What is the FDA product code for Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)?

MHX. It is classified under 21 CFR 870.1025 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)

Q: Who is the manufacturer of Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)?

Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. filed the 510(k) submission for Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1) (K143195).

K143195 · Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · MHX · Dec 22, 2014 · Cardiovascular

Device Facts

Record ID	K143195
Device Name	Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)
Applicant	Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.
Product Code	MHX · Cardiovascular
Decision Date	Dec 22, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1025
Device Class	Class 2
Attributes	Pediatric

Intended Use

The Passport 17M and Passport 12M patient monitors are intended for monitoring, displaying, reviewing, and transferring of multiple physiological parameters including ECG (3-lead , 5-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, and heart rate (HR)), respiration rate (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-mvasive blood pressure (NIBP), invasive blood pressure(IBP), pulmonary artery wedge pressure (PAWP), cardiac output (C.O.), continuous cardiac output (CCO), mixed/central venous oxygen saturation (Sy()//Scy(), carbon dioxide (CO2), Oxygen (O2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS), and respiration mechanics (RM). The equipment also provides an interpretation of resting 12-lead ECG. All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following: - . The arrhythmia detection. ST Segment analysis of Mortara algorithm. BIS, RM, CCO, SvOz/Scv02, and PAWP monitoring are intended for adult and pediatric patients only: - ST Segment analysis of Mindray algorithm is intended for adult patients only: ● - C.O. monitoring is restricted to adult patients only: ● - ICG monitoring is only for use on adult patients who meet the following ● requirements: height: 122 to 229cm, weight: 30 to 155kg. The monitor is to be used in healthcare facilities by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use. The T1 Patient Monitor is intended for monitoring, displaying, reviewing, storing, and transferring of multiple physiological parameters including ECG (3-lead, or 12-lead selectable, arrhythmia detection, ST Segment analysis, and heart rate (HR)), respiration (Resp), temperature (Temp), pulse oxygen saturation (SpOz), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), pulmonary artery wedge pressure (PAWP), and carbon dioxide (CO2). The equipment also provides an interpretation of resting 12-lead ECG. All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following: The arrhythmia detection, ST Segment analysis of Mortara algorithm, and PAWP monitoring are intended for adult and pediatric patients; ST Segment analysis of Mindray ECG algorithm is intended for adult patients only; The monitor is to be used in healthcare facilities by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use.

Device Story

Passport Series (17M, 12M, T1) are multiparameter patient monitors; inputs include ECG, respiration, temperature, SpO2, NIBP, IBP, CO2, and other specialized modules (BIS, ICG, AG). Devices process signals to display waveforms, numerics, and trends; provide arrhythmia detection, ST-segment analysis, and resting 12-lead ECG interpretation. Used in healthcare facilities by clinicians; T1 functions as a standalone monitor or a module for 12M/17M. Outputs assist clinicians in patient assessment and clinical decision-making. Modifications include wireless functionality, 12-lead ECG interpretation, and J-point auto-detection.

Clinical Evidence

Bench testing only. Functional and system-level testing performed to verify modifications (wireless modules, 12-lead ECG interpretation, J-point auto-detection). Conformance to consensus standards and FDA Class II Special Controls Guidance for Arrhythmia Detector and Alarm (2003) confirmed.

Technological Characteristics

Multiparameter monitors with integrated touchscreens (17", 12", 5"). Connectivity via wireless modules (ASUS, Silex, Cyberlink). Power: AC/DC or rechargeable Li-ion batteries. Parameters: ECG, SpO2, NIBP, IBP, CO2, etc. Software includes arrhythmia detection, ST-segment analysis (Mortara and Mindray algorithms), and 12-lead ECG interpretation. Data storage via Compact Flash or SD cards.

Indications for Use

Indicated for adult, pediatric, and neonatal patients in healthcare facilities for monitoring physiological parameters (ECG, Resp, Temp, SpO2, PR, NIBP, IBP, PAWP, CO2, O2, AG, ICG, BIS, RM). Specific parameter restrictions apply based on patient age/size (e.g., C.O. adult only; ICG adult height/weight requirements). Not for home, ambulance, or helicopter use.

