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 healthes 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 Bene Vision 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, and TM80.

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 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 reviewed locally on the display of the monitor. The CentralStation will support ECG, Heart Rate, SpO2, NIBP, Resp, Pulse Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the TM80.

The BeneVision Central Monitoring System is intended for use in professional healthcare facilities under the direct supervision of a licensed healthcare practitioner.

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.

The BeneVision Central Monitoring System consists of the following components:

1. CentralStation
1. ViewStation
1. WorkStation
1. CMSViewer
1. Telemetry Systems (TMS 6016, Telepak-608, TMS60,TM80)

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 processing, display, and alarm.

AI/ML Overview

This document is a 510(k) Pre-market Notification for the BeneVision Central Monitoring System. It's a submission to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This type of document generally focuses on comparing the new device's features and performance to an existing one, rather than presenting a standalone study showing general device performance against predefined acceptance criteria in the way a clinical trial for a new drug or diagnostic might.

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the format you requested. Instead, it relies on comparison to a predicate device and adherence to recognized standards. The "Performance Data" section states that 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."

This implies that the "acceptance criteria" are essentially to meet the performance specifications of the predicate device and relevant consensus standards. The performance is reported as meeting these specifications and being equivalent.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for any test sets, nor does it provide details on data provenance (country of origin, retrospective/prospective). The testing mentioned is "functional and system level testing," which typically involves engineering and verification testing rather than testing on patient data in a clinical setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. Given the nature of the device (a central monitoring system that displays, stores, and transfers data from other physiological monitors, rather than performing primary diagnostic analysis), the "ground truth" would likely be established through technical validation against known input signals or simulated data according to engineering specifications, rather than expert clinical consensus on actual patient cases.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/not provided. Adjudication methods are typically relevant for studies involving human interpretation or labeling of complex data (e.g., medical images). The testing described appears to be technical validation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC study was not conducted. This device is a central monitoring system, not an AI-powered diagnostic tool for interpretation by human readers. It primarily displays, stores, and transfers data. There is no mention of AI assistance in the document.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable in the sense of a diagnostic algorithm. The "algorithm" here refers to the system's ability to accurately process and display physiological data. The performance section describes "functional and system level testing" and "Wireless functionality testing," which evaluate the system's technical operation in a standalone manner (i.e., the system's ability to perform its stated functions without direct human intervention in the data processing). The device description explicitly states: "No data processing is done by the BeneVision Central Monitoring System for data received from compatible monitors." This suggests it acts as a relay and display, not an analytical engine for raw data interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document doesn't explicitly state the type of "ground truth." However, for a device like a central monitoring system, the ground truth for testing would primarily involve:

Known input signals: Generating physiological signals (ECG, SpO2, NIBP, Respiration) with known values and waveforms to verify accurate reception, display, and storage by the BeneVision system.
System specifications: Verifying that the system meets its own design specifications for data transfer, alarm functionality, display accuracy, and configuration synchronization.
Compliance with standards: Demonstrating adherence to relevant consensus standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, etc.) which often involve specific test methodologies and criteria.

8. The sample size for the training set

The document does not describe a "training set." This type of system (a central monitoring system) does not typically involve machine learning or AI models that require training sets in the conventional sense. Its functionality is based on established engineering principles for data acquisition, transfer, and display.

9. How the ground truth for the training set was established

Not applicable, as there is no mention of a training set.

Summary of the study and acceptance criteria based on the provided document:

The submission for the BeneVision Central Monitoring System is a 510(k) Pre-market Notification, which primarily aims to demonstrate substantial equivalence to a predicate device (Hypervisor IX Monitoring System, K150632).

Acceptance Criteria (Implied, not explicitly stated numerically):

The implied acceptance criteria are that the BeneVision Central Monitoring System:

Performs its stated functions (real-time viewing, storage, historical review, printing, configuration synchronization, data transfer) equivalently to or better than the predicate device.
Meets its own design specifications for functional and system level performance.
Complies with relevant national and international consensus standards for medical electrical equipment and patient monitoring.
The differences from the predicate (e.g., added display sizes, increased monitor capacity, added TM80 telemetry support with NIBP/Resp/WiFi/6-lead ECG, increased data review storage) do not raise new questions of safety or effectiveness.

Reported Device Performance:

The document states:

"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." (A list of specific standards is provided).

