ePM Series Patient monitors

K191769 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · MHX · Oct 31, 2019 · Cardiovascular

Device Facts

• Record ID: K191769
• Device Name: ePM Series Patient monitors
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: MHX · Cardiovascular
• Decision Date: Oct 31, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ePM 10/ePM 12/ePM 15/ePM 10M/ePM 12M/ePM 15M patient monitors are intended for monitoring, displaying, reviewing, storing, 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.), Carbon Dioxide (CO2), Oxygen (O2) and Anesthetic Gas (AG). The system also provides an interpretation of resting 12-lead ECG. All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following: · The arrhythmia detection and 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 ePM 12/ePM 15/ePM 10M/ePM 12M/ePM 15M monitors are not intended for helicopter transport, hospital ambulance, or home use.

Device Story

ePM Series Patient Monitors (ePM 10, 12, 15, 10M, 12M, 15M) are multi-parameter monitors for healthcare facilities. Devices accept inputs via sensors for ECG, respiration, temperature, SpO2, pulse rate, NIBP, IBP, PAWP, C.O., CO2, O2, and anesthetic gas. System processes signals to display waveforms, numerics, and alarms; provides arrhythmia detection, ST-segment analysis, QT analysis, and resting 12-lead ECG interpretation. Operated by trained clinical professionals. Output displayed on integrated touchscreen; supports data storage, transfer, and integration with 3rd party devices via RS-232. Enables real-time patient status monitoring, assisting clinicians in identifying physiological changes and deterioration (via EWS scores like MEWS, NEWS, NEWS 2.0). Benefits include continuous patient surveillance and timely clinical intervention.

Clinical Evidence

Bench testing only. No clinical data provided. Performance validated through functional and system-level testing, including conformance to consensus standards (IEC 60601 series, ISO 80601 series, AAMI/ANSI EC57) for arrhythmia detection, ST-segment measurement, and physiological parameter accuracy.

Technological Characteristics

Multi-parameter patient monitors with 10.1" to 15.6" touchscreens. Powered by AC or rechargeable Li-ion batteries. Connectivity via 2.4GHz/5GHz wireless or RS-232. Modules include ECG, SpO2 (Mindray/Masimo/Nellcor), NIBP, IBP, C.O., CO2, O2, and AG. Software performs arrhythmia detection, ST/QT analysis, and EWS scoring. Complies with IEC 60601-1, 60601-1-2, 60601-2-25/27/34, 80601-2-49/55/56/61, and UL 62133.

Indications for Use

Indicated for monitoring, displaying, reviewing, storing, and transferring physiological parameters (ECG, Resp, Temp, SpO2, PR, NIBP, IBP, PAWP, C.O., CO2, O2, AG) and resting 12-lead ECG interpretation in adult, pediatric, and neonatal patients. Arrhythmia detection and PAWP monitoring limited to adult/pediatric; C.O. monitoring limited to adult patients. For use in healthcare facilities by trained clinical professionals.

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

• BeneVision N Series Patient Monitors (K182075)

Submission Summary (Full Text)

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October 31, 2019

Shenzhen Mindray Bio-medical Electronics Co., LTD. Yanhong Bai Manager Regulatory Affairs, Technical Regulation Department Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan Shenzhen, 518057 Cn

Re: K191769

Trade/Device Name: ePM Series 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 Dated: September 30, 2019 Received: October 1, 2019

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. 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 located 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.

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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Jennifer Shih Acting 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

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### Indications for Use

510(k) Number (if known) K191769

Device Name ePM Series Patient Monitors

### Indications for Use (Describe)

The ePM 10/ePM 12/ePM 15/ePM 10M/ePM 15M 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, 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.), Carbon Dioxide (CO2), Oxygen (O2) and Anesthetic Gas (AG). The system also provides an interpretation of resting 12-lead ECG. All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following: · The arrhythmia detection and 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 ePM 12/ePM 15/ePM 10M/ePM 12M/ePM 15M monitors are not intended for helicopter transport, hospital ambulance, or home use.

Type of Use (Select one or both, as applicable)

| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------|
| <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the ePM Series Patient Monitors is provided below.

