(122 days)
Not Found
No
The document describes a central monitoring system for viewing patient data and alarms, with no mention of AI or ML capabilities in the intended use, device description, or performance studies.
No
The device is intended for central viewing, alarming, and retrospective review of physiological data from other networked medical devices; it does not directly apply therapy to a patient.
No
The device is described as a central viewing and monitoring system that displays data from other networked medical devices and provides alarm notifications. It is not stated to make diagnoses or assist in diagnostic decision-making. Its primary function is information display and management.
Yes
The device description explicitly states it is a "medical device software product that runs on a PC platform including a proprietary license key (ITE equipment)." While it runs on a PC (ITE equipment), the device itself is defined as the software product.
Based on the provided information, the Philips SureSigns Central is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "central viewing of physiologic waves, parameters and trends from other networked medical devices (patient monitors and vital signs monitors) for multiple patients." It focuses on displaying and managing data from other medical devices that are monitoring the patient directly.
- Lack of mention of in vitro testing: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to diagnose diseases or conditions.
- Device Description: The description highlights it as "medical device software product that runs on a PC platform." This aligns with a data management and display system, not an IVD.
- No mention of biological samples or reagents: IVD devices typically involve the use of biological samples and often reagents for testing. These are not mentioned in the description or intended use.
In summary, the Philips SureSigns Central is a patient monitoring information system that aggregates and displays data from other patient monitoring devices. It does not perform any diagnostic tests on biological samples, which is the core function of an IVD device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
74 MHX, 74 MSX, 74 DSJ, 74 DPS, 74 DSF, NSX
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).
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
Not Found
Intended User / Care Setting
healthcare professionals / hospitals and out-of-hospital patient care settings (such as clinics, outpatient surgery facilities, long-term care facilities and physician offices)
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
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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 Central meets reliability requirements and performance claims and supports a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K070588, K081983, K102495, K852514
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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).
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- The submitter of this pre-market notification is:
Mary Kruitwagen Philips Medical Systems 3000 Minuteman Road Andover, MA 01810 United States
- The submitter of this pre-market notification is:
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.
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- 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
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- The Classification names are as follows:
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| Cardiovascular | 870.1025, II | 74 MHX | Monitor, Physiological, Patient |
| (With Arrhythmia Detection Or | |||
| Alarms) | |||
| 870.2300, II | 74 MSX | System, Network and | |
| Communication, Physiological | |||
| Monitors | |||
| 870.1100, II | 74 DSJ | Alarm, Blood Pressure | |
| 870.2340, II | 74 DPS | Electrocardiograph | |
| 870.2810, I | 74 DSF | Recorder, Paper Chart | |
| General | |||
| Hospital | Not classified | NSX | Software, transmission and |
| storage, patient data |
1
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.
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- 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).
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- 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.
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- 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)
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- 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.
2
Image /page/2/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
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
3
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
4
Intended Use
510 (k) Number (if known):
Device Name: Philips SureSigns Central (model number: S863291)
Intended Use
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.
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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