Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a system for measuring and recording physiological signals (pressure, volume, flow, EMG) and performing predefined tests. There is no mention of AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms. The analysis is based on established techniques for measuring pressure signals.

Therapeutic

No
The device is intended to measure and record the functioning of the patient's urinary tract and anorectal function, comprising EMG and pressure recordings, which falls under diagnostic rather than therapeutic use.

Diagnostic

Yes
The device is described as "intended to measure and record the functioning of the patient's urinary tract and anorectal function" and performs "measurements comprise recording of pressure, volume, flow and EMG." These measurements are used to assess function, which is a diagnostic purpose. The predefined tests listed for measuring in the rectum further support its role in diagnosing anorectal conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system includes transducers, devices, tubing, catheters, and electrodes, which are hardware components. While software is mentioned (requiring a license), it is part of a larger hardware-based system for measuring physiological parameters.

IVD (In Vitro Diagnostic)

Based on the provided information, the Duet-with Anorectal Manometry Suite is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the living body ("in vitro").
Device Function: The Duet-with Anorectal Manometry Suite directly measures and records physiological parameters (pressure, volume, flow, EMG) within the patient's body (anorectal function). This is an in vivo measurement.
Intended Use: The intended use is to measure and record the functioning of the patient's urinary tract and anorectal function, not to analyze specimens taken from the patient.
Device Description: The description details the system's components (transducers, catheters, electrodes) and the types of tests performed, all of which involve direct interaction with the patient's body.

Therefore, the Duet-with Anorectal Manometry Suite falls under the category of a diagnostic device that performs in vivo measurements, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Duet-with Anorectal Manometry Suite is intended to measure and record the functioning of the patient's urinary tract and anorectal function*. The measurements comprise recording of pressure, volume, flow and EMG. The system includes transducers, devices, tubing, catheters and electrodes.

expanded indication for use due to the Anorectal Manometry Suite.

Product codes

78 FFX

Device Description

The Anorectal Manometry Suit is together with Duet/Duet MultiP intended to record a patients anorectal function compromising EMG and pressure recordings. The whole system includes transducers, devices, tubing, catheters and electrodes.

The Duet / Duet MultiP is an apparatus capable of registration of pressure signals over a long time. The measurements and analysis have originally been developed for urodynamics tests, but since anorectal tests also are measuring pressure signals over a period of time, it is suitable to use the same technique for these types of tests, i.e. anorectal tests.

The device is used in a dedicated clinical setup. The following sets of test types are predefined tests for measuring in the rectum:

Sphincter Profile,
. Resting Pressure,
Rectal Balloon test,
비 Balloon Expulsion Test,
피 Squeeze Test
l Recto-Anal Inhibitory Test.

The tests are operated just like the urodynamic tests. A license number is required to enable the software for the Anorectal Manometry Suite.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

patient's urinary tract and anorectal

Indicated Patient Age Range

Pediatric to Adults

Intended User / Care Setting

dedicated clinical setup.

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

Verifications results shows that the enhanced system performs as its predicate system. Clinical evaluation not performed.

Key Metrics

Not Found

Predicate Device(s)

K972439

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

0

510(k) Notification 23S20 Anorectal Manometry Suite for Duet / Duet MultiP

510(k) SUMMARY

as required per 807.92(c) 動画 2017 06:00 【 10:00 【 10:00 【 10:00 【 10:00 【 10:00 】 10:00 【 10:00 】 10:00 【 1

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: Ann-Christine Jönsson Date submission was prepared: 19th April, 1999

2. Trade Name, Common Name and Classification Name:

Anorectal Manometry Suite for Duet / Duet MultiP A. Trade Name:

B. Common Name, Classification Name, Class and Regulation Number:

| Common Name | Classification
Number | Class | Regulation Number |
|---------------------------|--------------------------|-------|-------------------|
| Anorectal Manometry suite | 78 FFX | II | 21 CFR 876.1725 |

3. Predicate Device Identification:

The scientific technology and the functionality and intended use of the Anorectal Manometry Suit for Duet is equivalent to Medtronic Synectics Anorectal Manomentry Analysis Module (K972439).

1 (4)

COMPANY CONFIDENTIAL

Medtronic Functional Diagnostics A/S

Tonsbakken 16-18 MIT 2740 CUATIT TINING

1

4. Device Description:

The Anorectal Manometry Suit is together with Duet/Duet MultiP intended to record a patients anorectal function compromising EMG and pressure recordings. The whole system includes transducers, devices, tubing, catheters and electrodes.

The Duet / Duet MultiP is an apparatus capable of registration of pressure signals over a long time. The measurements and analysis have originally been developed for urodynamics tests, but since anorectal tests also are measuring pressure signals over a period of time, it is suitable to use the same technique for these types of tests, i.e. anorectal tests.

The device is used in a dedicated clinical setup. The following sets of test types are predefined tests for measuring in the rectum:

Sphincter Profile,
. Resting Pressure,
Rectal Balloon test,
비 Balloon Expulsion Test,
피 Squeeze Test
l Recto-Anal Inhibitory Test.

The tests are operated just like the urodynamic tests. A license number is required to enable the software for the Anorectal Manometry Suite.

