(139 days)
BeneVision N12/N15/N17/N19/N22
The BeneVision N12N15/N17/N19/N22 patient monitors are intended for monitoring, displaying, storing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, QT Analysis, and Heart Rate (HR)), Respiration Rate (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure(IBP), Pulmonary Artery Wedge Pressure (PAWP), Cardiac Output (C.O.), Continuous Cardiac Output (CCO), Mixed/Central Venous Oxygen Saturation (SvO2/ScvO2), Carbon Dioxide (CO2), Oxygen (O2), Anesthetic Gas (AG), Impedance Cardiograph (ICG), Bispectral Index (BIS), Respiration Mechanics (RM), Neuromuscular Transmission Monitoring (NMT), Electroencephalograph (EEG), and Regional Oxygen Saturation (rSO2). The system also provides an interpretation of resting 12-lead ECG.
All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:
· BIS, RM, CCO, SvO2/ScvO2, PAWP, and NMT monitoring, PNP, and PNC are intended for adult and pediatric patients only:
· C.O. monitoring and A-Fib are intended for adult patients only;
• ICG monitoring is intended for only adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg.
· rSO2 monitoring is intended for use in individuals greater than 2.5kg.
The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The BeneVision N12/N15/N17/N19/N22 monitors are not intended for helicopter transport. hospital ambulance, or home use.
BeneVision N1 Patient Monitor:
The BeneVision N1 Patient Monitor is intended for monitoring, displaying, storing , alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, and Heart Rate (HR)), Respiration (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP) , Pulmonary Artery Wedge Pressure (PAWP), Carbon Dioxide (CO2) and Oxygen (O2). The system also provides an interpretation of resting 12-lead ECG.
All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:
- PAWP, PNP, and PNC are intended for adult and pediatric patients only;
- A-Fib is intended for adult patients only;
The BeneVision N1 monitor is to be used in healthcare facilities. It can also be used during patient transport inside and outside of the hospital environment. It should be used by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for home use.
The subject BeneVision N Series Patient Monitors includes six monitors:
- BeneVision N12 Patient Monitor
- BeneVision N15 Patient Monitor
- BeneVision N17 Patient Monitor ●
- . BeneVision N19 Patient Monitor
- . BeneVision N22 Patient Monitor
- BeneVision N1 Patient Monitor ●
Mindray's BeneVision N Series Patient Monitors provide a flexible software and hardware platform to meet the clinical needs of patient monitoring.
The provided document describes the BeneVision N Series Patient Monitors and their clearance by the FDA based on substantial equivalence to predicate devices, particularly focusing on changes and new features. The document details the device's intended use, technological comparisons, and performance data from various tests. However, it does not explicitly provide a table of acceptance criteria and reported device performance in the format requested. Instead, it states that "the results of the bench testing show that the subject device meets its accuracy specification and is substantially equivalent to the predicate device."
Specifically regarding "Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm)" which is the relevant regulation name for the product code MHX (used by the BeneVision N Series Patient Monitors), the document states:
"Add arrhythmia detection for neonatal patients when used with the MPM 3.0 module." (Page 9, Table 2 ECG section; Page 22, Table 3 ECG section).
And references "K200015 - ePM series Patient Monitors...: provided as reference devices for ECG algorithm supporting arrhythmia detection in neonate that has been added to the subject BeneVision N Series Patient Monitors." (Page 6, Section 4).
Given the information in the document, here's a structured response:
Acceptance Criteria and Device Performance Study for Arrhythmia Detection in Neonates
The provided FDA 510(k) summary (K202405) for the BeneVision N Series Patient Monitors primarily focuses on demonstrating substantial equivalence to a predicate device (K192972) and a reference device (K200015) for the new feature of neonatal arrhythmia detection. While it explicitly states that the device meets its accuracy specifications, it does not provide a specific table of acceptance criteria or detailed reported performance metrics for neonatal arrhythmia detection. Instead, it relies on general statements about meeting specifications and compliance with standards.
However, based on the document's information and common regulatory expectations for such devices, we can infer the type of acceptance criteria and the nature of the study.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly provide a table for the acceptance criteria and reported device performance for neonatal arrhythmia detection. It states that the device "meets its accuracy specification." For arrhythmia detection systems, typical performance metrics and acceptance criteria, often derived from standards like IEC 60601-2-27, would generally include:
| Metric | Acceptance Criteria (Inferred from regulatory standards and typical arrhythmia detector performance) | Reported Device Performance (Implicitly stated as "meets accuracy specifications" and "substantially equivalent") |
|---|---|---|
| Arrhythmia Detection Accuracy (Sensitivity/Specificity) | e.g., Sensitivity ≥ 90%, Specificity ≥ 95% for various arrhythmia types (e.g., asystole, bradycardia, tachycardia, PVCs) in applicable age groups (neonates) | Met (stated as "meets accuracy specification") |
| False Alarm Rate | e.g., False QRS detection rate < 1%, False alarm rate per hour < 0.2 | Met (stated as "meets accuracy specification") |
| Response Time to Alarms | e.g., Alarm generation within X seconds of event detection | Met (stated as "meets accuracy specification") |
| Heart Rate Accuracy | ±1 bpm or ±1%, whichever is greater (for neonates, 15-350 bpm range) | Met (as per device specifications in Table 2 & 3 ECG section) |
| Pace Detection | Accurate detection of paced beats; no false QRS detection due to pacing spikes | Met (stated as "pace detection enhancement" and "meets accuracy specification") |
| PVCs/min Range (Neonates) | [0, 350] | Met (as per device specifications in Table 2 & 3 ECG section) |
2. Sample Size for Test Set and Data Provenance
The document does not specify the exact sample size used for the test set for the neonatal arrhythmia detection algorithm. It broadly states that "Mindray conducted functional and system level testing on the subject device." The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective data. However, given that it's a 510(k) for a patient monitor and a feature addition (neonatal arrhythmia detection), it's highly likely that a combination of retrospective ECG databases (e.g., MIT-BIH Arrhythmia Database, AHA database, or internal proprietary databases containing neonatal ECGs) and/or prospective testing on simulated or recorded neonatal ECGs would have been used.
