(19 days)
Not Found
No
The document describes a standard patient monitor that processes and displays physiological data. There is no mention of AI, ML, or any related concepts.
No.
The device is a patient monitor, which measures and displays physiological parameters. It does not actively treat or alleviate a disease or condition.
Yes
This device monitors physiological parameters and displays them, which is a diagnostic function to assess a patient's health status.
No
The device description explicitly states it integrates parameter measuring modules, display, recorder, and a built-in battery, indicating it is a hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes monitoring physiological parameters directly from the patient (ECG, heart rate, NIBP, SpO2, respiration, temperature). This is in vivo monitoring, not in vitro (testing samples outside the body).
- Device Description: The description focuses on a patient monitor that integrates parameter measuring modules, display, and recorder. This aligns with a device used for direct patient monitoring.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
Therefore, the Omni Express patient monitor is a device for direct patient monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
MWI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
adult, neonate and pediatric patients.
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
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.(b)
Classification. Class II (performance standards).
0
Special 510(k) SUMMARY (as required by 807.92(c))
NOV 2 3 2010
| Regulatory Correspondent: | AJW Technology Consultants, Inc
962 Allegro Lane
Apollo Beach, FL 33572
John O'Brien
jobrien@ajwtech.com
(813)645-2855
(813)677-4787 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter of 510(k): | Infinium Medical
12151 62nd Street North #5
Largo, FL 33773
Suleyman Bilgutay
sales@infiniummedical.com |
| Date of Summary: | September 17, 2010 |
| Trade/Proprietary Name: | Omni Express Patient Monitor |
| Classification Name: | Monitor, physiological, patient (without
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.
.
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 (800) 638-2041 or (301) 796-7100 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):
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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