MX40 Release B.07

K172226 · Philips Medical Systems · MHX · Nov 9, 2017 · Cardiovascular

Device Facts

• Record ID: K172226
• Device Name: MX40 Release B.07
• Applicant: Philips Medical Systems
• Product Code: MHX · Cardiovascular
• Decision Date: Nov 9, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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.

Device Story

MX40 is a battery-operated, wearable multi-parameter patient monitor. It acquires physiological data (ECG, respiration, SpO2, NIBP) and generates alarms/technical alerts. It integrates multi-radio design (Smart Hopping 1.4GHz, 802.11a/b/g/h, Short Range Radio 2.4 GHz) for wireless connectivity to Philips telemetry networks and IntelliVue monitors. Used in hospitals and during transport by healthcare professionals. Output is transmitted to local monitoring systems, bedside monitors, or information systems. Clinicians use output for real-time patient monitoring and clinical decision-making. Benefits include continuous patient surveillance and mobility within hospital environments.

Clinical Evidence

No clinical performance testing was performed. Substantial equivalence was established through non-clinical verification and validation activities, including risk analysis, design reviews, and system-level performance testing based on cleared predicate specifications.

Technological Characteristics

Battery-operated wearable monitor. Multi-radio connectivity (1.4GHz, 802.11a/b/g/h, 2.4GHz SRR). Parameters: ECG, Resp, SpO2, NIBP. Complies with IEC60601-1 3rd edition. Includes MCS PigTail and Block Adapter for respiration. Software-based monitoring with alarm generation and network communication capabilities.

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.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• INTELLIVUE MX40 PATIENT MONITOR (K103646)

Reference Devices

• Philips CL SpO2 Pod (K101600)
• Philips CL NBP Pod (K111905)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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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 Systems<br>3000 Minuteman Road<br>Andover, MA 01810 USA |
|---------------|-------------------------------------------------------------------------|
|---------------|-------------------------------------------------------------------------|

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

> Tel: [phone] Fax: [phone] Email: [e-mail]

#### 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

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).

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 Intended<br>Use/Indications for Use | The intended use of the MX40 is to: |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The device is intended for monitoring and recording of and to generate<br>alarms for, multiple physiological parameters of adults and pediatrics in a<br>hospital environment and during patient transport inside hospitals. Not<br>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<br>for monitoring the physiological parameters of patients. Intended for<br>monitoring and recording of, and to generate alarms for, multiple<br>physiological parameters of adults and pediatrics in hospital<br>environments 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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Image /page/6/Picture/0 description: The image shows the word "PHILIPS" in large, blue, sans-serif font. Below the word "PHILIPS" is the text "MX40 Release B.07" and "Special 510(k)" in a smaller, black, sans-serif font. The text appears to be a label or identifier for a product or software release.

| Key Characteristic | Predicate MX40<br>K103646, K113125 | MX40 Release B.07 |
|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use<br>Intended Use<br>Statement | Indicated for use by health care<br>professionals whenever there is a need<br>for monitoring the physiological<br>parameters of patients. Intended for<br>monitoring and recording of, and to<br>generate alarms for, multiple<br>physiological parameters of adults and<br>pediatrics in hospital environments and<br>during transport inside hospitals.<br>Intended for monitoring and recording of<br>and to generate alarms for, multiple<br>physiological parameters of adults and<br>pediatrics in a hospital environment and<br>during patient transport inside hospitals.<br>Not intended for home use. Intended for<br>use by health care professionals. | Same |
| Target Patient<br>Population | Adult and pediatric | Same |
| Users | Trained health care professionals | Same |
| System Interface | Connects to the Philips IntelliVue<br>Information Center for transmission of<br>patient parameters | Same |
| Care and Cleaning | Available instructions in IFU | Same |
| Communication | Smart Hopping 1.4GHz (CTS) Radio<br>802.11a/b/g/h Radio<br>Short Range Radio 2.4 GHz | Same |
| Multi-Parameter<br>patient monitoring | ECG, Resp, SpO2, and NIBP (data<br>acquisition for NIBP is not done by the<br>MX40) | Same |
| Device Software,<br>Device safety,<br>environmental<br>specifications, and all<br>specifications of<br>measurement<br>characteristics | Unchanged, as previously submitted | 1. Heart Rate Alarm<br>from Pulse,<br>requires PIC IX<br>version C.01 or<br>higher.<br>2. Auto report<br>battery inop<br>(Technical Alert)<br>when Standby is<br>in low battery<br>state<br>3. Support CI<br>(Connection<br>Indication)<br>message<br>transport using<br>Unicast protocol<br>for WLAN<br>4. Malfunc Inop for<br>software license<br>failure - Added<br>self-test to MX40<br>to allow for<br>confirmation of<br>Software License<br>version to assist<br>users to identify<br>compatibility to<br>other systems<br>5. Claim IEC60601-1<br>3rd edition<br>update IFU and<br>Product Labeling<br>appropriately<br>6. AAMI screen - A<br>new portrait<br>screen 1-wave<br>and 2 numerics to<br>support AAMI<br>EC13 display, local<br>control only &<br>cannot default to<br>this screen from<br>PIC-iX |
| Device Accessories | Unchanged, as previously submitted | MCS PigTail and Block<br>Adapter* Hardware to<br>support Respiration<br>measurements.<br>*Use of Block Adapter<br>requires MX40<br>software B.06 or<br>higher. |
| 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.