(152 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the device and its functions do not mention any AI or ML capabilities.
No
The device is described as a patient monitor intended for "monitoring, displaying, alarming, and transferring of multiple physiological parameters," which indicates a diagnostic or monitoring function rather than a therapeutic one.
No
The device is described as a "patient monitor" intended for "monitoring, displaying, alarming, and transferring of multiple physiological parameters." While it performs analyses (like ST segment, arrhythmia detection, QT analysis, interpretation of resting 12-lead ECG), its primary function is monitoring and providing real-time data on physiological parameters, not diagnosing a specific disease or condition. The "interpretation of resting 12-lead ECG" is an analytical component, but the overall scope points to monitoring, which informs diagnosis but isn't a diagnostic device in itself based on the provided text.
No
The device description explicitly states that the device includes "two monitors" and that patient monitoring capabilities are based on "user selected modules that are plugged into the main monitor," indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for various health issues.
- Device Function: The description clearly states that the Passport 17m and Passport 12m patient monitors are intended for monitoring, displaying, alarming, and transferring of multiple physiological parameters. These parameters are measured directly from the patient's body (e.g., ECG, blood pressure, oxygen saturation) using sensors and probes applied externally or invasively.
- No Sample Analysis: There is no mention of the device analyzing samples taken from the patient's body. The measurements are taken on the patient.
Therefore, the device falls under the category of patient monitoring equipment, which is distinct from in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Passport 17m and Passport 12m patient monitors are intended for monitoring, displaying, alarming, and transferring of multiple physiological parameters including ECG (3-lead or 12-lead selectable, arrhythmia detection. ST segment analysis, oT 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 (Sv02/Scv02), carbon dioxide (C02), Oxygen (02), anesthetic gas (AG), impedance cardiograph (ICC), bispectral index (BIS), respiration mechanics (RM), and neuromuscular transmission monitoring (NMT). 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, SvO2/ScvO2, PAWP monitoring and NMT 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.
Product codes
MHX, DSI, MLD, DRT, DXN, DSK, FLL, DQA, DPZ, CCK, CBQ, CBS, CBR, CCL, DSB, DXG, OLW, DSJ, KOI, GXY
Device Description
The subject Passport Series Patient Monitors includes two monitors:
- . Passport 12m Patient Monitor
- Passport 17m Patient Monitor ●
The Passport 12m and 17m 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.
Adult and pediatric for arrhythmia detection, ST Segment analysis of Mortara algorithm, BIS, RM, CCO, SvO2/ScvO2, PAWP monitoring and NMT monitoring.
Adult patients only for ST Segment analysis of Mindray algorithm and C.O. monitoring.
Adult patients (height: 122 to 229cm, weight: 30 to 155kg) for ICG monitoring.
Intended User / Care Setting
Healthcare facilities by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use.
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)
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: IEC 60601-1:2005+A1:2012, IEC 60601-1-2:2007, IEC 60601-2-10:2012, IEC 60601-2-49:2011, ISO 80601-2-55:2011.
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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a symbol of three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 23, 2017
Shenzhen Mindray Bio-medical Electronics Co., LTD. Yanhong Bai Manager Regulatory Affairs Mindrav Building. Keii 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen, 518057, P.R. China
Re: K170876
Trade/Device Name: Passport Series Patient Monitors (Passport 12m, Passport 17m) Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm Regulatory Class: Class II Product Code: MHX, DSI, MLD, DRT, DXN, DSK, FLL, DQA, DPZ, CCK, CBQ, CBS, CBR, CCL, DSB, DXG, OLW, DSJ, KOI, GXY Dated: July 14, 2017 Received: July 17, 2017
Dear 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 (DICE) 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 (DICE) 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,
Jessica E. Paulsen -S
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) K170876
Device Name
Passport Series Patient Monitors (Passport 12m and Passport 17m)
Indications for Use (Describe)
The Passport 17m and Passport 12m patient monitors are intended for monitoring, displaying, alarming, and transferring of multiple physiological parameters including ECG (3-lead or 12-lead selectable, arrhythmia detection. ST segment analysis, oT 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 (Sv02/Scv02), carbon dioxide (C02), Oxygen (02), anesthetic gas (AG), impedance cardiograph (ICC), bispectral index (BIS), respiration mechanics (RM), and neuromuscular transmission monitoring (NMT). 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, SvO2/ScvO2, PAWP monitoring and NMT 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.
