K Number

Device Name

SureSigns VS3, SureSigns VS4

Manufacturer

PHILLIPS MEDICAL SYSTEMS

Date Cleared

2015-09-29

(92 days)

Product Code

DSJ CCK DSK FLL

Regulation Number

870.1100

Intended Use

The SureSigns VS3 vital signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSignsVS3 is for monitoring, 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 | | NBP | √ | √ | √ | | SpO2 | √ | √ | √ | | Temperature | √ | √ | √ | The SureSigns VS4 vital signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS4 is for monitoring, 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 | | NBP | √ | √ | √ | | SpO2 | √ | √ | √ | | Temperature | √ | √ | √ | | CO2 | √ | √ | √ | | RRa | √ | √ | | | SpHb | √ | √ | |

Device Description

The subject devices are SureSigns VS3 and SureSigns VS4 multi-parameter patient monitors. Modifications include adding connectivity to IntelliVue GuardianSoftware (IGS), adding Temporal Temperature measurement to VS3, and other enhancements such as additional title bar indicators, expanded patient records pane, display patient name or primary ID, expanded QuickCapture entries, default CO2 setting alignment (VS4 only), temperature high and low alarms color change, increased SpO2 alarm delay defaults, option to prevent inadvertently clearing NBP programs, and RFID patient ID entry.

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

K133961, K133961

Reference Devices

K111905, K122223, K011291

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard vital signs monitoring and connectivity enhancements, with no mention of AI or ML technologies.

Therapeutic

No
The device is described as a "vital signs monitor" for "monitoring, recording and alarming of multiple physiological parameters," indicating observation and alarming functions rather than therapeutic intervention.

Diagnostic

The device is described as a "vital signs monitor" for "monitoring, recording and alarming of multiple physiological parameters." It measures parameters like NBP, SpO2, Temperature, CO2, RRa, and SpHb. While these measurements are crucial for patient care, the description does not state that the device is used to diagnose a disease or condition, but rather to track physiological parameters.

SaMD (Software as a Medical Device)

The device description explicitly states the devices are "multi-parameter patient monitors," which are hardware devices. The modifications mentioned are enhancements to existing hardware monitors, not a standalone software application.

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 clearly states the device is for "monitoring, recording and alarming of multiple physiological parameters in healthcare environments." This involves measuring vital signs directly from the patient's body (NBP, SpO2, Temperature, CO2, RRa, SpHb).
IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Description: The device description reinforces that it's a "multi-parameter patient monitor," which is consistent with a device that measures physiological parameters directly from the patient.
Lack of IVD Indicators: There is no mention of analyzing samples, reagents, or any other components typically associated with in vitro diagnostic testing.

Therefore, the SureSigns VS3 and VS4 vital signs monitors are patient monitoring devices, not in vitro diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Indications for Use for SureSigns VS3 Vital Signs Monitor

	Patient Types
Parameter	Adult	Pediatric	Neonatal
NBP	√	√	√
SpO2	√	√	√
Temperature	√	√	√

Indications for Use for SureSigns VS4 Vital Signs Monitor

The SureSigns VS4 vital signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS4 is for monitoring, 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
NBP	√	√	√
SpO2	√	√	√
Temperature	√	√	√
CO2	√	√	√
RRa	√	√
SpHb	√	√

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

DSJ, DSK, FLL, CCK, DQA, DSA, DXN

Device Description

The names of the subject devices are as following: SureSigns VS3, SureSigns VS4. The trade names of the devices are SureSigns VS3 and SureSigns VS4. The common usual name for both the VS3 and the VS4 is multi-parameter patient monitor.

The modifications are as follows:
a) The subject VS3 and VS4 will add connectivity to IntelliVue GuardianSoftware (IGS). This IGS connectivity includes new QuickCheck work flows, QuickAlert prompts, and configurable Modified Early Warning Scores (MEWS).
IGS is a documentation, charting, and decision support software that can be configured to collect vital signs data from the VS3. VS4 monitors. The monitors validate the patient ID from IGS, send records to IGS, and receive early warning scores, single-parameter scores, and alert messages from IGS. The IGS connectivity to VS3 and VS4 is a change of software only.
The IntelliVue GuardianSoftware (IGS) is a software medical device owned by Philips Medizine Systeme Boeblingen GmbH, in Germany. The IGS was FDA cleared through 510(k) K111905 for Rev. A and 510(k) K122223 for Rev. B. The IGS has been revised to Rev. C which will allow IGS and VS3, VS4 to be connected. Philips Medizine Systeme Boeblingen GmbH will submit its own 510(k) for the Rev. C of IGS. The VS3 and VS4 software is verified by Philips Medical Systems following out QMS process. The modified software for VS3 and VS4 is version A.06 and it complies with IEC 62304: 2006- Medical Device Software life-cycle processes.