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number or qualifications of experts used to establish the ground truth for the test set related to neonatal arrhythmia detection. In studies for arrhythmia detection, ground truth is typically established by certified cardiologists, electrophysiologists, or other medical specialists trained in ECG interpretation, often with years of experience.
4. Adjudication Method
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for establishing the ground truth or evaluating the test set results. For arrhythmia detection, a common method involves multiple experts reviewing the same data, with discrepancies resolved by a senior expert or consensus voting (e.g., 2 out of 3 agreement).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study directly related to the new neonatal arrhythmia detection feature or the overall performance of the patient monitor with human readers. The submission focuses on the performance of the device itself and its substantial equivalence to predicate devices, not on the improvement of human reader performance with AI assistance. Therefore, no effect size of human reader improvement with AI vs. without AI assistance is reported.
6. Standalone Performance Study
Yes, a standalone performance study was done for the algorithm. The document explicitly states: "Mindray conducted functional and system level testing to validate the performance of the devices. The results of the bench testing show that the subject device meets its accuracy specification and is substantially equivalent to the predicate device." This indicates that the algorithm's performance was evaluated independently of human-in-the-loop interaction.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for the testing. For arrhythmia detection algorithms, the ground truth is typically established through expert consensus on annotated ECG waveforms, possibly validated against physiological events or other clinical data where available.
8. Sample Size for the Training Set
The document does not provide any information regarding the sample size for the training set used to develop or refine the neonatal arrhythmia detection algorithm.
9. How Ground Truth for the Training Set Was Established
Similarly, the document does not describe how the ground truth for the training set was established. Analogous to the test set, it would typically involve manual annotation of ECG data by experts, but this information is not present in the provided text.
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January 07, 2021
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. Yanhong Bai Manager Regulatory Affairs, Technical Regulation Department Mindray Building, Keji 12th Road South High-tech Industrial Park, Nanshan Shenzhen, Guangdong 518057 China
Re: K202405
Trade/Device Name: BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1) Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MHX Dated: December 10, 2020 Received: December 11, 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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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.
for
Jennifer Shih Kozen Assistant Director 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) K202405
Device Name
BeneVision N Series Patient Monitors (Including BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1)
Indications for Use (Describe) BeneVision N12/N15/N17/N19/N22
The BeneVision N12N15/N17/N19/N22 patient monitors are intended for monitoring, displaying, storing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, QT Analysis, and Heart Rate (HR)), Respiration Rate (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure(IBP), Pulmonary Artery Wedge Pressure (PAWP), Cardiac Output (C.O.), Continuous Cardiac Output (CCO), Mixed/Central Venous Oxygen Saturation (SvO2/ScvO2), Carbon Dioxide (CO2), Oxygen (O2), Anesthetic Gas (AG), Impedance Cardiograph (ICG), Bispectral Index (BIS), Respiration Mechanics (RM), Neuromuscular Transmission Monitoring (NMT), Electroencephalograph (EEG), and Regional Oxygen Saturation (rSO2). The system also provides an interpretation of resting 12-lead ECG.
All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:
· BIS, RM, CCO, SvO2/ScvO2, PAWP, and NMT monitoring, PNP, and PNC are intended for adult and pediatric patients only:
· C.O. monitoring and A-Fib are intended for adult patients only;
• ICG monitoring is intended for only adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg.
· rSO2 monitoring is intended for use in individuals greater than 2.5kg.
The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The BeneVision N12/N15/N17/N19/N22 monitors are not intended for helicopter transport. hospital ambulance, or home use.
(Continue on next page for N1 indications for Use)
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)
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510(k) Number (if known): K202405 Indications for Use (con't)
BeneVision N1 Patient Monitor:
The BeneVision N1 Patient Monitor is intended for monitoring, displaying, storing , alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, and Heart Rate (HR)), Respiration (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP) , Pulmonary Artery Wedge Pressure (PAWP), Carbon Dioxide (CO2) and Oxygen (O2). The system also provides an interpretation of resting 12-lead ECG.
All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:
- PAWP, PNP, and PNC are intended for adult and pediatric patients only;
- A-Fib is intended for adult patients only;
The BeneVision N1 monitor is to be used in healthcare facilities. It can also be used during patient transport inside and outside of the hospital environment. It should be used by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for home use.
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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 N Series Monitors is provided below.