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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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 (Passport 12m |
| and Passport 17m) | |
| Submitter: | Shenzhen Mindray Bio-medical Electronics Co., LTD. |
| Mindray Building, Keji 12th Road South, | |
| Hi-tech Industrial Park, Nanshan, | |
| Shenzhen, 518057, P. R. China | |
| Tel: +86 755 8188 8998 | |
| Fax: +86 755 2658 2680 | |
| Contact: | Ms. Yanhong Bai |
| Manager Regulatory Affairs | |
| 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 | |
| E-mail: baiyanhong@mindray.com | |
| Date Prepared: | March 17, 2017 |
| Classification Regulation: | 21 CFR 870.1025, Class II, Arrhythmia detector and alarm |
| (including ST-segment measurement and alarm) | |
| Panel: | Cardiovascular |
4
| 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) | |
| 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) | |
| CBS | 21 | CFR | Anesthesiology | Halothane gas analyzer | analyzer, gas, halothane, gaseous-phase (anesthetic conc.) |
| CBR | 21 | CFR | Anesthesiology | Nitrous oxide gas analyzer | analyzer, gas, nitrous-oxide, gaseous phase (anesthetic conc.) |
| CCL | 21 | CFR | Anesthesiology | Oxygen gas analyzer | analyzer, gas, oxygen, gaseous-phase |
| DSB | 21 | CFR | Cardiovascular | Impedance plethysmograph | plethysmograph, impedance |
| DXG | 21 | CFR | Cardiovascular | Single-function, preprogrammed diagnostic computer | computer, diagnostic, pre-programmed, single-function |
| OLW | 21 | CFR | Neurology | Electroencephalograph | index-generating electroencephalograph software |
| DSJ | 21 | CFR | Cardiovascular | Blood pressure alarm | alarm, blood-pressure |
| KOI | 21 | CFR | Anesthesiology | Electrical peripheral nerve stimulator | stimulator, nerve, peripheral, electric |
| GXY | 21 | CFR | Neurology | Cutaneous electrode. | electrode, cutaneous |
| | 868.1620 | | | | |
| | 868.1700 | | | | |
| | 868.1720 | | | | |
| | 870.2770 | | | | |
| | 870.1435 | | | | |
| | 882.1400 | | | | |
| | 870.1100 | | | | |
| | 868.2775 | | | | |
| | 870.1320 | | | | |
Classification Regulation, Classification Name and Product Codes:
5
Primary Predicate Device: K152902 - Passport Series Patient Monitors (Passport 12m, Passport 17m, and T1); Shenzhen Mindray Bio-Medical Electronics Co., Ltd
Secondary Predicate Device:
K161531 - IntelliVue Patient Monitors (Philips Medizin Systeme Boeblingen GmbH)
Indications for Use:
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, QT 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
6
respiration mechanics (RM), neuromuscular transmission monitoring(NMT). 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, SvO2/ScvO2, PAWP monitoring and NMT 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.
Device Description:
The subject Passport Series Patient Monitors includes two monitors:
- . Passport 12m Patient Monitor
- Passport 17m Patient Monitor ●
The Passport 12m and 17m 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 (Passport 12m and Passport 17m), 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.
