(218 days)
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, NMT monitoring, PNP, and PNC are intended for adult and pediatric patients only. CCO using FloTrac is intended for adult 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.
The BeneVision N1 Patient Monitor is intended for monitoring, reviewing, 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, whereas N1 configured with WMTS technology can be used inside the hospital only. 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.
This document is a 510(k) Summary for the Mindray BeneVision N Series Patient Monitors, which focuses on demonstrating substantial equivalence to a previously cleared predicate device (K202405).
The information provided primarily details the device's technical specifications and comparisons to a predicate device, rather than a full study proving the device meets acceptance criteria for a specific medical condition or AI diagnostic output.
Therefore, I cannot fully answer all parts of your request as the document does not contain the detailed clinical study results (like sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, or specific AI performance metrics) that would typically be found for a device requiring those types of studies (e.g., an AI-powered diagnostic tool).
However, I can extract the relevant information regarding the device's functional and technical performance as demonstrated in this 510(k) submission.
Here's a breakdown of what can be inferred and what is missing:
Acceptance Criteria and Reported Device Performance
The "acceptance criteria" in this context are related to meeting the performance specifications of the predicate device and relevant consensus standards. The "reported device performance" is demonstrated through functional and system-level testing, ensuring the device meets its accuracy specifications for the various physiological parameters it monitors.
Table of "Acceptance Criteria" (Implied Specifications) and "Reported Device Performance" (Conformance):
| Parameter / Feature | Implied Acceptance Criteria (from Predicate/Standards) | Reported Device Performance (as stated in document) |
|---|---|---|
| General Device Performance | Reliability, accuracy, and safety equivalent to the predicate device (K202405). Compliance with general controls and specific standards. | "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." "The results of the bench testing show that the subject device meets its accuracy specification and is substantially equivalent to the predicate device." |
| ECG (HR) | HR Measurement range: 15 | No specific deviation reported from these specifications. The device supports intelligent arrhythmia alarms, adjustment of QT calculation, SVT and SVCs/min high arrhythmia alarm, and Multi-lead ECG synchronization analysis. |
| ECG (ST) | ST Measurement range: -2.0mV~+2.0mV; Accuracy: -0.8mV~+0.8mV, ±0.02mV or ±10%, whichever is greater, other range: not specified. | No specific deviation reported from these specifications. |
| ECG (QT) | QT Measurement range: 200~800ms; Accuracy: ±30ms. | No specific deviation reported from these specifications. Adjustment of QT calculation is a new feature. |
| Respiration Rate (Resp) | 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. | No specific deviation reported from these specifications. |
| Temperature (Temp) | Measurement range: 0 to 50°C (32 to 122°F). Accuracy: ±0.1°C or ±0.2°F (without probe). | No specific deviation reported from these specifications. |
| Pulse Oxygen Saturation (SpO2) | Mindray SpO2 module: Range: 0~100% Accuracy: 70% | No specific deviation reported from these specifications. |
| Pulse Rate (PR) | Accuracy: ±3 bpm (Mindray SpO2), ±3 bpm without motion, ±5 bpm with motion (Masimo SpO2); 20 | No specific deviation reported from these specifications. |
| Non-invasive Blood Pressure (NIBP) | Max mean error: ±5mmHg; Max standard deviation: 8mmHg. PR: ±3 bpm or ±3%, whichever is greater. | No specific deviation reported from these specifications. |