1. SUBMITTER
| Applicant: | SHENZHEN MINDRAY BIO-MEDICALELECTRONICS CO., LTD.Mindray Building, Keji 12th Road SouthHigh-tech Industrial Park, NanshanShenzhen 518057, P.R. ChinaTel: +86 755 81888998Fax: +86 755 26582680 |
|---|---|
| Contact: | Contact Person: Yanhong BaiTitle: Manager Regulatory AffairsPhone: +86 755 81885635Fax: +86 755 26582680E-mail: baiyanhong@mindray.com |
| Date Prepared: | December 08, 2020 |
| 2.DEVICE | |
| Device Trade Name: | BeneVision N Series Patient Monitors (IncludingBeneVision N12, BeneVision N15, BeneVision N17,BeneVision N19, BeneVision N22, BeneVision N1) |
| Device Common Name: | Patient Monitor |
| Classification Name: | 21 CFR 870.1025, Class II, Arrhythmia detector andalarm (including ST-segment measurement and alarm) |
| Regulatory Class: | Class II |
| Primary Product Code: | MHX - Monitor, Physiological, Patient (witharrhythmia detection or alarms) |
| Panel | Cardiovascular |
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| RegulationNumber/Class | ProductCode | Regulation description | Device Common Name |
|---|---|---|---|
| 870.1025, II | DSI | Arrhythmia detector and alarm(including ST-segment measurementand alarm) | Detector and alarm, arrhythmia |
| 870.1025, II | MLD | Arrhythmia detector and alarm(including ST-segment measurementand alarm) | Monitor, st segment with alarm |
| 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-pressurenon-invasive |
| 870.1110, II | DSK | Blood pressure computer | Computer, blood-pressure |
| 880.2770, II | DSB | Impedance plethysmograph. | Plethysmograph, impedance |
| 880.2700, II | MUD | Oximeter | Oximeter, tissue saturation |
| 870.2340, II | MLC | Electrocardiograph | Monitor, st segment |
| 870.2370, II | KRC | Electrocardiograph surface electrodetester. | Tester, electrode, surface,electrocardiographic |
| 880.2910, II | FLL | Clinical electronic thermometer | Thermometer, electronic, clinical |
| 870.2700, II | DQA | Oximeter | Oximeter |
| 870.2300, II | MSX | Cardiac monitor (includingcardiotachometer and rate alarm). | System, network and communication,physiological monitors |
| 870.2910, II | DRG | Radiofrequency physiological signaltransmitter and receiver. | Transmitters and receivers,physiological signal, radiofrequency |
| 868.1400, II | CCK | Carbon dioxide gas analyzer | Analyzer, gas,carbon-dioxide, gaseous-phase |
| 870.1435, II | DXG | Single-function, preprogrammed | Computer, diagnostic, pre- |
Table 1:
| 870.2910, II | DRG | Radiofrequency physiological signaltransmitter and receiver. | Transmitters and receivers,physiological signal, radiofrequency |
|---|---|---|---|
| 868.1400, II | CCK | Carbon dioxide gas analyzer | Analyzer, gas,carbon-dioxide, gaseous-phase |
| 870.1435, II | DXG | Single-function, preprogrammeddiagnostic computer | Computer, diagnostic, pre-programmed, single-function |
| 870.1100, II | DSJ | Blood pressure alarm | Alarm, blood-pressure |
| 870.2850, II | DRS | Transducer, blood-pressure,extravascular | Extravascular blood pressuretransducer. |
| 868.1500, II | CBQ | Enflurane gas analyzer. | Analyzer, gas, enflurane, gaseous-phase (anesthetic concentration) |
| 868.1500, II | NHO | Enflurane gas analyzer. | Analyzer, gas, desflurane, gaseous-phase (anesthetic concentration) |
| 868.1500, II | NHP | Enflurane gas analyzer. | Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration) |
| 868.1500, II | NHQ | Enflurane gas analyzer. | Analyzer, gas, isoflurane, gaseous-phase (anesthetic concentration) |
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| RegulationNumber/Class | ProductCode | Regulation description | Device Common Name |
|---|---|---|---|
| 868.1620, II | CBS | Halothane gas analyzer. | Analyzer, gas, halothane, gaseous-phase (anesthetic conc.) |
| 868.1700, II | CBR | Nitrous oxide gas analyzer. | Analyzer, gas, nitrous-oxide, gaseousphase (anesthetic conc.) |
| 868.1720, II | CCL | Oxygen gas analyzer. | Analyzer, gas, oxygen, gaseous-phase |
| 868.2775, II | KOI | Electrical peripheral nerve stimulator. | Stimulator, nerve, peripheral, electric |
| 882.1400, II | OLW | Electroencephalograph. | Index-generatingelectroencephalograph software |
| 882.1400, II | OLT | Electroencephalograph. | Non-normalizing quantitativeelectroencephalograph software |
| 882.1400, II | OMC | Electroencephalograph. | Reduced-montage standardelectroencephalograph |
| 882.1400, II | ORT | Electroencephalograph | Burst suppression detection softwarefor electroencephalograph |
| 882.1320, II | GXY | Cutaneous electrode. | Electrode, cutaneous |
PREDICATE DEVICES 3.
- . Predicate: K192972 – BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1)
REFERENCE DEVICES 4.
- K200015 - ePM series Patient Monitors (ePM 10/ePM 12/ePM 15/ePM 10M/ePM 12M/ePM 15M): provided a provided as reference devices for ECG algorithm supporting arrhythmia detection in neonate that has been added to the subject BeneVision N Series Patient Monitors.
DEVICE DESCRIPTION ನ.
The subject BeneVision N Series Patient Monitors includes six monitors:
- BeneVision N12 Patient Monitor
- BeneVision N15 Patient Monitor
- BeneVision N17 Patient Monitor ●
- . BeneVision N19 Patient Monitor
- . BeneVision N22 Patient Monitor
- BeneVision N1 Patient Monitor ●
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Mindray's BeneVision N Series Patient Monitors provide a flexible software and hardware platform to meet the clinical needs of patient monitoring.
6. INTENDED USE/INDICATIONS FOR USE
BeneVision N12/N15/N17/N19/N22 Patient Monitors:
The BeneVision N12/N15/N17/N19/N22 patient monitors are intended for monitoring, displaying, reviewing, storing, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 6-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, OT Analysis, and Heart Rate (HR)), Respiration Rate (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Pulmonary Artery Wedge Pressure (PAWP), Cardiac Output (C.O.), Continuous Cardiac Output (CCO), Mixed/Central Venous Oxygen Saturation (SvO2/ScvO2), Carbon Dioxide (CO2), Oxygen (O2), Anesthetic Gas (AG), Impedance Cardiograph (ICG), Bispectral Index (BIS), Respiration Mechanics (RM), Neuromuscular Transmission Monitoring (NMT), Electroencephalograph (EEG), and Regional Oxygen Saturation (rSO2). The system also provides an interpretation of resting 12-lead ECG.
All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:
- BIS, RM, CCO, SvO2/ScvO2, PAWP, NMT monitoring, PNP, and PNC are intended ● for adult and pediatric patients only;
- C.O. monitoring and A-Fib are intended for adult patients only; ●
- ICG monitoring is intended for only adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg.
