Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

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

Therapeutic

No
The device is described as a patient monitor intended for monitoring, displaying, reviewing, storing, alarming, and transferring of physiological parameters, which are diagnostic functions, not therapeutic ones.

Diagnostic

Yes
The device is intended for "monitoring, displaying, reviewing, storing, alarming, and transferring of multiple physiological parameters" and "also provides an interpretation of resting 12-lead ECG," which are functions consistent with diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the ePM Series Patient Monitors are a new generation monitoring product family with ergonomic and flexible design in a platform of both software and hardware. This indicates the device includes physical hardware components in addition to software.

IVD (In Vitro Diagnostic)

Based on the provided information, 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. They are used to diagnose, monitor, or screen for various health issues.
Device Function: The ePM Series Patient Monitors are described as devices 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 probes attached to the patient.
No Sample Analysis: There is no mention of the device analyzing samples taken from the patient. The measurements are taken on the patient.

Therefore, the ePM Series Patient Monitors fall under the category of patient monitoring devices, not 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. 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.

Product codes (comma separated list FDA assigned to the subject device)

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

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.

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, with specific parameters limited to adult and pediatric (arrhythmia detection, PAWP monitoring) or adult only (C.O. monitoring).

Intended User / Care Setting

Healthcare facilities by clinical professionals or under their guidance. Only to be used by persons who have received adequate training in their use. 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)

Mindray conducted functional and system level testing to validate the performance of the devices. The testing provided an evaluation of the performance of the device relevant to each of the differences between the subject device and the predicate device. The results of the functional and system level testing show that the subject device meets its specifications and is substantially equivalent to the predicate device.
Mindray has conducted testing to ensure the subject devices meet relevant consensus standards.
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 testing was performed.
Bench testing was performed to validate accuracy specifications and substantial equivalence.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K182075

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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 is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

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,

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

2

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)

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

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3

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: | October 23, 2019 | | | | |
| 2.
DEVICE | | | | | |
| Device Trade Name: | ePM Series Patient Monitors (Including ePM 10, ePM
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
alarm (including ST-segment measurement and alarm) | | | | |
| Regulatory Class: | Class II | | | | |
| Panel: | Cardiovascular | | | | |
| Primary Product Code: | MHX - Monitor, Physiological, Patient (with
arrhythmia detection or alarms) | | | | |

4

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

5

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.

6

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
15	ePM
12	ePM
10	ePM
15M	ePM
12M	ePM
10M
Display and
touchscreen	12.1" 1280*800 pixels.	15.6"
1366*
768
pixels.	12.1"
1280*
800
pixels	10.1"
1280*
800
pixels.	15.6"
1366*
768
pixels	12.1''
1280*
800
pixels.	10.1"
1280*
800
pixels
Secondary
display	Mirrored display.	Mirrored display.
Wireless	2.4GHz/5GHz dual band module.	2.4GHz/5GHz dual band module.
Power
supply	Battery or AC power.	Battery or AC power
Battery	Rechargeable Lithium-Ion, 11.1 VDC,
4500 mAh.	Rechargeable Lithium-Ion, 10.8VDC, 5600 mAh.
Rechargeable Lithium-Ion, 10.95 VDC, 4500 mAh.
Rechargeable Lithium-Ion, 10.95 VDC, 2600 mA
Data storage	Embedded Multi Media Card
(eMMC).	Same
Data
Recorder	Supports internal thermal recorder.	Same
Device
integration	Use Benelink Module to integrate 3rd
party devices. Allow parameter values
and alarms from 3rd party devices to
be displayed, stored and printed.	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.
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.
Supports Alarm Volume Escalation	Same

Table 2: Device Comparison Table

7

	Predicate Devices (K182075)	Subject ePM Devices
Feature	N12	ePM
15	ePM
12	ePM
10	ePM
15M	ePM
12M	ePM
10M
ECG	Use ECG module of MPM3.0
3-lead, 5-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 pediatric.

Supports intelligent arrhythmia alarm.

ST segment analysis is intended for
adult, pediatric and neonate. | 3-lead, 5-lead, 6-lead or 12-lead selectable, arrhythmia
detection, ST segment analysis, QT analysis, an
interpretation of resting 12-lead ECG, J-point Auto
detection, Dual Channel Pace detection, adjustable
QRS threshold and heart rate (HR).

