(177 days)
Not Found
No
The summary describes a standard patient monitor that processes and displays physiological data. There is no mention of AI, ML, or any advanced analytical techniques beyond basic parameter processing. The software level of concern is "Moderate," which is less likely to involve complex AI/ML algorithms.
No
The device is described as a "patient monitor" which collects and displays physiological parameters (NIBP, SpO2, ETCO2). Its purpose is to monitor, not to provide therapy or treatment.
No
This device is a patient monitor that tracks physiological parameters (NIBP, SpO2, ETCO2) to observe a patient's condition, rather than to diagnose a disease or condition. The term "monitor" implies observation, not diagnosis.
No
The device description explicitly states it is a "comprehensive monitoring system" that "integrates parameter measuring modules, display and recorder in one device," and mentions associated hardware accessories like sensors, a monitor, a cuff, and a module. It also details electrical safety, EMC, and mechanical testing, which are indicative of a hardware device.
Based on the provided information, the CLEO patient monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device monitors basic physiological parameters (NIBP, SpO2, ETCO2) directly from the patient. IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a system that connects to the patient (via sensors and cuffs) to measure these parameters. It doesn't mention any components for handling or analyzing biological samples.
- Performance Studies: The performance studies focus on the accuracy and safety of the direct patient measurements (NIBP, SpO2, ETCO2) and the electrical and mechanical aspects of the device. There are no studies related to the analysis of biological specimens.
In summary, the CLEO patient monitor is a device that directly measures physiological parameters from a living patient, which is characteristic of a patient monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The purpose and function of the CLEO patient monitor is to monitor basic physiological parameters including
- NIBP (systolic and diastolic)
- SpO2
- ETCO2
The target population is for adults only.
It can be used in all hospital areas and hospital-type facilities. It may be used as bedside or portable monitor and be used in all hospitals and hospital-type facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.
Product codes (comma separated list FDA assigned to the subject device)
MWI, DXN, DQA, CCK
Device Description
The CLEO monitor is a comprehensive monitoring system with two or three traces compiling, and processing, analyzing and displaying data from up to three 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 CLEO Patient 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.
The associated accessories include:
- Sp02 Finger Sensors
- NIBP Monitor
- Blood Pressure Cuff
- ETCO2 Module
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The target population is for adults only.
Intended User / Care Setting
It can be used in all hospital areas and hospital-type facilities. It may be used as bedside or portable monitor and be used in all hospitals and hospital-type facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
The following performance date were provided in support of the substantial equivalence determination
Biocompatibility Testing
The product contact materials utilized in the CLEO Patient Monitor have been well characterized chemically and physically and have a long history of safe use in predicate devices and are categorized as Generally Regarded as Safe (GRAS). In addition, all patient contact components have been FDA cleared through the 510(k) Premarket Notification process and have been tested for biocompatibility.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Infinium device, consisting of the CLEO Monitor, NIBP Monitor and Cuff, SPO2 finger Sensors and the ETCO> Module. The system complies with the IEC 60601-1 standards for safety and the IEC 60601-1-2 standard for EMC.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern, since a failure or latent flaw could directly result in minor injury to the patient or operator.
Mechanical Testing
- CO2 Measurement Accuracy and Drift of Measurement Accuracy
- Gas Sampling Rate Accuracy
- System Response/Rise Time
- Respiratory Rate Accuracy
- Gas Mixture Accuracy
- Interfering Agents
- SPO2 Performance Test
- NIBP Performance Test
Summary of Non-Clinical Data:
The Cleo Patient Monitor underwent testing according to several different performance standards.
| Devices | Performance Test | Standard of Compliance |
|---|---|---|
| CLEO Monitor | NIBP | ANSI/AAMI SP10:1992 and |
| 2002, ANSI/AAMI/IEC 80601- | ||
| 2-30:2009 | ||
| SPO2 | EN ISO 9919:2009 | |
| Electrical Safety | IEC 60601-1:2005/ EN 60601- | |
| 1:2006 | ||
| EMC | IEC 60601-1-2:2007 | |
| ETCO2 | 80601-2-55:2011 |
The testing completed demonstrates that the CLEO Patient Monitor exhibits comparable mechanical and functional characteristics to the predicate device in addition to being biocompatible acceptable. Based on those characteristics, the CLEO Patient Monitor is substantially equivalent to the predicate device in safety and effectiveness in addition to being intended for the same uses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is a stylized image of three human profiles facing right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 6, 2015
Infinium Medical % John O'Brien Regulatory and Quality Systems Lead AJW Technology Consultants, Inc 445 Apollo Beach Blvd. Apollo Beach, Florida 33572
Re: K142244
Trade/Device Name: Cleo Patient Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI, DXN, DQA, CCK Dated: January 6, 2015 Received: January 8, 2015
Dear John 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 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 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
1
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 contact the Division of Industry and Consumer Education 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 Industry and Consumer Education 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.
Melissa A. Torres -S
For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K142244
Device Name: CLEO Patient Monitor
The purpose and function of the CLEO patient monitor is to monitor basic physiological parameters including
- NIBP (systolic and diastolic)
- SpO2
- ETCO2
The target population is for adults only.