| Invasive Blood Pressure (IBP) | Accuracy of module: ±2% or ±1mmHg, whichever is greater (without sensor). | No specific deviation reported from these specifications. New feature: Artifact flag of Arterial Blood Pressure (ABP) shields alarms monitoring support. BeneVision N1 now supports up to 4 IBP channels (vs. 2 in predicate). |
| Cardiac Output (C.O.) | Accuracy: ±5% or ±0.1L/min, whichever is greater. TB, TI: ±0.1°C (without sensor). | No specific deviation reported from these specifications. |
| Continuous Cardiac Output (FloTrac) | (Not supported in predicate) Measurement range: CCO: 1.0-20.0L/min; Reproducibility: ±6% or 0.1 L/min, whichever is greater. PR:0~220bpm, Arms ≤3bpm. Live pressure display range: -34 to 312 mmHg. MAP/DIA/SYS display range: 0-300 mmHg. Accuracy: ±4% or ±4 mmHg, whichever is greater, in the range of -30 mmHg to 300 mmHg. | Added feature with stated performance specifications as listed. (This is a new feature compared to the predicate, and its performance data is listed as its "acceptance criteria" and "reported performance" upon introduction.) |
| Carbon Dioxide (CO2) | Sidestream: CO2: 0 | No specific deviation reported from these specifications. For BeneVision N1: component changes for Sidestream CO2 1.0 and 2.0 modules. |
| Oxygen (O2) | Accuracy: 0 | No specific deviation reported from these specifications. |
| Anesthetic Gas (AG) | Various specific accuracies for N2O, HAL, ENF, ISO, SEV, DES based on concentration ranges. awRR: 2~60rpm, ±1rpm, >60rpm, not specified. | No specific deviation reported from these specifications. Internal electronic component changes for the AG module. |
| Electroencephalograph (EEG/aEEG) | Frequency response: 0.5Hz ~ 50 Hz (-3 dB). Input range: 4 mVpp. DC offset: ±500 mV. CMRR: ≥ 100 dB @ 51 KΩ and 60 Hz. Noise level: ≤ 0.5 uV rms (1Hz to 30 Hz). Differential input resistance: > 15 MΩ @ 10 Hz. Electrode resistance: 0 to 90 KΩ, resolution: ±1 KΩ or 10%, whichever is the greater. | Added EEG-1 module and aEEG module, with their performance specifications stated as meeting these criteria. |
| A-Fib Overview | (Not supported in predicate) The A-Fib overview function only collects atrial fibrillation, atrial fibrillation with rapid ventricular rate, atrial fibrillation with R-R long interval and other related events, and the A-Fib overview screen displays the A-Fib specifications. | This is a newly added feature with its intended functionality described. |
| Electromagnetic Compatibility & Electrical Safety | Compliance with relevant standards (ANSI/AAMI ES 60601-1:2005, IEC 60601-1-2:2014). | Assessed for conformity and found to comply with ANSI/AAMI ES 60601-1:2005/(R) 2012 and IEC 60601-1-2:2014. Also meets IEC 60601-1-8:2020 for alarm systems. |
| Software Verification & Validation | Meets FDA Guidance for Software Contained in Medical Devices. | "Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance... Verification... was conducted to ensure that the product works as designed. Validation was conducted to check the design and performance of the product." |
Detailed Study Information (Based on Document Content):
-
Sample sizes used for the test set and the data provenance:
- The document states that "functional and system level testing" and "bench testing" were conducted.
- However, no specific sample sizes for test sets (e.g., number of patients, number of data recordings) are provided for any of the performance evaluations.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The tests described are generic "bench testing" to ensure compliance with technical specifications and standards, not clinical studies.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. This document describes engineering and bench testing against pre-defined technical specifications and industry standards for physiological measurement accuracy. It does not describe a clinical study involving human experts establishing ground truth for diagnostic interpretation (e.g., for an AI algorithm interpreting medical images).
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. Same reason as above.
