(85 days)
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No
The description focuses on basic data analysis and calculation of parameters (min, max, length) from selected segments, which are standard software functions, not indicative of AI/ML. There is no mention of AI, ML, deep learning, training data, or performance metrics typically associated with AI/ML algorithms.
No.
The device's intended use is to analyze intragastroesophageal pressure data, not to treat or directly manage a medical condition. It is a diagnostic tool, providing information for analysis rather than administering therapy.
Yes
The device analyzes intragastroesophageal pressure data and compares it with normal values, which are typical functions of a diagnostic device used to assess health conditions.
Yes
The device is described as an "Analysis Module" added to existing "Polygram Software for Windows". The description focuses entirely on the software's analytical functions and data handling, with no mention of associated hardware components included in this specific submission. The reference to the predicate device (K946322) also describes "Polygram Software for Windows," further supporting the software-only nature of this submission.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The Esophageal Manometry Analysis Module analyzes pressure data collected within the gastrointestinal tract (intragastroesophageal pressure). This data is physiological and collected directly from the patient's body, not from a sample taken from the body.
- Lack of sample analysis: The description focuses on analyzing pressure signals and comparing them to normal values, not on analyzing the composition or properties of a biological sample.
Therefore, the device falls under the category of a medical device that analyzes physiological data collected in vivo, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Esophageal Manometry Analysis Module has been designed to analyze intragastroesophageal pressure data throughout the gastrointestinal tract. The Esophageal Manometry Analysis Module has been designed for the same intended use (analyze intragastroesophageal pH data) in both pediatric and adult populations.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
By adding the Esophageal Manometry Analysis Module to the Polygram Software for Windows, the user can also have all the pressure data analyzed in terms of physiological properties, comparison with normal values, etc. The analyzed data can thereafter be viewed on screen or printed out on a separate paper. The Esophageal Manometry Analysis Module has been designed to analyze intragastroesophageal pressure data throughout the gastrointestinal tract.
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
gastrointestinal tract
Indicated Patient Age Range
pediatric and adult populations
Intended User / Care Setting
The product is to be used on patients in the hospital environment under supervision of a trained physician.
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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§ 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
JUN || 1996
9. SMDA 510(k) Summarv or Statement
DRAERD 510(k) Summary of Safety and Effectiveness Information
Esophageal Manometry Analysis Module
The Polygram Software for Windows (K946322) was designed to record and handle/store physiological parameters. After a recording, the user is able to review the tracings on the computer screen and print the signal tracings or just parts of them. When reviewing the data on the computer screen, the user is able to mark certain segments and calculate certain parameters from the selected signal segments. These parameters are minimum value, maximum value, and the length of the selection.
By adding the Esophageal Manometry Analysis Module to the Polygram Software for Windows, the user can also have all the pressure data analyzed in terms of physiological properties, comparison with normal values, etc. The analyzed data can thereafter be viewed on screen or printed out on a separate paper.
The Esophageal Manometry Analysis Module has been designed to analyze intragastroesophageal pressure data throughout the gastrointestinal tract.
The Esophageal Manometry Analysis Module has been designed for the same intended use (analyze intragastroesophageal pH data) in both pediatric and adult populations. The product is to be used on patients in the hospital environment under supervision of a trained physician.
Sincerely Synectics Medical