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 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 Description

The subject ePM Series Patient Monitors includes six monitors:

ePM 10 Patient Monitor
ePM 12 Patient Monitor
ePM 15 Patient Monitor
. ePM 10M Patient Monitor
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.

AI/ML Overview

The provided document is a 510(k) Summary for the ePM Series Patient Monitors (K200015) by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. This document describes the device, its intended use, and the data presented to the FDA to demonstrate substantial equivalence to predicate devices.

While the document details various performance specifications and mentions "functional and system level testing," and "bench testing," it does not provide explicit acceptance criteria in a table format, nor does it present detailed study results proving the device meets specific criteria for the entire suite of monitored parameters. It primarily focuses on demonstrating that the subject device's technological characteristics and performance are substantially equivalent to previously cleared predicate devices and meet relevant consensus standards.

However, based on the provided text, I can extract and infer information about performance and testing related to the ECG and Arrhythmia detection features, which are directly relevant to the regulation number 21 CFR 870.1025.

Here's an attempt to answer your questions based on the available information, with specific limitations noted where details are not provided:

Acceptance Criteria and Study Details for ePM Series Patient Monitors (K200015)

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" as a separate, quantified target for each parameter, but rather lists "accuracy" or "measurement range" as performance specifications. The "reported device performance" is essentially implied to be within these stated specifications as a result of the conducted testing.

