Passport Series Patient Monitors (Including Passport 8, Passport 12)

K153448 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · MHX · Mar 3, 2016 · Cardiovascular

Device Facts

• Record ID: K153448
• Device Name: Passport Series Patient Monitors (Including Passport 8, Passport 12)
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: MHX · Cardiovascular
• Decision Date: Mar 3, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Passport Series Patient Monitors(Passport 12), are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead, or 12-lead selectable), arrhythmia detection and ST Segment analysis, QT analysis, heart rate (HR), respiration (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO2), and anesthetic gas (AG). All the parameters can be applied to single adult, pediatric and neonatal patients with the following: - C.O. monitoring is restricted to adult patients only; - PAWP monitoring is not intended for neonatal patients; - The Mortara ECG Algorithm arrhythmia detection and ST Segment analysis is intended for adult and pediatric patients. The Mindray ECG Algorithm arrhythmia detection is intended for adult and pediatric patients, and the Mindray ECG Algorithm ST Segment analysis is intended for adult patients only. - 12-lead monitoring and AG monitoring are available for Passport 12 Patient Monitor only. The monitors are to be used in healthcare facilities by clinical physiciate medical staff under the direction of physicians.

Device Story

Multiparameter patient monitors (Passport 8, Passport 12) for healthcare facilities; operated by clinical staff. Inputs: ECG, SpO2, NIBP, IBP, C.O., CO2, anesthetic gas sensors. Transforms physiological signals into real-time waveforms, numerics, and alarms via integrated touchscreen display. Features include arrhythmia detection (Mindray/Mortara algorithms), ST-segment analysis, QT analysis, and pulse pressure variation (PPV). Outputs: visual/audible alarms, patient data storage, and RS232 data output. Assists clinicians in patient status assessment and decision-making; enables continuous monitoring of vital signs to improve patient safety.

Clinical Evidence

Bench testing only. Functional and system-level testing performed to evaluate modifications against predicate specifications. Conformance to consensus standards and FDA Class II Special Controls Guidance for Arrhythmia Detector and Alarm (2003) verified.

Technological Characteristics

Multiparameter monitors with 8.4" (Passport 8) or 12.1" (Passport 12) touchscreen displays. Powered by AC or rechargeable Lithium-ion batteries (11.1 VDC, 4500 mAh). Connectivity via RS232 port. ECG analysis uses Mindray or Mortara algorithms. Modules for SpO2 (Mindray, Masimo, Nellcor), NIBP (oscillometric), IBP, C.O. (thermodilution), CO2 (sidestream/microstream/mainstream), and AG. Software includes arrhythmia, ST-segment, QT, and PPV analysis.

Indications for Use

Indicated for adult, pediatric, and neonatal patients requiring monitoring of physiological parameters including ECG, arrhythmia, ST segment, QT, HR, respiration, temperature, SpO2, PR, NIBP, IBP, C.O., CO2, and anesthetic gas. C.O. monitoring restricted to adults; PAWP not for neonates. 12-lead and AG monitoring for Passport 12 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

• Passport Series Patient Monitors (Including Passport 8, Passport 12) (K132662)

Reference Devices

• Passport Series Patient Monitors (Including Passport 12M, Passport 17M, T1) (K132075)
• Philips ST/AR ST and Arrhythmia Software Model (K101521)
• V Series Monitoring System (K150352)
• Hypervisor IX Monitoring System (K150632)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 3. 2016

Shenzhen Mindrav Bio-medical Electronics Co., Ltd Bai Yanhong Product Approval Engineer, Technical Regulation Department Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan Nanshan, 518057 CN

Re: K153448

Trade/Device Name: Passport Series Patient Monitors (Passport 8 and Passport 12) Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MHX Dated: February 4, 2016 Received: February 8, 2016

Dear Bai Yanhong:

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. 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

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with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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

for Bram 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)

K153448

#### Device Name

Passport Series Patient Monitors (Passport 8 and Passport 12)

Indications for Use (Describe)

The Passport Series Patient Monitors(Passport 12), are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead, or 12-lead selectable), arrhythmia detection and ST Segment analysis, QT analysis, heart rate (HR), respiration (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO2), and anesthetic gas (AG).

