uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors

{0} FDA U.S. FOOD &amp; DRUG ADMINISTRATION April 16, 2026 Shenzhen Mindray Bio-medical Electronics Co., LTD. Lei Li Manager Regulatory Affairs Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen, Guangdong 518057 China Re: K253170 Trade/Device Name: uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors 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 Dated: September 20, 2025 Received: September 26, 2025 Dear Lei Li: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. U.S. Food &amp; Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K253170 - Lei Li Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- {2} K253170 - Lei Li Page 3 assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, KIMBERLY N. Digitally signed CYROWLEY -S by KIMBERLY N. CROWLEY -S For: Jennifer Kozen Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K253170 | ? | | Please provide the device trade name(s). | | ? | | uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors | | | | Please provide your Indications for Use below. | | ? | | The uMEC 60/uMEC 70/uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors are intended for monitoring, displaying, reviewing, storing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 6-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.) and Carbon Dioxide (CO2). All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following: • The PAWP monitoring is intended for adult and pediatric patients only; • C.O. monitoring is intended for adult patients only; The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The uMEC 60/uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 monitors are not intended for helicopter transport, hospital ambulance, or home use. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} 510(k) Summary K253170 Page 1 of 12 # 510(K) SUMMARY In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Mindray uMEC 60/uMEC 70/uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors is provided below. # 1. SUBMITTER 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: Li Lei Title: Manager Regulatory Affairs Phone: +86 755 81885953 Fax: +86 755 26582680 E-mail: lilei.js@mindray.com Date Prepared: September 25, 2025 # 2. DEVICE Device Trade Name: uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors Device Common Name: Patient Monitor Classification Name: 21 CFR 870.1025, Class II, Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: II Primary Product Code: MHX Subsequent Product Codes Refer to Tabel 1 Panel: Cardiovascular Table 1: Secondary Product Codes | Regulation Number/Class | Product Codes | Regulation description | Device Common Name | | --- | --- | --- | --- | | 870.1025, II | DSI | Arrhythmia detector and alarm (including ST-segment measurement and alarm) | Detector and alarm, arrhythmia | {5} 510(k) Summary K253170 Page 2 of 12 | 870.1025, II | MLD | Arrhythmia detector and alarm (including ST-segment measurement and alarm) | Monitor, st segment with alarm | | --- | --- | --- | --- | | 870.2300, II | DRT | Cardiac Monitor (including cardiotachometer and rate alarm) | Monitor, cardiac (incl. cardiotachometer & rate alarm) | | 870.1130, II | DXN | Noninvasive blood pressure measurement system | System, measurement, blood-pressure, non-invasive | | 870.1110, II | DSK | Blood pressure computer | Computer, blood-pressure | | 880.2910, II | FLL | Clinical electronic thermometer | Thermometer, electronic, clinical | | 870.2700, II | DQA | Oximeter | Oximeter | | 868.1400, II | CCK | Carbon dioxide gas analyzer | Analyzer, gas, carbon-dioxide, gaseous-phase | | 870.1435, II | DXG | Single-function, preprogrammed diagnostic computer | Computer, diagnostic, pre-programmed, single-function | | 870.1100, II | DSJ | Blood pressure alarm | Alarm, blood-pressure | ## 3. PREDICATE DEVICES Primary predicate device: - K200015- ePM Series Patient monitors, ShenZhen Mindray Bio-Medical Electronics CO., LTD. ## 4. DEVICE DESCRIPTION The subject uMEC 60/uMEC 70/uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors includes six monitors: - uMEC 60 Patient Monitor - uMEC 70 Patient Monitor - uMEC 80 Patient Monitor - uMEC 100 Patient Monitor - uMEC 120 Patient Monitor - uMEC 150 Patient Monitor {6} 510(k) Summary K253170 Page 3 of 12 The above mentioned 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. ## 