(142 days)
The uMEC Series Patient Monitor family consists of the uMEC7, uMEC10, uMEC12, uMEC15 and uMEC15S patient monitors. All of the devices in the family are multiparameter monitors indicated for monitoring, displaying, reviewing, and transferring multiple physiological parameters. The specific indications for use are provided below.
The uMEC series patient monitors are intended for monitoring, displaying, and transferring of multiple physiological parameters including ECG (3-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), cardiac output (C.O.), carbon dioxide (CO2).
All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following: The arrhythmia detection and SpO2 are intended for adult and pediatric patients only; ST Segment analysis is intended for adult patients only; and C.O. monitoring is restricted to adult patients only.
The monitor is to be used in healthcare facilities by clinical professionals or under their guidance.
The subject uMEC Series Patient Monitors include six monitors:
- uMEC6 Patient Monitor
- uMEC7 Patient Monitor
- uMEC10 Patient Monitor
- uMEC12 Patient Monitor
- uMEC15 Patient Monitor
- uMEC15S Patient Monitor
The uMEC Series Patient Monitors are Mindray's new generation monitoring product family with ergonomic and flexible design in platform of both software and hardware to meet the clinical needs of monitoring.
The provided document is a 510(k) Summary for patient monitors, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study demonstrating device performance against specific acceptance criteria for AI algorithms.
Therefore, many of the requested elements for describing the acceptance criteria and the study proving the device meets them (especially those related to AI and human-in-the-loop performance) cannot be directly extracted from this document. The document outlines performance data related to the functional and system-level performance of the patient monitors (such as ECG accuracy, NIBP accuracy, etc.) by conforming to established consensus standards and conducting internal testing, but it does not describe a clinical study of an AI-based algorithm.
However, I can extract information regarding the performance specifications for various physiological parameters as presented in the "Comparison of Technological Characteristics" section, which can be interpreted as the device's inherent acceptance criteria for these parameters.
Let's break down what can be extracted and what cannot:
Information that can be extracted or inferred:
- Acceptance Criteria (as performance specifications): The comparison table details measurement ranges and accuracies for various physiological parameters (ECG, Respiration, Temp, SpO2, PR, NIBP, IBP, C.O., CO2). These are effectively the performance claims the device must meet.
- Study Proving Acceptance Criteria: The document states that "Mindray conducted functional and system level testing on the subject device" and "Mindray has conducted testing to ensure the subject device meets relevant consensus standards." This indicates the type of study/testing performed, which is primarily non-clinical, bench testing, and verification against standards.
Information that CANNOT be extracted from this document:
- AI-specific Acceptance Criteria/Performance: The document does not describe AI components or their performance.
- Sample size for test set (clinical): The document refers to "functional and system level testing" and conformity to standards, not a specific clinical test set with a patient sample size.
- Data provenance for test set: Not available as it's not a clinical study on a data set.
- Number/qualifications of experts for ground truth: Not applicable for non-clinical, functional testing.
- Adjudication method for test set: Not applicable.
- MRMC comparative effectiveness study: Not mentioned, as it's not an AI device.
- Standalone (algorithm-only) performance: Not mentioned.
- Type of ground truth used (clinical): Not specified beyond "relevant consensus standards" for verification.
- Sample size for training set (AI): Not applicable.
- How ground truth for training set was established (AI): Not applicable.
Given these limitations, here is the information based on the provided document:
1. A table of acceptance criteria and the reported device performance
For a patient monitor, "acceptance criteria" are typically defined by the accuracy and measurement ranges across various physiological parameters. The document compares the subject device's performance claims against those of the predicate device.
