(85 days)
Not Found
No
The description focuses on basic data analysis, calculation of parameters, and comparison with normal values, without mentioning any AI/ML techniques.
No
The device is a software program designed to analyze pressure data from the lower gastrointestinal tract, rather than providing or directly managing therapy. It supports diagnostic and analytical functions for physicians.
Yes
The device analyzes pressure data from the lower gastrointestinal tract, compares it with normal values, and generates an analysis report including an interpretation section. This process of analyzing physiological properties and providing data for interpretation aligns with the function of a diagnostic device.
Yes
The device is described as a "software program" and an "Anorectal Analysis Module" added to existing software. The description focuses entirely on the software's functionality for analyzing and presenting data, with no mention of accompanying hardware components being part of the submitted device.
Based on the provided information, the Anorectal Analysis Module 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 Anorectal Analysis Module analyzes pressure data recorded from the lower gastrointestinal tract. This data is collected in vivo (within the living body) using a separate device (likely a pressure catheter or probe). The software then processes and analyzes this in vivo data.
- Lack of sample analysis: The description does not mention the analysis of any biological samples taken from the patient.
The device is a software program that analyzes physiological data collected from the patient, not from a sample taken from the patient. This places it outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Anorectal Analysis Module is a software program that has been designed to analyze pressure data recorded from the lower gastrointestinal tract in pediatric and adult populations.
Product codes (comma separated list FDA assigned to the subject device)
78 FFX
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 minimum and maximum values, length of selection.
By adding the Anorectal 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 analysis report includes sections such as patient demographics; interpretation and comment (for user to insert); procedure summary; Anorectal tracing; analyses (as specified below); and physician signature section.
Analyses:
Vector Volume Analysis
Automatic Base Line Analysis
Intepretation and Comments Analysis
Rectal Balloon Analysis
Tri-Level Analysis
Radial Pressure Analysis
Anal Canal Vector Volume Analysis
Tracing Clip-Out Analysis
Quick Calculation Analysis
The analysis report can then serve as a tool for 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
lower gastrointestinal tract
Indicated Patient Age Range
pediatric and adult populations
Intended User / Care Setting
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.
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)
The Anorectal Analysis Module has been thoroghly tested during the development phase, that is, alpha testing in terms of integration testing has been performed and documented and beta testing in terms of hospital site testing has been done and documented.
It has been concluded that the alpha and beta testing has meet and passed the specified objectives and should therefore be released to the market.
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.
Polygram Software (DOS environment) (included in 872712 - Polygraf)
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.
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
K972439
P192
DRAERD 510(k) Summary of Safety and Effectiveness Information
| Submitter's name | Synectics Medical AB
Renstiernas gata 12
S-116 28 Stockholm
Sweden |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Synectics Medical Inc
3850 Victoria Street North
Mail Stop V215
Shoreview, MN 55126-2978 |
| | SEP 23 1997 |
| | Contact: Anna Pettersson |
| | Contact: Keith Jung |
| Name of device | Anorectal Manometry Analysis Module |
| Name of equivalent device | Polygram Software (DOS environment)
(included in 872712 - Polygraf) |
| | The Anorectal Analysis Module is identical, in function and types of analyses that can be performed, to the Polygram Software (DOS). The main difference is that the Polygram Software (DOS) is written for the DOS environment and the Anorectal Analysis Module is written for the Windows environment. Polygram Software (DOS) works in the DOS environment and the Anorectal Analysis Module works in the Windows environment. |
| 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 minimum and maximum values, length of selection. |
| | By adding the Anorectal 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 analysis report includes sections such as patient demographics; interpretation and comment (for user to insert); procedure summary; Anorectal tracing; analyses (as specified below); and physician signature section. |
| | Analyses: |
| | Vector Volume AnalysisAutomatic Base Line AnalysisIntepretation and Comments AnalysisRectal Balloon AnalysisTri-Level AnalysisRadial Pressure AnalysisAnal Canal Vector Volume AnalysisTracing Clip-Out AnalysisQuick Calculation Analysis |
| | The analysis report can then serve as a tool for the physician's diagnosis and |
(
The analysis report can then serve as a tool for the physician's diagnosis and post treatment evaluation.
1
| Performance
Testing | The Anorectal Analysis Module has been thoroghly tested during the
development phase, that is, alpha testing in terms of integration testing has been
performed and documented and beta testing in terms of hospital site testing has
been done and documented.
It has been concluded that the alpha and beta testing has meet and passed the
specified objectives and should therefore be released to the market. |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Statement of
intended
use/indication
for use | The Anorectal Analysis Module is a software program that has been designed to
analyze pressure data recorded from the lower gastrointestinal tract in pediatric
and adult populations. |
| | The Anorectal Analysis Module includes the following analyses: |
| | • Vector Volume Analysis |
| | • Automatic Base Line Analysis |
| | • Intepretation and Comments Analysis |
| | • Rectal Balloon Analysis |
| | • Tri-Level Analysis |
| | • Radial Pressure Analysis |
| | • Anal Canal Vector Volume Analysis |
| | • Tracing Clip-Out Analysis |
| | • Quick Calculation Analysis |
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.
202
2
Image /page/2/Picture/0 description: The image shows a black and white logo. The logo consists of two parts: a symbol on the right and text on the left. The symbol is a stylized depiction of an eagle or bird with three curved lines representing its wings. The text on the left is arranged vertically and reads "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Micael Hamberg Medtronic Synectics Synectics Medical AB Renstiernas gata 12 S-116 28 Stockholm Sweden
Re: K972439 Anorectal Manometry Analysis Module Dated: June 26, 1997 Received: June 30, 1997 Regulatory Class: II SEP 2 3 1997 21 CFR 876.1725/Procode: 78 FFX
Dear Mr. Hamberg:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification sobmission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) prematet notification. The FDA finding of substantial equivalence of your device to a legally marked predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours.
William Yu, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page_1_of_1_
510(k) Number (if known): K972438
Device Name: Anorectal Manometry Analysis Module
Indications For Use:
The Anorectal Analysis Module is a suflware program that has heen designed to analyse pressure duta recorded from the lower gastrointestinal tract in podiatic and adult populations.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ONE)
ાત
Prescription Use (Optional Format 1-2-96)
Over-The-Counter Use (Per 21 CFR 801 109)
Taher N. Rotting/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number