Patient Monitor

K160981 · Edan Instruments, Inc. · MHX · Dec 22, 2016 · Cardiovascular

Device Facts

• Record ID: K160981
• Device Name: Patient Monitor
• Applicant: Edan Instruments, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Dec 22, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The monitors are 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), invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.), anesthetic gas (AG), bispectral index (BIS), respiration mechanics (RM) and impedance cardiography (ICG). BIS is intended for use on adult and pediatric patients. ICG monitoring is intended for use on adults only. The arrhythmia detection and ST Segment analysis are intended for adult patients. The monitors are additionally intended for use during patient transport inside hospitals. The monitors are not intended for MRI environments.

Device Story

V series patient monitors (elite V5, V6, V8) provide continuous monitoring of physiological parameters including ECG, RESP, TEMP, SpO2, PR, NIBP, IBP, CO2, C.O., AG, BIS, RM, and ICG. Input data is acquired via various parameter-specific modules. The device processes these signals to display waveforms, store data, and trigger alarms for abnormal conditions. Used in hospital environments (including transport) by trained healthcare professionals. Output is presented on a color TFT touch screen (12.1, 15, or 17 inches). Clinicians use the visual and audible alarms to identify patient status changes, facilitating timely intervention. Benefits include continuous patient surveillance and early detection of physiological abnormalities.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and performance testing against various recognized standards (e.g., IEC 60601-2-27 for ECG, ISO 80601-2-55 for gas monitors).

Technological Characteristics

Modular patient monitoring system with 12.1-17 inch TFT touch screens. Powered by AC or internal Lithium-ion battery. Connectivity includes networking and online software upgrades. Biocompatibility per ISO 10993-1. Safety standards: IEC 60601-1, IEC 60601-1-8, IEC 60601-2-49, ISO 80601-2-55, ISO 80601-2-56, ISO 80601-2-61, ISO 81060-2.

Indications for Use

Indicated for monitoring, storing, and alarming of physiological parameters in adult, pediatric, and neonatal patients in hospital environments. Arrhythmia detection, ST-segment analysis, and ICG are restricted to adult patients. BIS is indicated for adult and pediatric patients. Not for MRI environments.

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

• Patient Monitor Model elite V8 (K120173)
• BeneView T8 (K092449)
• iM70 (K131971)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine.

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

December 22, 2016

Edan Instruments, Inc. % Doug Worth Edan Medical 1200 Crossman Ave. Suite 200 Sunnyvale, California 94089

Re: K160981 Trade/Device Name: Patient Monitor, models elite V5, elite V6 and elite V8 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, DRT, CBQ, DXN, DSK, CBR, DQA, NHO, CBS, NHQ, NHP, CCK, DSB, CCL, BZQ, BZK, DPS, FLL, DRG, MLD Dated: November 30, 2016 Received: November 30, 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 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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.

Mude Jellm
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) K160981

Device Name

Patient Monitor, models elite V5, elite V6 and elite V8

Indications for Use (Describe)

The monitors are intended to be used for monitoring, storing, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitors are intended 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), invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.), anesthetic gas (AG), bispectral index (BIS), respiration mechanics (RM) and impedance cardiography (ICG).

BIS is intended for use on adult and pediatric patients.

ICG monitoring is intended for use on adults only.

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

The monitors are additionally intended for use during patient transport inside hospitals.

The monitors are not intended for MRI environments.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510 (K) Summary

## 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,<br>518067 P.R. China<br>Tel: [phone]<br>Fax: [phone] |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Queena Chen |
| Preparing date: | March 30, 2016 |
| 2. Device name and<br>classification: | Device Name: Patient Monitor<br>Model: elite V5, elite V6, elite V8<br>Classification Name/ Product code:<br>870.1025 monitor, physiological, patient(with arrhythmia<br>detection or alarms)/ MHX<br>870.1025 Detector and Alarm, Arrhythmia/ DSI<br>870.1025 Monitor, ST Segment with Alarm/ MLD<br>870.2300 Cardiac monitor (including cardiotachometer and rate<br>alarm)/ DRT<br>870.1130 Non-Invasive blood pressure/ DXN<br>870.1110 Blood pressure computer/ DSK<br>880.2910 Clinical Electronic Thermometers-Temperature<br>Monitor with Probe/ FLL<br>870.2700 Oximeter, Pulse/ DQA<br>868.1400 Carbon Dioxide Gas Analyzer/ CCK<br>868.1500 Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic<br>Concentration)/ CBQ<br>868.1500 Analyzer, Gas, Desflurane, Gaseous-Phase<br>(Anesthetic Concentration)/NHO<br>868.1500 Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic<br>Concentration)/NHQ<br>868.1500 Analyzer, Gas, Sevoflurane, Gaseous-Phase<br>(Anesthetic Concentration)/NHP<br>868.1620 Halothane gas analyzer/ CBS<br>868.1700 Nitrous Oxide gas analyzer/ CBR<br>868.1720 Oxygen gas analyzer/ CCL |

