(167 days)
Not Found
No
The summary explicitly states "No data processing is done by the BeneVision Central Monitoring System for data received from compatible monitors." and there are no mentions of AI, ML, or related concepts.
No.
This device is a patient monitoring system designed to display, store, print, and transfer patient clinical data and alarms, and is specifically stated to perform "No data processing... for data received from compatible monitors." It does not provide any therapy or treatment to the patient.
No.
The BeneVision Central Monitoring System is a patient monitoring system that displays, stores, prints, and transfers clinical data and alarms from compatible physiological monitors. It explicitly states, "No data processing is done by the BeneVision Central Monitoring System for data received from compatible monitors," indicating it does not perform diagnostic interpretation or analysis of the patient data.
No
The device description explicitly lists hardware components (CentralStation, ViewStation, WorkStation, CMS Viewer, and various Telemetry Systems) as part of the BeneVision Central Monitoring System.
Based on the provided information, the BeneVision Central Monitoring System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- BeneVision Central Monitoring System Function: The BeneVision Central Monitoring System is described as a networked patient monitoring system that displays, stores, prints, and transfers physiological data (ECG, SpO2, NIBP, Resp) received from compatible physiological monitors and telemetry systems. It does not process or analyze biological specimens.
- Intended Use: The intended use focuses on real-time viewing, storage, review, printing, configuration, and transfer of patient clinical data and alarms. This is consistent with patient monitoring, not in vitro testing.
- Device Description: The components and function described are related to receiving, displaying, and managing physiological data from external sensors attached to the patient.
Therefore, the BeneVision Central Monitoring System falls under the category of a patient monitoring system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- The indications for use of the BeneVision Central Monitoring System include:
- · Real time viewing of patient clinical data and 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 CentralStations
The Bene Vision 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 (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 Bene Vision Central Monitoring System supports bi-directional configuration of the compatible monitors. No data processing is done by the BeneVision Central Monitoring System for data received from 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 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 CentralStation 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 CentralStation 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.
Product codes (comma separated list FDA assigned to the subject device)
MSX, DRQ, MHX, DRT, DXN, DQA, DSB
Device Description
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. No data processing is done by the BeneVision Central Monitoring System for data received from compatible monitors or the TM80/TM70 Telemetry Monitors.
The BeneVision Central Monitoring System consists of the following components:
-
- CentralStation
-
- ViewStation
-
- WorkStation
-
- CMS Viewer
-
- Telemetry Systems (TMS 6016, Telepak-608, TMS60, TM80, TM70)
The TMS 6016, Telepak-608, TMS60 telemetry monitoring systems operate in the 608M WMTS frequency range within a defined coverage area. All of the supported telemetry systems transmit data to the CentralStation for processing, display, and alarm.
The TM80 telemetry monitor uses the Wireless WIFI connection to transmit data to the CentralStation for display, storage, and printing.
The TM70 telemetry monitor operates in the 608M or the 1.4G WMTS frequency range within a defined coverage area, and transmits data to the CentralStation for display, storage, and printing.
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 Pediatric patients (for TMS-6016, Telepack-608, TMS60, TM80, TM70), and Adult and Pediatric patients over three years old (for TMS60, TM80/TM70).
Intended User / Care Setting
professional healthcare facilities under the direct supervision of a licensed healthcare practitioner.
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)
Mindray conducted functional and system level testing on the subject device. The testing provided an evaluation of the performance of the device relevant to each of the differences between the subject device and the predicate device. The functional and system level testing showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate. Mindray conducted wireless functionality testing to ensure the performance of the BeneVision Central Monitoring System meets wireless specifications and is equivalent to the predicate device. Mindray has conducted testing to ensure the subject device meets relevant consensus standards. Bench Testing: IEC 60601-2-27:2011 to validate performance. Wireless performance and coexistence testing per AAMI TIR 69: 2017 and ANSI C63.27: 2017 for TM70 (608 MHz and 1.4 GHz) and TM80 (2412-2472 MHz and 5180-5825 MHz). For TM80, up to 16 wireless medical devices can operate within a single AP. For TM70, up to 14 wireless medical devices per single AP for 608 MHz and 16 wireless medical devices per single AP for 1.4 GHz. Testing for possible sources of interference in co-channel and adjacent band was performed.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font size.
