SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8

K123900 · Philips Medical Systems · MHX · Apr 18, 2013 · Cardiovascular

Device Facts

• Record ID: K123900
• Device Name: SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8
• Applicant: Philips Medical Systems
• Product Code: MHX · Cardiovascular
• Decision Date: Apr 18, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SureSigns VM4, VM6 and VM8 Patient Monitors are for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility

Device Story

SureSigns VM4, VM6, and VM8 are multi-parameter patient monitors used in healthcare facilities for bedside and transport monitoring. Devices accept inputs from sensors for ECG, respiration, NBP, SpO2, IBP, CO2, and temperature. Monitors process these signals to display real-time waveforms and numerical values, perform arrhythmia analysis, and trigger alarms based on user-defined limits. Healthcare professionals operate the devices to observe patient status and make clinical decisions. Modifications include addition of arrhythmia analysis to VM4, LED display backlighting, RoHS-compliant CO2 module, increased trend database (120 hours), and software hooks for future central station connectivity. Output is visualized on the monitor screen and can be printed; device provides continuous physiological surveillance to assist in patient management.

Clinical Evidence

Bench testing only. Verification and validation activities included system-level tests, performance tests, and safety testing based on hazard analysis. Pass/Fail criteria were based on specifications cleared for the predicate devices.

Technological Characteristics

Multi-parameter patient monitor. Components: LED display backlight (mercury-free), RoHS-compliant microMedi OEM CO2 module. Connectivity: Software hooks for future central station integration. Arrhythmia analysis software. Parameters: ECG, Respiration, NBP, SpO2, IBP, CO2, Temperature.

Indications for Use

Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients (adult, pediatric, neonatal). Parameters include ECG, respiration, NBP, SpO2, IBP, CO2, and temperature.

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

• SureSigns VM4, VM6 and VM8 Patient Monitors (K052707, K080495, K090483, K101067)
• Oridion Capnostream 20 (K094012)
• Oridion Capnography Inc. (K103652)

Submission Summary (Full Text)

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## K123900 pg 1 of 3

#### 510K Summary

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(c).

- 1. The submitter of this pre-market notification is:
Mary Kruitwagen Philips Medical Systems 3000 Minuteman Road Andover, MA 01810 United States

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

This summary was prepared on December 17, 2012.

- 2. The names of the subject devices are the Philips SureSigns Series Patient Monitors, SureSigns VM4, VM6, and VM8 Patient Monitors
- 3. The trade names of the devices are the SureSigns VM4, SureSigns VM6, and SureSigns VM8 Patient Monitors.
- 4. The common usual name is multi-parameter patient monitor
- 5. The Classification names are as follows:

| Device Panel | Classification | ProCode | Description | Applicable<br>Subject<br>Devices |
|-----------------------------------------|----------------|---------|--------------------------------------------------------------------------|----------------------------------|
| Circulatory System<br>Devices | 870.1025, II | MHX | Monitor, Physiological, Patient (with<br>arrhythmia detection or alarms) | VM4, VM6,<br>VM8 |
| | 870.1110, II | DSJ | Alarm, Blood Pressure | VM4, VM6,<br>VM8 |
| | 870.1110, II | DSK | Computer, Blood Pressure | VM4, VM6,<br>VM8 |
| | 870.1130, II | DXN | System, Measurement, Blood<br>Pressure, Non-Invasive | VM4, VM6,<br>VM8 |
| | 870.2300, II | DRT | Monitor, Cardiac (incl.<br>Cardiotachometer & Rate Alarm | VM4, VM6,<br>VM8 |
| | 870.2700, II | DQA | Oximeter | VM4, VM6,<br>VM8 |
| | 870.2900, I | DSA | Cable, Transducer and Electrode,<br>incl. Patient connector | VM4, VM6,<br>VM8 |
| General Hospital<br>and Personal Use | 880.2910, II | FLL | Thermometer, Electronic, Clinical | VM4 |
| Anesthesiology &<br>Respiratory Therapy | 868.1400, II | CCK | Analyzer, Gas, | VM8. |

6. The modified devices are substantially equivalent to previously cleared Philips device, SureSigns VM4, VM6 and VM8 Patient Monitors marketed pursuant to K052707, K080495, K090483, and K101067. The predicate 510Ks for this submission are: K103652 and K094012 (May 12 2010) by Oridion Capnography Inc.

