(122 days)
The ePM 10/ePM 12/ePM 15/ePM 10M/ePM 12M/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.
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.
The provided text describes a 510(k) premarket notification for the ePM Series Patient Monitors, arguing their substantial equivalence to a predicate device (BeneVision N Series Patient Monitors). The document outlines various performance characteristics and how they compare to the predicate, along with general statements about testing performed.
There is no specific study detailed that "proves the device meets the acceptance criteria" in terms of clinical performance or a comparative effectiveness study with human readers. The document primarily focuses on demonstrating that the new device's technological characteristics and performance specifications are equivalent to the predicate device. The information details bench testing and compliance with consensus standards to show that the device meets its accuracy specifications and does not raise new questions of safety and effectiveness.
Therefore, the requested information elements related to a specific study, such as sample size, expert adjudication, MRMC studies, or standalone algorithm performance, cannot be extracted from this document as such a study is not described. The document discusses performance specifications and claims that bench testing validates these specifications and shows substantial equivalence.
Here's what can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the predicate device's specifications and compliance with relevant standards. The reported device performance is presented as being "the same" or having "minor circuit board layout differences" but maintaining the same specifications as the predicate. The document doesn't provide a direct table of acceptance criteria with reported performance, but rather a comparison table of features and specifications between the subject device and the predicate.
Below is a summary derived from the "Technological Comparison" table (Table 2) and subsequent explanatory text, focusing on the measurement parameters where performance specifications are explicitly mentioned or affirmed as "same":
| Feature | Predicate Devices (K182075) Performance/Specifications (Acceptance Criteria) | Subject ePM Devices Reported Performance/Specifications |
|---|---|---|
| ECG | 3-, 5-, 12-lead selectable, arrhythmia detection, ST segment analysis, QT analysis, interpretation of resting 12-lead ECG, J-point Auto detection, Dual Channel Pace detection, adjustable QRS threshold, HR. Arrhythmia for adult/pediatric, ST for adult/pediatric/neonate, intelligent arrhythmia alarm. | Same as predicate, with 6-lead option added. |
| 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. | Same as predicate. |
| Respiration Rate (Resp) | Range: Adult: 0-120 rpm; Pediatric, neonate: 0-150 rpm. Accuracy: 7-150 rpm: ±2 rpm or ±2% (greater); 0-6 rpm: Not specified. | Measurement specifications are the same. Minor circuit board layout differences. |
| Temperature (Temp) | Range: 0-50°C (32-122°F). Accuracy: ±0.1°C or ±0.2ºF (without probe). | Measurement specifications are the same. Minor circuit board layout differences. |
| Pulse Oxygen Saturation (SpO2) (Mindray) | Range: 0-100%. Accuracy: 70-100%: ±2% (adult/pediatric); 70-100%: ±3% (neonate); 0-69%: Not specified. | Same specifications. Minor circuit board layout differences in internal module. |
| Pulse Oxygen Saturation (SpO2) (Masimo) | Range: 1-100%. Accuracy: 70-100%: ±2% (without motion in adult/pediatric); 70-100%: ±3% (without motion in neonate); 70-100%: ±3% (with motion); 1-69%: Not specified. | Same specifications. Internal module identical to predicate's. |
| Pulse Oxygen Saturation (SpO2) (Nellcor) | Range: 0-100%. Accuracy: 70-100%: ±2% (adult/pediatric); 70-100%: ±3% (neonate); 0-69%: Not specified. | Same specifications. Internal module identical to predicate's. |
| Pulse Rate (PR) (from Mindray SpO2) | Range: 20-254 bpm. Accuracy: ±3 bpm. | Same as predicate. |
| Pulse Rate (PR) (from Masimo SpO2) | Range: 25-240 bpm. Accuracy: ±3 bpm (without motion); ±5 bpm (with motion). | Same as predicate. |
| Pulse Rate (PR) (from Nellcor SpO2) | Range: 20-300 bpm. Accuracy: 20-250 bpm: ±3 bpm; 251-300 bpm: Not specified. | Same as predicate. |
