(146 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard patient monitoring functionalities and network capabilities.
No.
The device is a monitoring system that displays, stores, prints, and transfers patient data but does not provide any therapeutic intervention.
Yes
Justification: The device receives, displays, stores, and analyzes physiological data (ECG, SpO2, NIBP, Resp) and provides interpretations like "Resting 12 Lead interpretation," "Arrhythmia analysis," and "ST Segment Analysis," which are all diagnostic functions.
No
The device description and intended use clearly indicate that the system includes hardware components such as physiological monitors and transmitters (TMS-6016, Telepack-608, TMS60, TM80, TM70) which acquire physiological data. The Central Monitoring System itself is a networked system that receives, displays, stores, and transfers data from these hardware devices. While software is a critical part of the system, it is not solely a software device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The BeneVision Central Monitoring System is described as a networked patient monitoring system that displays, stores, prints, and transfers physiological data received from compatible monitors. This data includes things like ECG, SpO2, NIBP, and Resp.
- Lack of Sample Analysis: The description does not mention the device analyzing any samples taken from the patient's body. It processes data about the patient's physiological state, which is different from analyzing a biological sample.
The device is clearly focused on monitoring and managing real-time and historical physiological data from patients, which falls under the category of patient monitoring systems, not in vitro diagnostics.
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
- 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 (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.
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 config 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
MSX, DRT, DQA, DXN, DSB, MHX, DRQ
Device Description
The BeneVision Central Monitoring System (CMS) is a networked patient monitoring system intended for use in healthcare settings by, or under the direction of, a physician to provide clinicians remote patient monitoring. The target patient population is adult patients and pediatrics.
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.
The TMS60 transmitter is intended for use on Adult and Pediatric patients over three years old.
The TM80/TM70 telemetry monitor is intended for use on Adult and Pediatric patients over three years old.
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 to validate the performance of the devices. The results of the bench testing show that the subject device meets its specifications and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of human figures, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue font.
June 1, 2022
Shenzhen Mindray Bio-Medical Electronics Co., LTD Li Lei Manager Regulatory Affairs, Technical Regulation Department Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan Shenzhen, Guangdong 518057 China
Re: K220058
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. DRT, DQA, DXN, DSB, MHX, DRO Dated: December 27, 2021 Received: January 6, 2022
Dear Li Lei:
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.
1
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 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 Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220058
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
- 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 (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.
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 config 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 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: Li Lei
Title: Manager Regulatory Affairs
Phone: +86 755 81885953
Fax: +86 755 26582680
E-mail: lilei.js@mindray.com |
| Date Prepared: | December 27, 2021 |
2. DEVICE
| Device Trade Name: | BeneVision Central Monitoring System |
|---|---|
| Device Common Name: | System, network and communication, physiological monitors |
| Classification Name and Regulation | 21 CFR 870.2300, Cardiac monitor (including cardiotachometer and rate alarm) |
| Primary Product Code: | MSX - System, network and communication, physiological monitors |
| Regulatory Class | Class II |
| Panel | Cardiovascular |
5
| Product
Code | Regulation
Number | Panel | Regulation description | Device Common Name |
|-----------------|----------------------|----------------|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| DRT | 21 CFR
870.2300 | Cardiovascular | Cardiac Monitor
(including
cardiotachometer and rate
alarm) | Monitor, cardiac (incl.
cardiotachometer & rate
alarm) |
| DQA | 21 CFR
870.2700 | Anesthesiology | Oximeter | Oximeter |
| DXN | 21 CFR
870.1130 | Cardiovascular | Noninvasive blood
pressure measurement
system | System, measurement,
blood-pressure, non-
invasive |
| DSB | 21 CFR
870.2770 | Cardiovascular | Impedance
plethysmograph | Plethysmograph,
impedance |
| MHX | 21 CFR
870.1025 | Cardiovascular | Arrhythmia detector and
alarm (including ST-
segment measurement and
alarm). | Monitor, physiological,
patient (with arrhythmia
detection or alarms) |
| DRQ | 21 CFR
870.2060 | Cardiovascular | Transducer signal
amplifier and conditioner | Amplifier and signal
conditioner, transducer
signal |
| Table 1: | Secondary Product Codes |
|---|---|
| ---------- | ------------------------- |
3. PREDICATE DEVICE
Predicate Device: K193391 - BeneVision Central Monitoring System (SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD)
K163584 - M3290B Patient Information Center iX Release C.01(Philips Reference Device: Medical Systems)
K202405 - BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1) (SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD)
DEVICE DESCRIPTION 4.
The BeneVision Central Monitoring System (CMS) is a networked patient monitoring system intended for use in healthcare settings by, or under the direction of, a physician to provide clinicians remote patient monitoring. The target patient population is adult patients and pediatrics.