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7. The modifications are as follows:

- 1. Add arrhythmia analysis to the VM4, using the same arrhythmia software algorithm as in the VM6 and VM8\
- Add standby mode into CO2 menu to preserve "time to calibration' for situations 2. where the monitor is in use, but not CO2 monitoring.
- 3. The LCD display backlight has changed to an LED backlight. The new backlight does not contain mercury.
- Replace the current Oridion CO2 module with a RoHS compliant Oridion CO2 module. 4. This module, also referred to as the microMedi OEM board, is included in the Oridion Capnostream 20. and is cleared under K094012.
- 5. Enhancement requests include:
- Display the word 'Filter' in the ECG trace pane when the filter bandwidth setting . is enabled. Filter will also be printed on strip recordings
- Add a choice to enable a SpO2 high/low and/or SpO2 Desaturation alarm delay . time. When enabled, the SpO2 alarm delay will result in the SpO2 alarm generation once the delay time has elapsed.
- The temperature label, previously called temp, is now called T1. ●
- Add a chime tone when a manually initiated NBP measurement is completed. .
- The patient demographic information may be edited through an additional access ● point of the title bar.
- Separate Heart Rate (HR) and Pulse (Pulse) into distinct viewing panes with . separate alarm limits. No other changes were made.
- . Increase the trend database to allow for 120 hours of data to be stored
- Add software hooks that will allow for connection to the Philips central station (trade 6. name yet to be determined) once the central stations is developed, cleared and released. The following information is sent to the central:
- Patient ID information ●
- Patient type (adult, pediatric, neonatal)
- Monitor name
- Serial number of the connected monitor
- Waveforms
- Measurements
- Alarm limits
- Alarms ●
- ECG lead setting .
- Pace detection setting .
- NBP interval mode setting
- Demo mode notification
- . Working mode notification (whether monitor is in monitor mode, spot check mode and whether CO2 is in standby, if applicable)
- . Audio off/audio paused
- Waveform information including: Arrhythmia off, pacer pulse detection off, cannot analyze ECG, ECG (wave) freeze, IBP zero, Filter on.
- The subject devices have the same intended Use and Indications for Use as the legally 8. marketed predicate device:

"The SureSigns VM4, VM6 and VM8 Patient Monitors are for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in

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# K123900 pg 3 of 3

healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility",

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

Standard and optional parameters include:

- · ECG
· Respiration

• NBP

• SpOz

• IBP

· CO2

- · Temperature
- ல் The subject devices have the same fundamental technological characteristics as the legally marketed predicate devices. The subject devices use the same design as the predicate devices.

i

- 10. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the subject devices with respect to the predicates. 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, the specifications of the subject device and test results showed substantial equivalence. The results demonstrate that the Philips SureSigns VM4, VM6 and VM8 Patient Monitors meet all reliability requirements and performance claims and supports a determination of substantial equivalence.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

April 18, 2013

Philips Medical Systems North America, Co. c/o: Mary Kruitwagen Regulatory Engineer 3000 Minuteman Road . Andover, MA 01810

Re: K123900

Trade Name: SureSigns VM4, SureSignsVM6, and SureSigns VM8 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, DSJ, DSK, DXN, DRT, DOA, DSA, FLL, CCK Dated: March 12, 2013 Received: March 19, 2013

Dear Ms. 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.

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### Page 2 - Ms. Mary Kruitwagen

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 (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/CDRH/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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Owen P. Faris -S

for

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

Enclosure

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K123900

## Indications for Use

510 (k) Number (if known):

Device Name: SureSigns VM4 (reference number: 863063) SureSigns VM6 (reference numbers: 863064, 863065) SureSigns VM8 (reference numbers: 863066, 863068)

#### Indications for Use:

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

Standard and optional parameters include:

- · ECG
- · Respiration
- NBP
- SpO2
- IBP
- · CO2
- · Temperature

Prescription Use: YES AND/OR over-the-counter Use: _________________________________________________________________________________________________________________________________________________ NO (Part 21 CFFR 801 Subpart D) (21 CFR 807 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

Owen P. Faris -S
2013.04.18
15:59:41 -04'00'

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