Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard physiological parameter monitoring and analysis algorithms (like ECG algorithms).

Therapeutic

No.
The device is described as a patient monitor intended for monitoring, displaying, reviewing, storing, and alarming of multiple physiological parameters; it does not provide therapy.

Diagnostic

Yes

The device is intended for "monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters" including ECG, heart rate, respiration, temperature, SpO2, blood pressure, etc. It also performs "arrhythmia detection and ST Segment analysis," which are diagnostic functions.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the Passport Series Patient Monitors are hardware devices ("main monitor") that accept plug-in modules for various physiological parameters. This indicates it is a hardware-based medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the Passport Series Patient Monitors (Passport 12) are not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly states that the device is for "monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters" directly from the patient (ECG, respiration, temperature, SpO2, NIBP, IBP, C.O., CO2, AG).
Nature of Measurements: The parameters measured are physiological signals and values obtained directly from the patient's body, not from samples of bodily fluids or tissues analyzed outside the body.
Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or the use of reagents, which are hallmarks of IVD devices.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Passport Series Patient Monitors are designed for direct patient monitoring of vital signs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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.

Product codes (comma separated list FDA assigned to the subject device)

MHX, DSI, MLD, DRT, DXN, DSK, FLL, DQA, DPZ, CCK, CBQ, CBS, CBR, CCL, DXG

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.

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

Adult, pediatric and neonatal patients.

Intended User / Care Setting

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

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

To establish the substantial equivalence of the 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K132662

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K132075, K101521, K150352, K150632

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, formed by three human profiles facing to the right.

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

1

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 (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

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.
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:	Baiyanhong
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:	November 18, 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) |

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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
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
DPZ	21 CFR
870.2710	Cardiovascular	Ear oximeter	oximeter, ear
CCK	21 CFR
868.1400	Anesthesiology	Carbon dioxide gas analyzer	analyzer, gas, carbon-dioxide,
gaseous-phase
CBQ	21 CFR
868.1500	Anesthesiology	Enflurane gas analyzer	analyzer, gas, enflurane,
gaseous-phase (anesthetic
concentration)
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

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
display and
touchscreen	8.4" 800*600 pixels	12.1" 800*600 pixels	Same	Same
Secondary
display	Display is linked to integrated display		Same
Power supply	One rechargeable Lithium-ion
batteries or AC power supply	Two rechargeable
Lithium-ion battery or AC
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,
measurement numerics, and waveforms.		Same
Speaker	Give alarm tones (45 to 85 dB), key tones, QRS tones; support
PITCH TONE and multi-level tone modulation		Same
ECG (Mindray
Algorithm)	3-lead , 5-lead or 12-lead selectable, arrhythmia detection, ST
segment analysis, Pace detection and heart rate (HR)		Added QT analysis , Added an
additional Pace detection channel
to enhance the Pace detection
function, added ECG J-point auto
detection , added adjustable QRS
Detection Threshold
ECG (Mortara
Algorithm)	3-lead , 5-lead or 12-lead selectable, arrhythmia detection, ST
segment analysis, , and heart rate (HR)		Same
Arrhythmia
Analysis
(Mindray
Algorithm)	Asystole, VFib/VTac, Vtac, Vent. Brady, Extreme Tachy,
Extreme Brady, PVC, Couplet, Bigeminy, Trigeminy, R on T,
VT>2, PVCs, Tachy, Brady, Missed Beats, Vent. Rhythm,
PNP, PNC, Multif. PVC,
Nonsus. Vtac, Pause, Irr. Rhythm		Added AFib
Arrhythmia
Analysis
(Mortara
Algorithm)	Asystole, Vfib, Vtac, Vent. Rhythm, Couplet, VT>2,
Bigeminy, Trigeminy, R on T, Multif. PVC, Irr. Rhythm,
Tachy, Brady, Missed Beats, PNP, PNC		Same
Respiration rate
(Resp)	Measurement range: Adult: 0 to 120 rpm; Pediatric, neonate: 0
to 150 rpm.
Accuracy: 7 to 150 rpm:±2 rpm or ±2%, whichever is greater;
0 to 6 rpm: Not specified.		Same
	Predicate Device (K132662)		Subject Devices
Feature	Passport 8	Passport 12	Passport 8	Passport 12
Temperature
(Temp)	Measurement range: 0 to 50°C (32 to 122°F)
Accuracy: ±0.1°C (without probe)	Measurement range: 0 to 50°C (32 to 122°F)
Accuracy: ±0.1°C (without probe)	Same
Pulse oxygen
saturation
(SpO2)	Is compatible with the following 3 modules to measure oxygen
saturation:
• Mindray SpO2 Module
• Masimo SpO2 Module
• Nellcor SpO2 Module

Mindray SpO2 Module
Measurement range: 0 to 100%
Accuracy:70 to 100%: ±2% (in adult/pediatric mode)
70 to 100%: ±3% (in neonate mode)
0% to 69%: Not specified

Masimo SpO2 Module
Measurement range: 1 to 100%
Accuracy:70 to 100%: ±2% (measured without motion in
adult/pediatric mode)
70 to 100%: ±3% (measured without motion in neonate mode)
70 to 100%: ±3% (measured with motion)
1% to 69%: Not specified.

