K Number

Device Name

SureSigns VS3; SureSigns VS4

Manufacturer

Philips Medical Systems

Date Cleared

2017-03-31

(98 days)

Product Code

DSJ CCK DQA DSA DSK DXN FLL

Regulation Number

870.1100

Intended Use

Indications for Use for SureSigns VS3 Vital Signs Monitor 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. Parameter (patient types): NBP (Adult, Pediatric, Neonatal); SpO2 (Adult, Pediatric, Neonatal); Temperature (Adult, Pediatric, Neonatal) Contraindications: Not for transport outside the healthcare facility 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. Parameter (patient types): NBP (Adult, Pediatric, Neonatal); SpO2 (Adult, Pediatric, Neonatal); Temperature (Adult, Pediatric. Neonatal); CO2 (Adult, Pediatric. Neonatal); RRa (Adult, Pediatric); SpHb (Adult, Pediatric) Contraindications: Not for transport outside the healthcare facility

Device Description

The subject VS3 and VS4 will be modified with the current QuickAlert to include On-device multi-parameter configurable Modified Early Warning Scores (MEWS).

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

K151761

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a vital signs monitor with a modified early warning score (MEWS) feature. MEWS is a rule-based scoring system, not typically considered AI/ML. There is no mention of AI, ML, or related terms in the provided text.

Therapeutic

No
The device is described as a "Vital Signs Monitor" used for "monitoring, recording and alarming of multiple physiological parameters," not for treating conditions.

Diagnostic

Explanation: The device is described as a "vital signs monitor" for "monitoring, recording and alarming of multiple physiological parameters." While it provides data on a patient's physiological state, its primary stated purpose is monitoring and not diagnosing a specific condition or disease. The addition of MEWS (Modified Early Warning Scores) still falls under monitoring and alerting for potential deterioration, rather than a diagnostic function.

SaMD (Software as a Medical Device)

The device description explicitly refers to "Vital Signs Monitor" and mentions monitoring physiological parameters like NBP, SpO2, Temperature, CO2, RRa, and SpHb. These parameters are typically measured by hardware sensors and components integrated into a physical device, not solely through software. The modification described is an addition of a software feature (MEWS) to existing hardware monitors (VS3 and VS4).

IVD (In Vitro Diagnostic)

Based on the provided text, these devices are not IVDs (In Vitro Diagnostics).

Here's why:

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 Function: The SureSigns VS3 and VS4 Vital Signs Monitors are described as devices for monitoring, recording, and alarming of multiple physiological parameters in patients. These parameters (NBP, SpO2, Temperature, CO2, RRa, SpHb) are measured directly from the patient's body, not from a sample taken from the body.
Lack of Sample Analysis: There is no mention of analyzing biological samples in the provided text.

Therefore, these devices fall under the category of patient monitoring devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Indications for Use for SureSigns VS3 Vital Signs Monitor

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.

Parameter (patient types): NBP (Adult, Pediatric, Neonatal); SpO2 (Adult, Pediatric, Neonatal); Temperature (Adult, Pediatric, Neonatal)

Contraindications: Not for transport outside the healthcare facility

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.

Parameter (patient types): NBP (Adult, Pediatric, Neonatal); SpO2 (Adult, Pediatric, Neonatal); Temperature (Adult, Pediatric. Neonatal); CO2 (Adult, Pediatric. Neonatal); RRa (Adult, Pediatric); SpHb (Adult, Pediatric)

Contraindications: Not for transport outside the healthcare facility

Product codes

DSJ, DSK, DXN, DOA, DSA, FLL and CCK (for VS4 only)

Device Description

The modified devices are SureSigns VS3 Vital Signs Monitor and SureSigns VS4 Vital Signs Monitor. The modifications include the current QuickAlert to include On-device multi-parameter configurable Modified Early Warning Scores (MEWS). There is no addition, deletion or change to the current measurements or alarming, no specification change to current SureSigns VS3 or SureSigns VS4 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

Adult, Pediatric, Neonatal

Intended User / Care Setting

healthcare professionals; healthcare environments; 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

Description of the test set, sample size, data source, and annotation protocol: Not Found - "Testing involved system level tests, performance tests and tests according risk assessment. Pass/Fail criteria were based on the specifications cleared for the subject device and test results showed substantial equivalence."

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 tests according risk assessment. Pass/Fail criteria were based on the specifications cleared for the subject device and test results showed substantial equivalence. The modified VS3 and VS4 monitors passed all specified verification tests. The results demonstrate that the Philips SureSigns VS3 Vital Signs monitor and the Philips SureSigns VS4 Vital Signs monitor meet all performance claims and support a determination of substantial equivalence.

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

Not Found

Predicate Device(s)

K151761

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling three stylized human profiles facing to the right, stacked on top of each other.

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

April 19, 2017

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

Re: K163649

Trade/Device Name: SureSigns VS3 Vital Signs Monitor (reference numbers: 863071, 863072, 863073, 863074) SureSigns VS4 Vital Signs Monitor (reference number: 863283)

Regulation Number: 21 CFR 870.1100 Regulation Name: Blood Pressure Alarm Regulatory Class: Class II Product Codes: DSJ, DSK, DXN, DOA, DSA, FLL and CCK (for VS4 only) Dated: December 16, 2016 Received: December 23, 2016

Dear Mr. Greg Li:

This letter corrects our substantially equivalent letter of March 31, 2017.

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 (reporting of medical devicerelated 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 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 vours.

Mude Jellm
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) K163649

Device Name

SureSigns VS3 Vital Signs Monitor (reference numbers: 863071, 863073, 863074) SureSigns VS4 Vital Signs Monitor (reference number: 863283)

Indications for Use (Describe)

Indications for Use for SureSigns VS3 Vital Signs Monitor

Parameter (patient types): NBP (Adult, Pediatric, Neonatal); SpO2 (Adult, Pediatric, Neonatal); Temperature (Adult, Pediatric, Neonatal)

Contraindications: Not for transport outside the healthcare facility

Indications for Use for SureSigns VS4 Vital Signs Monitor

Contraindications: Not for transport outside the healthcare facility

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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 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 16 December, 2016.
The names of the subject devices are as following: 3. SureSigns VS3 Vital Signs Monitor SureSigns VS4 Vital Signs Monitor
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

| 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 Classification names are as follows:

1. The modified devices are substantially equivalent to previously cleared devices from Philips:
  SureSigns VS3 Vital Signs Monitor cleared under K151761 SureSigns VS4 Vital Signs Monitor cleared under K151761
1. The modifications are as following:
  The subiect VS3 and VS4 will be modified with the current QuickAlert to include On-device multi-parameter configurable Modified Early Warning Scores (MEWS).
1. The subject device VS3 has identical 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	√	√	√

Contraindications: Not for transport outside the healthcare facility

The subject device VS4 has identical 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	✓	✓

Contraindications: Not for transport outside the healthcare facility

1. The subject devices VS3 and VS4 have the same fundamental technological characteristics as the legally marketed predicate devices VS3 and VS4. There is no addition, deletion or change to the current measurements or alarming, no specification change to current SureSigns VS3 or SureSigns VS4 monitor.
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 tests according risk assessment. Pass/Fail criteria were based on the specifications cleared for the subject device and test results showed substantial equivalence. The modified VS3 and VS4 monitors passed all specified verification tests. The results demonstrate that the Philips SureSigns VS3 Vital Signs monitor and the Philips SureSigns VS4 Vital Signs monitor meet all performance claims and support a determination of substantial equivalence.