OMNI PATENT MONITORS
Device Facts
| Record ID | K132229 |
|---|---|
| Device Name | OMNI PATENT MONITORS |
| Applicant | Infinium Medical |
| Product Code | MWI · Cardiovascular |
| Decision Date | Feb 21, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2300 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The purpose and function of the OMNI patient monitor is to monitor basic physiological parameters including ECG waveform derived from 3, 5 or 12 lead measurements . Heart Rate . NIBP(systolic, diastolic, and mean arterial pressure) . . SpO2 Respiration . Temperature up to 2 channels (Dual Temperature) . . CO2 IBP . Anesthetic agents . The target population is for adult, neonate and pediatric patients. It may be used as bedside or portable monitor and be used in all hospitals and hospitaltype facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.
Device Story
Omni Series Patient Monitors (Omni, Omni II, Omni III, Omni Express) are comprehensive, portable, battery-powered systems for monitoring physiological parameters. Inputs include ECG (3/5/12-lead), NIBP, SpO2, respiration, temperature, CO2, IBP, anesthetic agents, and cardiac output. The device integrates measuring modules, display, and recorder into a single unit. Used in hospitals, clinics, and emergency rooms by healthcare practitioners for bedside or transport monitoring. Data is processed and displayed in real-time to assist clinicians in patient assessment. Benefits include continuous patient status tracking and portability during transport.
Clinical Evidence
Bench testing only. Compliance with BS EN 60601-2-34:2000 for IBP and ANSI/AAMI EC13:2002/(R)2007 for ECG. Cardiac output testing performed without a specific standard. No clinical data provided.
Technological Characteristics
Portable, battery-powered patient monitoring system. Features integrated parameter modules, display, and recorder. Connectivity includes multi-lead ECG, NIBP, SpO2, temperature, CO2, IBP, and anesthetic agent sensors. Standards: BS EN 60601-2-34:2000 (IBP), ANSI/AAMI EC13:2002/(R)2007 (ECG).
Indications for Use
Indicated for adult, neonate, and pediatric patients requiring monitoring of physiological parameters (ECG, heart rate, NIBP, SpO2, respiration, temperature, CO2, IBP, anesthetic agents, and cardiac output). Cardiac output monitoring is restricted to adult patients only. For use in hospitals, clinics, and emergency facilities under direct supervision of a licensed healthcare practitioner.
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
- Datascope Corp. Spectrum™ Monitor (K062098)
- OMNI Patient Monitor (K112329)
- OMNI II Patient Monitor (K103737)
- OMNI III Patient Monitor (K101052)
- OMNI Express Patient Monitor (K1037268)
Submission Summary (Full Text)
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FEB 2 1 2014
ﮨﮯ ﻧ
# 510(k) SUMMARY (as required by 807.92(c))
| Regulatory Correspondent: | AJW Technology Consultants Inc<br>445 Apollo Beach Blvd<br>Apollo Beach, FL 33572<br>John O'Brien<br>jobrien@ajwtech.com<br>813-645-2855 x101<br>813-645-2856 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter of 510(k): | Infinium Medical<br>12151 62nd Street North #5<br>Largo, FL 33773<br>Suleyman Bilgutay<br>sales@infiniummedical.com |
| Date of Summary: | June 8, 2013 |
| Trade/Proprietary Name: | Omni Series Patient Monitors |
| Common Name: | Patient Physiological Monitor (without Arrhythmia<br>Detection or Alarms) |
| Classification Name: | Monitor, physiological, patient (without Arrhythmia<br>detection or alarms) |
| Device Class: | II |
| Device Panel: | Cardiovascular |
| Product Code: | MWI |
# Subsequent Product Codes:
| Regulation Number | Description | Product Code | Applicable Monitor |
|-------------------|----------------------------------------------|--------------|--------------------|
| 870.2340 | Electrocardiograph | DPS | All |
| 870.1130 | Noninvasive Blood<br>Pressure<br>Measurement | DXN | All |
| 870.2700 | Oximeter | DQA | All |
| 868.2375 | Breathing frequency | BZQ | All |
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K132229
page 2 of 7
| | monitor | | |
|----------|----------------------------------------------------------|-----|----------------------------|
| 880.2910 | Clinical Electronic<br>Thermometer | FLL | All |
| 870.1110 | Blood Pressure<br>Computer | DSK | OMNI, OMNI II,<br>OMNI III |
| 870.1425 | Programmable<br>diagnostic computer | DQK | All |
| 870.1435 | Single-function,<br>preprogrammed<br>diagnostic computer | DXG | OMNI II, OMNI III |
| 868.1400 | Carbon dioxide gas<br>analyzer | CCK | All |
# Intended Use:
#### OMNI
The purpose and function of the OMNI patient monitor is to monitor basic physiological parameters including
- ECG waveform derived from 3, 5 or 12 lead measurements .
- Heart Rate .
- NIBP(systolic, diastolic, and mean arterial pressure) .