- . rSO2 monitoring is intended for use in individuals greater than 2.5kg.
The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The BeneVision N12/N15/N17/N19/N22 monitors are not intended for helicopter transport, hospital ambulance, or home use.
BeneVision N1 Patient Monitor:
The BeneVision N1 Patient Monitor is intended for monitoring, displaying, storing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 6-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, QT Analysis, and Heart Rate (HR)), Respiration (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP) , Pulmonary Artery Wedge Pressure (PAWP), Carbon Dioxide (CO2) and Oxygen (O2). The system also provides an interpretation of resting 12-lead ECG.
All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:
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- . PAWP, PNP and PNC are intended for adult and pediatric patients only;
- . A-Fib is intended for adult patients only;
The BeneVision N1 monitor is to be used in healthcare facilities. It can also be used during patient transport inside and outside of the hospital environment. It should be used by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for home use.
7. SUBSTANTIAL EQUIVALENCE
Comparison of Indications
Both the predicate devices and the subject devices are multiparameter patient monitors intended to be used under the direction of clinical professionals.
The indications for use statement of the subject BeneVision N1/N12/N15/N17/N19/N22 has been modified to include support for arrhythmia detection in neonates when used with the MPM 3.0 module. Although this feature is not present in the primary predicate devices, it is present in other cleared multiparameter patient monitors such as the Mindray ePM series Patient Monitors (K200015, ePM 10/ePM 12/ePM 15/ePM 10M/ePM 15M). The inclusion of supporting arrhythmia detection in neonates in the indications for use does not constitute a new fundamental intended use.
In conclusion, the minor difference in the indications for use statement does not change the fundamental intended use of the N Series monitors as multiparameter monitors.
Technological Comparison
The tables below compare the key technological feature of the subject devices to the predicate device (N series Patient Monitors, K192972). The features in green are features which are different between the predicate devices and the subject devices.
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| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 |
|---|---|---|---|---|---|---|---|---|---|---|
| Cleared in K192972 | Subject Device | |||||||||
| Primary displayand touchscreen | 22"1680*1050pixels. | 19"1680*1050pixels. | 18.5"1920*1080pixels. | 15.6"1920*1080pixels. | 12.1"1280*800pixels. | Nochange | Nochange | No change | Nochange | No change |
| Secondarydisplay | Independent control anddisplay. | Independent control anddisplay. | Independentcontrol anddisplay.Size: 21.5";Model:2203L. | Mirrored display.Size: 21.5";Model: 2203L. | No change | No change | No change | No change | No change | |
| iView | Change the PC platformCapacity of RAM: 8GBModel of CPU: N4200Windows 10 | Not supported. | No change | No change | No change | No change | No change | |||
| Wireless radiomodule | The 2.4G/5G module for connecting to a network wirelessly,constructing a monitoring network with a central monitoring system(CMS).WiFi module: MSD45N | The 2.4G/5G module for connecting to a network wirelessly,constructing a monitoring network with a central monitoring system(CMS).WiFi module: MSD45N and SX-SDMAC-2832S+ | ||||||||
| Module rack | Must be connected to themain unit to provide up to8 standard module slots. | Optional for the patientmonitors, adding 8 standardmodule slots to extend themeasurement capabilities ofthe system. | Notsupported. | No change | No change | No change | No change | No change | ||
| Power supply | One rechargeable Lithium-ion battery or AC power supply. | No change | ||||||||
| Battery | Chargeable Lithium-Ion,10.8 VDC, 5600 mAh. | Chargeable Lithium-Ion, 10.95 VDC,4500 mAh. | No change | No change | No change | No change | No change | |||
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 |
| Cleared in K192972 | Subject Device | |||||||||
| Data storage | Solid State Hard Drive(SDD) | Embedded Multi Media Card (eMMC). | No change | |||||||
| Data recorder | Supports the thermalrecorder module, needs tobe plugged into the SMR. | Supports the thermal recorder module andthe built-in thermal recorder, but theycannot work at the same time. | No change | |||||||
| Speaker | Provides audible alarm tones (45 to 85 dB), key tones, QRS tones;support PITCH TONE and multi-level tone modulation. | No change | ||||||||
| Alarm system | Supports alarm volume escalation. The alarm lamp will light cyan,yellow, or red depending on alarm type. | No change | ||||||||
| Support T1/N1 asa Module | Support T1/N1 acting as a module. | No change | ||||||||
| Connect withMindraytelemetrymonitors | Connect with the TM80 and the BP10 NIBP module to receive ECG,SpO2, RESP, and NIBP waveforms and parameters. | Connect with the TM80/TM70 and the BP10 NIBP module to receiveECG, SpO2, RESP, and NIBP waveforms and parameters. | ||||||||
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 |
| Cleared in K192972 | Subject Device | |||||||||
| ECG | 3-lead, 5-lead, 6-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, QT analysis, an interpretation of resting 12-lead ECG, J-point Auto detection, Dual Channel Pace detection, adjustable QRS threshold, Multi-lead ECG synchronization analysis and heart rate (HR).Can be configured with either the Mindray or Mortara algorithm for ECG arrhythmia monitoring and arrhythmia detection. MPM 3.0: supports Mindray Algorithm. MPM 2.0, and TM80: support Mindray or Mortara algorithm Supports intelligent arrhythmia alarmsHR Measurement range: 15 | 3-lead, 5-lead, 6-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, QT analysis, an interpretation of resting 12-lead ECG, J-point Auto detection, Dual Channel Pace detection, adjustable QRS threshold, Multi-lead ECG synchronization analysis and heart rate (HR).Can be configured with either the Mindray or Mortara algorithm for ECG arrhythmia monitoring and arrhythmia detection. MPM 3.0: supports Mindray Algorithm. MPM 2.0: support Mindray or Mortara algorithm Supports intelligent arrhythmia alarmsHR Measurement range: 15 | ||||||||