-
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:
- No. This device is a patient monitor. It detects physiological parameters and provides alarms, and some interpretations of ECG (e.g., 12-lead ECG interpretation, arrhythmia detection). It is not an AI-assisted diagnostic device in the sense of image interpretation for which MRMC studies are typically performed. The document details that "optimized auditory ALARM SIGNALS" and "alarm highlight" were added, suggesting improvements to the human-device interface, but not a formal MRMC study on diagnostic improvement.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies that algorithms for ECG (Mindray or Mortara algorithm for arrhythmia and ST-segment analysis) are embedded in the device. The listed accuracy specifications for these measurements (e.g., HR, ST, QT) reflect the standalone performance of these measurement algorithms and sensors against established benchmarks. However, a formal "standalone study" with detailed methodology, distinct from the general bench testing, is not specifically described or provided with separate results. The performance data listed (e.g., accuracy for HR, ST, QT) serves as the "standalone" performance verification for these integrated functionalities.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For physiological measurements (ECG, SpO2, NIBP, etc.), the "ground truth" would typically refer to reference measurement devices or calibrated simulators used during bench testing to verify the accuracy of the monitor's readings against a known, accurate value.
- For the ECG interpretation (e.g., 12-lead ECG interpretation, arrhythmia detection), the ground truth for the algorithms would have been established during their development and previous clearance processes (Mindray or Mortara algorithms). This document focuses on demonstrating that the integration and revised features maintain that established accuracy rather than re-proving the core algorithms.
-
The sample size for the training set:
- Not provided. This document pertains to the 510(k) clearance of updates to an existing patient monitor series. It does not detail the development or training of new AI/ML algorithms, which would typically involve substantial training datasets. The ECG algorithms (Mindray or Mortara) were presumably "trained" (or developed and validated) previously as part of their initial predicate clearances.
-
How the ground truth for the training set was established:
- Not provided. (See point 7). For existing algorithms like Mortara or Mindray ECG algorithms, ground truth for their original development would likely have been established using large, diverse ECG databases with expert cardiologist interpretations and/or correlation with clinical outcomes where relevant. This particular 510(k) document is concerned with demonstrating equivalence and continued performance with minor changes, not the original algorithm development.
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July 12, 2022
Shenzhen Mindray Bio-medical Electronics Co., Ltd. Li Lei Manager Regulatory Affairs Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen, Guangdong 518057 China
Re: K213799
Trade/Device Name: N Series Patient Monitors 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, DSI, MLD, DRT, DXN, DSK, FLL, DQA Dated: June 9, 2022 Received: June 10, 2022
Dear Li Lei:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
BeneVision N Series Patient Monitors (including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22)
Indications for Use (Describe)
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, NMT monitoring, PNP, and PNC are intended for adult and pediatric patients only. CCO using FloTrac is intended for adult 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 N1 indications for use)
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Number (if known): Indications for Use (con't)
BeneVision N1 Patient Monitor:
The BeneVision N1 Patient Monitor is intended for monitoring, reviewing, 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, whereas N1 configured with WMTS technology can be used inside the hospital only. 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.
SUBMITTER 1.
| 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: Li LeiTitle: Manager Regulatory AffairsPhone: +86 755 81885953Fax: +86 755 26582680E-mail: lilei.js@mindray.com |
| Date Prepared: | December 2, 2021 |
| 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-pressure,non-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, 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) |
| 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 |
Table 1: Secondary Product Codes
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PREDICATE DEVICES 3.
- Predicate: K202405 BeneVision N Series Patient Monitors (Including BeneVision N12, . BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1)
4. REFERENCE DEVICES
- Philips InterlliVue MX600, MX800 patient monitors (K161531): provided as reference devices for SVT and SVCs/min High, Artifact flag of ABP shields alarms function, and combined alarm function.
- . GE Carescape B850 patient monitor (K131414) is provided as reference device for SVT and SVCs/min High and SVCs/min value.
- . Edwards HemoSphere Advanced Monitor (K180881) is provided as reference device for the Flotrac CCO cable.
- . Philips InterlliVue MX850 patient monitors (K210906) are provided as reference devices for the aEEG module.
- Mindray BeneVision central monitoring system (K193391, including TM70 telemetry ● system) is provided as reference device for the WMTS module of TM70.
- Philips InterlliVue MX series patient monitors (K182979) are provided as reference ● devices for the Alarm Threshold.
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DEVICE DESCRIPTION 5.
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.
