IntelliVue MP40, MP50, MP60, MP70, MP80, MP90 and MX800 and IntelliBridge EC10 and EC5 IC Module: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

IntelliVue TcG10 Measurement Module:

Indicated for use by health care professionals whenever there is a need to support the continuous and noninvasive monitoring of transcutaneous partial pressures of blood gas carbon dioxide and oxygen of patients not under gas anesthesia.

Device Description

The modified Philips MP40, MP50, MP70, MP80, MP90, and MX800 IntelliVue Patient Monitors are a flexible and modular monitoring solution optimized for the surgical, cardiac, general medical and neonatal care environments. The monitors can be connected to the Philips Multi-Measurement Module (MMS) family with its extensions and to the IntelliVue family plug-in measurement modules. The monitors can also be connected to the IntelliVue anesthetic gas modules and to the new Intellivue TcG10 Measurement Module.

The modified Philips IntelliBridge EC10 and EC5 ID modules build an external medical device solution to collect data from external devices at the bedside providing the data to patient monitors, and patient monitoring networks. The modified EC10 and EC5 ID modules support the interface of the IntelliVue patient monitors with the new IntellVue TcG10 Measurement Module.

The new IntellVue TcG10 Measurement Module is a device for the continuous and noninvasive measurement of the transcutaneous partial pressures of blood gas carbon dioxide (pCO2) and oxygen (p02) of patients from all pediatric subgroups and of adult patients not under gas anesthesia in hospital environment. The transcutaneous measurement of pCO2 and pO2 makes use of the fact that carbon dioxide and oxygen gases are able to diffuse through body tissue and skin and can be detected by a sensor placed at the skin surface. By warming up this sensor, a local hyperemia is induced, which increases the supply of arterial blood to the dermal capillary bed below the sensor. The transcutaneous blood gas values (tcpCO2 and tcpO2) have to be interpreted primarily as the blood gas partial pressures prevailing at the level of the arterialized skin tissue. In general, this value correlates well with the corresponding arterial blood gas partial pressure.

AI/ML Overview

The provided 510(k) summary (K110474) describes the Philips IntelliVue TcG10 Measurement Module and related system components. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical bench testing. It explicitly states that clinical data are not required for this type of device according to specific guidance documents.

Therefore, the information requested regarding a study proving acceptance criteria for AI performance is largely not applicable to this submission, as it concerns a medical device that measures transcutaneous blood gas pressures, not an AI-powered diagnostic or assistive tool.

However, I can extract the information that is present about performance and testing from the document.

Acceptance Criteria and Device Performance (Based on "within specifications" and "substantially equivalent"):

Acceptance Criteria (Implied)	Reported Device Performance
Performance "within specifications" for cutaneous CO2 and O2 measurement	"The bench performance testing has demonstrated that the system... has performed within specifications, which have been substantially equivalent to those of the predicate device." (It's implied that the new device meets the same performance specifications as the cleared predicate.)
Safety and Effectiveness comparable to predicate devices	"The system... is as safe, as effective, and performs as the predicate devices has been demonstrated by non-clinical performance and clinical evaluation tests."
Functionality and Reliability	"Verification and validation testing activities were conducted to establish the safety, performance, functionality, and reliability characteristics of the modified and news devices with respect to the predicate devices." (Implied successful demonstration)

Study Details:

Sample size used for the test set and the data provenance: Not specified for a "test set" in the context of an AI study, as this refers to a medical device's performance testing. The document states "bench performance testing."
- Data provenance: Not applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI test set is not relevant to this device's non-clinical performance testing.
Adjudication method for the test set: Not applicable.
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: Not applicable. This device is a measurement module, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable in the context of an AI algorithm. This device is a standalone measurement module. Its performance was tested as a system comprising the measurement module and modified patient monitors/interface modules.
The type of ground truth used:
- For the non-clinical performance tests: The ground truth was based on the specifications cleared for the predicate devices. This implies that measurements from the new device were compared to established engineering and performance standards expected for such devices, likely using calibrated instruments or reference methods in a laboratory setting.
- "Pass/Fail criteria were based on the specifications cleared for the predicate devices."
The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established: Not applicable.

Additional Notes from the Document:

Clinical Performance Tests: "Clinical data are not required in accordance to the special controls guidance document... A clinical evaluation was conducted including literature review and clinical acceptance studies with experienced nursing and physician staff." This "clinical evaluation" appears to be an assessment of user experience and acceptance rather than a clinical trial to establish diagnostic accuracy against a ground truth.
Basis of Equivalence: The primary basis for substantial equivalence is the use of "identical functional measurement and calibration module as the predicate device" and "identical Radiometer tc Sensor 84 and the identical medical accessories." The changes are primarily software modifications for interfacing and an internal power supply.

