Philips SureSigns VS3 Vital Signs Monitor and the SureSigns VS4 Vital Signs Monitor. Common usual name for both the VS3 and the VS4 are multi-parameter patient monitor.

AI/ML Overview

This Philips 510(k) summary does not contain the detailed acceptance criteria or a comprehensive study report with specific performance metrics as requested. The available information primarily focuses on establishing substantial equivalence to a predicate device, rather than providing robust statistical evidence of performance against defined acceptance criteria.

However, based on the provided text, here’s an attempt to extract and infer the closest available information:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria	Reported Device Performance
Overall	(Not explicitly stated in the provided text)	"meet all reliability requirements and performance claims and supports a determination of substantial equivalence."

Explanation:
The document states, "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."

This indicates that some acceptance criteria existed, based on the cleared specifications of the predicate device (SureSigns VS3, K082280 and K090483). However, the specific numerical or qualitative acceptance criteria (e.g., accuracy ranges for NBP, SpO2, Temperature) are not detailed in this summary. The reported performance is a general statement of compliance, without specific metrics.

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

This information is not provided in the given text. There are no details regarding the number of test subjects, the type of data (e.g., country of origin, retrospective/prospective), or the specific test protocols followed.

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

This information is not provided in the given text. The testing appears to be device-centric (system level, performance, safety) rather than relying on expert consensus for clinical ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the given text. Adjudication methods like 2+1 or 3+1 are typically used when expert consensus is required for ground truth, which isn't described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or implied in the provided text. The document focuses on the device's technical performance and safety, not on human reader improvement with or without AI assistance. This device is a vital signs monitor, which typically provides direct measurements rather than interpreting complex medical images or data that would necessitate an MRMC study.

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

Yes, the testing described appears to be a standalone performance evaluation of the device. The text mentions "system level tests, performance tests, and safety testing from hazard analysis," which are typically conducted to assess the device's internal algorithms and hardware functionality independently. The statement "The subject devices use the same algorithms for the measurements as the predicate devices" further supports that the algorithms themselves were evaluated for performance.

7. The Type of Ground Truth Used

The type of "ground truth" implicitly used for this device would be calibrated reference standards and established physiological measurement techniques. For vital signs monitors, this typically involves:

For NBP: Comparison against invasive arterial blood pressure measurements or highly accurate non-invasive methods in a controlled setting.
For SpO2: Comparison against co-oximetry readings of arterial blood samples.
For Temperature: Comparison against highly accurate reference thermometers.

The document states that "Pass/Fail criteria were based on the specifications cleared for the subject device," which implies these specifications included accuracy ranges against such reference standards. However, the specific methods are not detailed.

8. The Sample Size for the Training Set

This information is not provided in the given text. The document indicates that the devices use "the same algorithms for the measurements as the predicate devices," suggesting that any algorithm training would have occurred during the development of the predicate device, or that the algorithms are based on established physiological principles rather than machine learning requiring a training set in the contemporary sense.

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

This information is not provided in the given text, and the concept of a "training set" in a machine learning context is not directly applicable given the device type and the description provided. If algorithms were "trained" in a broader sense (e.g., fine-tuning parameters), their "ground truth" would likely have been established through controlled studies using calibrated reference measurements, similar to the ground truth for validation, but this is speculative given the lack of detail.

Summary of Limitations in the Provided Text:

The provided 510(k) summary is very high-level and lacks the specific details required to fully address your questions. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study with explicit acceptance criteria, sample sizes, expert involvement, or specific ground truth methodologies. For these details, one would typically need to refer to the full testing documentation submitted to the FDA, which is not included in this summary.

Summary

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FEB 1 4 2012

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: 978-659-4481 Email: mary kruitwagen@philips.com

This summary was prepared on January 16, 2012.

1. a) The name of the subject device is Philips SureSigns VS3 Vital Signs Monitor and the SureSigns VS4 Vital Signs Monitor.
  b) The trade name of the device is SureSigns VS3 Vital Signs Monitor and the SureSigns VS4 Vital Signs Monitor.

c) The common usual name for both the VS3 and the VS4 are multi-parameter patient monitor

Device Panel	Classification	ProCode	Description
Cardiovascular	870.1110, II	DSJ	Alarm, Blood Pressure
	870.1110, II	DSK	Computer, Blood Pressure
	870.1435, II	DXG	Computer, Diagnostic, Preprogrammed,Single-function
	870.2700, II	DQA	Oximeter
	870.2850, I	DSA	Cable, transducer and electrode, patientconnector
	870.2810, I	DSF	Recorder, Paper Chart
General Hospital and Personal Use	880.2910, II	FLI	Thermometer, Electronic, Clinical

The Classification names are as follows:

૩. The modified devices are substantially equivalent to previously cleared Philips device, SureSigns VS3 cleared under K082280 and K090483.
1. The modifications are as follows:
- Introduction of the VS4 Vital Signs monitor (the predicate device is VS3) �
- Modify VS3 ●
ഗ് The subject devices have the same intended use as the legally marketed predicate device SureSigns VS3. The Indications for Use is unchanged although the available measurements are listed.

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ි. The subject 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.
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 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 & Human Services. The logo consists of a stylized eagle-like bird with its wings spread, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird.

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

FEB 1 4 2012

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

Re: K120132

Trade/Device Name: SureSigns VS3/VS4 Vital Signs Monitors 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, DSF, FLL Dated: January 16, 2012 Received: January 27, 2012

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,

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 VS3 (reference numbers: 863069, 863071, 863072, 863073, 863074) SureSigns VS4 (reference numbers: 863283)

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
SpOz .
Temperature �

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

(Division Sign-Off)

Division of Cardiovascular Devices

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510(k) Number_________________________________________________________________________________________________________________________________________________________________

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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).