5. Intended Use:

The Duet-with anorectal manometry suite is intended as a diagnostic tool to measure and record the functioning of the patient's urinary tract and anorectal function *. The measurements comprise recording of pressure, volume, flow and EMG.

expanded indication for use due to the Anorectal Manometry Suit.

2 (4) COMPANY CONFIDENTIAL

Medtronic Functional Diagnostics A/S

Tonsbakken 16-18 DK-2740 SKOVI I'NDU

2

6. Table of Device Similarities and differences to predicate device

| Manufacturer | Medtronic Synectics AB | Medtronic Functional
Diagnostics | - |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | Predicate Device | Modified Device | |
| | Anorectal Manometry
Analysis Module for Polygraf
HR - K 972439 | Anorectal manometry
Suite for Duet/Duet
MultiP - K tbd | |
| General: | Predicate devices: | Modified Device | Explanation of the
differences compared
to the Predicate device |
| Intended Use /
Indication of Use | Analyse pressure data recorded
from the lower gastrointestinal
tract. | Record pressure data from the
lower gastrointestinal tract. | The Modified Device does
only record pressure and
EMG, no comparisons are
made, only actual results or
calculation heroff is made. |
| Intended Populations | Pediatric to Adults | Same | --- |
| Sterilization | Accessories are not supplied
sterile, manufacturer label the
accessories with cleaning
instructions. | Same | --- |
| Biocompatibility | Sensors are the only part that
comes into contact with the
patients. | Same | --- |
| Features: | Predicate devices | Modified Device | Explanation of the
differences compared
to the Predicate device |
| Signal to measure | Pressure, EMG | Same | |
| Analyzing signals | Pressure data is analyzed in terms
of physiological properties,
comparison with normal values,
etc. | No analysis or interparetation
is made - only calculations
(max, min, duration, etc values
of tracings. The following tests
are specified:
Sphincter Profile
Resting Pressure
Rectal Balloon Test
Squeeze Test
Balloon Expulsion Test
Recto-Anal Inhibitory Reflex | Modified Device presents
recorded signals and results
only. It does not contain
normal values and no
comparison is made. |
| Data displayed | Raw signal data | Same | --- |
| User commands
Software
Environment | Menu selections
Dos and Windows | Same
Windows | ---
Modified Device runs under
Windows 95 / 98 |
| Reports | Signal tracings and reports. | Same | --- |
| Patient database | Database | Relational database with
logical patient- recording
relations | Modified Device uses MS
Access (ODBCII Driver) |
| Additional patient
data | Comment field | Same | --- |
| User help system | Separate command description | Same | --- |
| Signal review
method | Time - tracing based | Same | --- |
| Recording control | Real time monitoring of signals | Same | --- |
| Recording configur. | User definable configuration | Same | --- |

3 (4)

COMPANY CONFIDENTIAL

Medtronic Functional Diagnostics A/S

Tonsbakken 16-18 DK_2740 SKAVI UNITE ...

3

7. Assessment of non-clinical performance data for equivalence:

Verifications results shows that the enhanced system performs as its predicate system.

8. Assessment of clinical performance data for equivalence:

Clinical evaluation not performed.

9. Biocompatability:

This new anorectal suit is an extension of the software and there is no contact with the patient. The only part of this system that comes into contact with the body are the accessories and they are already in commercial distribution on the US market.

10. Sterilization:

Not applicable

11. Standards and Guidances:

The Duet / Duet MultiP complies to the following standard:

EN 60601-1:1990 and Amendments A1, A11, A12 and A13

The Anorectal manometry suite is a pure software enabling and doesn't affect the hardware.

COMPANY CONFIDENTIAL

Medtronic Functional Diagnostics A/S

Tonsbakken 16-18 DK-2740 SKOVI IINDR

Tel: + 45 44 57 90 00 Nor. + 45 14 57 00 10

4

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 15 1999

Ms. Ann-Christine Jönsson Regulatory Affairs Medtronic Functional Diagnostics A/S Tonsbakken 16-18 DK-2740 Skovlunde DENMARK

Re: K991389 Anorectal Manometry Suite for Duet/Duet MultiP Dated: April 19, 1999 Received: April 21, 1999 Requiatory Class: II 21 CFR §876.1725/Procode: 78 FFX

Dear Ms. Jönsson:

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 legally marketed predicate 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, market the device, 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 (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requirin regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 Compiance 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

5

510(k) Notification 23S20 Anorectal Manometry Suite for Duet /Duet MultiP

Indication for Use Statement

Page 1 of 1 _ Market Land (1982) - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1991

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Anorectal Manometry Suit

Indications for Use:

The Duet-with Anorectal Manometry Suite is intended to measure and record the functioning of the patient's urinary tract and anorectal function*. The measurements comprise recording of pressure, volume, flow and EMG. The system includes transducers, devices, tubing, catheters and electrodes.

expanded indication for use due to the Anorectal Manometry Suite.

MRI Compatibility Statement:

The Duet with Anorectal Manometry Suite is not compatible for use in a MRI magnetic field.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K99/389

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use
----------------------	--

(Optional Format 1-2-96)COMPANY CONFIDENTIAL

Medtronic Functional Diagnostics A/S

Tonsbakken 16-18 1787 Tel: + 45 44 57 90 00