OMNI II PATIENT MONITOR

K103737 · Infinium Medical · MWI · Jun 2, 2011 · Cardiovascular

Device Facts

• Record ID: K103737
• Device Name: OMNI II PATIENT MONITOR
• Applicant: Infinium Medical
• Product Code: MWI · Cardiovascular
• Decision Date: Jun 2, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The purpose and function of the OMNI II Patient monitor is to monitor ECG, heart rate, NIBP (systolic, diastolic, and mean arterial pressures), SpO2, respiration, and temperature, for adult, neonate and pediatric patients. It may be used as a bedside or portable monitor and be used in all hospitals and hospital type facilities such as clinics and emergency room facilities.

Device Story

Omni II is a comprehensive physiological monitoring system; inputs include ECG, heart rate, NIBP, SpO2, respiration, and temperature sensors. Device processes, analyzes, and displays data from up to eight parameters on a 12.1-inch screen. Used in hospitals, clinics, and emergency rooms as a bedside or portable monitor; operated by healthcare professionals. Features integrated parameter modules, display, and recorder; powered by internal rechargeable lead-acid battery or AC power. Output provides real-time patient vital signs to clinicians for assessment and decision-making; portability facilitates patient transport.

Clinical Evidence

Bench testing only. Performance verified through electrical safety and software validation testing, including ANSI/AAMI EC13:2002 (cardiac monitors), IEC 60601-1-2:2007 (EMC), ISO 9919:2005 (pulse oximeters), IEC 60601-2-27:2005 (ECG monitoring), and AAMI/ANSI SP10:2002 (sphygmomanometers).

Technological Characteristics

Comprehensive monitoring system with 4, 6, or 8 traces. 12.1-inch display. Powered by internal rechargeable lead-acid battery or AC power. Parameters: ECG, heart rate, NIBP, SpO2, respiration, temperature. Integrated parameter modules, display, and recorder. Compact, portable form factor.

Indications for Use

Indicated for adult, pediatric, and neonate patients requiring monitoring of ECG, heart rate, NIBP (systolic, diastolic, mean arterial pressure), SpO2, respiration, and temperature in hospital or clinical settings.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Predicate Devices

• OMNI Express Patient Monitor (K103268)

Submission Summary (Full Text)

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

103737

# JUN - 2 2011

1/2

# Special 510(k) SUMMARY (as required by 807.92(c))

Regulatory Correspondent:

ﻨﺔ.. . . ﺧﺘ

.

AJW Technology Consultants, Inc 962 Allegro Lane Apollo Beach, FL 33572 John O'Brien [e-mail] [phone] [phone]

Submitter of 510(k):

Infinium Medical 12151 62nd Street North #5 Largo, FL 33773 Suleyman Bilgutay [e-mail]

Date of Summary:

Classification Name:

Trade/Proprietary Name:

Omni II Patient Monitor

December 10, 2010

Monitor, physiological, patient (without arrhythmia detection or alarms.

#### Product Code: MWI

### Reason for Submission:

The reason for this submission is to provide information that will verify the safety and effectiveness of the Omni II patient monitor in order to be cleared for sale in the United States. The main differences between the Omni II and the Omni Express are:

- The Omni II is larger which enables it to have a display that is 12.1 inches compared to . the predicates 7 inch display.
- The Omni II uses a rechargeable lead acid battery and the predicate uses a rechargeable . lithium ion battery.

#### Intended Use:

The purpose and function of the Omni II patient monitor basic physiological parameters including, ECG, heart rate, NIBP (systolic, and mean arterial pressures), SpO2, respiration, and temperature for adult, neonate and pediatric patients. It may be used as a bedside or portable monitor and be used in all hospital-type facilities such as clinics and emergency room facilities.

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

## Device Description:

.

The OMNI II monitor is a comprehensive monitoring system with four, six or eight traces compiling, processing, analyzing and displaying data from up to eight different patient parameters. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Built-in battery facilitates transportation of patient.

The OMNI II monitor can be powered by an internal battery pack that provides 1 hour of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor.

| Predicate Device: | K103268 - OMNI Express Patient Monitor |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence: | The proposed device is substantially equivalent to the<br>Infinium OMNI Express Patient monitor which has been<br>cleared under K103268. The proposed device has the<br>same intended use and similar technological<br>characteristics as compared to the predicate device. |
| Performance Testing: | The Omni II Patient monitor underwent several electrical<br>safety tests to verify safety and effectiveness as well as<br>Software Validation.<br>• ANSI/AAMI EC13:2002 - Cardiac Monitors,<br>Heart rate meters and alarms<br>• IEC 60601-1-2:2007 - Medical electrical<br>equipment - Part 1-2: General requirements for<br>safety - Collateral standard: Electromagnetic<br>compatibility - Requirements and tests<br>• ISO 9919:2005 Medical electrical equipment -<br>particular requirements for the basic safety and<br>essential performance of pulse oximeters.<br>• IEC 60601-2-27: (2005-08), Medical electrical<br>equipment -- Part 2-27: Particular requirements<br>for the safety, including essential performance,<br>of electrocardiographic monitoring equipment.<br>• AAMI/ANSI SP10:2002 Manual, electronic or<br>automated sphygmomanometers.<br>(Cardiovascular)<br>Based on the conclusions of each of these tests it is<br>determined that the Omni II patient monitor is safe and<br>effective. |

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

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name written around the perimeter. Inside the circle is a stylized image of a human figure embracing a bird, symbolizing the department's mission to protect and promote the health and well-being of all Americans.

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

JUN - 2 2011

Infinium Medical c/o Mr. John O' Brien Regulatory Specialist AJW Technology Consultants, Inc. 962 Allegro Lane Apollo Beach, FL 33572

-Re:---- K-103737-

Trade/Device Name: OMNI II Patient Monitor Regulatory Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including Cardiotachometer and Rate Alarm) Regulatory Class: Class II (Two) Product Code: MWI Dated: April 27, 2011 Received: May 2, 2011

Dear Mr. O'Brien:

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.

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

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

Page 2 - Mr. John O' Brien

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Barry D. Zuckerman, M.D.

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

Enclosure

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

### Section 4- Indications for Use

k103737 510(k) Number (if known): _

Device Name: OMNI II Patient Monitor

The purpose and function of the OMNI II Patient monitor is to monitor ECG, heart rate, NIBP (systolic, diastolic, and mean arterial pressures), SpO2, respiration, and temperature, for adult, neonate and pediatric patients. It may be used as a bedside or portable monitor and be used in all hospitals and hospital type facilities such as clinics and emergency room facilities.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number_

Page 1 of 1

Special 510k - Omni II Patient Monitor

10 of 170