No
The document describes a standard patient monitor with various physiological parameter measurements and analysis (like arrhythmia detection and ECG interpretation), but it does not mention or imply the use of AI or ML technologies. The performance studies focus on functional equivalence to a predicate device and standard accuracy metrics, not on AI/ML specific performance measures.
No
Explanation: The device is described as a "patient monitor" which is used for "monitoring, displaying, storing, alarming, and transferring of multiple physiological parameters." It does not provide any treatment or therapeutic intervention.
Yes
The device monitors, displays, and stores multiple physiological parameters and provides interpretations, such as for resting 12-lead ECG, which are used to assess a patient's health status. This falls under the definition of a diagnostic device.
No
The device description explicitly states that the BeneVision N Series Patient Monitors provide a "flexible software and hardware platform," indicating the presence of hardware components in addition to software.
Based on the provided text, the BeneVision N12/N15/N17/N19/N22 and N1 patient monitors are not IVD (In Vitro Diagnostic) devices.
Here's why:
- Intended Use: The intended use clearly states that the devices are for "monitoring, displaying, storing, alarming, and transferring of multiple physiological parameters". These parameters are measured directly from the patient's body (e.g., ECG, blood pressure, temperature, oxygen saturation).
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a physiological state, health, or disease.
- Lack of Specimen Analysis: The description of the device and its intended use does not mention the analysis of any biological specimens. The measurements are taken directly from the patient.
Therefore, these patient monitors fall under the category of patient monitoring devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
MHX, DSI, MLD, DRT, DXN, DSK, DSB, MUD, MLC, KRC, FLL, DQA, MSX, DRG, CCK, DXG, DSJ, DRS, CBQ, NHO, NHP, NHQ, CBS, CBR, CCL, KOI, OLW, OLT, OMC, ORT, GXY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
BeneVision N12/N15/N17/N19/N22: All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:
- The arrhythmia detection, BIS, RM, CCO, SvO2/ScvO2, PAWP, and NMT monitoring are intended for adult and pediatric patients only;
- C.O. monitoring is 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.
BeneVision N1 Patient Monitor: All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:
- The arrhythmia detection and PAWP is intended for adult and pediatric patients only
Intended User / Care Setting
BeneVision N12/N15/N17/N19/N22: 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 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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K182075 BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K190011 Passport 12m, Passport 17m, T1, K163381 Hemosphere Monitor
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other related products.
May 7, 2020
Shenzhen Mindray Bio-medical Electronics Co., LTD. Yanhong Bai Manager Regulatory Affairs, Technical Regulation Department Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen, China 518057
Re: K192972
Trade/Device Name: Patient Monitor 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: April 7, 2020 Received: April 8, 2020
Dear Yanhong Bai:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer Shih Assistant Director (Acting) Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
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, 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: · The arrhythmia detection, BIS, RM, CCO, SvO2/ScvO2, PAWP, and NMT monitoring are intended for adult and pediatric patients only:
· C.O. monitoring is 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)
| Transaction (For 21 CFR 801 Subpart D) | Own Use Compounding (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Number (if known): K192972 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:
• The arrhythmia detection and PAWP is intended for adult and pediatric 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.
4
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-MEDICAL
ELECTRONICS CO., LTD.