| Parameter | Acceptance Criteria (Predicate Device) | Reported Device Performance (uMEC Series) |
|---|---|---|
| ECG Heart Rate (HR) | Measurement Range:Neonate: 15 to 350 bpm;Pediatric: 15 to 350 bpm;Adult: 15 to 300 bpm;Accuracy: ±1 bpm or ±1%, whichever is greater. | Same as predicate device. |
| ECG ST Segment | Measurement Range: -2.0 to 2.0 mV RTI;Accuracy:-0.8 to 0.8 mV: ±0.02 mV or ±10%, whichever is greater.Beyond this range: Not specified. | Same as predicate device. |
| ECG QT | Measurement Range: [200, 800]ms;Accuracy: ±30ms | Same as predicate device. |
| Arrhythmia Analysis | Asystole, VFib/VTac, Vtac, Vent. Brady, ExtremeTechy, Extreme Brady, PVC, Couplet, Bigeminy, Trigeminy, R on T, RunPVCs,PVCs, Tachy, Brady, Missed Beats, Vent. Rhythm, PNP, PNC, Multif. PVC, Nonsus. Vtac, Pause, Irr. Rhythm, Afib. | Same as predicate device. |
| 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 as predicate device. |
| Temperature (Temp) | Measurement Range: 0 to 50 °C (32 to 122 F)Accuracy: ±0.1 °C or ±0.2 F (without probe) | Same as predicate device. |
| Pulse Oxygen Saturation (SpO2) | MindraySpO2 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.(Note: Masimo & Nellcor SpO2 Modules also listed for predicate) | MindraySpO2 Module:Measurement Range: 0 to 100%Accuracy: 70 to 100%: ±2% (adult/pediatric mode)0% to 69%: Not specified.MindraySpO2 Module do not support neonate mode and the specifications for Adult/pediatric are same.Not Support Masimo and NellcorSpO2 Module. (This is a difference, not an identical acceptance criterion, and indicates a narrower scope for the uMEC). |
| Pulse Rate (PR) | From MindraySpO2 Module:Measurement Range: 20 to 254 bpmAccuracy: ±3 bpm(Other module PR also listed) | From MindraySpO2 Module:Measurement Range: 20 to 254 bpmAccuracy: ±3 bpmNot Support Masimo and NellcorSpO2 Module.From IBP Module:Measurement Range: 25 to 350 bpmAccuracy: ±1 bpm or ±1%, whichever is greater. |
| Non-Invasive Blood Pressure (NIBP) | Measurement Ranges (Systolic/Diastolic/Mean):Adult: 40-270 / 10-210 / 20-230 mmHgPediatric: 40-200 / 10-150 / 20-165 mmHgNeonate: 40-135 / 10-100 / 20-110 mmHgAccuracy: Max mean error: ±5 mmHg, Max standard deviation: 8 mmHg | Measurement Ranges (Systolic/Diastolic/Mean):Adult: 25-290 / 10-250 / 15-260 mmHgPediatric: 25-240 / 10-200 / 15-215 mmHgNeonate: 25-140 / 10-115 / 15-125 mmHgAccuracy: Max mean error: ±5 mmHg, Max standard deviation: 8 mmHgThe measurement range of subject devices is wider than the predicate device. |
| Invasive Blood Pressure (IBP) | Measurement Range: -50 to 300 mmHgAccuracy: ±2% or ±1 mmHg, whichever is greater (without sensor) | Same as predicate device (where supported). uMEC6 does not support IBP. |
| Cardiac Output (C.O.) | Measurement Range: C.O: 0.1 to 20 L/min; TB: 23 to 43 °C; TI: 0 to 27 °CAccuracy: C.O: ±5% or ±0.1 L /min, whichever is greater; TB, TI: ±0.1 °C (without sensor) | Same as predicate device (where supported). Not supported by uMEC6, uMEC10, uMEC7. |
| Carbon Dioxide (CO2) | Sidestream CO2 Module:Measurement Range: 0 - 13%Accuracy: 0-5%: ±0.26% abs; 5-10%: ±5% of the reading; 10-13%: ±10% of the reading; ±0.3% ABS increase in error for ISO accuracy mode.awRR Range: 0 to 120rpmawRR Accuracy: ±2rpm | Sidestream CO2 Module:Measurement Range: 0 to 20%Accuracy: CO2 concentration<1%: ±0.1%; 1%≤CO2<5%: ±0.2%; 5%≤CO2<7%: ±0.3%; 7%≤CO2<12%: ±0.4%; 12%≤CO2≤13%: ±0.5%; 13%<CO2≤20%: ±(0.43%+8%rel); ±0.3% ABS increase in error for ISO accuracy mode.awRR Range: 0 to 150rpmawRR Accuracy: <60rpm: ±1rpm; 60 to 150 rpm: ±2rpm.The CO2 measurement range of subject devices is wider than the predicate device. The awRR measurement range of subject devices is wider than the predicate device. The Accuracy of awRR is also improved. Not supported by uMEC6, uMEC10, uMEC7. |
Study that proves the device meets the acceptance criteria:
The document describes the following types of testing:
- "Functional and system level testing": Mindray conducted this testing on the subject device to evaluate its performance relevant to differences between the subject and predicate devices. This testing "showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate."
