(543 days)
K 981733
Not Found
No
The summary does not mention AI, ML, or related terms, and the description focuses on data capture, recording, and display for analysis by a trained user.
No
The device is intended for diagnosis of reflux disorders by recording, storing, viewing, and analyzing refluxate data and for assisting in catheter placement, not for treating the condition.
Yes
The "Intended Use / Indications for Use" states that the system is intended to "diagnose reflux disorders."
No
The device description explicitly mentions "sensors in the patient" and the "Bilitec 2000," which are hardware components used to measure and capture data. The software is used for data upload, display, analysis, and reporting, but it is part of a system that includes hardware.
Based on the provided information, the Polygram 98 pH Testing System is likely an IVD (In Vitro Diagnostic) device, although it has some characteristics that might make it a borderline case.
Here's the breakdown:
Arguments for it being an IVD:
- Intended Use: The primary intended use is to "record, store, view and analyze esophageal and gastric refluxate data to diagnose reflux disorders." This involves analyzing biological samples (refluxate) to provide information for diagnosis.
- Device Description: It "measures bile online using sensors in the patient." While the measurement is done in vivo (within the patient), the analysis of the data derived from these measurements is used for diagnosis. IVD devices often involve the analysis of biological samples, even if the initial collection or measurement is done in the body.
- Analysis and Reporting: The data is uploaded and analyzed using software for "later display, analysis and reporting." This analytical step is a key component of IVD devices, where data from biological samples is processed to provide diagnostic information.
Arguments against it being a clear-cut IVD (or reasons for it being borderline):
- In Vivo Measurement: The initial measurement of bile is done in vivo using sensors in the patient. Traditional IVD devices typically involve testing samples outside the body (in vitro).
- Focus on Data Analysis: While the data is derived from biological samples, the system's function heavily relies on the software for analysis and interpretation, which is a characteristic of some medical devices that aren't strictly IVDs.
Why it leans towards IVD:
Despite the in vivo measurement, the core function of the system is to analyze biological data (refluxate/bile) to provide information for the diagnosis of a medical condition (reflux disorders). This aligns strongly with the definition of an IVD device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
Conclusion:
Given the intended use of analyzing biological data for diagnosis, the Polygram 98 pH Testing System fits the description of an IVD device. The in vivo measurement aspect makes it a bit less of a traditional IVD, but the subsequent analysis and use of the data for diagnosis are key IVD characteristics. Regulatory bodies often classify devices based on their intended use and how they contribute to diagnosis, and this device clearly plays a role in providing diagnostic information from biological sources.
N/A
Intended Use / Indications for Use
The Polygram 98 pH Testing System is intended to record, store, view and analyze esophageal and gastric refluxate data to diagnose reflux disorders. The Polygram 98 pH Testing System can also be used to locate the position of the proximal Lower Esophageal Sphincter (LES) manometrically, to assist in the accurate placement of the pH catheter.
Product codes (comma separated list FDA assigned to the subject device)
78 FFX
Device Description
The system is an ambulatory system for use in evaluating reflux disorders in the gastrointestinal tract. The system measures bile online using sensors in the patient. The data is captured and recorded. The data is uploaded from the Bilitec 2000 by use of the Polygram 98 pH Testing Application software for later display, analysis and reporting. In its daily use, a trained technician and/or physician are the main user of the system.
The Main tasks when performing a reflux festing procedure:
- . Prepare equipment including calibration
- . Enter patient demographic information
- perform procedure and obtain relevant data .
- Review, analysis and post procedure activities
- . Create and print a report
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophageal and gastric
Indicated Patient Age Range
Pediatric to Adults
Intended User / Care Setting
a trained technician and/or physician
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical trials have not been performed. This new system does not raise any new safety or performance issues.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K 981733
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.
Not Found
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).
Not Found
§ 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
8 2002 NOV
K011471 Page 1 of 5
510(k) Notification 43S11 Polygram 98 pH Testing System (incl. bile)
510(k) SUMMARY
as required per 807.92(c)
1. Submitters Name, Address:
Medtronic Functional Diagnostics A/S Tonsbakken 16-18 DK-2740 SKOVLUNDE Tel: + 45 44 57 95 02 Fax: + 45 44 57 90 10 Contact person for this submission: Tove Kjaer Date submission was prepared: May 10, 2001
2. Trade Name, Common Name and Classification Name:
A. Trade Name: Polygram 98 pH Testing System (incl. bile)
B. Common Name, Classification Name, Class and Regulation Number:
| Common Name | Classificat
ion
Number | Class | Regulation
Number |
|------------------------------------|------------------------------|-------|----------------------|
| Bilitec 2000 | 78 FFX | II | 21 CFR 876.1725 |
| Optical Fiber Probe | 78 FFX | II | 21 CFR 876.1725 |
| Polygram 98 pH Testing Application | 78 FFX | II | 21 CFR 876.1725 |
3. Predicate Device Identification:
The functionality and intended use of the Polygram 98 pH Testing System (incl. bile) is equivalent to Medtronic Functional Diagnostics A/S's Polygram 98 pH Testing System (K 981733).
