(543 days)
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No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware stimulation and measurement, not algorithmic interpretation or learning.
No
The device is described as a monitoring system that measures patient relaxation and nerve responses, not one that treats a condition or restores health.
Yes
The device "provides relaxation measurement of patient" and "measures the responses from the NMT module, calculates the NMT values, displays the NMT values, handles NMT trending and NMT monitor features." This indicates it's used to assess a patient's physiological state (relaxation level) to inform medical decisions during and after anesthesia, which aligns with the definition of a diagnostic device.
No
The device description explicitly states "The NMT measurement hardware is in the NMT Module" and that it "stimulates the Mores the patient controlled by the Net Compact Monitor central unit." This indicates the device includes hardware components for stimulation and measurement, making it a hardware-software combination, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for monitoring patient relaxation during and after anesthesia and for regional block stimulation. This involves direct interaction with the patient's body (stimulating nerves and measuring responses), not testing samples taken from the body.
- Device Description: The device stimulates the patient and measures responses. This is a physiological measurement, not an in vitro test.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples (blood, urine, tissue, etc.) or performing tests outside of the body.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The product is designed to be used for monitoring relaxation of patient during and after anesthesia and for regional block stimulation for nerve location.
Product codes
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Device Description
The AS/3™ NMT Module is a part of the modular anesthesia monitoring system AS/3™. It provides relaxation measurement of patient.
The NMT measurement hardware is in the NMT Module stimulates the Mores the patient controlled by the Net Compact Monitor central unit. The News NMT Module measures the respon responses from the NMT module, calculates the NMT values, displays the NMT values, handles NMT trending and NMT monitor features.
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
The intended environment of use is anesthesia department, including operation rooms (OR) and post-anesthesia care units (PACU) 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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 868.2775 Electrical peripheral nerve stimulator.
(a)
Identification. An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY
23.02.96
APR 28 1997
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
AS/3™ M-NMT Device name:
Neuromuscular transmission Device Common name:
DESCRIPTION OF THE DEVICE
The AS/3™ NMT Module is a part of the modular anesthesia monitoring system AS/3™. It provides relaxation measurement of patient.
The product is designed to be used for monitoring relaxation of patient during and after anesthesia and for regional block stimulation for nerve location. The intended environment of use is anesthesia department, including operation rooms (OR) and post-anesthesia care units (PACU) etc.
The NMT measurement hardware is in the NMT Module stimulates the Mores the
patient controlled by the Net Compact Monitor central unit. The News
NMT Module measures the respon responses from the NMT module, calculates the NMT values, displays the NMT values, handles NMT trending and NMT monitor features.