be extracted and what is missing based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence: Device performs the same intended functions as predicate devices.	"Testing involved system level tests... The results successfully demonstrate that [the modified devices] meet all reliability requirements and performance claims."
Safety: Device operates safely.	"Testing involved...safety...tests."
EMC (Electromagnetic Compatibility): Device meets EMC standards.	"Testing involved...EMC...tests."
Performance: Device meets performance specifications.	"Testing involved...performance...tests. Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence."
Reliability: Device is reliable in operation.	"The results successfully demonstrate that [the modified devices] meet all reliability requirements..."
Environmental: Device performs as expected in various environments.	"Testing involved...environmental...tests."

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

Sample Size for Test Set: Not specified. The document states "system level tests, safety, EMC, performance, environmental and functionality tests" were involved, but no details on sample size (e.g., number of patients, number of readings/events) are provided for these tests.
Data Provenance: Not specified. It's implied that the testing was conducted internally by Philips Medizin Systeme Boeblingen GmbH. No mention of country of origin of data or whether it was retrospective or prospective is given.

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

Not applicable/Not specified. Since this is a device modification for connectivity and not a new diagnostic or detection algorithm, the concept of "ground truth" established by experts in the context of clinical accuracy (e.g., for disease detection) is not explicitly relevant or reported here. The "pass/fail criteria" were based on existing predicate device specifications.

4. Adjudication Method for the Test Set:

Not applicable/Not specified. No adjudication method is mentioned, as the testing appears to be primarily technical and functional rather than expert-driven clinical assessment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. An MRMC study is typically performed to evaluate the impact of an AI algorithm on human reader performance, usually for diagnostic tasks. This submission is for a monitor connectivity modification and does not involve AI/CAD features that would necessitate an MRMC study.

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

Not directly applicable in the terms of an "algorithm" for diagnosis. The device itself (monitor and telemetry system) performs functions (like arrhythmia detection, ST segment monitoring as per the regulation names), but the modification here is about wireless connection. The existing functions were "substantially equivalent" to predicate devices. The "standalone performance" was assessed through various engineering and functional tests.

7. The Type of Ground Truth Used:

The "ground truth" for this type of submission refers to the established specifications and performance of the predicate devices. The modified device's performance was compared against these pre-defined benchmarks. The document states: "Pass/Fail criteria were based on the specifications cleared for the predicate devices."

8. The Sample Size for the Training Set:

Not applicable/Not specified. This submission is for a hardware modification (wireless connectivity) of an existing monitor system, not a new AI/machine learning algorithm requiring a training set in the typical sense.

9. How the Ground Truth for the Training Set was Established:

Not applicable/Not specified, as there is no mention of a "training set" in the context of artificial intelligence.

In summary: This 510(k) pertains to a hardware modification (wireless connectivity) for an existing medical device, not a new AI-powered diagnostic tool. The "study" described is a series of verification and validation tests to ensure the modified device maintains functional equivalence, safety, and performance as compared to its legally marketed predicate devices, with acceptance criteria based on the predicate device's established specifications. The document lacks the detailed clinical study data often associated with new diagnostic algorithms.

Summary

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KOS 1793

510 (k) Summary

OCT 1 4 2008

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: Markus Stacha Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Fax: ++49 7031 463-2442 Tel: ++49 7031 463-2840, e-mail: markus.stacha@philips.com

This summary was prepared on June 23, 2008.

1. The names of the devices are: Philips MP5 and MP5T IntelliVue Patient Monitors and Philips TRx4841A IntelliVue Telemetry System Transceiver. 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)
	$870.1435, II	DXG	Computer, Diagnostic, Pre-Programmed, Single-Function
	$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
	$870.2800, II	DSH	Recorder, Magnetic tape,Medical
	$870.2810, I	DSF	Recorder, Paper Chart
	$870.2900, I	DSA	Cable, Transducer andElectrode, incl. PatientConnector
	-	MSX	System, Network andCommunication, PhysiologicalMonitors
	$870.2910, II	DRG	Transmitters and Receivers,Physiological Signal,Radiofrequency
AnesthesiologyDevices	$868.2375, II	BZQ	Monitor, Breathing Frequency

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1. The modified devices are substantially equivalent to previously cleared Philips MP5 and MP5T IntelliVue Patient Monitors and the Philips TRx4841A IntelliVue Telemetry System Transceiver marketed pursuant to K062392, K063725, K040357, and K041741.
1. The modification is a change that adds wireless connection between the Philips MP5 and MP5T IntelliVue Patient Monitors and the Philips TRx4841A IntelliVue Telemetry System Transceiver as an alternative to the existing cable connection.
1. The modified devices have the same intended use as the legally marketed predicate devices. They are intended for the monitoring, recording, and alarminq of multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.
1. The modified devices have the same technological characteristics as the legally marketed predicate devices.
1. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified devices with respect to the predicates. Testing involved system level tests, safety, EMC, performance, environmental and functionality tests. Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence. The results successfully demonstrate that the Philips MP5 and MP5T IntelliVue Patient Monitors with Philips TRx4841A IntelliVue Telemetry System Transceiver meet all reliability requirements and performance claims.

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 14

Philips Medizin Systeme Boeblingen GmbH Cardiac and Monitoring Systems c/o Mr. Egon Pfeil Regulatory Affairs Engineer Hewlett-Packard-Str. 2, D-71034 Boeblingen. Germany

Re: K081793

Trade/Device Name: Philips MP5 and MP51 IntelliVue Patient Monitors, and Philips 1 Rx4841 A Intelli Vue Telemetry System Transceiver Regulation 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: September 12, 2008 Received: September 15, 2008

Dear Mr. Stacha:

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 such 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.

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

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Page 2 - Mr. Egon Pfcil

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation cntitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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-frec number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

2 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

510(k) Number (if known): K081793

Device Name:

Philips MP5 and MP5T IntelliVue Patient Monitors and Philips TRx4841A IntelliVue Telemetry System Transceiver.

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

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

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

OF NEEDED)

Concurrence of CDRM, Office of Device Evaluation (ODE)

Hth Stin /M Bruckermey

(Division Sign-On) /
Division of Cardiovascular Devices

510(k) Number

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.