(152 days)
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/Scv02, 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.
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.
The provided text describes a 510(k) premarket notification for the Passport Series Patient Monitors (Passport 12m and Passport 17m). The information mainly focuses on establishing substantial equivalence to predicate devices and does not detail specific acceptance criteria or a dedicated study proving performance against these criteria for the entire device.
However, the document does contain a "Device Comparison Table" that includes performance specifications for the Neuromuscular Transmission (NMT) module, which is a new feature for the subject device compared to the primary predicate, but present in a secondary predicate. This section implies a comparison of performance against the secondary predicate for the NMT module.
Based on the provided text, here's an attempt to extract the requested information, primarily focusing on the NMT module due to the lack of detailed performance study information for the overall patient monitor device:
1. Table of Acceptance Criteria and the Reported Device Performance
For the NMT module, the "acceptance criteria" can be inferred from the performance specifications of the secondary predicate device (Philips IntelliVue NMT module) and the "reported device performance" refers to the subject Mindray NMT module's specifications.
| Feature / Parameter | Acceptance Criteria (Secondary Predicate Device: Philips NMT - K161531) | Reported Device Performance (Subject Mindray NMT) | Compliance / Comparison |
|---|---|---|---|
| Stimulation Output | |||
| Current pulse type | 100, 200, or 300μs; monophasic rectangle pulse | 100, 200 or 300μs; monophasic rectangle pulse; Pulse width Accuracy: ±10% | Same |
| Current Range | 5 to 60 mA in increments of 5 mA | 0 - 60 mA in increments of 5 mA | Actual output current of both sides are 5 to 60 mA. Same. |
| Current Accuracy | ± 5% or ± 2 mA, whichever is greater | ± 5% or ± 2 mA, whichever is greater | Same |
| Max. Skin Resistance / Impedance | 3 kOhm | 3kohm | Same |
| Max. Output Voltage | 300 V | 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 / ST-Ratio | 0 to 200% | 0 to 200% | Same |
| Measurement interval (ST) | Manual, or 1s, 12s, 30s | Manual, 1s, 10s, 20s | Different Measurement interval |
| Train-Of-Four Stimulation Mode: | |||
| TOF Count | 0 to 4 | 0 to 4 | Same |
| TOF Ratio | 5 to 150% | 5 to 160% | Wider TOF-Ratio Range |
| Measurement interval (TOF) | Manual, or 12s, 30s, 1min, 5min, 10min, 15min, 30min, 60min | Manual, 12s, 15s, 20s, 30s, 1min, 5min, 15min, 30min, 60min | Different Measurement interval |
| Post-Tetanic-Count Stimulation Mode: | |||
| PTC | 0 to 20 | 0 to 20 | Same |
| Measurement interval (PTC) | Manual | Manual | Same |
| Double-Burst Stimulation Mode: | |||
| Measurement interval (DBS) | Manual | Manual, 15s, 20s, 30s, 1min, 5min, 15min, 30min, 60min | More Measurement intervals |
Study Proving Device Meets Acceptance Criteria:
The document states: "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."
For the NMT module specifically, the comparison table indicates that while some measurement intervals and the TOF-Ratio range differ, the underlying principles and most specifications are either "Same" or provide a "Wider TOF-Ratio Range" or "More Measurement intervals," implying that these variations are acceptable or represent an improvement.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on the sample size used for the test set for performance validation for the NMT module or other parameters. It only mentions "functional and system level testing." The data provenance (country of origin, retrospective/prospective) is also not specified.
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)
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This document describes a patient monitor, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the performance of a medical device (patient monitor) and its modules, including the NMT module. The performance described in the comparison table are standalone specifications for the device's functionality. There is no explicit mention of an "algorithm only" study in the context of the device's overall operation, as it is a physical monitoring device. The NMT module's performance characteristics (e.g., current ranges, accuracies, measurement modes) are inherent to its design and function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the NMT module's performance specifications, the "ground truth" implicitly would be established through calibrated laboratory equipment and standard measurement techniques to verify the accuracy of stimulation outputs, ranges, and timing. For other physiological parameters, similar direct measurement against known standards would apply. The document does not explicitly state the methodology for establishing ground truth for any of the parameters.