Mindray Building, Keji 12th Road South
High-tech Industrial Park, Nanshan
Shenzhen 518057, P.R. China
Tel: +86 755 81888998
Fax: +86 755 26582680 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Contact Person: Yanhong Bai
Title: Manager Regulatory Affairs
Phone: +86 755 81885635
Fax: +86 755 26582680
E-mail: baiyanhong@mindray.com |
| Date Prepared: | October 22, 2019 |
| 2. | DEVICE |
| Device Trade Name: | BeneVision N Series Patient Monitors (Including
BeneVision 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 and
alarm (including ST-segment measurement and alarm) |
| Regulatory Class: | Class II |
| Primary Product Code: | MHX - Monitor, Physiological, Patient (with
arrhythmia detection or alarms) |
| Table 1:
| Secondary Product Codes |
|---|
| ------------------------------------- |
| Regulation Number/Class | Product Code | Regulation description | Device Common Name |
|---|---|---|---|
| 870.1025, II | DSI | Arrhythmia detector and alarm (including ST-segment measurement and alarm) | Detector and alarm, arrhythmia |
| Regulation | |||
| Number/Class | Product | ||
| Code | Regulation description | Device Common Name | |
| 870.1025, II | MLD | Arrhythmia detector and alarm | |
| (including ST-segment measurement | |||
| and alarm) | Monitor, st segment with alarm | ||
| 870.2300, II | DRT | Cardiac Monitor (including | |
| cardiotachometer and rate | |||
| alarm) | Monitor, cardiac (incl. | ||
| cardiotachometer & rate alarm) | |||
| 870.1130, II | DXN | Noninvasive blood pressure | |
| measurement system | System, measurement, blood-pressure, | ||
| non-invasive | |||
| 870.1110, 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 electrode | |
| tester. | 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 (including | |
| cardiotachometer and rate alarm). | System, network and communication, | ||
| physiological monitors | |||
| 870.2910, II | DRG | Radiofrequency physiological signal | |
| transmitter 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 | |
| diagnostic 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 pressure | ||
| transducer. | |||
| 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) | |||
| 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, gaseous |
| phase (anesthetic conc.) | |||
| 868.1720, II | CCL | Oxygen gas analyzer. | Analyzer, gas, oxygen, gaseous-phase |
| Regulation | |||
| Number/Class | Product | ||
| Code | Regulation description | Device Common Name | |
| 868.2775, II | KOI | Electrical peripheral nerve stimulator. | Stimulator, nerve, peripheral, electric |
| 882.1400, II | OLW | Electroencephalograph. | Index-generating |
| electroencephalograph software | |||
| 882.1400, II | OLT | Electroencephalograph. | Non-normalizing quantitative |
| electroencephalograph software | |||
| 882.1400, II | OMC | Electroencephalograph. | Reduced-montage standard |
| electroencephalograph | |||
| 882.1400, II | ORT | Electroencephalograph. | Burst suppression detection software |
| for electroencephalograph | |||
| 882.1320, II | GXY | Cutaneous electrode. | Electrode, cutaneous |
5
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3. PREDICATE DEVICES
- Predicate: K182075 BeneVision N Series Patient Monitors (Including BeneVision N12, ● BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1)
REFERENCE DEVICES 4.
- K190011 Passport 12m, Passport 17m, T1: provided as reference devices for ● the BIS module that has been added to the subject BeneVision N Series Patient Monitors.
- K163381 Hemosphere Monitor: provided as a reference device in support the device ● integration functionality and PPV parameters.
5. DEVICE DESCRIPTION
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.
7
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 transfering 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 (Sv02/Scv02), 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:
- The arrhythmia detection, BIS, RM, CCO, SvO2/ScvO2, PAWP, and NMT monitoring are intended for adult and pediatric patients only;
- C.O. monitoring is 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/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:
- The arrhythmia detection and PAWP is intended for adult and pediatric 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
8
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 the BIS parameter used on adult and pediatric patients. Although this feature is not present in the primary predicate devices, it is present in other cleared multiparameter patient monitors such as the Passport series Patient Monitors (K190011, Passport 17m. T1). The inclusion of BIS in the indications for use does not constitute a new fundamental intended use.
The indications for use statement of the subject BeneVision N1 has not been changed.
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, K182075). The features in gray are features which are different between the predicate devices and the subject devices.