All the parameters can be applied to single adult, pediatric and neonatal patients with the following:

- ·C.O. monitoring is restricted to adult patients only;
· PAWP monitoring is not intended for neonatal patients;

· The Mortara ECG Algorithm arrhythmia detection and ST Segment analysis is intended for adult and pediatric patients. The Mindray ECG Algorithm arrhythmia detection is intended for adult and pediatric patients, and the Mindray ECG Algorithm ST Segment analysis is intended for adult patients only.

· 12-lead monitoring and AG monitoring are available for Passport 12 Patient Monitor only.

The monitors are to be used in healthcare facilities by clinical physiciate medical staff under the direction of physicians.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-----------------------------------------------|
| ✔ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(K) SUMMARY

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Passport Series Patient Monitors is provided below.

| Device Common Name: | Patient Monitor |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Proprietary Name: | Passport Series Patient Monitors |
| Submitter: | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.<br>Mindray Building, Keji 12th Road South High-tech Industrial Park,<br>Nanshan Shenzhen 518057, P.R. China<br>Tel: [phone]<br>Fax: [phone] |
| Contact: | Baiyanhong<br>Manager Regulatory Affairs<br>SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.<br>Mindray Building, Keji 12th Road South High-tech Industrial Park,<br>Nanshan 518057, P.R. China<br>Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared: | November 18, 2015 |
| Classification Regulation: | 21 CFR 870.1025, Class II, Arrhythmia detector and alarm (including<br>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 ST-segment measurement<br>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 measurement<br>and alarm) | detector and alarm, arrhythmia |
| MLD | 21 CFR<br>870.1025 | Cardiovascular | Arrhythmia detector and alarm<br>(including ST-segment measurement<br>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) |

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K153448 page 2 of 8

| DXN | 21 CFR | Cardiovascular | Noninvasive blood pressure | system, measurement, |
|-----|--------------------|----------------|-------------------------------------------------------|--------------------------------------------------------------------------|
| | 870.1130 | | measurement system | blood-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, clinical |
| DQA | 21 CFR<br>870.2700 | Cardiovascular | Oximeter | Oximeter |
| DPZ | 21 CFR<br>870.2710 | Cardiovascular | Ear oximeter | oximeter, ear |
| CCK | 21 CFR<br>868.1400 | Anesthesiology | Carbon dioxide gas analyzer | analyzer, gas, carbon-dioxide,<br>gaseous-phase |
| CBQ | 21 CFR<br>868.1500 | Anesthesiology | Enflurane gas analyzer | analyzer, gas, enflurane,<br>gaseous-phase (anesthetic<br>concentration) |
| CBS | 21 CFR<br>868.1620 | Anesthesiology | Halothane gas analyzer | analyzer, gas, halothane,<br>gaseous-phase (anesthetic conc.) |
| CBR | 21 CFR<br>868.1700 | Anesthesiology | Nitrous oxide gas analyzer | analyzer, gas, nitrous-oxide,<br>gaseous phase (anesthetic 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,<br>pre-programmed, single-function |

Primary Predicate Device: K132662 - Passport Series Patient Monitors (Including Passport 8, Passport 12); Shenzhen Mindray Bio-Medical Electronics Co., Ltd

## Reference Predicates:

K132075 - Passport Series Patient Monitors (Including Passport 12M, Passport 17M,T1); Shenzhen Mindray Bio-Medical Electronics Co., Ltd

K101521 - Philips ST/AR ST and Arrhythmia Software Model; Philips Medical Systems K150352 - V Series Monitoring System; Shenzhen Mindray Bio-Medical Electronics Co., Ltd K150632 - Hypervisor IX Monitoring System; Shenzhen Mindray Bio-Medical Electronics Co., Ltd

## Indications for Use:

The Passport Series Patient Monitors(Passport 12), are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead, or 5-lead, or 12-lead selectable), arrhythmia detection and ST Segment analysis, OT analysis, heart rate (HR), respiration (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO2), and anesthetic gas (AG).