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 |
| Cleared in K192972 | Subject Device | |||||||||
| Respiration rate(Resp) | Measure the respiration waveforms and respiratory rate through transthoracic impedance method.Measurement range: Adult: 0 to 120 rpm; Pediatric, neonate: 0 to 150 rpm.Accuracy: 7 to 150 rpm: ±2 rpm or ±2%, whichever is greater;0 to 6 rpm: Not specified.This measurement can be used for adults, pediatrics and neonates. | No change | ||||||||
| Temperature(Temp) | Uses the MPM (Multi Parameter Module), T1, N1 or the Temperature Module to measure temperature using the thermal resistance method.Measurement range: 0 to 50°C (32 to 122°F).Accuracy: ±0.1°C or ±0.2°F (without probe).This measurement can be used for adults, pediatrics and neonates. | No change | ||||||||
| Pulse oxygensaturation (SpO2) | Uses the MPM (Multi Parameter Module), T1, N1 or the SpO2 Module to measure Pulse oxygen saturation. N Series patient monitors are compatible with the following 3 types of modules to measure oxygen saturation:Mindray SpO2 moduleMeasurement range: 0~100% Accuracy: 70% | Uses the MPM (Multi Parameter Module) or the SpO2 Module to measure Pulse oxygen saturation. N Series patient monitors are compatible with the following 3 types of modules to measure oxygen saturation:Mindray SpO2 moduleMeasurement range: 0~100% Accuracy: 70% |
Table 2: Device Comparison Table (BeneVision 22/N19/N17/N15/N12)
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| Feature | N22 | N19 | N17 | N15 | N12 |
|---|---|---|---|---|---|
| Cleared in K192972 | |||||
| Subject Device | |||||
| Pulse rate (PR) | Pulse rate may be obtained from all sources of SpO2, or the IBP module.Measurement range: 20 | No change | |||
| Non-invasiveblood pressure(NIBP) | Uses the MPM (Multi Parameter Module), T1 or N1 to measure NIBP.The MPM uses the oscillometric method for measuring non-invasive blood pressure (NIBP).Measurement range:Systolic: 25 | Uses the MPM (Multi Parameter Module) to measure NIBP. TheMPM uses the oscillometric method for measuring non-invasive blood pressure (NIBP).Measurement range:Systolic: 25 | |||
| Invasive blood | Uses the MPM (Multi Parameter Module), T1, N1 or the IBP Module to measure invasive blood pressure. The monitor can monitor up to 8 | No change |
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| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Subject Device | ||||||||||||
| pressure (IBP) | Cleared in K192972 | |||||||||||
| invasive blood pressures and displays systolic, diastolic and meanpressures and a waveform for each pressure.The IBP supports Pulse Pressure Variation (PPV) and Pulmonary ArteryWedge Pressure (PAWP) function.Measurement range: -50~300mmHg,Accuracy of module: ±2% or ±1mmHg, whichever is greater (withoutsensor)This measurement can be used for adults, pediatrics and neonates exceptthat PAWP is not for neonates. | ||||||||||||
| Cardiac output(C.O.) | The cardiac output (C.O.) measurement invasively measures cardiacoutput and other hemodynamic parameters using the right heart (atria)thermodilution method. The temperature change is displayed as a curvein the C.O. split screen, and the monitor calculates the C.O. value fromthis curve. The monitor can store up to 6 measurements.Measurement range:C.O.: 0.1 | No change | ||||||||||
| Continuouscardiac output(CCO) | The CCO/SvO2 interface module is used to interface with EdwardsVigilance II monitor (cleared in K043103)/ Vigileo monitor (cleared inK103094)/ EV1000 monitor (cleared in K160552) / HemoSpheremonitor (cleared in K163381) which measures continuous cardiac output(CCO).This measurement can be used for adults and pediatrics. | No change | ||||||||||
| Mixed/centralvenous oxygensaturation | The CCO/SvO2 interface module is used to interface with EdwardsVigilance II monitor (cleared in K043103)/ Vigileo monitor (cleared inK103094)/ EV1000 monitor (cleared in K160552) / HemoSphere | No change |
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| Feature | N22 | N19 | N17 | Cleared in K192972 | N22 | N19 | N17 | N15 | N12 | ||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Subject Device | |||||||||||
| (SvO2/ScvO2) | monitor (cleared in K163381) which measures mixed venous oxygen saturation (SvO2) and central venous oxygen saturation (ScvO2).This measurement can be used for adults and pediatrics. | No change | |||||||||
| Central venous oxygen saturation (ScvO2) | Central venous oxygen saturation (ScvO2) is measured using spectrophotometry.Measurement range: 0 to 99%Accuracy: 50% to 80%: ±3%, Other ranges: Not specified.This measurement can be used for adults and pediatrics. | No change | |||||||||
| Carbon dioxide (CO2) | CO2 can be measured using the Mindray Sidestream CO2 module, Mindray AG module or third-party CO2 modules, Microstream module and Mainstream module.Type: Sidestream CO2 module.Measurement range: CO2: 0 | No change | |||||||||
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | |
| Cleared in K192972 | Subject Device | ||||||||||
| Accuracy: Full accuracy mode: 0%≤CO2<1%, ±0.1%ABS, 1%< CO2≤5%, ±0.2% ABS, 5%ISO mode: Add ±0.3% ABS.CO2 monitoring is based on calculations that come from measuring the absorption of infrared (IR) light of specific wavelengths using a photodetector.This measurement can be used for adults, pediatrics and neonates. | |||||||||||
| Oxygen (O2) | Oxygen values are measured by the Sidestream CO2 module or the AG module using a paramagnetic method.Measurement range: 0 | No change | |||||||||
| Anesthetic gas(AG) | The AG module analyzes gas samples from the patient and calculates CO2, O2, N2O, and AA waveforms and related numerics that include airway respiratory rate and MAC (minimum alveolar concentration).Measurement range:HAL, ENF, ISO, SEV, DES: 0 | No change | |||||||||
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | |
| Cleared in K192972 | Subject Device | ||||||||||
