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 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.

AI/ML Overview

This document is a 510(k) premarket notification for the Passport Series Patient Monitors (Passport 8 and Passport 12), not a study report. It states that "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."

Therefore, most of the information required to answer the question is not present in the provided text. The document refers to "Mindray conducted functional and system level testing" and "testing to ensure the subject devices meet relevant consensus standards" but does not detail the specific studies, sample sizes, or ground truth methodologies that would typically be found in a clinical study report.

However, based on the provided text, here is what can be inferred or explicitly stated regarding acceptance criteria and performance:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly present a table of "acceptance criteria" alongside "reported device performance" like a typical study report. Instead, it compares the "Subject Devices" (Passport 8 and Passport 12) with a "Predicate Device (K132662)" and notes changes and additions in features. The "Performance Data" section broadly states that testing showed the devices "continue to meet specifications and the performance of the device is equivalent to the predicate."

For features where "Same" is indicated, the "Predicate Device" rows effectively represent the performance (specifications) that the current devices are expected to meet. For new or modified features, the stated capabilities in the "Subject Devices" row serve as the claimed performance.

Let's extract an example for a specific parameter based on the device comparison table:

Feature/Parameter	Acceptance Criteria (Implied from Predicate/New Feature)	Reported Device Performance (Implied from Subject Device Row)
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
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

Crucially, the document does NOT provide quantitative performance metrics (e.g., sensitivity, specificity, accuracy, error margins) that would typically serve as acceptance criteria or reported performance figures from a clinical study for these algorithms. It only lists the features that the device supports and how they compare to the predicate.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not provided. The document states "Mindray conducted functional and system level testing," but no details about the sample size of the test set or the provenance of the data (e.g., patient demographics, country, retrospective/prospective nature) are given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not provided. The document does not mention the use of experts for establishing ground truth for any testing performed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not provided. No information regarding adjudication methods is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable / Not provided. This device is a patient monitor, not an AI-assisted diagnostic imaging device requiring human-in-the-loop comparison. The document focuses on the device's technical specifications and equivalence to predicate devices, not on improving human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Implied, but details are not provided. The document states that "Mindray conducted functional and system level testing on the subject devices." This implies standalone testing of the algorithms (e.g., for arrhythmia detection, ST segment analysis, QT analysis, NIBP accuracy) as part of ensuring they "meet specifications and the performance of the device is equivalent to the predicate." However, specific details of these standalone performance studies (metrics, methodologies) are not included.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not provided. The document doesn't specify how ground truth was established for the "functional and system level testing." For vital sign monitors, ground truth often involves comparison to established reference standards or expert-derived measurements.

8. The sample size for the training set

Not applicable / Not provided. This document describes a medical device's premarket notification, not the development or validation of a machine learning algorithm where a distinct "training set" would typically be discussed. While the algorithms within the monitor (e.g., ECG algorithms) would have been developed and "trained," this document does not provide details of that process or associated training set sizes.

9. How the ground truth for the training set was established

Not applicable / Not provided. (See point 8).

In summary, the provided FDA 510(k) document is a regulatory submission for substantial equivalence, not a detailed scientific study report. It asserts that the device "meets specifications and the performance of the device is equivalent to the predicate" based on internal testing, but it does not provide the specific, granular data (sample sizes, expert qualifications, quantitative performance metrics, ground truth methodologies) that would be required to fully answer your questions about acceptance criteria and study particulars.

Summary

{0}------------------------------------------------

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K153448

Device Name

Passport Series Patient Monitors (Passport 8 and Passport 12)

Indications for Use (Describe)

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;

· 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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. ChinaTel: +86 755 81885635Fax: +86 755 26582680
Contact:	BaiyanhongManager Regulatory AffairsSHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.Mindray Building, Keji 12th Road South High-tech Industrial Park,Nanshan 518057, P.R. ChinaTel: +86 755 81885635Fax: +86 755 26582680E-mail: baiyanhong@mindray.com
Date Prepared:	November 18, 2015
Classification Regulation:	21 CFR 870.1025, Class II, Arrhythmia detector and alarm (includingST-segment measurement and alarm)
Panel:	Cardiovascular

Classification Regulation, Classification Name and Product Codes:

ProductCode	RegulationNumber	Panel	Regulation Description	Device Common Name
Primary
MHX	21 CFR870.1025	Cardiovascular	Arrhythmia detector and alarm(including ST-segment measurementand alarm)	monitor, physiological, patient(with arrhythmia detection oralarms)
Secondary
ProductCode	RegulationNumber	Panel	Regulation Description	Device Common Name
DSI	21 CFR870.1025	Cardiovascular	Arrhythmia detector and alarm(including ST-segment measurementand alarm)	detector and alarm, arrhythmia
MLD	21 CFR870.1025	Cardiovascular	Arrhythmia detector and alarm(including ST-segment measurementand alarm)	monitor, st segment with alarm
DRT	21 CFR870.2300	Cardiovascular	Cardiac Monitor (includingcardiotachometer and rate alarm)	monitor, cardiac (incl.cardiotachometer & rate alarm)

{4}------------------------------------------------

K153448 page 2 of 8

DXN	21 CFR	Cardiovascular	Noninvasive blood pressure	system, measurement,
	870.1130		measurement system	blood-pressure, non-invasive
DSK	21 CFR870.1110	Cardiovascular	Blood pressure computer	computer, blood-pressure
FLL	21 CFR880.2910	Cardiovascular	Clinical electronic thermometer	thermometer, electronic, clinical
DQA	21 CFR870.2700	Cardiovascular	Oximeter	Oximeter
DPZ	21 CFR870.2710	Cardiovascular	Ear oximeter	oximeter, ear
CCK	21 CFR868.1400	Anesthesiology	Carbon dioxide gas analyzer	analyzer, gas, carbon-dioxide,gaseous-phase
CBQ	21 CFR868.1500	Anesthesiology	Enflurane gas analyzer	analyzer, gas, enflurane,gaseous-phase (anestheticconcentration)
CBS	21 CFR868.1620	Anesthesiology	Halothane gas analyzer	analyzer, gas, halothane,gaseous-phase (anesthetic conc.)
CBR	21 CFR868.1700	Anesthesiology	Nitrous oxide gas analyzer	analyzer, gas, nitrous-oxide,gaseous phase (anesthetic conc.)
CCL	21 CFR868.1720	Anesthesiology	Oxygen gas analyzer	analyzer, gas, oxygen,gaseous-phase
DXG	21 CFR870.1435	Cardiovascular	Single-function, preprogrammeddiagnostic 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:

{5}------------------------------------------------

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 ●

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.

