VITAL SIGNS MONITOR

K120144 · Edan Instruments, Inc. · DXN · Feb 14, 2012 · Cardiovascular

Device Facts

• Record ID: K120144
• Device Name: VITAL SIGNS MONITOR
• Applicant: Edan Instruments, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Feb 14, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Vital Signs Monitor models M3 and M3A (hereinafter called monitor) is intended to be used for non-invasive continuous monitoring of SpO2 (oxygen saturation of the blood), NIBP (non-invasive blood pressure) and TEMP (temperature). The monitor is intended to be used only under regular supervision of clinical personnel. It is applicable to adult, pediatric, and neonatal usage in hospitals, hospital type facilities and intra-hospital moves. 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

Vital Signs Monitor M3/M3A provides continuous non-invasive monitoring of SpO2, NIBP, and temperature; utilizes LCD/LED display for numeric and waveform data; includes infrared ear temperature measurement and Nellcor or EDAN SpO2 modules. Operated by clinical personnel in hospitals or during intra-hospital transport; features nurse call, visual/audible alarms for system faults or parameter limit breaches, and trend graph review. Data storage via USB; wired/wireless network capability. Output allows clinicians to track patient physiological status; supports clinical decision-making through real-time monitoring and alarm notifications. Powered by built-in Lithium-ion battery.

Clinical Evidence

Bench testing only. Evidence includes software testing, safety testing, performance testing, risk analysis, and final validation to demonstrate substantial equivalence.

Technological Characteristics

Non-invasive monitoring system; includes LCD/LED display, Nellcor or EDAN SpO2 modules, and infrared ear temperature sensors. Features wired/wireless network connectivity and USB data storage. Powered by internal Lithium-ion battery. Class II device.

Indications for Use

Indicated for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, and during intra-hospital transport for continuous non-invasive monitoring of SpO2, NIBP, and temperature.

Regulatory Classification

Identification

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

Predicate Devices

• M3, M3A (K102835)
• THP59J (K111637)

Submission Summary (Full Text)

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KI20144

### FEB 1 4 2012 510K)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: Jiang Yucai |
| | |
| Proprietary Name: | Vital Signs Monitor Models M3 and M3A |
| Classification Name: | 21 CFR 870.1130 Noninvasive blood pressure measurement system |
| | 21 CFR 870.2700, Oximeter |
| | 21 CFR 880.2910 Clinical electronic thermometer |
| Product code: | DQA, DXN, FLL |
| Classification: | Class II |
| Predicate Devices: | |

| Manufacturer | Predicate Device | 510(k) # |
|--------------------------|------------------|----------|
| EDAN INSTRUMENTS, INC. | M3,M3A | K102835 |
| RADIANT INNOVATION, INC. | THP59J | K111637 |

M3 and M3A Vital Signs Monitor is a patient monitoring device providing the Device Description: patient with a continuous vital physiological monitoring of non-invasive continuous monitoring of SpO2 (oxygen saturation of the blood), NIBP (non-invasive blood pressure) and TEMP (temperature), in a hospital, hospital type facilities environment and intra-hospital moves. The following lists the detailed features of the subject device.

- . LCD or LED display
- SpO2, Pulse Rate NIBP and fast TEMP measurement .
- Infrared ear temperature measurement �
- Nellcor or EDAN SpO2 module .
- Display numeric and waveform information simultaneously .
- Nurse call feature .
- Built-in Lithium-ion Battery .

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- . Suitable for adult, pediatric and neonate patients
- Visual and audible alarm .
- Trend graph review and record .
- USB data storage and review .
- Wired and wireless network capability .

#### Comparison with predicate device

| Monitoring unctions | Subject device | Predicated device |
|---------------------|----------------|-------------------|
| SpO2 | yes | yes |
| Pulse Rate | yes | yes |
| Alarm feature | yes | yes |
| NIBP | yes | yes |
| Temperature | yes | yes |

#### Intended Use:

The Vital Signs Monitor models M3 and M3A (hereinafter called monitor) is intended to be used for non-invasive continuous monitoring of SpO2 (oxygen saturation of the blood), NIBP (non-invasive blood pressure) and TEMP (temperature).

The monitor is intended to be used only under regular supervision of clinical personnel. It is applicable to adult, pediatric, and neonatal usage in hospitals, hospital type facilities and intra-hospital moves.

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 following quality assurance measures were applied to the Test Summary: development of the Vital Signs Monitor Models M3 and M3A:

- Software testing
- · Safety testing
- · Performance testing
- · Risk analysis
- Final validation

## Verification and validation testing were conducted on the Vital Signs Conclusion: Monitor Models M3 and M3A. This premarket notification submission demonstrates that Vital Signs Monitor Models M3 and M3A is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

FEB 1 4 2012

Edan Instruments, Inc. c/o Mr. Randy Jiang Certification Engineer 3/F-B, Nanshan Medical Equipment Park, Nanhai Rd., 1019 No. Shenzhen CHINA 518067

Re: K120144

Trade/Device Name: Vital Signs Monitor, Models M3 and M3A Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II (two) Product Codes: DXN, DQA, FLL Dated: January 16, 2012 Received: January 18, 2012

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 for association 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.

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 i hat FDA has made a determination that your device complies with other requirements of the Act

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## Page 2 - Mr. Randy Jiang

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

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EXHIBIT #3

# Indications for Use

510(k) Number (if known):

K120144

Device Name: Vital Signs Monitor models M3 and M3A

The Vital Signs Monitor models M3 and M3A (hereinafter called monitor) is intended to be used for non-invasive continuous monitoring of SpO2 (oxygen saturation of the blood), NIBP (non-invasive blood pressure) and TEMP (temperature).

The monitor is intended to be used only under regular supervision of clinical personnel. It is applicable to adult, pediatric, and neonatal usage in hospitals, hospital type facilities and intra-hospital moves.

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)

sion of Cardiovascular Devices

510(k) Number K120144