(167 days)
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.
The BeneVision Central Monitoring System is a networked patient monitoring system intended for use in a fixed location, installed in professional healthcare facilities to provide clinicians remote patient monitoring. The network connections between the various devices can be any combination of Ethernet (Wired), Wireless WIFI (WLAN), and Wireless WMTS.
The BeneVision Central Monitoring System supports one or more Mindray compatible physiological monitors and will display, store, print, and transfer information received from the compatible monitors. The BeneVision Central Monitoring System supports bi-directional configuration of the compatible monitors. No data processing is done by the BeneVision Central Monitoring System for data received from compatible monitors or the TM80/TM70 Telemetry Monitors.
The BeneVision Central Monitoring System consists of the following components:
-
- CentralStation
-
- ViewStation
-
- WorkStation
-
- CMS Viewer
-
- Telemetry Systems (TMS 6016, Telepak-608, TMS60, TM80, TM70)
The TMS 6016, Telepak-608, TMS60 telemetry monitoring systems operate in the 608M WMTS frequency range within a defined coverage area. All of the supported telemetry systems transmit data to the CentralStation for processing, display, and alarm.
The TM80 telemetry monitor uses the Wireless WIFI connection to transmit data to the CentralStation for display, storage, and printing.
The TM70 telemetry monitor operates in the 608M or the 1.4G WMTS frequency range within a defined coverage area, and transmits data to the CentralStation for display, storage, and printing.
The provided document is a 510(k) premarket notification for the BeneVision Central Monitoring System. It describes the device, its intended use, and comparisons to predicate devices, along with testing undertaken to demonstrate substantial equivalence. However, it does not explicitly define "acceptance criteria" in the format of a table with quantitative metrics for device performance (e.g., sensitivity, specificity, accuracy for an AI/algorithm). Instead, it explains that the modifications to the device (primarily updated host computers, increased connection/monitor support, and changes to telemetry modules and their wireless components) were assessed through functional and system-level testing to ensure they continue to meet specifications and have equivalent performance to the predicate devices.
The document is a regulatory submission for a medical device that monitors physiological data, not an AI/algorithm for diagnostic purposes, which typically involves sensitivity, specificity, or ROC curve analysis. The device's "performance" here relates to its ability to accurately acquire, display, store, print, and transfer physiological data, and its wireless connectivity capabilities, rather than a diagnostic accuracy measure that would be subject to stringent acceptance criteria for an AI model.
Therefore, many of the specific questions regarding AI/algorithm performance metrics, sample sizes for test sets, expert ground truth establishment, MRMC studies, and training set details are not directly applicable to this type of device submission as described in the provided text.
Based on the content, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a table of quantitative acceptance criteria for "device performance" in the way one would expect for an AI algorithm (e.g., a specific sensitivity threshold). Instead, the acceptance criteria are implicitly tied to the device's ability to maintain its intended functions and specifications when new components or features are introduced, demonstrating "substantial equivalence" to predicate devices. The reported performance is the successful completion of various tests and compliance with relevant standards.
| Acceptance Criterion (Implicit) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Functional Equivalence: Device continues to perform its stated indications for use (real-time viewing, storage, printing, configuration, data transfer) as effectively as the predicate. | Functional and system level testing showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate. Specifically, with increased WorkStation/ViewStation connections (32 vs 16) and monitor support (32 vs 24), and extended NIBP/event review (3000 vs 1000 measurements/events), the changes were considered to "not raise different questions of safety and effectiveness." |
| Wireless Module Performance: New WiFi (TM80) and WMTS (TM70) modules perform communication functions (data rate, frequency, security) comparably to previous/predicate equivalents. | TM80 (new WIFI module): Passed FCC certification. "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." TM70 (WMTS module): Passed FCC certification. "These differences do not raise different questions of safety and effectiveness, and testing demonstrates that the new wireless modification comply with relevant safety standards and have equivalent performance." Wireless functionality testing was conducted to ensure performance meets specifications and is equivalent. |
| Pace Detection Performance: The new software pace detection in TM80/TM70 performs equivalently to the previous hardware-based detection. | "The pace detection specifications have not been changed." "Testing demonstrates that the software pace detection modification comply with relevant safety standards and have equivalent performance." EMC (IEC 60601-1-2) and performance (IEC 60601-2-27) testing conducted. |
| Electromagnetic Compatibility (EMC): Device complies with EMC standards. | Assessed for conformity with IEC 60601-1-2:2014 and found to comply. Specifically, wireless coexistence testing (AAMI TIR 69, ANSI C63.27) and RFID interaction testing (AIM Standard 7351731) were performed for TM70 and TM80. |
| Electrical Safety: Device complies with electrical safety standards. | Assessed for conformity with relevant standards (e.g., ANSI/AAMI ES60601-1:2005) and found to comply. UL 60950-1 testing for AP70, SYNC70, AC70 (TM70 components). |
| Software Integrity: Software changes are verified and validated. | Software verification and validation testing was conducted and documentation provided as recommended by FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." |
| Performance Testing: Device meets specifications as demonstrated by bench testing. | Bench testing conducted per IEC 60601-2-27:2011 to validate performance. Results show the subject device meets specifications and is substantially equivalent. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified quantitatively. The document refers generally to "functional and system level testing," "bench testing," and "wireless functionality testing." For wireless coexistence, it mentions testing was performed for "up to 16 wireless medical devices... within a single AP" for TM80, and "up to 14 wireless medical devices per single AP for 608 MHz and 16 wireless medical devices per single AP for 1.4 GHz" for TM70. For wireless networking stability, it mentions "Each of the TM70 roam 30 times, at least 3 TM70s roam at the same time." These are details about the test conditions (number of devices tested simultaneously or repetitively) rather than a statistical "sample size" of patient data for algorithm performance.