6
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
- 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 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 config 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.
7
SUBSTANTIAL EQUIVALENCE 6.
Comparison of Indications
Both the predicate device and the subject device are patient monitoring systems intended to be used in healthcare facilities under the direction of clinical professionals.
The indications for use statement of the subject BeneVision Central Monitoring System has been modified to include support a resting 12 Lead interpretation. Although this feature is not present in the predicate BeneVision Central Monitoring System, it is present in Mindray's N Series Monitors (K202405).
In conclusion, the difference of the indications for use do not change the fundamental intended use of the BeneVision Central Monitoring System.
Technological Comparisons
The table below provides a comparison of the technological features of the BeneVision CentralStation, WorkStation, ViewStation, and CMS Viewer compared to the CentralStation, WorkStation, ViewStation, and CMS Viewer cleared in K193391. The features in gray are features which are different between the predicate device and the subject devices. These changes marked with an asterisks (*) are non-significant.
8
Feature
| Technological Comparison | |||||
|---|---|---|---|---|---|
| As Cleared in K193391 | Modificatio | ||||
| ns Made to | |||||
| Subject | |||||
| Device | Applied To | ||||
| CentralSt | |||||
| ation | WorkSta | ||||
| tion | ViewSta | ||||
| tion | CMS | ||||
| Viewer | |||||
| Microsoft Windows | |||||
| 7/8/10/Server 2012/Server | |||||
| 2016 | 1.Added | ||||
| Microsoft | |||||
| Windows | |||||
| Server 2019 |
- | A
(CentralSt
ation only
supports
Windows
10/Server | A
(WorkSta
tion only
supports
Windows
- | A
(ViewSta
tion only
supports
Windows
s 10) | A
(CMS
Viewer
only
supports
Windows |
| | 2. Deleted | | | | |
Table 2: Technological Com
| | | ns Made to
Subject
Device | CentralSt
ation | WorkSta
tion | ViewSta
tion | CMS
Viewer |
|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|----------------------------------------------------------|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Operation
System | Microsoft Windows
7/8/10/Server 2012/Server
2016 | 1.Added
Microsoft
Windows
Server 2019
*
2. Deleted
Microsoft
Windows 7
3.The
CentralStati
on supports
installation
on the
Virtual
Machine
Platform
when
running as
service such
as VMWare
and Hyper-
V | A
(CentralSt
ation only
supports
Windows
10/Server
2016/Serv
er 2019) | A
(WorkSta
tion only
supports
Windows
10) | A
(ViewSta
tion only
supports
Window
s 10) | A
(CMS
Viewer
only
supports
Windows
8/10/Serv
er 2012) |
| Display
(including
touchscree
n
capability) | resolution:1920 x
1080,1280*1024 | No change | A | A | A | A |
| Audio | Built-in speakers | No change | A | A | A | NA |
| Recorder | Mindray thermal array
module product | No change | A | A | A | NA |
| Network | 100 Mbps, Ethernet 802.3 | No change | A | A | A | A |
| Max
connection
sare
supported
for one
CentralStat
ion | Up to 32 WorkStation or
ViewStation connections
are supported for one
CentralStation | No change | A | NA | NA | NA |
| Feature | As Cleared in K193391 | Modifications Made to Subject Device | Applied To | | | |
| | | | CentralStation | WorkStation | ViewStation | CMS Viewer |
| Patient Monitor Numbers – Number Supported | 1.Support 32 monitors running as application.
2. Running as service
Up to 128 montors with no patient display, the display is provided by WorkStations | Support 64 monitors running as application * | A | A | A | A (CMSViewer only support 36 monitors) * |
| Feature | As Cleared in K193391 | Modifications Made to Subject Device | Applied To | | | |
| | | | CentralStation | WorkStation | ViewStation | CMS Viewer |
| Telemetry Systems and monitors | Supports the following telemetry systems and monitors:
– TMS-6016 (K183238)
– TMS60 (K183238)
– Telepack-608 (K183238)
– TM80(K193391)
– TM70(K193391) | No change | A | A | A | A |
| Communication protocol (and compatible monitors) | CMS+ protocol:
DPM3 (K072235 )
DPM4/5 (K070791)
DPM6/7 (K092449)
Passport 12m/17m (170876)
Passport8/12 (K153448)
Passport V (K091834)
Accutorr 7/VS-900 (K170712)
T1 (K152902)
ELAN protocol:
Spectrum (K062098)
Spectrum OR (K062098)
Passport II (K020550)
V12/21 (K150352)
MD2 protocol:
CMS Viewer (K193391)
ViewStation (K193391)
WorkStation (K193391)
TM80 (K193391)
TM70(K193391)
BeneVision N22/N19/N17/N15/N12/N 1(K199391) | 1.Added VS 8/8A/9(K21 1475) *
2.Added ePM Series Patient Monitors (Including ePM 10, ePM12, ePM 15, ePM 10M, ePM 12M, ePM 15M) (K200015) * | A | A | A | A |
| Feature | As Cleared in K193391 | Modifications Made to Subject Device | Applied To | | | |
| | | | CentralStation | WorkStation | ViewStation | CMS Viewer |
| Bi-directional
Configuration | Patient demographics, alarm settings and parameter settings
For TM80: patient demographics, alarm settings and parameter setup information can be set by both the CentralStation and TM80.