5. INTENDED USE/INDICATIONS FOR USE The uMEC 60/uMEC 70/uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors are intended for monitoring, displaying, reviewing, storing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 6-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.) and Carbon Dioxide (CO₂). All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following: - The PAWP monitoring is intended for adult and pediatric patients only; - C.O. monitoring is intended for adult patients only; The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The uMEC 60/uMEC 70/uMEC 80/uMEC 100/uMEC 120/uMEC 150 monitors are not intended for helicopter transport, hospital ambulance, or home use. ## 6. SUBSTANTIAL EQUIVALENCE ### Comparison of Indications Both the predicate devices and the subject devices are multi parameter patient monitors intended to be used under the direction of clinical professionals. Comparing with the primary predicate ePM Series Patient Monitors (K200015), the indications for use for the subject device uMEC 60/uMEC 70/uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors are equivalent. The subject and Primary predicate devices have the same use environment (healthcare facilities), and patient population (adult, pediatric, and neonatal patients). In conclusion, the intended use of the subject device uMEC 60/uMEC 70/uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors is substantially equivalent to that of the primary predicate ePM Series Patient Monitors (K200015). ### Comparison of Technological Characteristics The table below compare the key technological features of the subject devices to the primary predicate devices (K200015, ePM Series Patient Monitors). The features in grey are features which are different between the predicate devices and the subject devices. Where appropriate, the specific differences of the features are bolded. {7} 510(k) Summary K253170 Page 4 of 12 | Feature | ePM 10 | ePM 12 | ePM 15 | ePM 10M | ePM 12M | ePM 15M | uM E C 10 0 | uM E C 60 | uM EC 120 | uM EC 70 | uM EC 150 | uM EC 80 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Cleared in K200015 | | | | | | | Subject Device | | | | | | | Primary display and touch screen | 10.1” 1024 ×800 pixels | 12.1” 1280* 800 pixels | 15.6 1366 ×768 pixels | 10.1” 1024 ×800 pixels | 12.1” 1280* 800pixels | 15.6 1366 ×768 pixels | 10.1” 1024×600 pixels | | 12.1” 1280×800 pixels | | 15.6 1366×768 pixels | | | Secondary display | Mirrored display | | | | | | Mirrored display | | | | | | | Power supply | Battery or AC power | | | | | | Battery or AC power | | | | | | | Battery | Rechargeable Lithium-Ion, 10.8VDC, 5600 mAh. Rechargeable Lithium-Ion, 10.95 VDC, 4500 mAh. Rechargeable Lithium-Ion, 10.95 VDC, 2600 mA | | | | | | Rechargeable Lithium-Ion,10.95V, 5200mAh | | | | | | | Data storage | Embedded Multi Media Card(eMMC) | | | | | | Embedded Multi Media Card(eMMC) | | | | | | | Data recorder | Supports internal thermal recorder | | | | | | Supports internal thermal recorder | | | | | | | Speaker | Give alarm tones (45 to 85 dB), key tones, QRS tones; support PITCH TONE and multi-level tone modulation | | | | | | Give alarm tones (45 to 85 dB), key tones, QRS tones; support PITCH TONE and multi-level tone modulation | | | | | | | Alarm system | The alarm lamp is cyan, yellow, or red depending on alarm type | | | | | | The alarm lamp is yellow, or red depending on alarm type | | | | | | | ECG | 3-lead, 5-lead, 6-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, QT analysis, an interpretation of resting 12-lead ECG, J-point Auto detection, Dual Channel Pace detection, adjustable QRS threshold and heart rate (HR). Arrhythmia detection is intended for adult, pediatric and neonate. Supports intelligent arrhythmia alarm. ST segment analysis is intended for adult, pediatric and neonate. | | | | | | 3-lead, 5-lead, 6-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, QT analysis, J-point Auto detection, Dual Channel Pace detection, adjustable QRS threshold and heart rate (HR). Arrhythmia detection is intended for adult, pediatric and neonate. Supports intelligent arrhythmia alarm. ST segment analysis is intended for adult, pediatric and neonate. The measurement module has circuit board layout differences. | | | | | | | Arrhythmia Analysis | Asystole, VFib/Vtac, Vtac, Vent.Brady, Extreme