May 21, 2020
Shenzhen Mindray Bio-medical Electronics Co., LTD. Yanhong Bai Manager Regulatory Affairs, Technical Regulation Department Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen, Guangdong 518057 China
Re: K193391
Trade/Device Name: BeneVision Central Monitoring System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II Product Code: MSX, DRQ, MHX, DRT, DXN, DQA, DSB Dated: April 22, 2020 Received: April 23, 2020
Dear Yanhong Bai:
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. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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 Shih Assistant Director (Acting) Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193391
Device Name
BeneVision Central Monitoring System
Indications for Use (Describe)
- The indications for use of the BeneVision Central Monitoring System include:
- · Real time viewing of patient clinical data and 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 CentralStations
The Bene Vision 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 (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 Bene Vision Central Monitoring System supports bi-directional configuration of the compatible monitors. No data processing is done by the BeneVision Central Monitoring System for data received from 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 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 CentralStation 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 CentralStation 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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Mindray BeneVision Central Monitoring System is provided below.
SUBMITTER 1.
| Applicant: | SHENZHEN MINDRAY BIO-MEDICAL
ELECTRONICS CO., LTD.
Mindray Building, Keji 12th Road South
High-tech Industrial Park, Nanshan
Shenzhen 518057
P.R. China
Tel: +86 755 81888998
Fax: +86 755 26582680 |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Contact Person: Yanhong Bai
Title: Manager Regulatory Affairs
Phone: +86 755 81885635
Fax: +86 755 26582680
E-mail: baiyanhong@mindray.com |
| Date Prepared: | April 22, 2020 |
| 2.
DEVICE | |
| Device Trade Name: | BeneVision Central Monitoring System |
| Device Common Name: | System, network and communication, physiological
monitors |
| Classification Name: | 870.2300 – Cardiac Monitor (including cardiotachometer and
rate alarm) |
| Regulatory Class: | Class II |
| Primary Product Code: | MSX – System, network and
communication, physiological monitors |
5
| Regulation
Number/Class | Product
Code | Regulation description | Device Common Name |
|----------------------------|-----------------|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| 870.2300, II | DRT | Cardiac Monitor (including
cardiotachometer and rate
alarm) | Monitor, cardiac (incl.
cardiotachometer & rate alarm) |
| 870.1130, II | DXN | Noninvasive blood pressure
measurement system | System, measurement, blood-
pressure, non-invasive |
| 870.2700, II | DQA | Oximeter | Oximeter |
| 880.2770, II | DSB | Impedance plethysmograph. | Plethysmograph, impedance |
| 870.1025, II | MHX | Arrhythmia detector and alarm
(including ST-segment
measurement and alarm). | Monitor, physiological,
patient(with arrhythmia detection
or alarms) |
| 870.2060, II | DRQ | Transducer signal amplifier and
conditioner. | Amplifier and signal conditioner,
transducer signal |
Table 1: Secondary Product Codes
PREDICATE DEVICE 3.
- Primary predicate device
The cleared BeneVision Central Monitoring System (K183238) is provided as the primary predicate device for both Indications for Use and technology.
Primary Product Code: MSX
Subsequent Product Codes: DOA, DRO, DRT, DSB, DXN, MHX
- . Secondary predicate device
The cleared Philips MX40 Release B.07 (cleared in K172226) is provided as a second predicate device that uses the WMTS-1.4G wireless network function. This wireless network function has been added to the subject TM70 of the BeneVision Central Monitoring System.
Primary Product Code: MHX
Subsequent Product Codes: DQA, DRG, DRW, DSA, DSI, MLD, MSX
DEVICE DESCRIPTION 4.
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
6
compatible monitors. The BeneVision Central Monitoring System supports bi-directional configuration of the compatible monitors. No data processing is done by the BeneVision Central Monitoring System for data received from compatible monitors or the TM80/TM70 Telemetry Monitors.
The BeneVision Central Monitoring System consists of the following components:
-
- CentralStation
-
- ViewStation
-
- WorkStation
-
- CMS Viewer
-
- Telemetry Systems (TMS 6016, Telepak-608, TMS60, TM80, TM70)
The TMS 6016, Telepak-608, TMS60 telemetry monitoring systems operate in the 608M WMTS frequency range within a defined coverage area. All of the supported telemetry systems transmit data to the CentralStation for processing, display, and alarm.