- Conformity to Consensus Standards: Mindray asserts that they "has conducted testing to ensure the subject device meets relevant consensus standards" including:
- AAMI / ANSI EC57:2012 (Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms)
- IEC 60601-1:2005/(R)2012 and A1:2012,C1:2009/(R)2012 and A2:2010/(R)2012 (General requirements for basic safety and essential performance)
- IEC 60601-1-2:2007 (Electromagnetic compatibility)
- IEC 60601-1-8:2012 (Alarm systems)
- IEC 60601-1-6: 2013 (Usability)
- IEC 60601-2-49:2011 (Multifunction patient monitoring equipment)
- IEC 60601-2-27:2011 (Electrocardiographic monitoring equipment)
- IEC 60601-2-34:2011 (Invasive blood pressure monitoring equipment)
- IEC 80601-2-30:2013 (Automated non-invasive sphygmomanometers)
- ISO 80601-2-56: 2009 (Clinical thermometers for body temperature measurement)
- ISO 80601-2-61: 2011 (Pulse oximeter equipment)
- ISO 80601-2-55: 2011 (Respiratory gas monitors)
- IEC 62133: 2012 (Secondary cells and batteries safety requirements)
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document as the testing described is primarily functional/system-level verification against standards, not a clinical study on a patient test set.
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 as the ground truth refers to the performance specifications against which the device was tested, validated by adherence to consensus standards, rather than expert annotation of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as it relates to clinical data adjudication, which is not described.
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
No such study was mentioned. The device is a patient monitor, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not relevant to the described functional testing of a patient monitor.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is established by the international consensus standards listed in the "Performance Data" section (e.g., AAMI / ANSI EC57 for cardiac rhythm and ST-segment algorithms, various IEC and ISO standards for different parameters). The device's performance is validated by meeting the specifications and requirements set forth in these standards.
8. The sample size for the training set
This information is not applicable as the document describes a patient monitor that is not indicated for using AI/machine learning with a "training set" in the context of diagnostic algorithms.
9. How the ground truth for the training set was established
This information is not applicable as there is no mention of a training set for an AI algorithm.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
November 15, 2017
Shenzhen Mindray Bio-Medical Electronics Co., Ltd Yanhong Bai Manager Regulatory Affairs Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan Shenzhen, 518057 CN
Re: K171901
Trade/Device Name: uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC12, uMEC15, uMEC15S) Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including St-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MHX, DSI, MLD, DRT, DXN, DSK, FLL, DQA, CCK, DXG, DSJ, DRS Dated: October 11, 2017 Received: October 16, 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 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
{1}------------------------------------------------
801); medical device reporting of medical device-related 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
M& Millelreme
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) K171901
Device Name
uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC12, uMEC12, uMEC15, uMEC15S)
Indications for Use (Describe)
The uMEC Series Patient Monitor family consists of the uMEC7, uMEC10, uMEC12, uMEC15 and uMEC15S patient monitors. All of the devices in the family are multiparameter monitors indicated for monitoring, displaying, reviewing, and transferring multiple physiological parameters. The specific indications for use are provided below.
The uMEC series patient monitors are intended for monitoring, displaying, and transferring of multiple physiological parameters including ECG (3-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), cardiac output (C.O.), carbon dioxide (CO2).
All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following: The arrhythmia detection and SpO2 are intended for adult and pediatric patients only;
ST Segment analysis is intended for adult patients only; and
C.O. monitoring is restricted to adult patients only.
The monitor is to be used in healthcare facilities by clinical professionals or under their guidance.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(K) SUMMARY
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the uMEC series patient monitors is provided below.