#### 1. SUBMITTER

| Applicant: | SHENZHEN MINDRAY BIO-MEDICAL<br>ELECTRONICS CO., LTD.<br>Mindray Building, Keji 12th Road South<br>High-tech Industrial Park, Nanshan<br>Shenzhen 518057, P.R. China<br>Tel: [phone]<br>Fax: [phone] | | | | |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| Contact: | Contact Person: Yanhong Bai<br>Title: Manager Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] | | | | |
| Date Prepared: | October 23, 2019 | | | | |
| 2.<br>DEVICE | | | | | |
| Device Trade Name: | ePM Series Patient Monitors (Including ePM 10, ePM<br>12, ePM 15, ePM 10M, ePM 12M, ePM 15M) | | | | |
| Device Common Name: | Patient Monitor | | | | |
| Classification Name: | 21 CFR 870.1025, Class II, Arrhythmia detector and<br>alarm (including ST-segment measurement and alarm) | | | | |
| Regulatory Class: | Class II | | | | |
| Panel: | Cardiovascular | | | | |
| Primary Product Code: | MHX - Monitor, Physiological, Patient (with<br>arrhythmia detection or alarms) | | | | |

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| Regulation<br>Number/Class | Product<br>Code | Regulation description | Device Common Name |
|----------------------------|-----------------|----------------------------------------------------------------------------------|------------------------------------------------------------------------|
| 870.1025, II | DSI | Arrhythmia detector and alarm<br>(including ST-segment measurement<br>and alarm) | Detector and alarm, arrhythmia |
| 870.1025, II | MLD | Arrhythmia detector and alarm<br>(including ST-segment measurement<br>and alarm) | Monitor, st segment with alarm |
| 870.2300, II | DRT | Cardiac Monitor (including<br>cardiotachometer and rate<br>alarm) | Monitor, cardiac (incl.<br>cardiotachometer & rate alarm) |
| 870.1130, II | DXN | Noninvasive blood pressure<br>measurement system | System, measurement, blood-pressure,<br>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 |
| 870.2710, II | DPZ | Ear oximeter | Oximeter, ear |
| 868.1400, II | CCK | Carbon dioxide gas analyzer | Analyzer, gas,<br>carbon-dioxide, gaseous-phase |
| 870.1435, II | DXG | Single-function, preprogrammed<br>diagnostic computer | Computer, diagnostic, pre-<br>programmed, single-function |
| 870.1100, II | DSJ | Blood pressure alarm | Alarm, blood-pressure |
| 868.1500, II | CBQ | Enflurane gas analyzer. | Analyzer, gas, enflurane, gaseous-<br>phase (anesthetic concentration) |
| 868.1620, II | CBS | Halothane gas analyzer. | Analyzer, gas, halothane, gaseous-<br>phase (anesthetic conc.) |
| 868.1700, II | CBR | Nitrous oxide gas analyzer. | Analyzer, gas, nitrous-oxide, gaseous<br>phase (anesthetic conc.) |
| 868.1720, II | CCI | Oxygen gas analyzer. | Analyzer, gas, oxygen, gaseous-phase |

Table 1: Secondary Product Codes

#### 3. PREDICATE DEVICES

- o Predicate: K182075- BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1) (Shenzhen Minray Bio-Medical Electronics Co., LTD)
#### DEVICE DESCRIPTION 4.

The subject ePM Series Patient Monitors includes six monitors:

- . ePM 10 Patient Monitor
- ePM 12 Patient Monitor ●

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- o ePM 15 Patient Monitor
- ePM 10M Patient Monitor
- o ePM 12M Patient Monitor
- ePM 15M Patient Monitor

The ePM 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.

#### ട്. INTENDED USE/INDICATIONS FOR USE

The ePM 10/ePM 12/ePM 15/ePM 10M/ePM 12M/ePM 15M patient monitors are intended for monitoring, displaying, reviewing, storing, 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.), Carbon Dioxide (CO2), Oxygen (O2) and Anesthetic Gas (AG). The system also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:

- o The arrhythmia detection and 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 ePM 10/ePM 12/ePM 15/ePM 10M/ePM 12M/ePM 15M monitors are not intended for helicopter transport, hospital ambulance, or home use.

