(153 days)
No
The summary describes a central monitoring system for displaying, storing, and managing patient data from other medical devices. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on data aggregation and display, not analysis or interpretation using AI/ML.
No
The device is a central monitoring system for displaying, storing, and managing patient clinical data from other medical devices; it does not directly provide therapy.
No
This device is a central monitoring system for displaying, storing, and managing patient clinical data from other medical devices, not for actively diagnosing conditions.
Yes
The device description and performance studies focus solely on software verification and validation, and the device's function is described as managing and displaying data from other medical devices, which is a software-based task. There is no mention of hardware components included with the MFM-CMS itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the MFM-CMS supports the centralized management of clinical data provided by other medical devices. It focuses on viewing, storing, reviewing, printing, and accessing this data. It does not mention analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
- Device Description: The description reinforces that it connects to and manages information from other medical devices. It doesn't describe any components or processes related to sample analysis.
- Lack of IVD-specific information: The document does not mention any aspects typically associated with IVDs, such as reagents, calibrators, controls, sample types, or analytical methods.
IVD devices are specifically designed to perform tests on biological samples to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The MFM-CMS is a data management system for clinical data, not a device that performs diagnostic tests on samples.
N/A
Intended Use / Indications for Use
MFM-CMS central monitoring system (hereinafter referred to as MFM-CMS) supports centralized management of patients' clinical data provided by EDAN medical devices. Clinicians can obtain patient clinical data via MFM-CMS. The indications for use of the MFM-CMS central monitoring system include:
- Viewing patient real-time clinical data and alarms.
- Storing and reviewing patient clinical data and alarms.
- Printing real-time and history patient data.
- Configuring local settings as well as synchronizing settings to a remote device through network.
- Accessing patient clinical data between several departments.
MFM-CMS is intended to be used only in clinical or hospital environment by well-trained healthcare professionals.
MFM-CMS is indicated for use when monitoring adult and/or pediatric and/or neonate patients as indicated by labeling of the medical device providing the data.
Product codes (comma separated list FDA assigned to the subject device)
MHX
Device Description
MFM-CMS is a central monitoring system product, which can connect and manage information from EDAN medical devices. MFM-CMS offers central management for monitoring information from the medical devices. All these collected information can be displayed, printed, alarmed and recorded.
Modifications:
The following are the main changes to the software which is the subject of this
-
- Add distributed function.
-
- Add license authorization.
-
- Support department management, device management and user management.
-
- Support time synchronization function.
-
- Support data automatic dump function.
-
- Replace the software development platform.
-
- Supports simultaneous login of multiple clients.
-
- Support domain account to log in to the CMS client.
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
Adult and/or pediatric and/or neonate patients
Intended User / Care Setting
MFM-CMS is intended to be used only in clinical or hospital environment by well-trained healthcare professionals.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Non-clinical test:
- Biocompatibility Testing: Not applicable.
- Electrical safety and electromagnetic compatibility (EMC): Not applicable.
- Software Verification and Validation Testing: Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- Bench Testing: Edan has conducted functional and system level testing to validate the performance of the results of the bench testing show that the subject device meets relevant consensus standards.
- IEC 60601-1-8:2006 + Am1:2012 Medical electrical equipment - part 1-8: general requirements for basic safety and essential performance - collateral standard: general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- Clinical testing: Not applicable. Clinical testing is not required to establish substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
February 5, 2024
Edan Instruments, Inc. Tracy Yue Regulatory Engineer 15 Jinhui Road, Jinsha Community, Kengzi Sub-district, Pingshan District Shenzhen, 518122 China
Re: K232694
Trade/Device Name: Central Monitoring System (MFM-CMS) Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: Class II Product Code: MHX Dated: January 5, 2024 Received: January 5, 2024
Dear Tracy Yue:
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 (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer W. Shih -S
Jennifer Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
2
Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Central Monitoring System (MFM-CMS)
Indications for Use (Describe)
MFM-CMS central monitoring system (hereinafter referred to as MFM-CMS) supports centralized management of patients' clinical data provided by EDAN medical devices. Clinicians can obtain patient clinical data via MFM-CMS. The indications for use of the MFM-CMS central monitoring system include:
- · Viewing patient real-time clinical data and alarms.
- · Storing and reviewing patient clinical data and alarms.
- · Printing real-time and history patient data.
- · Configuring local settings as well as synchronizing settings to a remote device through network.
- · Accessing patient clinical data between several departments.
MFM-CMS is intended to be used only in clinical or hospital environment by well-trained healthcare professionals.
