PHILIPS SURESIGNS CENTRAL by PHILIPS MEDICAL SYSTEMS

The Philips SureSigns Central is intended for central viewing of physiologic waves, parameters and trends from other networked medical devices (patient monitors and vital signs monitors) for multiple patients. It provides secondary operator notification of alarms from other networked medical devices. It provides for the retrospective review of alarm conditions, physiologic waveforms and parameters from multiple patients. The intended use of the printer, when present, is to provide hardcopy text, graphics and waveform data .The Philips SureSigns Central may provide for connection and information exchange to external systems. The Philips SureSigns Central is intended for use in hospitals and out-of-hospital patient care settings (such as clinics, outpatient surgery facilities, long-term care facilities and physician offices) in which care is administered by healthcare professionals.

Device Description

The subject device Philips SureSigns Central, model S863291, is a medical device software product that runs on a PC platform including a proprietary license key (ITE equipment).

AI/ML Overview

The provided text describes the Philips SureSigns Central, a central station for viewing physiological data, but it does not contain the specific study details to directly populate all requested fields. The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed clinical study report with specific acceptance criteria and performance metrics in the way your request outlines.

Here's an attempt to extract and infer information based on the provided text, with clear indications where information is not available from the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly states that "Pass/Fail criteria were based on the specifications cleared for the subject device and test results showed substantial equivalence." However, it does not provide a specific table of quantitative acceptance criteria or detailed performance metrics.

Acceptance Criteria	Reported Device Performance
Not explicitly defined in the document. The general criteria relate to meeting specifications for substantial equivalence.	The document states: "The results demonstrate that the Philips SureSigns Central meets reliability requirements and performance claims and supports a determination of substantial equivalence."

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

Sample size for test set: Not specified. The document mentions "system level tests, performance tests, and safety testing from hazard analysis" but does not detail the number of cases, patients, or data points used in these tests.
Data provenance (country of origin, retrospective/prospective): Not specified.

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

Number of experts: Not applicable/not specified. This type of device (a central station) does not typically involve human expert adjudication for its core functionality in the way, for example, an AI diagnostic algorithm would. Its performance is validated against its specifications for data display, alarm handling, and communication, not against human expert diagnoses.
Qualifications of experts: Not applicable/not specified.

4. Adjudication Method for the Test Set

Adjudication method: Not applicable/not specified. As with point 3, the concept of expert adjudication for ground truth is not typically relevant for this type of device's validation.

5. Multi-Reader-Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No. The document does not mention any MRMC study or comparison of human reader performance with or without AI assistance. This device is an information display and communication system, not an AI diagnostic tool intended to directly improve human reader performance through assistance.
Effect size of human readers improvement with/without AI assistance: Not applicable, as no such study was conducted.

6. Standalone Performance Study

Was a standalone (algorithm only) performance study done? A "standalone" performance study in the context of an algorithm's diagnostic accuracy is not explicitly detailed. However, the document does state that "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." This indicates that the device's functions (e.g., displaying waves, parameters, trends, alarm notification, data review) were tested to ensure they met their specifications independently. The "algorithm" here refers to the software's operational logic rather than a diagnostic AI algorithm.

7. Type of Ground Truth Used

Type of ground truth: The "ground truth" for this device would be its own design specifications and the accuracy of the data input from compatible patient monitors, as well as the correct functioning of its display, alarm, and communication features. It's not based on expert consensus, pathology, or outcomes data in the traditional sense of a diagnostic device. The validation would verify that the device accurately reflects the data it receives and performs its intended functions according to its technical requirements.

8. Sample Size for the Training Set

Sample size for training set: Not applicable/not specified. This device is a software product for data display and management, not an AI/machine learning model that undergoes "training" on a specific dataset. Its development involves software engineering testing rather than AI training.

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

How ground truth was established: Not applicable, as there is no "training set" in the context of an AI model for this device.

Summary

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K131032 P 1/2

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 of this pre-market notification is:
  Mary Kruitwagen Philips Medical Systems 3000 Minuteman Road Andover, MA 01810 United States

AUG 1 2 2013

Tel: 978-659-4932 Fax: 978-659-7323 Email: mary.kruitwagen@philips.com

This summary was prepared on April 10, 2013.

1. a) The name of the subject device is Philips SureSigns Central
- b) The trade name of the device is Philips SureSigns Central.
- c) The common usual name is central station
- 1. The Classification names are as follows:

Device Panel	Classification	ProCode	Description
Cardiovascular	870.1025, II	74 MHX	Monitor, Physiological, Patient(With Arrhythmia Detection OrAlarms)
	870.2300, II	74 MSX	System, Network andCommunication, PhysiologicalMonitors
	870.1100, II	74 DSJ	Alarm, Blood Pressure
	870.2340, II	74 DPS	Electrocardiograph
	870.2810, I	74 DSF	Recorder, Paper Chart
GeneralHospital	Not classified	NSX	Software, transmission andstorage, patient data

1. The subject device Philips SureSigns Central is substantially equivalent to previously cleared Philips devices, SureSigns VSV cleared under K070588 and Philips IntelliVue Information Center station M3290A rel L.0 cleared under K081983,

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K131032 P 2/2

M3290B Philips IntelliVue Information Center iX Software rel A.0 under K102495 and Hewlett-Packard 78560 Central Station Patient Information System under K852514.

1. The purpose of this submission is to receive clearance to market a new model central station called the Philips SureSigns Central, model S863291. This is a medical device software product that runs on a PC platform including a proprietary license key (ITE equipment).
1. The subject device Philips SureSigns Central has a modified intended use as that of the legally marketed predicate devices, the Philips SureSigns VSV, the Philips IntelliVue Information Center (PIIC) M3290A and M3290B and the Hewlett-Packard 78560 Central Station Patient Information System.
1. The subject device Philips SureSigns Central has similar fundamental technological characteristics as the legally marketed predicate devices. The subject device has the same safety and effectiveness as the predicate devices.
- a) Philips IntelliVue Information Center iX (PIIC) M3290B with regards to the operating system, the qualified ITE equipment to run the subject software.
- b) Philips SureSigns VSV with regards to compatible patient monitors, physiological measurements received and processed, alarm handling and icon usage. The user interface is the similar for the same functionality.
- c) Philips IntelliVue Information Center (PIIC) M3290A with regards to the functions of retrospective review data, electronic calipers, admit and discharge, remote NBP start/stop
- d) Hewlett-Packard 78560 Central Station Patient Information System with regards to the multi-page monitoring (called overview on the predicate device)
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 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 Central meets reliability requirements and performance claims and supports a determination of substantial equivalence.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

August 12, 2013

Philips Medical Systems c/o Ms. Mary Kruitwagen Regulatory Engineer 3000 Minuteman Rd Andover, MA 01810 US

Re: K131032

Trade/Device Name: Philips SureSigns Central Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (With Arrhythmia Detection Or Alarms) Regulatory Class: Class II Product Code: MHX Dated: July 8, 2013 Received: July 9, 2013

Dear Ms. Mary 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. 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

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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.goy/MedicalDevices/Safety/ReportaProblem/default.htmfor 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Owen P. Faris -S

for

Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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K131032

Intended Use

510 (k) Number (if known):

Device Name: Philips SureSigns Central (model number: S863291)

Intended 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)

For

T
Digitally signed by
Owen P. Faris -S
Date: 2013.08.12
11:32:29-04'00'

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Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.