SURESIGNS VS3, SURESIGNS VS4

• K Number: K133961
• Device Name: SURESIGNS VS3, SURESIGNS VS4
• Manufacturer: PHILIPS MEDICAL SYSTEMS
• Date Cleared: 2014-06-26 ( 184 days)
• Product Code: DSJ DQA DSA DSK DXN 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. 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.

Device Description

The subject devices are multi-parameter patient monitors, specifically the SureSigns VS3 and SureSigns VS4. Modifications to the VS4 include the addition of CO2, SpHb, Respiratory Rate RRa, and Masimo SpO2 measurements. Both VS3 and VS4 have the QuickNBP mode added.

Predicate Devices

K120132, K123900, K100428, K011291, K094012

Reference Devices

K120132,K123900,K100428,K011291,K094012

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related concepts, and the device description focuses on standard physiological parameter monitoring.

Therapeutic

No
The document describes the SureSigns VS3 and VS4 as monitors for physiological parameters, focusing on monitoring, recording, and alarming. This is a diagnostic function, not a therapeutic function which would involve treatment or healing.

Diagnostic

No
The text describes the device as a vital signs monitor used for "monitoring, recording and alarming of multiple physiological parameters". This indicates a device used for observing and tracking patient health status, not for determining the nature of a patient's condition or disease.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the subject devices are "multi-parameter patient monitors," which are hardware devices. The modifications mentioned also relate to adding hardware measurement capabilities (CO2, SpHb, etc.).

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use/Indications for Use: The description clearly states the device is for "monitoring the physiological parameters of patients." This involves measuring vital signs directly from the patient's body (e.g., blood pressure, heart rate, temperature, SpO2, CO2, SpHb).
• Device Description: The device is described as a "multi-parameter patient monitor." This type of device is used for real-time monitoring of a patient's physiological state.
• Lack of mention of in vitro testing: There is no mention of the device being used to test samples taken from the body (like blood, urine, tissue, etc.) in a laboratory setting. IVD devices are specifically designed for analyzing these types of samples to diagnose or monitor conditions.

The SureSigns VS3 and VS4 are patient monitoring devices, which are a different category of medical device than IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.
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.

Product codes

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

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) Add CO2 measurement to VS4. This is achieved by using the Oridion MicroMedi OEM module.
b) Add SpHb measurement to VS4. This measurement and the following new added Respiratory (c) and Masimo SpO2 (d) are achieved using the OEM Masimo Rainbow SET module (MX board).
c) Add Respiratory Rate RRa measurement to VS4.
d) Add Masimo SpO2 measurement with Pulse rate to VS4.
e) Add Temporal Temperature measurement to VS4. This is achieved by using the OEM Exergen TemporalScanner Thermometer.
Add QuickNBP mode to both VS3 and VS4. QuickNBP measurement mode f) utilizes a single oscillometric pulse for the determination of the pressure level at a particular pressure step. This compares to the regular NBP measurement mode that utilizes multiple oscillometric pulses to determine the pressure level at a particular pressure step.

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

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 and performance claims and support a determination of substantial equivalence.

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

Not Found

Predicate Device(s)

K120132, K123900, K100428, K011291, K094012

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

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K133961 JUN 2 6 2014

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

• 2. Date this summary is prepared: This summary is prepared on December 19, 2013.
• 3. The names of the subject devices are as following: SureSigns VS3 SureSigns VS4
• 4. 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 5. 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 |

• 6. The Classification names are as follows:
     |
• 7. The modified devices are substantially equivalent to previously cleared devices from Philips and suppliers:
     SureSigns VS3 Vital Signs Monitor cleared under K120132 SureSigns VS4 Vital Signs Monitor cleared under K120132 SureSigns VM8 Patient Monitor cleared under K123900

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Masimo Rainbow SET Radical 7R CO-Oximeter cleared under K100428 Exergen TemporalScanner Thermometer cleared under K011291 Oridion Capnography Inc for Capnostream 20 with microMediCO2 module cleared under K094012

