(205 days)
Datex AS/3 ™ Compact Monitor ^ with ESTP and NIBP modules
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No
The summary describes a standard vital signs monitor and does not mention any AI or ML capabilities.
No
The device is a monitor intended for measuring and monitoring vital signs, not for providing treatment or therapy.
Yes
The device monitors a patient's vital signs (ECG, blood pressure, SpO2, temperature), which are used by healthcare professionals to diagnose conditions.
No
The device description explicitly states it is a "portable patient monitor which measures ECG, 2 invasive blood pressures, oxygen saturation SpO2, 2 temperatures and non-invasive blood pressure NIBP," indicating it is a hardware device with integrated measurement capabilities, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "stationary and mobile indoor monitoring of a patient's vital signs." This describes a device used to monitor physiological parameters directly from a patient, not to test samples taken from the body.
- Device Description: The device measures vital signs like ECG, blood pressure, oxygen saturation, and temperature. These are all direct measurements from the patient's body, not tests performed on biological samples.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue) to provide information about a person's health status, diagnose, monitor, or predict disease. This device does not perform such tests on specimens.
Therefore, the AS/3 Light Monitor falls under the category of a patient monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
AS/3 Light Monitor is intended for stationary and mobile indoor monitoring of a patient's vital signs.
Product codes
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Device Description
AS/3 Light Monitor is a portable patient monitor which measures ECG, 2 invasive blood pressures, oxygen saturation SpO2, 2 temperatures and non-invasive blood pressure NIBP. The measurement technics are similar to the AS/3 Compact Monitor with ESTP module and NIBP module. See section 3 for details.
AS/3 Light Monitor will be available in two following configurations:
LM which measures ECG, SpO2, 1 temperature and NIBP and
LMP which measures ECG, SpO2, 2 invasive blood pressures, 2 temperatures and NIBP. The monitor can be driven with battery or with mains power.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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
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Summary of Performance Studies
The specifications of the monitors were compared and AS/3TM Light Monitor was tested against the specifications. The results showed that AS/3TM Light Monitor is substantially equivalent with AS/3TM Compact Monitor.
Key Metrics
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Predicate Device(s)
Datex AS/3 ™ Compact Monitor ^ with ESTP and NIBP modules
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the word "Datex" in white letters on a black background. The word is centered and the font is bold. The background is a rounded rectangle.
510(k) SUMMARY
OCT 23 1996
27 March, 1996
Datex-Engström Division Instrumentarium Corp. P.O. Box 446 FIN-00101 Helsinki Finland Tel: +358 0 39411 Fax: +358 0 1463310
Contact person: Rauno Ruoho
PRODUCT NAMES
| Device name: | AS/3TM Light Monitor |
|---|---|
| -------------- | ---------------------- |
Common name: Hemodynamic measurement device
DESCRIPTION OF THE DEVICE
AS/3 Light Monitor is a portable patient monitor which measures ECG, 2 invasive blood pressures, oxygen saturation SpO2, 2 temperatures and non-invasive blood pressure NIBP. The measurement technics are similar to the AS/3 Compact Monitor with ESTP module and NIBP module. See section 3 for details.
AS/3 Light Monitor will be available in two following configurations:
LM which measures ECG, SpO2, 1 temperature and NIBP and
LMP which measures ECG, SpO2, 2 invasive blood pressures, 2 temperatures and NIBP. The monitor can be driven with battery or with mains power.
INTENDED USE
AS/3 Light Monitor is intended for stationary and mobile indoor monitoring of a patient's vital signs.
SUBSTANTIAL EQUIVALENCE
In terms of overall functions and parameters measured, the AS/3 TM Light Monitor is substantially equivalent in safety and effectiveness to Datex AS/3 ™ Compact Monitor ^ with ESTP and NIBP modules .
1
Measurement parameters are the same as in Datex AS/3 ™ Compact Monitor with ESTP and NIBP modules. Measurement units are redesigned, but measurement technics and algorithms are the same.
The specifications of the monitors were compared and AS/3TM Light Monitor was tested against the specifications. The results showed that AS/3TM Light Monitor is substantially equivalent with AS/3TM Compact Monitor.