Arrhythmia detection is intended for adult, pediatric.

Supports intelligent arrhythmia alarm.

ST segment analysis is intended for adult, pediatric
and neonate. | | | | | | |
| Arrhythmia
Analysis | Asystole, VFib/Vtac, Vtac,
Vent.Brady, Extreme Tachy, Extreme
Brady, PVCs, Couplet, Bigeminy,
Trigeminy, R on T, Run PVCs,
PVCs/min, Tachy, Brady, Missed
Beats, Vent Rhythm, Pacer Not
Pacing, Pacer Not Capture,
Multif.PVC, Nonsus.Vtac, Pause,
Vent.Rhythm, Afib, Pauses/min,
Pauses/min; | Same | | | | | | |
| Respiration
rate (Resp) | Use Respiration module of MPM 3.0
Measurement range: Adult: 0 to 120
rpm; Pediatric, neonate: 0 to 150 rpm.
Accuracy: 7 to 150 rpm: ±2 rpm or
±2%, whichever is greater;
0 to 6 rpm: Not specified. | Measurement specifications are the same.
The measurement module has minor circuit board
layout differences. | | | | | | |
| Temperatur
e (Temp) | Use temperature module of MPM 3.0
Measurement range: 0 to 50°C (32 to
122°F)
Accuracy: ±0.1°C or ±0.2ºF (without
probe). | Measurement specifications are same.
The measurement module has minor circuit board
layout differences. | | | | | | |
| | Predicate Devices (K182075) | Subject ePM Devices | | | | | | |
| Feature | N12 | ePM
15 | ePM
12 | ePM
10 | ePM
15M | ePM
12M | ePM
10M | |
| Pulse oxygen saturation (SpO2) | Supports Mindray SpO2 function, Masimo SpO2 function and Nellcor SpO2 function from MPM 3.0 module.

Mindray SpO2 function
Measurement range: 0 to 100%;
Accuracy:70 to 100%: ±2% (adult/pediatric mode);
70 to 100%: ±3% (neonate mode);
0% to 69%: Not specified.

Masimo SpO2 function
Measurement range: 1 to 100%;
Accuracy:70 to 100%: ±2% (measured without motion in adult/pediatric mode);
70 to 100%: ±3% (measured without motion in neonate mode);
70 to 100%: ±3% (measured with motion);
1% to 69%: Not specified.

Nellcor SpO2 function
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. | Supports Mindray SpO2 function, Masimo SpO2 function and Nellcor SpO2 function from multi parameter module.

The specifications for various SpO2 functions are the same.

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.