INTENDED USE/INDICATIONS FOR USE 6.
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, 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, NMT monitoring, PNP, and PNC are intended ● for adult and pediatric patients only. CCO using FloTrac is intended for adult 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.
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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, OT 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, whereas N1 configured with WMTS technology can be used inside the hospital only. 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 N12/N15/N17/N19/N22 has been modified to include support for CCO using FloTrac in adult patients. Although this feature is not present in the primary predicate devices, it is present in HemoSphere Advanced Monitor (K180881, including Pressure Cable).
The indications for use statement of the subject BeneVision N1 has been modified to include WMTS technology for use inside the hospital only.
In conclusion, the minor difference in the indications for use statements do 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, K202405). The features in grey are features which are different between the predicate devices and the subject devices.
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| Table 2: | Device Comparison Table (BeneVision 22/N19/N17/N15/N12) | |
|---|---|---|
| ---------- | --------------------------------------------------------- | -- |
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cleared in K202405 | Subject Device | |||||||||||
| Primary display andtouchscreen | 22"1680*1050pixels. | 19"1680*1050pixels. | 18.5"1920*1080pixels. | 15.6"1920*1080pixels. | 12.1"1280*800pixels. | No change | No change | No change | No change | No change | ||
| Secondary display | Independent control anddisplay. | Independentcontrol anddisplay.Size: 21.5"Model:ET2203LM. | Mirrored display.Size: 21.5"Model: ET2203LM. | No change | No change | No change | No change | No change | ||||
| iView | iView is an isolated PC platform thatallows the user to run 3rd partyapplications using a limited set offunctions. The iView system is notintended to be used as a primary alarmdevice.Capacity of RAM: 8GBModel of CPU: N4200Windows 10 | Not supported. | No change | No change | ||||||||
| Wireless radio module | The 2.4G/5G module for connecting to a network wirelessly,constructing a monitoring network with a central monitoring system(CMS). | No change | ||||||||||
| Module rack | Must be connected to themain unit to provide upto 8 standard moduleslots. | Optional for the patientmonitor, adding 8 standardmodule slots to extend themeasurement capabilities ofthe system. | Notsupported. | 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 | ||||||||
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | ||
| Cleared in K202405 | Subject Device | |||||||||||
| Data storage | Solid State Hard Drive(SDD) | Embedded Multi Media Card (eMMC). | No change | |||||||||
| Data recorder | Supports the thermalrecorder module, needsto be plugged in theSMR. | 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. | Provides audible alarm tones (45 to 85 dB), key tones,QRS tones; support PITCH TONE and multi-leveltone modulation.* Replace the manufacturer of the speaker. | ||||||||||
| Main control board | CPU module: E3827DDR3 capacity: 2GB | CPU module: AM3358DDR3 capacity: 1GB | CPU module: E3845DD3 capacity: 4 GB* Modifications formain control board.Refer to | No change | ||||||||
| Alarm system | Supports alarm volume escalation. The alarm lamp will light cyan,yellow, or red depending on alarm type. | Supports alarm volume escalation. The alarm lampwill light cyan, yellow, or red depending on alarmtype.Support combined alarm monitoring, optimizedauditory ALARM SIGNALS, Adjustment ofDefault Alarm Threshold, alarm highlight.Combined alarm monitoring. * Optimized auditory ALARM SIGNALS. * Adjustment of Default AlarmThreshold. * Alarm highlight. | ||||||||||
| Support T1/N1 as aModule | Support T1/N1 acting as a module. | No change | ||||||||||
| Connect with Mindraytelemetry monitors | Connect with the TM80/TM70 and the BP10 NIBP module to receiveECG, SpO2, RESP, and NIBP waveforms and parameters. | No change | ||||||||||