All the parameters can be applied to single adult, pediatric and neonatal patients with the exception of the following:

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- C.O. monitoring is restricted to adult patients only; O
- O PAWP monitoring is not intended for neonatal patients;
- The Mortara ECG Algorithm arrhythmia detection and ST Segment analysis is intended for adult and pediatric patients. The Mindray ECG Algorithm arrhythmia detection is intended for adult and pediatric patients, and the Mindray ECG Algorithm ST Segment analysis is intended for adult patients only.
- 12-lead monitoring and AG monitoring are available for Passport 12 Patient Monitor only.

The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.

#### Device Description:

The subject Passport Series Patient Monitors includes two monitors:

- Passport 8 Patient Monitor ●
- Passport 12 Patient Monitor ●

All of the devices in the family are multiparameter monitors indicated for monitoring, displaying. reviewing, alarming, and transferring multiple physiological parameters. The Passport 8 and Passport 12 Patient monitors provide patient monitoring capabilities based on the user selected modules that are plugged into the main monitor.

#### Performance Data:

· To establish the substantial equivalence of the Passport Series Patient Monitors (including Passport 8, Passport 12), Mindray conducted functional and system level 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 functional and system level testing showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate.

· In addition, 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.

## Substantial Equivalence:

Comparison of Indications - Both the predicate device and the subject Passport 8 and Passport 12 monitors are multiparameter patient monitors intended to be used in healthcare facilities under the direction of clinical professionals. The indications for use of the subject devices have been modified to include the new feature of QT analysis. Although this feature is not present in the predicate device, it is present in the cleared Philips ST/AR ST and Arrhythmia software (K101521), and thus does not constitute a new intended use for a multi-parameter monitor.

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In conclusion, the minor changes to the indications for use do not change the fundamental intended use of the Passport 8 and Passport 12 as multiparameter monitors.

Comparison of Technological Characteristics - The table below compares the key technological feature of the subject devices to the primary predicate device (Passport Series Patient Monitors K132662). The features in grey are the features that have been modified since their previous clearances and that are the subject of this 510(k).

