PATIENT MONITORS VARIOUS MODELS

K151812 · Philips Medical Systems · MHX · Jan 26, 2016 · Cardiovascular

Device Facts

• Record ID: K151812
• Device Name: PATIENT MONITORS VARIOUS MODELS
• Applicant: Philips Medical Systems
• Product Code: MHX · Cardiovascular
• Decision Date: Jan 26, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Efficia CM10, CM12, CM100, CM120 and CM150 patient monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The Efficia CM10, CM12, CM100, CM120 and CM150 patient monitors are intended for monitoring, analysis, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility.

Device Story

Efficia CM10/12/100/120/150 are multi-parameter patient monitors for healthcare environments. Devices accept inputs via sensors for ECG, respiration (impedance/acoustic/capnography), NBP, SpO2/SpHb/SpCO, temperature, IBP, CO2, and cardiac output. Monitors process signals using established Philips and third-party (Masimo, Respironics) algorithms to perform arrhythmia detection, ST-segment analysis, and vital sign calculation. Outputs are displayed on 10-15 inch screens, providing real-time monitoring, recording, and alarming. Operated by healthcare professionals in clinical settings or during intra-facility transport. Output informs clinical decision-making regarding patient status and intervention. Benefits include continuous physiological surveillance and timely alerts for abnormal conditions.

Clinical Evidence

No clinical trials were conducted. Substantial equivalence is supported by bench testing, performance verification, and usability studies. Devices comply with IEC 60601-1, IEC 60601-2-27, ISO 80601-2-55, ISO 80601-2-56, ISO 80601-2-61, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 62366, IEC 62304, IEC 80601-2-30, IEC 60601-2-34, IEC 60601-2-49, and ANSI/AAMI EC-13.

Technological Characteristics

Multi-parameter monitors with 10, 12, or 15-inch displays. Powered by AC with secondary battery. Materials identical to primary predicate. Algorithms: Philips proprietary (ECG, NBP, IBP, Temp), Masimo (SpO2, SpHb, SpCO, acoustic respiration), Respironics (mainstream CO2), and Philips ST/AR (arrhythmia/ST-segment). Connectivity includes standard patient monitoring interfaces. Compliant with IEC 60601 series, ISO 80601 series, and ANSI/AAMI EC-13.

Indications for Use

Indicated for healthcare professionals to monitor, analyze, record, and alarm physiological parameters in adult, pediatric, and neonatal patients within healthcare facilities, including intra-facility transport. Parameters include ECG, Respiration (Impedance, RRa, awRR), NBP, SpO2, SpHb, SpCO, Temperature, CO2, IBP, Cardiac Output, Arrhythmia, and ST-segment analysis. Contraindicated for transport outside the healthcare facility.

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

• Philips SureSigns VM Series Patient Monitors (K123900)
• Philips MP20, MP30, MP40, MP50, MP60, MP70 MP90 IntellliVue Patient Monitor (K050762)
• Respironics CAPNOSTAT 5 CO2 sensor (K042601)
• Masimo Rainbow SET® Radical 7R CO-Oximeter and Accessories (K100428)
• Philips ST/AR ST and Arrhythmia Software, Release K.O (K101521)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The text is centered horizontally. The background is white.

Public Health Service

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

January 26, 2016

Philips Medical Systems Mary Kruitwagen OA and Regulatory Affairs 3000 Minuteman Road Andover, MA 01810-1099

Re: K151812

Trade/Device Name: Philips Efficia CM10 863301, Philips Efficia CM12 863303, Philips Efficia CM100 863300. Philips Efficia CM120 863302, Philips Efficia CM150 863304 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, MLD, DSJ, DSK, DXN, DRT, DQA, DSA, FLL, CCK, BZQ Dated: December 16, 2015 Received: December 21, 2015

Dear Mary Kruitwagen:

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

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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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

[signature]