Parameter	Acceptance Criteria (Implied / Stated Specification)	Reported Device Performance (Implied as meeting specification)
Arrhythmia Detection (ECG)	Referenced standards: IEC 60601-2-27:2011 (Medical electrical equipment--Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment) and AAMI / ANSI EC57:2012 (Testing and reporting performance results of cardiac rhythm and st-segment measurement algorithms).Specific arrhythmia types listed.	Performance demonstrated to meet relevant consensus standards (IEC 60601-2-27:2011, AAMI / ANSI EC57:2012).Supports detection of various arrythmias including 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, Nonsus.Vtac, Pause, Vent.Rhythm, Afib, Pauses/min.
ST Segment Analysis (ECG)	Referenced standards: As above (AAMI / ANSI EC57:2012).	Performance demonstrated to meet relevant consensus standards. J-point Auto detection included.
Heart Rate (HR) (ECG)	Referenced standards: As above (IEC 60601-2-27:2011, AAMI / ANSI EC57:2012).	Performance demonstrated to meet relevant consensus standards.
Respiration Rate (Resp)	Measurement range: Adult: 0-120 rpm; Pediatric, neonate: 0-150 rpm.Accuracy: 7-150 rpm: ±2 rpm or ±2%, whichever is greater; 0-6 rpm: Not specified.	Performance stated to meet these specifications.
Temperature (Temp)	Measurement range: 0-50 °C (32-122 F).Accuracy: ±0.1 °C or ±0.2 F (without probe).	Performance stated to meet these specifications.
Pulse Oxygen Saturation (SpO2)	Mindray SpO2: Range: 0-100%; Accuracy: 70-100%: ±2% (adult/pediatric), ±3% (neonate); 0-69%: Not specified.Masimo SpO2: Range: 1-100%; Accuracy: 70-100%: ±2% (adult/pediatric, no motion), ±3% (neonate, no motion), ±3% (with motion); 1-69%: Not specified.Nellcor SpO2: Range: 0-100%; Accuracy: 70-100%: ±2% (adult/pediatric), ±3% (neonate); 0-69%: Not specified.	Performance stated to meet these specifications.
Pulse Rate (PR)	Mindray SpO2 Module: Range: 20-254 bpm; Accuracy: ±3 bpm.Masimo SpO2 Module: Range: 25-240 bpm; Accuracy: ±3 bpm (no motion), ±5 bpm (with motion).Nellcor SpO2 Module: Range: 20-300 bpm; Accuracy: 20-250 bpm: ±3 bpm; 251-300 bpm: Not specified.	Performance stated to meet these specifications.
Non-invasive Blood Pressure (NIBP)	Adult: Systolic: 25-290, Diastolic: 10-250, Mean: 15-260.Pediatric: Systolic: 25-240, Diastolic: 10-200, Mean: 15-215.Neonate: Systolic: 25-140, Diastolic: 10-115, Mean: 15-125.Accuracy: Max mean error: ±5 mmHg; Max standard deviation: 8 mmHg.	Performance stated to meet these specifications.
Invasive Blood Pressure (IBP)	Measurement range: -50 to 300 mmHg.Accuracy: ±2% or ±1 mmHg, whichever is greater (without sensor).	Performance stated to meet these specifications.
Cardiac Output (C.O.)	Measurement range: C.O: 0.1-20 L/min; TB: 23-43 °C; TI: 0-27 °C.Accuracy: C.O: ±5% or ±0.1 L/min, whichever is greater; TB, TI: ±0.1 °C (without sensor).	Performance stated to meet these specifications.
Carbon Dioxide (CO2)	Sidestream CO2 2.0: 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). AwRR: <60rpm, ±1rpm, 60-150rpm, ±2rpm.Microstream CO2: CO2: 0-99mmHg; Accuracy: 0-38mmHg: ±2mmHg; 39-99mmHg: ±5% of the reading+0.08% of (the reading-38). AwRR: 0-70rpm: ±1rpm, 71-120rpm: ±2rpm,121-150rpm: ±3rpm.Mainstream CO2: CO2: 0-150mmHg; Accuracy: 0-40mmHg: ±2mmHg, 41-70mmHg: ±5% of the reading, 71-100mmHg: ±8% of the reading, 101-150mmHg: ±10% of the reading. AwRR: ±1rpm.	Performance stated to meet these specifications.
Oxygen (O2)	Measurement range: 0-100%; Accuracy: 0-25%, ±1%; 26-80%,±2%; 81-100%, ±3%.	Performance stated to meet these specifications.
Anesthetic Gas (AG)	Ranges for CO2, HAL, ENF, ISO, SEV, DES, O2, N2O, awRR. Detailed accuracy specified for each gas and range (e.g., CO2: 0%=<CO2=<1%, ±0.1%ABS).	Performance stated to meet these specifications.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes (e.g., number of patients, number of ECG recordings) for any of the performance tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of data collection). It refers to "functional and system level testing" and "bench testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not mention the use of experts to establish ground truth for any test set. The testing described appears to be technical validation against device specifications and consensus standards, not clinical evaluation against expert interpretations. For cardiac rhythm and ST-segment algorithms, ground truth (reference data) might come from adjudicated annotated databases, but this is not detailed in the summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any adjudication method. This is consistent with the lack of mention of expert ground truth establishment.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study is mentioned in the document. This submission is for a patient monitor, which provides measurements and alarms, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The entire device, including its measurement algorithms for ECG, arrhythmia detection, ST-segment analysis, SpO2, NIBP, etc., operates in a "standalone" mode in terms of generating these measurements and alarms. The document states that "software verification and validation testing was conducted" and "bench testing" was performed to ensure the device meets its accuracy specifications and relevant consensus standards. This implies algorithm-only performance assessment against known inputs or reference standards rather than a human-in-the-loop study.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document primarily states that the device's performance was validated against its internal specifications and relevant consensus standards (e.g., IEC 60601-2-27, AAMI / ANSI EC57). For these types of medical devices (patient monitors), ground truth for performance characteristics like accuracy and detection capability often comes from:

Physiological simulators: Generating known, controlled signals for parameters like ECG arrhythmias, SpO2, NIBP.
Standardized databases: For ECG analysis, widely accepted databases of annotated ECG waveforms (e.g., MIT-BIH Arrhythmia Database) are often used to test algorithm performance against "expert consensus" annotations within those databases.
Reference measurement equipment: Calibrated instruments used to establish the true value of a physiological parameter during bench testing.

The document does not explicitly state which specific type of ground truth was used beyond referring to "bench testing" and "consensus standards."

8. The sample size for the training set

The document discusses "software verification and validation testing" and "bench testing" but does not mention a "training set". This implies that the device's algorithms were developed and validated internally against specifications and standards, rather than explicitly being derived from a separate "training set" as might be seen for machine learning or AI models with a distinct learning phase. If machine learning was used, details about its training would be expected.

9. How the ground truth for the training set was established

Since no "training set" is described, the method for establishing its ground truth is also not provided.

