(203 days)
Not Found
No
The document describes standard physiological monitoring parameters and calculations, with no mention of AI or ML technologies. The performance studies focus on equivalence to predicate devices and compliance with standards, not on AI/ML model performance.
No
This device is a monitoring system that measures physiological parameters. It does not provide therapy or treatment.
Yes
The device continuously monitors various human physiological parameters, including ECG, heart rate, blood pressure, and respiratory gases. It performs ST Segment Analysis, Arrhythmia Detection, and 12-lead ECG interpretation, all of which are diagnostic functions.
No
The device description explicitly lists multiple hardware components including Display Control Units (DCU), Docking Stations, Module Racks, VPS Modules, and other specific parameter modules, all of which are physical hardware.
Based on the provided text, the V Series Monitoring System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Intended Use of the V Series Monitoring System: The intended use of the V Series Monitoring System is for the continuous monitoring of human physiological parameters directly from the patient (ECG, SpO2, NIBP, IBP, etc.). It does not involve the analysis of specimens taken from the body.
- Device Description: The device description details components that acquire physiological data directly from the patient (sensors, modules connected to the patient) and display/process this data. There is no mention of components for handling or analyzing biological specimens.
Therefore, the V Series Monitoring System falls under the category of patient monitoring devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The V Series Monitoring System is intra hospital use under the direct supervision of a licensed healthcare practitioner. The Indications for Use for the V12/V21 Monitor include the continuous monitoring of the following human physiological parameters:
- ECG waveform derived from 3, 5 and 12 Lead measurements
- Heart Rate
- ST Segment Analysis
- Arrhythmia Detection
- 12-lead ECG interpretation
- OT Analysis
- Pulse Oximetry (SpO2)
- Pulse Rate (PR)
- Non Invasive Blood Pressure (NIBP)
- Invasive Blood Pressure (IBP)
- Cardiac Output (C.O.)
- Respiratory Gases (02, CO2)
- Respiration Rate (RESP)
- Anesthetic Gases (Iso, Enf, Sev, Hal, Des, N2O)
- Temperature (TEMP)
- Bispectral Index (BIS)
The V12/V21 Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.
The target populations are adult, pediatric and neonate with the exception of:
- Arrhythmia detection, ST Segment Analysis, for which the target population are adult and pediatric only.
- IV Drug Calculations for which the target population is adult only,
- Cardiac Output for which the target population are adult and pediatric only, and
- Bispectral Index(BIS) for which the target population are adult and pediatric only.
Product codes
MHX, DSI, MLD, DRT, DXN, DSK, FLL, DQA, CCK, CBS, CBR, CCL, DXG, DQK, MUD, BWM, NHO, CBQ, NHQ, NHP
Device Description
The subject V Series Monitoring System includes two monitors, one incorporating a12" display (V12 Monitor) and the other incorporating a 21" display (V21 Monitor), and includes the following system components:
- Display Control Unit (DCU) Display Control Unit (DCU) includes the system . processor, monitor display, user interface and appropriate connectors for communication to peripheral devices. The 12-inch (V12) monitor display features a touch screen display that accommodates up to 8 waveforms and corresponding numerics. It includes an internal module rack in the back which holds up to 6 modules, depending on their size. It can be removed from the docking station and used as an intra hospital transport monitor. The 21-inch (V21) monitor display features a touch screen display that accommodates up to 12 waveforms and corresponding numerics. It also includes a touch pad as an optional method to interact with the software.
- Docking Station (Model name: V Dock) The Docking Station is a physical mount for the DCU. The Docking Station incorporates multiple connectivity ports designed to enable quick connection and release for mobility. It provides power to the monitoring system. It features a quick release mechanism that allows the DCU to be easily and quickly removed and reattached. The docking station also provides connectivity to other external devices and systems such as remote displays or nurse call systems and mounts to a wall mount or rolling stand. The Docking Station used in the subject V Series is referred to in Mindray internal documents as "V Dock" or "Dock".