Summary

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SEP 3 0 2011

510 (k) Summary

K110474

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:

Dr. Jens-Peter Seher Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Tel: ++49 7031 463-2086 Fax: ++49 7031 463-2442 e-mail: jens-peter.seher@philips.com

This summary was prepared on February 11, 2011.

The names of the devices are:

For the modified devices: Trade Name: Philips MP40, MP50, MP70, MP80, MP90, and MX800 IntelliVue Patient Monitor Common Name: Multiparameter Patient Monitor

and

Trade Name: Philips IntelliBridge EC10 and EC5 ID Module Common Name: Interface Module

and

。

For the new device: Trade name: Philips IntelliVue TcG10 Measurement Module Common name: tcpCO2/tcpO2 Measurement Module

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Classification names are as follows:

Device Panel	Classification	ProCode	Description
CardiovascularDevices	$870.1435, II	DXG	Computer, Diagnostic, Pre-Programmed, Single-Function
	$870.2060, II	DRQ	Amplifier and SignalConditioner, Transducer Signal
	$870.2900, I	DSA	Cable, Transducer andElectrode, incl. PatientConnector
AnesthesiologyDevices	$868.2480, II	LKD	Monitor, Carbon Dioxide,Cutaneous
	$868.2500, II	KLK	Monitor, Oxygen, Cutaneous, forInfant not under Gas Anesthesia
	$868.2500, II	LPP	Monitor, Oxygen, Cutaneous, forUse other than for Infant notunder Gas Anesthesia

1. The modified Philips MP40, MP50, MP60, MP70, MP80, MP90, and MX800 IntelliVue Patient Monitors are substantially equivalent to the previously cleared Philips IntelliVue Patient Monitors marketed pursuant to K013199, K032858, K040304, K041235, K050762, K053522, K062392, K71426, K081793, K082633, K083517, K091927, K100939, K101449 and K102562.
  The modified Philips IntelliBridge EC10 and EC5 ID modules are substantially equivalent to the previously cleared Philips IntelliBridge EC10 and EC5 ID modules marketed pursuant to ко82483.

Module IntelliVue TcG10 Measurement i s Philips The new substantially equivalent to the previously cleared TCM CombiM Monitoring System marketed pursuant to K093154 and in particular to the TCM CombiM Measurement Module which is the measurement unit of the TCM CombiM Monitoring System.

1. Description of the devices
  The modified Philips MP40, MP50, MP70, MP80, MP90, and MX800 IntelliVue Patient Monitors are a flexible and modular monitoring solution optimized for the surgical, cardiac, general medical and neonatal care environments. The monitors can be connected to the Philips Multi-Measurement Module (MMS) family with its extensions and to the IntelliVue family plug-in measurement modules. The monitors can also be connected to the IntelliVue anesthetic gas modules and to the new Intellivue TcG10 Measurement Module.

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1. Indications for Use
  IntelliVue MP40, MP50, MP60, MP70, MP80, MP90 and MX800 and IntelliBridge EC10 and EC5 IC Module: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

IntelliVue TcG10 Measurement Module:

Technological characteristics

modified and new devices have the same substantial The technological characteristics, such as fundamental design, user interface, materials, energy source, and measurement technology, as the legally marketed predicate devices.

The modification of the Philips MP40, MP50, MP60, MP70, MP80, MP90, and MX800 IntelliVue Patient Monitors is solely limited to software changes which are necessary to interface the patient monitors to the new IntelliVue TcG10 Measurement Module via the IntelliBridge EC10 and EC5 ID Module.

The modifications of the IntelliBridge EC10 and EC5 ID Module are solely limited to software changes.

software change for the EC10 is necessary the due to The communication between the new IntelliVue TcG10 Measurement Module and the patient monitors.

The modification for the EC5 ID is necessary to add specific device identifiers for the new IntelliVue TcG10 Measurement Module.

The fundamental communication and identification procedures are not changed.

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The new IntelliVue TcG10 Measurement Module uses the identical functional measurement and calibration module as the predicate device. The interface software to external devices has been modified to the general RS232 protocol and an internal power supply has been added. With this software modification and this internal power supply the IntelliVue TcG10 Measurement Module is able to operate independent of the predicate host system but now interfaced to the IntelliVue monitor family. The new IntelliVue TcG10 Measurement Module uses the identical Radiometer tc Sensor 84 and the identical medical accessories, which come into contact with the patient skin, as the predicate device.