Summary

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June 8, 2020

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 China

Re: K200015

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, DPZ, CCK, DXG, DSJ, CBQ, CBS, CBR. CCL Dated: May 9, 2020 Received: May 12, 2020

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jennifer Shih Assistant Director (Acting) Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices 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) K200015

Device Name ePM Series Patient Monitors

Indications for Use (Describe)

· C.O. monitoring is intended for adult patients only;

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)

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510(K) SUMMARY

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

1. SUBMITTER

Applicant:	SHENZHEN MINDRAY BIO-MEDICALELECTRONICS CO., LTD.Mindray Building, Keji 12th Road SouthHigh-tech Industrial Park, NanshanShenzhen 518057, P.R. ChinaTel: +86 755 81888998Fax: +86 755 26582680
Contact:	Contact Person: Yanhong BaiTitle: Manager Regulatory AffairsPhone: +86 755 81885635Fax: +86 755 26582680E-mail: baiyanhong@mindray.com
Date Prepared:	December 28, 2019
DEVICE
Device Trade Name:	ePM Series Patient Monitors
Device Common Name:	Patient Monitor
Classification Name:	21 CFR 870.1025, Class II, Arrhythmia detector andalarm (including ST-segment measurement and alarm)
Regulatory Class:	Class II
Panel:	Cardiovascular

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Primary Product Code: MHX - Monitor, Physiological, Patient (with arrhythmia detection or alarms)

Table 1:	Secondary Product Codes
----------	-------------------------

RegulationNumber/Class	ProductCode	Regulation description	Device Common Name
870.1025, II	DSI	Arrhythmia detector and alarm(including ST-segment measurementand alarm)	Detector and alarm,arrhythmia
870.1025, II	MLD	Arrhythmia detector and alarm(including ST-segment measurementand alarm)	Monitor, st segment withalarm
870.2300, II	DRT	Cardiac Monitor (includingcardiotachometer and rate alarm)	Monitor, cardiac (incl.cardiotachometer & ratealarm)
870.1130, II	DXN	Noninvasive blood pressuremeasurement 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
870.2710, II	DPZ	Ear oximeter	Oximeter, ear
868.1400, II	CCK	Carbon dioxide gas analyzer	Analyzer, gas,carbon-dioxide,gaseous-phase
870.1435, II	DXG	Single-function, preprogrammeddiagnostic computer	Computer, diagnostic,pre-programmed,single-function
870.1100, II	DSJ	Blood pressure alarm	Alarm, blood-pressure
868.1500, II	CBQ	Enflurane gas analyzer	Analyzer, gas, enflurane,gaseous-phase (anestheticconcentration)
868.1620, II	CBS	Halothane gas analyzer	Analyzer, gas, halothane,gaseous-phase (anestheticconc.)
868.1700, II	CBR	Nitrous oxide gas analyzer	Analyzer, gas, nitrous-oxide,gaseous phase (anestheticconc.)
868.1720, II	CCL	Oxygen gas analyzer	Analyzer, gas, oxygen,gaseous-phase

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3. PREDICATE DEVICES

K191769 - ePM Series Patient Monitors (Including ePM 10/ePM 15/ePM 15/ePM 10M/ePM 12M/ePM 15M) (SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD)

4. REFERENCE DEVICE

K103142 - The spacelabs Multi-parameter Module (SPACELABS HEALTHCARE, INC.)

5. DEVICE DESCRIPTION

The subject ePM Series Patient Monitors includes six monitors:

ePM 10 Patient Monitor
ePM 12 Patient Monitor
ePM 15 Patient Monitor
. ePM 10M Patient Monitor
ePM 12M Patient Monitor ●
ePM 15M Patient Monitor ●

6. INDICATIONS FOR USE

The ePM 10/12/15/10M/12M/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, OT Analysis, and Heart Rate (HR)), Respiration Rate (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure(IBP), Pulmonary Artery Wedge Pressure (PAWP), Cardiac Output (C.O.), 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 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

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guidance. They should only be used by persons who have received adequate training in their use. The ePM 10/12/15/10M/12M/15M monitors are not intended for helicopter transport, hospital ambulance, or home use.

7. 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. The monitoring parameters supported by the subject ePM series are identical with those supported by the predicate ePM series monitors (K191769).

The indications for use statement of the subject devices include Arrhythmia Detection used on neonatal patients. Although this feature is not present in the primary predicate devices, it is present in the cleared spacelabs Multi-parameter Module (K103142) and does not constitute a new intended use.

