K021422 · Philips Medical Systems · MHX · May 15, 2002 · Cardiovascular
Device Facts
Record ID
K021422
Device Name
PHILIPS INFORMATION CENTER SOFTWARE REVISION D.02
Applicant
Philips Medical Systems
Product Code
MHX · Cardiovascular
Decision Date
May 15, 2002
Decision
SESE
Submission Type
Special
Regulation
21 CFR 870.1025
Device Class
Class 2
Attributes
Software as a Medical Device, Pediatric
Indications for Use
For central monitoring of adult, pediatric, and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms. They are used to display physiologic waves, parameters and, trends, to format data for compliant strip chart recorders, to format data for printed reports, and the secondary annunciation of alarms for up to 16 patients from other networked medical devices at a centralized location. To provide retrospective review of alarms, physiologic waves and parameters. And to provide primary annunciation of alarms, and configuration and control access for networked telemetry monitors at a centralized location.
Device Story
Centralized monitoring system for adult, pediatric, and neonatal patients; receives physiologic waves, parameters, and alarm data from networked telemetry monitors; displays data at centralized station; provides retrospective review of alarms and physiologic data; enables primary alarm annunciation and configuration/control of networked monitors; supports up to 16 patients; adds tabular trend review and ICA-compatible application serving; used by clinicians in clinical settings to facilitate patient management and treatment decisions.
Clinical Evidence
Bench testing only. Verification and validation activities included system-level tests, integration tests, and safety testing based on hazard analysis. Pass/Fail criteria were based on predicate device specifications; results demonstrated substantial equivalence and met all reliability and performance requirements.
Technological Characteristics
Software-based system; networked architecture; supports physiologic wave/parameter display, alarm annunciation, and trend review; connectivity via TCP/IP and UDP protocols; provides configuration/control access for telemetry monitors.
Indications for Use
Indicated for central monitoring of adult, pediatric, and neonatal patients; monitoring cardiac arrhythmia in all age groups; and ST segment monitoring in adult patients to inform treatment decisions, monitor treatment adequacy, or exclude symptom causes.
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.
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# MAY 1 5 2002
## 9.0 510(k) 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 C.F.R. §807.92.
1. The submitter of this premarket notification is: Dave Osborn Quality Program Manager Cardiac and Monitoring Systems Philips Medical Systems 3000 Minuteman Road Andover, MA 01810-1085
> 978 659 3178 Tel: 978 685 5624 Fax: Email: d.g.osborn@ieee.org
This summary was prepared on May 1, 2002.
The name of this device is the PIC Software Release D.02.
- PIC Software, Release D.02 .
- Application Server Software, Release A.0 .
- UDP Server Software, Release A.0 .
- TCP/IP PC Client Software, Release A.0 ●
- UDP PC Client Software, Release A.0. .
2. Classification names are as follows:
| Device Panel | Classification | ProCode | Description |
|----------------------------|----------------|---------|--------------------------------------------------------------------|
| Panel 74<br>Cardiovascular | None | 74 MHX | Physiological<br>Monitor, Patient<br>Monitor |
| | 870.1025, III | 74 DSI | Arrhythmia Detector<br>and Alarm |
| | 870.1025, III | 74 MLD | Monitor, ST Alarm |
| | 870.2800, II | 74 DSH | Recorder, Magnetic<br>Tape, Medical |
| | 870.2300, II | 74 MSX | System, Network and<br>Communication,<br>Physiological<br>Monitors |
- 3. The new device is substantially equivalent to the previously cleared HP CentralVue Software device marketed pursuant to K964832, K993171, K993907, K001057, and K011093.
- 4. The modification is a software-based change that adds tabular trends to the trend review capability and permits ICA compatible applications to be served to both PIC Software and other clients.
- 5. The new device has the same intended use as the legally marketed They are used to display physiologic waves, predicate devices. parameters and, trends, to format data for compliant strip chart recorders, to format data for printed reports, and the secondary annunciation of alarms for up to 16 patients from other networked medical devices at a centralized location. To provide retrospective review of alarms, physiologic waves and parameters. And to provide
103
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primary annunciation of alarms, and configuration and control access for networked telemetry monitors at a centralized location.
021422
104
- 6. The new device has the same technological characteristics as the legally marketed predicate devices.
- 7. Verification, validation, and testing activities established the performance, functionality, and reliability characteristics of the new device with respect to the predicates. Testing involved system level tests, integration tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence. The results demonstrate that the software functionality meets all reliability requirements and performance claims.
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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 5 2002
Ms. Dave Osborn Quality Program Manager Philips Medical Systems Cardiac and Monitoring Systems 3000 Minuteman Road Andover, MA 01810-1099
Re: K021422
Trade Name: Philips M3290A Information Center Software, Revision D.02 Philips M2387A Application Server Software for M2385A, Release A.0 Philips M2389A UDP Server Software, Release A.0 Philips M2390A TCP/IP PC Client, Release A.0 Philips M2391A UDP PC Client, Release A.0 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: MHX Dated: May 2, 2002 Received: May 3, 2002
Dear Mr. Osborn:
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.
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# Page 2 - Ms. Dave Osborn
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
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K021422
Page
of
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Philips M3290A Information Center Software, Release D.02 Philips M2387A Application Server Software for M2385A, Release A.0 Philips M2389A UDP Server Software, Release A.0 Philips M2390A TCP/IP PC Client, Release A.0 Philips M2391A UDP PC Client, Release A.0
Indications for Use: For central monitoring of adult, pediatric, and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR | Over-The-Counter Use |
|----------------------|----|----------------------|
| (Per 21 CFR 801.109) | | |
(Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number K021422
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.
