K120727 · Edan Instruments, Inc. · MHX · Jun 21, 2013 · Cardiovascular
Device Facts
Record ID
K120727
Device Name
MFM-CMS CENTRAL MONITORING SYSTEM
Applicant
Edan Instruments, Inc.
Product Code
MHX · Cardiovascular
Decision Date
Jun 21, 2013
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 870.1025
Device Class
Class 2
Attributes
Software as a Medical Device, Pediatric
Indications for Use
MFM-CMS is a software application that is intended for use as a clinical data managing system (also referred to as a clinical information system - CIS).The MFM-CMS Central Monitoring System offers centralized physiological information management of adult, pediatric and neonatal patients which is automatically acquired from multiple bedside monitors. The MFM-CMS provides: collection, display and documentation of data from bedside monitors, viewing of patient physiologic data at remote locations and alarms when the results of the physiologic parameters exceed the user defined limit. It operates with off-the-shelf software. The system is intended for use in a hospital/clinical environment.
Device Story
MFM-CMS is a software-based central monitoring system running on standard PCs (Windows XP/7). It connects to up to 64 EDAN bedside monitors via Ethernet to aggregate physiological data, including ECG, RESP, PLETH, IBP, CO2, AG, and other vital parameters. The system provides real-time waveform/parameter display, trend data storage (240-hour), alarm management, and drug titration tables. It supports bidirectional control, allowing clinicians to remotely adjust bedside monitor alarm limits and initiate NIBP measurements. Used in hospital/clinical settings by healthcare professionals, the system facilitates centralized patient surveillance, enabling timely clinical intervention through remote observation and alarm notification. It supports HL7 integration and web-based observation within the hospital network.
Clinical Evidence
Bench testing only. No clinical data provided. Verification and validation included software testing, risk analysis, safety testing, and performance testing to ensure the system meets requirements for data collection, display, and alarm management.
Technological Characteristics
Software-based system running on PC platform (Windows XP/7). Connectivity via Ethernet. Supports up to 64 bedside monitors. Features include real-time waveform display, trend data storage, and bidirectional control of bedside monitors. Complies with HL7 standards.
Indications for Use
Indicated for centralized physiological information management of adult, pediatric, and neonatal patients in hospital/clinical environments. Used for data collection, display, documentation, and alarm management from bedside monitors.
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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## 510(K)Summary of Safety and Effectiveness
This summary of 510k safety and effectiveness is being submitted in according with 21CFR part 807.92
| Submitter: | Edan Instruments, Inc<br>3/F - B, Nanshan Medical<br>Equipments Park, Nanhai Rd 1019#,<br>shekou, Nanshan Shenzhen,<br>518067 P.R. China<br>Tel: +86755 26882220<br>Fax:+86 755 26882223 |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Cherry Sun |
| Preparing date: | 2012-08-10 |
| Proprietary Name: | Central Monitoring System (model MFM-CMS) |
| Classification<br>information: | 870.1025 monitor, physiological, patient(with arrhythmia<br>detection or alarms)<br>Class II |
| Product code: | MHX |
| Predicate Devices: | HYPERVISOR VI Central Monitoring System (K062194) |
| Device Description: | The MFM-CMS Central Monitoring System is a software<br>production which runs on PC platform with Microsoft<br>Windows XP or Microsoft Windows 7 operating system.<br>Through specified EDAN protocol, one MFM-CMS can<br>connect with multi-monitor manufactured by EDAN to<br>collect patients' information and monitoring data such as<br>physiological waveforms, physiological parameters and<br>alarms. The MFM-CMS can also send bidirectional control<br>instructions to bedside monitors to change patients'<br>information, alarm limits, and conduct NIBP measurements.<br>The bedside Patient Physiological Monitors have been<br>cleared by FDA under K101539, K120144, K110922,<br>K113623, K113653 and K120173 separately. The monitoring<br>information collect by the MFM-CMS can be saved and |
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printed. At the same time, the old records can be searched conveniently and quickly.
