Who is the manufacturer of BeneVision Central Monitoring System?

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. filed the 510(k) submission for BeneVision Central Monitoring System (K193391).

What is the FDA product code for BeneVision Central Monitoring System?

MSX. It is classified under 21 CFR 870.2300 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for BeneVision Central Monitoring System?

510(k) clearance (submission type: Special).

What are the predicate devices for BeneVision Central Monitoring System?

BeneVision Central Monitoring System (K183238); Philips MX40 Release B.07 (K172226).

Who can help prepare an FDA 510(k) submission like BeneVision Central Monitoring System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BeneVision Central Monitoring System

K193391 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · MSX · May 21, 2020 · Cardiovascular

Device Facts

Record ID	K193391
Device Name	BeneVision Central Monitoring System
Applicant	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Product Code	MSX · Cardiovascular
Decision Date	May 21, 2020
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.2300
Device Class	Class 2
Attributes	Pediatric

Intended Use

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.

Device Story

Networked patient monitoring system for professional healthcare facilities; provides remote monitoring of physiological data (ECG, SpO2, NIBP, Resp) from compatible Mindray telemetry transmitters (TMS-6016, Telepack-608, TMS60, TM80, TM70). Inputs include physiological signals transmitted via Ethernet, WIFI, or WMTS (608MHz/1.4GHz). System components include CentralStation, ViewStation, WorkStation, and CMS Viewer. CentralStation displays, stores, prints, and transfers data; supports bi-directional configuration of monitors. Clinicians use the system for real-time alarm management and historical data review. Enhances patient safety by enabling continuous monitoring of ambulating patients and centralized clinical oversight.

Clinical Evidence

Bench testing only. Performance validated via functional and system-level testing, including wireless functionality, coexistence testing (AAMI TIR 69, ANSI C63.27), and electrical safety/EMC testing (IEC 60601-1-2, IEC 60601-2-27). No clinical data provided.

Technological Characteristics

Networked system using Ethernet, WIFI (802.11a/b/g/n/ac), and WMTS (608MHz/1.4GHz). Components: CentralStation, ViewStation, WorkStation, CMS Viewer. Telemetry monitors (TM70/TM80) use GFSK modulation for WMTS or WIFI. Software pace detection uses ADC conversion in the pacer pulse channel. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-27, ISO 80601-2-61, and ANSI/AAMI EC57.

Indications for Use

Indicated for real-time viewing, storage, historical review, printing, and configuration of patient clinical data and alarms in professional healthcare facilities under direct supervision of a licensed healthcare practitioner. Supports telemetry monitoring for ambulating patients (Adult/Pediatric >3 years) via TMS-6016, Telepack-608, TMS60, TM80, and TM70 transmitters to monitor ECG, SpO2, NIBP, and Resp.

Regulatory Classification

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.

Predicate Devices

BeneVision Central Monitoring System (K183238)
Philips MX40 Release B.07 (K172226)

Related Devices

K162607 — BeneVision Central Monitoring System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Apr 20, 2017
K183238 — BeneVision Central Monitoring System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 13, 2019
K150632 — Hypervisor IX Monitoring System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jul 6, 2015
K220058 — BeneVision Central Monitoring System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jun 1, 2022
K242728 — BeneVision Central Monitoring System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jul 31, 2025

Submission Summary (Full Text)

{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}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ 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: - 1. CentralStation - 2. ViewStation - 3. WorkStation - 4. CMS Viewer - 5. 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}------------------------------------------------ {12}------------------------------------------------ # 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 | | | {13}------------------------------------------------ {14}------------------------------------------------ | 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…