The intended use of the MX40 is to: The device is intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults and pediatrics in a hospital environment and during patient transport inside hospitals. Not intended for home use. Intended for use by health care professionals.

Indications for Use: 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. Rx only.

Device Description

The MX40 is a multi-parameter, battery operated patient monitor that is small enough to be worn by the patient. Its multi-radio design enables device operation within existing Philips telemetry networks while providing compatibility to the IntelliVue Information Center solutions. Along with infrastructure radios, the MX40 integrates a short-range radio (SRR), enabling wireless connectivity to the IntelliVue family of monitors. Acquired physiological data, along with physiological alarms and technical alert information are provided to multiple monitoring systems (local, bedsides and /or information systems).

AI/ML Overview

The provided document is a 510(k) summary for the Philips MX40 Release B.07, a physiological patient monitor. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its own performance against pre-defined acceptance criteria for a novel AI/software component within the device.

Therefore, many of the requested details about acceptance criteria, specific studies proving performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not present in this document as it pertains to a modification of an existing device rather than a new device with new clinical claims. Manufacturers typically demonstrate substantial equivalence through verification and validation testing, often against established standards and internal specifications, rather than large-scale clinical trials for minor modifications.

Here's an attempt to answer the questions based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of specific acceptance criteria (e.g., sensitivity, specificity thresholds) or quantitative device performance metrics. Instead, it states:

Acceptance Criteria (Implied): "Pass/Fail criteria were based on the specifications cleared for the predicate device." (Page 8)
Reported Device Performance: "test results showed substantial equivalence." (Page 8) and "The MX40 Release B.07 meets all defined reliability requirements and performance claims." (Page 8)

The document lists changes to functionalities, such as:

Heart Rate Alarm from Pulse, requiring PIC IX version C.01 or higher.
Auto report battery inop (Technical Alert) when Standby is in low battery state.
Support CI (Connection Indication) message transport using Unicast protocol for WLAN.
Malfunc Inop for software license failure - Added self-test to MX40 to allow for confirmation of Software License version to assist users to identify compatibility to other systems.
Claim IEC60601-1 3rd edition update IFU and Product Labeling appropriately.
AAMI screen - A new portrait screen 1-wave and 2 numerics to support AAMI EC13 display, local control only & cannot default to this screen from PIC-iX.
MCS PigTail and Block Adapter hardware to support Respiration measurements.

The "reported device performance" is broadly stated as meeting the specifications of the predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "system level tests, performance tests, and safety testing from hazard analysis" (Page 8), but does not specify sample sizes or data provenance for these non-clinical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document, as clinical performance testing, which would typically involve expert ground truth, was not performed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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

No MRMC comparative effectiveness study was mentioned or performed, as the device is a physiological monitor and not an AI-assisted diagnostic tool.

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

The document states that "Clinical Performance testing for MX40 Release B.07 was not performed, as there were no new clinical applications that had hazards or risk mitigations that required a clinical performance testing to support equivalence." (Page 8). Therefore, no standalone clinical performance study was done for this particular submission. The device itself is a standalone physiological monitor, but the nature of the submission (modifications to an existing device) did not necessitate a new standalone performance study against clinical ground truth.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical testing performed, the ground truth would have been based on established specifications, standards, and expected performance characteristics of the predicate device and the new functionalities, rather than clinical ground truth like pathology or expert consensus. The changes relate to hardware and software updates, not new diagnostic algorithms requiring clinical validation.

8. The sample size for the training set

This information is not applicable as the document does not describe the development or testing of an AI/machine learning algorithm with a training set. The device is a physiological monitor with specified functionalities.

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

This information is not applicable as there is no mention of an AI/machine learning component or a training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 9, 2017

Philips Medical Systems Theresa Poole Regulatory Specialist 3000 Minuteman Road Andover, Massachusetts 01810

Re: K172226

Trade/Device Name: MX40 Release B.07 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, DSI, DOA, DSA, DRW, DRG, MLD, MSX Dated: July 18, 2017 Received: July 25, 2017

Dear Theresa Poole:

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. 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.

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 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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Page 2 - Theresa Poole

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

M.A. Wilhelm

for 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)

K172226

Device Name

MX40 Release B.07

Indications for Use (Describe)

The intended use of the MX40 is to:

The device is intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults and pediatrics in a hospital environment and during patient transport inside hospitals. Not intended for home use. Intended for use by health care professionals.

Indications for Use

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.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. Below the word "PHILIPS" is the text "MX40 Release B.07" in a smaller font size. Underneath that, the text "Special 510(k)" is displayed.

510(k) Summary MX40 Release B.07

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 807.92(c).

Date Prepared: 17 July 2017

I. Submitter's name and address

Manufacturer:	Philips Medical Systems3000 Minuteman RoadAndover, MA 01810 USA
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Theresa Poole Contact Person: Regulatory Affairs Specialist Philips Medical Systems 3000 Minuteman Road, MS0480 Andover, MA 01810-1099

Tel: 978 659 7621 Fax: 978 685 5624 Email: theresa.poole@philips.com

II. Device information

Device Name: MX40 Release B.07 Common Name: Physiological Monitor, Patient Monitor Classification panel: 74 - Cardiovascular

Classification names are as follows:

Classification	ProCode	Description
§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 or alarms)
§870.2350, II	DRW	Electrocardiograph, Lead Switching Adapter
§870.2700, II	DQA	Oximeter
§870.2900, I	DSA	Cable, Transducer and Electrode, incl. Patient Connector
§870.2300, II	MSX	System, Network and Communication, Physiological Monitors
§870.2910, II	DRG	Transmitters and Receivers, Physiological Signal, Radiofrequency
§870.2300, II	DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

III. Predicate device information

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INTELLIVUE MX40 PATIENT MONITOR Trade name: Manufacturer: Philips Medical Systems 510(k) clearance: K103646 Classification name: Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms) Device class: Class II Classification regulation: 21 CFR 870.1025 Classification panel: Cardiovascular Product code: MHX

IV.Device Description

Previously cleared compatible Accessories are still in use, no new accessories in this filing. The MX40 is compatible with the legally marketed Philips CL SpO2 Pod and CL NBP Pod (K101600, K111905). The CL SpO2/NBP Pods are small battery powered devices that measure oxygen saturation, pulse rate and blood pressure, pulse rate, respectively. A list of all accessories is available in the Instructions for Use.

