PATIENT MONITOR

K120173 · Edan Instruments, Inc. · MHX · May 16, 2012 · Cardiovascular

Device Facts

• Record ID: K120173
• Device Name: PATIENT MONITOR
• Applicant: Edan Instruments, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: May 16, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

This monitor is intended to be used for monitoring, storing, recording, and generating alarms for multiple physiological parameters including ECG, respiration (RESP), temperature (TEMP), functional arterial oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), expired CO2, cardiac output (C.O.) and anesthetic gas (AG)of adults, pediatrics and neonates in hospital environments. 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. This monitor is suitable for use in hospital environments including but not limited to OR, PACU, ICU and neonate intensive care room.

Device Story

Elite V8 is a multi-parameter patient monitor for continuous physiological data acquisition; inputs include ECG, RESP, TEMP, SpO2, NIBP, IBP, CO2, C.O., and anesthetic gases via modular sensors. Device processes signals to store, display, and analyze parameters; triggers alarms for system faults or operator-defined physiological limit breaches. Operated by clinicians in hospital environments (OR, ICU, PACU, NICU). Features 17-inch touch screen and internal battery. Output allows real-time visualization and review of patient status, supporting clinical decision-making through continuous monitoring and alert generation. Benefits include timely detection of patient abnormalities and system status.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, including software, hardware, safety, and environmental testing, alongside risk analysis and final validation.

Technological Characteristics

Modular patient monitor with 17-inch touch screen and internal Lithium-ion battery. Supports ECG, RESP, TEMP, SpO2, NIBP, IBP, CO2, C.O., and AG modules. Connectivity includes networking and online software upgrades. Sterilization not specified; materials not detailed. Software-based processing for physiological parameter analysis and alarm generation.

Indications for Use

Indicated for adult, pediatric, and neonatal patients in hospital settings (OR, PACU, ICU, NICU) requiring continuous monitoring of ECG, RESP, TEMP, SpO2, PR, NIBP, IBP, CO2, C.O., and anesthetic gases. Contraindicated for home use or use 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

• M3 and M3A (K102825)
• MP70 (K100939)
• M3B (K083821)
• ZOLL M series NIBP option (K032363)
• Carbon-dioxide gas analyzer (K103604)

Submission Summary (Full Text)

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Section 1

# 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: 2011-12-02

#### Proprietary Name: Patient Monitor Model elite V8

Classification:

| Description | Classification | Product<br>code |
|-----------------------------------------------------------------------------------------|----------------|-----------------|
| 21 CFR 870.1025 monitor, physiological, patient(with arrhythmia detection<br>or alarms) | II | MHX |
| 21 CFR 870.2300 Cardiac monitor (including cardiotachoment and rate<br>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<br>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<br>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

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| Manufacturer | Predicate Device | 510(k) # | Cleared date |
|-----------------------------|--------------------------------|----------|---------------|
| Edan Instruments, Inc | M3 and M3A | K102825 | Dec.27.2010 |
| Philips Medical System | MP70 | K100939 | April.1.2010 |
| Edan Instruments, Inc | M3B | K083821 | May. 14,2009 |
| ZOLL Medical<br>Corporation | ZOLL M series NIBP<br>option | K032363 | July 30, 2003 |
| PHASEIN AB | Carbon-dioxide gas<br>analyzer | K103604 | March.28,2011 |

### Legally Marketed Predicate Devices::

### Device Description:

The elite V8 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 abnormities happen.

The elite V8 realizes 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, CO2, IBP, C.O. and AG.

The above is the maximum configuration for elite V8, the user may select different monitoring parameters in according with the requirement.

Elite V8 configures with 17-inch touch screen and build-in Lithium-ion battery. Besides, elite V8 supports software upgrade online and networking.

#### Comparison with predicate device

The elite V8 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 or similar performance specifications .

In summary, the elite V8 Patient Monitor described in this submission is, in our opinion, substantially equivalent to the

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device.

| | predicate device |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | This monitor is intended to be used for monitoring, storing, reviewing, recording, and generating alarms for multiple physiological parameters including ECG, respiration (RESP), temperature (TEMP), functional arterial oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), expired CO2, cardiac output (C.O.) and anesthetic gas (AG)of adults, pediatrics and neonates in hospital environments.<br>This monitor is suitable for use in hospital environments including but not limited to OR, PACU, ICU and neonate intensive care room. |
| 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 <ul><li>Software testing</li><li>Hardware testing</li><li>Safety testing</li><li>Environment test</li><li>Risk analysis</li><li>Final validation</li></ul> |
| 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

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three wavy lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

#### Public Health Service

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

MAY 1 6 2012

Edan Instruments, Inc. c/o Mr. Randy Jiang Regulation Affairs Engineer 3/F - B. Nanshan Medical Equipments Park Nanhai Rd 1019#, shekou, Nanshan Shenzhen 518067 P.R. China

Re: K120173

Trade/Device Name: Patient Monitor Elite V8

Regulation Number: 21 CFR 870.1025

Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: Class II (two)

Product Code: MHX. DRT, DXN, DSK, FLL, DQA, CCK, CBQ, CBS, CBR, CCL, DSA, DRT, DSI, MLD

Dated: April 24, 2012

Received: April 25, 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 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.

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## Page 2 - Mr. Randy Jiang

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 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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#### Indication for Use

510(k) Number (if known): .

Device Name: Elite V8 Patient Monitor

This monitor is intended to be used for monitoring, storing, recording, and generating alarms for multiple physiological parameters including ECG, respiration (RESP), temperature (TEMP), functional arterial oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), expired CO2, cardiac output (C.O.) and anesthetic gas (AG)of adults, pediatrics and neonates in hospital environments. 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.

This monitor is suitable for use in hospital environments including but not limited to OR, PACU, ICU and neonate intensive care room.

Prescription Use x (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)

Division Sign-Off) Division of Cardiovascular Devices

20175 510(k) Numb

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