- Data Provenance: Not applicable in the context of physiological data for an AI model. The testing is primarily bench-top (in vitro) and system-level, concerned with internal device performance and wireless communication, not analysis of patient data by an algorithm to produce a clinical output. The device itself collects patient data, but the testing described here focuses on the device's functional integrity.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable. This submission is for a central monitoring system and telemetry modules, not a device that relies on expert interpretation to establish a "ground truth" for an AI algorithm's diagnostic output. The "ground truth" for the device's performance would be engineering specifications and standards compliance, verified through bench testing and measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes where there might be disagreement in ground truth labeling for AI model training or testing. This device's testing relates to hardware and software functionality and compliance with engineering standards.
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:
Not applicable. This is not an AI-assisted diagnostic device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The "BeneVision Central Monitoring System" is a system for displaying and managing physiological data, not a standalone AI algorithm. It's a medical device system, where the listed software functions for pace detection or arrhythmia analysis are integral parts of the physiological monitoring, not separate AI algorithms in the sense of a standalone diagnostic tool. The document states "No data processing is done by the BeneVision Central Monitoring System for data received from compatible monitors." This implies the system primarily relays and displays data without independent algorithmic analysis beyond what the individual monitors (e.g., TMS60, TM70, TM80) might perform for parameters like arrhythmia or ST-segment analysis. The "software pace detection" mentioned is an update to how the hardware detects pacemakers, not an AI diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is not derived from clinical expert consensus or pathology. Instead, it is based on:
- Engineering specifications and design requirements: The device's components and system are tested against predefined performance parameters (e.g., signal accuracy, wireless range, data integrity, latency, alarm thresholds).
- Industry and regulatory standards: Compliance with consensus standards such as IEC 60601-1-2 (EMC), IEC 60601-2-27 (ECG monitoring), AAMI TIR 69 (wireless coexistence), and FCC certifications (wireless performance).
- Predicate device equivalence: Demonstrating that the modified device performs "equivalently" to previously cleared, substantially equivalent devices.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a "training set" in the common sense (i.e., for a deep learning model). The software is developed using traditional software engineering processes (V&V testing).
9. How the ground truth for the training set was established:
Not applicable. As there's no stated AI/ML training set, the concept of establishing ground truth for it doesn't apply to this submission.
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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
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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
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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.
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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-MEDICALELECTRONICS CO., LTD.Mindray Building, Keji 12th Road SouthHigh-tech Industrial Park, NanshanShenzhen 518057P.R. ChinaTel: +86 755 81888998Fax: +86 755 26582680 |
|---|---|
| Contact: | Contact Person: Yanhong BaiTitle: Manager Regulatory AffairsPhone: +86 755 81885635Fax: +86 755 26582680E-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, physiologicalmonitors |
| Classification Name: | 870.2300 – Cardiac Monitor (including cardiotachometer andrate alarm) |
| Regulatory Class: | Class II |
| Primary Product Code: | MSX – System, network andcommunication, physiological monitors |
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| RegulationNumber/Class | ProductCode | Regulation description | Device Common Name |
|---|---|---|---|
| 870.2300, II | DRT | Cardiac Monitor (includingcardiotachometer and ratealarm) | Monitor, cardiac (incl.cardiotachometer & rate alarm) |
| 870.1130, II | DXN | Noninvasive blood pressuremeasurement 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-segmentmeasurement and alarm). | Monitor, physiological,patient(with arrhythmia detectionor alarms) |
| 870.2060, II | DRQ | Transducer signal amplifier andconditioner. | 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
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compatible monitors. The BeneVision Central Monitoring System supports bi-directional configuration of the compatible monitors. No data processing is done by the BeneVision Central Monitoring System for data received from compatible monitors or the TM80/TM70 Telemetry Monitors.