9
Page 6 of 28
Table 2: Device Comparison Table (BeneVision 22/N19/N17/N15/N12)
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Cleared in K182075 | Subject Device | ||||||||||
| Primary display | |||||||||||
| and touchscreen | 22" | ||||||||||
| 1680*1050 | |||||||||||
| pixels. | 19" | ||||||||||
| 1680*1050 | |||||||||||
| pixels. | 18.5" | ||||||||||
| 1920*1080 | |||||||||||
| pixels. | 15.6" | ||||||||||
| 1920*1080 | |||||||||||
| pixels. | 12.1" | ||||||||||
| 1280*800 | |||||||||||
| pixels. | No | ||||||||||
| change | No | ||||||||||
| change | No change | No | |||||||||
| change | No | ||||||||||
| change | |||||||||||
| Secondary | |||||||||||
| display | Independent control and | ||||||||||
| display. | Independent control and | ||||||||||
| display. | Independent | ||||||||||
| control and | |||||||||||
| display. | |||||||||||
| Size:18.5"; | |||||||||||
| Model: | |||||||||||
| ET1919LM; | Mirrored display. | ||||||||||
| Size:18.5"; | |||||||||||
| Model: ET1919LM; | No change | No change | Independent | ||||||||
| control and | |||||||||||
| display. | |||||||||||
| Size: 21.5"; | |||||||||||
| Model:2203L | Mirrored display. | ||||||||||
| Size: 21.5"; | |||||||||||
| Model: 2203L; | |||||||||||
| iView | iView is an isolated PC platform that allows | ||||||||||
| the user to run 3rd party applications using a | |||||||||||
| limited set of functions. The iView system is | |||||||||||
| not intended to be used as a primary alarm | |||||||||||
| device. | |||||||||||
| Capacity of RAM: 4GB | |||||||||||
| Model of CPU: J1900 | |||||||||||
| Windows 7 | Not supported. | Change the PC platform | |||||||||
| Capacity of RAM: 8GB | |||||||||||
| Model of CPU: N4200 | |||||||||||
| Windows 10 | Change the PC platform | ||||||||||
| Capacity of RAM: 8GB | |||||||||||
| Model of CPU: N4200 | |||||||||||
| Windows 10 | 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 the | ||||||||||
| main unit to provide up to | |||||||||||
| 8 standard module slots. | Must be connected to the | ||||||||||
| main unit to provide up to | |||||||||||
| 8 standard module slots. | Optional for the patient | ||||||||||
| monitors, adding 8 standard | |||||||||||
| module slots to extend the | |||||||||||
| measurement capabilities of | |||||||||||
| the system. | Not | ||||||||||
| supported. | Not | ||||||||||
| supported. | No change | ||||||||||
| Power supply | One rechargeable Lithium-ion battery or AC power supply. | No change | |||||||||
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | |
| Cleared in K182075 | Subject Device | ||||||||||
| Battery | Chargeable Lithium-Ion, 11.3 VDC, 5600 mAh. | Chargeable Lithium-Ion, 11.1 VDC, 4500 mAh. | Chargeable Lithium-Ion, 10.8 VDC, 5600 mAh. | Chargeable Lithium-Ion, 10.95 VDC, 4500 mAh. | |||||||
| Data storage | Solid State Hard Drive (SDD) | Embedded Multi Media Card (eMMC). | No change | ||||||||
| Data recorder | Supports the thermal recorder module, needs to be plugged into the SMR. | Supports the thermal recorder module and the built-in thermal recorder, but they cannot 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 as a Module | Support T1/N1 acting as a module. | No change | |||||||||
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | |
| ECG | Cleared in K182075 | Subject Device | |||||||||
| 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, N1: supports Mindray Algorithm. T1, MPM 2.0, and TM80: support Mindray or Mortara algorithm Supports intelligent arrhythmia alarms | |||||||||||
| HR Measurement range: 15 | |||||||||||
| ST Measurement range: -2.0mV~+2.0mV; Accuracy: -0.8mV~+0.8mV, ±0.02mV or ±10%, whichever is greater, other range: not specified. | |||||||||||
| QT Measurement range: 200~800ms; Accuracy: ±30ms. | |||||||||||