The TM80 telemetry monitor uses the Wireless WIFI connection to transmit data to the CentralStation for display, storage, and printing.
The TM70 telemetry monitor operates in the 608M or the 1.4G WMTS frequency range within a defined coverage area, and transmits data to the CentralStation for display, storage, and printing.
INTENDED USE/INDICATIONS FOR USE 5.
The indications for use of the BeneVision Central Monitoring System include:
- Real time viewing of patient clinical data and 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 CentralStations
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. No data processing is done by the BeneVision Central Monitoring System for data received from compatible monitors.
7
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 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 CentralStation 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 CentralStation 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.
LIST OF CONSENSUS STANDARDS 6.
The proposed device is in conformity with the requirements of the following consensus standards:
| Recognition
| Number | Standard Name and Version |
|---|---|
| Not recognized | IEC 60950-1:2005+A1:2009+A2:2013 Information technology |
| equipment - Safety - Part 1: General requirements | |
| Not recognized* | IEC 60601-2-49: 2018,Medical electrical equipment - Part 2-49: |
| Particular requirements for the basic safety and essential performance of | |
| multifunction patient monitoring equipment | |
| 19-4* | ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 |
| and A2:2010/(R)2012 Medical electrical equipment—Part 1: General | |
| requirements for basic safety and essential performance | |
| 19-8 | IEC 60601-1-2:2014 Medical electrical equipment – Part 1-2: General |
| requirements for basic safety and essential performance – Collateral | |
| Standard: Electromagnetic disturbances - Requirements and tests | |
| 19-30 | AIM Standard 7351731: 2017 Medical Electrical Equipment and |
| System Electromagnetic Immunity Test for Exposure to Radio | |
| Frequency Identification Readers | |
| 5-89* | IEC 60601-1-6: 2013 Medical electrical equipment - Part 1-6: General |
| requirements for basic safety and essential performance - Collateral | |
| standard: Usability | |
| 5-76* | IEC 60601-1-8: 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 | |
| 3-126 | IEC 60601-2-27:2011 Medical electrical equipment--Part 2-27: |
| Particular requirements for the basic safety and essential performance of | |
| electrocardiographic monitoring equipment | |
| 3-123* | IEC 80601-2-30:2018 Medical electrical equipment - Part 2-30: |
| Particular requirements for the basic safety and essential performance of | |
| automated type non-invasive sphygmomanometers | |
| 1-139* | ISO 80601-2-61: 2017 Medical electrical equipment - Part 2-61: |
| Particular requirements for basic safety and essential performance of | |
| pulse oximeter equipment | |
| 5-40 | ISO 14971 Second edition 2007-03-01 Medical devices - Application of |
| risk management to medical devices | |
| 2-220* | ISO 10993-1 Fourth edition 2009-10-15 Biological evaluation of |
| medical devices - Part 1: Evaluation and testing within a risk | |
| management process [Including: Technical Corrigendum 1 (2010)] | |
| 2-245* | ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical |
| devices - Part 5: Tests for in vitro cytotoxicity | |
| 2-174* | ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of |
| medical devices - Part 10: Tests for irritation and skin sensitization | |
| 3-129* | ANSI/AAMI:EC53:2013 ECG cables and lead wires |
| 3-118* | ANSI AAMI EC57:2012 Testing and reporting performance results of |
| cardiac rhythm and ST-segment measurement algorithms | |
| 19-29 | ANSI IEEE C63.27-2017 American National Standard for Evaluation of |
| Wireless Coexistence | |
| 19-22 | AAMI TIR69: 2017 Technical Information Report Risk management of |
| radio-frequency wireless coexistence for medical devices and systems | |
| 13-79 | ANSI AAMI IEC 62304:2006/A1:2016 Medical device software - |
| Software life cycle processes [Including Amendment 1 (2016)] |
Table 2: List of consensus standards
8
9
*Indicates standards the predicate device was tested to but were not repeated for this 510(k).
SUBSTANTIAL EQUIVALENCE 7.
Comparison of Indications
Both the predicate devices and the subject device are patient monitoring systems intended to be used in healthcare facilities under the direction of clinical professionals.
The new device type TM70 is added to the intended use. There are no other modifications to the intended use.