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

Comparison of Technological Characteristics

The table below compares the key technological feature of the subject device to the primary predicate device (ePM series Patient Monitors, K191769). The features in gray are features which are different between the predicate devices and the subject devices.

	Predicate Devices (K191769)					Subject ePM Devices
Feature	ePM 15	ePM12	ePM10	ePM15M	ePM12M	ePM10M	ePM15	ePM12	ePM10	ePM15M	ePM12M	ePM10M
Display andtouchscreen	15.6”1366*768pixels	12.1”1280*800pixels	10.1”1280*800pixels	15.6”1366*768pixels	12.1”1280*800pixels	10.1”1280*800pixels	15.6”1366*768pixels	12.1”1280*800pixels	10.1”1280*800pixels	15.6”1366*768pixels	12.1”1280*800pixels	10.1”1280*800pixels
Secon	Mirrored display						Same

Table 2:	Device Comparison Table
darydisplay
Wireless	2.4GHz/5GHz dual band module	Same
Powersupply	Battery or AC power	Same
Battery	Rechargeable Lithium-Ion, 10.8VDC, 5600 mAh.Rechargeable Lithium-Ion, 10.95 VDC, 4500 mAh.Rechargeable Lithium-Ion, 10.95 VDC, 2600 mA	Same
Datastorage	Embedded Multi Media Card(eMMC)	Same
DataRecorder	Supports internal thermal recorder	Same
Deviceintegration	Use the RS-232 interface to integrate 3rd party devices.Allow parameter values, waveforms and alarms from 3rd party devices to be displayed, stored and printed.	Same
Speaker	Give alarm tones (45 to 85 dB), key tones, QRS tones; support PITCH TONE and multi-level tone modulation	Same
Alarmsystem	The alarm lamp is cyan, yellow, or red depending on alarm type	Same
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).	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 and	Arrhythmia detection is intended for adult,
	pediatric.	pediatric and neonate.
	Supports intelligent arrhythmia alarm.	Supports intelligent arrhythmia alarm.
	ST segment analysis is intended for adult, pediatric	ST segment analysis is intended for adult,
	and neonate.	pediatric and neonate.

		Refer to Section 12.3.
	Asystole, VFib/Vtac, Vtac, Vent.Brady, Extreme
Arrhy	Tachy, Extreme Brady, PVCs, Couplet, Bigeminy,
thmia	Trigeminy, R on T, Run PVCs, PVCs/min, Tachy,
Analy	Brady, Missed Beats, Vent Rhythm, Pacer Not	Same
	Pacing, Pacer Not Capture, Multif.PVC,
sis	Nonsus.Vtac, Pause, Vent.Rhythm, Afib,
	Pauses/min, Pauses/min
Respir	Measurement range:
ation	Adult: 0 to 120 rpm;
rate	Pediatric, neonate: 0 to 150 rpm.	Same
(Resp	Accuracy:
)	7 to 150 rpm: ±2 rpm or ±2%, whichever is greater;
	0 to 6 rpm: Not specified.
Temp
eratur
e	Measurement range: 0 to 50 °C (32 to 122 F)	Same
(Temp	Accuracy: ±0.1 °C or ±0.2 F (without probe).
)
	Supports Mindray SpO2 function, Masimo SpO2
	function and Nellcor SpO2 function from multi
Pulse	parameter module.
oxyge	Mindray SpO2 function
n	Measurement range: 0 to 100%;
	Accuracy:	Same
satura	70 to 100%: ±2% (adult/pediatric mode);
tion	70 to 100%: ±3% (neonate mode);
(SpO2	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).

