SURESIGNS VS2 VITAL SIGNS MONITOR

K111114 · Philips Medical Systems · DXN · May 20, 2011 · Cardiovascular

Device Facts

• Record ID: K111114
• Device Name: SURESIGNS VS2 VITAL SIGNS MONITOR
• Applicant: Philips Medical Systems
• Product Code: DXN · Cardiovascular
• Decision Date: May 20, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SureSigns VS2* Vital Signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Standard and optional parameters include: NBP, SpO2, and Temperature. Intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare environments. Additionally, the monitors may be used in transport situations within a healthcare facility.

Device Story

SureSigns VS2+ Vital Signs Monitor is a multi-parameter patient monitor used by healthcare professionals in clinical and transport settings. It acquires physiological data via sensors for non-invasive blood pressure (NBP), SpO2, and temperature. The device processes these inputs to provide real-time monitoring, recording, and alarming of patient vital signs. It operates on an internal power supply with improved battery life compared to the predicate. Clinicians use the visual output to assess patient status and make clinical decisions. The device benefits patients by providing continuous, reliable physiological monitoring across various hospital environments.

Clinical Evidence

Bench testing only. Performance, functionality, and reliability were established through system-level tests, performance tests, and hazard analysis based on predicate specifications.

Technological Characteristics

Multi-parameter monitor for NBP, SpO2, and temperature. Internal power supply with battery operation. Form factor designed for clinical and transport use. Software-controlled monitoring and alarming.

Indications for Use

Indicated for use by health care professionals for monitoring, recording, and alarming physiological parameters (NBP, SpO2, Temperature) in adult, pediatric, and neonatal patients within healthcare environments, including transport.

Regulatory Classification

Identification

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

Predicate Devices

• SureSigns VS2 Patient Monitor (K082280)
• SureSigns VS2 Patient Monitor (K090483)

Submission Summary (Full Text)

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KIIII14 P1/2

MAY 2 0 2011

## 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:
Kristen Lessard Philips Medical Systems 3000 Minuteman Road Andover, MA 01810 United States

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

This summary was prepared on April 13, 2011

- 2. The name of the subject device is the Philips SureSigns VS2 Vital Signs Monitor.
- The trade name of the device is the SureSigns VS2* Vital Signs Monitor. 3.
- 4. The common usual name is multi-parameter patient monitor
- 5. The Classification names are as follows:

| Device Panel | Classification | ProCode | Description |
|--------------------------------------|----------------|---------|-------------------------------------------------------------|
| Cardiovascular | 870.1110, II | DSJ | Alarm, Blood Pressure |
| | 870.1110, II | DSK | Computer, Blood Pressure |
| | 870.1130, II | DXN | System, Measurement, Blood Pressure,<br>Non-Invasive |
| | 870.1435, II | DXG | Computer, Diagnostic, Pre-programmed,<br>Single function |
| | 870.2700, II | DQA | Oximeter |
| | 870.2900, I | DSA | Cable, Transducer and Electrode, incl.<br>Patient connector |
| General Hospital and<br>Personal Use | 880.2910, II | FLL | Thermometer, Electronic, Clinical |

- 6. The modified device is substantially equivalent to previously cleared Philips device. SureSigns VS2 Patient Monitor marketed pursuant to 510(k) K082280 cleared for software revision A.00 and under 510(k) K090483.
- This submission is to introduce a new model, the Philips SureSigns VS2* Vital Signs Monitor 7. that compliments the existing VS2/VS3 Vital Signs monitors.
- ర్. The subject device has the same intended use and indications for use as the legally marketed predicate device. The SureSigns VS2* Vital Signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Standard and optional parameters include: NBP, SpO2, and Temperature. Intended for monitoring, recording, and alarming of multiple physiological parameters of adults,

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pediatrics and neonates in healthcare environments. Additionally, the monitors may be used in transport situations within a healthcare facility.

- The subject device has the same fundamental technological characteristics as the legally 9. marketed predicate device. The subject device use the same design as the predict device. The energy source of the subject device is an internal power supply. The VS2* can run on battery power with batteries similar to the predicate device, however, with improved battery life.
- 10. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the subject device with respect to the predicate. 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 VS2* Vital Signs monitor meets all reliability requirements and performance claims and supports a determination of substantial equivalence,

KUMI4

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.

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

Philips Medical Systems. c/o Ms. Kristen Lessard Quality & Regulatory Engineer Philips Medical Systems 3000 Minuteman Road Andover, MA 01810

MAY 2 0 2011

Re: K11114

> Trade/Device Name: SureSigns VS2+ Vital Signs Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Codes: DXN, DQA, DSJ, DSK, DXG, DSA, FLL Dated: April 15, 2011 Received: April 21, 2011

Dear Ms. Lessard:

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

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Page 2 - Ms. Kristen Lessard

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/CDRI-I/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D.
Director

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): __ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Device Name: SureSigns VS2* (reference numbers: 863278, 863279)

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:

- . NBP
- SpO2 .
- Temperature .

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off)<br>Division of Cardiovascular Devices | Page 1 of 1 |
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