| Non-invasive Blood Pressure (NIBP) | Range: Systolic adult 25-290, pedi 25-240, neon 25-140; Diastolic adult 10-250, pedi 10-200, neon 10-115; Mean adult 15-260, pedi 15-215, neon 15-125. Accuracy: Max mean error: ±5 mmHg; Max standard deviation: 8 mmHg. | Measurement specifications are the same. Minor circuit board layout and overpressure protection channel differences. |
| Invasive Blood Pressure (IBP) | Range: -50 to 300 mmHg. Accuracy: ±2% or ±1 mmHg (greater, without sensor). | Measurement specifications are the same. Minor circuit board layout differences. |
| Cardiac Output (C.O.) | 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 (greater); TB, TI: ±0.1°C (without sensor). | Internal C.O. module is identical to external C.O. module in predicate. |
| Carbon Dioxide (CO2) (Sidestream 2.0) | Range: 0-150 mmHg. Accuracy: 0-40 mmHg: ±2mmHg; 41-76 mmHg: ±5% of reading; 77-99 mmHg: ±10% of reading; 100-150mmHg: ±(3mmHg + 8% of reading). awRR Range: 0-150 rpm. awRR Acc: <60rpm, ±1rpm; 60-150rpm, ±2rpm. | Same as predicate. |
| Carbon Dioxide (CO2) (Microstream) | Range CO2: 0-99 mmHg; awRR: 0-150 rpm. Accuracy CO2: 0-38mmHg: ±2mmHg; 39-99mmHg: ±5% of reading + 0.08% of (reading-38). awRR: 0-70rpm: ±1rpm, 71-120rpm: ±2rpm, 121-150rpm: ±3rpm. | Same as predicate. |
| Carbon Dioxide (CO2) (Mainstream) | Range CO2: 0-150 mmHg; awRR: 0-150 rpm. Accuracy CO2: 0-40mmHg: ±2mmHg; 41-70mmHg: ±5% of reading; 71-100mmHg: ±8% of reading; 101-150mmHg: ±10% of reading. awRR: ±1rpm. | Same as predicate. |
| Oxygen (O2) (via CO2 or AG module) | Range: 0-100%. Accuracy: 0-25%, ±1%; 26-80%, ±2%; 81-100%, ±3%. | Same as predicate (for models supporting O2). (Note: ePM 15, 12, 10 do not support O2). |
| Anesthetic Gas (AG) | CO2, HAL, ENF, ISO, SEV, DES: 0-30%; O2, N2O: 0-100%; awRR: 2-100 rpm. Detailed accuracy for each gas listed in the table. | Measurement specifications are the same. Pogo pin interface difference. (Note: ePM 15, 12, 10 do not support AG). |
| ECG 24h Summary | Provides statistical results of HR changes and cardiac arrhythmia within 24 hours, including HR, ARR, ST, QT/QTc, and Pace statistics. | Same as predicate. |
| EWS (MEWS, NEWS) | MEWS, NEWS, and user-configurable Custom Score to assist in recognizing early signs of deterioration. | MEWS and NEWS are the same. NEWS 2.0 added. Custom Score added NIBP-D and NIBP-M options. Updated user interface. |
| Glasgow Coma Scale (GCS) | Scoring system to assess consciousness based on eye-opening, verbal response, and limb movement. | Same as predicate. |
2. Sample size used for the test set and the data provenance:
- Not specified. The document mentions "functional and system level testing" and "bench testing" to validate performance and show compliance with specifications and standards but does not provide details on the sample sizes of any test sets or the provenance (e.g., country of origin, retrospective/prospective nature) of data used in these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. No mention of experts establishing ground truth for any test sets. The testing referenced is primarily device-centric (bench testing, software verification).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified. No information about adjudication methods.
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 study was done or reported. The device is a patient monitor, 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 performance described relates to the device's ability to measure physiological parameters in a standalone capacity. The "reported device performance" entries in the table indicate that the device met the measurement specifications (accuracy, range) without human interpretation in the loop. The document states a "standalone" performance was done in the sense that the device's own measurements were tested against its specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the performance testing, the ground truth is implied to be reference measurements from known standards and calibrated equipment during "bench testing" against accuracy specifications and consensus standards (e.g., IEC standards for ECG, NIBP, SpO2). There is no mention of clinical expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
- Not applicable / not specified. The document describes a patient monitor that directly measures physiological parameters. It does not refer to machine learning models that require training sets.
9. How the ground truth for the training set was established:
- Not applicable. As no training set is discussed, there is no information on how its ground truth was established.