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 M SERIES PATIENT MONITORING (INCLUDING MODELS PASSPORT 17M AND PASSPORT 12M) (K132075)

Reference Devices

Mindray V Series Monitoring System (K132026)
T1 Patient Monitor (K123074)
SPO2 sensors (K132037)
NIBP cuffs (K092449)

Related Devices

K152902 — Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Feb 18, 2016
K190011 — Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jul 10, 2019
K153448 — Passport Series Patient Monitors (Including Passport 8, Passport 12) · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 3, 2016
K132075 — PASSPORT M SERIES PATIENT MONITORING (INCLUDING MODELS PASSPORT 17M AND PASSPORT 12M) · Mindray North America · Apr 18, 2014
K132662 — PASSPORT SERIES PATIENT MONITORS · Shenzhen Mindray Biomedical Electronics Co., Ltd. · Aug 1, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 22, 2014 Shenzhen Mindray Bio-Medical Electronics Co., Ltd c/o Ms. Yanhong Bai Manager Regulatory Affairs, Technical Regulation Department Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen, 518057 P.R. China Re: K143195 > Trade/Device Name: Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1) Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (With Arrhythmia Detection Or Alarms) Regulatory Class: Class II Product Code: MHX Dated: Undated Received: November 6, 2014 Dear Ms. Yanhong Bai, 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 (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, Melissa A. Torres -S For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ K143195 Page 1 510(k) Number (if known): K143195 Device Name : Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1) #### Passport 12M and 17M Patient Monitors : The Passport 17M and Passport 12M patient monitors are intended for monitoring. displaying, reviewing, and transferring of multiple physiological parameters including ECG (3-lead , 5-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, and heart rate (HR)), respiration rate (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-mvasive blood pressure (NIBP), invasive blood pressure(IBP), pulmonary artery wedge pressure (PAWP), cardiac output (C.O.), continuous cardiac output (CCO), mixed/central venous oxygen saturation (Sy()//Scy(), carbon dioxide (CO2), Oxygen (O2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS), and respiration mechanics (RM). The equipment also provides an interpretation of resting 12-lead ECG. All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following: - . The arrhythmia detection. ST Segment analysis of Mortara algorithm. BIS, RM, CCO. SvOz/Scv02, and PAWP monitoring are intended for adult and pediatric patients only: - ST Segment analysis of Mindray algorithm is intended for adult patients only; ● - C.O. monitoring is restricted to adult patients only: ● - ICG monitoring is only for use on adult patients who meet the following ● requirements: height: 122 to 229cm, weight: 30 to 155kg. The monitor is to be used in healthcare facilities by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use. ### T1 Patient Monitor: The T1 Patient Monitor is intended for monitoring, displaying, reviewing, storing, and transferring of multiple physiological parameters including ECG (3-lead, or 12-lead selectable, arrhythmia detection, ST Segment analysis, and heart rate (HR)), respiration (Resp), temperature (Temp), pulse oxygen saturation (SpOz), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), pulmonary artery wedge pressure (PAWP), and carbon dioxide (CO2). The equipment also provides an interpretation of resting 12-lead ECG. {3}------------------------------------------------ #### K143195 Page __ 2__ of __ 2__ All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following: The arrhythmia detection, ST Segment analysis of Mortara algorithm, and PAWP monitoring are intended for adult and pediatric patients; ST Segment analysis of Mindray ECG algorithm is intended for adult patients only; The monitor is to be used in healthcare facilities by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use. ### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use X (Per 21 CFR 801.109) Over-The-Counter Use OR {4}------------------------------------------------ #### 510(K) SUMMARY 1. 