V Series Monitoring System (including V12 and V21 Monitors)

K150352 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · MHX · Sep 2, 2015 · Cardiovascular

Device Facts

• Record ID: K150352
• Device Name: V Series Monitoring System (including V12 and V21 Monitors)
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: MHX · Cardiovascular
• Decision Date: Sep 2, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

V Series Monitoring System (V12/V21) is a multi-parameter patient monitor for intra-hospital use. It acquires physiological data via modular sensors (ECG, SpO2, NIBP, IBP, CO2, anesthetic gases, temperature, BIS). The system consists of a Display Control Unit (DCU), docking station, and module rack. It processes signals to provide real-time waveforms, numerics, arrhythmia detection, ST-segment analysis, 12-lead ECG interpretation, and QT analysis. Data is displayed on a touchscreen; clinicians use the output for patient assessment and clinical decision-making. The device supports wireless functionality and network interfacing. It benefits patients by providing continuous, real-time vital sign monitoring and automated alerts for physiological abnormalities.

Clinical Evidence

Bench testing only. System and performance testing confirmed that the modified V Series meets specifications and is equivalent to the predicate. Compliance with consensus standards (e.g., IEC 60601-2-49, IEC 60601-1-8, ISO 81060-2) was verified.

Technological Characteristics

Multi-parameter monitor with 12" or 21" TFT touchscreen. Modular architecture (VPS module, V Hub). Connectivity via wireless modules and network ports. Power: AC or Li-ion battery. Software-based analysis for ECG, arrhythmia, ST-segment, QT, and BIS. Complies with ANSI/AAMI ES60601-1, IEC 60601-2-49, and various ISO/IEC standards for specific parameters.

Indications for Use

Indicated for continuous monitoring of physiological parameters in adult, pediatric, and neonate populations. Exceptions: Arrhythmia detection, ST Segment Analysis, and QT Analysis (adult/pediatric only); IV Drug Calculations (adult only); Cardiac Output and Bispectral Index (adult/pediatric only).

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• V Series Monitoring System (K132026)
• Passport Series Patient Monitors (K143195)
• ST/AR ST AND ARRHYTHMIA SOFTWARE (K101521)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# 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)

K150352

Page 2 of 2

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#### 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<br>detection or alarms) |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Proprietary Name: | V Series Monitoring System (including V12 and V21<br>Monitors) |
| Submitter: | SHENZHEN MINDRAY BIO-MEDICAL<br>ELECTRONICS CO., LTD.<br>Mindray Building, Keji 12th Road South<br>High-tech Industrial Park, Nanshan<br>Shenzhen 518057, P.R. China<br>Tel: [phone]<br>Fax: [phone] |
| Contact: | Yanhong Bai<br>Manager Regulatory Affairs<br>SHENZHEN MINDRAY BIO-MEDICAL<br>ELECTRONICS CO., LTD.<br>Mindray Building, Keji 12th Road South<br>High-tech Industrial Park, Nanshan<br>518057, P.R. China<br>Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared: | January 29, 2015 |
| Classification Regulation: | 21 CFR 870.1025, Class II, Arrhythmia detector and alarm<br>(including ST-segment measurement and alarm) |
| Panel: | Cardiovascular |

# Classification Regulation, Classification Name and Product Codes:

| Product<br>Code | Regulation<br>Number | Panel | Regulation Description | Device Common Name |
|-----------------|----------------------|----------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Primary | | | | |
| MHX | 21 CFR<br>870.1025 | Cardiovascular | Arrhythmia detector and alarm<br>(including<br>ST-segment<br>measurement and alarm) | Monitor, physiological, patient<br>(with arrhythmia detection or<br>alarms) |
| Secondary | | | | |
| Product<br>Code | Regulation<br>Number | Panel | Regulation Description | Device Common Name |
| DSI | 21 CFR<br>870.1025 | Cardiovascular | Arrhythmia detector and alarm<br>(including ST-segment<br>measurement and alarm) | Detector and alarm, arrhythmia |
| MLD | 21 CFR<br>870.1025 | Cardiovascular | Arrhythmia detector and alarm<br>(including ST-segment<br>measurement and alarm) | Monitor, st segment with alarm |
| DRT | 21 CFR<br>870.2300 | Cardiovascular | Cardiac Monitor (including<br>cardiotachometer and rate alarm) | Monitor, cardiac (incl.<br>cardiotachometer & rate alarm) |
| DXN | 21 CFR<br>870.1130 | Cardiovascular | Noninvasive blood pressure<br>measurement system | System, measurement, blood-<br>pressure, non-invasive |
| DSK | 21 CFR<br>870.1110 | Cardiovascular | Blood pressure computer | Computer, blood-pressure |
| FLL | 21 CFR<br>880.2910 | Cardiovascular | Clinical electronic thermometer | Thermometer, electronic,<br>clinical |
| DQA | 21 CFR<br>870.2700 | Cardiovascular | Oximeter | Oximeter |
| CCK | 21 CFR<br>868.1400 | Anesthesiology | Carbon dioxide gas analyzer | Analyzer, gas, carbon-dioxide,<br>gaseous-phase |
| CBS | 21 CFR<br>868.1620 | Anesthesiology | Halothane gas analyzer | Analyzer, gas, halothane,<br>gaseous-phase (anesthetic<br>conc.) |
| CBR | 21 CFR<br>868.1700 | Anesthesiology | Nitrous oxide gas analyzer | Analyzer, gas, nitrous-oxide,<br>gaseous phase (anesthetic<br>conc.) |
| CCL | 21 CFR<br>868.1720 | Anesthesiology | Oxygen gas analyzer | Analyzer, gas, oxygen,<br>gaseous-phase |
| DXG | 21 CFR<br>870.1435 | Cardiovascular | Single-function, preprogrammed<br>diagnostic computer | Computer, diagnostic, pre-<br>programmed, single-function |
| DQK | 870.1425 | Cardiovascular | Programmable diagnostic<br>computer | Computer, diagnostic,<br>programmable |
| MUD | 870.2700 | Cardiovascular | oximeter | Oximeter, tissue saturation |
| GWM | 822.1620 | Neurology | Intracranial pressure monitoring<br>device | Device, monitoring,<br>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<br>Code | Regulation<br>Number | Panel | Regulation Description | Device Common Name |
| NHP | 868.1500 | Anesthesiology | Enflurane gas analyzer | Analyzer, gas, sevoflurane,<br>(anesthetic<br>gaseous-phase<br>concentration) |

