OMNI EXPRESS

K103268 · Infinium Medical · MWI · Nov 23, 2010 · Cardiovascular

Device Facts

• Record ID: K103268
• Device Name: OMNI EXPRESS
• Applicant: Infinium Medical
• Product Code: MWI · Cardiovascular
• Decision Date: Nov 23, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The purpose and function of the Omni Express patient monitor is to monitor basic physiological parameters including, 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 anf hospital-type facilities such as clinics and emergency room facilities.

Device Story

Omni Express is a compact, portable patient monitor for bedside or transport use. It accepts inputs from sensors for ECG, heart rate, NIBP, SpO2, respiration, and temperature. The device processes and displays up to eight physiological parameters simultaneously via integrated measuring modules. It features a built-in battery providing 3 hours of operation, with continuous recharging when connected to AC power. Operated by clinicians in hospitals, clinics, or emergency rooms, the device provides real-time data visualization to assist healthcare providers in patient assessment and clinical decision-making. The primary benefit is continuous, portable physiological monitoring.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Compact, portable patient monitor with integrated parameter measuring modules, display, and recorder. Powered by internal battery (3-hour capacity) or AC power. Monitors ECG, heart rate, NIBP, SpO2, respiration, and temperature. Connectivity includes AC power interface. No specific materials or software architecture details provided.

Indications for Use

Indicated for adult, neonate, and pediatric patients requiring monitoring of ECG, heart rate, NIBP (systolic, diastolic, mean arterial), SpO2, respiration, and temperature in hospital, clinic, or emergency room 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 III Patient Monitor (K101052)

Submission Summary (Full Text)

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K103268

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

NOV 2 3 2010

| Regulatory Correspondent: | AJW Technology Consultants, Inc<br>962 Allegro Lane<br>Apollo Beach, FL 33572<br>John O'Brien<br>[e-mail]<br>[phone]<br>[phone] |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter of 510(k): | Infinium Medical<br>12151 62nd Street North #5<br>Largo, FL 33773<br>Suleyman Bilgutay<br>[e-mail] |
| Date of Summary: | September 17, 2010 |
| Trade/Proprietary Name: | Omni Express Patient Monitor |
| Classification Name: | Monitor, physiological, patient (without<br>arrhythmia detection or alarms. |
| Product Code: | MWI |

#### Intended Use:

The purpose and function of the Omni Express patient monitor is to monitor basic physiological parameters including, 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 anf hospital-type facilities such as clinics and emergency room facilities.

#### Device Description:

The OMNI Express patient monitor is a comprehensive monitoring system with two or three 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 Express monitor can be powered by an internal battery pack that provides 3 hours of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor.

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Predicate Device:

## Substantial Equivalence:

K101052 – OMNI III Patient Monitor

The proposed device is substantially equivalent to the Infinium OMNI III Patient monitor which has been cleared under K101052. The proposed device has the same intended use and similar technological characteristics as compared to the predicate device.

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Special 510k Omni Express Patient Monitor

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Image /page/2/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 bars representing the three branches of government. The logo is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular pattern.

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

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

NOV 2 3 2010

Re: K103268

> Trade/Device Name: OMNI Express Patient Monitor Regulatory Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) Regulatory Class: II (two) Product Code: 74 MWI Dated: September 17, 2010 Received: November 4, 2010

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 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 - Mr. John O'Brien

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 (OS) 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.html 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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Indications for Use

510(k) Number (if known):

K103268

NOV 2 3 2010

Device Name: Omni Express

The purpose and function of the OMNI Express 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) on of Cardiovascular Devices

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510/k) Numbe

Special 510k Omni Express Patient Monitor

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