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
15 | ePM
12 | ePM
10 | ePM
15M | ePM
12M | ePM
10M | |
| Pulse rate
(PR) | PR from Mindray SpO2 Module
Measurement range: 20 to 254 bpm;
Accuracy: ±3 bpm.
PR from Masimo SpO2 Module
Measurement range: 25 to 240 bpm;
Accuracy: ±3 bpm (measured without
motion);
±5 bpm (measured with motion).
PR from Nellcor SpO2 Module
Measurement range: 20 to 300 bpm;
Accuracy:20 to 250 bpm: ±3 bpm;
251 to 300 bpm, not specified.
PR from IBP Module
Measurement range: 25 to 350 bpm;
Accuracy: ±1 bpm or ±1%, whichever
is greater. | PR from built-in Mindray
SpO2 Module
Measurement range: 20 to
254 bpm;
Accuracy: ±3 bpm.
PR from built-in Masimo
SpO2 Module
Measurement range: 25 to
240 bpm;
Accuracy: ±3 bpm
(measured without
motion);
±5 bpm (measured with
motion).
PR from built-in Nellcor
SpO2 Module
Measurement range: 20 to
300 bpm;
Accuracy:20 to 250 bpm:
±3 bpm;
251 to 300 bpm, not
specified.
Same | PR from built-in Mindray
SpO2 Module
Measurement range: 20 to
254 bpm;
Accuracy: ±3 bpm.
PR from built-in Masimo
SpO2 Module
Measurement range: 25 to
240 bpm;
Accuracy: ±3 bpm
(measured without
motion);
±5 bpm (measured with
motion).
PR from built-in Nellcor
SpO2 Module
Measurement range: 20 to
300 bpm;
Accuracy:20 to 250 bpm:
±3 bpm;
251 to 300 bpm, not
specified. | | PR from built-in Mindray
SpO2 Module
Measurement range: 20 to
254 bpm;
Accuracy: ±3 bpm.
PR from built-in Masimo
SpO2 Module
Measurement range: 25 to
240 bpm;
Accuracy: ±3 bpm
(measured without
motion);
±5 bpm (measured with
motion).
PR from built-in Nellcor
SpO2 Module
Measurement range: 20 to
300 bpm;
Accuracy:20 to 250 bpm:
±3 bpm;
251 to 300 bpm, not
specified.
PR from external IBP
Module
Measurement range: 25 to
350 bpm;
Accuracy: ±1 bpm or
±1%, whichever is
greater.
Same | PR from built-in Mindray
SpO2 Module
Measurement range: 20 to
254 bpm;
Accuracy: ±3 bpm.
PR from built-in Masimo
SpO2 Module
Measurement range: 25 to
240 bpm;
Accuracy: ±3 bpm
(measured without
motion);
±5 bpm (measured with
motion).
PR from built-in Nellcor
SpO2 Module
Measurement range: 20 to
300 bpm;
Accuracy:20 to 250 bpm:
±3 bpm;
251 to 300 bpm, not
specified.
PR from external IBP
Module
Measurement range: 25 to
350 bpm;
Accuracy: ±1 bpm or
±1%, whichever is
greater.
Same | PR from built-in Mindray
SpO2 Module
Measurement range: 20 to
254 bpm;
Accuracy: ±3 bpm.
PR from built-in Masimo
SpO2 Module
Measurement range: 25 to
240 bpm;
Accuracy: ±3 bpm
(measured without
motion);
±5 bpm (measured with
motion).
PR from built-in Nellcor
SpO2 Module
Measurement range: 20 to
300 bpm;
Accuracy:20 to 250 bpm:
±3 bpm;
251 to 300 bpm, not
specified.
PR from external IBP
Module
Measurement range: 25 to
350 bpm;
Accuracy: ±1 bpm or
±1%, whichever is
greater.
Same | |
| Non-
invasive
blood
pressure
(NIBP) | | Measurement specifications are the same. | | | | | | |
| | | Measurement range: | Adult | Pedi
atric | Neon
ate | The measurement module has minor differences
related to the circuit board layout and over
pressure protection channel. | | |
| | | 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: ±5 mmHg; | | | | | | |
| | | Max standard deviation: 8 mmHg. | | | | | | |
| | Predicate Devices (K182075) | | Subject ePM Devices | | | | | |
| Feature | N12 | | ePM
15 | ePM
12 | ePM
10 | ePM
15M | ePM
12M | ePM
10M |
| Invasive
blood
pressure
(IBP) | Uses the MPM3.0 or the external 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: ±2% or ±1 mmHg,
whichever is greater (without sensor). | | Uses an internal IBP
module
The circuit board layout
has minor differences
compared to the
predicate.
Measurement
specifications are the
same | | | Uses an internal IBP
module or stand-alone
IBP Module
The circuit board layout
of the internal IBP
module has minor
differences compared to
the predicate.
The stand-alone IBP
module is identical with
the predicate device's
Measurement
specifications are the
same. | | |
| Cardiac
output
(C.O.) | Use external C.O. module
The cardiac output (C.O.)
measurement invasively measures
cardiac output and other
hemodynamic parameters using the
right heart (atria) thermodilution
method. The temperature change 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). | | Use internal C.O. module
Internal C.O. module is
identical to the external
C.O. module in K182075 | | Use internal or external
C.O. module
The built-in C.O. module
is identical with the
external C.O. module in
K182075.
The only difference
between the subject
external C.O. module and
the external C.O. module
in K182075 is that the
subject module includes a
pogo pin interface | | | |
| | Predicate Devices (K182075) | Subject ePM Devices | | | | | | |
| Feature | N12 | ePM
15 | ePM
12 | ePM
10 | ePM
15M | ePM
12M | ePM
10M | |
| Carbon
dioxide
(CO2) | Compatible with the following 4
modules to measure carbon dioxide:
• Sidestream CO2 1.0 module
• Sidestream CO2 2.0 module
• Mainstream CO2 module
• MicroStream CO2 module | Compatible with 3
internal CO2 modules:
• Sidestream CO2 2.0
module
• Mainstream CO2
module
• MicroStream CO2
module

The internal CO2 modules
are identical to the
external CO2 module in
K182075 | | | Compatible with 4
internal or external CO2
modules:
• Sidestream CO2 1.0
module
• Sidestream CO2 2.0
module
• Mainstream CO2
module
• MicroStream CO2
module

*10M does not support
external CO2 modules

The subject internal CO2
modules are identical
with predicate external
CO2.

