PATIENT MONITOR

K110922 · Edan Instruments, Inc. · MHX · Jul 20, 2011 · Cardiovascular

Device Facts

• Record ID: K110922
• Device Name: PATIENT MONITOR
• Applicant: Edan Instruments, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Jul 20, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

M80: The monitor monitors parameters such as ECG (3-lead, 5-lead, 12-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. M50: The monitor monitors parameters such as ECG (3-lead, 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (dual-IBP, NIBP), Temperature (dual-TEMP), Expired CO2 and Quick Temperature (Quick TEMP. 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. The arrhythmia detection and ST Segment analysis are not intended for neonatal patients.

Device Story

Patient monitors M50/M80 provide continuous physiological monitoring; inputs include ECG, SpO2, NIBP, IBP, RESP, TEMP, CO2, CO, and AG via patient-connected sensors/electrodes. Device processes signals to display real-time waveforms and numeric values; performs arrhythmia and ST-segment analysis; triggers visual/audible alarms for abnormal physiological states or system faults. Used in clinical environments by physicians and nurses; touch-screen interface allows parameter configuration and alarm management. Output assists clinicians in patient assessment and timely intervention. Benefits include continuous oversight of patient status and rapid detection of adverse events.

Clinical Evidence

Bench testing only. Evidence includes software testing, hardware testing, safety testing, environmental testing, risk analysis, and final validation to demonstrate substantial equivalence to predicate devices.

Technological Characteristics

Modular patient monitoring system; M50 (8.4-inch) and M80 (15-inch) touch-screen displays. Parameters: ECG, SpO2 (EDAN/Nellcor modules), NIBP (EDAN/Omron modules), IBP, RESP, TEMP, CO2, CO, AG. Connectivity via standard patient leads/transducers. Class II device; software-based arrhythmia and ST-segment analysis.

Indications for Use

Indicated for continuous monitoring of physiological parameters including ECG, respiration, SpO2, NIBP/IBP, temperature, CO2, cardiac output, and anesthetic gas in clinical settings. Arrhythmia detection and ST segment analysis are contraindicated for neonatal patients. Not for home 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

• PM-8000 Express (K053193)
• M3B (K083821)
• BX-10 (K032857)
• BeneView T5 (K073280)

Reference Devices

• H100B Pulse Oximeter (K092727)
• PC ECG (K102854)
• PC ECG (K092010)

Submission Summary (Full Text)

{0}------------------------------------------------

JUL 2 0 2011

Patient Monitor Traditional 510K Submission

# 510(k) Summary of Safety and Effectiveness

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: Randy Jiang

Date of Preparation:

2011-03-20

Proprietary Name:

Patient Monitor (Models M50 and M80)

- Classification:

| Description | Classification | Product<br>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 connector) | II | DSA |
| 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

K110922
pi/4

{1}------------------------------------------------

Section 1

## Patient Monitor Traditional 510K Submission

Legally Marketed Predicate Devices: :

| Manufacturer | Predicate Device | 510(k) number | Cleared date |
|------------------------------------------------------|------------------|---------------|---------------|
| Shenzhen Mindray Bio-medical<br>Electronics co., LTD | PM-8000 Express | K053193 | Oct.25.2005 |
| Edan Instruments, Inc | M3B | K083821 | May. 14.2009 |
| Colin Medical Instruments Corp | BX-10 | K032857 | April.21.2003 |
| Shenzhen Mindray Bio-medical<br>Electronics co., LTD | BeneView T5 | K073280 | Nov.8.2007 |

#### Device Description:

.. `

M50/M80 Patient Monitor provides the following primary features:

M50/M80 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.

M50 Patient Monitor can monitor parameters including SpO2, NIBP. ECG, RESP, TEMP, CO2, IBP.

M80 Patient Monitor can monitor parameters including SpO2, NIBP, ECG RESP, TEMP, CO2, IBP, C.O. and AG.

M50 is outfitted with a 8.4-inch display screen, M80 is 15-inch, as well as an equal large touch screen. which enables the operation by touching the screen, thus offering convenience for doctors and nurses.

M50 Patient Monitor has parameter modules including 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. CO2, IBP and Ouick Temp.

M80 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, CO2, CO, IBP, AG

The EDAN SpO2 module used in M80 and M50 is also used by H100B Pulse Oximeter which has been cleared by FDA under K092727. The CO2 module and Nellcor SpO2 module used in M80 are the same to those used in M3B, which has been cleared by K083821 in May 14, 2009.

M80 could be configured with two different NIBP modules, one is EDAN NIBP module, the other one is Omron M3600 NIBP module; M3600 module used in M80 is the same to that used in BX-10. which has been cleared by K032857 in April.21.2003.

{2}------------------------------------------------

### Patient Monitor Traditional 510K Submission

### Section 1

CO2 module and Nellcor SpO2 module used in M50 are the same to those used in M3B, which has been cleared by K083821 in May 14, 2009.

Arrhythmia and ST Analysis used in M80 is the same to that in PC ECG which has been cleared by FDA under K102854 and K092010

### Comparison with predicate device

The M50 and M80 Patient Monitors have the following similarities to that which previously received 510(k) concurrence:

· have the same indications for use,

· use the similar 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 M50 and M80 Patient Monitor described in this submission is, in our opinion, substantially equivalent to the predicate device

#### Intended Use:

| M80: | The monitor monitors parameters such as ECG (3-lead, 5-lead, 12-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. |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| M50: | The monitor monitors parameters such as ECG (3-lead, 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (dual-IBP, NIBP), Temperature (dual-TEMP), Expired CO2 and Quick Temperature (Quick TEMP. 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. The arrhythmia detection and ST Segment analysis are not intended for neonatal patients. |
| 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 |

{3}------------------------------------------------

Section 1

## Patient Monitor Traditional 510K Submission

| | · Software testing | |
|--|--------------------|--|
|--|--------------------|--|

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

## Conclusion:

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.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services USA. The logo features the department's emblem, which is a stylized representation of an eagle or bird in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the upper half of the circle, following its curvature. The emblem is positioned in the center of the circle, with the text surrounding it.

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

Edan Instruments, Inc. c/o Mr. Randy Jiang Certificate Engineer 3/F-B, Nanshan Medical Equipments Park, Nanhai RD1019 Shenzhen, Guangdong CHINA 518067

JUL 20 2011

Re: K110922

> Trade/Device Name: Patient Monitor Models M50 and M80 Regulatory Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: MHX, DRT, DXN, DSK, FLL, DQA, CCK, CBQ, CBS, CBR, CCL, DSA, . DRT, DSF, and MLD Dated: June 25, 2011 Received: June 27, 2011

Dear Mr. Jiang:

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 Amendmouts, or to devices that have been reclassified in accordance with the provisions of the Federal Foond, Orug 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, issue of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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 ann be

{5}------------------------------------------------

Page 2 - Mr. Randy Jiang

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or.at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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

Enclosure

{6}------------------------------------------------

Section 1

### Indication for Use

510(k) Number (if known):

Device Name: Patient Monitor Models M50 and M80

M80:

The monitor monitors parameters such as ECG (3-lead, 12-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.

MSO:

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

The arrhythmia detection and ST Segment analysis are not intended for neonatal patients.

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 Evaluatio

Atith De for B. Zuckerman

(Division Sign-Off)
7/20/201
Division of Cardiovascular Devices
510(k) Number K110922