MFM-CMS is indicated for use when monitoring adult and/or pediatric and/or neonate patients as indicated by labeling of the medical device providing the data.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
| Prepared in accordance with the requirements of 21 CFR Part 807.92 | |
|---|---|
| 1. Submitter: | Edan Instruments, Inc. |
| #15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District, | |
| Shenzhen, 518122 P.R.China. | |
| Tel: +86(0755) 84513592 | |
| Fax: +86(0755) 26882223 | |
| 2. Contact person: | |
| Preparing date: | Tracy Yue |
| Sep. 4, 2023 | |
| 3. Device name and | |
| classification: | Trade name: Central Monitoring System, model: MFM-CMS |
| Classification Name/ Product code: | |
| 21 CFR 870.1025 Monitor, Physiological, Patient(With Arrhythmia Detection | |
| Or Alarms) | |
| MHX | |
| Regulatory Class: Class II | |
| 4. Predicate Device(s): | 1) Shenzhen Mindray Bio-Medical Electronics Co., LTD, BeneVision Central |
| Monitoring System, cleared under K220058 (Primary) |
- Edan Instruments, MFM-CMS Central Monitoring System, cleared under
K120727 (Reference) |
| 5. Reason for
Submission | By submission of the Traditional 510(k), Edan Instruments is requesting
clearance for an updated version of the MFM-CMS Central Monitoring System
(K120727). |
| 6. Device Description: | MFM-CMS is a central monitoring system product, which can connect and
manage information from EDAN medical devices. MFM-CMS offers central
management for monitoring information from the medical devices. All these
collected information can be displayed, printed, alarmed and recorded.
Modifications:
The following are the main changes to the software which is the subject of this |
510(k) Summary
5
-
- Add distributed function.
-
- Add license authorization.
-
- Support department management, device management and user management.
-
- Support time synchronization function.
-
- Support data automatic dump function.
-
- Replace the software development platform.
-
- Supports simultaneous login of multiple clients.
-
- Support domain account to log in to the CMS client.
-
- Indication for Use MFM-CMS central monitoring system (hereinafter referred to as MFM-CMS) supports centralized management of patients' clinical data provided by EDAN medical devices. Clinicians can obtain patient clinical data via MFM-CMS. The indications for use of the MFM-CMS central monitoring system include:
- . Viewing patient real-time clinical data and alarms.
- Storing and reviewing patient clinical data and alarms. .
- . Printing real-time and history patient data.
- Configuring local settings as well as synchronizing settings to a remote . device through network.
- Accessing patient clinical data between several departments. .
MFM-CMS is intended to be used only in clinical or hospital environment by well-trained healthcare professionals.
MFM-CMS is indicated for use when monitoring adult and/or pediatric and/or neonate patients as indicated by labeling of the medical device providing the data.
9. Predicate Device Comparison
The subject device is technologically equivalent to predicate devices. Any differences are explained to demonstrate in this submission that these differences do not raise any new questions of safety and effectiveness. The table below compares the intended use and technological characteristics of the subject and primary predicate device:
| Item |
MFM-CMS Central Monitoring System |
BeneVision Central Monitoring System
(K220058) | Comparison
Result |
|-----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Intended Use | | | |
| Intended use | MFM-CMS central monitoring system
(hereinafter referred to as MFM-CMS)
supports centralized management of patients' | The indications for use of the BeneVision
Central Monitoring System include:
• Real time viewing of patient clinical data and | Different |
| Item |
MFM-CMS Central Monitoring System |
BeneVision Central Monitoring System
(K220058) | Comparison
Result |
| | clinical data provided by EDAN medical
devices. Clinicians can obtain patient clinical
data via MFM-CMS. The indications for use
of the MFM-CMS central monitoring system
include:
■ Viewing patient real-time clinical data
and alarms.
■ Storing and reviewing patient clinical
data and alarms.
■ Printing real-time and history patient
data.
■ Configuring local settings as well as
synchronizing settings to a remote
device through network.
■ Accessing patient clinical data between
several departments. | alarms
■ Storage and historical review of patient
clinical data and alarms
■ Printing of real time and historical patient
data
■ Configuration of local settings as well as
synchronizing settings across the network to a
remote device
■ Transfer of patient clinical data and settings
between several Central Stations
■ Provides a Resting 12 Lead interpretation of
previously stored data
The BeneVision Central Monitoring System is
a networked patient monitoring system
intended for use in a fixed location, installed in
professional healthcare facilities to provide
clinicians remote patient monitoring. The
network connections between the various
devices can be any combination of Ethernet
(Wired), Wireless WIFI (WLAN), and
Wireless WMTS.
The BeneVision Central Monitoring System
supports one or more Mindray compatible
physiological monitors and will display, store,
print, and transfer information received from
the compatible monitors; The BeneVision
Central Monitoring System supports
bi-directional configuration of the compatible
monitors.
The telemetry monitoring systems are designed
to acquire and monitor physiological data for
ambulating patients within a defined coverage
area. The BeneVision Central Monitoring
System supports Telemetry Systems:
TMS-6016, Telepack-608, TMS60, TM80, and
TM70.