The BeneVision Central Monitoring System consists of the following components:
-
- CentralStation
-
- ViewStation
-
- WorkStation
-
- CMS Viewer
-
- Telemetry Systems (TMS 6016, Telepak-608, TMS60, TM80, TM70)
The TMS 6016, Telepak-608, TMS60 telemetry monitoring systems operate in the 608M WMTS frequency range within a defined coverage area. All of the supported telemetry systems transmit data to the CentralStation for processing, display, and alarm.
The TM80 telemetry monitor uses the Wireless WIFI connection to transmit data to the CentralStation for display, storage, and printing.
The TM70 telemetry monitor operates in the 608M or the 1.4G WMTS frequency range within a defined coverage area, and transmits data to the CentralStation for display, storage, and printing.
INTENDED USE/INDICATIONS FOR USE 5.
The indications for use of the BeneVision Central Monitoring System include:
- Real time viewing of patient clinical data and alarms
- . Storage and historical review of patient clinical data and alarms
- Printing of real time and historical patient data ●
- . Configuration of local settings as well as synchronizing settings across the network to a remote device
- Transfer of patient clinical data and settings between several CentralStations
The BeneVision Central Monitoring System is a networked patient monitoring system intended for use in a fixed location, installed in professional healthcare facilities to provide clinicians remote patient monitoring. The network connections between the various devices can be any combination of Ethernet (Wired), Wireless WIFI (WLAN), and Wireless WMTS.
The BeneVision Central Monitoring System supports one or more Mindray compatible physiological monitors and will display, store, print, and transfer information received from the compatible monitors; The BeneVision Central Monitoring System supports bi-directional configuration of the compatible monitors. No data processing is done by the BeneVision Central Monitoring System for data received from compatible monitors.
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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:
| RecognitionNumber | Standard Name and Version |
|---|---|
| Not recognized | IEC 60950-1:2005+A1:2009+A2:2013 Information technologyequipment - 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 ofmultifunction patient monitoring equipment |
| 19-4* | ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012and A2:2010/(R)2012 Medical electrical equipment—Part 1: Generalrequirements for basic safety and essential performance |
| 19-8 | IEC 60601-1-2:2014 Medical electrical equipment – Part 1-2: Generalrequirements for basic safety and essential performance – CollateralStandard: Electromagnetic disturbances - Requirements and tests |
| 19-30 | AIM Standard 7351731: 2017 Medical Electrical Equipment andSystem Electromagnetic Immunity Test for Exposure to RadioFrequency Identification Readers |
| 5-89* | IEC 60601-1-6: 2013 Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essential performance - Collateralstandard: Usability |
| 5-76* | IEC 60601-1-8: 2012 Medical electrical equipment - Part 1-8: Generalrequirements for basic safety and essential performance - collateralstandard: General requirements, tests and guidance for alarm systems inmedical 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 ofelectrocardiographic monitoring equipment |
| 3-123* | IEC 80601-2-30:2018 Medical electrical equipment - Part 2-30:Particular requirements for the basic safety and essential performance ofautomated 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 ofpulse oximeter equipment |
| 5-40 | ISO 14971 Second edition 2007-03-01 Medical devices - Application ofrisk management to medical devices |
| 2-220* | ISO 10993-1 Fourth edition 2009-10-15 Biological evaluation ofmedical devices - Part 1: Evaluation and testing within a riskmanagement process [Including: Technical Corrigendum 1 (2010)] |
| 2-245* | ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medicaldevices - Part 5: Tests for in vitro cytotoxicity |
| 2-174* | ISO 10993-10 Third Edition 2010-08-01 Biological evaluation ofmedical 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 ofcardiac rhythm and ST-segment measurement algorithms |
| 19-29 | ANSI IEEE C63.27-2017 American National Standard for Evaluation ofWireless Coexistence |
| 19-22 | AAMI TIR69: 2017 Technical Information Report Risk management ofradio-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
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*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).