b) Add Temporal Temperature measurement to VS3. This is achieved by using the OEM Exergen TemporalScanner Thermometer. This Exergen TemporalScanner Thermometer is FDA cleared under K011291. The OEM thermometer has a RS232 cable added to connect the thermometer to the VS3 monitor. This same Temporal Temperature measurement was implemented on VS4 which was 510(k) cleared in June 2014 through K133961. Both VS3 and VS4 use the same solution for this measurement. and both complies with ISO 80601-2-56: 2009 + CORR. 2 (2007). Medical electrical equipment - Part 2-56: Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement.

c) Other enhancements to VS3 and VS4 are described as following:

. Additional Title Bar Indicators
. Expanded Patients Records Pane
Display Patient Name or Primary ID
Expanded QuickCapture Entries ●
. Default CO2 Setting Alignment (VS4 only)
Temperature High and Low Alarms Color Change .
Increased SpO2 Alarm Delay Defaults
. Option to Prevent Inadvertently Clearing NBP Programs
RFID patient ID entry.

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

Adult, Pediatric, Neonatal. Some parameters (RRa, SpHb) are not for Neonatal use.

Intended User / Care Setting

health care professionals / healthcare environments / transport situations within a healthcare facility

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 safety and reliability requirements, performance claims and support 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.

SureSigns VS3 Vital Signs Monitor cleared under K133961, SureSigns VS4 Vital Signs Monitor cleared under K133961

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.

K111905, K122223, K011291

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

§ 870.1100 Blood pressure alarm.

(a)
Identification. A blood pressure alarm is a device that accepts the signal from a blood pressure transducer amplifier, processes the signal, and emits an alarm when the blood pressure falls outside a pre-set upper or lower limit.(b)
Classification. Class II (performance standards).

Summary

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Public Health Service

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

September 29, 2015

Phillips Medical Systems Greg Li Regulatory Affairs Specialist 3000 Minuteman Rd. Andover, Massachusetts 01810

Re: K151761

Trade/Device Name: SureSigns VS3, SureSigns VS4 Regulation Number: 21 CFR 870.1100 Regulation Name: Blood Pressure Alarm Regulatory Class: Class II Product Code: DSJ, DSK, FLL, CCK, DQA, DSA, DXN Dated: August 21, 2015 Received: August 28, 2015

Dear Greg Li:

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 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 (OS) 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Mitchell Stein

for 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: 863071, 863072, 863073, 863074) SureSigns VS4 (reference number: 863283)

Indications for Use for SureSigns VS3 Vital Signs Monitor

	Patient Types
Parameter	Adult	Pediatric	Neonatal
NBP	√	√	√
SpO2	√	√	√
Temperature	√	√	√

Indications for Use for SureSigns VS4 Vital Signs Monitor

	Patient Types
Parameter	Adult	Pediatric	Neonatal
NBP	√	√	√
SpO2	√	√	√
Temperature	√	√	√
CO2	√	√	√
RRa	√	√
SpHb	√	√

Prescription Use: YES 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)

Page ____ of _________________________________________________________________________________________________________________________________________________________________

Page 1 of 1

Philips SureSigns VS3 and VS4 Special 510K

010 Indications for Use Statement

011_510(k) Summary

The following section contains the 510(k) Summary as defined by the Medical Devices Act of 1990 and 21 CFR 807-92(c).

