(320 days)
The pH Analysis Module is a software program that has been designed to analyze intragastroesophageal pH data recorded from the gastrointestinal tract in pediatric and adult populations.
The program is to be used on a personal computer analyzing patient data in the hospital environment under supervision of a trained physician. The analyzed data can be viewed on the computer screen or printed out on a separate paper.
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 include min and max values, length of selection.
By adding the pH Analysis Module to the Polygram Software for Windows, the user can also have all the intragastroesophageal pH data analyzed (data recorded from the gastrointestinal tract in pediatric and adult population). The analysis report includes sections such as patient demographics; intepretation and comment (for user to insert); procedure summary; pH tracing; period table including number such as duration of recording, number of periods of interest, time where pH was below certain threshold value, symptom correlation, scoring; physician signature section.
The analysis report can then serve as a part of the physician's diagnosis and post treatment evaluation.
The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The submission is a 510(k) summary for a pH Analysis Module, focusing on its description, intended use, and equivalence to a previously cleared device. It lacks details regarding specific performance metrics, sample sizes for testing, expert involvement, or ground truth establishment.
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SMDA 510(k) Summary or Statement 9.
DRAERD 510(k) Summary of Safety and Effectiveness Information
| Submitter's name | Synectics Medical ABRenstiernas gata 12S-116 28 StockholmSwedenContact: Anna Pettersson |
|---|---|
| Name of device | pH Analysis Module |
| Name of equivalent device | EsopHogram Software (DOS environment)(included in K859361 - Synectics pH System ComprisingDigitrapper Mark II, EsopHogram Software & MonocrystantCatheter) |
| Description of device | The Polygram Software for Windows (K946322) was designed torecord and handle/store physiological parameters. After a recording,the user is able to review the tracings on the computer screen andprint the signal tracings or just parts of them. When reviewing thedata on the computer screen, the user is able to mark certainsegments and calculate certain parameters from the selected signalsegments. These parameters include min and max values, length ofselection.By adding the pH Analysis Module to the Polygram Software forWindows, the user can also have all the intragastroesophageal pHdata analyzed (data recorded from the gastrointestinal tract inpediatric and adult population). The analysis report includes sectionssuch as patient demographics; intepretation and comment (for userto insert); procedure summary; pH tracing; period table includingnumber such as duration of recording, number of periods of interest,time where pH was below certain threshold value, symptomcorrelation, scoring; physician signature section.The analysis report can then serve as a part of the physician'sdiagnosis and post treatment evaluation. |
| Statement of intendeduse/Indication for use | The pH Analysis Module is a software program that has beendesigned to analyze intragastroesophageal pH data recorded fromthe gastrointestinal tract in pediatric and adult populations.The program is to be used on a personal computer analyzing patientdata in the hospital environment under supervision of a trainedphysician. The analyzed data can be viewed on the computer screenor printed out on a separate paper. |
§ 876.1400 Stomach pH electrode.
(a)
Identification. A stomach pH electrode is a device used to measure intragastric and intraesophageal pH (hydrogen ion concentration). The pH electrode is at the end of a flexible lead which may be inserted into the esophagus or stomach through the patient's mouth. The device may include an integral gastrointestinal tube.(b)
Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.