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| <b>3.Premarket Notification Class III Certification and Summary</b> | 870.2770 Impedance plethysmograph/ DSB<br>868.1850 Monitoring spirometer/ BZK<br>868.2375 Monitor, Breathing Frequency/BZQ<br>870.2340 Electrocardiograph/DPS<br>870.2910 Radiofrequency physiological signal transmitter and receiver/ DRG<br>Regulatory Class: Class II<br>Not applicable, the subject device is Class II. |
|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>4. Predicate Device(s):</b> | 1) Edan Instruments, Inc. / Patient Monitor Model elite V8/ K120173<br>2) Shenzhen Mindray Bio-Medical Electronics Co., Ltd/ BeneView T8 /K092449.<br>3) Edan Instruments, Inc. / iM70/ K131971 |
| <b>5. Reason for Submission</b> | Modification for previous product elite V8 and introduce two new models elite V5 and elite V6. |
| <b>6. Pre-Submission, IDE</b> | Not applicable, there is no prior submission. |
| <b>7. Device Description:</b> | V series Patient Monitor including elite V5, elite V6 and elite V8 which can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time.<br>The V series Patient Monitor realize the monitoring of physiological parameters by configuration with different parameter modules which include SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, ECG, RESP(respiration), CO2, IBP, C.O. and AG(anesthetic gas), RM(respiratory mechanics), BIS(bispectral index) and ICG(impedance cardiography).<br>The above is the maximum configuration for V series Patient Monitor, the user may select different monitoring parameters in according with their requirements.<br>elite V5 configures with 12.1-inch color TFT touch screen , elite V6 and elite V8 with same screen except different sizes |

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15-inch and 17-inch separately. Three models are all build-in Lithium-ion battery, support software upgrade online and networking.

8. Intended Use: The monitors are 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), invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.), anesthetic gas (AG), bispectral index (BIS), respiration mechanics (RM) and impedance cardiography (ICG).

BIS is intended for use on adult and pediatric patients.

ICG monitoring is intended for use on adults only.

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

The monitors are additionally intended for use during patient transport inside hospitals.

The monitors are not intended for 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, for example accuracy for RESP Module is better, minor differences on NIBP module, different measurement range, accuracy and Sample flow rate for CO2 module and different Warm-up time, Sample flow rate, measurement range, accuracy for AG module. Please refer to the following tables for details.

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# Comparison to Primary Predicate elite V8