| | Predicate Device (K132662) | | Subject Devices | |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Feature | Passport 8 | Passport 12 | Passport 8 | Passport 12 |
| Integrated<br>display and<br>touchscreen | 8.4" 800*600 pixels | 12.1" 800*600 pixels | Same | Same |
| Secondary<br>display | Display is linked to integrated display | | Same | |
| Power supply | One rechargeable Lithium-ion<br>batteries or AC power supply | Two rechargeable<br>Lithium-ion battery or AC<br>power supply | Same | Same |
| Battery | Chargeable Lithium-Ion, 11.1 VDC, 4500 mAh | Same | Same | |
| Data Recorder | The thermal recorder can be used to print patient information,<br>measurement numerics, and waveforms. | | Same | |
| Speaker | Give alarm tones (45 to 85 dB), key tones, QRS tones; support<br>PITCH TONE and multi-level tone modulation | | Same | |
| ECG (Mindray<br>Algorithm) | 3-lead , 5-lead or 12-lead selectable, arrhythmia detection, ST<br>segment analysis, Pace detection and heart rate (HR) | | Added QT analysis , Added an<br>additional Pace detection channel<br>to enhance the Pace detection<br>function, added ECG J-point auto<br>detection , added adjustable QRS<br>Detection Threshold | |
| ECG (Mortara<br>Algorithm) | 3-lead , 5-lead or 12-lead selectable, arrhythmia detection, ST<br>segment analysis, , and heart rate (HR) | | Same | |
| Arrhythmia<br>Analysis<br>(Mindray<br>Algorithm) | Asystole, VFib/VTac, Vtac, Vent. Brady, Extreme Tachy,<br>Extreme Brady, PVC, Couplet, Bigeminy, Trigeminy, R on T,<br>VT>2, PVCs, Tachy, Brady, Missed Beats, Vent. Rhythm,<br>PNP, PNC, Multif. PVC,<br>Nonsus. Vtac, Pause, Irr. Rhythm | | Added AFib | |
| Arrhythmia<br>Analysis<br>(Mortara<br>Algorithm) | Asystole, Vfib, Vtac, Vent. Rhythm, Couplet, VT>2,<br>Bigeminy, Trigeminy, R on T, Multif. PVC, Irr. Rhythm,<br>Tachy, Brady, Missed Beats, PNP, PNC | | Same | |
| Respiration rate<br>(Resp) | Measurement range: Adult: 0 to 120 rpm; Pediatric, neonate: 0<br>to 150 rpm.<br>Accuracy: 7 to 150 rpm:±2 rpm or ±2%, whichever is greater;<br>0 to 6 rpm: Not specified. | | Same | |
| | Predicate Device (K132662) | | Subject Devices | |
| Feature | Passport 8 | Passport 12 | Passport 8 | Passport 12 |
| Temperature<br>(Temp) | Measurement range: 0 to 50°C (32 to 122°F)<br>Accuracy: ±0.1°C (without probe) | Measurement range: 0 to 50°C (32 to 122°F)<br>Accuracy: ±0.1°C (without probe) | Same | |
| Pulse oxygen<br>saturation<br>(SpO2) | Is compatible with the following 3 modules to measure oxygen<br>saturation:<br>• Mindray SpO2 Module<br>• Masimo SpO2 Module<br>• Nellcor SpO2 Module<br><br>Mindray SpO2 Module<br>Measurement range: 0 to 100%<br>Accuracy:70 to 100%: ±2% (in adult/pediatric mode)<br>70 to 100%: ±3% (in neonate mode)<br>0% to 69%: Not specified<br><br>Masimo SpO2 Module<br>Measurement range: 1 to 100%<br>Accuracy:70 to 100%: ±2% (measured without motion in<br>adult/pediatric mode)<br>70 to 100%: ±3% (measured without motion in neonate mode)<br>70 to 100%: ±3% (measured with motion)<br>1% to 69%: Not specified.<br><br>Nellcor SpO2 Module<br>Measurement range: 0 to 100%<br>Accuracy:70 to 100%: ±2% (adult/pediatric)<br>70 to 100%: ±3% (neonate)<br>0% to 69%: Not specified. | Is compatible with the following 3 modules to measure oxygen<br>saturation:<br>• Mindray SpO2 Module<br>• Masimo SpO2 Module<br>• Nellcor SpO2 Module<br><br>Mindray SpO2 Module<br>Measurement range: 0 to 100%<br>Accuracy:70 to 100%: ±2% (in adult/pediatric mode)<br>70 to 100%: ±3% (in neonate mode)<br>0% to 69%: Not specified<br><br>Masimo SpO2 Module<br>Measurement range: 1 to 100%<br>Accuracy:70 to 100%: ±2% (measured without motion in<br>adult/pediatric mode)<br>70 to 100%: ±3% (measured without motion in neonate mode)<br>70 to 100%: ±3% (measured with motion)<br>1% to 69%: Not specified.<br><br>Nellcor SpO2 Module<br>Measurement range: 0 to 100%<br>Accuracy:70 to 100%: ±2% (adult/pediatric)<br>70 to 100%: ±3% (neonate)<br>0% to 69%: Not specified. | Same | |
