(580 days)
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No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard physiological monitoring measurements and signal analysis without mentioning AI/ML techniques.
No
The device is a part of a modular anesthesia monitoring system and is described as measuring physiological parameters like ECG, SpO2, pressure, and temperature, which are diagnostic or monitoring functions, not therapeutic.
Yes
The device is a monitoring system that measures physiological parameters such as ECG, SpO2, pressure, temperature, and respiration. These measurements aid in assessing a patient's physiological state, which is a diagnostic function.
No
The device description explicitly states that the AS/300 ESTPR Module is a part of a modular anesthesia monitoring system and includes hardware components for measurements like impedance respiration. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The AS/3™ ESTPR module measures physiological parameters directly from the patient's body (ECG, SpO2, invasive pressure, temperature, impedance respiration). It does not analyze samples taken from the body.
- Intended Use: The intended use describes monitoring patients in clinical settings, not analyzing biological samples.
Therefore, the AS/3™ ESTPR module falls under the category of a patient monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The AS/3™ ESTPR module is intended to be used in the Datex AS/3" Anaeshesia Monitor or in the AS/3" Compact Monitor in anesthesia department, in recovery rooms, operation theatres etc.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The AS/300 ESTPR Module is a part of the modular anesthesia monitoring system AS/300. It provides ECG, SpO2, 2 invasive pressure and 2 temperature channels and impedance respiration measurements. The impedance respiration measurement hardware is in the ESTPR module. The ESTPR Module software measures the respiration signal is sent to the AS/3™ Anaesthesia or Compact Monitor central unit. The AS/3" monitor software receives the respiration signal from the ESTPR module, analyzes the respiration waveform, displays respiration rate and waveform, handles the alarms, trending and other general monitor features. The hardware and software of ECG, SpO2, pleth, invasive pressure and temperature measurements of M-ESTPR are same as in the M-ESTP.
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
anesthesia department, in recovery rooms, operation theatres etc.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
Image /page/0/Picture/0 description: The image shows the word "Datex" in white letters on a black, rounded rectangular background. The word is written in a sans-serif font, and the letters are evenly spaced. The background is a solid black color, and the rounded corners of the rectangle give the image a smooth, modern look.
FEB - 6 1997
05.07.95
510(k) SUMMARY
Datex 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/3™ M-ESTPR
Common name: Electrocardiographic Device
DESCRIPTION OF THE DEVICE
The AS/300 ESTPR Module is a part of the modular anesthesia monitoring system AS/300. It provides ECG, SpO2, 2 invasive pressure and 2 temperature channels and impedance respiration measurements.
The AS/3™ ESTPR module is intended to be used in the Datex AS/3" Anaeshesia
Monitor or in the AS/3" Compact Monitor in anesthesia department, in recovery rooms, operation theatres etc.
The impedance respiration measurement hardware is in the ESTPR module. The ESTPR Module software measures the respiration signal is sent to the AS/3™
Anaesthesia or Compact Monitor central unit. The AS/3" monitor software receives the respiration signal from the ESTPR module, analyzes the respiration waveform, displays respiration rate and waveform, handles the alarms, trending and other general monitor features.
The hardware and software of ECG, SpO2, pleth, invasive pressure and temperature measurements of M-ESTPR are same as in the M-ESTP.