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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
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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,
for Jennifer Shih Acting Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191769
Device Name ePM Series Patient Monitors
Indications for Use (Describe)
The ePM 10/ePM 12/ePM 15/ePM 10M/ePM 15M patient monitors are intended for monitoring, displaying, reviewing, storing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 6-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, and Heart Rate (HR)), Respiration Rate (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Pulmonary Artery Wedge Pressure (PAWP), Cardiac Output (C.O.), Carbon Dioxide (CO2), Oxygen (O2) and Anesthetic Gas (AG). The system also provides an interpretation of resting 12-lead ECG. All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following: · The arrhythmia detection and PAWP monitoring is intended for adult and pediatric patients only;
· C.O. monitoring is intended for adult patients only;
The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The ePM 12/ePM 15/ePM 10M/ePM 12M/ePM 15M monitors are not intended for helicopter transport, hospital ambulance, or home use.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the ePM Series Patient Monitors is provided below.
1. SUBMITTER
| Applicant: | SHENZHEN MINDRAY BIO-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: | October 23, 2019 | ||||
| 2.DEVICE | |||||
| Device Trade Name: | ePM Series Patient Monitors (Including ePM 10, ePM12, ePM 15, ePM 10M, ePM 12M, ePM 15M) | ||||
| 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 | ||||
| Primary Product Code: | MHX - Monitor, Physiological, Patient (witharrhythmia detection or alarms) |
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| 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 with alarm |
| 870.2300, II | DRT | Cardiac Monitor (includingcardiotachometer and ratealarm) | Monitor, cardiac (incl.cardiotachometer & rate alarm) |
| 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 (anesthetic concentration) |
| 868.1620, II | CBS | Halothane gas analyzer. | Analyzer, gas, halothane, gaseous-phase (anesthetic conc.) |
| 868.1700, II | CBR | Nitrous oxide gas analyzer. | Analyzer, gas, nitrous-oxide, gaseousphase (anesthetic conc.) |
| 868.1720, II | CCI | Oxygen gas analyzer. | Analyzer, gas, oxygen, gaseous-phase |
Table 1: Secondary Product Codes
3. PREDICATE DEVICES
- o Predicate: K182075- BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1) (Shenzhen Minray Bio-Medical Electronics Co., LTD)
DEVICE DESCRIPTION 4.
The subject ePM Series Patient Monitors includes six monitors:
- . ePM 10 Patient Monitor
- ePM 12 Patient Monitor ●
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- o ePM 15 Patient Monitor
- ePM 10M Patient Monitor
- o ePM 12M Patient Monitor
- ePM 15M Patient Monitor
The ePM Series Patient Monitors are Mindray's new generation monitoring product family with ergonomic and flexible design in platform of both software and hardware to meet the clinical needs of monitoring.
ട്. INTENDED USE/INDICATIONS FOR USE
The ePM 10/ePM 12/ePM 15/ePM 10M/ePM 12M/ePM 15M patient monitors are intended for monitoring, displaying, reviewing, storing, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 6-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, QT Analysis, and Heart Rate (HR)), Respiration Rate (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Pulmonary Artery Wedge Pressure (PAWP), Cardiac Output (C.O.), Carbon Dioxide (CO2), Oxygen (O2) and Anesthetic Gas (AG). The system also provides an interpretation of resting 12-lead ECG.
All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:
- o The arrhythmia detection and PAWP monitoring is intended for adult and pediatric patients only;
- C.O. monitoring is intended for adult patients only;
The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The ePM 10/ePM 12/ePM 15/ePM 10M/ePM 12M/ePM 15M monitors are not intended for helicopter transport, hospital ambulance, or home use.
SUBSTANTIAL EQUIVALENCE 6.
Comparison of Indications
Both the predicate devices and the subject devices are multi parameter patient monitors intended to be used under the direction of clinical professionals. The monitoring parameters supported by the ePM series are a subset of those supported by the predicate BeneVision N series monitors (K182075).
In conclusion, the minor differences of the indications for use do not change the fundamental intended use of the ePM Series as a multiparameter monitor.
