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510(k) Data Aggregation
K Number
K233216Device Name
CLEWICU System
Manufacturer
Clew Medical Ltd.
Date Cleared
2024-01-13
(107 days)
Product Code
QNL
Regulation Number
870.2210Why did this record match?
Applicant Name (Manufacturer) :
Clew Medical Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CLEWICU provides the clinician with physiological insight into a patient's likelihood of future hemodynamic instability. CLEWICU is intended for use in hospital critical care settings for patients 18 years and over. CLEWICU is considered to provide additional information regarding the patient's predicted future risk for clinical deterioration, as well as identifying patients at low risk for deterioration. The product predictions are for reference only and no therapeutic decisions should be made based solely on the CLEWICU predictions.
Device Description
The CLEWICU System is a stand-alone analytical software product that includes the ClewICUServer and the ClewICUnitor. It uses models derived from machine learning to calculate the likelihood of occurrence of certain clinically significant events for patients in hospital critical care settings including:
- Intensive Care Unit (ICU) .
- . Emergency Department's (ED) Critical Care or Resuscitation area
- Post-Anesthesia Care Unit (PACU) .
- . Step-Down Unit
- Post-Surgical Recovery Unit .
- . Other Specialized Care Units (e.g., Cardiac Care Unit (CCU), Neurocritical Care Unit (NCU), High-dependency Care Unit (HDU)
ClewICUServer and ClewICUnitor are software-only devices that are run on a user-provided server or cloud-infrastructure.
The ClewICUServer is a backend software platform that imports patient data from various sources including Electronic Health Record (EHR) data and patient monitoring devices through an HL7 data connection. The data are then used by models operating within the ClewICUServer to compute and store the CLEWHI index (likelihood of hemodynamic instability requiring vasopressor / inotrope support), and CLEWLR (indication that the patient is at "low risk" for deterioration).
The ClewICUnitor is the web-based user interface displaying CLEWHI, and CLEWLR associated notifications and related measures, as well as presenting the overall unit status.
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K Number
K200717Device Name
CLEWICU System (ClewICUServer and ClewICUnitor)
Manufacturer
CLEW Medical Ltd.
Date Cleared
2021-01-09
(297 days)
Product Code
QNL
Regulation Number
870.2210Why did this record match?
Applicant Name (Manufacturer) :
CLEW Medical Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CLEWICU provides the clinician with physiological insight into a patient's likelihood of future hemodynamic instability. CLEWICU is intended for use with intensive care unit (ICU) patients 18 years and over. CLEWICU is considered to provide additional information regarding the patient's predicted future risk for clinical deterioration, as well as identifying patients at low risk for deterioration. The product predictions are for reference only and no therapeutic decisions should be made based solely on the CLEWICU predictions.
Device Description
The CLEWICU System is a stand-alone analytical software product that includes the ClewICUServer and the ClewICUnitor. It uses models derived from machine learning to calculate the likelihood of occurrence of certain clinically significant events for patients in the intensive care unit (ICU). ClewICUServer and ClewICUnitor are software-only devices that are installed on user-provided hardware. The ClewICUServer is a backend software platform that imports patient data from various sources including Electronic Health Record (EHR) data and medical device data. The data are then used by models operating within the ClewICUServer to compute and store the CLEWHI index (likelihood of hemodynamic instability requiring vasopressor / inotrope support), and CLEWLR (indication that the patient is at "low risk" for deterioration). The ClewICUnitor is the web-based user interface displaying CLEWHI, and CLEWLR associated notifications and related measures, as well as presenting the overall unit status.
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