It can be used in all hospital areas and hospital-type facilities. It may be used as bedside or portable monitor and be used in all hospitals and hospital-type 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)
Page 1 of 1
3
510(k) SUMMARY (as required by 807.92)
I. SUBMITTER
Infinium Medical 12151 62nd Street North #5 Largo, FL 33773
Phone: 727-531-8434 Fax: 727-531-8436
Contact Person: Oz Ozkaya Date Prepared: August 1, 2014
REGULATORY CORRESPONDENT
AJW Technology Consultants, Inc 445 Apollo Beach, Blvd Apollo Beach, FL 33572
Phone: 813-645-2855 x101 Fax: 813-645-2856
Contact Person: John O'Brien Email: jobrien@ajwtech.com
II. DEVICE
Name of Device: CLEO Patient Monitor Common or Usual Name: Patient Physiological Monitor (without Arrhythmia Detection or Alarm) Classification Name: Monitor, physiological, patient (without Arrhythmia detection or alarms) Device Panel: Cardiovascular Regulatory Class: II Product Code: MWI
Subsequent Product Codes:
| Regulation
| Number | Description | Product Code |
|---|---|---|
| 870.1130 | Noninvasive Blood Pressure | |
| Measurement | DXN | |
| 870.2700 | Oximeter | DQA |
| 868.1400 | Carbon dioxide gas analyzer | CCK |
4
III. PREDICATE DEVICE
The CLEO patent monitor is substantially equivalent in intended use and similar technological characteristics of NIBP, ETC02, and Sp02 as the OMNI Express Patient Monitor which is one of the monitors cleared as part of K132229. The internal Infinium CAPNOTRAK CO2 sensor is substantially equivalent in intended use and technological characteristics to the Respironics LoFlo CO2 Sensor which was cleared under K053174.
This predicate has not been subject to a design-related recall. No reference devices were used in this submission
DEVICE DESCRIPTION IV.
The CLEO monitor is a comprehensive monitoring system with two or three traces compiling, and processing, analyzing and displaying data from up to three 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 CLEO Patient 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.
The associated accessories include:
- Sp02 Finger Sensors ●
- NIBP Monitor ●
- Blood Pressure Cuff ●
- ETCO2 Module ●
V. INDICATIONS FOR USE
The purpose and function of the CLEO patient monitor is to monitor basic physiological parameters including
- NIBP (systolic and diastolic)
- SpO2 ●
- ETCO2 ●
The target population is for adults only.
It can be used in all hospital areas and hospital-type facilities. It may be used as bedside or portable monitor and be used in all hospitals and hospital-type facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.
5
VI. COMPARISON OF TECHNOLIGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The monitoring of basic physiological parameters is the technological principle for both the subject and predicate devices. It is based on the use of modules and accessories that are either connected internally or externally to the monitors in order to monitor the specific physiological parameter. At a high level, the subject and predicate devices are based on the following same technological characteristics:
- Energy Source ●
- The monitoring of Non-invasive blood pressure
- The monitoring of pulse oximetry
- The monitoring of End Tidal CO2 ●
- Touch Screen Technology ●
- . Software
Because CLEO Patient Monitor's NIBP subsystem is identical to Suntech Medical's NIBP subsystem cleared under K040799 substantial equivalence was not based on performance testing.
The following technological differences exist between the subject and predicate devices:
- . ECG waveform
- Heart Rate Monitoring ●
- Respiration ●
- Temperature
- Anesthetic agents
- Physical Dimensions
VII. PERFORMANCE DATA
The following performance date were provided in support of the substantial equivalence determination
Biocompatibility Testing
The product contact materials utilized in the CLEO Patient Monitor have been well characterized chemically and physically and have a long history of safe use in predicate devices and are categorized as Generally Regarded as Safe (GRAS). In addition, all patient contact components have been FDA cleared through the 510(k) Premarket Notification process and have been tested for biocompatibility.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Infinium device, consisting of the CLEO Monitor, NIBP Monitor and Cuff, SPO2 finger Sensors
6
and the ETCO> Module. The system complies with the IEC 60601-1 standards for safety and the IEC 60601-1-2 standard for EMC.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern, since a failure or latent flaw could directly result in minor injury to the patient or operator.
Mechanical Testing
- CO2 Measurement Accuracy and Drift of Measurement Accuracy
- Gas Sampling Rate Accuracy ●
- System Response/Rise Time ●
- Respiratory Rate Accuracy ●
- Gas Mixture Accuracy ●
- Interfering Agents
- SPO2 Performance Test ●
- NIBP Performance Test ●
Summary of Non-Clinical Data:
The Cleo Patient Monitor underwent testing according to several different performance standards. Below is a chart of the different testing that was completed.
| Devices | Performance Test | Standard of Compliance |
|---|---|---|
| CLEO Monitor | NIBP | ANSI/AAMI SP10:1992 and |
| 2002, ANSI/AAMI/IEC 80601- | ||
| 2-30:2009 | ||
| SPO2 | EN ISO 9919:2009 | |
| Electrical Safety | IEC 60601-1:2005/ EN 60601- | |
| 1:2006 | ||
| EMC | IEC 60601-1-2:2007 | |
| ETCO2 | 80601-2-55:2011 |
VIII. CONCLUSIONS
7
The testing completed demonstrates that the CLEO Patient Monitor exhibits comparable mechanical and functional characteristics to the predicate device in addition to being biocompatible acceptable. Based on those characteristics, the CLEO Patient Monitor is substantially equivalent to the predicate device in safety and effectiveness in addition to being intended for the same uses.