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Technological Comparison
The table below compares the key technological feature of the subject devices to the predicate device (N series Patient Monitors, K182075). The features in gray are features which are different between the predicate devices and the subject devices.
| Predicate Devices (K182075) | Subject ePM Devices | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Feature | N12 | ePM15 | ePM12 | ePM10 | ePM15M | ePM12M | ePM10M | ||
| Display andtouchscreen | 12.1" 1280*800 pixels. | 15.6"1366*768pixels. | 12.1"1280*800pixels | 10.1"1280*800pixels. | 15.6"1366*768pixels | 12.1''1280*800pixels. | 10.1"1280*800pixels | ||
| Secondarydisplay | Mirrored display. | Mirrored display. | |||||||
| Wireless | 2.4GHz/5GHz dual band module. | 2.4GHz/5GHz dual band module. | |||||||
| Powersupply | 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 | |||||||
| DataRecorder | Supports internal thermal recorder. | Same | |||||||
| Deviceintegration | Use Benelink Module to integrate 3rdparty devices. Allow parameter valuesand alarms from 3rd party devices tobe displayed, stored and printed. | Use the RS-232 interface to integrate 3rd partydevices.Allow parameter values, waveforms and alarms from3rd party devices to be displayed, stored and printed. | |||||||
| Speaker | Give alarm tones (45 to 85 dB), keytones, QRS tones; support PITCHTONE and multi-level tonemodulation. | Same | |||||||
| Alarmsystem | The alarm lamp is cyan, yellow, or reddepending on alarm type.Supports Alarm Volume Escalation | Same |
Table 2: Device Comparison Table
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| Predicate Devices (K182075) | Subject ePM Devices | |||||||
|---|---|---|---|---|---|---|---|---|
| Feature | N12 | ePM15 | ePM12 | ePM10 | ePM15M | ePM12M | ePM10M | |
| ECG | Use ECG module of MPM3.03-lead, 5-lead or 12-lead selectable,arrhythmia detection, ST segmentanalysis, QT analysis, aninterpretation of resting 12-lead ECG,J-point Auto detection, Dual ChannelPace detection, adjustable QRSthreshold and heart rate (HR);Arrhythmia detection is intended foradult and pediatric.Supports intelligent arrhythmia alarm.ST segment analysis is intended foradult, pediatric and neonate. | 3-lead, 5-lead, 6-lead or 12-lead selectable, arrhythmiadetection, ST segment analysis, QT analysis, aninterpretation of resting 12-lead ECG, J-point Autodetection, Dual Channel Pace detection, adjustableQRS threshold and heart rate (HR).Arrhythmia detection is intended for adult, pediatric.Supports intelligent arrhythmia alarm.ST segment analysis is intended for adult, pediatricand neonate. | ||||||
| ArrhythmiaAnalysis | Asystole, VFib/Vtac, Vtac,Vent.Brady, Extreme Tachy, ExtremeBrady, PVCs, Couplet, Bigeminy,Trigeminy, R on T, Run PVCs,PVCs/min, Tachy, Brady, MissedBeats, Vent Rhythm, Pacer NotPacing, Pacer Not Capture,Multif.PVC, Nonsus.Vtac, Pause,Vent.Rhythm, Afib, Pauses/min,Pauses/min; | Same | ||||||
| Respirationrate (Resp) | Use Respiration module of MPM 3.0Measurement range: Adult: 0 to 120rpm; 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 boardlayout differences. | ||||||
| Temperature (Temp) | Use temperature module of MPM 3.0Measurement range: 0 to 50°C (32 to122°F)Accuracy: ±0.1°C or ±0.2ºF (withoutprobe). | Measurement specifications are same.The measurement module has minor circuit boardlayout differences. | ||||||
| Predicate Devices (K182075) | Subject ePM Devices | |||||||
| Feature | N12 | ePM15 | ePM12 | ePM10 | ePM15M | ePM12M | ePM10M | |
| Pulse oxygen saturation (SpO2) | Supports Mindray SpO2 function, Masimo SpO2 function and Nellcor SpO2 function from MPM 3.0 module.Mindray SpO2 functionMeasurement 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 functionMeasurement 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 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 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 | ePM15 | ePM12 | ePM10 | ePM15M | ePM12M | ePM10M | ||