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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:

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- 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

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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 ●

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#### 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<br>(K132026) | | Subject Devices | |
|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | V12 | V21 | V12 | V21 |
| Integrate<br>d display<br>and<br>touch<br>screen | 12.1" TFT<br>1024 x 768 pixels | 21.3" TFT<br>1600 x 1200<br>pixels | Same | Same |
| Seconda<br>ry<br>display | Display is linked to integrated<br>display | | Same | Same |
| | Predicate Device / V Series<br>(K132026) | | Subject Devices | |
| Feature | V12 | V21 | V12 | V21 |
| Module<br>rack | Independent of<br>the patient<br>monitor,<br>provides 1<br>integrated and 2<br>extended<br>module slots to<br>extend the<br>measurement<br>capabilities of<br>the system | Independent<br>of the patient<br>monitor,<br>provides 3<br>extended<br>module slots<br>to extend the<br>measurement<br>capabilities<br>of the system | Same | Same |
| Power<br>supply | Three<br>rechargeable<br>Lithium-ion<br>battery(maximu<br>m) or AC power<br>supply | AC power<br>supply | Same | Same |
| Battery | Chargeable<br>Lithium-Ion,<br>11.1 VDC, 4.8<br>Ah (one battery) | Not<br>supported | Same | Same |
| External<br>memory<br>card | USB Memory Stick | | Same | Same |
| Data<br>Recorder | The thermal recorder records<br>patient information,<br>measurement numerics, up to<br>three waveforms, etc. | | Same | Same |
| Speaker | Give alarm tones (45 to 85 dB),<br>key tones, QRS tones, warning<br>tone; support PITCH TONE and<br>multi-level tone modulation. | | Same | Same |
| Printer | Laser Printer and Thermal Printer<br>(the addition of the Strip Chart<br>Recorder Module supports the<br>thermal printer) | | Same | Same |
| ECG<br>wavefor<br>m | 3-lead , 5-lead, 6-lead or 12-lead<br>selectable | | 3-lead , 5-lead or 12-lead<br>selectable | 3-lead , 5-lead or 12-lead<br>selectable |
| | Predicate Device / V Series<br>(K132026) | | Subject Devices | |
| Feature | V12 | V21 | V12 | V21 |
| Heart<br>Rate<br>Meter<br>(ECG) | Measurement range:<br>3, 5 / 6 lead:<br>Adult/Pediatric:30-300 bpm;<br>Neonatal:30-350bmp<br>12 lead:<br>Adult/Pediatric:30-300 bpm;<br>Neonatal: 30-350bpm<br>Accuracy:<br>$± 3 bpm or ± 3%$ in the range of<br>30 to 250 bpm, whichever is<br>greater<br>$± 5%$ in the range of 251 bpm to<br>350 bpm | Measurement range:<br>3, 5lead:<br>Adult/Pediatric:20-300 bpm;<br>Neonatal:20-350bpm<br>12 lead:<br>Adult/Pediatric:20-300 bpm;<br>Neonatal :20-350bpm<br>Accuracy:<br>$± 3 bpm or ± 3%$ in the range of<br>20 bpm to 250 bpm, whichever<br>is greater<br>$± 5%$ in the range of 251 bpm to<br>350 bpm | Measurement range:<br>3, 5lead:<br>Adult/Pediatric:20-300 bpm;<br>Neonatal:20-350bpm<br>12 lead:<br>Adult/Pediatric:20-300 bpm;<br>Neonatal :20-350bpm<br>Accuracy:<br>$± 3 bpm or ± 3%$ in the range of<br>20 bpm to 250 bpm, whichever<br>is greater<br>$± 5%$ in the range of 251 bpm to<br>350 bpm | Measurement range:<br>3, 5lead:<br>Adult/Pediatric:20-300 bpm;<br>Neonatal:20-350bpm<br>12 lead:<br>Adult/Pediatric:20-300 bpm;<br>Neonatal:20-350bpm<br>Accuracy:<br>$± 3 bpm or ± 3%$ in the range of<br>20 bpm to 250 bpm, whichever<br>is greater<br>$± 5%$ in the range of 251 bpm to<br>350 bpm |
