Who can help prepare an FDA 510(k) submission like uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)?

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

uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)

Q: Who is the manufacturer of uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)?

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. filed the 510(k) submission for uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S) (K171901).

Q: What is the FDA product code for uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)?

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

Q: What is the regulatory pathway for uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)?

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

Q: What are the predicate devices for uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)?

Passport Series Patient Monitors (K152902).

K171901 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · MHX · Nov 15, 2017 · Cardiovascular

Device Facts

Record ID	K171901
Device Name	uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)
Applicant	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Product Code	MHX · Cardiovascular
Decision Date	Nov 15, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1025
Device Class	Class 2
Attributes	Pediatric

Intended Use

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.

Device Story

Multiparameter patient monitors for healthcare facilities; operated by clinical professionals. Inputs: ECG leads, SpO2 sensors, temperature probes, NIBP cuffs, IBP transducers, C.O. sensors, CO2 sampling lines. Transforms physiological signals into real-time waveforms, numeric values, and alarms. Outputs: Integrated touchscreen display, thermal recorder, and audible/visual alarms. Assists clinicians in patient status assessment and decision-making. Benefits: Continuous monitoring of vital signs to detect physiological changes.

Clinical Evidence

Bench testing only. Functional and system-level testing performed to verify performance against specifications and consensus standards (e.g., IEC 60601 series, AAMI/ANSI EC57). No clinical data provided.

Technological Characteristics

Multiparameter monitors with integrated touchscreen (10.4" to 15"). Power: AC or rechargeable Li-ion battery. Connectivity: Data transfer capabilities. Standards: ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-49, IEC 60601-2-27, IEC 60601-2-34, ISO 80601-2-56, ISO 80601-2-61, ISO 80601-2-55, AAMI/ANSI EC57. Software: Mindray proprietary algorithms for ECG, arrhythmia, ST, QT, and physiological parameter processing.

Indications for Use

Indicated for adult, pediatric, and neonatal patients for monitoring, displaying, and transferring physiological parameters including ECG, Resp, Temp, SpO2, PR, NIBP, IBP, C.O., and CO2. Arrhythmia detection and SpO2 limited to adult/pediatric; ST segment analysis and C.O. limited to adult patients only.

Regulatory Classification

Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Predicate Devices

Passport Series Patient Monitors (K152902)

Related Devices

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K970445 — VITALMAX 4000 CONFIGURED/VITALMAX 4000 MODULAR/VITALMAX 4100/MINIPACK 3100/3000/VITALMAX 800+/MINIPACK 300 · Pace Tech Medical Monitors, Inc. · Jan 30, 1998
K122253 — PROCARE MONITOR B20 · Ge Medical Systems China Co., Ltd. · Mar 22, 2013

Submission Summary (Full Text)