510(k) 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 and contact person of this pre-market notification is:
  Greg Li Philips Medical Systems 3000 Minuteman Road Andover, MA 01810 United States

Tel: 978-659-4227 Fax: 978-659-7323 Email: Greg.li@philips.com

1. Date this summary is prepared: This summary is prepared on 10 June, 2015.
The names of the subject devices are as following: 3. SureSigns VS3 SureSigns VS4
1. The trade names of the devices are SureSigns VS3 and SureSigns VS4.
1. The common usual name for both the VS3 and the VS4 is multi-parameter patient monitor
1. The Classification names are as follows:

Device Panel	Classification	ProCode	Description	Applicable subject devices
Cardiovascular	870.1100, II	DSJ	Alarm, Blood Pressure	VS3, VS4
	870.1110, II	DSK	Computer, Blood Pressure	VS3, VS4
	870.1130, II	DXN	System, Measurement, Blood Pressure, Non-Invasive	VS3, VS4
	870.2700, II	DQA	Oximeter	VS3, VS4
	870.2900, II	DSA	Cable, transducer and electrode, patient connector	VS3, VS4
General Hospital and Personal Use	880.2910, II	FLL	Thermometer, Electronic, Clinical	VS3, VS4
Anesthesiology & Respiratory Therapy	868.1400, II	CCK	Analyzer, Gas	VS4

1. The modified devices are substantially equivalent to previously cleared devices from Philips:
  SureSigns VS3 Vital Signs Monitor cleared under K133961 SureSigns VS4 Vital Signs Monitor cleared under K133961
1. The modifications are as follows:
- a) The subject VS3 and VS4 will add connectivity to IntelliVue GuardianSoftware (IGS). This IGS connectivity includes new QuickCheck work flows, QuickAlert prompts, and configurable Modified Early Warning Scores (MEWS).

IGS is a documentation, charting, and decision support software that can be configured to collect vital signs data from the VS3. VS4 monitors. The monitors validate the patient ID from IGS, send records to IGS, and receive early warning scores, single-parameter scores, and alert messages from IGS. The IGS connectivity to VS3 and VS4 is a change of software only.

The IntelliVue GuardianSoftware (IGS) is a software medical device owned by Philips Medizine Systeme Boeblingen GmbH, in Germany. The IGS was FDA cleared through 510(k) K111905 for Rev. A and 510(k) K122223 for Rev. B. The IGS has been revised to Rev. C which will allow IGS and VS3, VS4 to be connected. Philips Medizine Systeme Boeblingen GmbH will submit its own 510(k) for the Rev. C of IGS.

The VS3 and VS4 software is verified by Philips Medical Systems following out QMS process. The modified software for VS3 and VS4 is version A.06 and it complies with IEC 62304: 2006- Medical Device Software life-cycle processes.

b) Add Temporal Temperature measurement to VS3. This is achieved by using the OEM Exergen TemporalScanner Thermometer. This Exergen TemporalScanner Thermometer is FDA cleared under K011291. The OEM thermometer has a RS232 cable added to connect the thermometer to the VS3 monitor. This same Temporal Temperature measurement was implemented on VS4 which was 510(k) cleared in June 2014 through K133961. Both VS3 and VS4 use the same solution for this measurement. and both complies with ISO 80601-2-56: 2009 + CORR. 2 (2007). Medical electrical equipment - Part 2-56: Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement.
c) Other enhancements to VS3 and VS4 are described as following:
- . Additional Title Bar Indicators
- . Expanded Patients Records Pane
- Display Patient Name or Primary ID

Expanded QuickCapture Entries ●
. Default CO2 Setting Alignment (VS4 only)
Temperature High and Low Alarms Color Change .
Increased SpO2 Alarm Delay Defaults
. Option to Prevent Inadvertently Clearing NBP Programs
RFID patient ID entry.
1. The subject device VS3 has the same Intended Use and Indications for Use as the legally marketed predicate device, currently marketed VS3:

Indications for Use for SureSigns VS3 Vital Signs Monitor

	Patient Types
Parameter	Adult	Pediatric	Neonatal
NBP
SpO2
Temperature

The subject device VS4 has the same Intended Use and Indications for Use as the legally marketed predicate device, currently marketed VS4:

Indications for Use for SureSigns VS4 Vital Signs Monitor

	Patient Types
Parameter	Adult	Pediatric	Neonatal
NBP	√	√	√
SpO2	√	√	√
Temperature	√	√	√
CO2	√	√	√
RRa	√	√
SpHb	√	√

1. The subject devices VS3 and VS4 have the same fundamental technological characteristics as the leqally marketed predicate devices VS3 and VS4. There are no specification change to VS4. The added Temporal Temperature measurement to VS3 will have the same specification with that from the predicate VS4. The subject devices use the same algorithms for the measurements as the predicate devices.
1. 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 safety and reliability requirements, performance claims and support a determination of substantial equivalence.