8. The sample size for the training set
This is not applicable as the document describes a physical patient monitor with integrated measurement capabilities, not an AI/machine learning model that requires a "training set."
9. How the ground truth for the training set was established
This is not applicable for the reasons stated above.
Summary of Limitations Based on Document:
The provided 510(k) summary focuses on demonstrating "substantial equivalence" of the Passport Series Patient Monitors to existing predicate devices, particularly regarding modifications and the addition of the NMT module. It provides a technical comparison of specifications rather than detailed clinical study data with explicit acceptance criteria and performance against those for all parameters. Information on sample sizes, data provenance, expert involvement for ground truth, and specific study methodologies (beyond "functional and system level testing") is not present in this document.
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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
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with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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
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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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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 12mand 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. ChinaTel: +86 755 8188 8998Fax: +86 755 2658 2680 |
| Contact: | Ms. Yanhong BaiManager Regulatory AffairsShenzhen Mindray Bio-medical Electronics Co., LTD.Mindray Building, Keji 12th Road South,High-tech Industrial Park, Nanshan, Shenzhen518057, P.R. ChinaTel: +86 755 81885635Fax: +86 755 26582680E-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 |
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| ProductCode | RegulationNumber | Panel | Regulation description | Device Common Name | |
|---|---|---|---|---|---|
| Primary | |||||
| MHX | 21 CFR870.1025 | Cardiovascular | Arrhythmia detector and alarm (including ST-segment measurement and alarm) | monitor, physiological, patient(with arrhythmia detection or alarms) | |
| Secondary | |||||
| ProductCode | RegulationNumber | Panel | Regulation description | Device Common Name | |
| DSI | 21 CFR870.1025 | Cardiovascular | Arrhythmia detector and alarm (including ST-segment measurement and alarm) | detector and alarm, arrhythmia | |
| MLD | 21 CFR870.1025 | Cardiovascular | Arrhythmia detector and alarm (including ST-segment measurement and alarm) | monitor, st segment with alarm | |
| DRT | 21 CFR870.2300 | Cardiovascular | Cardiac Monitor (including cardiotachometer and rate alarm) | monitor, cardiac (incl. cardiotachometer & rate alarm) | |
| DXN | 21 CFR870.1130 | Cardiovascular | Noninvasive blood pressure measurement system | system, measurement, 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 (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:
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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
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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 ●
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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 |
| Wirelessmodule | The ASUS module isused for connecting to anetwork wirelessly,constructing a monitoringnetwork with a centralmonitoring system(CMS). | The ASUS and Silexmodules are used forconnecting to a networkwirelessly, constructing amonitoring network with acentral monitoring system(CMS). | Same | Laird(2.4G/5G)wirelessmodule isadded. |
| Module rack | Independent of the patient monitor, provides 8 standardmodule slots to extend the measurement capabilities ofthe system | Same | ||