{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-MEDICAL ELECTRONICS CO., LTD. Mindray Building, Keji 12th Road South High-tech Industrial Park, Nanshan Shenzhen 518057, P.R. China Tel: +86 755 81888998 Fax: +86 755 26582680 | | Contact: | Yanhong Bai Manager Regulatory Affairs SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. Mindray Building, Keji 12th Road South High-tech Industrial Park, Nanshan 518057, P.R. China Tel: +86 755 81885635 Fax: +86 755 26582680 E-mail: baiyanhong@mindray.com | | Date Prepared: | June 23, 2017 | | Classification Regulation: | 870.1025 - Arrhythmia detector and alarm (including ST-segment measurement and alarm) | | | Class II | | Panel: | Cardiovascular | | Product Code: | MHX - monitor, physiological, patient (with arrhythmia detection or alarms) | {4}------------------------------------------------ ### Subsequent Product Codes: | 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, | | 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 | | CCK | 21 CFR 868.1400 | Anesthesiology | Carbon dioxide gas analyzer | analyzer, gas, carbon-dioxide, | | DXG | 21 CFR 870.1435 | Cardiovascular | Single-function, preprogrammed diagnostic | computer, diagnostic, pre-programmed, | | DSJ | 21 CFR 870.1100 | Cardiovascular | Blood pressure alarm | alarm, blood-pressure | | DRS | 21 CFR 870.2850 | Cardiovascular | transducer, blood-pressure, extravascular | Extravascular blood pressure 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 | | Integrated display and touchscreen | 17" 1280*1024 pixels | 10.4" 800*600 pixels | 10.4" 800*600 pixels | 12.1" 800*600 pixels | 12.1" 800*600 pixels | 15" 1024*768 pixels | 15" 1024*768 pixels | | Power supply | Two rechargeable Lithium-ion battery or AC power supply | One standard Rechargeable Lithium-ion battery or One optional Rechargeable Lithium-ion battery or AC 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 ) | | | | | | | 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 | | | | | | | ECG | 3-lead , 5-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, QT analysis, an interpretation of resting 12-lead ECG, and heart rate (HR); Support Mindray and Mortara algorithm. | 3-lead , 5-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, QT analysis andheart rate (HR); Only support Mindray algorithm and don't support interpretation of resting 12-lead ECG | | | | | | | ECG measurement range and Accuracy | 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 | | | | | | | 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 | | | | | | | | Predicate Device (K152902) | Subject Devices | | | | | | | Feature | Passport 17m | uMEC6 | uMEC1 0 | uMEC 7 | uMEC1 2 | uMEC1 5 | uMEC15 S | | 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 | | | | | | | Temperatur e (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) | 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. MasimoSpO2 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. NellcorSpO2 Module Measurement range: 0 to 100% Accuracy:70 to 100%: ±2% (adult/pediatric) 70 to 100%: ±3% (neonate) 0% to 69%: Not specified. | 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 | | | | | | | Pulse rate (PR) | PR from MindraySpO2 Module Measurement range: 20 to 254 bpm Accuracy: ±3 bpm PR from MasimoSpO2 Module Measurement range: 25 to 240 bpm Accuracy: ±3 bpm (measured without motion) ±5 bpm (measured with motion) PR from NellcorSpO2 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 | PR from MindraySpO2 Module Measurement range: 20 to 254 bpm Accuracy:±3 bpm PR specifications from MindraySpO2 module are same Not Support Masimo and NellcorSpO2 Module | | PR from MindraySpO2 Module Measurement range: 20 to 254 bpm Accuracy: ±3 bpm | PR from IBP Module Measurement range: 25 to 350 bpm Accuracy: ±1 bpm or ±1%, whichever is greater | PR specifications from MindraySpO2 module and IBP Module are same Not Support Masimo and NellcorSpO2 Module | | {8}------------------------------------------------ {9}------------------------------------------------ | | Predicate Device (K152902) | | | Subject Devices | | | | | | |-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|-----------|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|------------|------------|-------------|--| | Feature | Passport 17m | | | uMEC6 0 | uMEC1 7 | uMEC1 2 | uMEC1 5 | uMEC15 S | | | Non- invasive blood pressure (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 mmHg Max standard deviation: 8 mmHg | | | | Accuracy: Max mean error: ±5 mmHg Max standard deviation: 8 mmHg The measurement range of subject devices is wider than the predicate device | | | | | | Invasive blood pressure (IBP) | Measurement range: -50 to 300 mmHg Accuracy: ±2% or ±1 mmHg, whichever is greater (without sensor) | | | Not Supported | Same as the predicate device | | | | | | Cardiac output (C.O.) | Measurement range: C.O: 0.1 to 20 L/min TB: 23 to 43 °C TI: 0 to 27 °C Accuracy C.O: ±5% or ±0.1 L /min, whichever is greater TB, TI: ±0.1 °C (without sensor) | | | Not Supported | Same as the predicate device | | | | | {10}------------------------------------------------ | | Predicate Device (K152902) | Subject Devices | | | | | | |----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|------------|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|-------------| | Feature | Passport 17m | uMEC6 | uMEC1 0 | uMEC1 7 | uMEC1 2 | uMEC1 5 | uMEC15 S | | Carbon dioxide (CO2) | Sidestream CO2 Module: Measurement range0 - 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 measurement: awRR measurement range: 0 to 120rpm awRR 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%≤CO2 concentration<7%±0.3%7%≤CO2 concentration<12% ±0.4% 12%≤CO2 concentration≤13%±0.5% 13%<CO2 concentration≤20%±(0.43%+8%rel) ±0.3% ABS increase in error for ISO accuracy mode awRR measurement: awRR measurement range: 0 to 150rpm awRR measurement accuracy: <60rpm: ±1rpm 60 to 150 rpm: ±2rpm The CO2 measurement range of subject devices is wider than thepredicate device The awRR measurement range of subject devices 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.