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	70 to 100%: ±3% (measured without motion inneonate mode);70 to 100%: ±3% (measured with motion);1% to 69%: Not specified.Nellcor SpO2 functionMeasurement range: 0 to 100%;Accuracy:70 to 100%: ±2% (adult/pediatric);70 to 100%: ±3% (neonate);0% to 69%: Not specified.Note: The specifictions of the various SpO2functions provided by each manufacturer are thesame across platforms.
		PR from built-inMindray SpO2ModuleMeasurementrange:20 to 254 bpm;Accuracy: ±3 bpm.
	PR from built-inMindray SpO2 ModuleMeasurement range: 20to 254 bpm;Accuracy: ±3 bpm.	PR from built-inMasimo SpO2ModuleMeasurementrange:25 to 240 bpm;Accuracy: ±3 bpm(measuredwithoutmotion);±5 bpm(measured withmotion).	Same	Same
Pulserate(PR)	PR from built-in NellcorSpO2 ModuleMeasurement range: 20to 300 bpm;Accuracy:20 to 250 bpm: ±3 bpm;251 to 300 bpm, notspecified.	PR from built-inNellcor SpO2ModuleMeasurementrange:20 to 300 bpm;Accuracy:20 to 250 bpm:±3 bpm;251 to 300 bpm,not specified.PR fromexternal IBPModuleMeasurement

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	range:25 to 350 bpm;Accuracy:$\pm$ 1 bpm or $\pm$ 1%,whichever isgreater.
Non-invasivebloodpressure(NIBP)	Measurement range:	Adult	Pediatric	Neonate	Same
	Systolic	25-290	25-240	25-140
	Diastolic	10-250	10-200	10-115
	Mean	15-260	15-215	15-125
	Accuracy:
	Max mean error: $\pm$ 5 mmHg;
	Max standard deviation: 8 mmHg.
Invasivebloodpressure(IBP)	Uses an internal IBP moduleto measure invasive bloodpressure. The monitor canmonitor up to 8 invasiveblood pressures and displayssystolic, diastolic and meanpressures and a waveformfor each pressure. SupportPPV function. Measurementrange: -50 to 300 mmHg;Accuracy: $\pm$ 2% or $\pm$ 1mmHg, whichever is greater(without sensor).			Uses an internal IBP module or stand-alone IBPModule to measure invasive bloodpressure. Themonitor canmonitor up to 8invasive bloodpressures anddisplays systolic,diastolic and meanpressures and awaveform for eachpressure. SupportPPV function.Measurementrange: -50 to 300mmHg;Accuracy: $\pm$ 2% or$\pm$ 1mmHg,whichever is greater(without sensor).		Same
Cardiacoutput	Use internal C.O. module.The cardiac output (C.O.)measurement invasively		Use internal orexternal C.O.module.	Same	Same

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(C.O.)	measures	The cardiac output(C.O.)measurement
	cardiac output and otherhemodynamic parametersusing the right heart (atria)thermodilution method. Thetemperature change isdisplayed as a curve in theC.O. split screen, and themonitor calculates theC.O. value from this curve.The monitor is capable ofstoring 6 measurements.Measurement range: C.O:0.1 to 20 L/min; TB: 23 to43 °C;TI: 0 to 27 °C;Accuracy:C.O: ±5% or ±0.1 L /min,whichever is greater;TB, TI: ±0.1 °C (withoutsensor).	invasivelymeasurescardiac output andother hemodynamicparameters usingthe right heart(atria)thermodilutionmethod. Thetemperature changeis displayed as acurve in the C.O.split screen, and themonitor calculatestheC.O. value fromthis curve. Themonitor is capableof storing 6measurements.Measurementrange: C.O: 0.1 to20 L/min; TB: 23 to43 °C;TI: 0 to 27 °C;Accuracy:C.O: ±5% or ±0.1 L/min, whichever isgreater;TB, TI: ±0.1 °C(without sensor).
Carbondioxide(CO2)	Compatible with 3 internalCO2 modules:Sidestream CO2 2.0 moduleMainstream CO2ModuleMicroStream CO2module	Compatible with 4internal or externalCO2 modules:Sidestream CO21.0 ModuleSidestream CO22.0 moduleMainstream CO2	Same	Same

ePM Series Patient Monitors

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	moduleMicroStream CO2module*10M does notsupport externalCO2 modules
Type: Sidestream CO2 Module (CO2 2.0):Measurement range: 0~~150mmHgAccuracy: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 modeAwRR measurement:awRR measurement range: 0 to 150rpm;awRR:<60rpm, ±1rpm,60~~150rpm, ±2rpm.		Same
Type: Microstream CO2 ModuleMeasurement range:CO2: 0~~99mmHg;awRR: 0~~150rpm;Accuracy:CO2:0~~38mmHg: ±2mmHg;39~~99mmHg: ±5% of the reading+0.08% of (the reading-38).awRR:0~~70rpm: ±1rpm,71~~120rpm: ±2rpm,121~150rpm: ±3rpm		Same
Type: Mainstream CO2Module 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		Same