- Module Rack (Model name: V Hub) The Module Rack is a physical mount for the modules capable of holding up to 6 modules, depending on their size. It features a quick release mechanism that allows the Module Rack to be easily and quickly removed and reattached to a wall mount or rolling stand to be used during intra hospital transports. The Module Rack used in the subject V Series is referred to in Mindray internal documents as "V Hub" or "Hub".
- VPS Module - The VPS is the main parameter module of the subject V Series that provides the core parameters: 3/5/12-lead ECG, SpO2, Respiration, NIBP, 2 invasive pressures and 1 temperature channel. The VPS is a parameter acquisition device designed to acquire and store real-time vital sign data. Its modular design allows it to be moved with the patient between V Series Monitoring Systems.
- Modules - Modules are data acquisition devices that add parameter and interface capability to the subject V Series. These modules are parameter specific and include temperature, invasive blood pressure (IBP), cardiac output (C.O.), CO2, and strip recorder. One module, the VDI (V Device Integrator), is configurable to allow interface to other medical devices such as continuous cardiac output (CCO), regional oxymetry saturation (rSO2), respiratory gas, and DIAP (previously cleared under the predicate V Series K132026). One module, the BIS interface module, is configurable to allow interface to BIS module (Mindray is seeking clearance for this new feature under this 510(k)).
- View 12 (12 lead ECG cable) - The View 12 will monitor 12 lead ECG and respiration through the ECG port connection on the VPS Module.
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
The target populations are adult, pediatric and neonate with the exception of:
- Arrhythmia detection, ST Segment Analysis and QT Analysis, for which the target population are adult and pediatric only,
- IV Drug Calculations for which the target population is adult only,
- Cardiac Output for which the target population are adult and pediatric only, and
- Bispectral Index (BIS) for which the target population are adult and pediatric only.
Intended User / Care Setting
intra hospital use under the direct supervision of a licensed healthcare practitioner.
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)
Mindray conducted system and performance testing on the subject devices. The testing provided an evaluation of the performance of the device relevant to each of the modifications to the subject devices since their previous clearance. The system and performance testing showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate.
Mindray has conducted testing to ensure the subject devices meet relevant consensus standards.
Mindray has also followed the FDA Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm issues on October 28, 2003.
The V Series Monitoring System has been modified to provide wireless functionality. Mindray conducted Wireless functionality testing to ensure the performance of the new wireless modules meet specifications and are equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is simple and professional, reflecting the department's role in public health and human services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 2, 2015
Shenzhen Mindray Bio-medical Electronics Co., Ltd Yanhong Bai Manager Regulatory Affairs Mindray Building, Keji 12th Road South, Hi-tech Industrial Park Nanshan, Shenzhen 518057, P.R. China
Re: K150352
Trade/Device Name: V Series Monitoring System (including V12 And V21 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, CCK, CBS, CBR, CCL, DXG, DQK, MUD, BWM, NHO, CBQ, NHQ, NHP Dated: July 31, 2015 Received: August 4, 2015
Dear Yanhong Bai:
We have reviewed vour 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. 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
1
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mitchell Stein
forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150352
Page 1 of 2
Device Name
V Series Monitoring System (including V12 and V21 Monitors)
Indications for Use (Describe)
The V Series Monitoring System is intra hospital use under the direct supervision of a licensed healthcare practitioner. The Indications for Use for the V12/V21 Monitor include the continuous monitoring of the following human physiological parameters:
- · ECG waveform derived from 3, 5 and 12 Lead measurements
- · Heart Rate
- · ST Segment Analysis
- · Arrhythmia Detection
- 12-lead ECG interpretation
- · OT Analysis
- · Pulse Oximetry (SpO2)
- · Pulse Rate (PR)
- · Non Invasive Blood Pressure (NIBP)
- · Invasive Blood Pressure (IBP)
- · Cardiac Output (C.O.)
- · Respiratory Gases (02, CO2)
- · Respiration Rate (RESP)
- · Anesthetic Gases (Iso, Enf, Sev, Hal, Des, N2O)
- · Temperature (TEMP)
- · Bispectral Index (BIS)
The V12/V21 Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.
