(298 days)
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No
The document describes a data collection and storage system with subsequent analysis by a physician and software. There is no mention of AI/ML algorithms being used for the analysis itself.
No
Explanation: The device is described as a noninvasive ambulatory monitoring device that collects and stores physiological data for later analysis by a physician, aiding in diagnosis and treatment. It does not actively provide therapy.
Yes
The "Intended Use / Indications for Use" states that the system provides data for "later analysis by a physician" and as "an aid to diagnosis and treatment."
No
The device description explicitly details hardware components like a "noninvasive ambulatory monitoring device," a "CompactFlash™ memory card," a "portable battery powered Handspring Visor®," and optional connections for a "NONIN pulse oximeter and Critikon noninvasive blood pressure monitor." While software is mentioned ("VivoLogic 1.0 software program"), the system is clearly a combination of hardware and software.
Based on the provided information, the Life Shirt system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Life Shirt Function: The Life Shirt system is described as a noninvasive ambulatory monitoring device that collects physiological data directly from the patient's body (respiration, ECG, pulse oximetry, blood pressure, body position) through external sensors. It does not involve the analysis of specimens taken from the body.
- Intended Use: The intended use is to collect and store physiological data for later analysis by a physician to aid in diagnosis and treatment. This is consistent with a physiological monitoring device, not an IVD.
Therefore, the Life Shirt system falls under the category of a physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Life Shirt system is intended for use by one adult during daily activities of The Life Shirt System is michaea cerading physiological data for later analysis by a physician. Respiration, ECG, pulse oximetry, blood pressure, and body position a physician. The system is intended to provide analysis of breathing data may be conected. Thic tyot appeas as well as displaying heart rate changes patterns as an all in claboring aparis the wake and sleeping states as well as trom electrocardidographic wavelorms in all was were aceutical studies in which acuvities of daily fiving. Trippiesul indicator, or the general healthcare market respiratory information is a userel manue and the data provided to their physicians as an aid to diagnosis and treatment.
Product codes (comma separated list FDA assigned to the subject device)
DQK
Device Description
The LifeShirt is a noninvasive ambulatory monitoring device that continuously monitors and stores respiration and ECG onto a CompactFlash™ memory card within a portable battery powered Handspring Visor® worn on a belt or within a pocket. The patient may be located at home or in an alternate care setting. The monitored subject can enter symptoms, activities, and medications into the Handspring Visor® that becomes part of the digital data stream. An optional NONIN pulse oximeter and Critikon noninvasive blood pressure monitor can be connected into the Visor for recordings during sleep or defined activities. The purpose of this system is to collect and store cardiac, respiratory, and blood pressure data as well as body position, various types of activities annotated with symptoms and a medication diary for subsequent analysis and archival at a data center utilizing the VivoLogic 1.0 software program. Data is transferred to the data center generally after the end of a patient data recording session.
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
Intended User / Care Setting
licensed physician, data center personnel, health care providers, at home or in an alternate care setting.
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.
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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§ 870.1425 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
Image /page/0/Picture/0 description: The image shows the logo for VivoMetrics. The logo consists of a stylized "V" shape with a curved line above it, resembling a heartbeat monitor. Below the symbol is the text "VivoMetrics" in a serif font, with the tagline "Makers of LifeShirt TM" in a smaller font underneath.
APR 1 2 2002