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101~150mmHg: ±10% of the reading;
awRR: ±1rpm.
Oxygen(02)	Not support	Oxygen values aremeasured by theSidestream CO2 2.0or the AG moduleusingaparamagneticmethod.Measurementrange: 0~~100%(CO2 and AG),Accuracy:0~~25%, ±1%;26~~80%,±2%;81~~100%, ±3%(CO2 and AG).	Same	Same
Anestheticgas(AG)	Not support	The AG moduleanalyzes gassamples from thepatient andcalculates CO2, O2,N2O, and AAwaveforms andrelated numericsthat include airwayrespiratory rate andMAC (minimumalveolarconcentration).Measurementrange:CO2, HAL, ENF,ISO, SEV, DES:0~~30 %;O2, N2O: 0~~100 %;awRR: 2~100 rpm.Accuracy:	Same	Same

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	mode:
	CO2:0%≤CO2≤1%
	, ±0.1%ABS, 1%<
	CO2<5%, = =0.2%
	ABS, ABS, ABS, ABS,5%<
	CO2≤7%,
	±0.3% ABS, 7%<
	CO2<10%, ±0.5%
	ABS, 10%< CO2
	not specified;
	N2O: 0〜20%REL:
	±2% ABS,
	20~100%REL:
	±3% ABS;
	02 0~25%, ±1%;
	26~80%, ±2%;
	81~100%, ±3%;
	HAL, ENF, ISO:
	0~1%REL: ±0.15%
	ABS, 1~5%REL:
	±0.2%
	ABS, >5%REL, not
	specified;
	SEV: 0~1%REL:
	=0.15%ABS,
	1~5%REL:
	#0.2% = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =ABS,
	5~8%REL: ±0.4%
	ABS, >8%REL, not
	specified;
	DES: 0~1%REL:
	40.15%ABS,
	1~5%REL: =0.2%
	ABS, 5~10%REL:
	ABS,±0.4% ========================================================================================================================================================================
	10~15%REL:
	=0.6%
	ABS ,15~18%REL:
	±1%
	ABS ,>18%REL,
	not specified;
	awRR:2~60rpm,

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	±1rpm, >60rpm, not specified.
Wirelessfunction	The Wireless radio module (Laird) is used forconnecting to a wireless monitoring network with acentral monitoring system (CMS).	Same
ECG24hSummary	Provides the function to statistical results of heartrate changes and cardiac arrhythmia of patientswithin 24 hours, including HR statistics, ARRstatistics, ST statistics, QT/QTc statistics and Pacestatistics.	Same
EWS	The EWS is a set of early warning scores that areintended to assist clinicians in recognizing the earlysigns of deterioration in patients based on vitalsigns and clinical observations. The three types ofEWS provided are Modified Early Warning Score(MEWS), National Early Warning Score (NEWSand NEWS2) and user configurable Custom Score.	Same
GlasgOWComaScale(GCS)	The GCS a well-established scoring system used toassess the state of consciousness based three sub-components: eye-opening response, verbalresponse, and limb movement.	Same

Substantial Equivalence Conclusion

In conclusion, the differences in technological characteristics do not raise new questions of safety and effectiveness.

8. PERFORMANCE DATA

To establish the substantial equivalence of the ePM Series 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

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The ePM Series 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 Premarket Submissions for Software Contained in Medical Devices." Verification of the ePM Series 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

There have been no changes to the hardware and mechanical construction of the ePM Series Monitors since their previous clearance. Therefore additional Electromagnetic Compatibility and Electrical Safety testing is not required to demonstrate substantial equivalence.

Bench Testing

To establish the substantial equivalence of the ePM Series 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.

IEC 60601-2-27:2011 Medical electrical equipment--Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
. AAMI / ANSI EC57:2012 Testing and reporting performance results of cardiac rhythm and st-segment measurement algorithms

9. CONCLUSION

Based on the detailed comparison between the predicate devices and the subject devices, the performance testing and conformance with applicable standards, the ePM Series Patient Monitors can be found substantially equivalent to the predicate devices.

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.