- IEC 60601-1:2005+A1:2012 Medical electrical equipment -- Part 1: General . requirements for basic safety and essential performance
- . IEC 60601-1-2:2007 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-2-10:2012 Medical electrical equipment Part 2-10: Particular . requirements for the basic safety and essential performance of nerve and muscle stimulators
- IEC 60601-2-49:2011 Medical electrical equipment Part 2-49: Particular ●
7
requirements for the basic safety and essential performance of multifunction patient monitoring equipment
- . ISO 80601-2-55:2011 Medical electrical equipment -- Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
Substantial Equivalence:
Comparison of Indications - Both the predicate device and the subject Passport 12m and Passport 17m 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 devices (Passport 12m and Passport 17m) have been modified to include the new module of NMT. Although this feature is not present in the predicate device, it is present in the cleared Philips (K161531), and thus does not constitute a new intended use for a multi-parameter monitor. In conclusion, the minor changes to the indications for use do not change the fundamental intended use of the Passport 12m and Passport 17m 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 K152902). 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 (K152902) | Subject Devices | |||
|---|---|---|---|---|
| Feature | Passport 17m | Passport 12m | Passport 17m | Passport 12m |
| Integrated display and touchscreen | 17" 1280*1024 pixels | 12" 800*600 pixels | Same | Same |
| Secondary display | Independent control and display | Display is linked to integrated display | Same | Same |
| Additional display features | The minitrends diagram, OxyCRG diagram, other monitor view, and calculation can be viewed when using an external LCD screen | Same | Same | |
| Predicate Device (K152902) | Subject Devices | |||
| Feature | Passport 17m | Passport 12m | Passport 17m | Passport 12m |
| Wireless | ||||
| module | The ASUS module is | |||
| used for connecting to a | ||||
| network wirelessly, | ||||
| constructing a monitoring | ||||
| network with a central | ||||
| monitoring system | ||||
| (CMS). | The ASUS and Silex | |||
| modules are used for | ||||
| connecting to a network | ||||
| wirelessly, constructing a | ||||
| monitoring network with a | ||||
| central monitoring system | ||||
| (CMS). | Same | Laird | ||
| (2.4G/5G) | ||||
| wireless | ||||
| module is | ||||
| added. | ||||
| Module rack | Independent of the patient monitor, provides 8 standard | |||
| module slots to extend the measurement capabilities of | ||||
| the system | Same | |||
| Power supply | Two rechargeable Lithium-ion | |||
| battery or AC power supply | One rechargeable | |||
| Lithium-ion battery | ||||
| or AC power supply | Same | Same | ||
| Battery | Chargeable Lithium-Ion, 11.1 VDC, 4500 mAh, 350 g | Same | ||
| External | ||||
| memory card | Compact Flash | Same | ||
| Data Recorder | The thermal recorder records patient information, | |||
| measurement numerics, up to three waveforms, etc. | Same | |||
| Speaker | Give alarm tones (45 to 85 dB), key tones, QRS tones; | |||
| support PITCH TONE and multi-level tone modulation | Same | |||
| Supports T1 as | ||||
| a module | Supported | Same | ||
| ECG | 3-lead , 5-lead or 12-lead selectable, arrhythmia | |||
| detection, ST segment analysis, QT analysis, heart rate | ||||
| (HR), an interpretation of resting 12-lead ECG, J-point | ||||
| Auto detection, Dual Channel Pace detection and | ||||
| Adjustable QRS Detection Threshold | Same | |||
| Arrhythmia | ||||
| Analysis | ||||
| (Mindray | ||||
| Algorithm) | Asystole, VFib/VTac, Vtac, Vent. Brady, Extreme Tachy, | |||
| Extreme Brady, PVC, Couplet, Bigeminy, Trigeminy, R | ||||
| on T, Run PVCs, PVCs, Tachy, Brady, Missed Beats, | ||||
| Vent. Rhythm, PNP, PNC, Multif. PVC, Nonsus. Vtac, | ||||
| Pause, Irr. Rhythm, AFib | Same | |||
| Arrhythmia | ||||
| Analysis | ||||
| (Mortara | ||||
| Algorithm) | Asystole, Vfib, Vtac, Vent. Rhythm, Couplet, Run PVCs, | |||
| Bigeminy, Trigeminy, R on T, Multif. PVC, Irr. Rhythm, | ||||