| Device Common Name: | Patient Monitor |
|---|---|
| Device Trade Name: | uMEC Series Patient Monitors(including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S) |
| Applicant: | SHENZHEN MINDRAY BIO-MEDICALELECTRONICS CO., LTD.Mindray Building, Keji 12th Road SouthHigh-tech Industrial Park, NanshanShenzhen 518057, P.R. ChinaTel: +86 755 81888998Fax: +86 755 26582680 |
| Contact: | Yanhong BaiManager Regulatory AffairsSHENZHEN MINDRAY BIO-MEDICALELECTRONICS CO., LTD.Mindray Building, Keji 12th Road SouthHigh-tech Industrial Park, Nanshan 518057, P.R. ChinaTel: +86 755 81885635Fax: +86 755 26582680E-mail: baiyanhong@mindray.com |
| Date Prepared: | June 23, 2017 |
| Classification Regulation: | 870.1025 - Arrhythmia detector and alarm (includingST-segment measurement and alarm) |
| Class II | |
| Panel: | Cardiovascular |
| Product Code: | MHX - monitor, physiological, patient (with arrhythmiadetection or alarms) |
{4}------------------------------------------------
Subsequent Product Codes:
| 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 withalarm |
| DRT | 21 CFR870.2300 | Cardiovascular | Cardiac Monitor (including cardiotachometer and rate alarm) | monitor, cardiac (incl.cardiotachometer & ratealarm) |
| DXN | 21 CFR870.1130 | Cardiovascular | Noninvasive blood pressure measurement system | system, measurement, blood-pressure, |
| 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 |
| CCK | 21 CFR868.1400 | Anesthesiology | Carbon dioxide gas analyzer | analyzer, gas,carbon-dioxide, |
| DXG | 21 CFR870.1435 | Cardiovascular | Single-function, preprogrammed diagnostic | computer, diagnostic,pre-programmed, |
| DSJ | 21 CFR870.1100 | Cardiovascular | Blood pressure alarm | alarm, blood-pressure |
| DRS | 21 CFR870.2850 | Cardiovascular | transducer, blood-pressure, extravascular | Extravascular bloodpressure transducer. |
Predicate Device: K152902 –Passport Series Patient Monitors
Indication for Use:
The uMEC Series Patient Monitor family consists of the uMEC6, uMEC7, uMEC10, uMEC12, uMEC15 and uMEC15S patient monitors. All of the devices in the family are multiparameter monitors indicated for monitoring, displaying, reviewing, and transferring multiple physiological parameters. The specific indications for use are provided below.
The uMEC series patient monitors are intended for monitoring, displaying, reviewing, and K171901
{5}------------------------------------------------
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), cardiac output (C.O.), carbon dioxide (CO2).
All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following:
The arrhythmia detection and SpO2 are intended for adult and pediatric patients only; ST Segment analysis is intended for adult patients only;
C.O. monitoring is restricted to adult patients only;
The monitor is to be used in healthcare facilities by clinical professionals or under their guidance.
Device Description:
The subject uMEC Series Patient Monitors include six monitors:
- uMEC6 Patient Monitor ●
- . uMEC7 Patient Monitor
- . uMEC10 Patient Monitor
- uMEC12 Patient Monitor
- uMEC15 Patient Monitor
- uMEC15S Patient Monitor ●
The uMEC Series Patient Monitors are Mindray's new generation monitoring product family with ergonomic and flexible design in platform of both software and hardware to meet the clinical needs of monitoring.
Performance Data:
- To establish the substantial equivalence of the uMEC Series Patient Monitors, Mindray conducted functional and system level testing on the subject device. The testing provided an evaluation of the performance of the device relevant to each of the differences between the subject device and the predicate device. 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.
- Mindray has followed the following FDA Guidance Documents relevant to this device: .
- Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm Guidance for Industry and FDA (10/28/2003)
- Cardiac Monitor Guidance (Including Cardiotachometer and Rate Alarm)
- . Mindray has conducted testing to ensure the subject device meets relevant consensus standards.
{6}------------------------------------------------
ANSVAAMI ES60601-1:2005/(R)2012 and A1:2012,C1:2009/(R)2012 and A2:2010/(R)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 compatibility--Requirements and tests
IEC 60601-1-8:2012 Medical electrical equipment - part 1-8: general requirements for basic safety and essential performance - collateral standard: general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
IEC 60601-1-6: 2013 Medical electrical equipment-part 1-6: general requirements for basic safety and essential performance--collateral standard: usability
IEC 60601-2-49:2011 Medical electrical equipment --Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
IEC 60601-2-27:2011 Medical electrical equipment--Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
IEC 60601-2-34:2011 Medical electrical equipment - part 2-34: particular requirements for the basic safety, including essential performance, of invasive blood pressure monitoring equipment
IEC 80601-2-30:2013 Medical electrical equipment - part 2-30: particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
ISO 80601-2-56: 2009 Medical electrical equipment - part 2-56: particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
ISO 80601-2-61: 2011 Medical electrical equipment - part 2-61: particular requirements for basic safety and essential performance of pulse oximeter 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
AAMI / ANSI EC57:2012 testing and reporting performance results of cardiac rhythm and stsegment measurement algorithms
IEC 62133 : 2012 secondary cells and batteries containing alkaline or other non-acid electrolytes safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
Comparison of Indications:
Both the predicate device and the subject uMEC Series Patient Monitors are multiparameter patient monitors intended to be used in healthcare facilities under the direction of clinical professionals. Some features present in the cleared Passport Series Patient Monitors are not present in uMEC Series Patient Monitors. In conclusion, the minor differences to the indications K171901
{7}------------------------------------------------
for use do not change the fundamental intended use of the uMEC series Patient Monitors as multiparameter monitors.