| Power supply | Two rechargeable Lithium-ionbattery or AC power supply | One rechargeableLithium-ion batteryor AC power supply | Same | Same |
| Battery | Chargeable Lithium-Ion, 11.1 VDC, 4500 mAh, 350 g | Same | ||
| Externalmemory 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 asa module | Supported | Same | ||
| ECG | 3-lead , 5-lead or 12-lead selectable, arrhythmiadetection, ST segment analysis, QT analysis, heart rate(HR), an interpretation of resting 12-lead ECG, J-pointAuto detection, Dual Channel Pace detection andAdjustable QRS Detection Threshold | Same | ||
| ArrhythmiaAnalysis(MindrayAlgorithm) | Asystole, VFib/VTac, Vtac, Vent. Brady, Extreme Tachy,Extreme Brady, PVC, Couplet, Bigeminy, Trigeminy, Ron T, Run PVCs, PVCs, Tachy, Brady, Missed Beats,Vent. Rhythm, PNP, PNC, Multif. PVC, Nonsus. Vtac,Pause, Irr. Rhythm, AFib | Same | ||
| ArrhythmiaAnalysis(MortaraAlgorithm) | 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 oxygensaturation(SpO2) | Mindray SpO2 ModuleMeasurement 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 ModuleMeasurement range: 1 to 100%Accuracy:70 to 100%: ±2% (measured without motion inadult/pediatric mode)70 to 100%: ±3% (measured without motion in neonatemode)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 (K152902) | Subject Devices | |||
| Feature | Passport 17m | Passport 12m | Passport 17m | Passport 12m |
| Pulse rate (PR) | PR from Mindray SpO2 ModuleMeasurement range: 20 to 254 bpmAccuracy: ±3 bpmPR from Masimo SpO2 ModuleMeasurement range: 25 to 240 bpmAccuracy: ±3 bpm (measured without motion)±5 bpm (measured with motion)PR from Nellcor SpO2 ModuleMeasurement range: 20 to 300 bpmAccuracy:20 to 250 bpm: ±3 bpm251 to 300 bpm, not specifiedPR from IBP ModuleMeasurement range: 25 to 350 bpmAccuracy:±1 bpm or ±1%, whichever is greater" | Same | ||
| Non-invasive blood pressure (NIBP) | Measurement range:AdultNeonateSystolic: 40 to 270Diastolic: 10 to 210Mean: 20 to 230Accuracy:Max mean error: ±5 mmHgMax standard deviation: 8 mmHg | PediatricNeonateSystolic: 40 to 200Diastolic: 10 to 150Mean: 20 to 165 | Same | PediatricNeonateSystolic: 40 to 135Diastolic: 10 to 100Mean: 20 to 110 |
| Invasive blood pressure (IBP) | Measurement range: -50 to 300 mmHgAccuracy: ±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 |
| Continuouscardiac output(CCO) | CCO/SvO2 interface module is used to interfacewith Edwards Vigilance II monitor / VigileoMonitor which measures continuous cardiacoutput (CCO), mixed venous oxygen saturation(SvO2) and central venous oxygen saturation(ScvO2). | Same | ||
| Central venousoxygensaturation(ScvO2) | ScvO2 module is used to measure central venous oxygensaturation (ScvO2). | Same | ||
| Carbon dioxide(CO2) | 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 ±5% of thereading+0.08% of (the reading-38)Mainstream CO2 Module:Measurement range: 0 to 150 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 | ||
| Anesthetic gas(AG) | The AG module analyzes gas samples from the patientand calculates CO2, O2, N2O and AA waves and relatednumerics, airway respiratory rate, and MAC (minimumalveolar concentration).Supports the 3-slot AG module. | Added support for the2-slot AG module | ||
| Predicate Device (K152902) | Subject Devices | |||
| Feature | Passport 17m | Passport 12m | Passport17m | Passport12m |
| Impedancecardiograph(ICG) | Measurement range:SV: 5 to 250 mlHR: 44 to 2mC.O. 1.4 to 15 L/minAccuracy:SV: Not specified.HR: ±2 bpmC.O. Not specified. | Same | ||
| Bispectral index(BIS) | Measured parameters: EEG, BIS, BIS L, BIS R | Same | ||
| Respirationmechanics(RM) | Measurement range: Adult: 0 to 120 rpm; Pediatric: 0 to150 rpm.Accuracy: 7 to 150 rpm:±2 rpm or ±2%, whichever isgreater;0 to 6 rpm: Not specified." | Same | ||
| NMT | Not supported | Added |
Device Comparison Table (Compare with Passport 12m/17m (K152902))