The only difference
between the subject
external CO2 modules
and the predicate external
CO2 modules that the
subject modules include
a pogo pin interface | | | |
| | 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: ±0.15% ABS,
15%REL: ±0.2% ABS, 510%REL:
±0.4% ABS, 1015%REL: ±0.6%
ABS ,1518%REL: ±1% ABS ,>18%REL,
not specified;
awRR:260rpm, ±1rpm, >60rpm, not
specified.

This measurement can be used for
adults, pediatrics and neonates. | Not support | | | Measurement
specifications are the
same.

The only difference
between the subject AG
module the predicate AG
module is that the subject
module includes a pogo
pin interface | | | |
| Wireless
function | The Wireless radio module (Laird) is
used for connecting to a wireless
monitoring network with a central
monitoring system (CMS). | same | | | | | | |
| | Predicate Devices (K182075) | Subject ePM Devices | | | | | | |
| Feature | N12 | ePM
15 | ePM
12 | ePM
10 | ePM
15M | ePM
12M | ePM
10M | |
| ECG 24h
Summary | 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 user
configurable Custom Score. | MEWS and NEWS are same.
Added NEWS 2.0.
Custom Score added NIBP-D and NIBP-M options.
Updated the user interface. | | | | | | |
| Glasgow
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 | | | | | | |

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9

10

11

12

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

7. PERFORMANCE DATA

To establish the substantial equivalence of the ePM Series Patient Monitors, Mindray conducted functional and system level testing to validate the performance of the devices. The testing provided an evaluation of the performance of the device relevant to each of the differences between the subject device and the predicate device. The results of the functional and system level 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.

Mindray complies with the FDA Special Controls Document relevant to this device "Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm Guidance for Industry and FDA (10/28/2003)".

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Biocompatibility Testing

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

The ePM Series Patient Monitors were assessed for conformity with the relevant requirements of the following standards and found to comply:

ANSI/AAMI ES 60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R) ● 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-2:2014 (Fourth Edition) Medical electrical equipment Part 1-2: General ● requirements for basic safety and essential performance - Collateral Standard: electromagnetic disturbances - Requirements and tests.
UL 62133:2017 (Second Edition) Secondary cell and batteries containing alkaline or other ● non-acid electrolytes

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 60601-1-6: 2013 Medical electrical equipment-part 1-6: general requirements for basic safety and essential performance- collateral standard: usability
IEC 60601-1-8: 2012 Medical electrical equipment - part 1-8: general requirements for basic safety and essential performance - collateral standard: general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
IEC 60601-2-25:2011 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs

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IEC 60601-2-27:2011 Medical electrical equipment--Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
IEC 80601-2-30:2018 Medical electrical equipment - part 2-30: particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
IEC 60601-2-34:2011 Medical electrical equipment - part 2-34: particular requirements for the basic safety, including essential performance, of invasive blood pressure monitoring equipment
IEC 80601-2-49:2018 Medical electrical equipment -Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
ISO 80601-2-55: 2018 Medical electrical equipment - part 2-55: particular requirements for the basic safety and essential performance of respiratory gas monitors
ISO 80601-2-56: 2017 Medical electrical equipment - part 2-56: particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
ISO 80601-2-61: 2017 Medical electrical equipment - part 2-61: particular requirements for basic safety and essential performance of pulse oximeter equipment
IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
AAMI / ANSI EC57:2012 Testing and reporting performance results of cardiac rhythm and stsegment measurement algorithms

8. CONCLUSION

Based on the detailed comparison of specifications for each of the modifications to the previously cleared BeneVision N Series Patient Monitors (K182075), the performance testing and conformance with applicable standards, the ePM Series Patient Monitors (including ePM 10, ePM, 12, ePM 15, ePM 10M, ePM 12M, ePM 15M) can be found substantially equivalent to the predicate device.