INTELLIVUE MX40 PATIENT MONITOR

K113125 · Philips Medical Systems · DSI · Nov 17, 2011 · Cardiovascular

Device Facts

• Record ID: K113125
• Device Name: INTELLIVUE MX40 PATIENT MONITOR
• Applicant: Philips Medical Systems
• Product Code: DSI · Cardiovascular
• Decision Date: Nov 17, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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. Not intended for home use. Intended for use by health care professionals.

Device Story

IntelliVue MX40 Patient Monitor; portable device for monitoring/recording physiological parameters and generating alarms. Used in hospital environments and during intra-hospital transport. Operated by healthcare professionals. Device processes physiological signals; provides real-time monitoring data to clinicians to support clinical decision-making. Benefits include continuous patient surveillance during transport and bedside care.

Clinical Evidence

Bench testing only. Verification and validation activities included system-level tests, performance tests, and safety testing based on hazard analysis. Testing demonstrated compliance with voluntary standards including IEC 60601-1, IEC 60601-1-2, ANSI/AAMI EC 13, ISO 9919, and ISO 10993-1.

Technological Characteristics

Physiological monitor with arrhythmia detection, ST segment monitoring, and oximetry. Connectivity via network/communication system. Biocompatibility per ISO 10993-1 for accessory lead wires. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2. Standards: ANSI/AAMI EC 13, ISO 9919, IEC 60601-2-25, EC 53.

Indications for Use

Indicated for use by health care professionals whenever there is a need for monitoring physiological parameters of adult and pediatric patients 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

• MX40 Intelli Vue Patient Monitor (K103646)

Submission Summary (Full Text)

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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 CFR §807.92.

The submitter of this premarket notification is:

Theresa Poole Regulatory Affairs Specialist Patient Monitoring Philips Medical Systems 3000 Minuteman Road, MS0480 Andover, MA 01810-1099 Tel: [phone] Fax: [phone] Email: [e-mail]

This summary was prepared on 10 November 2011.

The name of this device is the IntelliVue MX40 Patient Monitor. Classification names are as follows:

| Classification | ProCode | Description |
|----------------|---------|--------------------------------------------------------------------------|
| none | 74 MHX | Physiological Monitor, Patient Monitor |
| §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<br>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<br>Connector |
| §870.2300, II | MSX | System, Network and Communication, Physiological<br>Monitors |
| §870.2910, II | DRG | Transmitters and Receivers, Physiological Signal,<br>Radiofrequency |

The modified device is substantially equivalent to the previously cleared MX40 Intelli Vue Patient Monitor (K103646). Updated compatibility to lead sets and other devices.

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.

The modified device has the same Indications for Use and Intended Use as the legally marketed predicate device.

The modified device has the same technological characteristics as the legally marketed predicate device.

Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system

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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 results demonstrate that MX40 patient monitor meets all defined reliability requirements and performance claims.

The following voluntary standards were used where applicable for this product modification per FDA Guidance of March 12, 2000 entitled "Use of Standards in Substantial Equivalence Determinations":

General Electrical Safety IEC 60601-1:1998 + A1:1991 + A2:1995

EMC IEC 60601-1-2:2001 + A1:2004

Safety and Performance ANSI/AAMI EC 13:2002 Cardiac monitors, heart rate monitors and alarms ISO EN 9919: 2005 IEC 60601-2-25:1993 + A1:1999 EC 53:1998 + A1:2008 ECG Cables and leadwires ISO 10993-1:2010 Biocompatability (only applicable to accessory lead wires) ISO 9919:2005

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

Philips Medical Systems. c/o Ms. Theresa Poole Regulatory Affairs Engineer Patient Monitoring Philips Medical Systems 3000 Minuteman Road Andover, MA 01810-1099

NOV 1 7 2011

Re: K113125

Trade/Device Name: Philips MX40 Patient Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: Class II (two) Product Codes: DSI, MHX, MLD, DRW, DQA, DSA, MSX, and DRG Dated: October 19, 2011 Received: October 24, 2011

Dear Ms. 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.

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

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## Page 2 - Ms. Theresa Poole

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 (OS) 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/CDRH0ffices/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.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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D.

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): K113125

Intelli Vue MX40 Patient Monitor Device Name:

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.

Prescription Use Yes (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use No (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Division Sign-Off) |
|------------------------------------|
| Division of Cardiovascular Devices |

| 30(k) Number | K/13125 |
|--------------|---------|
|--------------|---------|