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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 toSubject Device | Comparison analysis |
|---|---|---|---|
| OperationSystem | Unchanged, as previously submitted | ||
| Host | The Central Station supports5options for host computers:– HP Compaq 8380 Elite MT– HP EliteDesk 800 G3 SFF– HP EliteDesk 600G3DM(Only supportsWorkStation andViewStation)– HPE Proliant DL360 Gen9(Only supportsCentralStation)– Kontron KISS 2U V2KTQ87FLEX | Added support for thefollowing host computers:– HP EliteDesk 800 G4 SFF– Added HP ProDesk 600G4 DM (Only supportsWorkStation andViewStation)– Added HPE ProliantDL360 Gen10 (OnlysupportsCentralStation)No longer supports thefollowing host computer:– HP Compaq 8380 EliteMT | While there are 3 new hostoptions being added, they donot raise different questionsof safety and effectiveness. |
| Network | Unchanged, as previously submitted | ||
| Maxconnections aresupported foroneCentralStation | Up to 16 WorkStation orViewStation connections aresupported for oneCentralStation | Up to 32 WorkStation orViewStation connections aresupported for oneCentralStation | Only changed a numberfrom 16 to 32 in the code.The change does not raisedifferent questions of safetyand effectiveness. |
| Patient MonitorNumbers –NumberSupported | 1.Running as applicationUp to 16 monitors in thesingle-screen mode for1280*1024 resolutionUp to 24 monitors in thesingle-screen mode for 1920 x1080 resolutionUp to 32 monitors in multi-screen modeSupports up to four localdisplays2. Running as serviceUp to 128 monitors with nopatient display, the display isprovided by WorkStations | Support 32 monitors in thesingle screen mode for 1920x 1080 resolution running asapplication | Only changed a numberfrom 24 to 32 in the code.The change does not raisedifferent questions of safetyand effectiveness. |
| Feature | As Cleared in K183238 | Modifications Made toSubject Device | Comparison analysis |
| TelemetrySystems andmonitors | Supports the followingtelemetry systems andmonitors:– TMS-6016 (K183238)– TMS60 (K183238)– Telepack-608 (K183238)– TM80 (K183238) | Supports same telemetrysystems and added supportgot TM70 | The BeneVision CentralMonitoring System andpatient monitorscommunicate via the MD2protocol, CMS+ protocoland ELAN protocol. TheCentral Monitoring Systemdoes not differentiate themodels of patient monitors.The change does not raisedifferent questions of safetyand effectiveness. |
| Communicationprotocol (andcompatiblemonitors) | 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 samecommunication protocols aspredicate.Added TM70 andBeneVisionN22/N19/N17/N15/N12/N1.They use MD2 protocol. | The change does not raisedifferent questions of safetyand effectiveness. |
| Bi-directionalConfiguration | Unchanged, as previously submitted | ||
| Calculations | Unchanged, as previously submitted | ||
| View OtherBed | Unchanged, as previously submitted | ||
| HL7 Output | Unchanged, as previously submitted | ||
| PagingInterface | Unchanged, as previously submitted | ||
| Data Review | |||
| NIBP review | Most recent 1000 NIBPmeasurements | NIBP review Support mostrecent 3000 NIBPmeasurements | For this change, the onlychange was a number from1000 to 3000 in the code. |
| Feature | As Cleared in K183238 | Modifications Made toSubject Device | Comparison analysis |
| Event review | 1000 events | Event review Support 3000events | The change does not raisedifferent questions of safetyand effectiveness. |
| Dynamic shorttrendTrend reviewWave review12-lead reviewST reviewCardiac outputreview | Unchanged, as previously submitted | ||
| ECG Features | |||
| ECG AlgorithmECG FunctionsHRSTARRQT AnalysisPace markPace pulserejection | Unchanged, as previously submitted | ||
| New Features | |||
| WorkStationsupport todeletedischargedpatients | Not provided | The WorkStation providesthe ability to set whether toallow deleting dischargedpatients | In the predicate BeneVisionCentral Monitoring System(K183238), onlyCentralStation supportsdeletion of dischargedpatients. The subject CMSadds the ability forauthorized users to have thecapability to deletedischarged patients. Thechange does not raisedifferent questions of safetyand effectiveness. |
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Comparison of TM80
| Table 4: Device Comparison Table - TM80 | ||||
|---|---|---|---|---|
| -- | ------------------------------------------------ | -- | -- | -- |
| Feature | As cleared in K183238 | Subject Device(modifications in greyand/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 WIFImodule |
| WIFI Protocol | IEEE 802.11a/b/g/n | IEEE 802.11a/b/g/n/ac | The new WIFI modulesupports 802.11ac |
| Modulationmode | Unchanged, as previously submitted | ||
| Operatingfrequency | Unchanged, as previously submitted | ||
| Channel spacing | IEEE 802.11b/g/n (at2.4G): 5 MHzIEEE802.11a/n (at 5G):20MHz | IEEE 802.11b/g/n (at 2.4G):5 MHzIEEE802.11a/n/ac (at 5G):20MHz | The new Wi-Fi modulesupports 802.11ac |
