Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related terms, and the description focuses on standard physiological monitoring parameters and functions.

Therapeutic

No.
The device's intended use is for monitoring, displaying, reviewing, storing, alarming, and transferring of multiple physiological parameters; it does not mention any therapeutic intervention or treatment.

Diagnostic

Yes

The device is intended for "monitoring, displaying, reviewing, storing, alarming, and transferring of multiple physiological parameters" and "provides an interpretation of resting 12-lead ECG", which are activities performed to assess a patient's health status, classifying it as a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the ePM Series Patient Monitors are a "platform of both software and hardware." The intended use also describes monitoring multiple physiological parameters, which inherently requires hardware sensors and components to acquire the data.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The description clearly states that the ePM Series Patient Monitors are intended for monitoring, displaying, reviewing, storing, alarming, and transferring of multiple physiological parameters. These parameters (ECG, Respiration Rate, Temperature, SpO2, NIBP, IBP, etc.) are measured directly from the patient's body using sensors and electrodes, not from samples taken from the body.
No Mention of Samples: The text does not mention the collection or analysis of any biological samples.

Therefore, the device falls under the category of patient monitoring equipment, which is distinct from in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

MHX, DSI, MLD, DRT, DXN, DSK, FLL, DQA, DPZ, CCK, DXG, DSJ, CBQ, CBS, CBR, CCL

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Adult, pediatric, and neonatal patients. PAWP monitoring is for adult and pediatric patients only. C.O. monitoring is for adult patients only. Arrhythmia detection is intended for adult, pediatric and neonate. ST segment analysis is intended for adult, pediatric and neonate.

Intended User / Care Setting

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.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench Testing: 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.
Testing to ensure the subject devices meet relevant consensus standards: IEC 60601-2-27:2011 and AAMI / ANSI EC57:2012.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K191769

Reference Device(s)

K103142

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" below. The logo is simple and professional, reflecting the FDA's role in regulating food and drugs.

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

1

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

2

Indications for Use

510(k) Number (if known) K200015

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 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)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

510(K) SUMMARY

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the ePM Series 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: | Contact Person: Yanhong Bai
Title: Manager Regulatory Affairs
Phone: +86 755 81885635
Fax: +86 755 26582680
E-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 and
alarm (including ST-segment measurement and alarm) |
| Regulatory Class: | Class II |
| Panel: | Cardiovascular |

4

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

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

| Regulation
Number/Class | Product
Code | Regulation description |----------------------------|---- | 870.1025, II | DSI (including ST-segment measurement
and alarm) | Detector and alarm,
arrhythmia | 870.1025, II | MLD (including ST-segment measurement
and alarm) | Monitor, st alarm | 870.2300, II | DRT cardiotachometer and rate alarm) cardiotachometer & rate
alarm) |
| 870.1130, II | DXN measurement system blood-pressure, non-invasive | 870.1110, II | DSK | 880.2910, II | FLL clinical | 870.2700, II | DQA | 870.2710, II | DPZ | 868.1400, II | CCK carbon-dioxide,
gaseous-phase | 870.1435, II | DXG diagnostic computer pre-programmed,
single-function |
| 870.1100, II | DSJ | 868.1500, II | CBQ gaseous-phase (anesthetic
concentration) |
| 868.1620, II | CBS gaseous-phase (anesthetic
conc.) |
| 868.1700, II | CBR gaseous phase (anesthetic
conc.) |
| 868.1720, II | CCL gaseous-phase | Device Common Name |
-------------|----------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Arrhythmia detector and alarm
|
| Arrhythmia detector and alarm
segment with
|
| Cardiac Monitor (including
| Monitor, cardiac (incl.
| Noninvasive blood pressure
| System, measurement,
|
| Blood pressure computer | Computer, blood-pressure |
| Clinical electronic thermometer | Thermometer, electronic,
|
| Oximeter | Oximeter |
| Ear oximeter | Oximeter, ear |
| Carbon dioxide gas analyzer | Analyzer, gas,
|
| Single-function, preprogrammed
| Computer, diagnostic,
| Blood pressure alarm | Alarm, blood-pressure |
| Enflurane gas analyzer | Analyzer, gas, enflurane,
| Halothane gas analyzer | Analyzer, gas, halothane,
| Nitrous oxide gas analyzer | Analyzer, gas, nitrous-oxide,
| Oxygen gas analyzer | Analyzer, gas, oxygen,
|

5

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 ●

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.