| Item | Proposed device<br>(elite V5, elite V6, elite V8) | Predicate device<br>(elite V8) | Justification | |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|---------|
| K# | Current Submission | K120173 | — | |
| Intended use | | | | |
| Description | The monitors are intended to be used for<br>monitoring, storing, and reviewing of,<br>and to generate alarms for, multiple<br>physiological parameters of adults,<br>pediatrics and neonates. The monitors<br>are intended for use by trained<br>healthcare professionals in hospital<br>environments.<br>The monitored physiological parameters<br>include: ECG, respiration (RESP),<br>temperature (TEMP), oxygen saturation<br>of arterial blood (SpO2), pulse rate (PR),<br>non-invasive blood pressure (NIBP),<br>invasive blood pressure (IBP), carbon<br>dioxide (CO2), cardiac output (C.O.),<br>anesthetic gas (AG), bispectral index<br>(BIS), respiration mechanics (RM) and<br>impedance cardiography (ICG).<br>BIS is intended for use on adult and<br>pediatric patients.<br>ICG monitoring is intended for use on<br>adults only.<br>The arrhythmia detection and ST<br>Segment analysis are intended for adult<br>patients.<br>The monitors are additionally intended<br>for use during patient transport inside<br>hospitals.<br>The monitors are not intended for MRI<br>environments. | The monitor monitors parameters<br>such as ECG (3-lead, 5-lead<br>selectable), Respiration (RESP),<br>Functional arterial oxygen saturation<br>(SpO2), Invasive or noninvasive<br>blood pressure (dual-IBP, NIBP),<br>Temperature (dual-TEMP), Expired<br>CO2.<br>The monitor is equipped with alarms<br>that indicate system faults (such as<br>loose or defective electrodes).<br>physiologic parameters that have<br>exceeded the limits set by the<br>operator, or both.<br>The arrhythmia detection and ST<br>Segment analysis are not intended for<br>neonatal patients. | Similar | |
| Intended patient<br>population | adult, pediatric and neonatal patients | adult, pediatric and neonatal patients | Same | |
| Intended<br>application<br>environment | Hospital environment. | Hospital environment. | Similar | |
| ECG monitor | | | | |
| Lead Mode | 3-Lead: I, II, III<br>5-Leads: I, II, III, aVR, aVL, aVF, V<br>12-leads: I, II, III, aVR, aVL, aVF, V1 to<br>V6 | 3-Lead: I, II, III<br>5-Leads: I, II, III, aVR, aVL, aVF, V<br>12-leads: I, II, III, aVR, aVL, aVF,<br>V1 to V6 | Same | |
| Lead Naming<br>Style | AHA, IEC | AHA, IEC | Same | |
| Display<br>Sensitivity | 1.25mm/mV (×0.125), 2.5mm/mV<br>(×0.25), 5mm/mV (×0.5), 10mm/mV<br>(×1), 20mm/mV (×2), 40mm/mV (×4),<br>AUTO gain | 1.25 mm/mV (X0.125), 2.5 mm/mV<br>(X0.25), 5 mm/mV (X0.5),<br>10 mm/mV (X1), 20 mm/mV (X2),<br>40 mm/mV (X4), Auto | Same | |
| Sweep | 6.25mm/s, 12.5mm/s, 25mm/s, 50mm/s | 6.25 mm/s, 12.5 mm/s, 25 mm/s, 50<br>mm/s | Same | |
| Measurement<br>Range | Neonate: 15 to 350 bpm<br>Pediatric: 15 to 350 bpm<br>Adult: 15 to 300 bpm | Neonate: 15 to 350 bpm<br>Pediatric: 15 to 350 bpm<br>Adult: 15 to 300 bpm | Same | |
| CMRR<br>(Common Mode<br>Rejection Ratio) | Diagnosis: >95dB<br>Monitor: >105dB<br>Surgery: >105dB | Diagnosis: >95dB (the Notch filter is<br>off)<br>Monitor: >105dB (the Notch filter is<br>on)<br>Surgery: >105dB (the Notch filter is<br>on) | Similar | |
| Accuracy | ±1 bpm or ±1%, whichever is<br>greater | ±1 bpm or ±1%, whichever is<br>greater | Same | |
| Resolution | 1 bpm | 1 bpm | Same | |
| Sensibility | 200μV | 200µV (lead II) | Same | |
| Differential Input<br>Impedance | >5MΩ | ≥5 MΩ | Same | |
| Leakage Current<br>of Patient | <10μΑ | <10 μΑ | Same | |
| ST value | | | | |
| Measurement<br>Range | -2.0 mV ~ +2.0 mV | -2.0 mV ~ +2.0 mV | Same | |
| Accuracy | -0.8 mV to +0.8 mV: ±0.02 mV or 10%,<br>whichever is greater.<br>Beyond this range: not specified. | -0.8 to 0.8 mV: Beyond this<br>range:±0.02 mV or ±10%, whichever<br>is greater. Not specified. | Same | |
| Pace | | | | |
| Pulse Indicator | Amplitude: ±2 mV to ±700 mV<br>Width: 0.1 ms to2.0 ms<br>Ascending time: 10 µs to 100 µs | Amplitude: ±2 to ±700 mV<br>Width: 0.1 to 2 ms<br>Rise time: 10 to 100 µs | Same | |
| Pulse Rejection | Amplitude: ±2 mV to ±700 mV<br>Width: 0.1 ms to 2.0 ms<br>Ascending time: 10 µs to 100 µs | Amplitude: ±2 to ±700 mV<br>Width: 0.1 to 2 ms<br>Rise time: 10 to 100 µs | Same | |
| HR | | | | |
| Measurement range | Neonate: 15 to 350 bpm<br>Pediatric: 15 to 350 bpm<br>Adult: 15 to 300 bpm | | Neonate: 15 to 350 bpm<br>Pediatric: 15 to 350 bpm<br>Adult: 15 to 300 bpm | Same |
| Accuracy | ±1% or 1 bpm, whichever is greater | | ±1 bpm or ±1%, whichever is greater | Same |
| Resolution | 1 bpm | | 1 bpm | Same |
| RESP monitor | | | | |
| Principle of Operation | Thoracic impedance | | Trans-thoracic impedance | Same |
| Measurement Range | Adult: 0 to 120 rpm<br>Pediatric/neonate: 0 rpm to 150rpm |…