| Wireless baudrate(data rate) | IEEE 802.11b/g/n (at2.4G): 1-65 MbpsIEEE 802.11a/n(at 5G):6~65Mbps | IEEE 802.11b: 1 Mbps to 11MbpsIEEE 802.11a/g: 6 Mbps to54 MbpsIEEE 802.11n: MCS0(6.5Mbps) to MCS7(72.2Mbps)IEEE 802.11ac: MCS0 (6.5Mbps) to MCS8 (86.7Mbps) | Baud rate specifications aremore specific for802.11a/b/g/n,and the new WIFI modulesupport 802.11ac |
| Output power(transfer power) | Unchanged, as previously submitted | ||
| Operating mode | Unchanged, as previously submitted | ||
| Data security | Standard:WPA-PSK and WPA2-PSKWPA-Enterprise, WPA2-EnterpriseEAP method:PEAP-GTC, PEAP-MSCHAPv2, EAP-TLSEncryption: TKIP and AES | Standards:WPA/ WPA2 PSK,WPA/WPA2 EAP,WPA/WPA2 CCKMEAP methods:LEAP, TTLS, TLS, FAST,PEAP-MsChapV2,PEAPGTC,PEAP-TLSEncryption modes:TKIP and AES | The new WIFI modulesupport more securitystandard |
| Qos | Unchanged, as previously submitted | ||
| Communicationprotocol | Unchanged, as previously submitted | ||
| Main Bluetooth specification | |||
| Main Bluetoothspecification | Unchanged, as previously submitted |
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| ECG Specifications | |||
|---|---|---|---|
| Pace mark | Detects and marks pacepulse:Amplitude: ±2 to +700 mVDuration: 0.1 to 2 msRise time: 10 to 100 μsPace detected by hardwarecircuit which includespacer pulse edge detection,amplification andcomparison. | Detects and marks pace pulse:Amplitude: ±2 to ±700 mVDuration: 0.1 to 2 msRise time: 10 to 100 μsAdds ADC conversion in thepacer pulse detectionchannel and supportssoftware pace detectionfunction. | The subject TM80 adds ADC(analog-to-digital) conversionin the pacer pulse detectionchannel. The differences donot raise additional questionsof safety and effectiveness. |
| ECG AlgorithmECG FunctionsHRSTARRQT AnalysisPace pulserejection | Unchanged, as previously submitted | ||
| Resp Specifications | |||
| RespSpecifications | Unchanged, as previously submitted | ||
| SpO2 Specifications | |||
| SpO2Specifications | Unchanged, as previously submitted | ||
| BP10 NIBP module | |||
| BP10 NIBPmodule | 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
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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 clearedin K183238 | Subject TM70 Device(modifications in grey and/orbolded) | Comparison analysis |
|---|---|---|---|
| Power type | Unchanged, as previously submitted | ||
| Display | Unchanged, as previously submitted | ||
| Central Charger | Unchanged, as previously submitted | ||
| IPX | Unchanged, as previously submitted | ||
| Main Wireless Specification | |||
| Modulationmode | DSSS and OFDM | GFSK | |
| Operatingfrequency | FCC:2412Mhz-2462Mhz5180Mhz-5240Mhz,5745Mhz-5825MhzETSI:2412Mhz-2472Mhz5180Mhz-5240Mhz | WMTS-608M:608MHz(608~614MHz) | WMTS-1.4G:1.4GHz(1395~1400 MHzand1427~1432MHz) |
| Channelspacing | IEEE 802.11b/g/n (at2.4G): 5 MHzIEEE802.11a/n (at 5G):20MHz | WMTS-608M:600kHz | WMTS-1.4G:800kHz or600kHz |
| Wireless baudrate(data rate) | IEEE 802.11b/g/n (at2.4G): 1-65 MbpsIEEE 802.11a/n(at 5G):6~65Mbps | WMTS-608M:Max400kbps | WMTS-1.4G:433kbps for800kHzchannelspacing.400kbps for600kHzchannelspacing. |
| The difference between thesubject TM70 and the subjectTM80 is that TM70 usedWMTS instead of WIFI.The WMTS wireless functionis not used in TM80, but theWMTS (608MHz band) isalready used in TMS60(K183238), and the WMTS(1.4GHz band) already usedin Philips MX40 (K172226).The details of WMTS-608Mhave been discussed in Table6: Detailed Comparison ofWMTS-608M SpecificationsThe details of WMTS-1.4Ghave been discussed in Table7: Detailed Comparison ofWMTS-1.4G Specifications | |||
| Max Outputpower(transferpower) | <20 dBm (CErequirement: detectionmode – RMS);<30 dBm (FCCrequirement: detectionmode – peak power). | 10 dBm | |
| Data security | Standard:WPA-PSK and WPA2-PSKWPA-Enterprise, WPA2-EnterpriseEAP method:PEAP-GTC, PEAP-MSCHAPv2, EAP-TLSEncryption: TKIP andAES | Authentication: based onTLSEncryption : AES-128bit | |
| Main Bluetooth specification | |||
| Main Bluetoothspecification | Unchanged, as previously submitted | ||
| ECG Specifications | |||
| Pace mark | Detects and marks pacepulse:Amplitude: ±2 to ±700mVDuration: 0.1 to 2 msRise time: 10 to 100 μsPace detected byhardware circuit whichincludes pacer pulse edgedetection, amplificationand comparison. | Detects and marks pace pulse:Amplitude: ±2 to ±700 mVDuration: 0.1 to 2 msRise time: 10 to 100 μsAdds ADC conversion in thepacer pulse detection channeland supports software pacedetection function. | The subject TM70 adds ADCconversion in the pacer pulsedetection channel. Thedifferences do not raiseadditional questions of safetyand effectiveness. |
| ECG Algorithm | Unchanged, as previously submitted | ||
| ECG FunctionsHRSTARRQT AnalysisPace pulserejection | |||
| Resp Specifications | |||