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | ||
| Cleared in K202405 | Subject Device | |||||||||||
| ECG | 3-lead, 5-lead, 6-lead or 12-lead selectable, arrhythmia detection, STsegment analysis, QT analysis, an interpretation of resting 12-leadECG, J-point Auto detection, Dual Channel Pace detection, adjustableQRS threshold, Multi-lead ECG synchronization analysis and heartrate (HR).Can be configured with either the Mindray or Mortara algorithm forECG 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 | 3-lead, 5-lead, 6-lead or 12-lead selectable,arrhythmia detection, ST segment analysis, QTanalysis, an interpretation of resting 12-lead ECG, J-point Auto detection, Dual Channel Pace detection,adjustable QRS threshold, Multi-lead ECGsynchronization analysis and heart rate (HR).Can be configured with either the Mindray or Mortaraalgorithm for ECG arrhythmia monitoring andarrhythmia 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 K202405 | Subject Device | |||||||||||
| Respiration rate (Resp) | Measure the respiration waveforms and respiratory rate through trans-thoracic impedance method.Measurement range: Adult: 0 to 120 rpm; Pediatric, neonate: 0 to 150 rpm.Accuracy: 7 to 150 rpm: $\pm$ 2 rpm or $\pm$ 2%, whichever is greater;0 to 6 rpm: Not specified.This measurement can be used for adults, pediatrics and neonates. | This measurement can be used for adults, pediatrics, and neonates, except that:1. The arrhythmia detection and ST segment analysis of Mortara algorithm in MPM2.0 is intended for adult and pediatric patients only;2. The arrhythmia detection of Mindray algorithm in MPM2.0 is intended for adult and pediatric patients only;3. The ST Segment analysis of Mindray algorithm in MPM2.0 is intended for adult patients only. | ||||||||||
| 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: $\pm$ 0.1°C or $\pm$ 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) 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% | No change | ||||||||||
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | ||
| Cleared in K202405 | Subject Device | |||||||||||
| 70% | ||||||||||||
| Pulse rate (PR) | Pulse rate may be obtained from all sources of SpO2, or the IBP module.Measurement range: 20 | No change | ||||||||||
| Non-invasive bloodpressure (NIBP) | Uses the MPM (Multi Parameter Module) to measure NIBP. TheMPM uses the oscillometric method for measuring non-invasive bloodpressure (NIBP).Measurement range:Systolic: 25 | No change | ||||||||||
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | ||
| Cleared in K202405 | Subject Device | |||||||||||
| Invasive blood pressure (IBP) | Uses the MPM (Multi Parameter Module), T1, N1 or the IBP Module to measure invasive blood pressure. The monitor can monitor up to 8 invasive blood pressures and displays systolic, diastolic and mean pressures and a waveform for each pressure.The IBP supports Pulse Pressure Variation (PPV) and Pulmonary Artery Wedge Pressure (PAWP) function.Measurement range: -50~300mmHg,Accuracy of module: ±2% or ±1mmHg, whichever is greater (without sensor)This measurement can be used for adults, pediatrics and neonates except that PAWP is not for neonates. | Uses the MPM (Multi Parameter Module) or the IBP Module to measure invasive blood pressure. The monitor can monitor up to 8 invasive blood pressures and displays systolic, diastolic and mean pressures and a waveform for each pressure. Support Pulse Pressure Variation (PPV) and Pulmonary Artery Wedge Pressure (PAWP) function.Measurement range: -50~300mmHg,Accuracy of module: ±2% or ±1mmHg, whichever is greaterThis measurement can be used for adults, pediatrics and neonates except that PAWP is not for neonates.* The Artifact flag of Arterial Blood Pressure (ABP) shields alarms Monitoring Support | ||||||||||
| Cardiac output (C.O.) | The cardiac output (C.O.) measurement invasively measures cardiac output and other hemodynamic parameters using the right heart (atria) thermodilution method. The temperature change is displayed as a curve in the C.O. split screen, and the monitor calculates the C.O. value from this curve. The monitor can store up to 6 measurements.Measurement range:C.O.: 0.1 | No change | ||||||||||