Technological Comparison
The table below compares the key technological features of subject device to the predicate device (BeneVision Central Monitoring System) cleared in K183238. The features in grey are the features that are different from the predicate device and that are the subject of this 510(k).
10
Comparison of CentralStation, ViewStation, WorkStation and CMS Viewer
Table 3:Device Comparison Table – CentralStation, WorkStation, ViewStation, and CMS Viewer
| Feature | As Cleared in K183238 | Modifications Made to
Subject Device | Comparison analysis |
|------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operation
System | Unchanged, as previously submitted | | |
| Host | The Central Station supports
5options for host computers:
– HP Compaq 8380 Elite MT
– HP EliteDesk 800 G3 SFF
– HP EliteDesk 600
G3DM(Only supports
WorkStation and
ViewStation)
– HPE Proliant DL360 Gen9
(Only supports
CentralStation)
– Kontron KISS 2U V2
KTQ87FLEX | Added support for the
following host computers:
– HP EliteDesk 800 G4 SFF
– Added HP ProDesk 600
G4 DM (Only supports
WorkStation and
ViewStation)
– Added HPE Proliant
DL360 Gen10 (Only
supports
CentralStation)
No longer supports the
following host computer:
– HP Compaq 8380 Elite
MT | While there are 3 new host
options being added, they do
not raise different questions
of safety and effectiveness. |
| Network | Unchanged, as previously submitted | | |
| Max
connections are
supported for
one
CentralStation | Up to 16 WorkStation or
ViewStation connections are
supported for one
CentralStation | Up to 32 WorkStation or
ViewStation connections are
supported for one
CentralStation | Only changed a number
from 16 to 32 in the code.
The change does not raise
different questions of safety
and effectiveness. |
| Patient Monitor
Numbers –
Number
Supported | 1.Running as application
Up to 16 monitors in the
single-screen mode for
1280*1024 resolution
Up to 24 monitors in the
single-screen mode for 1920 x
1080 resolution
Up to 32 monitors in multi-
screen mode
Supports up to four local
displays
2. Running as service
Up to 128 monitors with no
patient display, the display is
provided by WorkStations | Support 32 monitors in the
single screen mode for 1920
x 1080 resolution running as
application | Only changed a number
from 24 to 32 in the code.
The change does not raise
different questions of safety
and effectiveness. |
| Feature | As Cleared in K183238 | Modifications Made to
Subject Device | Comparison analysis |
| Telemetry
Systems and
monitors | Supports the following
telemetry systems and
monitors:
– TMS-6016 (K183238)
– TMS60 (K183238)
– Telepack-608 (K183238)
– TM80 (K183238) | Supports same telemetry
systems and added support
got TM70 | The BeneVision Central
Monitoring System and
patient monitors
communicate via the MD2
protocol, CMS+ protocol
and ELAN protocol. The
Central Monitoring System
does not differentiate the
models of patient monitors.
The change does not raise
different questions of safety
and effectiveness. |
| Communication
protocol (and
compatible
monitors) | CMS+ protocol:
DPM3 (K072235)
DPM4/5 (K070791)
DPM6/7 (K092449)
Passport 12m/17m/T1
(190011)
Passport8/12 (K153448)
Passport V (K091834)
Accutorr 7/VS-900 (K170712)
ELAN protocol:
Spectrum (K062098)
Spectrum OR (K062098)
Passport II (K020550)
V12/21 (K150352)
MD2 protocol:
CMS Viewer (K183238)
ViewStation (K183238)
WorkStation (K183238)
TM80 (K183238) | Supports same
communication protocols as
predicate.
Added TM70 and
BeneVision
N22/N19/N17/N15/N12/N1.