| RespSpecifications | Unchanged, as previously submitted | ||
| SpO2 Specifications | |||
| SpO2Specifications | Unchanged, as previously submitted | ||
| BP10 NIBP module |
Table 5: Device Comparison Table - TM70
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| BP10 NIBPmodule | Unchanged, as previously submitted |
|---|---|
| --------------------- | ------------------------------------ |
Table 6: Detailed Comparison of WMTS-608M Specifications
| Feature | Predicate TMS60 WMTS608M function (K183238) | Subject TM70 WMTS 608Mfunction | Comparisonanalysis |
|---|---|---|---|
| Modulationmode | GFSK | GFSK | Same |
| Operatingfrequency | 608~614MHz (WMTS band) | 608~614MHz | Same |
| Channelspacing | 25kHz | 600KHz | TMS60 isnarrowbandcommunication andTM70 is broadbandcommunication |
| Wireless baudrate(data rate) | 8 kbps±3% | Max 400kbps | TMS60 isnarrowbandcommunication andTM70 is broadbandcommunication |
| Max Outputpower | 10 dBm (10 mW) | 10 dBm | Same |
| Receiversensitivity | ≤-110dBm (Bit error rate <1%) | ≤-90 dBm for AP≤-87 dBm for TM70 | TMS60 was aunidirectionalnarrowbandcommunication andTM70 is bi-directionalbroadbandcommunications. So,there are receiversensitivityspecifications at bothsides of AP andTM70 transmitter |
| Data security | Private protocol | Authentication based on TLSEncryption using AES-128 bit | TM70 data securityhas improved, to bein line with industrysecurity standards |
| RadioFrequencyAccuracy | Not claimed | ≤±50 kHz relative to channelfrequency | TM70 has a moreprecise definition |
| Occupiedbandwidth | Not claimed | ≤±300 kHz | TM70 has a moreprecise definition |
| Feature | Predicate TMS60 WMTS608M function (K183238) | Subject TM70 WMTS 608Mfunction | Comparisonanalysis |
| Communicationwith the centralstation | TMS60 Transmitters sendwaveforms, parameters, statusand technique alarms of ECG,SPO2;and parameters, status andtechnique alarms of RESP,NIBP to the central station. | TM70 transmits waveforms,parameters, status and alarms ofECG, SPO2, RESP;and parameters, status and alarms ofNIBP to the central station. | TM70 can sendRESP waveforms tothe central station. |
| Data Integrity | Bit error rate ≤1% | The time percentage when a TM70fails to transmit data to the centralstation shall not exceed 0.1% over a24-hour period. | TM70 has a moreprecise definitionand improved dataintegrity |
| Data Latency | Total delay for uploading ofdata from the transmitter to CSis equal to or smaller than 3 s | Total delay of data transmitted fromthe TM70 to the central station: ≤ 3S | Same |
| Transmissiondistance | The maximum distance ofdistinct vision from thetransmitter to the receiverdirect-connected antenna shallbe no less than 50 m. | The maximum distance of distinctvision from the transmitter to thereceiver direct-connected antennashall be no less than 50 m. | Same |
| Roaming | Not supported | The network switchover isautomatically implemented whenTM70 moves from the coveragearea of AP1 to the coverage areaof AP2 | TM70 supportsroaming betweenmultiple APs |
| Receivercapacity | 16 beds | Number of TM70s supported by asingle AP:14for 5-lead ECG;12 for 6-lead ECG;Each TM70 can communicate withthe central station. | TMS60 capacity wasscaled by addingmore receivers,TM70 capacity isscaled by addingmore APs. Both canscale to meet theoverall systemcapacityrequirements |
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| Feature | Predicate TMS60 WMTS608M function (K183238) | Subject TM70 WMTS 608Mfunction | Comparisonanalysis |
|---|---|---|---|
| Resistance towirelessinterference | When the distance betweeninterfering devices (wirelessequipment operated at 2.4GHz,cellular mobilecommunications networkdevice, microwave oven, andcordless phone) and TMS60Transmitters farther than20cm;and there is a -118dBm co-channel WMTS interference atantenna of the receiver. Thewireless functions of theTMS60 are normal. | When the distance betweeninterfering devices (wirelessequipment operated at 2.4GHz,cellular mobile communicationsnetwork device, microwave oven,and cordless phone) and TMS70Transmitter is farther than 20cm;The co-channel interferenceWMTS network (should be nogreater than -85dBm) and anadjacent-channel WMTS network(adjacent-channel power shouldbe no greater than -40dBm@1.2MHz) also exist;TMS70 does not encounternetwork interruption alarm event. | TM70 has a moreprecise definition |
| Dynamicnetworkingstability | The wireless functions of theTMS60 are normal whenTMS60 Transmitters aremoving at the rate of no morethan 3.75 m/s within thecoverage area of Antennaarray. | When TM70 is moving at the rate ofno more than 3.75 m/s within a 15mnon-blocking linear distance, it doesnot encounter network interruptionalarm event. | Same |
| Networkinterruptionalarm | When the communicationbetween the TMS60transmitter and receiver isinterrupted, the CS shouldgenerate an alarm within 8s. | When the network interruptionoccurs, the central station initiatesthe related alarms in 8s. | Same |