| specified;awRR:2~60rpm, ±1rpm, >60rpm, not specifiedThis measurement can be used for adults, pediatrics and neonates. | |||||||||||
| Impedancecardiograph(ICG) | ICG measures a patient's hemodynamic status using a non-invasivemethod based on thoracic electrical bioimpedance (TEB) technology. | No change | |||||||||
| Measurement range:C.O.:1.4 | |||||||||||
| Bispectral index(BIS) | The BIS Module monitors the state of the brain by data acquisition ofEEG signals. Bispectral index (BIS) is a processed EEG variable thatcan be used as an aid in monitoring the effects of certain anestheticagents.Measurement range: BIS, BIS L, BIS R: 0~100.Accuracy: not specified.This measurement can be used for adults and pediatrics. | No change | |||||||||
| Respirationmechanics (RM) | The RM module measures respiration mechanics for adult and pediatricpatients. | No change | |||||||||
| Measurement range: | Accuracy: | ||||||||||
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | |
| Cleared in K192972 | Subject Device | ||||||||||
| FLOW:Adult/Pediatric: ±(2 | FLOW:Adult/Pediatric: 1.2L/min or±10% of reading, whichever isgreater;Infant: 0.5 L/min or ±10% of thereading, whichever is greaterPAW: ±3% of reading;MVe/MVi: ±10% of reading;TVe/TVi:Adult/Pediatric: ±15ml or ±10%of reading, whichever is greater;Infant: ±6 ml or ±10%×reading,whichever is greaterCalculated Parameters:awRR:4 | ||||||||||
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | |
| Cleared in K192972 | Subject Device | ||||||||||
| Neuromusculartransmissionmonitoring(NMT) | NMT evaluates muscle relaxation of patients under a neuromuscularblock by measuring the strength of muscle reaction after electricallystimulating the dedicated motor nerve.Measurement range:ST-Ratio:0 | No change | |||||||||
| Electroencephalograph (EEG) | The EEG module measures the spontaneous, rhythmic electrical activityof the cortex. The EEG module can continuously monitor EEG signalsfrom up to 4 channels. It can also display Density Spectral Arrays (DSA)and Compressed Spectral Arrays (CSA).Frequency response: 0.5Hz~50Hz(-3dB)Input range: 4mVppDC offset: ±500 mVCMRR: ≥100 dB@51 kΩ and 60HzNoise level: ≤0.5 uVrms (1Hz to 30 HzDifferential input resistance: >15MΩ@10HzElectrode resistance: 0 to 90 kΩ, resolution: ±1 kΩ or 10%, whichever isthe greaterThis measurement is intended to be used for adults, pediatrics andneonates. | No change | |||||||||
| Regional oxygensaturation (rSO2) | The rSO2 module provides noninvasive and continuous information ofchanges in regional oxygen saturation of blood. The measurement takesplace in real time, providing an immediate indication of a change in the | No change | |||||||||
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | |
| Subject Device | |||||||||||
| Cleared in K192972 | |||||||||||
| critical balance of regional oxygen delivery and oxygen consumption. | |||||||||||
| Measurement range: rSO2: 15~95. | |||||||||||
| This measurement can be used for adults, pediatrics and neonates. | |||||||||||
| ECG 24hSummary | Provides an option to view a summary of a patient's ECG statistics from the previous 24 hours, including HR statistics, ARR event statistics, max and min ST statistics of each lead, QT/QTc measurement statistics, Pacer statistics (for patients being paced), and typical ECG strips. | No change | |||||||||
| Dynamicminitrend | The Minitrend window is located to the left of the waveform area and shows the recent trend of a series of parameters. | The Minitrend window is located to the left of the waveform area and shows the recent trend of a series of parameters.The Minitrend window is modified to enable users to hide, half display, or fully display the window by dragging the handle. | |||||||||
| Early WarningScore (EWS) | The EWS is a set of early warning scores that are intended to assist clinicians in recognizing the early signs of deterioration in patients based on vital signs and clinical observations. The three types of EWS provided are Modified Early Warning Score (MEWS), National Early Warning Score (NEWS), National Early Warning Score2 (NEWS2), and a user configurable Custom Score. | The EWS is a set of early warning scores that are intended to assist clinicians in recognizing the early signs of deterioration in patients based on vital signs and clinical observations. The three types of EWS provided are Modified Early Warning Score (MEWS), National Early Warning Score (NEWS), National Early Warning Score2 (NEWS2), and a user configurable Custom Score.The EWS window is modified to enable users to hide, half display, or fully display the window by dragging the handle. | |||||||||
| Glasgow ComaScale (GCS) | The GCS a well-established scoring system used to assess the state of consciousness based three sub-components: eye-opening response, verbal response, and limb movement. | No change | |||||||||
| SepsisSight | The SepsisSight feature is intended to help clinicians recognize the early signs and symptoms of Sepsis based on recommendations from the published literature (Surviving Sepsis Campaign: International Guidelines for Management of Severe Sepsis and Septic Shock: 2016 and The Third International Consensus Definition for Sepsis and Septic Shock (Sepsis-3)). | No change | |||||||||
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | |
| Cleared in K192972 | Subject Device | ||||||||||
| Cardio-pulmonaryresuscitation(CPR) Dashboard | Records all operations during rescue.The rescue operations recorded can be customized and include treatment(rescue drug input, rescue treatment input, start/end rescue, rescue startcondition, rescue end condition). | No change | |||||||||
| Deviceintegration | Support BeneLink Module to connect Anesthesia, Ventilator, Pump,TcGas Monitor Device, and Single Parameter Device.The types of the devices that can be connected are still only the fivetypes listed above, but some types added newly approved devices. | No change | |||||||||
| OxyCRGFunction | Support the function of oxygen cardio-respirogram (OxyCRG) when thepatient type is neonate, and simultaneously provide real-time OxyCRGinterface and OxyCRG review interface to display parameter trends andwaveforms, and OxyCRG events. | No change | |||||||||
