(162 days)
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.
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.
The Infinium Omni II Patient Monitor is a physiological monitoring system that measures ECG, heart rate, NIBP, SpO2, respiration, and temperature for adult, neonate, and pediatric patients. It is intended for use as a bedside or portable monitor in various hospital-type facilities.
Here's an analysis of its acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text doesn't specify numerical acceptance criteria for the device's performance (e.g., accuracy ranges for NIBP, SpO2, etc.). Instead, the device's performance is demonstrated by its compliance with recognized industry standards for safety and effectiveness.
| Acceptance Criteria (Demonstrated by Compliance with Standards) | Reported Device Performance (Compliance) |
|---|---|
| Electrical Safety & Cardiac Monitoring: Ensure safe electrical operation and accurate cardiac rhythm and heart rate monitoring. | Complies with ANSI/AAMI EC13:2002 (Cardiac Monitors, Heart rate meters and alarms) and IEC 60601-2-27: (2005-08) (Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment). |
| Electromagnetic Compatibility (EMC): Ensure the device functions correctly in its intended electromagnetic environment without causing or being susceptible to undue electromagnetic interference. | Complies with IEC 60601-1-2:2007 (Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests). |
| Pulse Oximetry Performance: Ensure accurate and reliable measurement of blood oxygen saturation. | Complies with ISO 9919:2005 (Medical electrical equipment - particular requirements for the basic safety and essential performance of pulse oximeters). |
| NIBP (Non-Invasive Blood Pressure) Performance: Ensure accurate and reliable measurement of non-invasive blood pressure. | Complies with AAMI/ANSI SP10:2002 (Manual, electronic or automated sphygmomanometers). |
| Software Validation: Ensure the software operates as intended and meets its specified requirements. | Software Validation was conducted. (Specific details of validation methods or results are not provided beyond the statement that it was performed.) |
| Overall Safety and Effectiveness: The device is safe and effective for its intended use. | Based on the conclusions of all listed tests, it is determined that the Omni II patient monitor is safe and effective. |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not specify sample sizes for any test sets related to clinical performance data. The performance testing mentioned is primarily focused on compliance with recognized electrical safety and performance standards. These standards often have their own specific testing protocols, which may involve various samples or simulated environments, but details are not provided within this document.
The document does not mention any patient data or clinical data provenance. The testing appears to be primarily bench testing and software validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable or not provided in the given document. The "ground truth" for compliance with electrical safety and performance standards typically relies on standardized test methods and calibrated equipment rather than expert human evaluation to establish a clinical ground truth.
4. Adjudication Method for the Test Set
This information is not applicable or not provided as the performance testing described doesn't involve subjective expert review or adjudication of results. The tests are based on objective measurements against established standard requirements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not done or is not mentioned in this document. This type of study is typically performed for AI or diagnostic imaging devices to evaluate the impact of the device on human reader performance. The Omni II Patient Monitor is a physiological monitoring device, and its safety and effectiveness are established through compliance with technical standards, not typically through MRMC studies.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
A standalone performance study, as typically understood for an AI algorithm without human intervention, was not performed or described in this document. The device itself is a physiological monitor that provides data for clinicians; it's not an AI analysis tool in the described context. Its "performance" is demonstrated by its adherence to the technical specifications outlined in the standards.
7. The Type of Ground Truth Used
The "ground truth" for the performance testing of the Omni II Patient Monitor is established by meeting the requirements and parameters defined in the referenced industry standards. For example, an NIBP measurement system is considered "accurate" if its readings fall within the specified error margins when compared to a reference standard, as outlined in AAMI/ANSI SP10:2002. Similarly, the performance of the pulse oximeter is validated against the requirements of ISO 9919:2005, which typically includes comparison against co-oximetry reference values or simulated physiological conditions.
8. The Sample Size for the Training Set
This information is not applicable or not provided. Physiological monitors like the Omni II typically rely on established measurement principles and software algorithms, not machine learning models that require a "training set" of data in the AI sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or not provided for the same reason as point 8. The device's functionality is based on established engineering principles and validation against industry standards, not on a machine learning training paradigm.
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103737
JUN - 2 2011
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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 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:
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.
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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 theInfinium OMNI Express Patient monitor which has beencleared under K103268. The proposed device has thesame intended use and similar technologicalcharacteristics as compared to the predicate device. |
| Performance Testing: | The Omni II Patient monitor underwent several electricalsafety tests to verify safety and effectiveness as well asSoftware Validation.• ANSI/AAMI EC13:2002 - Cardiac Monitors,Heart rate meters and alarms• IEC 60601-1-2:2007 - Medical electricalequipment - Part 1-2: General requirements forsafety - Collateral standard: Electromagneticcompatibility - Requirements and tests• ISO 9919:2005 Medical electrical equipment -particular requirements for the basic safety andessential performance of pulse oximeters.• IEC 60601-2-27: (2005-08), Medical electricalequipment -- Part 2-27: Particular requirementsfor the safety, including essential performance,of electrocardiographic monitoring equipment.• AAMI/ANSI SP10:2002 Manual, electronic orautomated sphygmomanometers.(Cardiovascular)Based on the conclusions of each of these tests it isdetermined that the Omni II patient monitor is safe andeffective. |
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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
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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 (800) 638-2041 or (301) 796-7100 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
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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
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§ 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).