| WirelessNetworkingstability | Not claimed | Each of the TM70 roam 30 times, atleast 3 TM70s roam at the sametime, the amount of time each TM70transporting data to central station isnot available shall be less than 0.1%over a 24 hour period. | TM70 has a moreprecise definition |
Table 7: Detailed Comparison of WMTS-1.4G Specifications
| Feature | Predicate MX40 WMTS1.4G function (K172226) | Subject TM70 WMTS 1.4Gfunction | Comparisonanalysis |
|---|---|---|---|
| System maincomponents | Telemetry MonitorCore Access PointAccess Point ControllerSynchronization Unit | Telemetry Monitor (TM70)WMTS Access Point (AP70)WMTS Access Controller (AC70)Synchronous Server (SYNC70) | Just differentnames, theirfunctions are same |
| Modulationmode | GFSK | GFSK | Same |
| Operatingfrequency | 1395 | 1395 | Same |
| Feature | Predicate MX40 WMTS1.4G function (K172226) | Subject TM70 WMTS 1.4Gfunction | Comparisonanalysis |
| Channelspacing | 1.6MHz | 800kHz or 600kHz | TM70 offersadditional flexibilityin spectrumutilization byoffering multiplechannel sizes |
| Wireless baudrate(data rate) | Not claimed | Max 433kbps for 800kHz channelspacing.Max 400kbps for 600kHz channelspacing. | TM70 has a moreprecise definition |
| Max Outputpower | 10 dBm (10 mW) | 10 dBm | Same |
| RadioFrequencyAccuracyduring normaloperation | <+60/-100 kHz relative tochannel frequency | <±50 kHz relative to channelfrequency | TM70 has a betterRadio FrequencyAccuracy |
| Occupiedbandwidth asdefined bypower in 99%BW | < +/- 800 kHz | <± 400 kHz | TM70 requires lessbandwidth |
| Receiversensitivity | Not claimed | ≤-90 dBm for AP≤-87 dBm for TM70 | TM70 has a moreprecise definition |
| Data security | Not claimed | authentication: based on TLSencryption : AES-128bit | TM70 has a moreprecise definition |
| Communicationwith the centralstation | Not claimed | TM70 transmits waveforms,parameters, status and alarms ofECG, SPO2, RESP; andparameters, status and alarms ofNIBP to the central station. | TM70 has a moreprecise definition |
| Data Integrity | Not claimed | The time percentage when aTM70 fails to transmit data to thecentral station shall not exceed0.1% over a 24-hour period. | TM70 has a moreprecise definition |
| Data Latency | Not claimed | Total delay of data transmittedfrom the TM70 to the centralstation: ≤3 s | TM70 has a moreprecise definition |
| Transmissiondistance | Not claimed | Distinct vision distance fromtheTM70 to the AP shall be no lessthan 50 m for LOS. | TM70 has a moreprecise definition |
| Roaming | Not claimed | The network switchover isautomatically implemented whenTM70 moves from the coveragearea of AP1 to the coverage areaof AP2 | TM70 has a moreprecise definition |
| Feature | Predicate MX40 WMTS1.4G function (K172226) | Subject TM70 WMTS 1.4Gfunction | Comparisonanalysis |
| Systemcapacity | 16 | Number of TM70s supported by asingle AP:16 for 800kHz channel spacing&5-lead ECG;14 for 800kHz channel spacing&6-lead ECG;14for 600kHz channel spacing &5-lead ECG;12 for 600kHz channel spacing&6-lead ECG;Each TM70 can communicate withthe central station. | TM70 has a moreprecise definition;The MX40 andTM70 capacity arescaled by addingmore APs. Both canscale to meet theoverall systemcapacityrequirements. |
| Resistance towirelessinterference | Not claimed | When the distance betweeninterfering devices (wirelessequipment operated at 2.4GHz,cellular mobile communicationsnetwork device, microwave oven,and cordless phone) and TMS70Transmitter is farther than 20cm;The co-channel interferenceWMTS network (should be nogreater than -85dBm) and anadjacent-channel WMTS network(adjacent-channel power shouldbe no greater than -40dBm@1.2MHz) also exist;TMS70 does not encounternetwork interruption alarm event. | TM70 has a moreprecise definition |
| Dynamicnetworkingstability | Not claimed | When TM70 is moving at the rateof no more than 3.75 m/s within a15m non-blocking linear distance,it does not encounter networkinterruption alarm event. | TM70 has moreprecise definition |
| Networkinterruptionalarm | Not claimed | When the network interruptionoccurs, the central station initiatesthe related alarms in 8s.When the network is reconnected,wireless connection recoversautomatically. | TM70 has moreprecise definition |
| WirelessNetworkingstability | Not claimed | Each of the TM70 roam 30 times,at least 3 TM70s roam at the sametime, the amount of time eachTM70 transporting data to centralstation is not available shall be lessthan 0.1% over a 24 hour period. | TM70 has a moreprecise definition |
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Summary of main changes for TM70
Wireless modification
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The main difference between the subject TM70 and the subject TM80 is that the TM70 uses WMTS instead of WIFI, as shown in Table 5.
