IM60/IM70 PATIENT MONITOR

K131971 · Edan Instruments, Inc. · MHX · Mar 20, 2014 · Cardiovascular

Device Facts

• Record ID: K131971
• Device Name: IM60/IM70 PATIENT MONITOR
• Applicant: Edan Instruments, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Mar 20, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Intended Use

iM60: The iM60 monitor monitors parameters such as ECG (3-lead, 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (2/4 channels IBP NIBP), Cardiac Output (CO), Temperature (dual-TEMP) and Expired CO2. The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both. iM70: The iM70 monitor monitors parameters such as ECG (3-lead, 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (2/4 channels IBP NIBP), Cardiac Output (CO), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG). The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.

Device Story

iM60/iM70 patient monitors provide continuous, real-time monitoring of physiological parameters; inputs include ECG, respiration, SpO2, NIBP/IBP, temperature, CO2, and anesthetic gas (iM70 only). Devices process signals via integrated modules (EDAN or Nellcor SpO2, Omron NIBP) to display waveforms and numerical data on touch screens (10.4-inch for iM60, 12.1-inch for iM70). Systems feature alarm functionality for system faults or physiological limit breaches. Used by physicians and nurses in clinical environments to facilitate timely patient assessment and clinical decision-making. Devices support data storage and analysis to assist in managing patient status.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including software, hardware, safety, and environmental testing, alongside risk analysis and final validation.

Technological Characteristics

Multi-parameter patient monitors with touch-screen interfaces. Modules include ECG, SpO2, NIBP, IBP, TEMP, RESP, EtCO2, C.O., and AG (iM70). Connectivity via integrated parameter modules. Software-based monitoring and alarm system. Class II device.

Indications for Use

Indicated for clinical monitoring of physiological parameters including ECG, respiration, SpO2, blood pressure (IBP/NIBP), cardiac output, temperature, CO2, and anesthetic gas. Intended for use by healthcare professionals in clinical settings; not for home use or without physician order.

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

• iM50 (K113623)
• iM80 (K113623)

Submission Summary (Full Text)

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K 131971 pg 1 of 4

# 510(k) Summary

This summary of 510k safety and effectiveness is being submitted in according with 21CFR part 807.92

| Submitter: | Edan Instruments, Inc |
|------------|-----------------------------------|
| | 3/F - B, Nanshan Medical |
| | Equipments Park, Nanhai Rd 1019#, |
| | shekou, Nanshan Shenzhen, |
| | 518067 P.R. China |
| | Tel: [phone] |
| | Fax:[phone] |
| | Contact person: Cherry Sun |
| | Email: [e-mail] |

Date of Preparation: 2013-01-20

| Proprietary Name: | Patient Monitor (Models iM60 and iM70) | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|--|
| promotion of the first for the first for the first for the first for the first of the first of the first of the first of the first of the first of the first and | | |

# Classification:

| Description | Classification | Product code |
|--------------------------------------------------------------------------------------------|----------------|--------------|
| 21 CFR 870.1025 Arrhythmia detector and alarm (Including ST-segment measurement and alarm) | II | MHX |
| 21 CFR 870.2300 Cardiac monitor (including cardiotachoment and rate alarm) | II | DRT |
| 21 CFR 870.1130 Non-Invasive blood pressure measurement System | II | DXN |
| 21 CFR 870.1110 Blood pressure computer | II | DSK |
| 21 CFR 880.2910 Clinical Electronic Thermometers-Temperature Monitor with Probe | II | FLL |
| 21 CFR 870.2700 Oximeter, Pulse | II | DQA |
| 21 CFR 870.1400 Carbon Dioxide Gas Analyzer | II | CCK |
| 21 CFR 868.1500 Enflurane gas analyzer | II | CBQ |
| 21 CFR 868.1620 Halothane gas analyzer | II | CBS |
| 21 CFR 868.1700 Nitrous Oxide gas analyzer | II | CBR |
| 21 CFR 868.1720 Oxygen gas analyzer | II | CCL |
| 21 CFR 868.2900 cable, transducer and electrode, patient, (including | II | DSA |