1
4. Device Description:
The system is an ambulatory system for use in evaluating reflux disorders in the gastrointestinal tract. The system measures bile online using sensors in the patient. The data is captured and recorded. The data is uploaded from the Bilitec 2000 by use of the Polygram 98 pH Testing Application software for later display, analysis and reporting. In its daily use, a trained technician and/or physician are the main user of the system.
The Main tasks when performing a reflux festing procedure:
- . Prepare equipment including calibration
- . Enter patient demographic information
- perform procedure and obtain relevant data .
- Review, analysis and post procedure activities
- . Create and print a report
5. Intended Use:
The Polygram 98 pH Testing System is intended to record, store, view and analyze esophageal and gastric refluxate data to diagnose reflux disorders. The Polygram 98 pH Testing System can also be used to locate the position of the proximal Lower Esophageal Sphincter (LES) manometrically, to assist in the accurate placement of the pH catheter.
6. Table of Device Similarities and differences to predicate device
| Manufacturer | Medtronic Synectics AB | Medtronic Functional
Diagnostics A/S | |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | Predicate Device
Polygram 98° pH
Testing System, i.e
• Digitrapper pH
• Polygram '98,
pH Testing
Application
• K 981733 | Modified Device
Polygram 98 pH Testing System
v2.2 (incl. Bile), i.e
• Bilitec 2000
• Polygram 98,
pH Testing Application v2.2
(including Bile) | Polygram 98 software has been
updated in order to facilitate
upload and analysis of data
recorded by the Bilitec 2000
device |
| General: | Predicate devics:
- all | Modified Device
- pH System | Explanation of the differences
compared
to the Predicate devices |
| Intended Use /
Indication of
Use | The pH System is
intended to record,
store, view and analyze
esophageal and gastric
pH data to diagnose
reflux disorders. The pH
System can also be
used to locate the
position of the proximal
Lower Esophageal
Sphincter (LES)
manometrically, to
assist in the accurate
positioning of the pH
catheter | The pH System is intended to
record, store, view and analyze
esophageal and gastric refluxate
to diagnose rellux disorders.
The pH System can also be
used to locate the position of the
proximal Lower Esophageal
Sphincter (LES) manometrically,
to assist in the accurate
positioning of the pH catheter | Same |
| Intended
Populations | Pediatric to Adults | Same | |
| Sterilization | Accessories are not
supplied sterile,
manufacturer label the
accessories with
cleaning instructions. | Same | |
| Biocompatibility | Catheters are the only
part that come into
contact with the
patients. | Same | |
| Technical
Features: | Predicate devices - Digitrapper pH | Modified Device
- Bilitec 2000 | Explanation of the differences
compared
To the Predicate devices |
| Number of
Channels | 4 channels pH, 1
pressure | 2 channels Bile | |
| Sampling rate | ¼ Hz | 1 Hz with 4, 8 or 16sec
averaging time | |
| Memory Size | 2Mb Flash Data RAM | 128 Kbytes flash memory | |
| Event markers | 3 | 1 event marker | |
| Built in memory
back up | Now has Flash ram (no
backup required). Clock
has 14 days backup. | Has Flash ram. | Flash RAM is non-volatile therefor
requires no 'backup'. The Bilitec
has no clock and no back-up of
date/time information is then
required |
| Power supply | 2 x 1.5V AA alkaline | 4 x 1,5V AA size alkaline
batteries | |
| Measuring
range | 0-9 pH | Absorbance from 0 to 1 unit | The spectrophotometric
measurement of the absorbance
of Bile (bilirubin) is measured in
the range of 0 to 1 (0-100%) |
| Recording time | 24 Hours | 24 Hours | |
| Current
consumption | 20mA | 30 mA in normal mode and 16
mA on average in Sampling/idle
mode | The set-up mode and the
spectrophotometric measurement
requires different levels of current
consumption |
| Communication | IrDA Communication
(Infra Red) | Serial communication 9600
baud | This is a standard serial port as on
all PC's. |
| Resolution | Better than 0.01pH | / | OR | Over-The-Counter Use ______ |
|----------------------|-------------------------------------------------------------------|----|-----------------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) |
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, | |
| and Radiological Devices | |
| 510(k) Number |