• 8. The modifications are as follows:
  • a) Add CO2 measurement to VS4. This is achieved by using the Oridion MicroMedi OEM module. This same module is used in Philips SureSigns VM8 patient monitor for the same measurement. The SureSigns VM8 was FDA cleared under K123900. Oridion microMediCO2 OEM module includes IP1 feature for its CO2 measurement. VM8 doesn't include the IPI feature. The predicate device for VS4 IPI feature is the Oridion microMediCO2 OEM module with. The Oridion microMedi CO2 OEM module was cleared under K094012.
  • b) Add SpHb measurement to VS4. This measurement and the following new added Respiratory (c) and Masimo SpO2 (d) are achieved using the OEM Masimo Rainbow SET module (MX board). The same module is used in the Masimo Rainbow SET Radical 7R CO-Oximeter for the same measurements. And the Masimo Rainbow SET Radical 7R CO-Oximeter is FDA cleared under K100428.
  • c) Add Respiratory Rate RRa measurement to VS4. Details refer to above item (b). In addition. FDA 510(k) K120984 cleared the RRa sensor, RAS-125c. for use on pediatric patients with body weight>10Kg. So RRa will be supported on both adult and pediatric patients.
  • d) Add Masimo SpO2 measurement with Pulse rate to VS4. Details refer to above item (b).
  • e) Add Temporal Temperature measurement to VS4. 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 VS4 monitor.
  • Add QuickNBP mode to both VS3 and VS4. QuickNBP measurement mode f) utilizes a single oscillometric pulse for the determination of the pressure level at a particular pressure step. This compares to the regular NBP measurement mode that utilizes multiple oscillometric pulses to determine the pressure level at a particular pressure step. QuickNBP is based on the same algorithm that provides the regular NBP measurements in SureSigns VS3, VS4 monitors. Same as measure method in STAT mode. The NBP specifications of VS3 and VS4 are not changed due to the addition of the QuickNBP mode.
• 9. 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:

The SureSigns VS3 vital signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of

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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 indications for Use of subiect VS4 has following parameters added to the legally marketed SureSigns VS4: CO2, RRa and SpHb

Indications for Use:

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
	Adult	Pediatric	Neonatal
NBP	✓	✓	✓
SpO2	✓	✓	✓
Temperature	✓	✓	✓
CO2	✓	✓	✓
RRa	✓	✓
SpHb	✓	✓

• 10. The subiect 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.
• 11. 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 and performance claims and support a determination of substantial equivalence.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Philips Medical Systems Greg Li 3000 Minuteman Rd Andover, MA 01810 US

Re: K133961

Trade/Device Name: SureSigns VS3, SureSigns VS4 Regulation Number: 21 CFR 870.1100 Regulation Name: Multi-Parameter Patient Monitor Regulatory Class: Class II Product Code: DSJ, DSK, DXN, DQA, DSA, FLL, CCK Dated: May 28, 2014 Received: May 29, 2014

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 of warranties. We remind you, however, that device labeling must be truthful and not misleading.

June 26, 2014

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

Image /page/3/Picture/10 description: The image shows a logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES.USA" around the perimeter. Inside the circle is a stylized symbol that resembles a bird or abstract human figure, composed of three curved lines.

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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 (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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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/MedicalDeyices/Safety/Reportallyoblem/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 vours

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): K133961

Device Name:

SureSigns VS3 (reference numbers: 863071, 863072, 863073, 863074) SureSigns VS4 (reference number: 863283)

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
	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	V	V	V
SpO2	V	V	V
Temperature	V	V	V
CO2	V	V	V
RRa	V	V	V
SpHb	V	V

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Philips SureSigns VS3 and VS4 Traditional 510K

010_Indications for Use Statement

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K133961

AND/OR over-the-counter Use: YES NO Prescription Use: (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)

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Philips SureSigns VS3 and VS4 Traditional 510K

010_Indications for Use Statement