| Continuous cardiac output (CCO) | The CCO/SvO2 interface module is used to interface with Edwards Vigilance II monitor (cleared in K043103)/ Vigileo monitor (cleared in K103094)/ EV1000 monitor (cleared in K160552) / HemoSphere monitor (cleared in K163381) which measures continuous cardiac output (CCO).This measurement can be used for adults and pediatrics. | No change | ||||||||||
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | ||
| Cleared in K202405 | Subject Device | |||||||||||
| Continuous cardiacoutput (FloTrac) | Not supported | Add Continuous cardiac output (FloTrac)parameter.FloTrac measures a patient's hemodynamic statususing a mini-invasive method based on pulse waveanalysis technology.Measurement range:CCO: 1.0-20.0L/min; Reproducibility: ±6% or 0.1L/min, whichever is greater.Resolution ratio: 0.1 L/minCCI: 0.0-20.0 L/min/m2SV: 0-300 mLSVI: 0-200 mL/m2SVR: 0-5000 DS/cm5SVRI: 0-9950 DS-m2/cm5SVV: 0-99%PPV: 0-99%PR:0~220bpm, Arms ≤3bpmLive pressure display range : -34 to 312 mmHgMAP/DIA/SYS display range: 0-300 mmHgAccuracy: ±4% or ±4 mmHg, whichever isgreater, in the range of -30 mmHg to 300 mmHgThis measurement is only indicated for adults. | ||||||||||
| Mixed/central venousoxygen saturation(SvO2/ScvO2) | The CCO/SvO2 interface module is used to interface with EdwardsVigilance II monitor (cleared in K043103)/ Vigileo monitor (clearedin K103094)/ EV1000 monitor (cleared in K160552) / HemoSpheremonitor (cleared in K163381) which measures mixed venous oxygensaturation (SvO2) and central venous oxygen saturation (ScvO2).This measurement can be used for adults and pediatrics. | No change | ||||||||||
| Central venous oxygensaturation (ScvO2) | Central venous oxygen saturation (ScvO2) is measured usingspectrophotometry.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 | ||||||||||
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | ||
| Cleared in K202405 | Subject Device | |||||||||||
| 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 | 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 | ||||||||||
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | ||
| Cleared in K202405 | Subject Device | |||||||||||
| 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 | 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 | ||||||||||
| Impedance cardiograph (ICG) | ICG measures a patient's hemodynamic status using a non-invasive method based on thoracic electrical bioimpedance (TEB) technology. | No change | ||||||||||
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | ||
| Cleared in K202405 | Subject Device | |||||||||||
| Measurement range:C.O.:1.4 | ||||||||||||
| Bispectral index (BIS) | The BIS Module monitors the state of the brain by data acquisition of EEG signals. Bispectral index (BIS) is a processed EEG variable that can be used as an aid in monitoring the effects of certain anesthetic agents.Measurement range: BIS, BIS L, BIS R: 0~100.Accuracy: not specified.This measurement can be used for adults and pediatrics. | No change | ||||||||||
| Respiration mechanics (RM) | The RM module measures respiration mechanics for adult and pediatric patients.Measurement range:FLOW:Adult/Pediatric: ±(2 | Accuracy:FLOW:Adult/Pediatric: 1.2L/min or ±10% of reading, whichever is greater;Infant: 0.5 L/min or ±10% of the reading, 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 | No change | |||||||||
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | ||
| Cleared in K202405 | Subject Device | |||||||||||
| Pmean:0 | ±10%×reading,whichever is greaterCalculated Parameters:awRR:4 | |||||||||||
| 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 ~ 200%;TOF-Count: 0 | No change | ||||||||||
| Electroencephalograph(EEG) | The EEG module measures the spontaneous, rhythmic electricalactivity of the cortex. The EEG module can continuously monitorEEG signals from up to 4 channels. It can also display DensitySpectral Arrays (DSA) and Compressed Spectral Arrays (CSA). | The EEG module and EEG-1 module measure thespontaneous, rhythmic electrical activity of the cortex.The EEG module can continuously monitor EEGsignals from up to 4 channels. It can also display | ||||||||||
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | ||
| Cleared in K202405 | Subject Device | |||||||||||