| Tachy, Brady, Missed Beats, PNP, PNC, PVCs | Same | |||
| Predicate Device (K152902) | Subject Devices | |||
| Feature | Passport 17m | Passport 12m | Passport 17m | Passport 12m |
| 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 | |||
| Temperature | ||||
| (Temp) | Measurement range: 0 to 50°C (32 to 122°F) | |||
| Accuracy: ±0.1°C or ±0.2°F (without probe) | Same | |||
| 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 | |||
| Predicate Device (K152902) | Subject Devices | |||
| Feature | Passport 17m | Passport 12m | Passport 17m | Passport 12m |
| Pulse rate (PR) | PR from Mindray SpO2 Module | |||
| Measurement range: 20 to 254 bpm | ||||
| Accuracy: ±3 bpm |
PR from Masimo SpO2 Module
Measurement range: 25 to 240 bpm
Accuracy: ±3 bpm (measured without motion)
±5 bpm (measured with motion)
PR from Nellcor SpO2 Module
Measurement range: 20 to 300 bpm
Accuracy:20 to 250 bpm: ±3 bpm
251 to 300 bpm, not specified
PR from IBP Module
Measurement range: 25 to 350 bpm
Accuracy:±1 bpm or ±1%, whichever is greater" | | Same | |
| Non-invasive blood pressure (NIBP) | Measurement range:
Adult
Neonate
Systolic: 40 to 270
Diastolic: 10 to 210
Mean: 20 to 230
Accuracy:
Max mean error: ±5 mmHg
Max standard deviation: 8 mmHg | Pediatric
Neonate
Systolic: 40 to 200
Diastolic: 10 to 150
Mean: 20 to 165 | Same | Pediatric
Neonate
Systolic: 40 to 135
Diastolic: 10 to 100
Mean: 20 to 110 |
| Invasive blood pressure (IBP) | Measurement range: -50 to 300 mmHg
Accuracy: ±2% or ±1 mmHg, whichever is greater (without sensor) | | Same | |
| Pulse Pressure Variation (PPV) | Supported feature of IBP | | Same | |
| 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 | |
| | Predicate Device (K152902) | | Subject Devices | |
| Feature | Passport 17m | Passport 12m | Passport 17m | Passport 12m |
| 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), mixed venous oxygen saturation
(SvO2) and central venous oxygen saturation
(ScvO2). | | Same | |
| Central venous
oxygen
saturation
(ScvO2) | ScvO2 module is used to measure central venous oxygen
saturation (ScvO2). | | Same | |
| 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
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 | | Same | |
| Anesthetic gas
(AG) | The AG module analyzes gas samples from the patient
and calculates CO2, O2, N2O and AA waves and related
numerics, airway respiratory rate, and MAC (minimum
alveolar concentration).
Supports the 3-slot AG module. | | Added support for the
2-slot AG module | |
| | Predicate Device (K152902) | | Subject Devices | |
| Feature | Passport 17m | Passport 12m | Passport
17m | Passport
12m |
| 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 | |
| Bispectral index
(BIS) | Measured parameters: EEG, BIS, BIS L, BIS R | | Same | |
| Respiration
mechanics
(RM) | Measurement range: Adult: 0 to 120 rpm; Pediatric: 0 to
150 rpm.
Accuracy: 7 to 150 rpm:±2 rpm or ±2%, whichever is
greater;
0 to 6 rpm: Not specified." | | Same | |
| NMT | Not supported | | Added | |
Device Comparison Table (Compare with Passport 12m/17m (K152902))
8
9
10
11
12
13
| Feature | Secondary Predicate Device
NMT (K152902) | Subject Mindray NMT in this
510(k) | Comparison
System |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Composition | Module and accessory cable | Module and accessory cable | Same |
| Intended use | The IntelliVue NMT
Module is intended to be
used as an objective
neuromuscular transmission
monitor, using
accelerometry for
measuring the muscle
contraction following an
electrical stimulation of a
peripheral nerve. The NMT
Module is intended to be
used with adult and
pediatric patients. | The neuromuscular
transmission (NMT) module
is intended to be used as an
objective neuromuscular
transmission monitor, using
accelerometry for measuring
the muscle contraction
following an electrical
stimulation of a peripheral
nerve. The NMT module is
intended to be used with adult
and pediatric patients. | Same |
| Principle of
measurement | Neuro Muscular
Transmission (NMT) and
its measurement enables the
evaluation of muscle
relaxation of patients under
Neuromuscular Block by
measuring the strength of
muscle reaction after
electrically stimulating the
dedicated motor nerve.