Tachy, Extreme Brady, PVCs, Couplet, Bigeminy, Trigeminy, R on T, Run PVCs, PVCs/min, Tachy, Brady, Missed Beats, Vent Rhythm, Pacer Not Pacing, Pacer Not Capture, Multif.PVC, | | | | | | Asystole, VFib/Vtac, Vtac, Vent.Brady, Extreme Tachy, Extreme Brady, PVCs, Couplet, Bigeminy, Trigeminy, R on T, Run PVCs, PVCs/min, Tachy, Brady, Missed Beats, Vent Rhythm, Pacer Not Pacing, Pacer Not Capture, Multif.PVC, | | | | | | {8} 510(k) Summary K253170 Page 5 of 12 | Feature | ePM 10 | ePM 12 | ePM 15 | ePM 10M | ePM 12M | ePM 15M | uM E C 10 0 | uM E C 60 | uM EC 120 | uM EC 70 | uM EC 150 | uM EC 80 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Cleared in K200015 | | | | | | | Subject Device | | | | | | | | Nonsus.Vtac, Pause, Vent.Rhythm, Afib, Pauses/min, Pauses/min | | | | | | Nonsus.Vtac, Pause, Vent.Rhythm, Afib, Pauses/min, Pauses/min | | | | | | | 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 | | | | | | 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 The measurement module has circuit board layout differences. | | | | | | | Temperature (Temp) | Measurement range: 0 to 50°C (32 to 122°F) Accuracy: ±0.1°C or ±0.2°F (without probe). | | | | | | Measurement range: 0 to 50°C (32 to 122°F) Accuracy: ±0.1°C or ±0.2°F (without probe). The measurement module has circuit board layout differences. | | | | | | | Pulse oxygen saturation (SpO_{2}) | Supports Mindray SpO2 function, Masimo SpO2 function and Nellcor SpO2 function from multi parameter module. Mindray SpO2 function Measurement range: 0 to 100%; Accuracy: 70 to 100%: ±2% (adult/pediatric mode); 70 to 100%: ±3% (neonate mode); 0% to 69%: Not specified. Masimo SpO2 function Measurement range: 1 to 100%; Accuracy: 70 to 100%: ±2% (measured without motion in adult/pediatric mode); 70 to 100%: ±3% (measured without motion in neonate mode); 70 to 100%: ±3% (measured with motion); 1% to 69%: Not specified. Nellcor SpO2 function | | | | | | Only support Mindray SpO2 function from multi parameter 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. The measurement module has circuit board layout differences. | | | | | | {9} 510(k) Summary K253170 Page 6 of 12 | Feature | ePM 10 | ePM 12 | ePM 15 | ePM 10M | ePM 12M | ePM 15M | uM E C 10 0 | uM E C 60 | uM EC 120 | uM EC 70 | uM EC 150 | uM EC 80 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | Cleared in K200015 | | | | | | Subject Device | | | | | | | | Measurement range: 0 to 100%; Accuracy: 70 to 100%: ±2% (adult/pediatric); 70 to 100%: ±3% (neonate); 0% to 69%: Not specified. | | | | | | | | | | | | | Pulse rate (PR) | PR from built-in Mindray SpO2 Module Measurement range: 20 to 254 bpm; Accuracy: ±3 bpm. PR from built-in Masimo SpO2 Module Measurement range: 25 to 240 bpm; Accuracy: ±3 bpm (measured without motion); ±5 bpm (measured with motion). PR from built-in Nellcor SpO2 Module Measurement range: 20 to 300 bpm; Accuracy: 20 to 250 bpm: ±3 bpm; 251 to 300 bpm, not specified | | | PR from built-in Mindray SpO2 Module Measurement range: 20 to 254 bpm; Accuracy: ±3 bpm. PR from built-in Masimo SpO2 Module Measurement range: 25 to 240 bpm; Accuracy: ±3 bpm (measured without motion); ±5 bpm (measured with motion). PR from built-in Nellcor SpO2 Module Measurement range: 20 to 300 bpm; Accuracy: 20 to 250 bpm: ±3 bpm; 251 to 300 bpm, not specified | | | PR from built-in Mindray SpO2 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. | | | | | | | Non-invasive blood pressure (NIBP) | Measurement range: | | | | | | Measurement range: | | | | | | | | | | Adult | Pediatric | Neonate | | | | Adult | Pediatri c | Neonate | | | | Systolic | | 25-290 | 25-240 | 25-140 | | | | | | | | | | Diastolic | | 10-250 | 10-200 | 10-115 | | Systolic | | 25-290 | 25-240 | 25-140 | | {10} 510(k) Summary K253170 Page 7 of 12 | Feature | ePM 10 | ePM 12 | ePM 15 | ePM 10M | ePM 12M | ePM 15M | uM E C 10 0 | uM E C 60 | uM EC 120 | uM EC 70 | uM EC 150 | uM EC 80 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Cleared in K200015 | | | | | | | Subject Device | | | | | | | | Accuracy: Max mean error: ±5 mmHg; Max standard deviation: 8 mmHg. | Diastolic | 10-250 | 10-200 | 10-115 | | | | | | | | | | | | | | | | | Mean | 15-260 | 15-215 | 15-125 | | | | | | | | | | | Accuracy: Max mean error: ±5 mmHg; Max standard deviation: 8 mmHg. The measurement module has circuit