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 (including Passport 17M, Passport 12M and T1) | | Submitter: | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. Mindray Building, Keji 12th Road South High-tech Industrial Park, Nanshan Shenzhen 518057, P.R. China Tel: +86 755 81885635 Fax: +86 755 26582680 | | Contact: | Yanhong Bai Manager Regulatory Affairs SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. Mindray Building, Keji 12th Road South High-tech Industrial Park, Nanshan 518057, P.R. China Tel: +86 755 81885635 Fax: +86 755 26582680 E-mail: baiyanhong@mindray.com | | Date Prepared: | November 4, 2014 | | 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 | | | | | | Product Code | Regulation Number | Panel | Regulation Description | Device Common Name | | 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 | | | | | | DSI | 21 CFR 870.1025 | Cardiovascular | Arrhythmia detector and alarm (including ST-segment measurement and alarm) | detector and alarm, arrhythmia | | MLD | 21 CFR 870.1025 | Cardiovascular | Arrhythmia detector and alarm (including ST-segment measurement and alarm) | monitor, st segment with alarm | | DRT | 21 CFR 870.2300 | Cardiovascular | Cardiac Monitor (including cardiotachometer and rate alarm) | monitor, cardiac (incl. cardiotachometer & rate alarm) | | DXN | 21 CFR 870.1130 | Cardiovascular | Noninvasive blood pressure measurement system | system, measurement, blood-pressure, non-invasive | | DSK | 21 CFR 870.1110 | Cardiovascular | Blood pressure computer | computer, blood-pressure | | FLL | 21 CFR 880.2910 | Cardiovascular | Clinical electronic thermometer | thermometer, electronic, clinical | | DQA | 21 CFR 870.2700 | Cardiovascular | Oximeter | Oximeter | | 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) | | Product Code | Regulation Number | Panel | Regulation Description | Device Common Name | | 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 | | DSB | 21 CFR 870.2770 | Cardiovascular | Impedance plethysmograph | plethysmograph, impedance | | DXG | 21 CFR 870.1435 | Cardiovascular | Single-function, preprogrammed diagnostic computer | computer, diagnostic, pre-programmed, single-function | | OLW | 21 CFR 882.1400 | Neurology | Electroencephalograph | index-generating electroencephalograph software | {5}------------------------------------------------ {6}------------------------------------------------ ### Predicate Device: ### K132075 - PASSPORT M SERIES PATIENT MONITORING (INCLUDING MODELS PASSPORT 17M AND PASSPORT 12M), Mindray North America. ### Indications for Use: ### Passport 12M and 17M Patient Monitors: The Passport 17M and Passport 12M patient monitors are intended for monitoring, displaying, reviewing, alarming, and transferring of multiple physiological parameters including ECG (3-lead , 5-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, and heart rate (HR)), respiration rate (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure(IBP), pulmonary artery wedge pressure (PAWP), cardiac output (C.O.), continuous cardiac output (CCO), mixed/central venous oxygen saturation (SvO2/ScvO2), carbon dioxide (CO2), Oxygen (O2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS), and respiration mechanics (RM). The equipment also provides an interpretation of resting 12-lead ECG. All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following: {7}------------------------------------------------ - The arrhythmia detection, ST Segment analysis of Mortara algorithm, ● BIS, RM, CCO, SvO2/ScvO2, and PAWP monitoring are intended for adult and pediatric patients only; - ST Segment analysis of Mindray algorithm is intended for adult patients ● only; - C.O. monitoring is restricted to adult patients only; - ICG monitoring is only for use on adult patients who meet the following ● requirements: height: 122 to 229cm, weight: 30 to 155kg. The monitor is to be used in healthcare facilities by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use. ### T1 Patient Monitor: The T1 Patient Monitor is intended for monitoring, displaying, reviewing, storing , alarming, and transferring of multiple physiological parameters including ECG (3-lead, or 5-lead, or 12-lead selectable, arrhythmia detection, ST Segment analysis, and heart rate (HR)), respiration (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), pulmonary artery wedge pressure (PAWP), and carbon dioxide (CO2). The equipment also provides an interpretation of resting 12-lead ECG. All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following: The arrhythmia detection, ST Segment analysis of Mortara algorithm, and PAWP monitoring are intended for adult and pediatric patients; ST Segment analysis of Mindray ECG algorithm is intended for adult patients only; The monitor is to be used in healthcare facilities by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use. ### Device Description: The subject Passport Series Patient Monitors includes three monitors: - . Passport 12M Patient Monitor - Passport 17M Patient Monitor ● - T1 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 12M and 17M Patient monitors provide patient monitoring capabilities based on the user selected modules that are plugged into the main monitor. The T1 {8}------------------------------------------------ patient monitor is one of the available modules that can be plugged into the Passport 17M or 12M monitor. The T1 can also be used as a standalone monitor and when used as a standalone monitor, it provides a subset of the functions that are provided by Passport 17M and 12M. Each of