for Pram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Food and Drug Administration | |
| <b>Indications for Use</b> | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. |
| 510(k) Number (if known) | K151812 |
| Device Name | Philips Efficia CM10 863301, Philips Efficia CM12 863303, Philips Efficia CM100 863300, Philips Efficia CM120 863302<br>Philips Efficia CM150 863304 |
| Indications for Use (Describe) | The Efficia CM10, CM12, CM100, CM120 and CM150 patient monitors are indicated for use by health care<br>professionals whenever there is a need for monitoring the physiological parameters of patients. The Efficia CM10,<br>CM12, CM100, CM120 and CM150 patient monitors are intended for monitoring, analysis, recording and alarming<br>of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the<br>monitor may be used in transport situations within a healthcare facility. |
| | Parameter (patient types): ECG (Adult, Pediatric, Neonatal); Respiration - Impedance (Adult, Pediatric, Neonatal);<br>Respiration - RRa (Adult); Respiration - awRR (Adult, Pediatric, Neonatal); NBP (Adult, Pediatric, Neonatal); SpO2<br>(Adult, Pediatric, Neonatal); SpHb (Adult, Pediatric); SpCO (Adult, Pediatric); Temperature (Adult, Pediatric, Neonatal);<br>CO2 (Adult, Pediatric, Neonatal); IBP (Adult, Pediatric, Neonatal); Cardiac Output (Adult, Pediatric); Arrhythmia<br>(Cardiotach) (Adult, Pediatric, Neonatal); Arrhythmia (Basic) (Adult, Pediatric); Arrhythmia (Advanced) (Adult,<br>Pediatric); ST segment Analysis (Adult); |
| | Contraindications: Not for transport outside the healthcare facility |
| Type of Use (Select one or both, as applicable) | |
| | <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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# Efficia CM10, CM12, CM100, CM120 and CM150 Patient Monitors 510(k) Summary

| Preparation Date | September 18, 2015 |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Type: | Traditional 510(k) |
| Regulatory Information<br>Classification | Physiological Monitor, Patient Monitor |
| Common/ Usual Name | Multi-parameter Patient monitor |
| Trade Name | Philips Efficia |
| Proprietary Name | Efficia CM10<br>Efficia CM12<br>Efficia CM100<br>Efficia CM120<br>Efficia CM150 |
| Models (with Reference numbers) | CM10 (863301)<br>CM12 (863303)<br>CM100 (863300)<br>CM120 (863302)<br>CM150 (863304) |
| Device Sponsor | Philips Medical Systems,<br>3000 Minuteman Rd,<br>Andover, MA, USA, 01810-1099 |
| Device Owner | Philips Medical Systems,<br>3000 Minuteman Rd,<br>Andover, MA, USA 01810-1099 |
| Establishment Registration number: | 1218950 |
| Sponsor/Manufacturer/Owner/Operator: | 1217116 |
| Contact | Mary Kruitwagen<br>Philips Medical Systems,<br>3000 Minuteman Rd,<br>Andover, MA, USA, 01810-1099<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |

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Peter Schipelliti, Philips Medical Systems, 3000 Minuteman Rd, Andover, MA 01810-1099 USA Email: [e-mail] Phone: [phone] Fax: [phone]

#### Device Classification:

The product codes and individual classification monographs applicable to the subject devices are listed below:

| Device Panel | Classification | ProCode | Description |
|-----------------------------------------|----------------|---------|-----------------------------------------------------------------------|
| Cardiovascular | 870.1025, II | MHX | Monitor, Physiological, Patient (with arrhythmia detection or alarms) |
| Cardiovascular | 870.1025, II | MLD | Monitor, St Segment With Alarm |
| Cardiovascular | 870.1110, II | DSJ | Alarm, Blood Pressure |
| Cardiovascular | 870.1110, II | DSK | Computer, Blood Pressure |
| Cardiovascular | 870.1130, II | DXN | System, Measurement, Blood Pressure, Non-Invasive |
| Cardiovascular | 870.2300, II | DRT | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Cardiovascular | 870.2700, II | DQA | Oximeter |
| Cardiovascular | 870.2900, I | DSA | Cable, Transducer and Electrode, incl. Patient connector |
| Cardiovascular | 890.1175, II | IKD | cable, electrode |
| General Hospital and<br>Personal Use | 880.2910, II | FLL | Thermometer, Electronic, Clinical |
| Anesthesiology &<br>Respiratory Therapy | 868.1400, II | CCK | Analyzer, Gas, |
| Anesthesiology &<br>Respiratory Therapy | 868.2375, II | BZQ | Monitor, Breathing Frequency |

#### Device Description

The subject Philips Efficia CM10, CM120 and CM150 patient monitors are a family of physiological vital signs monitors. The monitors come with a variety of display sized (10 inch, 12 inch or 15 inch) and with a variety of measurements, some optional. The monitors primarily run on AC power with a secondary battery. The exterior material is the same as the primary predicate devices.

#### Fundamental Scientific Technology:

The subject Efficia CM10, CM120 and CM150 patient monitors include the following parameters (some optional): ECG, Respiration, NBP, SpO, Temperature, Invasive Blood Pressure, Cardiac Output, Arrhythmia Analysis, ST-Segment monitoring, and CO2 .monitoring.