board layout differences. | | | | | | Invasive blood pressure (IBP) | Uses an internal IBP module to measure invasive blood pressure. The monitor can monitor invasive blood pressures and displays systolic, diastolic and mean pressures and a waveform for each pressure. Support PPV function. Measurement range: -50 to 300 mmHg; Accuracy: ±2% or ±1 mmHg, whichever is greater (without sensor). | | | Uses an internal IBP module or stand-alone IBP Module to measure invasive blood pressure. The monitor can monitor invasive blood pressures and displays systolic, diastolic and mean pressures and a waveform for each pressure. Support PPV function. Measurement range: -50 to 300 mmHg; Accuracy: ±2% or ±1 mmHg, whichever is greater (without sensor). | | | Not support | | | Uses an internal IBP module to measure invasive blood pressure. The monitor can monitor invasive blood pressures and displays systolic, diastolic and mean pressures and a waveform for each pressure. Support PPV function. Measurement range: -50 to 300 mmHg; Accuracy: ±2% or ±1 mmHg, whichever is greater (without sensor). | | | | Cardiac output (C.O.) | Use internal C.O. module. The cardiac output (C.O.) measurement invasively measures cardiac output and other hemodynamic parameters using the right heart (atria) thermodilution method. The temperature change | | | Use internal or external C.O. module. The cardiac output (C.O.) measurement invasively measures cardiac output and other hemodynamic parameters using the right heart (atria) thermodilution | | | Not support | | | Use internal C.O. module. The cardiac output (C.O.) measurement invasively measures cardiac output and other hemodynamic parameters using the right heart | | | {11} 510(k) Summary K253170 Page 8 of 12 | Feature | ePM 10 | ePM 12 | ePM 15 | ePM 10M | ePM 12M | ePM 15M | uM E C 10 0 | uM E C 60 | uM EC 120 | uM EC 70 | uM EC 150 | uM EC 80 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Cleared in K200015 | | | | | | | Subject Device | | | | | | | | 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. 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). | | | method. 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. 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). | | | | | | (atria) thermodilution method. 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. 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). | | | | Carbon dioxide (CO_{2}) | Compatible with 3 internal CO2 modules: Sidestream CO2 2.0 module Mainstream CO2 Module MicroStream CO2 module | | | Compatible with 4 internal or external CO2 modules: Sidestream CO2 1.0 Module Sidestream CO2 2.0 module Mainstream CO2 module MicroStream CO2 module *10M does not support external CO2 modules | | | Not support | | | Compatible with 1 internal CO2 modules: Sidestream CO2 2.0 module | | | {12} 510(k) Summary K253170 Page 9 of 12 | Feature | ePM 10 | ePM 12 | ePM 15 | ePM 10M | ePM 12M | ePM 15M | uM E C 10 0 | uM E C 60 | uM EC 120 | uM EC 70 | uM EC 150 | uM EC 80 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Cleared in K200015 | | | | | | | Subject Device | | | | | | | | Type: Sidestream CO2 Module (CO2 2.0): Measurement range: 0~150mmHg Accuracy: 0~40 mmHg: ±2mmHg, 41~76 mmHg: ±5% of reading, 77~99 mmHg: ±10% of reading, 100~150mmHg: ±(3mmHg + 8% of reading), ISO accuracy mode: Add ±2mmHg to the full accuracy mode AwRR measurement: awRR measurement range: 0 to 150rpm; awRR: <60rpm, ±1rpm, 60~150rpm, ±2rpm | | | | | | | Not support | | Type: Sidestream CO2 Module (CO2 2.0): Measurement range: 0~150mmHg Accuracy: 0~40 mmHg: ±2mmHg, 41~76 mmHg: ±5% of reading, 77~99 mmHg: ±10% of reading, 100~150mmHg: ±(3mmHg + 8% of reading), ISO accuracy mode: Add ±2mmHg to the full accuracy mode AwRR measurement: awRR measurement range: 0 to 150rpm; awRR: <60rpm, ±1rpm, 60~150rpm, ±2rpm | | | | | Type: Microstream CO2 Module Measurement range: CO2: 0~99mmHg; awRR: 0~150rpm; Accuracy: CO2: 0~38mmHg: ±2mmHg; 39~99mmHg: ±5% of the reading+0.08% of (the | | | | | | | Not support | | | | | {13} 510(k) Summary K253170 Page 10 of 12 | Feature | ePM 10 | ePM 12 | ePM 15 | ePM 10M | ePM 12M | ePM 15M | uM E C 10 0 | uM E C 60 | uM EC 120 | uM EC 70 | uM EC 150 | uM EC 80 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Cleared in K200015 | | | | | | | Subject Device | | | | | | | | reading-38). awRR: 0~70rpm: ±1rpm, 71~120rpm: ±2rpm,121~150rpm: ±3rpm | | | | | | | | | | | | | | Type: Mainstream CO2 Module Measurement range: CO2: 0~150mmHg; awRR: 0~150rpm; Accuracy: CO2: 0~40mmHg: ±2mmHg, 41~70mmHg: ±5% of the reading, 71~100mmHg: ±8% of the reading, 101~150mmHg: ±10% of the reading; awRR: ±1rpm. | | | | | | Not support | | | | | | In conclusion, the differences in technological characteristics do not raise new questions of safety and effectiveness. ## 7. PERFORMANCE DATA To establish the substantial equivalence of the uMEC 60/uMEC 70/uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors, Mindray conducted functional and system level testing to validate the performance of the devices. The results of the bench testing show that the subject device meets its specifications and is substantially equivalent to the predicate device. In addition, Mindray has conducted testing to ensure the subject devices meet relevant consensus standards. ## Biocompatibility Testing The uMEC 60/uMEC 70/uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors are not patient contacting. There are no new patient contacting accessories or components. There have been no material changes to the previously cleared patient contacting devices, therefore biocompatibility testing is not required. ## Software Verification and Validation Testing Software verification and validation testing was conducted and documentation was provided as recommended by FDA’s Guidance for Industry and FDA Staff, “Guidance for the Content of {14} 510(k) Summary K253170 Page 11 of 12 Premarket Submissions for Software Contained in Medical Devices.” Verification of the uMEC 60/uMEC 70/uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors was conducted to ensure that the product works as designed. Validation was conducted to check the design and performance of the product. ## Electromagnetic Compatibility and Electrical Safety The uMEC 60/uMEC 70/uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors were assessed for conformity with the relevant requirements of the following standards and found to comply: - IEC 60601-1:2005/AMD2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 MOD) [Including Amendment 2 (2021)] - IEC 60601-1-2 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests - IEC/TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems ## Bench Testing To establish the substantial equivalence of the uMEC 60/uMEC 70/uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors, Mindray conducted functional and system level testing to validate the performance of the devices. The results of the bench testing show that the subject device meets its accuracy specification and is substantially equivalent to the predicate device. In addition, Mindray has conducted testing to ensure the subject devices meet relevant consensus standards. - ANSI AAMI IEC 60601-2-27:2011(R)2016 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment - ANSI AAMI IEC 80601-2-30:2018 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers - IEC 60601-2-34 Edition 3.0 2011-05 Medical electrical equipment - Part 2-34: Particular requirements for the basic safety, including essential performance, of invasive blood pressure monitoring equipment {15} 510(k) Summary K253170 Page 12 of 12 - IEC 80601-2-49:2018 Medical electrical equipment –Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment - ISO 80601-2-55 Second edition 2018-02 [Including AMD1:2023] Medical electrical equipment--Part2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors - ISO 80601-2-56 Second edition 2017-03 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. [Including: Amendment 1 (2018)] - ISO 80601-2-61 Second edition 2017-12 (Corrected version 2018-02) Medical electrical equipment--Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment - IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability - ANSI AAMI IEC 60601-1-8:2006 and A1:2012 [Including AMD 2:2021] 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 [Including Amendment 2 (2021)] ## 8. CONCLUSION Based on the detailed comparison of specifications for each of the characteristics to the predicate devices, the performance testing and conformance with applicable standards, the uMEC 60/uMEC 70/uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors can be found substantially equivalent to the predicate device.