(55 days)
No
The summary describes a data integration and management system, focusing on data collection, transfer, and storage. There is no mention of AI or ML algorithms being used for analysis, interpretation, or decision support based on the collected data.
No
The device is described as a data collection and management system for clinical information, not a device used to treat or cure a disease or condition.
No
Explanation: The device is indicated for data collection and clinical information management, integrating medical device data into Hospital Information Systems (HIS). It is not intended for monitoring purposes or to control clinical devices, nor does it perform any diagnostic functions.
Yes
The device description explicitly states "DataEngine, device connectivity software" and describes its function as integrating data from independent bedside devices into a Hospital Information System (HIS). There is no mention of any hardware component being part of the DataEngine device itself.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that DataEngine is for "data collection and clinical information management." It explicitly states it is "not intended for monitoring purposes" and "not intended to control any of the clinical devices." IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. DataEngine's purpose is data handling, not analyzing biological samples.
- Device Description: The description focuses on integrating medical device data into HIS, converting data formats, and storing data. This aligns with data management and connectivity, not with the analysis of biological specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information based on such analysis.
Therefore, DataEngine falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
DataEngine is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. DataEngine is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.
Product codes
MWI
Device Description
DataEngine is a comprehensive solution to integrate medical device data into HIS. It is also designed to be compatible with XML and HL7. All data collected from medical device is able to transfer to readable format of XML and HL7. Caregiver or nurses will be beneficial from DataEngine, device connectivity software to collect data in real time and receive a complete electronic data for patient's record. Medical staffs do not have to spend much time on manual script. Every patient's real time data will be stored in database server for future research projects, education, and clinical study.
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
Not Found
Intended User / Care Setting
Caregiver or nurses
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)
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
2.1
K040969
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2. ADMINISTRATIVE INFORMATION
510(k) Summary
-
- Identification of the Device:
- Proprietary name: POISE DataEngine .
- Common Name : Patient Physiological Monitor .
- Classification number: MWI, Class II .
- Regulation Number: 870.2300 .
2. Equivalent legal marketed device:
- CAPSULE TECHNOLOGIE .
- Datacaptor, K032142 .
-
- Indications for Use ( intended use ) :
- DataEngine is indicated for use in data collection and clinical ● information management either directly or through networks with independent bedside devices. DataEngine is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices ( independent bedside devices / information systems ) it is connected to.
-
- Description of the Device:
- DataEngine is a comprehensive solution to integrate medical ● device data into HIS. It is also designed to be compatible with XML and HL7. All data collected from medical device is able to transfer to readable format of XML and HL7. Caregiver or nurses will be beneficial from DataEngine, device connectivity software to collect data in real time and receive a complete electronic data for patient's record. Medical staffs do not have to spend much time on manual script. Every patient's real time data will be stored in database server for future research projects, education, and clinical study.
- Safety and Effectiveness, comparison to predicate devices: Similarities
- Same intended use ●
- Same output mode ●
- Same technological characteristics software server application, ● not contact with the patients, not controlling any life sustaining devices
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