In essence, the "study" described is a series of engineering verification and validation tests (functional, system level, wireless functionality) performed by the manufacturer to demonstrate that the device meets its own specifications and relevant standards, and that its performance is equivalent to the legally marketed predicate device. It is not a clinical trial or a study involving human-in-the-loop performance measurement or AI comparative effectiveness.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 20, 2017

Shenzhen Mindray Bio-medical Electronics Co., Ltd. % Yanhong Bai Manager Regulatory Affairs, Technical Regulation Department Shenzhen Mindray Bio-medical Electronics Co., Ltd. Mindray Building, Keji 12th Road South Hi-tech Industrial Park Nanshan. Shenzhen. CN 518057 Guangdong

Re: K162607

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: March 22, 2017 Received: March 23, 2017

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. 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Mude Jellman
for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162607

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 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 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 reviewed locally on the display of the monitor. The CentralStation will support ECG, Heart Rate, SpO2, NIBP, Resp, Pulse Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the TM80.

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)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(K) SUMMARY

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.

Device Common Name:	System, network and communication, physiologicalmonitors
Device Trade Name:	BeneVision Central Monitoring System
Applicant:	SHENZHEN MINDRAY BIO-MEDICALELECTRONICS CO., LTD.Mindray Building, Keji 12th Road SouthHigh-tech Industrial Park, NanshanShenzhen 518057, P.R. ChinaTel: +86 755 81888998Fax: +86 755 26582680
Contact:	Yanhong BaiManager Regulatory AffairsSHENZHEN MINDRAY BIO-MEDICALELECTRONICS CO., LTD.Mindray Building, Keji 12th Road SouthHigh-tech Industrial Park, Nanshan 518057, P.R. ChinaTel: +86 755 81888998Fax: +86 755 26582680E-mail: baiyanhong@mindray.com
Date Prepared:	March 22nd, 2017
Classification Regulation:	870.2300 - Cardiac Monitor (including cardiotachometer andrate alarm)
	Class II
Panel:	Cardiovascular
Product Code:	MSX -System, network andcommunication, physiological monitors

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Subsequent Product Codes:	DRQ- amplifier and signal conditioner, transducer signal
	MHX - monitor, physiological, patient (with arrhythmia detection or alarms)
	DRT - monitor, cardiac (incl. cardiotachometer & rate alarm)
	DXN - system, measurement, blood-pressure, non-invasive
	DQA- Oximeter
	DSB- Impedance plethysmograph
Predicate Device:	K150632 -Hypervisor IX Monitoring System
Reference Predicates:	K152902-Passport Series Patient Monitors (Passport 12m, Passport 17m and T1)

Indication 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 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,

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NIBP, Resp. Pulse Rate. Arrhythmia analysis, OT monitoring, and ST Segment Analysis for the TMS60.

The TM80 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 reviewed locally on the display of the monitor. The CentralStation will support ECG, Heart Rate, SpO2, NIBP, Resp, Pulse Rate, Arrhythmia analysis, OT monitoring, and ST Segment Analysis for the TM80.
The BeneVision Central Monitoring System is intended for use in professional healthcare facilities under the direct supervision of a licensed healthcare practitioner.

Device Description:

The BeneVision Central Monitoring System consists of the following components:

1. CentralStation
1. ViewStation
1. WorkStation
1. CMSViewer
1. Telemetry Systems (TMS 6016, Telepak-608, TMS60,TM80)

The TM80 telemetry monitor uses the Wireless WIFI connection to transmit data to the CentralStation for processing, display, and alarm.

Performance Data:

To establish the substantial equivalence of the BeneVision Central Monitoring System, 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.

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Mindray has followed the following FDA Guidance Documents relevant to this device:
- Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm Guidance for Industry and FDA (10/28/2003)
- Cardiac Monitor Guidance (Including Cardiotachometer and Rate Alarm)
Mindray has conducted testing to ensure the subject device meets relevant consensus ● standards.
- AAMI /ANSI ES60601-1:2005/(R)2012 and A1:2012,C1:2009/(R)2012 and A2:2010/(R)2012
- IEC 60601-1-2: 2007 —
- | IEC60601-1-6: 2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 60601-2-27 Edition 3.0 2011-03 —
- IEC80601-2-30 Edition 1.1 2013-07 —
- IEC 60601-2-49: 2011 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
- AAMI ANSI:EC53:2013

Comparison of Technological Characteristics:

The technological characteristics of the subject device are compared to the predicate device in the table below.