#### SUBSTANTIAL EQUIVALENCE 6.

## 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. The monitoring parameters supported by the ePM series are a subset of those supported by the predicate BeneVision N series monitors (K182075).

In conclusion, the minor differences of the indications for use do not change the fundamental intended use of the ePM Series as a multiparameter monitor.

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# Technological Comparison

The table below compares the key technological feature of the subject devices to the predicate device (N series Patient Monitors, K182075). The features in gray are features which are different between the predicate devices and the subject devices.

| | Predicate Devices (K182075) | Subject ePM Devices | | | | | | | |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|----------------------------------|---------------------------------|-----------------------------------|---------------------------------|--|--|
| Feature | N12 | ePM<br>15 | ePM<br>12 | ePM<br>10 | ePM<br>15M | ePM<br>12M | ePM<br>10M | | |
| Display and<br>touchscreen | 12.1" 1280*800 pixels. | 15.6"<br>1366*<br>768<br>pixels. | 12.1"<br>1280*<br>800<br>pixels | 10.1"<br>1280*<br>800<br>pixels. | 15.6"<br>1366*<br>768<br>pixels | 12.1''<br>1280*<br>800<br>pixels. | 10.1"<br>1280*<br>800<br>pixels | | |
| Secondary<br>display | Mirrored display. | Mirrored display. | | | | | | | |
| Wireless | 2.4GHz/5GHz dual band module. | 2.4GHz/5GHz dual band module. | | | | | | | |
| Power<br>supply | Battery or AC power. | Battery or AC power | | | | | | | |
| Battery | Rechargeable Lithium-Ion, 11.1 VDC,<br>4500 mAh. | Rechargeable Lithium-Ion, 10.8VDC, 5600 mAh.<br>Rechargeable Lithium-Ion, 10.95 VDC, 4500 mAh.<br>Rechargeable Lithium-Ion, 10.95 VDC, 2600 mA | | | | | | | |
| Data storage | Embedded Multi Media Card<br>(eMMC). | Same | | | | | | | |
| Data<br>Recorder | Supports internal thermal recorder. | Same | | | | | | | |
| Device<br>integration | Use Benelink Module to integrate 3rd<br>party devices. Allow parameter values<br>and alarms from 3rd party devices to<br>be displayed, stored and printed. | Use the RS-232 interface to integrate 3rd party<br>devices.<br>Allow parameter values, waveforms and alarms from<br>3rd party devices to be displayed, stored and printed. | | | | | | | |
| Speaker | Give alarm tones (45 to 85 dB), key<br>tones, QRS tones; support PITCH<br>TONE and multi-level tone<br>modulation. | Same | | | | | | | |
| Alarm<br>system | The alarm lamp is cyan, yellow, or red<br>depending on alarm type.<br>Supports Alarm Volume Escalation | Same | | | | | | | |