Comparison of Technological Characteristics:
The technological characteristics of the subject device are compared to the predicate device in the table below.
| Predicate Device (K152902) | Subject Devices | ||||||
|---|---|---|---|---|---|---|---|
| Feature | Passport 17m | uMEC6 | uMEC10 | uMEC7 | uMEC12 | uMEC15 | uMEC15S |
| Integrateddisplay andtouchscreen | 17" 1280*1024 pixels | 10.4"800*600pixels | 10.4"800*600 pixels | 12.1"800*600 pixels | 12.1"800*600 pixels | 15"1024*768pixels | 15"1024*768 pixels |
| Powersupply | Two rechargeable Lithium-ion batteryor AC power supply | One standard Rechargeable Lithium-ion battery or One optionalRechargeable Lithium-ion battery orAC power supply | |||||
| Battery | Chargeable Lithium-Ion, 11.1 VDC,4500 mAh | Chargeable Lithium-Ion, 11.1 VDC, 2500 mAh (Standard)Chargeable Lithium-Ion, 11.1 VDC, 5000 mAh (Optional ) | |||||
| DataRecorder | The thermal recorder records patientinformation, measurement numerics,up to three waveforms, etc. | Same | |||||
| Speaker | Give alarm tones (45 to 85 dB), keytones, QRS tones; support PITCHTONE and multi-level tonemodulation | Same | |||||
| ECG | 3-lead , 5-lead or 12-lead selectable,arrhythmia detection, ST segmentanalysis, QT analysis, an interpretationof resting 12-lead ECG, and heart rate(HR);Support Mindray and Mortaraalgorithm. | 3-lead , 5-lead or 12-lead selectable, arrhythmia detection, STsegment analysis, QT analysis andheart rate (HR);Only support Mindray algorithm and don't support interpretationof resting 12-lead ECG | |||||
| ECGmeasurementrangeandAccuracy | HR: Neonate: 15 to 350 bpm;Pediatric: 15 to 350 bpm;Adult: 15 to 300 bpm;±1 bpm or ±1%, whichever is greater.ST: -2.0 to 2.0 mV RTI;-0.8 to 0.8 mV: ±0.02 mV or ±10%,whichever is greater.Beyond this range: Not specified.QT: [200, 800]ms; ±30ms | Same | |||||
| ArrhythmiaAnalysis | Asystole, VFib/VTac, Vtac, Vent.Brady, ExtremeTechy, ExtremeBrady, PVC, Couplet, Bigeminy,Trigeminy, R on T, RunPVCs,PVCs,Tachy, Brady, Missed Beats, Vent.Rhythm, PNP, PNC, Multif.PVC,Nonsus. Vtac, Pause, Irr.Rhythm, Afib | Same | |||||
| Predicate Device (K152902) | Subject Devices | ||||||
| Feature | Passport 17m | uMEC6 | uMEC10 | uMEC7 | uMEC12 | uMEC15 | uMEC15S |
| Respirationrate (Resp) | Measurement range: Adult: 0 to 120rpm; 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 to122 F)Accuracy: ±0.1 °C or ±0.2 F (withoutprobe) | Same | |||||
| Pulseoxygensaturation(SpO2) | MindraySpO2 ModuleMeasurement range: 0 to 100%Accuracy:70 to 100%: ±2%(adult/pediatric mode)70 to 100%: ±3% (neonate mode)0% to 69%: Not specified.MasimoSpO2 ModuleMeasurement range: 1 to 100%Accuracy:70 to 100%: ±2% (measuredwithout motion in adult/pediatricmode)70 to 100%: ±3% (measured withoutmotion in neonate mode)70 to 100%: ±3% (measured withmotion)1% to 69%: Not specified.NellcorSpO2 ModuleMeasurement range: 0 to 100%Accuracy:70 to 100%: ±2%(adult/pediatric)70 to 100%: ±3% (neonate)0% to 69%: Not specified. | MindraySpO2 ModuleMeasurement range: 0 to 100%Accuracy:70 to 100%: ±2% (adult/pediatric mode)0% to 69%: Not specified.MindraySpO2 Module do not support neonate mode and thespecifications for Adult/pediatric are sameNot Support Masimo and NellcorSpO2 Module | |||||