{6}------------------------------------------------

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
Integrateddisplay andtouchscreen	8.4" 800*600 pixels	12.1" 800*600 pixels	Same	Same
Secondarydisplay	Display is linked to integrated display		Same
Power supply	One rechargeable Lithium-ionbatteries or AC power supply	Two rechargeableLithium-ion battery or ACpower 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; supportPITCH TONE and multi-level tone modulation		Same
ECG (MindrayAlgorithm)	3-lead , 5-lead or 12-lead selectable, arrhythmia detection, STsegment analysis, Pace detection and heart rate (HR)		Added QT analysis , Added anadditional Pace detection channelto enhance the Pace detectionfunction, added ECG J-point autodetection , added adjustable QRSDetection Threshold
ECG (MortaraAlgorithm)	3-lead , 5-lead or 12-lead selectable, arrhythmia detection, STsegment analysis, , and heart rate (HR)		Same
ArrhythmiaAnalysis(MindrayAlgorithm)	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
ArrhythmiaAnalysis(MortaraAlgorithm)	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: 0to 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 oxygensaturation(SpO2)	Is compatible with the following 3 modules to measure oxygensaturation:• Mindray SpO2 Module• Masimo SpO2 Module• Nellcor SpO2 ModuleMindray SpO2 ModuleMeasurement range: 0 to 100%Accuracy:70 to 100%: ±2% (in adult/pediatric mode)70 to 100%: ±3% (in neonate mode)0% to 69%: Not specifiedMasimo SpO2 ModuleMeasurement range: 1 to 100%Accuracy:70 to 100%: ±2% (measured without motion inadult/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 ModuleMeasurement 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 oxygensaturation:• Mindray SpO2 Module• Masimo SpO2 Module• Nellcor SpO2 ModuleMindray SpO2 ModuleMeasurement range: 0 to 100%Accuracy:70 to 100%: ±2% (in adult/pediatric mode)70 to 100%: ±3% (in neonate mode)0% to 69%: Not specifiedMasimo SpO2 ModuleMeasurement range: 1 to 100%Accuracy:70 to 100%: ±2% (measured without motion inadult/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 ModuleMeasurement 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, NIBPmodule or the IBP module.PR from Mindray SpO2 ModuleMeasurement range: 20 to 254 bpmAccuracy: $\pm$ 3 bpmPR from Masimo SpO2 ModuleMeasurement range: 25 to 240 bpmAccuracy: $\pm$ 3 bpm (measured without motion)$\pm$ 5 bpm (measured with motion)PR from Nellcor SpO2 ModuleMeasurement range: 20 to 300 bpmAccuracy:20 to 250 bpm: $\pm$ 3 bpm251 to 300 bpm, not specifiedPR from NIBP ModuleMeasurement range: 40 to 240 bpmAccuracy: $\pm$ 3bpm or $\pm$ 3%, whichever is greaterPR from IBP ModuleMeasurement range: 25 to 350 bpmAccuracy: $\pm$ 1 bpm or $\pm$ 1%, whichever is greater"	Pulse rate may be obtained from the SpO2 module, NIBPmodule or the IBP module.	Same	Same
Non-invasiveblood pressure(NIBP)	Uses the oscillometric method for measuring non-invasiveblood pressure (NIBP). This measurement can be used foradults, pediatrics and neonates.Measurement range:AdultSystolic:40 to 270Diastolic:10 to 210Mean:20 to 230Accuracy:Max mean error: $\pm$ 5 mmHgMax standard deviation: 8 mmHg	PediatricNeonate40 to 20040 to 13510 to 15010 to 10020 to 16520 to 110	Same	Same
Invasive bloodpressure (IBP)	The monitor can measure invasive blood pressures and displayssystolic, diastolic and mean pressures and a waveform for eachpressure.Measurement range: -50 to 300 mmHgAccuracy: $\pm$ 2% or $\pm$ 1 mmHg, whichever is greater (withoutsensor)	The monitor can measure invasive blood pressures and displayssystolic, diastolic and mean pressures and a waveform for eachpressure.Measurement range: -50 to 300 mmHgAccuracy: $\pm$ 2% or $\pm$ 1 mmHg, whichever is greater (withoutsensor)	Same	Same
Pulse PressureVariation (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 measurescardiac output and other hemodynamic parameters using theright heart (atria) thermodilution method. The temperaturechange is displayed as a curve in the C.O. split screen, and themonitor calculates the C.O. value from this curve.		Same	Same
Carbon dioxide(CO2)	Is compatible with the following 3 modules to measure carbondioxide:Sidestream CO2 Module Microstream CO2 Module Mainstream CO2 Module CO2 monitoring is based on calculations from measuring theabsorption of infrared (IR) light of specific wavelengths using aphotodetector.Sidestream CO2 Module:Measurement range: 0 to 99 mmHgAccuracy:0 to 40 mmHg: ±2 mmHg41 to 76 mmHg: ±5% of the reading77 to 99 mmHg: ±10% of the readingMicrostream CO2 Module:Measurement range: 0 to 99 mmHgAccuracy:0 to 38 mmHg: ±2 mmHg39 to 99 mmHg: ±5% of the reading +0.08% of (thereading-38)Mainstream CO2 ModuleMeasurement range: 0 to150 mmHgAccuracy:0 to 40 mmHg: ±2 mmHg41 to 70 mmHg: ±5% of the reading71 to 100 mmHg: ±8% of the reading101 to 150 mmHg: ±10% of the reading		Same	Same
Anesthetic gas(AG)	Not supported	The AG module analyzesgas samples from thepatient and calculates CO2,O2, N2O and AA wavesand related numerics,airway respiratory rate, andMAC (minimum alveolarconcentration).	Same	Same
	Predicate Device (K132662)		Subject Devices
Feature	Passport 8	Passport 12	Passport 8	Passport 12
2 New neonatalpre-wiredelectrodes	Not supported		Added
DIAP output	Not supported.		Added.Output the measuring value and alarmlimits of all the parameters by RS232port.

Device Comparison Table

{7}------------------------------------------------

{8}------------------------------------------------

{9}------------------------------------------------

{10}------------------------------------------------

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.

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.