They use MD2 protocol. | The change does not raise
different questions of safety
and effectiveness. |
| Bi-directional
Configuration | Unchanged, as previously submitted | | |
| Calculations | Unchanged, as previously submitted | | |
| View Other
Bed | Unchanged, as previously submitted | | |
| HL7 Output | Unchanged, as previously submitted | | |
| Paging
Interface | Unchanged, as previously submitted | | |
| Data Review | | | |
| NIBP review | Most recent 1000 NIBP
measurements | NIBP review Support most
recent 3000 NIBP
measurements | For this change, the only
change was a number from
1000 to 3000 in the code. |
| Feature | As Cleared in K183238 | Modifications Made to
Subject Device | Comparison analysis |
| Event review | 1000 events | Event review Support 3000
events | The change does not raise
different questions of safety
and effectiveness. |
| Dynamic short
trend
Trend review
Wave review
12-lead review
ST review
Cardiac output
review | Unchanged, as previously submitted | | |
| ECG Features | | | |
| ECG Algorithm
ECG Functions
HR
ST
ARR
QT Analysis
Pace mark
Pace pulse
rejection | Unchanged, as previously submitted | | |
| New Features | | | |
| WorkStation
support to
delete
discharged
patients | Not provided | The WorkStation provides
the ability to set whether to
allow deleting discharged
patients | In the predicate BeneVision
Central Monitoring System
(K183238), only
CentralStation supports
deletion of discharged
patients. The subject CMS
adds the ability for
authorized users to have the
capability to delete
discharged patients. The
change does not raise
different questions of safety
and effectiveness. |
11
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Comparison of TM80
| Table 4: Device Comparison Table - TM80 | ||||
|---|---|---|---|---|
| -- | ------------------------------------------------ | -- | -- | -- |
| Feature | As cleared in K183238 | Subject Device
(modifications in grey
and/or bolded) | Comparison analysis |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Device Hardware | | | |
| Power type | Unchanged, as previously submitted | | |
| Display | Unchanged, as previously submitted | | |
| Central Charger | Unchanged, as previously submitted | | |
| IPX | Unchanged, as previously submitted | | |
| Main WIFI specification | | | |
| Supplier | Alinket: ALX850B | Silex: SX-SDMAC-2832S+ | New supplier and WIFI
module |
| WIFI Protocol | IEEE 802.11a/b/g/n | IEEE 802.11a/b/g/n/ac | The new WIFI module
supports 802.11ac |
| Modulation
mode | Unchanged, as previously submitted | | |
| Operating
frequency | Unchanged, as previously submitted | | |
| Channel spacing | IEEE 802.11b/g/n (at
2.4G): 5 MHz
IEEE802.11a/n (at 5G):
20MHz | IEEE 802.11b/g/n (at 2.4G):
5 MHz
IEEE802.11a/n/ac (at 5G):
20MHz | The new Wi-Fi module
supports 802.11ac |
| Wireless baud
rate
(data rate) | IEEE 802.11b/g/n (at
2.4G): 1-65 Mbps
IEEE 802.11a/n(at 5G):
6~65Mbps | IEEE 802.11b: 1 Mbps to 11
Mbps
IEEE 802.11a/g: 6 Mbps to
54 Mbps
IEEE 802.11n: MCS0
(6.5Mbps) to MCS7
(72.2Mbps)
IEEE 802.11ac: MCS0 (6.5
Mbps) to MCS8 (86.7
Mbps) | Baud rate specifications are
more specific for
802.11a/b/g/n,
and the new WIFI module
support 802.11ac |
| Output power
(transfer power) | Unchanged, as previously submitted | | |
| Operating mode | Unchanged, as previously submitted | | |
| Data security | Standard:
WPA-PSK and WPA2-
PSK
WPA-Enterprise, WPA2-
Enterprise
EAP method:
PEAP-GTC, PEAP-
MSCHAPv2, EAP-TLS
Encryption: TKIP and AES | Standards:
WPA/ WPA2 PSK,
WPA/WPA2 EAP,
WPA/WPA2 CCKM
EAP methods:
LEAP, TTLS, TLS, FAST,
PEAP-MsChapV2,
PEAPGTC,
PEAP-TLS
Encryption modes:
TKIP and AES | The new WIFI module
support more security
standard |
| Qos | Unchanged, as previously submitted | | |
| Communication
protocol | Unchanged, as previously submitted | | |
| Main Bluetooth specification | | | |
| Main Bluetooth
specification | Unchanged, as previously submitted | | |
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| ECG Specifications | |||
|---|---|---|---|
| Pace mark | Detects and marks pace | ||
| pulse: | |||
| Amplitude: ±2 to +700 mV | |||
| Duration: 0.1 to 2 ms | |||
| Rise time: 10 to 100 μs | |||
| Pace detected by hardware | |||
| circuit which includes | |||
| pacer pulse edge detection, | |||
| amplification and | |||
| comparison. | Detects and marks pace pulse: | ||
| Amplitude: ±2 to ±700 mV | |||
| Duration: 0.1 to 2 ms | |||
| Rise time: 10 to 100 μs | |||
| Adds ADC conversion in the | |||
| pacer pulse detection | |||
| channel and supports | |||
| software pace detection | |||
| function. | The subject TM80 adds ADC | ||
| (analog-to-digital) conversion | |||
| in the pacer pulse detection | |||
| channel. The differences do | |||
| not raise additional questions | |||
| of safety and effectiveness. | |||
| ECG Algorithm | |||
| ECG Functions | |||
| HR | |||
| ST | |||
| ARR | |||
| QT Analysis | |||
| Pace pulse | |||
| rejection | Unchanged, as previously submitted | ||
| Resp Specifications | |||
| Resp | |||
| Specifications | Unchanged, as previously submitted | ||
| SpO2 Specifications | |||
| SpO2 | |||
| Specifications | Unchanged, as previously submitted | ||
| BP10 NIBP module | |||
| BP10 NIBP | |||
| module | Unchanged, as previously submitted |
Summary of main changes for TM80
WIFI module difference
The WIFI module of the subject TM80 has been replaced because the previous components are no longer available from the supplier. The subject TM80 with the new WIFI module has passed the FCC certification test. The FCC ID is ZLZ-PMACS.
The differences of the WIFI module do not raise additional questions of safety and effectiveness through the safety impact analysis.
These differences do not raise different questions of safety and effectiveness, and testing demonstrates that the new WIFI module complies with relevant safety standards and has equivalent performance.
Software Pace Detection
The predicate TM80 detects pacemakers by a hardware circuit which includes pacer pulse edge detection, amplification and comparison. The subject TM80 now adds ADC conversion in the
15
The subject TM80 adds ADC conversion in the pacer pulse detection channel. The differences do not raise additional questions of safety and effectiveness through safety impact analysis. Mindray conducted EMC (IEC 60601-1-2) and performance (IEC 60601-2-27) testing
These differences do not raise different questions of safety and effectiveness, and testing demonstrates that the software pace detection modification comply with relevant safety standards and have equivalent performance.
Comparison of TM70
| Feature | Predicate TM80 cleared
in K183238 | Subject TM70 Device
(modifications in grey and/or
bolded) | Comparison analysis |
|----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Power type | Unchanged, as previously submitted | | |
| Display | Unchanged, as previously submitted | | |
| Central Charger | Unchanged, as previously submitted | | |
| IPX | Unchanged, as previously submitted | | |
| Main Wireless Specification | | | |
| Modulation
mode | DSSS and OFDM | GFSK | |
| Operating
frequency | FCC:
2412Mhz-2462Mhz
5180Mhz-5240Mhz,
5745Mhz-5825Mhz
ETSI:
2412Mhz-2472Mhz
5180Mhz-5240Mhz | WMTS-
608M:
608MHz(608
614MHz) | WMTS-1.4G:
1.4GHz(1395
1400 MHz
and
14271432M65Mbps | WMTS-
Hz) |
| Channel
spacing | IEEE 802.11b/g/n (at
2.4G): 5 MHz
IEEE802.11a/n (at 5G):
20MHz | WMTS-
608M:
600kHz | WMTS-1.4G:
800kHz or
600kHz |
| Wireless baud
rate
(data rate) | IEEE 802.11b/g/n (at
2.4G): 1-65 Mbps
IEEE 802.11a/n(at 5G):
6
608M:
Max
400kbps | WMTS-1.4G:
433kbps for
800kHz
channel
spacing.
400kbps for
600kHz
channel
spacing. |
| | | | The difference between the
subject TM70 and the subject
TM80 is that TM70 used
WMTS instead of WIFI.
The WMTS wireless function
is not used in TM80, but the
WMTS (608MHz band) is
already used in TMS60
(K183238), and the WMTS
(1.4GHz band) already used
in Philips MX40 (K172226).
The details of WMTS-608M
have been discussed in Table
6: Detailed Comparison of
WMTS-608M Specifications
The details of WMTS-1.4G
have been discussed in Table
7: Detailed Comparison of
WMTS-1.4G Specifications |
| Max Output
power
(transfer
power) |