| Pulse rate(PR) | PR from Mindray SpO2 ModuleMeasurement range: 20 to 254 bpm;Accuracy: ±3 bpm.PR from Masimo SpO2 ModuleMeasurement range: 25 to 240 bpm;Accuracy: ±3 bpm (measured withoutmotion);±5 bpm (measured with motion).PR from Nellcor SpO2 ModuleMeasurement range: 20 to 300 bpm;Accuracy:20 to 250 bpm: ±3 bpm;251 to 300 bpm, not specified.PR from IBP ModuleMeasurement range: 25 to 350 bpm;Accuracy: ±1 bpm or ±1%, whicheveris greater. | PR from built-in MindraySpO2 ModuleMeasurement range: 20 to254 bpm;Accuracy: ±3 bpm.PR from built-in MasimoSpO2 ModuleMeasurement range: 25 to240 bpm;Accuracy: ±3 bpm(measured withoutmotion);±5 bpm (measured withmotion).PR from built-in NellcorSpO2 ModuleMeasurement range: 20 to300 bpm;Accuracy:20 to 250 bpm:±3 bpm;251 to 300 bpm, notspecified.Same | PR from built-in MindraySpO2 ModuleMeasurement range: 20 to254 bpm;Accuracy: ±3 bpm.PR from built-in MasimoSpO2 ModuleMeasurement range: 25 to240 bpm;Accuracy: ±3 bpm(measured withoutmotion);±5 bpm (measured withmotion).PR from built-in NellcorSpO2 ModuleMeasurement range: 20 to300 bpm;Accuracy:20 to 250 bpm:±3 bpm;251 to 300 bpm, notspecified. | PR from built-in MindraySpO2 ModuleMeasurement range: 20 to254 bpm;Accuracy: ±3 bpm.PR from built-in MasimoSpO2 ModuleMeasurement range: 25 to240 bpm;Accuracy: ±3 bpm(measured withoutmotion);±5 bpm (measured withmotion).PR from built-in NellcorSpO2 ModuleMeasurement range: 20 to300 bpm;Accuracy:20 to 250 bpm:±3 bpm;251 to 300 bpm, notspecified.PR from external IBPModuleMeasurement range: 25 to350 bpm;Accuracy: ±1 bpm or±1%, whichever isgreater.Same | PR from built-in MindraySpO2 ModuleMeasurement range: 20 to254 bpm;Accuracy: ±3 bpm.PR from built-in MasimoSpO2 ModuleMeasurement range: 25 to240 bpm;Accuracy: ±3 bpm(measured withoutmotion);±5 bpm (measured withmotion).PR from built-in NellcorSpO2 ModuleMeasurement range: 20 to300 bpm;Accuracy:20 to 250 bpm:±3 bpm;251 to 300 bpm, notspecified.PR from external IBPModuleMeasurement range: 25 to350 bpm;Accuracy: ±1 bpm or±1%, whichever isgreater.Same | PR from built-in MindraySpO2 ModuleMeasurement range: 20 to254 bpm;Accuracy: ±3 bpm.PR from built-in MasimoSpO2 ModuleMeasurement range: 25 to240 bpm;Accuracy: ±3 bpm(measured withoutmotion);±5 bpm (measured withmotion).PR from built-in NellcorSpO2 ModuleMeasurement range: 20 to300 bpm;Accuracy:20 to 250 bpm:±3 bpm;251 to 300 bpm, notspecified.PR from external IBPModuleMeasurement range: 25 to350 bpm;Accuracy: ±1 bpm or±1%, whichever isgreater.Same | ||
| Non-invasivebloodpressure(NIBP) | Measurement specifications are the same. | |||||||
| Measurement range: | Adult | Pediatric | Neonate | The measurement module has minor differencesrelated to the circuit board layout and overpressure 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 | ePM15 | ePM12 | ePM10 | ePM15M | ePM12M | ePM10M | |
| Invasivebloodpressure(IBP) | Uses the MPM3.0 or the external IBPModule to measure invasive bloodpressure. The monitor can monitor upto 8 invasive blood pressures anddisplays systolic, diastolic and meanpressures and a waveform for eachpressure. Support PPV function.Measurement range: -50 to 300mmHg;Accuracy: ±2% or ±1 mmHg,whichever is greater (without sensor). | Uses an internal IBPmoduleThe circuit board layouthas minor differencescompared to thepredicate.Measurementspecifications are thesame | Uses an internal IBPmodule or stand-aloneIBP ModuleThe circuit board layoutof the internal IBPmodule has minordifferences compared tothe predicate.The stand-alone IBPmodule is identical withthe predicate device'sMeasurementspecifications are thesame. | |||||