### Device features:
- Connect maximum 64 bedside patient monitors with . � Ethernet.
- � Waveforms of each bedside monitor that can be displayed on the MFM-CMS include:
2 ECG waveform
- l RESP waveform
- 1 PLETH waveform
8 IBP waveform
1 CO2 waveform
- 4 AG waveforms for CO2, O2, N2O and AA
- Parameters of each bedside monitor that can be displayed on the MFM-CMS include:
ECG: HR, ST value, PVCs RESP: RR NIBP: SYS, DIA, MAP SPO2: SPO2, PR IBP: ART, PA, CVP, RAP, ICP, LAP, P1, P2 (only IBP supported by the monitor will be displayed) CO2: EtCO2, FiCO2, AwRR TEMP: T1, T2, TD AG: EtCO2, FiCO2, AwRR; EtO2, FiO2; EtN2O, FiN2O; HAL/ISO/ENF/SEV/DES: Et, Fi, MAC C.O.: C.O., TB
- · The central monitoring supports one or two displays. It can display up to 32 bedside monitors on one display and 64 bedside monitors on two displays simultaneously,
- . 240-hour trend data, 72-hour waveform, 720 alarm events, 1~12 hour short trend, 720-group NIBP measurement review for each bedside monitor.
- Drug calculation and titration table. .
- Print patient information, wave review, alarm review, . trend review, NIBP review, and drug calculation result.
- Audible & visible alarm.
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- . Web observation in the hospital local area network.
- Bidirectional control ●
- HL7
MFM-CMS provides centralized monitoring and critical care Intended Use: management for patients monitored by EDAN bedside monitors. From MFM-CMS, clinicians can gain access to patient information for patients on the Network. MFM-CMS displays waveforms, parameters and alarm status of EDAN bedside monitors for up to 32 patients on a single screen or up to 64 patients using two screens.
#### The following quality assurance measures were applied to Test Summary: the development of the MFM-CMS.
- Software testing
- Risk analysis
- Safety testing ●
- Performance test .
Conclusion: Verification and validation testing was done on MFM-CMS. This premarket notification submission demonstrates that the subject device MFM-CMS is substantially equivalent to the predicate device.
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#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 a stylized image of a caduceus, a symbol often associated with medicine and healthcare, featuring a staff with a serpent entwined around it.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 21, 2013
Edan Instruments, Inc. c/o Mr. Randy Jiang, Certification Engineer 3/F - B, Nanshan Medical Equipments Park Nanhai Rd. 1019# Shenzhen, Guangdong 518067 CHINA
Re: K120727
Trade/Device Names: MFM-CMS Central Monitoring System Regulatory Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-segment Measurement and Alarm) Regulatory Class: Class II (Two) Product Code: MHX Dated: June 3, 2013 Received: June 6, 2013
Dear Mr. Jiang:
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.
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#### Page 2 - Mr. Randy Jiang
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); 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
# Owen P. Faris -S
for Bram D. Zuckerman
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:
Device Name: Central Monitoring System (model MFM-CMS)
MFM-CMS is a software application that is intended for use as a clinical data managing system (also referred to as a clinical information system - CIS).The MFM-CMS Central Monitoring System offers centralized physiological information management of adult, pediatric and neonatal patients which is automatically acquired from multiple bedside monitors. The MFM-CMS provides: collection, display and documentation of data from bedside monitors, viewing of patient physiologic data at remote locations and alarms when the results of the physiologic parameters exceed the user defined limit. It operates with off-the-shelf software. The system is intended for use in a hospital/clinical environment.
× Prescription Use (21 CFR Part 801 Subpart D)
Over the Counter Use (21 CFR Part 801 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Or
Ow
201
15:0
Owen P. Faris -S 2013.06.21 15:01:01 -04'00'
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.