- . SpO2
- Respiration .
- Temperature up to 2 channels (Dual Temperature) .
- . CO2
- IBP .
- Anesthetic agents .
The target population is for adult, neonate and pediatric patients.
It may be used as bedside or portable monitor and be used in all hospitals and hospitaltype facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.
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## OMNI II
The purpose and function of the OMNI II patient monitor is to monitor basic physiological parameters including
- ECG waveform derived from 3, 5 or 12 lead measurements .
- Heart Rate .
- NIBP(systolic, diastolic, and mean arterial pressure) .
- SpO2 .
- Respiration .
- Temperature up to 2 channels (Dual Temperature) .
- . CO2
- . Cardiac Output
- IBP .
- . Anesthetic agents
The target population is for adult, neonate and pediatric patients with the exception of:
- · Cardiac Output for which the target population is adult only.
It may be used as bedside or portable monitor and be used in all hospitals and hospitaltype facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.
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#### page 4 of 7
### OMNI III
The purpose and function of the OMNI III patient monitor is to monitor basic physiological parameters including
- ECG waveform derived from 3, 5 or 12 lead measurements .
- Heart Rate .
- NIBP(systolic, diastolic, and mean arterial pressure) .
- SpO2 .
- Respiration .
- Temperature up to 2 channels (Dual Temperature) .
- CO2 .
- Cardiac Output ●
- . IBP
- Anesthetic agents .
The target population is for adult, neonate and pediatric patients with the exception of:
- · Cardiac Output for which the target population is adult only.
It may be used as bedside or portable monitor and be used in all hospitals and hospitaltype facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.
{4}------------------------------------------------
#### OMNI Express
The purpose and function of the OMNI Express patient monitor is to monitor basic physiological parameters including
- ECG waveform derived from 3 to 5 lead measurements .
- Heart Rate .
- NIBP(systolic, diastolic, and mean arterial pressure) ●
- . SpO2
- . Respiration
- . Temperature - up to 2 channels (Dual Temperature)
- CO2
- . Anesthetic agents
The target population is for adult, neonate and pediatric patients.
It may be used as bedside or portable monitor and be used in all hospitals and hospitaltype facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.
## Device Description:
#### OMNI
The OMNI monitor is a comprehensive monitoring system with four, six or eight traces compiling, and 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 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.
#### OMNI II
The OMNI II monitor is a comprehensive monitoring system with four, six or eight traces compiling, and 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.
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## OMNI III
The OMNI III monitor is a comprehensive monitoring system with eight traces compiling, and processing, analyzing and displaying data from up to six 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 III 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.
#### OMNI Express
The OMNI EXPRESS monitor is a comprehensive monitoring system with two or three traces compiling, and 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 2 hours of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor.
## Substantial Equivalence:
The OMNI patent monitor is substantial equivalent in intended use and similar technological characteristics of IBP, CO2. Anesthetic Agents, and 12 Lead ECG to the Datascope Corp. Spectrum™ Monitor under K062098.
The OMNI II and OMNI III are substantially equivalent to the Datascope Corp. Spectrum™ Monitor under K062098 in intended use and similar technological characteristics of IBP, CO2, Anesthetic Agents, 12 Lead ECG and Cardiac output .
The OMNI Express is substantially equivalent to the Datascope Corp. Spectrum™ Monitor under K062098 as it pertains to CO2 and Anesthetic Agents.
The OMNI Patient Monitors are substantially equivalent to the previously cleared OMNI Patient Monitors as it pertains to previously cleared technological characteristics and performance. A comparison of these technological characteristics is included in the submission.
| Device | Clearance Number | Substantial Equivalence to |
|-----------------------------------------|------------------|-------------------------------------------------------------------------------------|
| Datascope Corp - Spectrum<br>TM Monitor | K062098 | Intended use and functions of IBP,<br>CO2, Cardiac Output, Anesthetic<br>Agents |
| OMNI Patient Monitor | K112329 | Intended use<br>Previously Cleared Technological<br>Characteristics and Performance |
| OMNI II Patient Monitor | K103737 | Intended use |
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| | | Previously Cleared Technological<br>Characteristics and Performance |
|---------------------------------|----------|-------------------------------------------------------------------------------------|
| OMNI III Patient Monitor | K101052 | Intended use<br>Previously Cleared Technological<br>Characteristics and Performance |
| OMNI Express Patient<br>Monitor | K1037268 | Intended use<br>Previously Cleared Technological<br>Characteristics and Performance |
## Rational for Substantial Equivalence:
The testing completed in the previously cleared submissions along with the additional testing completed demonstrates that the OMNI Series Patient Monitors exhibit comparable mechanical and functional characteristics to the predicate devices in addition to being biocompatible acceptable. Based on those characteristics, the Infinium OMNI Patient Monitors are substantially equivalent to the predicate devices in safety and effectiveness in addition to being intended for the same uses.