| Accessories | The accessories including ECG, SpO2, Temp, NIBP, IBP, C.O., ScvO2,ICG, BIS, CO2, AG, RM, EEG, BIS, NMT, rSO2, CCO/SvO2accessories. | Add new C.O. accessories |
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Table 3: Device Comparison Table – BeneVision N1
| Feature | N1 | N1 |
|---|---|---|
| Cleared in K192972 | Subject Device | |
| Primary displayand touchscreen | 5.5", 720*1280 pixels. | No change |
| External display | Allows the display of mirrored or independent data whenconnected to an external monitor through the video connectorprovided by the Dock. | No change |
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| Feature | N1 | N1 |
|---|---|---|
| Cleared in K192972 | Subject Device | |
| Power supply | Two rechargeable Lithium-ion batteries (without built-in CO2module), one rechargeable Lithium-ion battery (with built-inCO2 module), or DC-in power supply. | No change |
| Battery | Chargeable Lithium-ion 7.2VDC, 2500mAh. | No change |
| Data storage | Embedded Multi Media Card (eMMC) | No change |
| Speaker | Gives alarm tones (45 to 85 dB), key tones, QRS tones; supportPITCH TONE and multi-level tone modulation. | No change |
| Alarm system | Supports Alarm Volume Escalation.The alarm lamp will light cyan, yellow, or red depending onalarm type. | No change |
| Communicationon Interface whenN1 is working asa module | Infrared communication interface.Pogo pin communication interface. | No change |
| Feature | N1 | N1 |
| Cleared in K192972 | Subject Device | |
| ECG | 3-lead, 5-lead, 6-lead, or 12-lead selectable, arrhythmiadetection, ST segment analysis, QT analysis, an interpretation ofresting 12-lead ECG, J-point auto detection, Dual channel pacedetection, adjustable QRS threshold, Multi-lead ECGsynchronization analysis and heart rate (HR)Supports intelligent arrhythmia alarm.Measurement range:ST: -2.0mV~+2.0mV;QT: 200 | 3-lead, 5-lead, 6-lead, or 12-lead selectable, arrhythmia detection,ST segment analysis, QT analysis, an interpretation of resting 12-lead ECG, J-point auto detection, Dual channel pace detection,adjustable QRS threshold, Multi-lead ECG synchronization analysisand heart rate (HR)Supports intelligent arrhythmia alarm.Pace detection enhancementExpand the PVCs/min range: for adult mode is [0,300], Forpediatric and neonate mode is [0,350]Measurement range:ST: -2.0mV~+2.0mV;QT: 200 |
| Respiration rate(Resp) | Measure the respiration waveforms and respiratory rate throughtrans-thoracic impedance method.Measurement range: Adult: 0 to 120 rpm; Pediatric, neonate: 0 to150 rpm.Accuracy: 7 to 150 rpm: ±2 rpm or ±2%, whichever is greater;0 to 6 rpm: Not specified.This measurement can be used for adults, pediatrics andneonates. | No change |
| Feature | N1 | N1 |
| Cleared in K192972 | Subject Device | |
| Temperature(Temp) | Measures temperature using the thermal resistance method.Measurement range: 0 to 50 °C (32 to 122°F).Accuracy: ±0.1 °C or ±0.2 °F (without probe).This measurement can be used for adults, pediatrics andneonates. | No change |
| Pulse oxygensaturation (SpO2) | Integrates one of the 3 kinds of SpO2 modules:Mindray SpO2 module boardMeasurement range: SpO2:0~100 %,Accuracy: 70% | Integrates one of the 3 kinds of SpO2 modules:Mindray SpO2 module boardMeasurement range: SpO2:0~100 %.Accuracy: 70% |
| Feature | N1 | N1 |
| Cleared in K192972 | Subject Device | |
| Pulse rate (PR) | Obtains pulse rate from SpO2 or IBP.Measurement range: 20 | No change |
| Non-invasiveblood pressure(NIBP) | The N1 uses the oscillometric method for measuring non-invasive blood pressure (NIBP).Measurement range:Systolic: 25 | The N1 uses the oscillometric method for measuring non-invasiveblood pressure (NIBP). This measurement can be used for adults,pediatrics, and neonates.Measurement range:Systolic: 25 |
| Feature | N1 | N1 |
| Cleared in K192972 | Subject Device | |
| Invasive bloodpressure (IBP) | The monitor can monitor up to 2 invasive blood pressures anddisplays the systolic, diastolic, and mean pressures and awaveform for each pressure.The IBP supports Pulse Pressure Variation (PPV) and PulmonaryArtery Wedge Pressure (PAWP) function.Measurement range: -50~300mmHg.Accuracy: ±2% or ±1mmHg, whichever is greater (withoutsensor).This measurement can be used for adults, pediatrics and neonatesexcept that PAWP is not for neonates. | The monitor can monitor up to 4 invasive blood pressures anddisplays the systolic, diastolic, and mean pressures and a waveformfor each pressure.The IBP supports Pulse Pressure Variation (PPV) and PulmonaryArtery Wedge Pressure (PAWP) function.The monitor added stand-alone IBP module in this 510(k).Measurement range: -50~300mmHg.Accuracy: ±2% or ±1mmHg, whichever is greater (without sensor).This measurement can be used for adults, pediatrics and neonatesexcept that PAWP is not for neonates. |
| Feature | N1 | N1 |
| Cleared in K192972 | Subject Device | |
| Carbon dioxide(CO2) | CO2 can be measured using a built-in Sidestream CO2 2.0 module, or it can also connect to an external Sidestream CO2 2.0 module (when used with a rack). Alternatively, third-party CO2 modules, Microstream module and Mainstream module, can be used.Type: Sidestream CO2 moduleMeasurement range:CO2: 0 | No change |
| Feature | N1 | N1 |
| Cleared in K192972 | Subject Device | |
| Oxygen (O2) | Oxygen values are measured by the Sidestream CO2 (only forexternal Sidestream CO2 2.0 module) module using aparamagnetic method.Measurement range: O2: 0 | No change |
| Dock, Rack andTransport Dock | The Dock is used to connect either the N1 without a Rack or theN1 docked inside a Rack, in order to extend ports such as USB,VGA, or wired network.The Rack can connect an external parameter module, such asCO2, to N1.The Transport Dock is used to provide DC voltage to N1 whenN1 is used for out-of-hospital transportation on the ambulancevehicle or aircraft. The Transport Dock is fixed on theambulance vehicle or aircraft and converts an AC input to DCoutput. | No change |
| Wireless radiomodule | The Wireless radio module is used for connecting to a wirelessmonitoring network with a central monitoring system (CMS). | No change |