-
The target populations are adult, pediatric and neonate with the exception of:
· Arrhythmia detection, ST Segment Analysis, for which the target population are adult and pediatric only. -
· IV Drug Calculations for which the target population is adult only,
-
· Cardiac Output for which the target population are adult and pediatric only, and
-
· Bispectral Index(BIS) for which the target population are adult and pediatric only.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Page 2 of 2
3
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4
5. 510(K) SUMMARY
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the V Series Monitoring System is provided below.
| Device Common Name: | Multi-Parameter Patient Monitor (with arrhythmia
detection or alarms) |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Proprietary Name: | V Series Monitoring System (including V12 and V21
Monitors) |
| Submitter: | 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 81885635
Fax: +86 755 26582680 |
| Contact: | Yanhong Bai
Manager Regulatory Affairs
SHENZHEN MINDRAY BIO-MEDICAL
ELECTRONICS CO., LTD.
Mindray Building, Keji 12th Road South
High-tech Industrial Park, Nanshan
518057, P.R. China
Tel: +86 755 81885635
Fax: +86 755 26582680
E-mail: baiyanhong@mindray.com |
| Date Prepared: | January 29, 2015 |
| Classification Regulation: | 21 CFR 870.1025, Class II, Arrhythmia detector and alarm
(including ST-segment measurement and alarm) |
| Panel: | Cardiovascular |
Classification Regulation, Classification Name and Product Codes:
| Product
Code | Regulation
Number | Panel | Regulation Description | Device Common Name |
|-----------------|----------------------|----------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Primary | | | | |
| MHX | 21 CFR
870.1025 | Cardiovascular | Arrhythmia detector and alarm
(including
ST-segment
measurement and alarm) | Monitor, physiological, patient
(with arrhythmia detection or
alarms) |
| Secondary | | | | |
| Product
Code | Regulation
Number | Panel | Regulation Description | Device Common Name |
| DSI | 21 CFR
870.1025 | Cardiovascular | Arrhythmia detector and alarm
(including ST-segment
measurement and alarm) | Detector and alarm, arrhythmia |
| MLD | 21 CFR
870.1025 | Cardiovascular | Arrhythmia detector and alarm
(including ST-segment
measurement and alarm) | Monitor, st segment with alarm |
| DRT | 21 CFR
870.2300 | Cardiovascular | Cardiac Monitor (including
cardiotachometer and rate alarm) | Monitor, cardiac (incl.
cardiotachometer & rate alarm) |
| DXN | 21 CFR
870.1130 | Cardiovascular | Noninvasive blood pressure
measurement system | System, measurement, blood-
pressure, non-invasive |
| DSK | 21 CFR
870.1110 | Cardiovascular | Blood pressure computer | Computer, blood-pressure |
| FLL | 21 CFR
880.2910 | Cardiovascular | Clinical electronic thermometer | Thermometer, electronic,
clinical |
| DQA | 21 CFR
870.2700 | Cardiovascular | Oximeter | Oximeter |
| CCK | 21 CFR
868.1400 | Anesthesiology | Carbon dioxide gas analyzer | Analyzer, gas, carbon-dioxide,
gaseous-phase |
| CBS | 21 CFR
868.1620 | Anesthesiology | Halothane gas analyzer | Analyzer, gas, halothane,
gaseous-phase (anesthetic
conc.) |
| CBR | 21 CFR
868.1700 | Anesthesiology | Nitrous oxide gas analyzer | Analyzer, gas, nitrous-oxide,
gaseous phase (anesthetic
conc.) |
| CCL | 21 CFR
868.1720 | Anesthesiology | Oxygen gas analyzer | Analyzer, gas, oxygen,
gaseous-phase |
| DXG | 21 CFR
870.1435 | Cardiovascular | Single-function, preprogrammed
diagnostic computer | Computer, diagnostic, pre-
programmed, single-function |
| DQK | 870.1425 | Cardiovascular | Programmable diagnostic
computer | Computer, diagnostic,
programmable |
| MUD | 870.2700 | Cardiovascular | oximeter | Oximeter, tissue saturation |
| GWM | 822.1620 | Neurology | Intracranial pressure monitoring
device | Device, monitoring,
intracranial pressure |
| NHO | 868.1500 | Anesthesiology | Enflurane gas analyzer | Analyzer, gas, desflurane, gaseous-phase (anesthetic concentration) |
| CBQ | 868.1500 | Anesthesiology | Enflurane gas analyzer | Analyzer, gas, enflurane, gaseous-phase (anesthetic concentration) |
| NHQ | 868.1500 | Anesthesiology | Enflurane gas analyzer. | Analyzer, gas, isoflurane, gaseous-phase (anesthetic concentration) |
| Product
Code | Regulation
Number | Panel | Regulation Description | Device Common Name |
| NHP | 868.1500 | Anesthesiology | Enflurane gas analyzer | Analyzer, gas, sevoflurane,
(anesthetic
gaseous-phase
concentration) |
5
6
Predicate Device:
K132026 - V Series Monitoring System (including V12 and V21), MINDRAY DS USA, INC.