| This measurement can be used for adults, pediatrics, and neonates, except that: The arrhythmia detection of MPM 3.0 is intended for adult and pediatric patients only; The arrhythmia detection and ST segment analysis of Mortara algorithm in T1, MPM 2.0, and TM80 (T1 is cleared in K190011, MPM 2.0 is cleared in K152902, and TM80 is cleared in K183238) are intended for adult and pediatric patients only; The arrhythmia detection of Mindray algorithm in T1, MPM 2.0, and TM80 is intended for adult and pediatric patients only; The ST Segment analysis of Mindray algorithm in T1, MPM 2.0, and TM80 is intended for adult patients only. | No change | ||||||||||
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | |
| Cleared in K182075 | 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: ±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 oxygen | |||||||||||
| saturation (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 module | |||||||||||
| Measurement range: 0~100 % Accuracy: 70%~100%: ±2% ABS (Adult/pediatric); 70% | |||||||||||
| Masimo SpO2 module | |||||||||||
| Measurement range: 1~100 %, Accuracy: without motion 70%~100%: | |||||||||||
| ±2% ABS (Adult/pediatric), 70% | |||||||||||
| Nellcor SpO2 module | |||||||||||
| Measurement range: 0~100 %, Accuracy: 70%~100% : ±2% ABS (Adult/pediatric); 70% | |||||||||||
| This measurement can be used for adults, pediatrics and neonates. | No change | ||||||||||
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | |
| Cleared in K182075 | Subject Device | ||||||||||
| Pulse rate (PR) | Pulse rate may be obtained from all sources of SpO2, or the IBP module. | ||||||||||
| Measurement range: 20 | |||||||||||
| SpO2), 20 | |||||||||||
| Accuracy: ±3 bpm (Mindray SpO2), ±3 bpm without motion, ±5 bpm with | |||||||||||
| motion (Masimo SpO2); 20 | |||||||||||
| (Nellcor SpO2); ±1 bpm or ±1%, whichever is greater (IBP). | |||||||||||
| This measurement can be used for adults, pediatrics and neonates. | No change | ||||||||||
| Non-invasive | |||||||||||
| blood 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 | |||||||||||
| mmHg (Neonate). | |||||||||||
| Diastolic: 10 | |||||||||||
| mmHg (Neonate). | |||||||||||
| Mean: 15 | |||||||||||
| (Neonate). | |||||||||||
| PR: 30~300bpm. | |||||||||||
| Accuracy: | |||||||||||
| NIBP: Max mean error: ±5mmHg; Max standard deviation: 8mmHg. | |||||||||||
| PR: ±3 bpm or ±3%, whichever is greater. | |||||||||||
| This measurement can be used for adults, pediatrics and neonates. | No change | ||||||||||
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | |
| Cleared in K182075 | 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. | No change | ||||||||||
| 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.: 0.1~20 L/min. | |||||||||||
| TB: 23 | |||||||||||
| Accuracy: | |||||||||||
| C.O.: ±5% or ±0.1L/min, whichever is greater. | |||||||||||
| TB, TI: ±0.1°C (without sensor). | |||||||||||
| This measurement can be used for adults. | 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) which measures continuous cardiac output (CCO). | ||||||||||
| This measurement can be used for adults and pediatrics. | 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. | |||||||||||
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | |
| Cleared in K182075 | Subject Device | ||||||||||
| Mixed/central | |||||||||||
| venous oxygen | |||||||||||
| saturation | |||||||||||
| (SvO2/ScvO2) | 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) which measures mixed | |||||||||||
| venous oxygen saturation (SvO2) and central venous oxygen saturation | |||||||||||
| (ScvO2). | |||||||||||
| This measurement can be used for adults and pediatrics. | 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 mixed venous oxygen saturation (SvO2) and | |||||||||||
| central venous oxygen saturation (ScvO2). | |||||||||||
| This measurement can be used for adults and pediatrics. | |||||||||||
| 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 | ||||||||||
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | |
| Cleared in K182075 | 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: 0150mmHg, awRR: 0150rpm.