The QRS threshold, ST point/ISO point/J point, and ST and QT template can only be set by the CentralStation. | No change | A | A | NA | NA |
| Calculations | Supports five calculation mode:
Drug Calculation
Hemodynamics Calculation
Oxygenation Calculation
Ventilation Calculation
Renal Calculation | No change | A | A | A | NA |
| View
Other Bed | Provides the user the ability to remotely view 32 patient's parameters, waveforms, and alarms from a patient monitor connected to anotherBeneVision Central Monitoring System | No change | A | A | A | NA |
| HL7
Output | Provide HL7 interface output | No change | A | NA | NA | NA |
| Paging
Interface | Enables transmission of configured alarm notifications to a third-party paging system | No change | A | A | NA | NA |
| Data Review | | | | | | |
| Dynamic
short trend | 8 hours | No change | A | A | A | A |
| Trend
review | 240 hours | No change | A | A | A | A |
| Feature | As Cleared in K193391 | Modifications Made to Subject Device | CentralStation | WorkStation | ViewStation | CMS Viewer |
| Wave review | 240 hours of full-disclosure waveforms and compressed waveforms | No change | A | A | A | A |
| NIBP review | Most recent 3000 NIBP measurements | No change | A | A | A | A |
| Event review | 3000 events | No change | A | A | A | A |
| 12-lead review | 720 12-lead analysis results, 12 analysis waveforms for each analysis result | No change | A | A | A | A |
| ST review | Most recent 240 hours of ST segments | No change | A | A | A | A |
| Cardiac output review | 720 measurements | No change | A | A | A | A |
| Print | 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 | No change | A | A | A | A |
| Feature | As Cleared in K193391 | Modificatio
ns Made to
Subject
Device | Applied To | | | |
| | | | CentralSt
ation | WorkSta
tion | ViewSta
tion | CMS
Viewer |
| Records | Patient information, real-
time waveform, real-time
alarm, waveform review,
C.O. measurement, events,
12-lead Review, ST
review, drug calculation,
hemodynamics
calculations, oxygenation
calculations, ventilation
calculations, renal
calculations, ICG
hemodynamic parameter,
CCO hemodynamic
parameter, SvO2/ScvO2
oxygenation parameters | No change | A | A | A | NA |
| Data
storage | The patient data will be
saved in an encrypted file. | No change | A | NA | NA | NA |
| ECG Features | | | | | | |
| ECG
Algorithm | Supports Mindray and
Mortara | No change | A | A | A | A |
| ECG
Functions | 3-lead, 5-lead, 6-lead
selectable,
Arrhythmia detection, ST
segment analysis, QT
Analysis, Heart rate | No change | A | A | A | A |
| HR | Adult:
Range:15300 bpm350 bpm
Accuracy : ±1 bpm or
±1%, whichever is
greater
Pediatric:
Range:15
accuracy : ±1 bpm or
±1%, whichever is
greater | No change | A | A | A | A |
| ST | Range: -2.0~2.0mV
Accuracy: ±0.02mV or
±10%, whichever is
greater, in the range of -
0.8mV to +0.8mV; not
specified in other range | No change | A | A | A | A |
| Feature | As Cleared in K193391 | Modifications Made to Subject Device | CentralStation | WorkStation | ViewStation | CMS Viewer |
| J Point Auto Detection | J-point Auto detection for ST algorithm. Supports automatically detecting the location of the J-point on the ST template. | No change | A | A | A | A |
| ARR | Mindray algorithm:
Asystol, V-Fib/V-Tach, V-Tach, Vent Brady, Extreme Tachy, Extreme Brady, PVCs/min, Vent Rhythm, Couplet, Bigeminy Trigeminy, R on T, Run PVCs, PVC, Tachy, Brady, Missed Beats, Pacer Not Pacing, Pacer Not Capture, Multiform PVC, Nonsus V-Tach, Pause, Irr Rhythm, Pauses/min, and A-Fib
Mortara algorithm:
Asystol, V-Fib, V-Tach, Vent Rhythm, Couplet, Run PVCs, PVCs/min, Bigeminy Trigeminy, R on T, Multiform PVC, Irr Rhythm, Tachy, Brady, Pacer Not Pacing, Pacer Not Capture, Extreme Tachy, Extreme Brady, Pause and Pauses/min | No change | A | A | A | A (CMS Viewer receives ARR alarms from CentralStation and only displays ARR alarms, therefore there are no modification) |
| Adjustable Leads for Arrhythmia Analysis | Adjustable Leads for Arrhythmia Analysis.
