K131032 · Philips Medical Systems · MHX · Aug 12, 2013 · Cardiovascular
Device Facts
Record ID
K131032
Device Name
PHILIPS SURESIGNS CENTRAL
Applicant
Philips Medical Systems
Product Code
MHX · Cardiovascular
Decision Date
Aug 12, 2013
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 870.1025
Device Class
Class 2
Attributes
Software as a Medical Device
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.
Device Story
Philips SureSigns Central (model S863291) is a central station software product running on a PC platform; receives physiologic waveforms, parameters, and alarm data from networked patient monitors and vital signs monitors. Functions include central viewing, secondary alarm notification, and retrospective review of patient data; supports multi-page monitoring (overview) and electronic calipers. Used in hospitals, clinics, outpatient surgery, and long-term care facilities by healthcare professionals. Output displayed on PC monitor; provides hardcopy via printer. Facilitates clinical decision-making by aggregating patient data for remote observation and alarm management.
Clinical Evidence
Bench testing only. Verification and validation activities included system-level tests, performance tests, and safety testing based on hazard analysis. Pass/Fail criteria were based on cleared specifications; results demonstrated substantial equivalence to predicate devices.
Technological Characteristics
Software-based central station running on qualified ITE PC hardware. Features include network connectivity for physiologic data acquisition, alarm management, and retrospective review. Connectivity includes external system integration. Operates as a secondary notification system for networked patient monitors. No specific materials or sterilization required as it is a software product.
Indications for Use
Indicated for central monitoring of physiologic waves, parameters, and trends for multiple patients in hospital and out-of-hospital clinical settings; intended for use by healthcare professionals for secondary alarm notification and retrospective data review.
Regulatory Classification
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.
Special Controls
*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.
Philips IntelliVue Information Center station M3290A (K081983)
Philips IntelliVue Information Center iX Software M3290B (K102495)
Hewlett-Packard 78560 Central Station Patient Information System (K852514)
Submission Summary (Full Text)
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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.
- 2. 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
- 4) The Classification names are as follows:
| Device Panel | Classification | ProCode | Description |
|---------------------|----------------|---------|-----------------------------------------------------------------------------|
| Cardiovascular | 870.1025, II | 74 MHX | Monitor, Physiological, Patient<br>(With Arrhythmia Detection Or<br>Alarms) |
| | 870.2300, II | 74 MSX | System, Network and<br>Communication, Physiological<br>Monitors |
| | 870.1100, II | 74 DSJ | Alarm, Blood Pressure |
| | 870.2340, II | 74 DPS | Electrocardiograph |
| | 870.2810, I | 74 DSF | Recorder, Paper Chart |
| General<br>Hospital | Not classified | NSX | Software, transmission and<br>storage, patient data |
- 3. 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.
- 4. 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).
- 5. 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.
- 6. 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)
- 7. 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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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
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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
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'
Page of of ___
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