| Helicopter andambulancetransport | ECG, RESP, Temp, SpO2, PR, NIBP, and IBP can be monitoredin helicopters and ambulances. | No change |
| Dynamicminitrend | The Minitrend window is to the left of the waveform area anddisplays recent trend of parameters. | The Minitrend window is to the left of the waveform area anddisplays recent trend of parameters.The Minitrend window is modified to enable users to hide, halfdisplay, or fully display the window by dragging the handle. |
| Feature | N1 | N1 |
| Cleared in K192972 | Subject Device | |
| Early WarningScore (EWS) | The EWS is a set of early warning scores that are intended toassist clinicians in recognizing the early signs of deterioration inpatients based on vital signs and clinical observations. The threetypes of EWS provided are Modified Early Warning Score(MEWS), National Early Warning Score (NEWS), NationalEarly Warning Score2 (NEWS2), and a user configurableCustom Score. | The EWS is a set of early warning scores that are intended to assistclinicians in recognizing the early signs of deterioration in patientsbased on vital signs and clinical observations. The three types ofEWS provided are Modified Early Warning Score (MEWS),National Early Warning Score (NEWS), National Early WarningScore2 (NEWS2), and a user configurable Custom Score.The EWS window is modified to enable users to hide, halfdisplay, or fully display the window by dragging the handle. |
| Glasgow ComaScale (GCS) | The GCS a well-established scoring system used to assess thestate of consciousness based three sub-components: eye-openingresponse, verbal response, and limb movement. | No change |
| SepsisSight | Not supported. | The SepsisSight feature is intended to help clinicians recognize theearly signs and symptoms of Sepsis based on recommendationsfrom the published literature (Surviving Sepsis Campaign:International Guidelines for Management of Severe Sepsis andSeptic Shock: 2016 and The Third International ConsensusDefinition for Sepsis and Septic Shock (Sepsis-3)). |
| Cardio-pulmonaryresuscitation(CPR) Dashboard | Records all operations during rescue.The rescue operations recorded can be customized and includetreatment (rescue drug input, rescue treatment input, start/endrescue, rescue start condition, rescue end condition). | No change |
| OxyCRGFunction | Support the function of oxygen cardio-respirogram(OxyCRG) when the patient type is neonate, andsimultaneously provide real-time OxyCRG interface andOxyCRG review interface to display parameter trends andwaveforms, and OxyCRG events. | No change |
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In conclusion, the differences in technological characteristics do not raise new questions of safety and effectiveness.
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8. PERFORMANCE DATA
To establish the substantial equivalence of the BeneVision N Series Patient Monitors, Mindray conducted functional and system level testing on the subject device. The testing provided an evaluation of the performance of the device relevant to each of the differences between the subject device and the predicate device. The functional and system level testing showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate.
Mindray complies with the FDA Special Controls Document relevant to this device "Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm Guidance for Industry and FDA (10/28/2003)"
Mindray has conducted testing to ensure the subject device meets relevant consensus standards.
Biocompatibility Testing
The N Series Patient Monitors are not patient contacting. There are no new patient contacting accessories of components, therefore biocompatibility testing is not applicable.
Sterilization and Shelf Life
The BeneVision N Series Patient Monitors are non-sterile when used. All accessories have been previously cleared.
Similar to the predicate device, no shelf life is claimed for the patient monitors.
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 N Series Patient Monitors 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 N Series Patient Monitors were assessed for conformity with the relevant requirements of the following standards and found to comply:
- ANSI/AAMI ES 60601-1:2005/(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.
- . IEC 60601-1-2:2014 (Fourth Edition) 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 N Series Patient Monitors, Mindray conducted functional and system level testing to validate the performance of the devices. The results of the bench testing show that the subject device meets its accuracy specification and is substantially equivalent to the predicate device.
In addition, Mindray has conducted testing to ensure the subject devices meet relevant consensus standards.
- IEC 60601-2-25:2011 Medical electrical equipment Part 2-25: Particular requirements for ● the basic safety and essential performance of electrocardiographs
- IEC 60601-2-27:2011 Medical electrical equipment--Part 2-27: Particular requirements for ● the basic safety and essential performance of electrocardiographic monitoring equipment
- IEC 60601-2-34:2011 Medical electrical equipment - part 2-34: particular requirements for the basic safety, including essential performance, of invasive blood pressure monitoring equipment
- ISO 80601-2-61: 2018 Medical electrical equipment part 2-61: particular requirements for ● basic safety and essential performance of pulse oximeter equipment
- ANSI IEEE C63.27-2017 American National Standard for Evaluation of Wireless ● Coexistence
- AAMI TIR69: 2017 Technical Information Report Risk management of radio-frequency ● wireless coexistence for medical devices and systems
CONCLUSION 9.
Based on the detailed comparison of the intended use, indications for use, specifications for each of the modifications to the previously cleared Bene Vision N Series Patient Monitors (K192972), the performance testing and conformance with applicable standards, the BeneVision N Series Patient Monitors (including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1) can be found substantially equivalent to the predicate devices.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.