(701 days)
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No
The description explicitly states the software "adds no new information, but takes existing information and rearranges it" and focuses on calculated results like duration, mean, maximum, etc., which are standard data processing techniques, not AI/ML. There is no mention of learning, pattern recognition beyond simple calculations, or any AI/ML-specific terminology.
No
The device provides visual guidance for data interpretation and rearranges existing information to make it more accessible. It does not provide any form of treatment or intervention, which are characteristics of a therapeutic device.
No
The "Intended Use" states that the software "is not considered in and of itself to be diagnostic without skilled interpretation." This indicates it is a tool to assist, but not perform, diagnosis.
Yes
The device description explicitly states "The software only provides visual guidance for data interpretation" and "The Small Bowel software adds no new information, but takes existing information and rearranges it". This strongly indicates the device is solely software that processes and presents data from an external source, without including any hardware components.
Based on the provided information, this device is likely not an IVD (In Vitro Diagnostic). Here's why:
- Intended Use: The intended use explicitly states that the software "only provides visual guidance for data interpretation" and "is not considered in and of itself to be diagnostic without skilled interpretation." This is a key characteristic that differentiates it from an IVD, which is typically intended to be used in vitro to diagnose a condition or provide information for diagnosis.
- Device Description: The description emphasizes that the software "adds no new information, but takes existing information and rearranges it to make it more accessible to interpretation." It processes existing data (amplitude vs. time) from continuous recordings and presents it in a more organized format with calculated metrics. This is more akin to a data analysis or reporting tool than a diagnostic test performed on a biological sample.
- Lack of IVD Characteristics: There is no mention of the device interacting with biological samples (blood, urine, tissue, etc.) or performing any tests in vitro. The input is described as "continuous recordings," which likely come from a physiological measurement device, not a sample analysis.
In summary, the device appears to be a software tool that aids in the interpretation of physiological data, rather than a diagnostic test performed on a biological sample in vitro.
Therefore, it does not fit the typical definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
Continuous recordings provide information in the form of amplitude versus time, but it is difficult to understand because of the visual complexity of the record due to channel separation and duration of the recorded traces and sporadic nature of the activity. The software reports arranges the information in concise, reproducible, consistent reports that are more consistent than visual analysis.
The Small Bowel software adds no new information, but takes existing information and rearranges it to make it more accessible to interpretation. Source information has dimensions of amplitude and time while the software presents the same information including numerous calculated results, such as duration, mean, maximum and median, motility index, frequency and cycle values for contractions and clusters (groups of contractions).
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
Small Bowel
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
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Key Metrics
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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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§ 876.1725 Gastrointestinal motility monitoring system.
(a)
Identification. A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.(b)
Classification. Class II (performance standards).
0
APPENDIX A
APR - 9 1996
Safety and Effectiveness
Continuous recordings provide information in the form of amplitude versus time, but it is difficult to understand because of the visual complexity of the record due to channel separation and duration of the recorded traces and sporadic nature of the activity. The software reports arranges the information in concise, reproducible, consistent reports that are more consistent than visual analysis.
The Small Bowel software adds no new information, but takes existing information and rearranges it to make it more accessible to interpretation. Source information has dimensions of amplitude and time while the software presents the same information including numerous calculated results, such as duration, mean, maximum and median, motility index, frequency and cycle values for contractions and clusters (groups of contractions).
Safety is assured in that the catheter and the sensors used to transduce the pressures are connected to fully electrically isolated amplifiers as per UL544.
The software only provides visual guidance for data interpretation. It is not considered in and of itself to be diagnostic without skilled interpretation.