K143195 - Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1), Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.
K101521 - ST/AR ST AND ARRHYTHMIA SOFTWARE, PHILIPS MEDICAL SYSTEMS.
Indications for Use:
The V Series Monitoring System is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The Indications for Use for the V12/V21 Monitor include the continuous monitoring of the following human physiological parameters:
- ECG waveform derived from 3, 5 and 12 Lead measurements
- Heart Rate ●
- ST Segment Analysis
- Arrhythmia Detection ●
- 12-lead ECG interpretation ●
- o OT Analysis
- Pulse Oximetry (SpO2) ●
- Pulse Rate (PR)
- Non Invasive Blood Pressure (NIBP) ●
- Invasive Blood Pressure (IBP)
- Cardiac Output (C.O.) ●
- Respiratory Gases (02, CO2)
- Respiration Rate (RESP) ●
- Anesthetic Gases (Iso, Enf, Sev, Hal, Des, N2O) ●
- Temperature (TEMP) ●
- Bispectral Index (BIS) ●
The V12/V21 Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.
The target populations are adult, pediatric and neonate with the exception of:
7
- Arrhythmia detection, ST Segment Analysis and QT Analysis, for which the target population are adult and pediatric only,
- IV Drug Calculations for which the target population is adult only,
- Cardiac Output for which the target population are adult and pediatric only, and ●
- Bispectral Index (BIS) for which the target population are adult and pediatric only. o
Device Description:
The subject V Series Monitoring System includes two monitors, one incorporating a12" display (V12 Monitor) and the other incorporating a 21" display (V21 Monitor), and includes the following system components:
- Display Control Unit (DCU) Display Control Unit (DCU) includes the system . processor, monitor display, user interface and appropriate connectors for communication to peripheral devices. The 12-inch (V12) monitor display features a touch screen display that accommodates up to 8 waveforms and corresponding numerics. It includes an internal module rack in the back which holds up to 6 modules, depending on their size. It can be removed from the docking station and used as an intra hospital transport monitor. The 21-inch (V21) monitor display features a touch screen display that accommodates up to 12 waveforms and corresponding numerics. It also includes a touch pad as an optional method to interact with the software.
- Docking Station (Model name: V Dock) The Docking Station is a physical mount ● for the DCU. The Docking Station incorporates multiple connectivity ports designed to enable quick connection and release for mobility. It provides power to the monitoring system. It features a quick release mechanism that allows the DCU to be easily and quickly removed and reattached. The docking station also provides connectivity to other external devices and systems such as remote displays or nurse call systems and mounts to a wall mount or rolling stand. The Docking Station used in the subject V Series is referred to in Mindray internal documents as "V Dock" or "Dock".
- Module Rack (Model name: V Hub) The Module Rack is a physical mount for the ● modules capable of holding up to 6 modules, depending on their size. It features a quick release mechanism that allows the Module Rack to be easily and quickly removed and reattached to a wall mount or rolling stand to be used during intra hospital transports. The Module Rack used in the subject V Series is referred to in Mindray internal documents as "V Hub" or "Hub".