the three monitors that are the subject of this 510(k) are modified versions of previously cleared Mindray devices. The Passport 17M and Passport 12M were previously cleared in K132075, on April 18, 2014 and the T1 was previously cleared in K123074 on July 3, 2013. ### Performance Data: - . To establish the substantial equivalence of the Passport Series Patient Monitors (including Passport 12M, Passport 17M and T1), 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. - . The T1 has been modified to provide wireless functionality. The existing wireless functionality of Passport 12M Monitor has been modified to include a new wireless module. The wireless capabilities of the Passport 17M remain unchanged. Mindray conducted Wireless functionality testing to ensure the performance of the new wireless modules meet specifications and are equivalent to the predicate device. ### Substantial Equivalence: Comparison of Indications - Both the predicate device and the subject family of devices are multiparameter patient monitors intended to be used in healthcare facilities under the direction of clinical professionals. The indications for use of the subject T1 device are a subset of those for the predicate device, as the T1 device includes a subset of the functionality. The indications for use of the Passport 12M, Passport 17M and T1 also include the new feature of 12-lead ECG interpretation. Although this feature is not present in the predicate device, it is present in the cleared Mindray V Series Monitoring System (K132026), and thus does not constitute a new intended use for a multi-parameter monitor. Comparison of Technological Characteristics - The table below compares the key technological feature of the subject devices to the primary predicate device (the Mindray Passport Series M K132075). The features in grey are the features that have been modified since their previous clearances and that are the subject of this 510(k). {9}------------------------------------------------ | | Predicate Device (K132075) | | Subject Devices | | | |------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|-----------------|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------| | Feature | 17M | 12M | 17M | 12M | T1 | | Integrated display and touchscreen | 17" 1280*1024 pixels | 12" 800*600 pixels | Same | Same | 5", 480*272 pixels (same as K123074) | | Secondary display | Independent control and display | Display is linked to integrated display | Same | Same | Independent display and control via a VGA port in the T1 docking station | | Additional display features | The minitrends diagram, OxyCRG diagram, other monitor view, and calculation can be viewed when using an external LCD screen | | Same | Same | Added | | Wireless module (ASUS) | The ASUS module is used for connecting to a network wirelessly, constructing a monitoring network with a central monitoring system (CMS). | | Same | Added support for Silex wireless module | Added wireless function using the Cyberlink wireless module | | Module rack | Independent of the patient monitor, provides 8 standard module slots to extend the measurement capabilities of the system | | Same | Same | Not supported | | Power supply | Two rechargeable Lithium-ion battery or AC power supply | One rechargeable Lithium-ion battery or AC power supply | Same | Same | One rechargeable Lithium-ion battery or DC power supply or AC power supply (same as K123074) | | Feature | Predicate Device (K132075) | | Subject Devices | | | | | 17M | 12M | 17M | 12M | T1 | | Battery | Chargeable Lithium-Ion, 11.1 VDC, 4500 mAh, 350 g | Same | Same | Same | Chargeable Lithium-Ion, 7.4 VDC, 2500 mAh (same as K123074) | | External memory card | Compact Flash | Same | Same | Same | Secure Digital (same as K123074) | | Data Recorder | The thermal recorder records patient information, measurement numerics, up to three waveforms, etc. | Same | Same | Same | Not supported | | Speaker | Give alarm tones (45 to 85 dB), key tones, QRS tones; support PITCH TONE and multi-level tone modulation | Same | Same | Same | Same | | ECG | 3-lead , 5-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, heart rate | Same | Same | Same | Same | | 12-lead ECG interpretation | Not supported | Supported | Supported | Supported | Supported | | ECG J-point auto detection | Supported | Same | Same | Same | Added | | Respiration rate (Resp) | Measurement range: Adult: 0 to 120 rpm; Pediatric, neonate: 0 to 150 rpm. Accuracy: 7 to 150 rpm: $\pm$ 2 rpm or $\pm$ 2%, whichever is greater; 0 to 6 rpm: Not specified. | Same | Same | Same | Same | | Temperature (Temp) | Measurement range: 0 to 50°C (32 to 122°F) Accuracy: $\pm$ 0.1°C or $\pm$ 0.2°F (without probe) | Same | Same | Same | Same | | Feature | Predicate Device (K132075) | | Subject Devices | | | | | 17M | 12M | 17M | 12M | T1 | | Pulse oxygen saturation (SpO2) | Mindray SpO2 Module Measurement range: 0 to 100% Accuracy:70 