SureSigns VS2*: 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, and Temperature. Intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare environments. Additionally, the monitors may be used in transport situations within a healthcare facility.

SureSigns VSi: 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, and Temperature. The SureSigns VSi vital signs monitor is intended 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 Description

The SureSigns VS2* Vital Signs Monitor and the SureSigns VSi Vital Signs Monitor are multi-parameter patient monitors. Standard and optional parameters include: NBP, SpO2, and Temperature. Modifications include the addition of an internal radio module, addition of several new accessories (SpO2 sensor and tabletop mount), and EMC Emissions Class changed to Class A.

AI/ML Overview

This 510(k) summary (K112652) describes modifications to existing Philips SureSigns Vital Signs Monitors (VS2+ and VSi), specifically the addition of an internal radio module and new accessories. The core functionality and algorithms of the devices remain unchanged from their predicate versions (K111114 for VS2+ and K110803 for VSi).

Given the nature of this submission, which focuses on hardware and EMC (Electromagnetic Compatibility) changes rather than a new algorithm or diagnostic capability, a typical "device performance" and "acceptance criteria" table as one might find for an AI/ML-based diagnostic device is not directly applicable or explicitly detailed in the provided documents. Instead, the "acceptance criteria" here refers to demonstrating that the modified devices continue to meet the safety and effectiveness standards of their predicates and relevant regulatory specifications.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As a direct table of specific numerical acceptance criteria for a diagnostic algorithm and corresponding performance metrics is not present for this type of device modification, a general interpretation of the implied acceptance criteria and reported performance is provided below. The "performance" here refers to maintaining the established safety and effectiveness of the existing predicate devices.

Acceptance Criteria Category	Description	Reported Device Performance
Substantial Equivalence	The modified devices (SureSigns VS2+ and VSi with software B.01 and internal radio module) must be substantially equivalent to their legally marketed predicate devices (SureSigns VS2+ and VSi with software B.00).	The submission asserts and FDA agrees that the devices are substantially equivalent to the predicate devices. The modifications did not alter the fundamental technological characteristics.
Intended Use	The intended use and indications for use of the modified devices must remain the same as the predicate devices.	The subject devices have the same intended use and indications for use as the legally marketed predicate devices.
Fundamental Technology	The subject devices must use the same design and algorithms as the predicate devices.	The subject devices use the same design and algorithms as the predicate devices.
Performance Testing	System-level tests, performance tests, and safety testing must confirm the performance, functionality, and reliability characteristics relative to predicates and hazard analysis.	Testing involved system level tests, performance tests, and safety testing from hazard analysis.
Pass/Fail Criteria	Pass/Fail criteria for testing were based on specifications cleared for predicate devices, and specifications of subject devices.	Test results showed substantial equivalence. The results demonstrate that the monitors meet all reliability requirements and performance claims.
EMC Emissions	The device's Electromagnetic Compatibility Emissions Class may change but must meet relevant standards (Class A in this case).	EMC Emissions Class changed to Class A (implies successful testing to meet Class A standards, though specific results are not detailed).

2. Sample Size Used for the Test Set and the Data Provenance

The document does not detail specific sample sizes for a "test set" in the context of diagnostic accuracy, as this submission is for a device modification rather than a new diagnostic algorithm. The "testing" mentioned refers to engineering verification and validation activities (system level, performance, safety testing) to ensure the modified hardware and software continue to function as intended and meet established specifications.

Test Set Sample Size: Not specified in terms of patient data or clinical accuracy. Testing would involve engineering samples of the modified devices.
Data Provenance: Not applicable in the context of clinical data for a diagnostic algorithm. The "data" here would be electrical, mechanical, and software test results.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable to this 510(k) submission. "Ground truth" established by clinical experts (like radiologists) is relevant for diagnostic devices that interpret images or physiological signals to make a diagnosis. This submission concerns a vital signs monitor, where the output (e.g., NBP, SpO2, Temperature) is a direct measurement, and the "ground truth" for its accuracy typically relies on calibrated reference equipment and standardized test methods, not expert consensus on interpretations.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used to resolve disagreements among multiple experts when establishing ground truth for diagnostic or interpretative tasks. This is not relevant for the type of verification and validation testing described for this vital signs monitor modification.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. MRMC studies are designed to assess the impact of a diagnostic aid (often AI) on human reader performance. This submission is for a vital signs monitor, which provides physiological measurements, not an interpretive aid for human readers. No AI component is described that would assist human readers in a diagnostic task.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

While the device itself operates in a standalone mode to measure vital signs, the concept of "standalone performance" in the context of AI/ML algorithms, which typically refers to the algorithm's diagnostic accuracy without human intervention, is not directly applicable here. The device's measurements (NBP, SpO2, Temp) constitute its "performance," and this performance is validated against established accuracy standards for such physiological measurements. The document confirms that the device uses the "same design and algorithms as the predicate devices," implying that the core measurement algorithms' performance has been previously established and remains unchanged.

7. The Type of Ground Truth Used

For vital signs monitors, the "ground truth" for performance testing typically involves:

Reference Standards: Calibrated reference instruments or patient simulators that provide known, accurate physiological values (e.g., a known blood pressure, SpO2 level, or temperature).
Clinical Studies (for initial device clearance): For predicate devices, this would have involved comparing device measurements against invasive reference methods (e.g., arterial line for NBP) or other gold standard clinical measurements.
Technical Specifications: The "ground truth" for the current submission's testing is adherence to the technical specifications and performance claims established for the predicate devices, as well as relevant national and international standards for medical devices (e.g., for biocompatibility, electrical safety, EMC).

8. The Sample Size for the Training Set

Not applicable. This device does not inherently have an "AI" or "machine learning" algorithm that requires a "training set" in the conventional sense of computational learning. Its algorithms are fixed, deterministic computational methods for processing physiological signals.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for an AI/ML algorithm described in this submission.

Summary

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K//2652

OCT 1 1 2011

510K Summarv

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: 978-659-4932 Fax: 978-659-4481 Email: mary.kruitwagen@philips.com
This summary was prepared on September 7, 2011
1. The name of the subject devices are the Philips SureSigns VS2* Vital Signs Monitor and the Philips SureSigns VSi Vital Signs Monitor.
  The trade names of the devices are the SureSigns VS2* Vital Signs Monitor and SureSigns VSi Vital Signs Monitor.

The common usual name for both devices is multi-parameter patient monitor

Device Panel Classification ProCode Description Cardiovascular 870.1110. Il DSJ Alarm, Blood Pressure 870.1110. Il DSK Computer, Blood Pressure 870.1130. Il System, Measurement, Blood Pressure, DXN Non-Invasive 870.1435. Il DXG Computer, Diagnostic, Pre-programmed. Single function 870.2700, II DQA Oximeter 870.2900, I DSA Cable, Transducer and Electrode, incl. Patient connector General Hospital and 880.2910, II FLL Thermometer, Electronic, Clinical Personal Use
1. The Classification names are as follows for the SureSigns VS2+:

The Classification names are as follows for the SureSigns VSi:

Device Panel	Classification	ProCode	Description
Cardiovascular	870.1110, II	DSK	Computer, Blood Pressure
	870.1130, II	DXN	System, Measurement, Blood Pressure, Non-Invasive
	870.2700, II	DQA	Oximeter
General Hospital andPersonal Use	880.2910, II	FLL	Thermometer, Electronic, Clinical

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Page 67 of 70

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1. The modified devices are substantially equivalent to previously cleared Philips devices, SureSigns VS2* Vital Signs Monitor marketed pursuant to 510(k) K111114 cleared for software revision B.00 and for the VSi Vital Signs Monitor pursuant to 510(k) K110803 cleared for revision B.00. With this modification the software revision will be revision B.01. This is the first version of software that will be marketing on the SureSigns VS2* and the SureSigns VSi vital signs monitors. The radio module is substantially equivalent to the wireless bridge used with the predicate SureSigns VS3 marketed pursuant to 510(k) K082280.
1. This submission is to announce the following modifications to the predicate VS2* and VSi :
- . Addition of an internal radio module
- . Addition of several new accessories- SpO2 sensor and tabletop mount
- . EMC Emissions Class changed to Class A
1. The SureSigns VS2* subject device has the same intended use and indications for use as the legally marketed predicate SureSigns VS2* device. The SureSigns VS2* Vital Signs monitor is 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, and Temperature. Intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare environments. Additionally, the monitors may be used in transport situations within a healthcare facility.

The SureSigns VSi subject device has the same intended use and indications for use as the legally marketed predicate SureSigns VSi device. 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. Standard and optional parameters include: NBP, SpO2, and Temperature. The SureSigns VSi vital signs monitor is intended 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.

7 . The subject devices have the same fundamental technological characteristics as the legally marketed predicate devices. The subject devices use the same design and algorithms as the predicate devices.
1. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the subject devices with respect to the predicates. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate devices, the specifications of the subject devices and test results showed substantial equivalence. The results demonstrate that the Philips SureSigns VS2* Vital Signs and the Philips SureSigns VSi Vital Signs monitors meet all reliability requirements and performance claims and supports a determination of substantial equivalence.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

CT 11 11 2011

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

Re: K112652

Trade/Device Name: Philips SureSigns Vs2+ Vital Signs Monitor, and Philips SureSigns VS1 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, DSJ, DSK, DXG, DSA, FLL Dated: September 9, 2011 Received: September 12, 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 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

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Page 2 - Ms. Marv Kruitwagen

CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/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.

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): k//2652

Device Name: SureSigns VS2* (reference numbers: 863278, 863279)

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 .
Sp02 .
Temperature ●

Prescription Use:	YES
(Part 21, CFFR 801 Subpart D)
AND/OR over-the-counter Use:	NO
(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)

Page

Division of Cardiovascular Devices

510(k) Number K112652

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Indications for Use

510 (k) Number (if known):

K//2652

Device Name: SureSigns VSi (reference numbers: 863275, 863276, 863267)

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 0
Temperature

YES Prescription Use: _ AND/OR over-the-counter 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)

Page 2 of 2

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).