- VPS Module - The VPS is the main parameter module of the subject V Series that provides the core parameters: 3/5/12-lead ECG, SpO2, Respiration, NIBP, 2 invasive pressures and 1 temperature channel. The VPS is a parameter acquisition device designed to acquire and store real-time vital sign data. Its modular design allows it to be moved with the patient between V Series Monitoring Systems.
- Modules - Modules are data acquisition devices that add parameter and interface capability to the subject V Series. These modules are parameter specific and include temperature, invasive blood pressure (IBP), cardiac output (C.O.), CO2, and strip recorder. One module, the VDI (V Device Integrator), is configurable to allow interface to other medical devices such as continuous cardiac output (CCO), regional oxymetry saturation (rSO2), respiratory gas, and DIAP (previously cleared under the
8
predicate V Series K132026). One module, the BIS interface module, is configurable to allow interface to BIS module (Mindray is seeking clearance for this new feature under this 510(k)).
- o View 12 (12 lead ECG cable) - The View 12 will monitor 12 lead ECG and respiration through the ECG port connection on the VPS Module.
Performance Data:
- o To establish the substantial equivalence of the V Series Monitoring System (including V12 and V21 Monitors), Mindray conducted system and performance testing on the subject devices. The testing provided an evaluation of the performance of the device relevant to each of the modifications to the subject devices since their previous clearance. The system and performance testing showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate.
- Mindray has conducted testing to ensure the subject devices meet relevant consensus standards.
- Mindray has also followed the FDA Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm issues on October 28, 2003.
- o The V Series Monitoring System has been modified to provide wireless functionality. Mindray conducted Wireless functionality testing to ensure the performance of the new wireless modules meet specifications and are equivalent to the predicate device.
Consensus Standards
The subject V Series Monitoring System has been tested and found to be in compliance with the following safety and performance standards:
- ANSI/AAMI ES60601-1:2005/(R) 2012 and A1:2012,C1:2009/(R)2012 and ● A2:2010/(R)2012
- IEC 60601-2-49:2011 ●
- IEC 60601-1-2:2007 ●
- IEC 60601-1-8:2012 ●
- o IEC 60601-1-6: 2013
- IEC 60601-2-25:2011
- IEC 60601-2-27:2011 ●
- ANSI/AAMI EC57: 2012 ●
- IEC 60601-2-34:2011
- IEC 80601-2-30:2013 ●
- ISO 81060-2: 2013 ●
- ISO 80601-2-56: 2009 ●
- ISO 80601-2-61: 2011 ●
- IEC 60601-2-26:2002 ●
- ISO 80601-2-55: 2011 ●
9
Substantial Equivalence:
Comparison of Indications:
Both the predicate and the subject V Series are multi-parameter patient monitors intended to be used in healthcare facilities under the direction of clinical professionals. The indications for use of the subject V Series have been modified to:
- o remove the feature of ECG waveform derived from 6 lead measurements from the subject V Series
- include the addition of a QT analysis feature and the interface to and display of o Bispectural Index (BIS)
For business reasons only, Mindray has decided to remove the feature of ECG waveform derived from 6 lead measurements from the subject V Series. Removal of this feature does not affect the safety and effectiveness of the subject device. So this change does not impact substantial equivalence.
Although the addition of the interface to and display of Bispectral Index (BIS) and QT Analysis feature are not presented in the primary predicate device V Series, the Bispectral Index (BIS) is presented in the cleared Passport Series (K143195), QT Analysis is presented in the cleared Philips (K101521), and thus does not constitute a new intended use for a multi-parameter monitor.
In conclusion, the changes to the indications for use do not change the fundamental intended use of the V Series as multi-parameter monitors.