- . The ECG algorithm is a Philips algorithm which is well established in the marketplace and is used in the primary predicate devices (K123900).
- Respiration rate can be measured through impedance technology, from capnography or via acoustic respiration. The Impedance respiration algorithm is the same algorithm as used in the primary predicate devices (K123900).
- Respiration from capnography, shown as awRR, is either from Microstream from the Oridion algorithm or main stream CO2.
- The Sidestream method is the same as in the primary predicate (K123900). The main stream CO2 including O respiration is from Respironics.
- The algorithm of the respirations from the mainstream CO₂ is from Respironics M2105A sensor (K042601 O and K050762) and is used unchanged in the subject devices.
- The acoustic respirations (awRR) measurement is achieved via the Masimo rainbow Set using their O algorithm unchanged and previously cleared (K100428).

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- The NBP algorithm is proprietary Philips algorithm and is the same algorithm as in the primary predicate device (K123900).
- The subject devices offer two different SpO3 algorithms. The default SpO3 algorithm is a Philips proprietary algorithm and is unchanged from the primary predicate device (K123900). Optionally, the user can select the Masimo Set or Masimo rainbow Set. This option uses Masimo's algorithm unchanged from its predicate (K100428). SpHb and SpCO are part of Masimo's algorithm and are implemented unchanged from the Masimo predicate.
- . The temperature measurement is similar algorithm of primary predicate (K123900).
- The invasive blood pressure algorithm is a Philips algorithm which is unchanged from that in the primary predicate device (K123900).
- . The arrhythmia algorithm and the ST-Segment analysis algorithm used the Philips ST/AR algorithm and incorporate a subset of the STAR algorithm as cleared by K101521.

Performance data supports that the subject devices performance to same or better level of safety and effectiveness as the predicate devices. Clinical user preference and usability studies support that the customer requirements are met. The subject devices are in compliance with the following standards:

| IEC 60601-1 | IEC 60601-2-27 | ISO 80601-2-55 |
|------------------------------|----------------|-----------------|
| IEC 60601-1-2 | IEC 80601-2-30 | ISO 80601-2-56 |
| IEC 60601-1-6 | IEC 60601-2-34 | ISO 80601-2-61 |
| IEC 62366 included IEC 62304 | IEC 60601-2-49 | ANSI/AAMI EC-13 |
| IEC 60601-1-8 | | |

The predicates for the subject devices are:

| K123900 | 03/19/2013 | Philips SureSigns VM Series Patient Monitors |
|--------------------------|------------|-----------------------------------------------------------------------------|
| K050762 | 04/22/2005 | Philips MP20, MP30, MP40, MP50, MP60, MP70 MP90 IntellliVue Patient Monitor |
| K042601 | 11/19/2004 | Respironics CAPNOSTAT 5 CO2 sensor |
| K100428 | 07/09/2010 | Masimo Rainbow SET® Radical 7R CO-Oximeter and Accessories |
| K101521 | 07/25/2010 | Philips ST/AR ST and Arrhythmia Software, Release K.O |
| Primary 510(k) Predicate | | |

Philips SureSigns VM Series Patient Monitors

#### K123900 03/19/2013

## Indications for Use:

Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The intended uses are for monitoring, analysis, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility.

| | Patient Types | | |
|-------------------------|---------------|-----------|----------|
| Parameter | Adult | Pediatric | Neonatal |
| ECG | √ | √ | √ |
| Respiration - Impedance | √ | √ | √ |
| Respiration - RRa | √ | | |

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| | Patient Types | | |
|-------------------------|---------------|-----------|----------|
| Parameter | Adult | Pediatric | Neonatal |
| Respiration - awRR | √ | √ | √ |
| NBP | √ | √ | √ |
| SpO2 | √ | √ | √ |
| SpHb | √ | √ | |
| SpCO | √ | √ | |
| Temperature | √ | √ | √ |
| CO2 | √ | √ | √ |
| IBP | √ | √ | √ |
| Cardiac Output | √ | √ | |
| Arrhythmia (Cardiotach) | √ | √ | √ |
| Arrhythmia (Basic) | √ | √ | |
| Arrhythmia (Advanced) | √ | √ | |
| ST segment Analysis | √ | | |

Contraindications: Not for transport outside the healthcare facility

### Conclusion

The subject Efficia CM10, CM120 and CM150 patient monitors utilize the same fundamental scientific technology as the predicate devices on the market. The energy source is electrical with secondary battery back like the primary predicate. The subject Efficia CM10, CM120 and CM150 patient monitors use the same algorithms and have the similar performance to their predicates. They have the same or better level of safety and essential performance as compared to their predicate devices when reviewing the data of the device history file. It is our assessment that the subject devices demonstrate that they are substantially equivalent to the identified predicates and have the same level of safety and effectiveness.