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

6

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)
Featu
re	ePM 15	ePM
12	eP
M
10	eP
M
15
M	eP
M
12
M	eP
M
1
0
M	eP
M
15	eP
M
12	ePM
10	eP
M
15
M	eP
M
12
M	e
P
M
1
0
M
Displa
y and
touchs
creen	15.6”
1366*768
pixels	12.1”
1280*8
00pixels	10.1”
1280*8
00pixels	15.6”
1366*768
pixels	12.1”
1280*8
00pixels	10.1”
1280*8
00pixels	15.6”
1366*768
pixels	12.1”
1280*8
00pixels	10.1”
1280*8
00pixels	15.6”
1366*768
pixels	12.1”
1280*8
00pixels	10.1”
1280*8
00pixels
Secon	Mirrored display		Same

Table 2:	Device Comparison Table
dary
display
Wireless	2.4GHz/5GHz dual band module	Same
Power
supply	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
Data
storage	Embedded Multi Media Card(eMMC)	Same
Data
Recorder	Supports internal thermal recorder	Same
Device
integration	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
Alarm
system	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).

7

8

9

| | 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
Measurement 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 SpO2
functions provided by each manufacturer are the
same across platforms. | | | |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|------|
| | | PR from built-in
Mindray SpO2
Module
Measurement
range:
20 to 254 bpm;
Accuracy: ±3 bpm. | | |
| | 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). | Same | Same |
| Pulse
rate
(PR) | 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
Nellcor SpO2
Module
Measurement
range:
20 to 300 bpm;
Accuracy:
20 to 250 bpm:
±3 bpm;
251 to 300 bpm,
not specified.

PR from
external IBP
Module
Measurement | | |

10

| | range:
25 to 350 bpm;
Accuracy:
$\pm$ 1 bpm or $\pm$ 1%,
whichever is
greater. | | | | | |
|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|------|
| Non-
invasi
ve
blood
pressu
re
(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. | | | | | |
| Invasi
ve
blood
pressu
re
(IBP) | Uses an internal IBP module
to measure invasive blood
pressure. The monitor can
monitor up to 8 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: $\pm$ 2% or $\pm$ 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 up to 8
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: $\pm$ 2% or
$\pm$ 1
mmHg,
whichever is greater
(without sensor). | | Same |
| Cardi
ac
output | Use internal C.O. module.
The cardiac output (C.O.)
measurement invasively | | Use internal or
external C.O.
module. | Same | Same | |

11

| (C.O.) | measures | The cardiac output
(C.O.)
measurement | | |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|------|
| | cardiac output and other
hemodynamic parameters
using the right heart (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). | invasively
measures
cardiac output and
other hemodynamic
parameters using
the right heart
(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(CO2) | 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 | Same | Same |

ePM Series Patient Monitors

12

| | module
MicroStream CO2
module
*10M does not
support external
CO2 modules | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|------|
| Type: Sidestream CO2 Module (CO2 2.0):
Measurement range: 0150mmHg
Accuracy:
040 mmHg: ±2mmHg,
4176 mmHg: ±5% of reading,
7799 mmHg: ±10% of reading,
100150mmHg: ±(3mmHg + 8% of reading),
ISO accuracy mode:
Add ±2mmHg to the full accuracy mode
AwRR measurement:
awRR measurement range: 0 to 150rpm;
awRR:
5%REL, not | |
| | specified; | |
| | SEV: 01%REL: | |
| | =0.15%
ABS, | |
| | 15%REL: | |
| | #0.2% = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
ABS, | |
| | 58%REL: ±0.4% | |
| | ABS, >8%REL, not | |
| | specified; | |
| | DES: 01%REL: | |
| | 40.15%
ABS, | |
| | 15%REL: =0.2% | |
| | ABS, 510%REL: | |
| | ABS,
±0.4% ======================================================================================================================================================================== | |
| | 1015%REL: | |
| | =0.6% | |
| | ABS ,1518%REL: | |
| | ±1% | |
| | ABS ,>18%REL, | |
| | not specified; | |
| | awRR:260rpm, | |

15

	±1rpm, >60rpm, not specified.
Wirel
ess
functi
on	The Wireless radio module (Laird) is used for
connecting to a wireless monitoring network with a
central monitoring system (CMS).	Same
ECG
24h
Summ
ary	Provides the function to statistical results of heart
rate changes and cardiac arrhythmia of patients
within 24 hours, including HR statistics, ARR
statistics, ST statistics, QT/QTc statistics and Pace
statistics.	Same
EWS	The EWS is a set of early warning scores that are
intended to assist clinicians in recognizing the early
signs of deterioration in patients based on vital
signs and clinical observations. The three types of
EWS provided are Modified Early Warning Score
(MEWS), National Early Warning Score (NEWS
and NEWS2) and user configurable Custom Score.	Same
Glasg
OW
Coma
Scale
(GCS)	The GCS a well-established scoring system used to
assess the state of consciousness based three sub-
components: eye-opening response, verbal
response, 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

16

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.