| 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 is the greaterThis measurement is intended to be used for adults, pediatrics andneonates. | Density Spectral Arrays (DSA) and Compressed Spectral Arrays (CSA). The aEEG module measures the electrical activity of the cortex to monitor the function of cerebral. The aEEG module can continuously monitor EEG signals from up to 4 channels.N Series patient monitors are compatible with the following 3 types of modules to measure EEG:EEG module:Frequency response: 0.5Hz ~ 50 Hz (-3 dB)Input range: 4 mVppDC offset: ±500 mVCMRR: ≥ 100 dB @ 51 KΩ and 60 HzNoise level: ≤ 0.5 uV rms (1Hz to 30 Hz)Differential input resistance: > 15 MΩ @ 10 HzElectrode resistance: 0 to 90 KΩ, resolution: ±1 KΩ or 10%, whichever is the greaterThis measurement is intended to be used for adults, pediatrics, and neonates.EEG-1 module:Frequency response: 0.5Hz ~ 50 Hz (-3 dB)Input range: 4 mVppDC offset: ±500 mVCMRR: ≥ 100 dB @ 51 KΩ and 60 HzNoise level: ≤ 0.5 uV rms (1Hz to 30 Hz)Differential input resistance: > 15 MΩ @ 10 HzElectrode resistance: 0 to 90 KΩ, resolution: ±1 KΩ or 10%, whichever is the greaterThis measurement is intended to be used for adults, pediatrics, and neonates. |
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| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 |
|---|---|---|---|---|---|---|---|---|---|---|
| Cleared in K202405 | Subject Device | |||||||||
| aEEG module:Frequency response: 0.5Hz ~ 50 Hz (-3 dB)Input range: 4 mVppDC offset: ±500 mVCMRR: ≥ 100 dB @ 51 kΩ and 60 HzNoise level: ≤ 0.5 uV rms (1Hz to 30 Hz)Differential input resistance: > 15 MΩ @ 10 HzElectrode resistance: 0 to 90 kΩ, resolution: ±1 kΩor 10%, whichever is the greater.This measurement is intended to be used foradults, pediatrics, and neonates.Added EEG-1 module.Added aEEG module. | ||||||||||
| Regional oxygensaturation (rSO2) | The rSO2 module provides noninvasive and continuous informationof changes in regional oxygen saturation of blood. The measurementtakes place in real time, providing an immediate indication of achange in the critical balance of regional oxygen delivery and oxygenconsumption. | Measurement range: rSO2: 15~95. | This measurement can be used for adults, pediatrics and neonates. | No change | ||||||
| Device integration | Support BeneLink Module to connect Anesthesia, Ventilator, Pump,TcGas Monitor Device, and Single Paramer Device. | No change | ||||||||
| A-Fib overview | Not supported | * The A-Fib overview function only collects atrialfibrillation, atrial fibrillation with rapidventricular rate, atrial fibrillation with R-R longinterval and other related events, and the A-Fiboverview screen displays the A-Fib specifications. | ||||||||
| Accessories | The accessories including ECG, SpO2, Temp, NIBP, IBP, C.O.,ScvO2, ICG, BIS, CO2, AG, RM, EEG, BIS, NMT, rSO2 | * Add new EEG cable | ||||||||
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 |
| Cleared in K202405 | Subject Device | |||||||||
| CCO/SvO2 accessories. |
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Table 3: Device Comparison Table – BeneVision N1
| Feature | N1 | N1 |
|---|---|---|
| Cleared in K202405 | 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 |
| 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. | Supports alarm volume escalation. The alarm lamp will light cyan,yellow, or red depending on alarm type.Support combined alarm monitoring, optimized auditory alarmsignals, Adjustment of Default Alarm Threshold, alarm highlight.Combined alarm monitoring.* Optimized auditory alarm signals.* Adjustment of Default Alarm Threshold.* Alarm highlight. |
| Feature | N1 | N1 |
| Cleared in K202405 | Subject Device | |
| Communicationon Interface whenN1 is working asa module | Infrared communication interface.Pogo pin communication interface. | No change |
| 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.Measurement range:ST: -2.0mV~+2.0mV;QT: 200 |
| Feature | N1 | N1 |
| Cleared in K202405 | Subject Device | |
| 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 |
| 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% | No change |
| Feature | N1 | N1 |
| Cleared in K202405 | Subject Device | |
| Pulse rate (PR) | Obtains pulse rate from SpO2 or IBP.Measurement range: 20 | No change |