to 100%: ±2% (adult/pediatric mode) 70 to 100%: ±3% (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 | Same | Same | ## Device Comparison Table {10}------------------------------------------------ {11}------------------------------------------------ K143195 Page 8 of 13 {12}------------------------------------------------ | | Predicate Device (K132075) | | Subject Devices | | | |-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------| | Feature | 17M | 12M | 17M | 12M | T1 | | Pulse rate (PR) | 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 IBP Module Measurement range: 25 to 350 bpm Accuracy: $\pm$ 1 bpm or $\pm$ 1%, whichever is greater" | | Same | Same | Same | | | Predicate Device (K132075) | | Subject Devices | | | | Feature | 17M | 12M | 17M | 12M | T1 | | Non-invasive blood pressure (NIBP) | Measurement range: Adult Pediatric Systolic: 40 to 270 200 Diastolic: 10 to 210 150 Mean: 20 to 230 to 165 Accuracy: Max mean error: ±5 mmHg Max standard deviation: 8 mmHg | Measurement range: Adult Pediatric Neonate 40 to 40 to 135 10 to 10 to 100 20 20 to 110 | Same | Same | Same | | Invasive blood pressure (IBP) | Measurement range: -50 to 300 mmHg Accuracy:±2% or ±1 mmHg, whichever is greater (without sensor) | | Same | Same | Same | | Pulse Pressure Variation (PPV) | Supported feature of IBP | | Same | Same | Added | | Cardiac output (C.O.) | The temperature change is displayed as a curve in the C.O. split screen, and the monitor calculates the C.O. value from this curve. The monitor is capable of storing 6 measurements. | | Same | Same | Not supported | | Continuous cardiac output (CCO) | CCO/SvO2 interface module is used to interface with Edwards Vigilance II monitor / Vigileo Monitor which measures continuous cardiac output (CCO) and mixed venous oxygen saturation (SvO2). | | Same | Same | Not supported | | Feature | Predicate Device (K132075) | | Subject Devices | | | | | 17M | 12M | 17M | 12M | T1 | | Mixed/central venous oxygen saturation (SvO2/ScvO2) | CCO/SvO2 interface module is used to interface with Edwards Vigilance II monitor / Vigileo Monitor which measures mixed venous oxygen saturation (SvO2) and central venous oxygen saturation (ScvO2). | | Same | Same | Not supported | | Carbon dioxide (CO2) | 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 | | Specifications unchanged Modules have been repackaged to occupy a single slot | Specifications unchanged Modules have been repackaged to occupy a single slot | Specifications unchanged Modules have been repackaged to occupy a single slot | | | Microstream CO2 Module: Measurement range: 0 to 99 mmHg Accuracy: 0 to 38 mmHg: ±2 mmHg 39 to 99 mmHg: ±5% of the reading ±5% of the reading+0.08% of (the reading-38) | | | | | | | Mainstream CO2 Module: Measurement range: 0 to 150 mmHg Accuracy: 0 to 40 mmHg: ±2 mmHg 41 to 70 mmHg: ±5% of the reading 71 to 100 mmHg: ±8% of the reading 101 to 150 mmHg: ±10% of the reading" | | | | | | Feature | Predicate Device (K132075) | | Subject Devices | | | | | 17M | 12M | 17M | 12M | T1 | | Oxygen (O2) | Oxygen values are calculated based on user input and not directly measured. | | Same | Same | Not supported | | Anesthetic gas (AG) | The AG module can identify two anesthetic gases in a mixture automatically and distinguish between them according to their contributions to the MAC value for display as the primary and secondary anesthetic agents. | | Same | Same | Not supported | | Impedance cardiograph (ICG) | Measurement range: SV: 5 to 250 ml HR: 44 to 2m C.O. 1.4 to 15 L/min Accuracy: SV: Not specified. HR: ±2 bpm C.O. Not specified." | | Same | Same | Not supported | | Bispectral index (BIS) | Measured parameters: EEG, BIS, BIS L, BIS R | | Same | Same | Not supported | | Respiration mechanics (RM) | 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 | Same | Not supported | | 3 Additional SpO2 Sensors | None | | The model names of the three SPO2 sensors are LNCS NeoPt, LNCS Neo, LNCS Inf. These three SPO2 sensors are cleared in K132037. | | | | 4 New NIBP cuffs | None | | The model names of the four NIBP cuffs are CM1306, CM1307, CM1506, CM1507. All this four NIBP cuffs are substantial equivalent to the NIBP cuffs which are cleared in K132075 and K092449. | | | | Supports T1 as a module | Not supported | | Supported | Supported | N/A | {13}------------------------------------------------ {14}------------------------------------------------ {15}------------------------------------------------ {16}------------------------------------------------ ### Substantial Equivalence Conclusion: Based on the detailed comparison of specifications for each of the modifications to the previously cleared Passport M Series devices, the performance testing and conformance with applicable standards, the Passport Series Patient Monitors (including Passport 12M, Passport 17M and T1) can be found substantially equivalent to the predicate device.