Comparison of Technological Characteristics:
The table below compares the key technological feature of the subject V Series to the primary predicate V Series (K132026). The features highlighted in grev are the features that have been modified since their previous clearances and that are the subject of this 510(k) for which Mindrav is seeking clearance.
| | Predicate Device / V Series
(K132026) | | Subject Devices | |
|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | V12 | V21 | V12 | V21 |
| Integrate
d display
and
touch
screen | 12.1" TFT
1024 x 768 pixels | 21.3" TFT
1600 x 1200
pixels | Same | Same |
| Seconda
ry
display | Display is linked to integrated
display | | Same | Same |
| | Predicate Device / V Series
(K132026) | | Subject Devices | |
| Feature | V12 | V21 | V12 | V21 |
| Module
rack | Independent of
the patient
monitor,
provides 1
integrated and 2
extended
module slots to
extend the
measurement
capabilities of
the system | Independent
of the patient
monitor,
provides 3
extended
module slots
to extend the
measurement
capabilities
of the system | Same | Same |
| Power
supply | Three
rechargeable
Lithium-ion
battery(maximu
m) or AC power
supply | AC power
supply | Same | Same |
| Battery | Chargeable
Lithium-Ion,
11.1 VDC, 4.8
Ah (one battery) | Not
supported | Same | Same |
| External
memory
card | USB Memory Stick | | Same | Same |
| Data
Recorder | The thermal recorder records
patient information,
measurement numerics, up to
three waveforms, etc. | | Same | Same |
| Speaker | Give alarm tones (45 to 85 dB),
key tones, QRS tones, warning
tone; support PITCH TONE and
multi-level tone modulation. | | Same | Same |
| Printer | Laser Printer and Thermal Printer
(the addition of the Strip Chart
Recorder Module supports the
thermal printer) | | Same | Same |
| ECG
wavefor
m | 3-lead , 5-lead, 6-lead or 12-lead
selectable | | 3-lead , 5-lead or 12-lead
selectable | 3-lead , 5-lead or 12-lead
selectable |
| | Predicate Device / V Series
(K132026) | | Subject Devices | |
| Feature | V12 | V21 | V12 | V21 |
| Heart
Rate
Meter
(ECG) | Measurement range:
3, 5 / 6 lead:
Adult/Pediatric:30-300 bpm;
Neonatal:30-350bmp
12 lead:
Adult/Pediatric:30-300 bpm;
Neonatal: 30-350bpm
Accuracy:
$± 3 bpm or ± 3%$ in the range of
30 to 250 bpm, whichever is
greater
$± 5%$ in the range of 251 bpm to
350 bpm | Measurement range:
3, 5lead:
Adult/Pediatric:20-300 bpm;
Neonatal:20-350bpm
12 lead:
Adult/Pediatric:20-300 bpm;
Neonatal :20-350bpm
Accuracy:
$± 3 bpm or ± 3%$ in the range of
20 bpm to 250 bpm, whichever
is greater
$± 5%$ in the range of 251 bpm to
350 bpm | Measurement range:
3, 5lead:
Adult/Pediatric:20-300 bpm;
Neonatal:20-350bpm
12 lead:
Adult/Pediatric:20-300 bpm;
Neonatal :20-350bpm
Accuracy:
$± 3 bpm or ± 3%$ in the range of
20 bpm to 250 bpm, whichever
is greater
$± 5%$ in the range of 251 bpm to
350 bpm | Measurement range:
3, 5lead:
Adult/Pediatric:20-300 bpm;
Neonatal:20-350bpm
12 lead:
Adult/Pediatric:20-300 bpm;
Neonatal:20-350bpm
Accuracy:
$± 3 bpm or ± 3%$ in the range of
20 bpm to 250 bpm, whichever
is greater
$± 5%$ in the range of 251 bpm to
350 bpm |
| QRS
wavefor
m
detection | Supported,
fixed threshold 0.2mV | Supported, | Supported,
adjustable threshold between
0.16mV to 0.48mV | Supported,
