(320 days)
No
The description focuses on standard data analysis and reporting features, with no mention of AI/ML terms or capabilities.
No.
The device is a software program that analyzes pH data for diagnosis and post-treatment evaluation, but does not directly treat or prevent a disease or condition.
Yes
The device analyzes recorded intragastroesophageal pH data, generating an analysis report that includes various parameters and can "serve as a part of the physician's diagnosis." This direct contribution to diagnosis qualifies it as a diagnostic device.
Yes
The device is described as a "software program" and an "Analysis Module" added to existing software. It analyzes data recorded from a separate device (implied by "intragastroesophageal pH data recorded from the gastrointestinal tract") and provides an analysis report. There is no mention of hardware components included with the pH Analysis Module itself.
Based on the provided information, the pH Analysis Module is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The pH Analysis Module analyzes in vivo data (pH data recorded directly from the gastrointestinal tract within the patient's body). It processes physiological signals, not in vitro specimens.
- Intended Use: The intended use is to analyze recorded pH data from the gastrointestinal tract to assist physicians in diagnosis and post-treatment evaluation. This is based on analyzing data collected from within the patient, not from a sample taken from the patient.
- Device Description: The description clearly states it analyzes "intragastroesophageal pH data recorded from the gastrointestinal tract." This confirms it's working with data collected in vivo.
Therefore, while it's a medical device used for diagnostic purposes, it falls under the category of devices that analyze physiological data collected directly from the patient, rather than analyzing in vitro specimens.
N/A
Intended Use / Indications for Use
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.
Product codes
Not Found
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal tract
Indicated Patient Age Range
pediatric and adult populations
Intended User / Care Setting
trained physician, hospital environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
SMDA 510(k) Summary or Statement 9.
DRAERD 510(k) Summary of Safety and Effectiveness Information
| Submitter's name | Synectics Medical AB
Renstiernas gata 12
S-116 28 Stockholm
Sweden
Contact: Anna Pettersson |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of device | pH Analysis Module |
| Name of equivalent device | EsopHogram Software (DOS environment)
(included in K859361 - Synectics pH System Comprising
Digitrapper Mark II, EsopHogram Software & Monocrystant
Catheter) |
| Description of device | 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. |
| Statement of intended
use/Indication for use | 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. |