Nellcor SpO2 Module
Measurement range: 0 to 100%
Accuracy:70 to 100%: ±2% (adult/pediatric)
70 to 100%: ±3% (neonate)
0% to 69%: Not specified. | Is compatible with the following 3 modules to measure oxygen
saturation:
• Mindray SpO2 Module
• Masimo SpO2 Module
• Nellcor SpO2 Module

Mindray SpO2 Module
Measurement range: 0 to 100%
Accuracy:70 to 100%: ±2% (in adult/pediatric mode)
70 to 100%: ±3% (in neonate mode)
0% to 69%: Not specified

Masimo SpO2 Module
Measurement range: 1 to 100%
Accuracy:70 to 100%: ±2% (measured without motion in
adult/pediatric mode)
70 to 100%: ±3% (measured without motion in neonate mode)
70 to 100%: ±3% (measured with motion)
1% to 69%: Not specified.

Nellcor SpO2 Module
Measurement range: 0 to 100%
Accuracy:70 to 100%: ±2% (adult/pediatric)
70 to 100%: ±3% (neonate)
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
module or the IBP module.
PR from Mindray SpO2 Module
Measurement range: 20 to 254 bpm
Accuracy: $\pm$ 3 bpm
PR from Masimo SpO2 Module
Measurement range: 25 to 240 bpm
Accuracy: $\pm$ 3 bpm (measured without motion)
$\pm$ 5 bpm (measured with motion)
PR from Nellcor SpO2 Module
Measurement range: 20 to 300 bpm
Accuracy:20 to 250 bpm: $\pm$ 3 bpm
251 to 300 bpm, not specified
PR from NIBP Module
Measurement range: 40 to 240 bpm
Accuracy: $\pm$ 3bpm or $\pm$ 3%, whichever is greater
PR from IBP Module
Measurement range: 25 to 350 bpm
Accuracy: $\pm$ 1 bpm or $\pm$ 1%, whichever is greater" | Pulse rate may be obtained from the SpO2 module, NIBP
module or the IBP module. | Same | Same |
| Non-invasive
blood pressure
(NIBP) | Uses the oscillometric method for measuring non-invasive
blood pressure (NIBP). This measurement can be used for
adults, pediatrics and neonates.
Measurement range:
Adult
Systolic:
40 to 270
Diastolic:
10 to 210
Mean:
20 to 230
Accuracy:
Max mean error: $\pm$ 5 mmHg
Max standard deviation: 8 mmHg | Pediatric
Neonate
40 to 200
40 to 135
10 to 150
10 to 100
20 to 165
20 to 110 | Same | Same |
| Invasive blood
pressure (IBP) | The monitor can measure invasive blood pressures and displays
systolic, diastolic and mean pressures and a waveform for each
pressure.
Measurement range: -50 to 300 mmHg
Accuracy: $\pm$ 2% or $\pm$ 1 mmHg, whichever is greater (without
sensor) | The monitor can measure invasive blood pressures and displays
systolic, diastolic and mean pressures and a waveform for each
pressure.
Measurement range: -50 to 300 mmHg
Accuracy: $\pm$ 2% or $\pm$ 1 mmHg, whichever is greater (without
sensor) | Same | Same |
| Pulse Pressure
Variation (PPV) | Not supported | Not supported | Added. | Added. |
| | Predicate Device (K132662) | | Subject Devices | |
| Feature | Passport 8 | Passport 12 | Passport 8 | Passport 12 |
| Cardiac output
(C.O.) | The cardiac output (C.O.) measurement invasively measures
cardiac output and other hemodynamic parameters using the
right heart (atria) thermodilution method. The temperature
change is displayed as a curve in the C.O. split screen, and the
monitor calculates the C.O. value from this curve. | | Same | Same |
| Carbon dioxide
(CO2) | Is compatible with the following 3 modules to measure carbon
dioxide:
Sidestream CO2 Module Microstream CO2 Module Mainstream CO2 Module CO2 monitoring is based on calculations from measuring the
absorption of infrared (IR) light of specific wavelengths using a
photodetector.

Sidestream CO2 Module:
Measurement range: 0 to 99 mmHg
Accuracy:
0 to 40 mmHg: ±2 mmHg
41 to 76 mmHg: ±5% of the reading
77 to 99 mmHg: ±10% of the reading

Microstream CO2 Module:
Measurement range: 0 to 99 mmHg
Accuracy:
0 to 38 mmHg: ±2 mmHg
39 to 99 mmHg: ±5% of the reading +0.08% of (the
reading-38)

Device Comparison Table

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8

9

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Substantial Equivalence Conclusion:

Based on the detailed comparison of specifications for each of the modifications to the previously cleared Passport Series devices (K132662) and relevant reference predicates, the performance testing and conformance with applicable standards, the Passport Series Patient Monitors (Passport 8 and Passport 12) can be found substantially equivalent to the predicate devices.