The WMTS wireless function is not used in TM80; but the WMTS (608MHz band) is already used in TMS60 (K183238), and the WMTS (1.4GHz band) is already used in Philips MX40 (K172226).
The comparison and analysis between predicate device TMS60 (K183238) and subject TM70 device regarding WMTS-608M feature is provided in Table 6.
The comparison and analysis between predicate device MX40 (K172226) and subject TM70 device regarding WMTS-1.4G feature is provided in Table 7.
The subject TM70 with the new WMTS technology have passed the FCC certification testing. And the FCC IDs are: ZLZ-WMTSTM70 and ZLZ-WMTSAP70.
The subject TM70 uses WMTS circuit instead of the WIFI circuit of TM80. This wireless module differences do not raise additional questions of safety and effectiveness, through safetv impact analysis.
Mindray conducted safety (UL 60950-1) testing for the AP70, SYNC70, AC70 of BeneVision TM70 Telemetry Monitoring System.
Mindray conducted EMC (IEC 60601-1-2) , wireless coexistence testing (according to AAMI TIR 69 and ANSI C63.27), testing for interaction with radio frequency identification (RFID) systems (AIM Standard 7351731) and software testing to the TM70.
These differences do not raise different questions of safety and effectiveness, and testing demonstrates that the new wireless modification comply with relevant safety standards and have equivalent performance.
Software Pace
The subject TM70 has the same software pace detection function as TM80 which has been changed in this 510K submitting.
The predicate TM70 detects pacemakers by a hardware circuit which includes pacer pulse edge detection, amplification and comparison. The subject TM70 now adds ADC conversion in the pacer pulse detection channel and supports software pace detection function. The pace detection specifications have not been changed. The modification is only for pace detect channel, the ECG channel is not changed, so the modification will not impact HR, ST, OT, ARR performance.
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.
8. 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
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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.
. • 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 for Industry (Including Cardiotachometer and Rate Alarm) (11/5/1998)
Biocompatibility Testing
The CentralStation, ViewStation and CMS viewer are not patient contacting devices, therefore biocompatibility is not applicable. There have been no changes to the patient contacting materials of the telemetry systems.
Sterilization and Shelf Life
The BeneVision Central Monitoring System (CentralStation, ViewStation, WorkStation, and CMS Viewer) is non-sterile when used. The devices are considered non-critical as defined in FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (3/17/2017). There have been no changes to the reprocessing instructions.
No shelf life is claimed for the device and similar to the predicate devices, shelf-life is not applicable because of the low likelihood of time dependent product degradation, therefore performance data is not needed to establish maintenance of device performance characteristics over the shelf-life period.
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 BeneVision 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.
Electromagnetic Compatibility and Electrical Safety
The BeneVision Central Monitoring System was assessed for conformity with the relevant requirements of the following standards and found to comply.
=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
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Bench Testing
To establish the substantial equivalence of the BeneVision Central Monitoring System, Mindray conducted IEC 60601-2-27:2011 Medical electrical equipment--Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment 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.
Wireless performance and coexistence testing
Testing was performed per AAMI TIR 69: 2017 and ANSI C63.27: 2017. Both the TM70 (608 MHz and 1.4 GHz) and TM80 (2412-2472 MHz and 5180-5825 MHz) were tested. For the TM80 up to 16 wireless medical devices can operate within a single AP, with each telemetry module communicating with the central station. For TM70, up to 14 wireless medical devices per single AP for 608 MHz and 16 wireless medical devices per single AP for 1.4 GHz. The device was tested for possible sources of interference in the co-channel and adjacent band.
9. CONCLUSION
Based on the detailed comparison of specifications for each of the modifications to the previously cleared predicates the performance testing, and conformance with applicable standards, the BeneVision Central Monitoring System can be found substantially equivalent to the predicate devices.
§ 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).