| Non-invasive blood pressure (NIBP) | The N1 uses the oscillometric method for measuring non-invasive blood pressure (NIBP). This measurement can be used for adults, pediatrics, and neonates.Measurement range:Systolic: 25 | No change |
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| Feature | N1 | N1 |
|---|---|---|
| Cleared in K202405 | 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.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.* The Artifact flag of Arterial Blood Pressure (ABP) shieldsalarms Monitoring Support. |
| Feature | N1 | N1 |
| Cleared in K202405 | Subject Device | |
| Carbon dioxide(CO2) | CO2 can be measured using a built-in Sidestream CO2 2.0module, or it can also connect to an external Sidestream CO2 2.0module (when used with a rack). Alternatively, third-party CO2modules, Microstream module and Mainstream module, can beused.Type: Sidestream CO2 moduleMeasurement range:CO2 :0 | CO2 can be measured using the Mindray Sidestream CO2 module orthird-party CO2 modules, Microstream module and Mainstreammodule.Type: Sidestream CO2 moduleMeasurement range:CO2 :0 |
| Feature | N1 | N1 |
| Cleared in K202405 | Subject Device | |
| specific wavelengths using a photodetector.This measurement can be used for adults, pediatrics andneonates. | Accuracy:CO2: 0 | |
| 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 |
| Feature | N1 | N1 |
| Cleared in K202405 | Subject Device | |
| Dock, Rack andTransport Dock | The Dock is used to connect either the N1 without a Rack or theN1 docked inside a Rack, to extending 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 transfers the 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). | The Wireless radio module is used for connecting to a wirelessmonitoring network with a central monitoring system (CMS).Added WMTS module |
| Helicopter andambulancetransport | ECG, RESP, Temp, SpO2, PR, NIBP, and IBP can be monitoredin helicopters and ambulances. | No change |
| A-Fib overview | Not supported | * The A-Fib overview function only collects atrial fibrillation,atrial fibrillation with rapid ventricular rate, atrial fibrillationwith R-R long interval and other related events, and the A-Fiboverview screen displays the A-Fib specifications. |
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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.
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.
Bench Testing
To establish the substantial equivalence of the BeneVision N Series Patient Monitors. Mindrav conducted functional and system level testing to validate the performance of the devices. The
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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 60601-1-8:2020 Medical electrical equipment Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- · IEC 60601-2-25:2011 Medical electrical equipment Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
- · IEC 60601-2-26:2012 Medical electrical equipment Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
- · 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 80601-2-30:2018 Medical electrical equipment Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
- IEC 60601-2-34:2011 Medical electrical equipment Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
- · IEC 80601-2-49:2018 Medical electrical equipment -Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
- · ISO 80601-2-55: 2018 Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
- · ISO 80601-2-56: 2017 Medical electrical equipment Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
- · ISO 80601-2-61: 2017 Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
- · ANSI 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.
- · ANSI AAMI EC57:2012 Testing and reporting performance results of cardiac rhythm and STsegment measurement algorithms
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CONCLUSION 9.
Based on the detailed comparison of the intended use, indications for use, specifications for each of the modifications to the previously cleared BeneVision N Series Patient Monitors (K202405), 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 device.
§ 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.