# Summary of Non-Clinical Data:
The OMNI series patient monitors underwent bench testing according to several different performance standards. Below is a chart of the different testing that was completed.
| Patient Monitor | Performance Test | Standard of Compliance |
|-------------------|------------------|--------------------------------|
| OMNI | IBP | BS EN 60601-2-34:2000 |
| OMNI | ECG | ANSI/AAMI<br>EC13:2002/(R)2007 |
| OMNI II, OMNI III | IBP | BS EN 60601-2-34:2000 |
| OMNI II, OMNI III | ECG | ANSI/AAMI<br>EC13:2002/(R)2007 |
| OMNI II, OMNI III | Cardiac Output | No Standard |
Based on the conclusions of each of these tests it is determined that the OMNI Patient Monitors are safe and effective.
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Public Health Scrvice
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Image /page/7/Picture/3 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: the department's name arranged in a circular fashion around the left side and a stylized symbol on the right. The symbol is a graphic representation of an abstract human figure embracing or protecting something, possibly representing health and well-being.
Re:
February 21, 2014
Infinium Medical c/o Mr. John O'Brien 445 Apollo Beach Blvd Apollo Beach, FL 33572 US
> K13229 Trade/Device Name: Omni Patient Monitors (Models: Omni, Omni II, Omni III and Omni Express) Regulation Number: 21 CFR 870.2340 Regulation Name: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Regulatory Class: Class II Product Code: MWI Dated: January 13, 2014 Received: January 16, 2014
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it r your device 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 statues 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 of medical device-related adverse labornig (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.
{8}------------------------------------------------
Page 2 - Mr. John O'Brien
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
# Owen P. Faris -S
for
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):
Device Name: OMNI Patient Monitor
The purpose and function of the OMNI patient monitor is to monitor basic physiological parameters including
- ECG waveform derived from 3, 5 or 12 lead measurements .
- Heart Rate .
- NIBP(systolic, diastolic, and mean arterial pressure) t
- . SpO2
- Respiration .
- Temperature up to 2 channels (Dual Temperature) .
- . CO2
- . IBP
- Anesthetic agents .
The target population is for adult, neonate and pediatric patients:
It may be used as bedside or portable monitor and be used in all hospitals and hospitaltype facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
the control control control control controllers.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
#### Concurrence of CDRH, Office of Device Evaluation (ODE)
Digitally signed by
Owen P. Faris -S
Date: 2014.02.21
14:03:26-05'00'
Page I of I
{10}------------------------------------------------
# K132229 page 2 of 4
Indications for Use
510(k) Number (if known):
Device Name: OMNI II Patient Monitor
The purpose and function of the OMNI II patient monitor is to monitor basic physiological parameters including
- ECG waveform derived from 3, 5 or 12 lead measurements .
- Heart Rate ●
- NIBP(systolic, diastolic, and mean arterial pressure) .
- SpOz ●
- Respiration .
- . Temperature - up to 2 channels (Dual Temperature)
- . CO2
- Cardiac Output ●
- . IBP
- Anesthetic agents ●
The target population is for adult, neonate and pediatric patients with the exception of:
- Cardiac Output for which the target population is adult only. .
It may be used as bedside or portable monitor and be used in all hospitals and hospitaltype facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.
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)
Digitally signed by
Owen P. Faris -S
Date: 2014.02.21
14:03:43 -05'00'
Page i of I
{11}------------------------------------------------
# K132229 page 3 of 4
Indications for Use
510(k) Number (if known):
Device Name: OMNI III Patient Monitor
The purpose and function of the OMNI III patient monitor is to monitor basic physiological parameters including
- ECG waveform derived from 3, 5 or 12 lead measurements ●
- Heart Rate �
- NIBP(systolic, diastolic, and mean arterial pressure) .
- . SpOz
- Respiration .
- Temperature up to 2 channels (Dual Temperature) ●
- � CO2
- Cardiac Output .
- IBP
- Anesthetic agents .
The target population is for adult, neonate and pediatric patients with the exception of:
- · Cardiac Output for which the target population is adult only.
It may be used as bedside or portable monitor and be used in all hospitals and hospitaltype facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.
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)
Digitally signed by
Owen P. Faris -5
Date: 2014.02.21
14:04:01 -05'00'
Page 1 of 1
{12}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name: OMNI Express Patient Monitor
The purpose and function of the OMNI Express patient monitor is to monitor basic physiological parameters including
- ECG waveform derived from 3 to 5 lead measurements .
- Heart Rate .
- NIBP(systolic, diastolic, and mean arterial pressure) .
- SpO2 .
- Respiration .
- Temperature up to 2 channels (Dual Temperature) .
- . CO2
- � Anesthetic agents
The target population is for adult, neonate and pediatric patients:
It may be used as bedside or portable monitor and be used in all hospitals and hospitaltype facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.
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)
Digitally signed by
Owen P. Faris -S
Date: 2014.02.21
14:04:19 -05'00'
Page 1 of 1