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| Feature | Secondary Predicate DeviceNMT (K152902) | Subject Mindray NMT in this510(k) | ComparisonSystem |
|---|---|---|---|
| Composition | Module and accessory cable | Module and accessory cable | Same |
| Intended use | The IntelliVue NMTModule is intended to beused as an objectiveneuromuscular transmissionmonitor, usingaccelerometry formeasuring the musclecontraction following anelectrical stimulation of aperipheral nerve. The NMTModule is intended to beused with adult andpediatric patients. | The neuromusculartransmission (NMT) moduleis intended to be used as anobjective neuromusculartransmission monitor, usingaccelerometry for measuringthe muscle contractionfollowing an electricalstimulation of a peripheralnerve. The NMT module isintended to be used with adultand pediatric patients. | Same |
| Principle ofmeasurement | Neuro MuscularTransmission (NMT) andits measurement enables theevaluation of musclerelaxation of patients underNeuromuscular Block bymeasuring the strength ofmuscle reaction afterelectrically stimulating thededicated motor nerve.The NMT Monitorelectrodes are placed on thepatient's skin over the ulnarnerve, a controllable currentsource delivers stimulationpulses to two skin surfaceelectrodes for the nervestimulation, the muscleresponse is measured withan acceleration sensor. | Neuromuscular Transmission(NMT) module evaluatesmuscle relaxation of patientsunder neuromuscular block bymeasuring the strength ofmuscle reaction afterelectrically stimulating thededicated motor nerve.The electrodes are placed onthe patient's skin over ulnarnerve, a controllable currentsource delivers stimulationpulses to two skin surfaceelectrodes for the nervestimulation, and the muscleresponse is measured with anacceleration sensor. | Same |
| Feature | Secondary Predicate DeviceNMT (K152902) | Subject Mindray NMT in this510(k) | ComparisonSystem |
| StimulationOutput | Current pulse: 100, 200, or300μs; monophasicrectangle pulse | Current Pulse: 100, 200 or300μs; monophasic rectanglepulse;Pulse width Accuracy: ±10% | Same |
| Current Range: 5 to 60 mAin increments of 5 mA | Current Range:0 - 60 mA inincrements of 5 mA | the actual outputcurrent of thetwo sides areboth 5 to 60 mASame | |
| Current Accuracy: ± 5% or± 2 mA, whichever isgreater | Current Accuracy: ± 5% or ±2 mA, whichever is greater | Same | |
| Max. Skin Resistance: 3kOhm | Max. Skin Impedance: 3kohm | Same | |
| Max. Output Voltage:300 V | Max. output voltage: 300 V | Same | |
| StimulationModes | 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 |
| PerformanceSpecifications | Single Twitch StimulationMode:Twitch: 0 to 200%Measurement interval:Manual, or 1s, 12s, 30s | Single Twitch StimulationMode:ST-Ratio: 0 to 200%Measurement interval:Manual, 1s, 10s, 20s | DifferentMeasurement interval |
| Feature | Secondary Predicate DeviceNMT (K152902) | Subject Mindray NMT in this510(k) | ComparisonSystem |
| Train-Of-Four StimulationMode:TOF Count (TOFcnt): 0 to4TOF Ratio (TOFrat): 5 to150%-Measurement interval:Manual, or 12s, 30s, 1min,5min, 10min, 15min,30min, 60min | Train-Of-Four StimulationMode:TOF-Count: 0 to 4TOF-Ratio: 5 to 160%Measurement interval:Manual, 12s, 15s, 20s, 30s,1min, 5min, 15min, 30min,60min | WiderTOF-RatioRange; DifferentMeasurementinterval | |
| Post-Tetanic-CountStimulation Mode:PTC:0 to 20Measurement interval:Manual | Post-Tetanic-CountStimulation Mode:PTC: 0 to 20Measurement interval:Manual | Same | |
| Double-Burst StimulationMode:Measurement interval:Manual | Double-Burst StimulationMode:Manual, 15s, 20s, 30s, 1min,5min, 15min, 30min, 60min | MoreMeasurementintervals |
Device Comparison Table (Compare with Philips NMT module (K161531))
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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.
§ 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.