| | Predicate Device (K132662) | | Subject Devices | |
| Feature | Passport 8 | Passport 12 | Passport 8 | Passport 12 |
| Pulse rate (PR) | Pulse rate may be obtained from the SpO2 module, NIBP<br>module or the IBP module.<br>PR from Mindray SpO2 Module<br>Measurement range: 20 to 254 bpm<br>Accuracy: $\pm$ 3 bpm<br>PR from Masimo SpO2 Module<br>Measurement range: 25 to 240 bpm<br>Accuracy: $\pm$ 3 bpm (measured without motion)<br>$\pm$ 5 bpm (measured with motion)<br>PR from Nellcor SpO2 Module<br>Measurement range: 20 to 300 bpm<br>Accuracy:20 to 250 bpm: $\pm$ 3 bpm<br>251 to 300 bpm, not specified<br>PR from NIBP Module<br>Measurement range: 40 to 240 bpm<br>Accuracy: $\pm$ 3bpm or $\pm$ 3%, whichever is greater<br>PR from IBP Module<br>Measurement range: 25 to 350 bpm<br>Accuracy: $\pm$ 1 bpm or $\pm$ 1%, whichever is greater" | Pulse rate may be obtained from the SpO2 module, NIBP<br>module or the IBP module. | Same | Same |
| Non-invasive<br>blood pressure<br>(NIBP) | Uses the oscillometric method for measuring non-invasive<br>blood pressure (NIBP). This measurement can be used for<br>adults, pediatrics and neonates.<br>Measurement range:<br>Adult<br>Systolic:<br>40 to 270<br>Diastolic:<br>10 to 210<br>Mean:<br>20 to 230<br>Accuracy:<br>Max mean error: $\pm$ 5 mmHg<br>Max standard deviation: 8 mmHg | Pediatric<br>Neonate<br>40 to 200<br>40 to 135<br>10 to 150<br>10 to 100<br>20 to 165<br>20 to 110 | Same | Same |
| Invasive blood<br>pressure (IBP) | The monitor can measure invasive blood pressures and displays<br>systolic, diastolic and mean pressures and a waveform for each<br>pressure.<br>Measurement range: -50 to 300 mmHg<br>Accuracy: $\pm$ 2% or $\pm$ 1 mmHg, whichever is greater (without<br>sensor) | The monitor can measure invasive blood pressures and displays<br>systolic, diastolic and mean pressures and a waveform for each<br>pressure.<br>Measurement range: -50 to 300 mmHg<br>Accuracy: $\pm$ 2% or $\pm$ 1 mmHg, whichever is greater (without<br>sensor) | Same | Same |
| Pulse Pressure<br>Variation (PPV) | Not supported | Not supported | Added. | Added. |
| | Predicate Device (K132662) | | Subject Devices | |
| Feature | Passport 8 | Passport 12 | Passport 8 | Passport 12 |
| Cardiac output<br>(C.O.) | The cardiac output (C.O.) measurement invasively measures<br>cardiac output and other hemodynamic parameters using the<br>right heart (atria) thermodilution method. The temperature<br>change is displayed as a curve in the C.O. split screen, and the<br>monitor calculates the C.O. value from this curve. | | Same | Same |
| Carbon dioxide<br>(CO2) | Is compatible with the following 3 modules to measure carbon<br>dioxide:<br>Sidestream CO2 Module Microstream CO2 Module Mainstream CO2 Module CO2 monitoring is based on calculations from measuring the<br>absorption of infrared (IR) light of specific wavelengths using a<br>photodetector.<br><br>Sidestream CO2 Module:<br>Measurement range: 0 to 99 mmHg<br>Accuracy:<br>0 to 40 mmHg: ±2 mmHg<br>41 to 76 mmHg: ±5% of the reading<br>77 to 99 mmHg: ±10% of the reading<br><br>Microstream CO2 Module:<br>Measurement range: 0 to 99 mmHg<br>Accuracy:<br>0 to 38 mmHg: ±2 mmHg<br>39 to 99 mmHg: ±5% of the reading +0.08% of (the<br>reading-38)<br><br>Mainstream CO2 Module<br>Measurement range: 0 to150 mmHg<br>Accuracy:<br>0 to 40 mmHg: ±2 mmHg<br>41 to 70 mmHg: ±5% of the reading<br>71 to 100 mmHg: ±8% of the reading<br>101 to 150 mmHg: ±10% of the reading | | Same | Same |
| Anesthetic gas<br>(AG) | Not supported | The AG module analyzes<br>gas samples from the<br>patient and calculates CO2,<br>O2, N2O and AA waves<br>and related numerics,<br>airway respiratory rate, and<br>MAC (minimum alveolar<br>concentration). | Same | Same |
| | Predicate Device (K132662) | | Subject Devices | |
| Feature | Passport 8 | Passport 12 | Passport 8 | Passport 12 |
| 2 New neonatal<br>pre-wired<br>electrodes | Not supported | | Added | |
| DIAP output | Not supported.…