Supports selectable ECG leads as primary detection lead, secondary detection lead and beat classification lead for arrhythmia analysis | No change | A | A | NA | NA |
| Feature | As Cleared in K193391 | Modifications Made to Subject Device | Applied To | | | |
| | | | CentralStation | WorkStation | ViewStation | CMS Viewer |
| QT Analysis | Mindray algorithm:
- QT measurement range: [200, 800] ms
- QT accuracy [200, 800] ms: ± 30 ms, beyond this range is not specified
- QT resolution: [200, 800] ms: 4 ms, beyond this range is not specified
- QTc measurement range: [200, 800] ms
- QTc resolution [200, 800] ms: 1 ms, beyond this range is not specified
- QT-HR measurement range: Adult: [15, 150] bpm, pediatric: [15, 180] bpm | No change | A | A | A | A |
| | Mortara algorithm: - QT measurement range: [300, 600] ms
- QT accuracy [300, 600] ms: ± 30 ms, beyond this range is not specified
- QT resolution: [300, 600] ms: 2 ms, beyond this range is not specified
- QTc measurement range: [300, 600] ms
- QTc resolution [300, 600] ms: 1 ms, beyond this range is not specified
- QT-HR measurement range: Adult: [43, 130] bpm, | | | | | |
| Feature | As Cleared in K193391 | Modifications Made to Subject Device | Applied To | | | |
| | | | CentralStation | WorkStation | ViewStation | CMS Viewer |
| QRS Detection Threshold | Adjustable QRS Detection threshold.
QRS threshold range: 0.16-0.48mV. | No change | A | A | NA | NA |
| Pace mark | Detects and marks pace pulse.
Amplitude: ±2 to ±700 mV
Duration: 0.1 to 2 ms
Rise time: 10 to 100 µs | No change | A | A | A | A |
| Pace pulse rejection | Meets the requirements of IEC60601-2-27 2011:
Section 201.12.1.101.13.
The following pulses without overshoot will be rejected:
Amplitude: ±2 to ±700 mV
Duration: 0.1 to 2 ms
Rise time: 10 to 100 με | No change | A | A | A | A |
| New Features
The system provides a resting 12 Lead interpretation of previously stored data | Not provided | Supports the user to select a period of waveform from the historical data storage to analyze, the result will be saved in 12 lead review | A | A | NA | NA |
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Substantial Equivalence Conclusion
In conclusion, the differences in respect to the indications for use and technological characteristics do not raise new questions of safety and effectiveness as compared to the predicate device.
To establish the substantial equivalence of the BeneVision Central Monitoring System, Mindray conducted functional and system level testing to validate the performance of the devices. The results of the bench testing show that the subject device meets its specifications and is substantially equivalent to the predicate device.
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In addition, Mindray has conducted testing to ensure the subject devices meet relevant consensus standards.
7. PERFORMANCE DATA
Biocompatibility Testing
Not applicable. The changes are just concerned with Software, not relate to Biocompatibility Testing.
Software Verification and Validation Testing
Software verification and validation testing was 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." Verification of the Bene Vision Central Monitoring System was conducted to ensure that the product works as designed. Validation was conducted to check the design and performance of the product.
Electrical safety and electromagnetic compatibility (EMC)
Not applicable. The changes are just concerned with Software, not relate to Electrical safety and electromagnetic compatibility.
Bench Testing
To establish the substantial equivalence of the BeneVision Central Monitoring System, Mindray conducted functional and system level testing to validate the performance of the devices. The results of the bench testing show that the subject device meets its accuracy specification, and is substantially equivalent to the predicate device.
In addition. Mindray has conducted testing to ensure the subject devices meet relevant consensus standards.
- . IEC 60601-2-25:2011 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
Animal Testing
Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.
Clinical Data
Not applicable. Clinical testing is not required to establish substantial equivalence to the predicate device.
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8. CONCLUSION
Based on the detailed comparison between the predicate devices and the subject devices, and the functional and system level testing, the BeneVision Central Monitoring System can be found substantially equivalent to the predicate devices.