| Cardiacoutput(C.O.) | Use external C.O. moduleThe cardiac output (C.O.)measurement invasively measurescardiac output and otherhemodynamic parameters using theright heart (atria) thermodilutionmethod. The temperature change isdisplayed as a curve in the C.O. splitscreen, and the monitor calculates theC.O. value from this curve. Themonitor is capable of storing 6measurements.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, whicheveris greater;TB, TI: ±0.1°C (without sensor). | Use internal C.O. moduleInternal C.O. module isidentical to the externalC.O. module in K182075 | Use internal or externalC.O. moduleThe built-in C.O. moduleis identical with theexternal C.O. module inK182075.The only differencebetween the subjectexternal C.O. module andthe external C.O. modulein K182075 is that thesubject module includes apogo pin interface | |||||
| Predicate Devices (K182075) | Subject ePM Devices | |||||||
| Feature | N12 | ePM15 | ePM12 | ePM10 | ePM15M | ePM12M | ePM10M | |
| Carbondioxide(CO2) | Compatible with the following 4modules to measure carbon dioxide:• Sidestream CO2 1.0 module• Sidestream CO2 2.0 module• Mainstream CO2 module• MicroStream CO2 module | Compatible with 3internal CO2 modules:• Sidestream CO2 2.0module• Mainstream CO2module• MicroStream CO2moduleThe internal CO2 modulesare identical to theexternal CO2 module inK182075 | Compatible with 4internal or external CO2modules:• Sidestream CO2 1.0module• Sidestream CO2 2.0module• Mainstream CO2module• MicroStream CO2module*10M does not supportexternal CO2 modulesThe subject internal CO2modules are identicalwith predicate externalCO2.The only differencebetween the subjectexternal CO2 modulesand the predicate externalCO2 modules that thesubject modules includea pogo pin interface | |||||
| Type: Sidestream CO2 Module (CO22.0):Measurement range: 0 | Same | Same | Same | Same | Same | Same | ||
| Predicate Devices (K182075) | Subject ePM Devices | |||||||
| Feature | N12 | ePM15 | ePM12 | ePM10 | ePM15M | ePM12M | ePM10M | |
| Type: Microstream CO2 ModuleMeasurement range:CO2: 0 | Same | Same | ||||||
| Type: Mainstream CO2 ModuleMeasurement range:CO2: 0 | Same | Same | ||||||
| Predicate Devices (K182075) | Subject ePM Devices | |||||||
| Feature | N12 | ePM15 | ePM12 | ePM10 | ePM15M | ePM12M | ePM10M | |
| Oxygen(O 2) | Oxygen values are measured by theSidestream CO2 2.0 or the AG moduleusing a paramagnetic method.Measurement range: 0 | Not support | Same | |||||
| Predicate Devices (K182075) | Subject ePM Devices | |||||||
| Feature | N12 | ePM15 | ePM12 | ePM10 | ePM15M | ePM12M | ePM10M | |
| Anestheticgas (AG) | The AG module analyzes gas samplesfrom the patient and calculates CO2,O2, N2O, and AA waveforms andrelated numerics that include airwayrespiratory rate and MAC (minimumalveolar concentration).Measurement range:CO2, HAL, ENF, ISO, SEV, DES:0 | Not support | Measurementspecifications are thesame.The only differencebetween the subject AGmodule the predicate AGmodule is that the subjectmodule includes a pogopin interface | |||||
| Wirelessfunction | The Wireless radio module (Laird) isused for connecting to a wirelessmonitoring network with a centralmonitoring system (CMS). | same | ||||||
| Predicate Devices (K182075) | Subject ePM Devices | |||||||
| Feature | N12 | ePM15 | ePM12 | ePM10 | ePM15M | ePM12M | ePM10M | |
| ECG 24hSummary | Provides the function to statisticalresults of heart rate changes andcardiac arrhythmia of patients within24 hours, including HR statistics,ARR statistics, ST statistics, QT/QTcstatistics and Pace statistics. | Same | ||||||
| EWS | The EWS is a set of early warningscores that are intended to assistclinicians in recognizing the earlysigns of deterioration in patients basedon vital signs and clinicalobservations. The three types of EWSprovided are Modified Early WarningScore (MEWS), National EarlyWarning Score (NEWS) and userconfigurable Custom Score. | MEWS and NEWS are same.Added NEWS 2.0.Custom Score added NIBP-D and NIBP-M options.Updated the user interface. | ||||||
| GlasgowComa Scale(GCS) | The GCS a well-established scoringsystem used to assess the state ofconsciousness based three sub-components: eye-opening response,verbal response, and limb movement | Same |
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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.
§ 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.