7. Brief discussion of non-clinical performance tests

The determination of substantial equivalence of the performance of the cutaneous carbon dioxide (pcCO2) and oxygen (pcO2) measurement of the new IntelliVue TcG10 Measurement Module interfaced to the IntelliVue patient monitors modified via the modified EC10 and EC5 ID Modules was based on bench IntelliBridge performance testing in accordance to the special controls guidance document "Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (pcCO2) and Oxygen (pcO2) Monitors; Guidance for Industry and FDA", document issued on December 13, 2002. The bench performance testing has demonstrated that the system consisting of modified MP40, MP50, MP60, MP70, MP80, MP90, and MX800 IntelliVue Patient Monitors, modified IntelliBridge EC10 and EC5 ID Module and new IntelliVue TcG10 Measurement Module has within specifications, which have been substantial performed equivalent to those of the predicate device.

8. Brief discussion of clinical performance tests

Clinical data are not required in accordance to the special controls guidance document "Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA", document issued on December 13, 2002, to IEC 60601-2-23:1999, and to IEC 60601-3-1:1996.

A clinical evaluation was conducted including literature review clinical acceptance studies with experienced nursing and and physican staff.

1. Conclusion nonclinical performance clinical evaluation tests demonstration that the system consisting of the modified The Philips MP40, MP50, MP60, MP70, MP80, MP90, and MX800 IntelliVue Patient Monitors, the modified IntelliBridge EC10 and EC5 ID Module, and the new IntelliVue TcG10 Measurement Module is as safe, as effective, and performs as the predicate devices has been demonstrated by non-clinical performance and clinical evaluation tests

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10. Summary and Conclusion

Verification and validation testing activities were conducted to establish the safety, performance, functionality, and reliability characteristics of the modified and news devices with respect to the predicate devices. vav testing were executed electromagnetic environmental testing, regression testing and testing from the hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate devices.

The results demonstrate that the modified Philips MP40, MP50, MP60, MP70, MP80, MP90, and MX800 IntelliVue Patient Monitors, the modified IntelliBridge EC10 and EC5 ID Module, and the new IntelliVue TcG10 Measurement Module are as safe and as effective and perform as the predicate devices.

The modified and the new devices are substantially equivalent in intended use and fundamental technological characteristics compared to the appropriate predicate devices. The modified and new devices introduce no new questions concerning the safety or efficacy and are, therefore, substantially equivalent to the predicate devices.

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Image /page/5/Picture/0 description: The image shows a logo with a stylized bird in flight. The bird is composed of three parallel, curved lines that suggest movement and speed. To the left of the bird, there is a partial circular border with text that is difficult to read due to the image quality. The overall design is simple and modern, likely representing themes of freedom, travel, or progress.

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

Dr. Jens-Peter Seher Sr. Regulatory Affairs Engineer Philips Medizin Systeme Boblingen GmbH. Hewlett-Packard - Str. 2 Boblingen Germany D 71034

SEP 3 0 2011

Re: K110474

Trade/Device Name: Philips MP40, MP50, MP70, MP70, MP80, MP90, and MX800 IntelliVue Patient Monitors, Philips IntelliBridge EC10 and EC5 HD Module, Philips IntelliVue TcG10 Measurement Module Regulation Number: 21 CFR 868.2480 Regulation Name: Cutaneous Carbon Dioxide (PcCO2) Monitor Regulatory Class: II Product Code: LKD, KLK, LPP Dated: September 23, 2011 Received: September 28, 2011

Dear Dr. Peter Seher:

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 w 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. 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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Page 2 - Dr. Peter Seher

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/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.html 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.

Nh for

Anthony D. Watson, B.S.. M.S.. M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K10474

Device Names:

Philips MP40, MP50, MP60, MP70, MP80, MP90, and MX800 ၊ IntelliVue Patient Monitors
Philips IntelliBridge EC10 and EC5 ID Module ー
ﺍ Philips IntelliVue TcG10 Measurement Module

Indications for Use:

IntelliVue MP40, MP50, MP60, MP70, MP80, MP90 and MX800 and IntelliBridge EC10 and EC5 IC Module:

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

IntelliVue TcG10 Measurement Module:

Prescription Use(Part 21 CFR 801 Subpart D)	X AND/OR Over-(21 C
-------------------------------------------------	-------------------------

-The-Counter Use (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)

L. Schult

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K 110474

Page 14

Regulation Number and Section

§ 868.2480 Cutaneous carbon dioxide (PcCO2) monitor.

(a)
Identification. A cutaneous carbon dioxide (PcCO2) monitor is a noninvasive heated sensor and a pH-sensitive glass electrode placed on a patient's skin, which is intended to monitor relative changes in a hemodynamically stable patient's cutaneous carbon dioxide tension as an adjunct to arterial carbon dioxide tension measurement.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA.” See § 868.1(e) for the availability of this guidance document.