adjustable threshold between
0.16mV to 0.48mV |
| ST
Segment
Analysis | Supported | Same | Same | Same |
| Arrhyth
mia
Detectio
n | Supported,
fixed leads for arrhythmia
analysis | Supported,
adjustable leads for
arrhythmia analysis,
Added Extreme Bradycardia
alarms, Extreme Tachycardia
alarms, Pacer Failure to
Capture alarms, Pacer Failure
to Sense alarms | Supported,
adjustable leads for
arrhythmia analysis,
Added Extreme Bradycardia
alarms, Extreme Tachycardia
alarms, Pacer Failure to
Capture alarms, Pacer Failure
to Sense alarms | Supported,
adjustable leads for
arrhythmia analysis
Added Extreme Bradycardia
alarms, Extreme Tachycardia
alarms, Pacer Failure to
Capture alarms, Pacer Failure
to Sense alarms |
| 12-lead
ECG
interpret
ation | Supported | Supported
Added Baseline Drift Removal
(BDR) filter, Muscle Artifact
filter and Beat markers | Supported
Added Baseline Drift Removal
(BDR) filter, Muscle Artifact
filter and Beat markers | Supported
Added Baseline Drift Removal
(BDR) filter, Muscle Artifact
filter and Beat markers |
| QT
Analysis | Not supported | Supported | Supported | Supported |
| | Predicate Device / V Series
(K132026) | | Subject Devices | |
| Feature | V12 | V21 | V12 | V21 |
| The
version
of
Mortara
arrhythmia
algorithm
analysis
software | 3.3.5 | | 4.0.0 | 4.0.0 |
| Pace
Detection | Single Pace detection channel | | Dual Pace detection channels | Dual Pace detection channels |
| Pulse
oxygen
saturation (SpO2) | SpO2 Range: 70-100%
SpO2 Accuracy
Nellcor:
With sensor: MAXAI, MAX-AL,
MAXPI, MAXII, MAXNI
(Adult), MAXNI (Neonate) 70%
to 100% ± 2 digits
With sensor: OxiCliq A, OxiCliq
P, OxiCliq I, OxiCliq N(Adult),
OxiCliq N (Neonate) 70% to
100% ± 2.5 digits
With sensor :DS-100A, D-YS
(Infant to Adult), OXI-A/N
(Adult), OXI-P/I 70% to 100% ±
3 digits
With sensor :D-YS with D-YSE
Ear Clip, D-YS with D-YSPD
Spot Clip 70% to 100% ± 3.5
digits
With sensor :D-YS (Neonate),
OXI-A/N (Neonate) 70% to
100% ± 4 digits
Masimo:
Adult,pediatric:
Maximum error of 2% with no
motion Maximum error of 3% in
the presence of
motion with motion resistant
sensors.
Neonatal: | | Same | Same |
Device Comparison Table
10
11
12
13
| | Predicate Device / V Series
(K132026) | | Subject Devices | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| Feature | V12 | V21 | V12 | V21 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Pulse
rate (PR) | PR range:
Nellcor:20-249 bpm
Masimo:26-239 bpm
PR Accuracy: ± 3bpm | Same | Same | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Non-invasive
blood
pressure
(NIBP) | Measurement
Technique:
Oscillometric
Pressure range(mmHg): | Measurement
Technique:
Oscillometric
Pressure range(mmHg): | Measurement
Technique:
Oscillometric
Pressure range(mmHg): | Measurement
Technique:
Oscillometric
Pressure range(mmHg): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Adult Pediatric Neonate Systolic 55 to 235 55 to 160 45 to 120 Diastolic 30 to 200 30 to 150 20 to 100 Accuracy:
Max mean error: ±5 mmHg
Max standard deviation: 8 mmHg
Pulse Rate Range(bpm):
Adult/Pediatric: 35 - 245
Neonatal: 70-245 | | | | | | | | | | | | | | | | | Adult Pediatric Neonate Systolic 55 to 270 55 to 170 45 to 130 Diastolic 30 to 200 30 to 150 20 to 100 Accuracy:
Max mean error: ±5 mmHg