Accuracy: CO2: Full accuracy mode: 040 mmHg: ±2mmHg, 4176
mmHg: ±5% of reading, 7799 mmHg: ±10% of reading, 100150mmHg:
±(3mmHg + 8% of reading),
ISO accuracy mode: Add ±2mmHg to the full accuracy mode.
awRR: 5%REL,
not specified;
SEV: 01%REL: $\pm$ 0.15% ABS, 15%REL: $\pm$ 0.2% ABS, 58%REL: $\pm$ 0.4%1%REL: $\pm$ 0.15% ABS, 1
ABS, >8%REL, not specified;
DES : 05%REL: $\pm$ 0.2% ABS, 510%REL: $\pm$ 0.4% ABS,
1015%REL: $\pm$ 0.6% ABS ,1518%REL: $\pm$ 1% ABS ,>18%REL, not specified;
awRR:260rpm, $\pm$ 1rpm, >60rpm, not specified15L/min;
This measurement can be used for adults, pediatrics and neonates. | | | | | No change | | | | | |
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | |
| | Cleared in K182075 | | | | | Subject Device | | | | | |
| Impedance
cardiograph
(ICG) | ICG measures a patient's hemodynamic status using a non-invasive method
based on thoracic electrical bioimpedance (TEB) technology. | | Measurement range:
C.O.:1.4
SV:5250ml;185bpm. | | Accuracy: HR: ±2bpm; other parameter: not specified.
HR: 44
This measurement can be used for adults. | No change | | | | | |
| Bispectral index
(BIS) | Not supported | | | | | 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: 0100.120)L/min;
Accuracy: not specified.
This measurement can be used for adults and pediatrics. | | | | | |
| Respiration
mechanics (RM) | The RM module measures respiration mechanics for adult and pediatric
patients. | | Measurement range: | | Accuracy: | No change | | | | | |
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | |
| | Cleared in K182075 | | | | | Subject Device | | | | | |
| | FLOW:
Adult/Pediatric: ±(2
Infant: ± (0.5 to 30) L/min
PAW:-20120 cmH2O;60L/min;
MVe/MVi:
Adult/Pediatric: 2
Infant: 0.5 to 15 L/min
TVe/TVi:
Adult/Pediatric: 1001500ml;120rpm;
Infant: 0.5 to 15 L/min
Calculated Parameters:
awRR:4
I:E:4:11:8;100%;
FEV1.0: 0
Pmean:0120 cmH2O;120 cmH2O;
PEEP:0
PEF:2120L/min;120L/min;
PIF:2
PIP: 0120 cmH2O;120 cmH2O;
Pplat:0
Compl: 0200ml/ cmH2O;4095rpm/L; | | | FLOW:
RSBI:0
Adult/Pediatric: 1.2L/min or ±10%
of reading, whichever is greater;
Infant: 0.5 L/min or ±10% of the
reading, whichever is greater
PAW: ±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 greater
Calculated Parameters:
awRR:499rpm: ±1rpm,120rpm, ±2rpm;
100
I:E: not specified;
FEV1.0: not specified;
Pmean: ±10%;
PEEP: not specified;
PEF: ±10%;
PIF: ±10%;
PIP: ±10%;
Pplat: not specified;
Compl: not specified;
RSBI: not specified; | | | | | | | |
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | |
| | | | Cleared in K182075 | | | | | Subject Device | | | |
| Neuromuscular
transmission
monitoring
(NMT) | NMT evaluates muscle relaxation of patients under a neuromuscular block
by measuring the strength of muscle reaction after electrically stimulating
the dedicated motor nerve.
Measurement range:
ST-Ratio:0 ~ 200%;
TOF-Count: 04;20;
TOF-Ratio: 5%160%;200%;
TOF-T1%: 0
PTC-Count:0
DBS-Count:02;95.
DBS-Ratio:5%160%50Hz(-3dB)
This measurement can be used for adults and pediatrics. | | | | | No change | | | | | |
| Electroencephalo
graph (EEG) | The EEG module measures the spontaneous, rhythmic electrical activity of
the cortex. The EEG module can continuously monitor EEG signals from
up to 4 channels. It can also display Density Spectral Arrays (DSA) and
Compressed Spectral Arrays (CSA).
Frequency response: 0.5Hz
Input range: 4mVpp
DC offset: ±500 mV
CMRR: ≥100 dB@51 kΩ and 60Hz
Noise level: ≤0.5 uVrms (1Hz to 30 Hz
Differential input resistance: >15MΩ@10Hz
Electrode resistance: 0 to 90 kΩ, resolution: ±1 KΩ or 10%, whichever is
the greater
This measurement is intended to be used for adults, pediatrics and
neonates. | | | | | No change | | | | | |
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | |
| | Cleared in K182075 | | | | | Subject Device | | | | | |
| Regional oxygen
saturation (rSO2) | The rSO2 module provides noninvasive and continuous information of
changes in regional oxygen saturation of blood. The measurement takes
place in real time, providing an immediate indication of a change in the
critical balance of regional oxygen delivery and oxygen consumption.
Measurement range: rSO2: 15
This measurement can be used for adults, pediatrics and neonates. | | | | | No change | | | | | |
| ECG 24h
Summary | 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 | | | | | |
| Early Warning
Score (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) 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.
Refer to Section 12.3.6 | | | | | |
| Glasgow Coma
Scale (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. | | | | | 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. | | | | | |
| 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: 2012
and and The Third International Consensus Definition for Sepsis and
Septic Shock (Sepsis-3)). | | | | | 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 and The Third International Consensus Definition for
Sepsis and Septic Shock (Sepsis-3))2. | | | | | |
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | |
| | Cleared in K182075 | | | | | Subject Device | | | | | |
| Cardio-
pulmonary
resuscitation
(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 start
condition, rescue end condition). | | | | No change | | | | | |
| Device
integration | Support BeneLink Module to connect Anesthesia, Ventilator, Pump,
TcGas Monitor Device, and Single Paramer Device. | | | | | Support BeneLink Module to connect Anesthesia,
Ventilator, Pump, TcGas Monitor Device, and Single Paramer
Device.
The types of the devices that can be connected are still
only the five types listed above, but some types added
newly approved devices. | | | | | |
| OxyCRG
Function | | Support the function of oxygen cardio-respirogram (OxyCRG) when
the patient type is neonate, and simultaneously provide real-time
OxyCRG interface and OxyCRG review interface to display parameter
trends and waveforms | | | | Support the function of oxygen cardio-respirogram
(OxyCRG) when the patient type is neonate, and
simultaneously provide real-time OxyCRG interface and
OxyCRG review interface to display parameter trends and
waveforms, and OxyCRG events. | | | | | |
| Security of
Patient
Information | Support Mindray proprietary encryption algorithm (XOR algorithm) | | | | | Support AES128 encryption algorithm | | | | | |
| Accessories | The accessories including ECG, SpO2, Temp, NIBP, IBP, C.O., ScvO2,
ICG, CO2, AG, RM, EEG, BIS, NMT, rSO2, CCO/SvO2 accessories. | | | | | Add new ECG, Temp, C.O., and IBP accessories | | | | | |
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Table 3: Device Comparison Table – N1
| Feature | N1 | N1 |
|---|---|---|
| Cleared in K182075 | Subject Device | |
| Primary display | ||
| and touchscreen | 5.5", 720*1280 pixels. | No change |
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| Feature | N1 | N1 |
|---|---|---|
| Cleared in K182075 | Subject Device | |
| External display | Allows the display of mirrored or independent data when connected to an | |
| external monitor through the video connector provided by the Dock. | No change | |
| Power supply | Two rechargeable Lithium-ion batteries (without built-in CO2 module), | |
