(90 days)
Not Found
No
The summary describes a system for recording and analyzing pressure data, but there is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No
The device is used to diagnose gastrointestinal disorders by recording and analyzing data, not to treat them.
Yes
The "Intended Use / Indications for Use" states that the system is intended "to assist in the diagnoses of gastrointestinal disorders."
No
The device description explicitly states the system uses "sensors on and in the patient" to measure pressure and other parameters, indicating the presence of hardware components beyond just software.
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. They are performed outside of the living body.
- Device Description: The description clearly states the system "measures pressure and other parameters online using sensors on and in the patient." This indicates the measurements are being taken directly from within the patient's body (in vivo), not from a sample taken from the patient.
- Intended Use: The intended use is to "record, store, view and analyze data on line in the gastrointestinal tract." This further confirms the in vivo nature of the data collection.
Therefore, because the device operates by taking measurements directly from within the patient's body rather than from a sample outside the body, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Esophageal Manometry System is intended to record, store, view and analyze data on line in the gastrointestinal tract to assist in the diagnoses of gastrointestinal disorders.
Product codes (comma separated list FDA assigned to the subject device)
FFX
Device Description
The system is a stationary manometry system for use in evaluating the function of the gastrointestinal tract. The system measures pressure and other parameters online using sensors on and in the patient. The parameters are presented during the capture and are also recorded for later display, analysis and reporting. In its daily use, a trained technician and/or a physician are the main users of the system.
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
Infant, Pediatric to Adults
Intended User / Care Setting
Trained technician and/or a 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)
Verifications results shows that the enhanced system performs as its predicate system. Clinical trials are not performed. This new system doesn't 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.
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
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 90 00 Fax: (+ 45 ) 44 57 90 10 Contact person for this submission: Ann-Christine Jönsson Date submission was prepared: 6d August, 1999
2. Trade Name, Common Name and Classification Name:
A. Trade Name: Esophageal Manometry System
B. Common Name, Classification Name, Class and Regulation Number:
| Common Name | Classification
Number | Class | Regulation Number |
|--------------------------------------------------|--------------------------|-------|-------------------|
| Polygraf ID | 78 FFX | II | 21 CFR 876.1725 |
| Polygram 98, Esophageal Manometry
Application | 78 KLA,
FFX | II | 21 CFR 876.1725 |
3. Predicate Device Identification:
The functionality and intended use of the Esophageal Manometry System is equivalent to Medtronic Synectics Polygraf HR (K872712) with Polygram for Windows, Base Module (K946322) and Esophageal Manometry Analysis Module (K961070).
4. Device Description:
The system is a stationary manometry system for use in evaluating the function of the gastrointestinal tract. The system measures pressure and other parameters online using sensors on and in the patient. The parameters are presented during the capture and are also recorded for later display, analysis and reporting.
In its daily use, a trained technician and/or a physician are the main users of the system.
1 (4) COMPANY CONFIDENTIAL
Medtronic Functional Diagnostics A/S
Tonsbakken 16-18 DK-2740 SKOVLUNDE
Tel: + 45 44 57 90 00 Fax: + 45 44 57 90 10
1
The main tasks when performing a manometry procedure with a stationary manometry system are:
- . Prepare equipment including calibration
- . Enter patient/study demographic information
- Perform procedure and obtain relevant data .
- Review, analysis and post procedure activities .
- . Create and print a report
The Polygram 98 Esophageal Manometry Application software runs on Microsoft Windows® 98
5. Intended Use:
The Esophageal Manometry System is intended to record, store, view and analyze data on line in the gastrointestinal tract to assist in the diagnoses of gastrointestinal disorders.
6. Table of Device Similarities and differences to predicate device
| Manufacturer | Medtronic Synectics AB | Medtronic Functional
Diagnostics A/S | - |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| 510(k) number | Predicate devices
• Polygraf HR
- K 872712
• Polygram software,
base module - K 946322
• Esophageal
Manometry Analysis
Module - K 961070 | Modified Device
Esophageal Manometry System,
(EM System) i.e - Polygraf ID &
- Polygram 98,
Esophageal Manometry
Application
K number to be decided | - |
| General: | Predicate devics:
- all | Modified Device
- EM System | Explanation of the differences
compared |
| | | | to the Predicate devices |
| Intended Use /
Indication of Use | Record, store, view and
analyze data on line in the
gastrointestinal tract to
assist in the diagnoses of
gastrointestinal disorders.. | Same | -- |
| Intended Populations | Infant, Pediatric to Adults | Same | -- |
| Sterilization | Accessories are not
supplied sterile,
manufacturer label the
accessories with cleaning
instructions. | Same | -- |
| Biocompatibility | The Sensors are the only
part that comes into
contact with the patients. | Same | -- |
COMPANY CONFIDENTIAL
Medtronic Functional Diagnostics A/S
Tonsbakken 16-18 DK-2740 SKOVLUNDE
Tel: + 45 44 57 90 00 Fax: + 45 44 57 90 10
2
| Technical Features: | Predicate devices
- Polygraf HR | Modified Device
- Polygraf ID | Explanation of the differences
compared
to the Predicate devices |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Number of Channels | Up to 16 | 4-16 channels | Enhanced performance |
| Sampling rate | 1/128 to 128 Hz | 105-1674 Hz | Enhanced performance |
| Power supply | 9-12 V DC | 24 V DC | 110-230 V Power Supply in one |
| Measuring range | 0-9 pH | -2.5 Vpm, 5 % to 2.5 Vpm 5% | Enhanced performance |
| Insulation | Burr Brown722 dual
isolated DC/DC converter | HCPL-0710. NMV 2405S, and
safety power supply: class I | Enhanced performance, isolation
provided also within each module of 4
channels (4, 8, 12, 16.) |
| Current consumption | 260 mA nom standard
(8bit) | Max 0.8 A | Enhanced performance requires more
power |
| Communication | Optical serial RS 232 | USB (Universal Serial Bus) | Enhanced performance (band width) |
| Resolution | 8 bit | 22 bit | Enhanced performance |
| Dimension | 11.2" x 2" x 6 " | 14" x 8.8" x 2.8" | More channels require more space |
| Weight | 1 050 g |