Max standard deviation: 8 mmHg
Pulse Rate Range(bpm):
Adult/Pediatric: 35 - 245
Neonatal: 70-245 | | | | | | | | | | | | | | | | | Adult Pediatric Neonate Systolic 55 to 270 55 to 170 45 to 130 Diastolic 30 to 200 30 to 150 20 to 100 Accuracy:
Max mean error: ±5 mmHg
Max standard deviation: 8 mmHg
Pulse Rate Range(bpm):
Adult/Pediatric: 35 - 245
Neonatal: 70-245 | | | | | | | | | | | | | | | | | Adult Pediatric Neonate Systolic 55 to 270 55 to 170 45 to 130 Diastolic 30 to 200 30 to 150 20 to 100 Accuracy:
Max mean error: ±5 mmHg
Max standard deviation: 8 mmHg
Pulse Rate Range(bpm):
Adult/Pediatric: 35 - 245
Neonatal: 70-245 | | | | | | | | | | | | | | |
| Invasive
blood
pressure
(IBP) | Accuracy:
± 2mmHg or 2% whichever is
greater
Zero Offset Range:
± 120 mmHg
IBP Heart Rate range:
30 to 300 bpm(Adult/Pediatric),
30 to 350 bpm(Neonatal)
IBP Heart Rate accuracy:
± 3 bpm or ± 3%, whichever is
greater at 30 to 250 bpm,
±5 BPM or ±5 from 251 to 350
BPM | Same | Same | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
14
| | Predicate Device / V Series
(K132026) | | Subject Devices | |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|-----------------|-----------|
| Feature | V12 | V21 | V12 | V21 |
| Cardiac
output
(C.O.) | 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.
C.O. Range:
0.2 to 20.0 liters/minute
C.O. Accuracy:
5% or 0.2 liters/minute,
whichever is greater
Blood Temperature Range:
17.5 - 43°C (63.5°F - 109.4°F)
Blood Temperature Accuracy:
$\pm$ 0.2°C ( $\pm$ 0.4°F), exclusive of
probe errors
Injectate Temperature Range:
(-)1.0 to 30.0 °C (30.2° F to 86°
F)
Injectate Temperature Accuracy:
$\pm$ 0.2°C ( $\pm$ 0.4°F), exclusive of
probe errors | | Same | Same |
| Capnogr
aphy
(EtCO2
and
FiCO2) | Measurement range:
0-99 mmHg
Accuracy:
0-38 mmHg : $\pm$ 2 mmHg
39-99 mmHg : $\pm$ (5% of reading
+0.08% for every 1 mmHg over
38 mmHg )
Accuracy applies for breath rates
of up to 80 bpm. For breath rates
above 80 bpm, accuracy is 4
mmHg or $\pm$ 12% of reading
whichever is greater, for EtCO2
values exceeding 18 mmHg.
Respiration Rate range
(respriations per minute):
0 to 150 rpm
Respiration Rate Accuracy:
$\pm$ 1 rpm from 0 to 70 rpm, $\pm$ 2
rpm from 71 to 120 rpm, $\pm$ 3 rpm
from 121 to 150 rpm | | Same | Same |
| | Predicate Device / V Series
(K132026) | | Subject Devices | |
| Feature | V12 | V21 | V12 | V21 |
| Respirati
on rate
(Resp) | Measurement range:
4 rpm to 199 rpm;
Accuracy: $\pm$ 2 or $\pm$ 2%,
whichever is greater from 4 to
150, $\pm$ 4% from 151 to 199 | | Same | Same |
| Tempera
ture
(Temp) | Measurement range:
15-45°C(59-113°F)
Accuracy:
$\pm$ 0.1°C (15°C to 45°C) exclusive
of probe errors or $\pm$ 0.2°F (59°F
to 113°F) exclusive of
probe
errors | | Same | Same |
| Bispectr
al index
(BIS) | Not supported | | Supported | Supported |
| 14
new
NIBP
cuffs | None | | Supported | Supported |
| Wireless
function
ality | Not supported | | Supported | Supported |
15
Substantial Equivalence Conclusion:
Based on the detailed comparison of specifications for each of the modifications to the identified predicate devices, the performance testing and conformance with applicable standards, the subject V Series has been demonstrated performance that is substantially equivalent to the predicate device.