| QRS<br>wavefor<br>m<br>detection | Supported,<br>fixed threshold 0.2mV | Supported, | Supported,<br>adjustable threshold between<br>0.16mV to 0.48mV | Supported,<br>adjustable threshold between<br>0.16mV to 0.48mV |
| ST<br>Segment<br>Analysis | Supported | Same | Same | Same |
| Arrhyth<br>mia<br>Detectio<br>n | Supported,<br>fixed leads for arrhythmia<br>analysis | Supported,<br>adjustable leads for<br>arrhythmia analysis,<br>Added Extreme Bradycardia<br>alarms, Extreme Tachycardia<br>alarms, Pacer Failure to<br>Capture alarms, Pacer Failure<br>to Sense alarms | Supported,<br>adjustable leads for<br>arrhythmia analysis,<br>Added Extreme Bradycardia<br>alarms, Extreme Tachycardia<br>alarms, Pacer Failure to<br>Capture alarms, Pacer Failure<br>to Sense alarms | Supported,<br>adjustable leads for<br>arrhythmia analysis<br>Added Extreme Bradycardia<br>alarms, Extreme Tachycardia<br>alarms, Pacer Failure to<br>Capture alarms, Pacer Failure<br>to Sense alarms |
| 12-lead<br>ECG<br>interpret<br>ation | Supported | Supported<br>Added Baseline Drift Removal<br>(BDR) filter, Muscle Artifact<br>filter and Beat markers | Supported<br>Added Baseline Drift Removal<br>(BDR) filter, Muscle Artifact<br>filter and Beat markers | Supported<br>Added Baseline Drift Removal<br>(BDR) filter, Muscle Artifact<br>filter and Beat markers |
| QT<br>Analysis | Not supported | Supported | Supported | Supported |
| | Predicate Device / V Series<br>(K132026) | | Subject Devices | |
| Feature | V12 | V21 | V12 | V21 |
| The<br>version<br>of<br>Mortara<br>arrhythmia<br>algorithm<br>analysis<br>software | 3.3.5 | | 4.0.0 | 4.0.0 |
| Pace<br>Detection | Single Pace detection channel | | Dual Pace detection channels | Dual Pace detection channels |
| Pulse<br>oxygen<br>saturation (SpO2) | SpO2 Range: 70-100%<br>SpO2 Accuracy<br>Nellcor:<br>With sensor: MAXAI, MAX-AL,<br>MAXPI, MAXII, MAXNI<br>(Adult), MAXNI (Neonate) 70%<br>to 100% ± 2 digits<br>With sensor: OxiCliq A, OxiCliq<br>P, OxiCliq I, OxiCliq N(Adult),<br>OxiCliq N (Neonate) 70% to<br>100% ± 2.5 digits<br>With sensor :DS-100A, D-YS<br>(Infant to Adult), OXI-A/N<br>(Adult), OXI-P/I 70% to 100% ±<br>3 digits<br>With sensor :D-YS with D-YSE<br>Ear Clip, D-YS with D-YSPD<br>Spot Clip 70% to 100% ± 3.5<br>digits<br>With sensor :D-YS (Neonate),<br>OXI-A/N (Neonate) 70% to<br>100% ± 4 digits<br>Masimo:<br>Adult,pediatric:<br>Maximum error of 2% with no<br>motion Maximum error of 3% in<br>the presence of<br>motion with motion resistant<br>sensors.<br>Neonatal: | | Same | Same |

#### Device Comparison Table

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| | Predicate Device / V Series<br>(K132026) | | Subject Devices | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| Feature | V12 | V21 | V12 | V21 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Pulse<br>rate (PR) | PR range:<br>Nellcor:20-249 bpm<br>Masimo:26-239 bpm<br>PR Accuracy: ± 3bpm | Same | Same | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Non-invasive<br>blood<br>pressure<br>(NIBP) | Measurement<br>Technique:<br>Oscillometric<br>Pressure range(mmHg): | Measurement<br>Technique:<br>Oscillometric<br>Pressure range(mmHg): | Measurement<br>Technique:<br>Oscillometric<br>Pressure range(mmHg): | Measurement<br>Technique:<br>Oscillometric<br>Pressure range(mmHg): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |…