SURESIGNS VSI VITAL SIGNS MONITOR by PHILIPS MEDICAL SYSTEMS

The SureSigns VSi Vital Signs monitor is 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. The VSi is different from the predicate device in that is has no physiological alarms, performs no continuous monitoring, has an internal power supply, and uses keys for navigation (no navigation wheel). The VSi stores less records than the predicate and does not have wireless communication.

AI/ML Overview

The provided text is a 510(k) summary for the Philips SureSigns VSi Vital Signs Monitor. It primarily focuses on demonstrating substantial equivalence to a predicate device (SureSigns VS2) and does not detail specific acceptance criteria or a dedicated study report with performance metrics.

However, based on the information provided, we can infer some aspects and highlight what is not present:

Key Takeaways from the document:

Device Type: Multi-parameter patient monitor for Non-Invasive Blood Pressure (NBP), SpO2 (Oximeter), and Temperature.
Purpose of Submission: To demonstrate substantial equivalence to the SureSigns VS2.
Testing Philosophy: "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 VSi Vital Signs monitor meets all reliability requirements and performance claims and supports a determination of substantial equivalence."

Given the above, I cannot provide a table of acceptance criteria and reported device performance with specific numerical values because this document does not contain them. This 510(k) summary asserts that internal tests were conducted against pre-defined specifications to demonstrate substantial equivalence, but it does not provide the details of those specifications or the quantitative results. This is common for 510(k) summaries, which are often high-level overviews.

Therefore, the following answers will reflect the information available and absent in the provided text.

1. A table of acceptance criteria and the reported device performance

Parameter	Acceptance Criteria (Implicit/General)	Reported Device Performance (Implicit/General)
NBP	To meet specifications aligned with the predicate device (SureSigns VS2).	Test results showed substantial equivalence to the predicate device. The same algorithms are used as the predicate device.
SpO2	To meet specifications aligned with the predicate device (SureSigns VS2).	Test results showed substantial equivalence to the predicate device. The same algorithms are used as the predicate device.
Temperature	To meet specifications aligned with the predicate device (SureSigns VS2).	Test results showed substantial equivalence to the predicate device. The same algorithms are used as the predicate device.
Overall	Meet all reliability requirements and performance claims for substantial equivalence.	Device meets all reliability requirements and performance claims, supporting a determination of substantial equivalence.

Explanation: The document states that "Pass/Fail criteria were based on the specifications cleared for the subject device and test results showed substantial equivalence." However, the specific numerical acceptance criteria (e.g., NBP accuracy ranges, SpO2 error margins, temperature precision) or detailed performance metrics from these tests are not provided in this 510(k) summary. It only broadly states that the device "meets all reliability requirements and performance claims."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The general statement "Verification, validation, and testing activities" does not specify the sample sizes for any of the tests conducted, nor does it indicate the provenance of any data (e.g., patient data for performance evaluation).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. For a vital signs monitor, "ground truth" might refer to reference measurements from highly accurate, calibrated instruments or clinical gold standards. The document does not describe the methodologies for establishing ground truth during testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. Adjudication methods are typically relevant for subjective assessments or when multiple experts are involved in interpreting results. For a vital signs monitor, testing would likely involve comparing device readings against reference standards, which wouldn't typically involve an adjudication process described in this manner.

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

This is not applicable and not provided in the document. An MRMC study is relevant for diagnostic imaging devices where human readers (e.g., radiologists) interpret images, often with or without AI assistance. The Philips SureSigns VSi Vital Signs Monitor is a device that directly measures physiological parameters and does not involve "human readers" in the context of interpreting complex medical images. It's a direct measurement device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not explicitly detailed in the context of "algorithm only performance." The document states, "The subject devices use the same algorithms for the measurements as the predicate device." It also mentions "system level tests, performance tests, and safety testing." While these tests would inherently evaluate the algorithms, the document doesn't isolate and report on "algorithm-only" performance metrics distinct from the integrated device performance. The device itself is designed for direct measurement, so its "standalone" performance is its operational performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not explicitly stated in the document. For a vital signs monitor, ground truth would typically be established by highly accurate, often invasive or laboratory-grade, reference measurement devices for NBP, SpO2, and temperature against which the SureSigns VSi's readings are compared. The document does not specify these reference methods.

8. The sample size for the training set

This information is not provided in the document. The document mentions that the device uses "the same algorithms for the measurements as the predicate device." This suggests that the algorithms were developed and potentially "trained" (if they involve machine learning, which is not indicated for these standard vital signs algorithms) prior to this specific device's development, likely for the predicate VS2 monitor. Details about the training set for those algorithms are not part of this 510(k) submission.

9. How the ground truth for the training set was established

This information is not provided in the document. Given that the algorithms are shared with the predicate device, the ground truth for their original development would have been established during the development of the predicate. This document does not detail those historical development practices.

Summary

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K110803 P1/2

MAY 2 0 2011

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: 978-685-5624 Email: mary.kruitwagen@philips.com

This summary was prepared on March 10, 2011.

1. a) The name of the subject device is Philips SureSigns VSi Vital Signs Monitor.
- b) The trade name of the device is SureSigns VSi Vital Signs Monitor.
- c) The common usual name is multi-parameter patient monitor

Device Panel	Classification	ProCode	Description	VSi	M1196S
Cardiovascular	870.1110, II	DSK	Computer, Blood Pressure	yes	no
	870.1130, II	DXN	System, Measurement,Blood Pressure, Non-Invasive	yes	no
	870.2700, II	DQA	Oximeter	yes	yes
GeneralHospital andPersonal Use	880.2910, II	FLL	Thermometer, Electronic, Clinical	yes	no

1. The Classification names are as follows:
The modified devices are substantially equivalent to previously cleared Philips device, 3. SureSigns VS2 cleared under K082280 and K090483, in a.
ধ The modifications are as follows:
- Introduction of the VSi Vital Signs monitor (the predicate device is VS2) .
The subject devices have a different intended use than the legally marketed predicate device ട്. SureSigns VS2. The indications for use is unchanged although the available measurements are listed. 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. The SureSigns VSi vital signs monitor is 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
1. The subject devices have the same fundamental technological characteristics as the legally marketed predicate device. The subject devices use the same algorithms for the measurements as the predicate device. The VSi is different from the predicate device in that is has no physiological alarms, performs no continuous monitoring, has an internal power

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supply, and uses keys for navigation (no navigation wheel). The VSi stores less records than the predicate and does not have wireless communication.

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 VSi Vital Signs monitor meets all reliability requirements and performance claims and supports a determination of substantial equivalence.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement around the bird figure.

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

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

MAY 20 2011

Re: K110803

Trade/Device Name: SureSigns VSi 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, FLL Dated: March 22, 2011 Received: March 23, 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

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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,

fa 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

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Indications for Use

510 (k) Number (if known):

Device Name: SureSigns VSi (reference numbers: 863275, 863276, 853277)

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 Temperature

Prescription Use: AND/OR over-the-counter Use: YES NO (Part 21 CFFR 801 Subpart D) (21 CFR 807 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE QN ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number	K110803

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).