The NMT Monitor
electrodes are placed on the
patient's skin over the ulnar
nerve, a controllable current
source delivers stimulation
pulses to two skin surface
electrodes for the nerve
stimulation, the muscle
response is measured with
an acceleration sensor. | Neuromuscular Transmission
(NMT) module evaluates
muscle relaxation of patients
under neuromuscular block by
measuring the strength of
muscle reaction after
electrically stimulating the
dedicated motor nerve.
The electrodes are placed on
the patient's skin over ulnar
nerve, a controllable current
source delivers stimulation
pulses to two skin surface
electrodes for the nerve
stimulation, and the muscle
response is measured with an
acceleration sensor. | Same |
| Feature | Secondary Predicate Device
NMT (K152902) | Subject Mindray NMT in this
510(k) | Comparison
System |
| Stimulation
Output | Current pulse: 100, 200, or
300μs; monophasic
rectangle pulse | Current Pulse: 100, 200 or
300μs; monophasic rectangle
pulse;
Pulse width Accuracy: ±10% | Same |
| | Current Range: 5 to 60 mA
in increments of 5 mA | Current Range:0 - 60 mA in
increments of 5 mA | the actual output
current of the
two sides are
both 5 to 60 mA
Same |
| | Current Accuracy: ± 5% or
± 2 mA, whichever is
greater | Current Accuracy: ± 5% or ±
2 mA, whichever is greater | Same |
| | Max. Skin Resistance: 3
kOhm | Max. Skin Impedance: 3kohm | Same |
| | Max. Output Voltage:300 V | Max. output voltage: 300 V | Same |
| Stimulation
Modes | Single Twitch (Twitch); Train-Of-Four (TOF); Post-Tetanic Count (PTC); Double-Burst Stimulation (DBS) | Single Twitch (ST); Train-Of-Four (TOF); Post-Tetanic Count (PTC); Double-Burst Stimulation (DBS) | Same |
| Performance
Specifications | Single Twitch Stimulation
Mode:
Twitch: 0 to 200%
Measurement interval:
Manual, or 1s, 12s, 30s | Single Twitch Stimulation
Mode:
ST-Ratio: 0 to 200%
Measurement interval:
Manual, 1s, 10s, 20s | Different
Measurement interval |
| Feature | Secondary Predicate Device
NMT (K152902) | Subject Mindray NMT in this
510(k) | Comparison
System |
| Train-Of-Four Stimulation
Mode:
TOF Count (TOFcnt): 0 to
4
TOF Ratio (TOFrat): 5 to
150%-
Measurement interval:
Manual, or 12s, 30s, 1min,
5min, 10min, 15min,
30min, 60min | Train-Of-Four Stimulation
Mode:
TOF-Count: 0 to 4
TOF-Ratio: 5 to 160%
Measurement interval:
Manual, 12s, 15s, 20s, 30s,
1min, 5min, 15min, 30min,
60min | Wider
TOF-Ratio
Range; Different
Measurement
interval | |
| Post-Tetanic-Count
Stimulation Mode:
PTC:0 to 20
Measurement interval:
Manual | Post-Tetanic-Count
Stimulation Mode:
PTC: 0 to 20
Measurement interval:
Manual | Same | |
| | Double-Burst Stimulation
Mode:
Measurement interval:
Manual | Double-Burst Stimulation
Mode:
Manual, 15s, 20s, 30s, 1min,
5min, 15min, 30min, 60min | More
Measurement
intervals |
Device Comparison Table (Compare with Philips NMT module (K161531))
14
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Substantial Equivalence Conclusion:
Based on the detailed comparison of specifications for each of the modifications to the primary predicate devices, Passport 12m and Passport 17m (K152902), the secondary predicate devices, IntelliVue Patient Monitors(K161531) , the performance testing results and conformance with applicable standards show that the Passport Series Patient Monitors (Passport 12m and Passport 17m) can be found substantially equivalent to the predicate devices.