SURESIGNS VSI VITAL SIGNS MONITOR

K110803 · Philips Medical Systems · DXN · May 20, 2011 · Cardiovascular

Device Facts

• Record ID: K110803
• Device Name: SURESIGNS VSI VITAL SIGNS MONITOR
• Applicant: Philips Medical Systems
• Product Code: DXN · Cardiovascular
• Decision Date: May 20, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SureSigns VSi Vital Signs monitor is indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VSi vital signs monitor is for measurement 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

Multi-parameter patient monitor for spot-check measurements of NBP, SpO2, and temperature. Used by healthcare professionals in clinical settings and facility transport. Device transforms sensor inputs into physiological parameter values using algorithms identical to the predicate VS2. Output displayed on monitor for clinical decision-making. Unlike the predicate, the VSi lacks physiological alarms, continuous monitoring, wireless communication, and navigation wheels; utilizes internal power supply and key-based navigation. Benefits include portable, non-continuous assessment of patient vitals.

Clinical Evidence

Bench testing only. Performance, functionality, and reliability established through system-level tests, performance tests, and safety testing based on hazard analysis. Results demonstrated substantial equivalence to the predicate device.

Technological Characteristics

Multi-parameter monitor for NBP, SpO2, and temperature. Features internal power supply, key-based navigation, and non-continuous monitoring. Lacks wireless communication and physiological alarms. Uses same measurement algorithms as predicate VS2.

Indications for Use

Indicated for use by healthcare professionals to monitor 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 (K082280, K090483)

Submission Summary (Full Text)

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K110803 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:

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 March 10, 2011.

- 2. a) The name of the subject device is Philips SureSigns VSi Vital Signs Monitor.
- b) The trade name of the device is SureSigns VSi Vital Signs Monitor.
- c) The common usual name is multi-parameter patient monitor

| Device Panel | Classification | ProCode | Description | VSi | M1196S |
|-----------------------------------------|----------------|---------|------------------------------------------------------|-----|--------|
| Cardiovascular | 870.1110, II | DSK | Computer, Blood Pressure | yes | no |
| | 870.1130, II | DXN | System, Measurement,<br>Blood Pressure, Non-Invasive | yes | no |
| | 870.2700, II | DQA | Oximeter | yes | yes |
| General<br>Hospital and<br>Personal Use | 880.2910, II | FLL | Thermometer, Electronic, Clinical | yes | no |

- 4) The Classification names are as follows:
- The modified devices are substantially equivalent to previously cleared Philips device, 3. SureSigns VS2 cleared under K082280 and K090483, in a.
- ধ The modifications are as follows:
- Introduction of the VSi Vital Signs monitor (the predicate device is VS2) .
- The subject devices have a different intended use than the legally marketed predicate device ട്. SureSigns VS2. The indications for use is unchanged although the available measurements are listed. The SureSigns VSi Vital Signs monitor is indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VSi vital signs monitor is for measurement 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
- 6. The subject devices have the same fundamental technological characteristics as the legally marketed predicate device. The subject devices use the same algorithms for the measurements as the predicate device. The VSi is different from the predicate device in that is has no physiological alarms, performs no continuous monitoring, has an internal power

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supply, and uses keys for navigation (no navigation wheel). The VSi stores less records than the predicate and does not have wireless communication.

Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the subject device. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the subject device and test results showed substantial equivalence. The results demonstrate that the Philips SureSigns VSi Vital Signs monitor meets all reliability requirements and performance claims and supports a determination of substantial equivalence.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement around the bird figure.

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

Philips Medical Systems. c/o Ms. Mary Kruitwagen Regulatory Affairs Specialist Philips Medical Systems 3000 Minuteman Road Andover, MA 01810

MAY 20 2011

Re: K110803

> Trade/Device Name: SureSigns VSi 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, FLL Dated: March 22, 2011 Received: March 23, 2011

Dear Ms. 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.

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. Mary Kruitwagen

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

fa 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):

Device Name: SureSigns VSi (reference numbers: 863275, 863276, 853277)

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

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

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| 510(k) Number | K110803 |