■ The TMS-6016 transmitter is intended for
use on Adult and Pediatric patients to monitor | |
| | MFM-CMS is intended to be used only in
clinical or hospital environment by
well-trained healthcare professionals.
MFM-CMS is indicated for use when
monitoring adult and/or pediatric and/or
neonate patients as indicated by labeling of
the medical device providing the data. | | |
| Item |
MFM-CMS Central Monitoring System |
BeneVision Central Monitoring System
(K220058) | Comparison
Result |
| | | ECG and SpO2 physiological data.
■ The Panorama Telepack-608 transmitter is
intended for use on Adult patients to monitor
ECG and SpO2 physiological data.
■ The TMS60 transmitter is intended for use on
Adult and Pediatric patients over three years
old to monitor ECG, SpO2, NIBP and Resp
physiological data. The physiological data can
be reviewed locally on the display of the
transmitter. The Central Station will support
ECG, Heart Rate, SpO2, NIBP, Resp, Pulse
Rate, Arrhythmia analysis, QT monitoring, and
ST Segment Analysis for the TMS60.
■ The TM80/TM70 telemetry monitor is
intended for use on Adult and Pediatric patients
over three years old to monitor ECG, SpO2,
NIBP and Resp physiological data. The
physiological data can be analyzed, alarmed,
stored, reviewed locally on the display of the
monitor, and the Central Station can configure
and display the physiological parameters from
the TM80/TM70.
The BeneVision Central Monitoring System is
intended for use in professional healthcare
facilities under the direct supervision of a
licensed healthcare practitioner. | |
| | Technical | | |
| Operation System | Support Windows 10 Pro 32/64 bit,
Windows 11 Pro 64 bit, Server 2012, Server
2016 | Support Microsoft Windows 8/10, Server
2012/Server 2016/ Server 2019 | Different |
| | Performance | | |
| Bi-directional
Configuration | Support | Support | Same |
| Data Review | Short trends for all parameters; trend graph
and trend table for all parameters; full
disclosure waveforms and ECG compressed
waveforms: physiological alarm events. | Trend data, events review, dynamic short trend,
C.O. measurements, ST segments,
full-disclosure waveforms and compressed
waveforms. NIBP measurements. 12-lead | Different |
| Item |
MFM-CMS Central Monitoring System |
BeneVision Central Monitoring System
(K220058) | Comparison
Result |
| nurse call events, and patient call events;
12-lead analysis results; NIBP measurement
data; C.O. measurement results; score trend
review. | analysis results, 12 analysis waveforms for
each analysis result | | |
| Calculations | MFM-CMS provides functions including
drug calculation and titration table,
hemodynamic calculation, oxygenation
calculation, renal function calculation and
ventilation calculation. | BeneVision provides functions including drug
calculation and titration table, hemodynamic
calculation, oxygenation calculation, renal
function calculation and ventilation calculation. | Same |
| Telemetry | Support | Support | Same |
| Print | Patient information, Real-time monitoring
data, Alarm list or waveform, Waveform
review, Trend table/graph, NIBP review,
12-lead analysis result, C.O. review, Score
trend, ECG, NIBP, Nursing report,
Calculation result | Patient information, Real-time waveform,
Real-time alarm, Alarm Settings, Multi-lead
ECG Report, CSA Report, Waveform review,
Arrhythmia Statistic Result, Trend Review,
C.O. measurement, events, 12-lead Review, ST
review, QT View Report, Drug calculations,
Hemodynamics calculations, Oxygenation
calculations, Ventilation calculations, Renal
calculations, ICG hemodynamic parameter,
CCO hemodynamic parameter, SvO2/ScvO2
oxygenation parameters | Different |
| Network Connect | Support wired and wireless network. | Support wired and wireless network. | Same |
| Patient Monitor Numbers
–Number Supported | 1. Support 64 monitors running as
application
2. Running as Monitoring Station
up to 128 monitors with no
patient display, the display is provided by
Viewer Stations | 1. Support 64 monitors running as application
2. Running as service
Up to 128 monitors with no patient display, the
display is provided by Work Stations | Similar |
6
7
8
10. Performance Data:
Non-clinical test:
Biocompatibility Testing
Not applicable.
9
Electrical safety and electromagnetic compatibility (EMC)
Not applicable.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Bench Testing:
Edan has conducted functional and system level testing to validate the performance of the results of the bench testing show that the subject device meets relevant consensus standards.
- . IEC 60601-1-8:2006 + Am1:2012 Medical electrical equipment - part 1-8: general requirements for basic safety and essential performance - collateral standard: general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
Clinical testing:
Not applicable. Clinical testing is not required to establish substantial equivalence to the predicate device.
11. Conclusion
The bench testing data and software verification and validation demonstrate that MFM-CMS Central Monitoring System is substantially equivalent to the predicate devices.