Table 2: Device Comparison Table

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| | Predicate Devices (K182075) | Subject ePM Devices | | | | | | |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Feature | N12 | ePM<br>15 | ePM<br>12 | ePM<br>10 | ePM<br>15M | ePM<br>12M | ePM<br>10M | |
| ECG | Use ECG module of MPM3.0<br>3-lead, 5-lead or 12-lead selectable,<br>arrhythmia detection, ST segment<br>analysis, QT analysis, an<br>interpretation of resting 12-lead ECG,<br>J-point Auto detection, Dual Channel<br>Pace detection, adjustable QRS<br>threshold and heart rate (HR);<br><br>Arrhythmia detection is intended for<br>adult and pediatric.<br><br>Supports intelligent arrhythmia alarm.<br><br>ST segment analysis is intended for<br>adult, pediatric and neonate. | 3-lead, 5-lead, 6-lead or 12-lead selectable, arrhythmia<br>detection, ST segment analysis, QT analysis, an<br>interpretation of resting 12-lead ECG, J-point Auto<br>detection, Dual Channel Pace detection, adjustable<br>QRS threshold and heart rate (HR).<br><br>Arrhythmia detection is intended for adult, pediatric.<br><br>Supports intelligent arrhythmia alarm.<br><br>ST segment analysis is intended for adult, pediatric<br>and neonate. | | | | | | |
| Arrhythmia<br>Analysis | Asystole, VFib/Vtac, Vtac,<br>Vent.Brady, Extreme Tachy, Extreme<br>Brady, PVCs, Couplet, Bigeminy,<br>Trigeminy, R on T, Run PVCs,<br>PVCs/min, Tachy, Brady, Missed<br>Beats, Vent Rhythm, Pacer Not<br>Pacing, Pacer Not Capture,<br>Multif.PVC, Nonsus.Vtac, Pause,<br>Vent.Rhythm, Afib, Pauses/min,<br>Pauses/min; | Same | | | | | | |
| Respiration<br>rate (Resp) | Use Respiration module of MPM 3.0<br>Measurement range: Adult: 0 to 120<br>rpm; Pediatric, neonate: 0 to 150 rpm.<br>Accuracy: 7 to 150 rpm: ±2 rpm or<br>±2%, whichever is greater;<br>0 to 6 rpm: Not specified. | Measurement specifications are the same.<br>The measurement module has minor circuit board<br>layout differences. | | | | | | |
| Temperatur<br>e (Temp) | Use temperature module of MPM 3.0<br>Measurement range: 0 to 50°C (32 to<br>122°F)<br>Accuracy: ±0.1°C or ±0.2ºF (without<br>probe). | Measurement specifications are same.<br>The measurement module has minor circuit board<br>layout differences. | | | | | | |
| | Predicate Devices (K182075) | Subject ePM Devices | | | | | | |
| Feature | N12 | ePM<br>15 | ePM<br>12 | ePM<br>10 | ePM<br>15M | ePM<br>12M | ePM<br>10M | |
| Pulse oxygen saturation (SpO2) | Supports Mindray SpO2 function, Masimo SpO2 function and Nellcor SpO2 function from MPM 3.0 module.<br><br>Mindray SpO2 function<br>Measurement range: 0 to 100%;<br>Accuracy:70 to 100%: ±2% (adult/pediatric mode);<br>70 to 100%: ±3% (neonate mode);<br>0% to 69%: Not specified.<br><br>Masimo SpO2 function<br>Measurement range: 1 to 100%;<br>Accuracy:70 to 100%: ±2% (measured without motion in adult/pediatric mode);<br>70 to 100%: ±3% (measured without motion in neonate mode);<br>70 to 100%: ±3% (measured with motion);<br>1% to 69%: Not specified.<br><br>Nellcor SpO2 function<br>Measurement range: 0 to 100%;<br>Accuracy:70 to 100%: ±2% (adult/pediatric);<br>70 to 100%: ±3% (neonate);<br>0% to 69%: Not specified.<br><br>Note: The specifictions of the various SpO2 functions provided by each manufacturer are the same across platforms. | Supports Mindray SpO2 function, Masimo SpO2 function and Nellcor SpO2 function from multi parameter module.<br><br>The specifications for various SpO2 functions are the same.<br><br>The Masimo SpO2 module and the Nellcor SpO2 module in the internal MPM 3.0 module are identical to the Masimo SpO2 module and the Nellcor SpO2 module in K182075.<br><br>The internal Mindray SpO2 minor circuit board layout differences when compared to the Mindray SpO2 module in K182075 | | | | | | |