| one rechargeable Lithium-ion battery (with built-in CO2 module), or DC- | ||
| in power supply. | No change | |
| Battery | Chargeable Lithium-ion 7.56VDC, 2500mAh. | Chargeable Lithium-ion 7.2VDC, 2500mAh. |
| Data storage | Embedded Multi Media Card (eMMC) | No change |
| Speaker | Gives 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 | |
| Communication | ||
| on Interface when | ||
| N1 is working as | ||
| a module | Infrared communication interface. | |
| Pogo pin communication interface. | No change | |
| Feature | N1 | N1 |
| Cleared in K182075 | 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) | ||
| Supports intelligent arrhythmia alarm. | ||
| Measurement range: | ||
| ST: -2.0mV~+2.0mV; | ||
| QT: 200~800ms; | ||
| HR: 15 | ||
| Accuracy: | ||
| ST: -0.8mV~+0.8mV, ±0.02mV or ±10%, whichever is greater, other | ||
| range: not specified; | ||
| QT: ±30ms; | ||
| HR: ±1 bpm or ±1%, whichever is greater. | ||
| This measurement can be used for adults, pediatrics and neonates except | ||
| for the arrhythmia detection. The arrhythmia detection is intended for | ||
| adult and pediatric patients only. | No change | |
| 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: ±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) | Measures temperature using the thermal resistance method. | |
| Measurement range: 0 to 50℃ (32 to 122°F). | ||
| Accuracy: ±0.1℃ or ±0.2 °F (without probe). | ||
| This measurement can be used for adults, pediatrics and neonates. | No change | |
| Feature | N1 | N1 |
| Cleared in K182075 | Subject Device | |
| Pulse oxygen saturation (SpO2) | Integrates one of the 3 kinds of SpO2 modules: | |
| Mindray SpO2 module board | ||
| Measurement range: SpO2:0~100 %, | ||
| Accuracy: 70%~100%: ±2% ABS (Adult/pediatric); 70% | ||
| Masimo SpO2 module board | ||
| Measurement range: 1~100 %, | ||
| Accuracy: without motion 70%~100%: ±2% ABS (Adult/pediatric), | ||
| 70% | ||
| 70% | ||
| Nellcor SpO2 module board | ||
| Measurement range: SpO2:0~100 %, | ||
| Accuracy: SpO2:70%~100%: ±2% ABS (Adult/pediatric); 70%~100% | ||
| : ±3% ABS (neonate); 0~69%: not specified. | ||
| This measurement can be used for adults, pediatrics and neonates. | No change | |
| Pulse rate (PR) | Obtains pulse rate from SpO2 or IBP. | |
| Measurement range: 20 | ||
| Accuracy: ±3 bpm (Mindray SpO2), ±3 bpm without motion, ±5 bpm with motion (Masimo SpO2); 20 | ||
| This measurement can be used for adults, pediatrics and neonates. | No change |
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510(k) Summary
| Feature | N1 | N1 |
|---|---|---|
| Cleared in K182075 | Subject Device | |
| Non-invasive | ||
| blood pressure | ||
| (NIBP) | The N1 uses the oscillometric method for measuring non-invasive blood | |
| pressure (NIBP). | ||
| Measurement range: | ||
| Systolic: 25 | ||
| 25~140mmHg (Neonate); | ||
| Diastolic: 10 | ||
| 10~115mmHg (Neonate); | ||
| Mean: 15 | ||
| (Neonate); | ||
| PR:30~300bpm. | ||
| Accuracy: | ||
| Max mean error: $\pm$ 5mmHg; Max standard deviation: 8mmHg; | ||
| PR: $\pm$ 3 bpm or $\pm$ 3%, whichever is greater. | ||
| This measurement can be used for adults, pediatrics, and neonates. | No change | |
| Invasive blood | ||
| pressure (IBP) | The monitor can monitor up to 2 invasive blood pressures and displays | |
| the 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: $\pm$ 2% or $\pm$ 1mmHg, whichever is greater (without sensor). | ||
| This measurement can be used for adults, pediatrics and neonates except | ||
| that PAWP is not for neonates. | No change | |
| Feature | N1 | |
| Cleared in K182075 | N1 | |
| 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 module | ||
| Measurement range: | ||
| CO2 :0 | ||
| Accuracy: | ||
| CO2: Full accuracy mode: 0 | ||
| of reading, 77 |
- 8% of reading), ISO accuracy mode: Add $\pm$ 2mmHg to the full accuracy
mode
awRR: