K Number

Device Name

SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VS4 VITAL SIGNS MONITOR

Manufacturer

PHILIPS MEDICAL SYSTEMS

Date Cleared

2012-02-14

(28 days)

Product Code

DXN DQA DSA DSF DSJ DSK DXG FLL

Regulation Number

870.1130

Intended 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 - SpOz . - Temperature

Device Description

Philips SureSigns VS3 Vital Signs Monitor and the SureSigns VS4 Vital Signs Monitor. Common usual name for both the VS3 and the VS4 are multi-parameter patient monitor.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K082280, K090483

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard vital signs monitor and does not mention any AI or ML capabilities.

Therapeutic

No
The device is a vital signs monitor used for monitoring physiological parameters, not for providing therapy or treatment.

Diagnostic

No
The device is a monitor for physiological parameters, which are tools used for monitoring and not for diagnosing a condition.

SaMD (Software as a Medical Device)

The device description explicitly states "Philips SureSigns VS3 Vital Signs Monitor and the SureSigns VS4 Vital Signs Monitor," which are hardware devices. The summary also mentions "system level tests, performance tests, and safety testing from hazard analysis," indicating hardware components are being evaluated.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for "monitoring the physiological parameters of patients." This involves measuring vital signs directly from the patient's body (NBP, SpO2, Temperature).
Device Description: The device is described as a "multi-parameter patient monitor." This type of device is used for direct patient monitoring, not for testing samples outside the body.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples to provide diagnostic information. IVDs are specifically designed for in vitro examination of specimens derived from the human body.

Therefore, the Philips SureSigns VS3 and VS4 Vital Signs Monitors are patient monitoring devices, not IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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
SpOz .
Temperature

Product codes (comma separated list FDA assigned to the subject device)

DXN, DQA, DSJ, DSK, DXG, DSA, DSF, FLL

Device Description

The subject device is named Philips SureSigns VS3 Vital Signs Monitor and the SureSigns VS4 Vital Signs Monitor. The common usual name for both the VS3 and the VS4 are multi-parameter patient monitor.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

health care professionals

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 VS3 Vital Signs monitor and the Philips SureSigns VS4 Vital Signs monitor meet all reliability requirements and performance claims and supports a determination of substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K082280, K090483

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

FEB 1 4 2012

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).

The submitter of this pre-market notification is:

Mary Kruitwagen Philips Medical Systems 3000 Minuteman Road Andover, MA 01810 United States

Tel: 978-659-4932 Fax: 978-659-4481 Email: mary kruitwagen@philips.com

This summary was prepared on January 16, 2012.

1. a) The name of the subject device is Philips SureSigns VS3 Vital Signs Monitor and the SureSigns VS4 Vital Signs Monitor.
  b) The trade name of the device is SureSigns VS3 Vital Signs Monitor and the SureSigns VS4 Vital Signs Monitor.

c) The common usual name for both the VS3 and the VS4 are multi-parameter patient monitor

Device Panel	Classification	ProCode	Description
Cardiovascular	870.1110, II	DSJ	Alarm, Blood Pressure
	870.1110, II	DSK	Computer, Blood Pressure
	870.1435, II	DXG	Computer, Diagnostic, Preprogrammed,
Single-function
	870.2700, II	DQA	Oximeter
	870.2850, I	DSA	Cable, transducer and electrode, patient
connector
	870.2810, I	DSF	Recorder, Paper Chart
General Hospital and Personal Use	880.2910, II	FLI	Thermometer, Electronic, Clinical

The Classification names are as follows:

૩. The modified devices are substantially equivalent to previously cleared Philips device, SureSigns VS3 cleared under K082280 and K090483.
1. The modifications are as follows:
- Introduction of the VS4 Vital Signs monitor (the predicate device is VS3) �
- Modify VS3 ●
ഗ് The subject devices have the same intended use as the legally marketed predicate device SureSigns VS3. The Indications for Use is unchanged although the available measurements are listed.

ි. The subject devices have the same fundamental technological characteristics as the legally marketed predicate devices. The subject devices use the same algorithms for the measurements as the predicate devices.
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 VS3 Vital Signs monitor and the Philips SureSigns VS4 Vital Signs monitor meet all reliability requirements and performance claims and supports a determination of substantial equivalence.

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-like bird with its wings spread, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird.

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

FEB 1 4 2012

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

Re: K120132

Trade/Device Name: SureSigns VS3/VS4 Vital Signs Monitors 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, DSF, FLL Dated: January 16, 2012 Received: January 27, 2012

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

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 (800) 638-2041 or (301) 796-7100 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

Indications for Use

510 (k) Number (if known):

Device Name: SureSigns VS3 (reference numbers: 863069, 863071, 863072, 863073, 863074) SureSigns VS4 (reference numbers: 863283)

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
SpOz .
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)

(Division Sign-Off)

Division of Cardiovascular Devices

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510(k) Number_________________________________________________________________________________________________________________________________________________________________

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