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| connector) | | |
|------------------------------------------------------------------------|----|-----|
| 21 CFR 870.2300 monitor, cardiac (incl. cardiotachometer & rate alarm) | II | DRT |
| 21 CFR 870.1025 Detector and Alarm, Arrhythmia | II | DSI |
| 21 CFR 870.1025 Monitor, ST Segment with Alarm | II | MLD |

#### Regulatory Class: Class II

### Legally Marketed Predicate Devices:

| Manufacturer | Predicate Device | 510(k) number | Cleared date |
|-----------------------|------------------|---------------|--------------|
| Edan Instruments, Inc | iM50 | K113623 | Feb.1.2012 |
| Edan Instruments, Inc | iM80 | K113623 | Feb.1.2012 |

Device Description: iM60/iM70 Patient Monitor 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.

> iM60 is outfitted with a 10.4-inch display screen, iM70 is I 2.1-inch, as well as an equally large touch screen, which enables the operation by touching the screen, thus offering convenience for doctors and nurses.

> iM60 Patient Monitor has parameter modules including SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP, TEMP, ECG, RESP, EtCO2, IBP and C.O..

> iM70 Patient Monitor has parameter modules including SpO2 with EDAN SpO2 module or Nellcor SPO2 module, NIBP with EDAN NIBP module or Omron M3600, TEMP, ECG, RESP, EtCO2, C.O., IBP, AG.

Comparison with predicate device

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The iM60 and iM70 Patient Monitors have the following similarities to that which previously received 510(k) concurrence:

- · have the same indications for use,
- · use the same operating principle,
- · have the same testing module, e.g. EDAN SpO2 module and Nellcor NELL-1 module.
- · have the same or similar performance specifications

In summary, the iM60 and iM70 Patient Monitor described in this submission are substantially equivalent to the predicate device.

### Intended Use:

### !M60:

The iM60 monitor monitors parameters such as ECG (3-lead, 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (2/4 channels IBP NIBP), Cardiac Output (CO), Temperature (dual-TEMP) and Expired CO2. The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both. iM70:

The iM70 monitor monitors parameters such as ECG (3-lead, 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (2/4 channels IBP NIBP), Cardiac Output (CO), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG). The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.

## Contraindications: It is not intended for use in patient's home or residence, or when it has not been ordered by a physician. Test Summary:

The following quality assurance measures were applied to the development of the Patient Monitor

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- Software testing
- Hardware testing
- Safety testing
- Environment test
- Risk analysis
- Final validation

# Conclusion:

ং : পর্যন্ত | ;

> Verification and validation testing was done on the Patient Monitor. This premarket notification submission demonstrates that Patient Monitor is substantially equivalent to the predicate device.

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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

March 20, 2014

Edan Instruments, Inc. Ms. Cherry Sun Certification Engineer 3/F-B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, Shekou, Nanshan, Shenzhen, Guangdong 518067 P.R. China

Re: K131971

Trade/Device Name: iM60/iM70 Patient Monitor 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, DRT, DXN, DSK, FLL, DQA, CCK, CBQ, CBS, CBR, CCL, DSA, DSI, MLD Dated: February 7, 2014 Received: February 10, 2014

Dear Ms. Sun:

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

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Page 2 - Ms. Cherry Sun

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); 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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/ReportalProblem/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 Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

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

Enclosure

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# Indication for Use

510(k) Number (if known): K 131971

Device Name: Patient Monitor Models iM60 and iM70

!M60:

The iM60 monitor monitors parameters such as ECG (3-lead, 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (2/4 channels IBP NIBP), Cardiac Output (CO), Temperature (dual-TEMP) and Expired CO2. The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.

iM70:

The iM70 monitor monitors parameters such as ECG (3-lead, 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (2/4 channels IBP NIBP), Cardiac Output (CO), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG). The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.

× Prescription Use (21 CFR Part 801 Subpart D) And/Or Over the Counter Use (21 CFR Part 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Date
21.03.20
10:38:47 -04'00'
for Bram Zuckerman