V. Intended use/ Indications for Use

MX40 IntendedUse/Indications for Use	The intended use of the MX40 is to:
	The device is intended for monitoring and recording of and to generatealarms for, multiple physiological parameters of adults and pediatrics in ahospital environment and during patient transport inside hospitals. Notintended for home use. Intended for use by health care professionals.
	Indications for Use
	Indicated for use by health care professionals whenever there is a needfor monitoring the physiological parameters of patients. Intended formonitoring and recording of, and to generate alarms for, multiplephysiological parameters of adults and pediatrics in hospitalenvironments and during transport inside hospitals.
	Rx only.

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Image /page/5/Picture/0 description: The image shows the word "PHILIPS" in a large, bold, blue font. Below the brand name, the text "MX40 Release B.07" is displayed in a smaller, black font. Underneath that, the phrase "Special 510(k)" is also written in black.

Comparison of Technological Characteristics with the Predicate Device

The device has the same technological characteristics as the legally marketed predicate devices. The change summary includes items listed in the table starting on page 4.

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Key Characteristic	Predicate MX40K103646, K113125	MX40 Release B.07
Indications for UseIntended UseStatement	Indicated for use by health careprofessionals whenever there is a needfor monitoring the physiologicalparameters of patients. Intended formonitoring and recording of, and togenerate alarms for, multiplephysiological parameters of adults andpediatrics in hospital environments andduring transport inside hospitals.Intended for monitoring and recording ofand to generate alarms for, multiplephysiological parameters of adults andpediatrics in a hospital environment andduring patient transport inside hospitals.Not intended for home use. Intended foruse by health care professionals.	Same
Target PatientPopulation	Adult and pediatric	Same
Users	Trained health care professionals	Same
System Interface	Connects to the Philips IntelliVueInformation Center for transmission ofpatient parameters	Same
Care and Cleaning	Available instructions in IFU	Same
Communication	Smart Hopping 1.4GHz (CTS) Radio802.11a/b/g/h RadioShort Range Radio 2.4 GHz	Same
Multi-Parameterpatient monitoring	ECG, Resp, SpO2, and NIBP (dataacquisition for NIBP is not done by theMX40)	Same
Device Software,Device safety,environmentalspecifications, and allspecifications ofmeasurementcharacteristics	Unchanged, as previously submitted	1. Heart Rate Alarmfrom Pulse,requires PIC IXversion C.01 orhigher.2. Auto reportbattery inop(Technical Alert)when Standby isin low batterystate3. Support CI(ConnectionIndication)messagetransport usingUnicast protocolfor WLAN4. Malfunc Inop forsoftware licensefailure - Addedself-test to MX40to allow forconfirmation ofSoftware Licenseversion to assistusers to identifycompatibility toother systems5. Claim IEC60601-13rd editionupdate IFU andProduct Labelingappropriately6. AAMI screen - Anew portraitscreen 1-waveand 2 numerics tosupport AAMIEC13 display, localcontrol only &cannot default tothis screen fromPIC-iX
Device Accessories	Unchanged, as previously submitted	MCS PigTail and BlockAdapter* Hardware tosupport Respirationmeasurements.*Use of Block Adapterrequires MX40software B.06 orhigher.
Device Hardware	Unchanged, as previously submitted	Same
Charging method	Unchanged, as previously submitted	Same

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Image /page/7/Picture/1 description: The image shows the word "PHILIPS" in a large, blue, sans-serif font. Below the word "PHILIPS" are the words "MX40 Release B.07" in a smaller, black, sans-serif font. Below that is the text "Special 510(k)" in the same font.

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Image /page/8/Picture/0 description: The image shows the word "PHILIPS" in large, blue, bold letters. Below the brand name, the text "MX40 Release B.07 Special 510(k)" is displayed in a smaller, black font. The text appears to be related to a specific product or software version of Philips, possibly indicating a special release or compliance with regulatory standards.

Summary of Non-clinical testing

No performance standards have been issued under the authority of Section 514. The MX40 Release B.07 was tested in accordance with Philips verification and validation processes. Quality Assurance measures were applied to the system design and development, including:

Risk Analysis ●
Product Specifications ●
Design Reviews
Verification & Validations ●

Summary of Clinical Testing

Clinical Performance testing for MX40 Release B.07 was not performed, as there were no new clinical applications that had hazards or risk mitigations that required a clinical performance testing to support equivalence.

Conclusions drawn from the Non-clinical and Clinical testing

Verification, validation, and testing activities, where required to establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate are performed. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The MX40 Release B.07 meets all defined reliability requirements and performance claims.

VI.Conclusion

In summary, there is no change in either intended use or in the fundamental scientific technology employed by the MX40 patient monitor in the modification for B.07. We consider these device modifications to be substantially equivalent to previously cleared devices. Additionally, substantial equivalence was demonstrated with non-clinical performance testing, which complied with the requirements specified in the international and FDA-recognized consensus standards. The non-clinical performance tests provided in this 510(k) premarket notification demonstrate that the subject device is as safe and effective as its predicate device without raising any new safety and/or effectiveness concerns.

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.