| Feature | Predicate Devices (K182075) | Subject ePM Devices | | | | | | |
| | N12 | ePM<br>15 | ePM<br>12 | ePM<br>10 | ePM<br>15M | ePM<br>12M | ePM<br>10M | |
| Pulse rate<br>(PR) | PR from Mindray SpO2 Module<br>Measurement range: 20 to 254 bpm;<br>Accuracy: ±3 bpm.<br>PR from Masimo SpO2 Module<br>Measurement range: 25 to 240 bpm;<br>Accuracy: ±3 bpm (measured without<br>motion);<br>±5 bpm (measured with motion).<br>PR from Nellcor SpO2 Module<br>Measurement range: 20 to 300 bpm;<br>Accuracy:20 to 250 bpm: ±3 bpm;<br>251 to 300 bpm, not specified.<br>PR from IBP Module<br>Measurement range: 25 to 350 bpm;<br>Accuracy: ±1 bpm or ±1%, whichever<br>is greater. | PR from built-in Mindray<br>SpO2 Module<br>Measurement range: 20 to<br>254 bpm;<br>Accuracy: ±3 bpm.<br>PR from built-in Masimo<br>SpO2 Module<br>Measurement range: 25 to<br>240 bpm;<br>Accuracy: ±3 bpm<br>(measured without<br>motion);<br>±5 bpm (measured with<br>motion).<br>PR from built-in Nellcor<br>SpO2 Module<br>Measurement range: 20 to<br>300 bpm;<br>Accuracy:20 to 250 bpm:<br>±3 bpm;<br>251 to 300 bpm, not<br>specified.<br>Same | PR from built-in Mindray<br>SpO2 Module<br>Measurement range: 20 to<br>254 bpm;<br>Accuracy: ±3 bpm.<br>PR from built-in Masimo<br>SpO2 Module<br>Measurement range: 25 to<br>240 bpm;<br>Accuracy: ±3 bpm<br>(measured without<br>motion);<br>±5 bpm (measured with<br>motion).<br>PR from built-in Nellcor<br>SpO2 Module<br>Measurement range: 20 to<br>300 bpm;<br>Accuracy:20 to 250 bpm:<br>±3 bpm;<br>251 to 300 bpm, not<br>specified. | | PR from built-in Mindray<br>SpO2 Module<br>Measurement range: 20 to<br>254 bpm;<br>Accuracy: ±3 bpm.<br>PR from built-in Masimo<br>SpO2 Module<br>Measurement range: 25 to<br>240 bpm;<br>Accuracy: ±3 bpm<br>(measured without<br>motion);<br>±5 bpm (measured with<br>motion).<br>PR from built-in Nellcor<br>SpO2 Module<br>Measurement range: 20 to<br>300 bpm;<br>Accuracy:20 to 250 bpm:<br>±3 bpm;<br>251 to 300 bpm, not<br>specified.<br>PR from external IBP<br>Module<br>Measurement range: 25 to<br>350 bpm;<br>Accuracy: ±1 bpm or<br>±1%, whichever is<br>greater.<br>Same | PR from built-in Mindray<br>SpO2 Module<br>Measurement range: 20 to<br>254 bpm;<br>Accuracy: ±3 bpm.<br>PR from built-in Masimo<br>SpO2 Module<br>Measurement range: 25 to<br>240 bpm;<br>Accuracy: ±3 bpm<br>(measured without<br>motion);<br>±5 bpm (measured with<br>motion).<br>PR from built-in Nellcor<br>SpO2 Module<br>Measurement range: 20 to<br>300 bpm;<br>Accuracy:20 to 250 bpm:<br>±3 bpm;<br>251 to 300 bpm, not<br>specified.<br>PR from external IBP<br>Module<br>Measurement range: 25 to<br>350 bpm;<br>Accuracy: ±1 bpm or<br>±1%, whichever is<br>greater.<br>Same | PR from built-in Mindray<br>SpO2 Module<br>Measurement range: 20 to<br>254 bpm;<br>Accuracy: ±3 bpm.<br>PR from built-in Masimo<br>SpO2 Module<br>Measurement range: 25 to<br>240 bpm;<br>Accuracy: ±3 bpm<br>(measured without<br>motion);<br>±5 bpm (measured with<br>motion).<br>PR from built-in Nellcor<br>SpO2 Module<br>Measurement range: 20 to<br>300 bpm;<br>Accuracy:20 to 250 bpm:<br>±3 bpm;<br>251 to 300 bpm, not<br>specified.<br>PR from external IBP<br>Module<br>Measurement range: 25 to<br>350 bpm;<br>Accuracy: ±1 bpm or<br>±1%, whichever is<br>greater.<br>Same | |
| Non-<br>invasive<br>blood<br>pressure<br>(NIBP) | | Measurement specifications are the same. | | | | | | |
| | | Measurement range: | Adult | Pedi<br>atric | Neon<br>ate | The measurement module has minor differences<br>related to the circuit board layout and over<br>pressure protection channel.…