(121 days)
Reusable Multiple-Patient LifeShirt with VivoLogic Analysis Software, LifeSync® Wireless ECG System, Teletrens Model TM10 Multi-Parameter Portable Patient Transmitter, Ambulatory X-12 Telemetry Module
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No
The summary describes standard physiological data collection and analysis software, with no mention of AI or ML techniques. The analysis described is focused on classifying apneas and displaying heart rate changes, which can be achieved with traditional signal processing and rule-based algorithms.
No.
The device is intended for recording physiological data for later analysis by a physician as an aid to diagnosis and treatment, not for providing therapy.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the device provides "analysis of breathing patterns as an aid in classifying apneas" and displays "heart rate changes," with data provided to physicians "as an aid to diagnosis and treatment." This indicates the device's role in assisting with medical diagnosis.
No
The device description explicitly lists hardware components such as the LifeShirt garment, Recorder/Transmitter, wireless flash card, and data Flash Card, in addition to the software.
Based on the provided information, the LifeShirt Real-Time is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices analyze samples taken from the human body (like blood, urine, tissue). The LifeShirt Real-Time collects physiological data from the body itself (respiration, ECG, pulse oximetry, blood pressure, temperature, body position).
- The intended use describes monitoring and recording physiological data for later analysis by a physician. This is typical of patient monitoring devices, not IVDs.
- The device components are external sensors and recording equipment. There is no mention of reagents, test strips, or other components associated with analyzing biological samples.
The LifeShirt Real-Time falls under the category of a physiological monitoring device.
N/A
Intended Use / Indications for Use
The LifeShirt Real-Time is intended for use during daily activities of living and sleep, for the purpose of recording physiological data for later analysis by a physician. Respiration, ECG, pulse oximetry, blood pressure, temperature, and body position data may be collected. The system is intended to provide analysis of breathing patterns as an aid in classifying apneas as well as displaying heart rate changes from electrocardiographic waveforms in the wake and sleeping states as well as activities of daily living. The LifeShirt Real-Time is indicated for reuse by multiple adult patients in applications that may include pharmaceutical studies in which respiratory information is a useful indicator, or the general healthcare market where patients may be monitored at home and the data provided to their physicians as an aid to diagnosis and treatment.
Product codes
DQK
Device Description
The LifeShirt Real-Time consists of the following components: the LifeShirt garment, LifeShirt Recorder/Transmitter, a wireless flash card, a data Flash Card, VivoMonitor™ real-time software and VivoLogic® analysis and reporting software. A cleared pulse oximeter, blood pressure cuff, and a temperature sensor are optional accessories provided for use with the device.
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
adult patients
Intended User / Care Setting
physician; patients may be monitored at home and the data provided to their physicians
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)
Performance testing included verification that data recorded by the LifeShirt recorder is accurately transmitted and received by the PC computer system. In addition, testing was performed to demonstrate electromagnetic compatibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reusable Multiple-Patient LifeShirt with VivoLogic Analysis Software, GMP Companies, Inc., LifeSync® Wireless ECG System, Life Sensing Instrument Company, Teletrens Model TM10 Multi-Parameter Portable Patient Transmitter, Mortara Instrument Inc., Ambulatory X-12 Telemetry Module
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
0