| Pulse rate(PR) | PR from MindraySpO2 ModuleMeasurement range: 20 to 254 bpmAccuracy: ±3 bpmPR from MasimoSpO2 ModuleMeasurement range: 25 to 240 bpmAccuracy: ±3 bpm (measured withoutmotion)±5 bpm (measured with motion)PR from NellcorSpO2 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%, whicheveris greater | PR fromMindraySpO2ModuleMeasurementrange: 20 to 254bpmAccuracy:±3 bpmPR specificationsfrom MindraySpO2module are sameNot SupportMasimo andNellcorSpO2Module | PR from MindraySpO2 ModuleMeasurement range: 20 to 254 bpmAccuracy: ±3 bpm | PR from IBP ModuleMeasurement range: 25 to 350 bpmAccuracy: ±1 bpm or ±1%, whichever isgreater | PR specifications from MindraySpO2module and IBP Module are sameNot Support Masimo and NellcorSpO2Module |
{8}------------------------------------------------
{9}------------------------------------------------
| Predicate Device (K152902) | Subject Devices | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Feature | Passport 17m | uMEC60 | uMEC17 | uMEC12 | uMEC15 | uMEC15S | |||
| Non-invasivebloodpressure(NIBP) | Measurement range: | Measurement range: | |||||||
| Adult | Pediatric | Neonate | Adult | Pediatric | Neonate | ||||
| Systolic | 40-270 | 40-200 | 40-135 | 25-290 | 25-240 | 25-140 | |||
| Diastolic | 10-210 | 10-150 | 10-100 | 10-250 | 10-200 | 10-115 | |||
| Mean | 20-230 | 20-165 | 20-110 | 15-260 | 15-215 | 15-125 | |||
| Accuracy:Max mean error: ±5 mmHgMax standard deviation: 8 mmHg | Accuracy:Max mean error: ±5 mmHgMax standard deviation: 8 mmHgThe measurement range of subject devices is wider than thepredicate device | ||||||||
| Invasivebloodpressure(IBP) | Measurement range: -50 to 300 mmHgAccuracy: ±2% or ±1 mmHg,whichever is greater (without sensor) | Not Supported | Same as the predicate device | ||||||
| Cardiacoutput(C.O.) | Measurement range:C.O: 0.1 to 20 L/minTB: 23 to 43 °CTI: 0 to 27 °CAccuracyC.O: ±5% or ±0.1 L /min, whicheveris greaterTB, TI: ±0.1 °C (without sensor) | Not Supported | Same as the predicate device |
{10}------------------------------------------------
| Predicate Device (K152902) | Subject Devices | ||||||
|---|---|---|---|---|---|---|---|
| Feature | Passport 17m | uMEC6 | uMEC10 | uMEC17 | uMEC12 | uMEC15 | uMEC15S |
| Carbondioxide(CO2) | Sidestream CO2 Module:Measurement range0 - 13% Accuracy:0-5%: ±0.26% abs5-10%: ±5% of the reading10-13%: ±10% of the reading±0.3% ABS increase in error for ISOaccuracy modeawRR measurement:awRR measurement range: 0 to120rpmawRR measurement accuracy: ±2rpm | Not Supported | Sidestream CO2 Module:Measurement range:0 to 20%Accuracy:CO2 concentration<1%:±0.1%1%≤CO2 concentration<5%: ±0.2%5%≤CO2concentration<7%±0.3%7%≤CO2concentration<12% ±0.4%12%≤CO2 concentration≤13%±0.5%13%<CO2concentration≤20%±(0.43%+8%rel)±0.3% ABS increase in error for ISOaccuracy modeawRR measurement:awRR measurement range: 0 to 150rpmawRR measurement accuracy: <60rpm:±1rpm60 to 150 rpm: ±2rpmThe CO2 measurement range of subjectdevices is wider than thepredicate deviceThe awRR measurement range of subjectdevices is wider than thepredicate device.The Accuracy of awRR is also improved |
Substantial Equivalence Conclusion:
Based on the detailed comparison between the previously cleared Passport Series devices (K152902) and the subject uMEC series devices, the performance testing and conformance with applicable standards, the uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S) 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.