	Predicate Device	Subject Device
Device Name	Hypervisor IX Monitoring System	BeneVision Central Monitoring System
Manufacturer	SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD	SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
510(k)	K150632	TBD
Regulation	870.2300 – Cardiac Monitor (including cardiotachometer and rate alarm)Class II	870.2300 – Cardiac Monitor (including cardiotachometer and rate alarm)Class II
Product Code	MSX – Physiological Monitors Network and Communication System	MSX – Physiological Monitors Network and Communication System
Operating System	Microsoft Windows 7 Professional Embedded SP1	Same
Network	100 Mbps, Ethernet 802.3	Same
Display	19" or larger LCD displaySupport Touch-Screen1280 x 1024 resolution, length-width ratio 4:3 or 5:4	Add 21" or larger widescreen LCD displaySupport Touch-Screen1920 x 1080 resolution, length-width ratio 16:9
HostComputers	HP Compaq 8380 Elite MTHP EliteDesk 800 G1 SFFKontron KISS 2U V2 KTQ87FLEX	Same
PatientMonitorNumbers	Up to 16 monitors in the single-screenmode and 32 monitors in the dual- ormulti-screen mode simultaneouslySupport up to four local displays	Add up to 24 monitors in the single-screenmode with 1920 x 1080 resolutions.Support up to four local displays
PatientMonitorConnectivity	Supports the following patient monitors:DPM3 (K072235)DPM4/5 (K070791)DPM6/7 (K092449)Passport 12M/17M (K152902)Passport8/12 (K153448)Accutorr 7 (K132038)T1 (K152902)TMS-6016 (K132036)Spectrum (K062098)Spectrum OR (K062098)Passport II (K020550)Passport V (K091834)V12/21 (K150352)	Same
TelemetrySystem	TMS-6016Telepack-608TMS60(K150632)	TMS-6016Telepack-608TMS60TM80Subject in this 510 (k)
Calculations	Supports five calculation modes:Drug CalculationHemodynamics CalculationOxygenation CalculationVentilation CalculationRenal Calculation	Same
RemoteMonitoring	Provided on supported monitor and on theViewStation and WorkStation. WorkStationallows for remote users to enter or changepatient demographic information, changealarm limits and priorities, or dischargepatients.	Same
Data ReviewFeatures	Dynamic shorttrend Trend reviewWave reviewNIBP reviewEvent Review12-lead eviewST reviewCardiac output reviewPrint and DisplayRecords	1.Change the display time of Dynamicshort trend from 4 hours to 8 hours2. Change the storage of NIBP reviewfrom most recent 240 hours to most recent1000 NIBP measurements.3. Change the storage of Event reviewfrom 720 events to 1000 events.The other features have no change.
Data storage	The patient datawill be saved inMySQL database.	The patient data will be saved inencryption file.
ECG Features	Mindray or Mortara ECG Algorithms -selectable3-lead or 5-lead selectablearrhythmia detection with adjustableleadsST segment analysisheart rate Pace MarkPace Pulse RejectionQT AnalysisJ Point Auto detectionQRS Detection Threshold	Mindray or Mortara ECG Algorithms -selectable3-lead, 5-lead and 6-lead selectablearrhythmia detection with adjustableleadsST segment analysisheart rate Pace MarkPace Pulse RejectionQT AnalysisJ Point Auto detectionQRS Detection Threshold
SpO2Features	Support SpO2 modules:Nonin SpO2 module (XPOD 3012LP)and sensorsMasimo SpO2 module (SET uSpO2) andsensors	Same
Resp Features	Not provided	Calculate Resp rate (RR)Display Resp waveformView and change Resp settings
NIBP Features	Not provided	Oscillometry method NIBPCan measure, display, store NIBPparameter, and send them to TMS60/TM80
WiFi Features	Not provided	TM80 communicates with the CentralStation via WiFi network :IEEE 802.11a/b/g/n ProtocolSupport WPA-PSK, WPA2-PSK, WPA-Enterprise, WPA2-Enterprise Security standardSupport PEAP-GTC, PEAP- MSCHAPv2,EAP-TLS EAP method

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Comparison of Indications:

The indication for use statement of the BeneVision Central Monitoring System includes the indication for the system as whole as well as cleared indications for each of the components of the system. Both the predicate device and the subject device are patient monitoring systems intended to be used in professional healthcare facilities under the direction of clinical professionals. Additional modules for the transmitter allow the addition of NIBP monitoring to the TMS60 and TM80. Resp monitoring is also added in TMS60 and TM80. WiFi function and 6-lead ECG function is added in TM80. Although NIBP and Resp monitoring. WiFi function and 6-lead ECG function was not included in the predicate Hypervisor device, it is present in the cleared T1 patient monitor (K152902), and thus does not constitute a new intended use.

Substantial Equivalence Conclusion:

Based on the detailed comparison of specifications for each of the modifications to the previously cleared Hypervisor IX Monitoring System, the functional and performance testing and conformance with applicable standards as well as the comparison of indications, the differences do not raise new questions of safety and effectiveness and the BeneVision Central Monitoring System can be found substantially equivalent to the predicate device.

Regulation Number and Section

§ 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).