Patient Monitor

K152552 · Edan Instruments, Inc. · MHX · Apr 29, 2016 · Cardiovascular

Device Facts

• Record ID: K152552
• Device Name: Patient Monitor
• Applicant: Edan Instruments, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Apr 29, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

iM20 Patient Monitor (hereinafter called monitor) is intended to be used for monitoring, storing, and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitors are intended for use by trained healthcare professionals in hospital environments. The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), and invasive blood pressure (IBP), and carbon dioxide (CO2). The arrhythmia detection and ST Segment analysis are intended for adult only. The monitor is additionally intended for use during patient transport inside and outside of the hospital environment. The monitor is not intended for airplane, helicopter transport, home use and MRI environments.

Device Story

iM20 is a portable patient monitor for continuous physiological monitoring (ECG, RESP, NIBP, SpO2, PR, TEMP, IBP, CO2). It functions as an independent monitor or as a module for V-series monitors (elite V5, V6, V8). Inputs include patient-connected sensors for electrical, pressure, and gas signals. The device processes these signals to display trends, store data, and trigger alarms for clinicians. Used in hospital settings and during patient transport; operated by trained healthcare professionals. When docked to V-series monitors, the host system controls alarms and power. Output allows clinicians to assess patient status and manage care. Benefits include continuous monitoring and portability for patient transport.

Clinical Evidence

Clinical validation of NIBP performed per ISO 81060-2:2013. Non-clinical evidence includes biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and performance testing against various IEC/ISO standards (e.g., IEC 60601-2-27 for ECG, ISO 80601-2-61 for SpO2). Software verification and validation conducted for 'major' level of concern.

Technological Characteristics

Portable patient monitor; 5-inch LCD (800x480); connectivity via Wi-Fi (802.11b/g/n). Materials comply with ISO 10993-1. Power: 11.1V-19.8V DC or AC-DC adapter. Standards: IEC 60601-1, IEC 60601-2-25/27/34/49, ISO 80601-2-55/56/61. Enclosure IP44. Arrhythmia/ST analysis algorithms for adults.

Indications for Use

Indicated for monitoring, storing, reviewing, and alarming of physiological parameters (ECG, RESP, TEMP, SpO2, PR, NIBP, IBP, CO2) in adult, pediatric, and neonatal patients by trained healthcare professionals in hospital and transport environments. Arrhythmia and ST-segment analysis indicated for adults only. Contraindicated for airplane, helicopter, home, and MRI use.

Regulatory Classification

Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Predicate Devices

• IntelliVue MP2 (K102562)
• iM70 (K131971)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 29, 2016

Edan Instruments. Inc. % Doug Worth Sr. Dir. US RA/QA Edan Medical 1200 Crossman Ave. Suite 200 Sunnyvale, California 94086

Re: K152552

Trade/Device Name: Patient Monitor, model iM20 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, CCK, GXY, DPS, DRG Dated: March 22, 2016 Received: March 28, 2016

Dear Doug Worth:

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. 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 statutes and regulations administered by other Federal agencies. You must comply

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mitchell Stein

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K152552

Device Name Patient Monitor, model iM20

#### Indications for Use (Describe)

iM20 Patient Monitor (hereinafter called monitor) is intended to be used for monitoring, and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitors are intended for use by trained healthcare professionals in hospital environments.

The monitored physiological parameters include: ECG. respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), and invasive blood pressure (IBP), and carbon dioxide (CO2).

The arrhythmia detection and ST Segment analysis are intended for adult only.

The monitor is additionally intended for use during patient transport inside of the hospital environment.

The monitor is not intended for airplane, helicopter transport, home use and MRI environments.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:20px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:20px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510 (K) Summary

# Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92

| 1. Submitter: | Edan Instruments, Inc<br>3/F - B, Nanshan Medical<br>Equipments Park, Nanhai Rd 1019#,<br>Shekou, Nanshan Shenzhen, |
|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 518067 P.R. China |
| | Tel: [phone] |
| | Fax: [phone] |
| Contact person: | Queena Chen |
| Preparing date: | March 22, 2015 |
| 2. Device name and<br>classification: | Device Name: Patient Monitor |
| | Model: iM20 |
| | Classification Name/ Product code: |
| | 870.1025 monitor, physiological, patient(with arrhythmia<br>detection or alarms)/ MHX |
| | 870.1025 Detector and Alarm, Arrhythmia/ DSI |
| | 870.1025 Monitor, ST Segment with Alarm/ MLD |
| | 870.2300 Cardiac monitor (including cardiotachometer and rate<br>alarm)/ DRT |
| | 870.1130 Non-Invasive blood pressure/ DXN |
| | 870.1110 Blood pressure computer/ DSK |
| | 880.2910 Clinical Electronic Thermometers-Temperature<br>Monitor with Probe/ FLL |
| | 870.2700 Oximeter, Pulse/ DQA |
| | 868.1400 Carbon Dioxide Gas Analyzer/ CCK |
| | 882.1320 Cutaneous electrode/GXY |
| | 870.2340 Electrocardiograph/DPS |
| | 870.2910 Radiofrequency physiological signal transmitter and<br>receiver/ DRG |
| | Regulatory Class: Class II |
| 3.Premarket<br>Notification Class III<br>Certification and<br>Summary | Not applicable, the subject device is Class II. |
| 4. Predicate Device(s): | 1) Philips Medizin.Systeme Boeblingen GmbH IntelliVue MP2 cleared under K102562. |
| | 2) Edan Instruments, Inc. iM70/ K131971 |
| 5. Reason for<br>Submission | Introduce new device iM20 |
| 6. Pre-Submission,<br>IDE | Not applicable, there is no prior submission. |
| 7. Device Description: | The iM20 Patient Monitor System (hereinafter called iM20) can<br>perform long-time continuous monitoring of multiple<br>physiological parameters, including ECG, respiration (RESP),<br>non-invasive blood pressure (NIBP), oxygen saturation of the<br>blood (SpO2), pulse rate (PR), temperature (TEMP), invasive<br>pressure (IBP), Carbon Dioxide (CO2). The system capabilities<br>include storing, displaying, analyzing and controlling such data<br>afterwards. When necessary, alarms will be produced so that<br>doctors and nurses can manage patient care appropriately. The<br>system is intended to be used during patient transport inside and<br>outside of the hospital environment.<br>iM20 can be utilized in two ways, as an independent monitor<br>and as a module of V series Patient Monitor (including models<br>elite V5, elite V6 and elite V8). When used as an independent<br>monitor, it can simultaneously monitor, store, review several<br>parameters data. And transfer patient data to V series patient<br>monitor only under the transport mode. As a highly portable<br>monitor, its compact design makes it particularly appropriate<br>inside hospital and vehicle ambulance transport environments.<br>When as a multi-measurement module, when the iM20 is<br>directly connected to a V series patient monitor, it can provide<br>the measurements, trends, and patient information.<br>When<br>connected, the V series Patient Monitor controls the connected<br>iM20, including all alarm functionality. So no alarms are<br>available on iM20 in such application and iM20 takes power<br>from the V series Patient Monitor. |
| 8. Intended<br>Use/Indications for<br>Use: | iM20 Patient Monitor (hereinafter called monitor) is intended to<br>be used for monitoring, storing, and reviewing of, and to<br>generate alarms for, multiple physiological parameters of<br>adults, pediatrics and neonates. The monitors are intended for<br>use by trained healthcare professionals in hospital<br>environments.<br><br>The monitored physiological parameters include: ECG,<br>respiration (RESP), temperature (TEMP), oxygen saturation of |

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pressure (NIBP), and invasive blood pressure (IBP), and carbon dioxide (CO2).

The arrhythmia detection and ST Segment analysis are intended for adult only.

The monitor is additionally intended for use during patient transport inside and outside of the hospital environment.

The monitor is not intended for airplane, helicopter transport, home use and MRI environments.

## 9. Predicate Device Comparison

The subject devices share the same characteristics in all items with the predicate device, concluding from using the same technology and principle. All the technological differences existed between the subject and predicate devices are only some performance parameters improvement, detailed substantial equivalence discussion are included in the following tables.

| Item | Proposed device: iM20 | Predicate device:<br>IntelliVue MP2 | Compariso<br>n Result |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| 510(k)<br>Number | Current Submission | K102562 | |
| | Indications for Use | | |
| Intended Use | iM20 Patient Monitor is intended to be used for monitoring, storing, and reviewing of, and to generate alarms for multiple physiological parameters of adults, pediatrics and neonates. The monitors are intended to be used by trained healthcare professionals in a hospital environment. The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), and carbon dioxide (CO2). The arrhythmia detection and ST-segment monitoring are intended for adult only. Neonatal and pediatric | Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording of, and to generate alarms for multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The | Different |
| | | | |
| | patients are not clinically validated.<br>The monitors are indicated for use by<br>health care professionals or under their<br>direction whenever there is a need for<br>monitoring the physiological parameters<br>of patients.<br>The monitors are additionally intended<br>for use during patient transport inside<br>and outside of the hospital environment.<br>The monitor is not intended for airplane,<br>helicopter transport, home use or MRI<br>environments. | MP2, X2, MP5,<br>MP5T, MP20,<br>MP30, MP40, and<br>MP50 are<br>additionally<br>intended for use in<br>transport situations<br>within hospital<br>environments. The<br>MP2, X2and MP5<br>are also intended<br>for use during<br>patient transport<br>outside of a<br>hospital<br>environment. | |
| ECG Function | | | |
| HR Calculation | | | |
| Range | ADU: 15 bpm to 300 bpm<br>PED/NEO: 15 bpm to 350 bpm | Adult/pedi: 15 to<br>300 bpm<br>Neo range: 15 to<br>350 bpm | Different |
| Accuracy | $\pm$ 1% or 1 bpm, whichever is greater | $\pm$ 1% of range | Different |
| Resolution | 1 bpm | 1bpm | Same |
| Sensitivity | $\ge$ 300 $\mu$ VPP | $\ge$ 200 $\mu$ Vpeak | Different |
| PVC Rate | | | |
| Range | ADU: 0 to 300 PVCs/ min<br>PED/NEO: 0 to 350 PVCs/ min | 0 to 300 bpm | Different |
| Resolution | 1 PVCs/min | 1 bpm | Different |
| ST Numeric | | | |
| Range | -2.0 mV to +2.0 mV | -20 to +20 mm | Different |
| Accuracy | -0.8 mV to +0.8 mV: $\pm$ 0.02 mV or 10%,<br>which ever one is greater.<br>Beyond this range: not specified. | $\pm$ 0.5mm or 15%,<br>which ever one is<br>greater | Different |
| Resolution | 0.01 mV | 0.1mm | Different |
| Range of Sinus and SV Rhythm | | | |
| Brady | Adult: RR interval for 5 consecutive<br>QRS complex $\ge$ 1.5 s.<br>Pediatric/neonatal: RR interval f…