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.

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, Balloon Expulsion Test, Squeeze Test, 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.

AI/ML Overview

The provided 510(k) summary for the "Anorectal Manometry Suite for Duet / Duet MultiP" does not contain specific acceptance criteria or a study demonstrating the device meets such criteria in the way typically expected for a machine learning or AI-driven device.

This submission is for a software suite that expands the functionality of an existing urodynamics system (Duet/Duet MultiP) to include anorectal manometry. The core of the submission focuses on establishing substantial equivalence to a predicate device (Medtronic Synectics Anorectal Manomentry Analysis Module K972439) based on similar intended use, technology, and features, with a key difference being that the new device only records and calculates basic parameters (max, min, duration) rather than performing complex analysis or comparison to normal values.

Therefore, the following information cannot be extracted from the provided text in the context of typical AI/ML device evaluations:

Table of acceptance criteria and reported device performance: No such criteria or performance metrics are defined for the anorectal manometry suite in this document. The device's performance is not evaluated against quantitative thresholds.
Sample size used for the test set and data provenance: Not applicable. There's no test set described for performance evaluation.
Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. No ground truth establishment process is described.
Adjudication method for the test set: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is not an AI-assisted diagnostic device that humans would use to improve their reading.
Standalone performance (algorithm only without human-in-the-loop performance): Not applicable. This device is a software suite that enables the recording and display of physiological signals, not an algorithmic diagnostic tool.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable. This is not a machine learning device that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary of available information related to equivalence and performance assessment:

Assessment of non-clinical performance data for equivalence: "Verifications results shows that the enhanced system performs as its predicate system." This statement broadly indicates that the system's basic functions (recording pressure and EMG) were verified to operate correctly, similar to the predicate device. However, specific performance metrics or acceptance criteria are not detailed.
Assessment of clinical performance data for equivalence: "Clinical evaluation not performed." This confirms that no clinical studies were conducted to evaluate the device's diagnostic accuracy or performance in a patient population. The equivalence is based on the technical similarity and intended use.
Ground Truth for Equivalence: The primary "ground truth" for this submission is the established function and safety of the predicate device (Medtronic Synectics Anorectal Manomentry Analysis Module K972439). The new device is deemed substantially equivalent because its intended use, measurement capabilities (recording pressure and EMG), and the fundamental technology for capturing these signals are similar, and its lack of complex analysis a simpler, and thus presumably a safer, claim than the predicate.

Summary

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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	ClassificationNumber	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

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4. Device Description:

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

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6. Table of Device Similarities and differences to predicate device

Manufacturer	Medtronic Synectics AB	Medtronic FunctionalDiagnostics	-
510(k) number	Predicate Device	Modified Device
	Anorectal ManometryAnalysis Module for PolygrafHR - K 972439	Anorectal manometrySuite for Duet/DuetMultiP - K tbd
General:	Predicate devices:	Modified Device	Explanation of thedifferences comparedto the Predicate device
Intended Use /Indication of Use	Analyse pressure data recordedfrom the lower gastrointestinaltract.	Record pressure data from thelower gastrointestinal tract.	The Modified Device doesonly record pressure andEMG, no comparisons aremade, only actual results orcalculation heroff is made.
Intended Populations	Pediatric to Adults	Same	---
Sterilization	Accessories are not suppliedsterile, manufacturer label theaccessories with cleaninginstructions.	Same	---
Biocompatibility	Sensors are the only part thatcomes into contact with thepatients.	Same	---
Features:	Predicate devices	Modified Device	Explanation of thedifferences comparedto the Predicate device
Signal to measure	Pressure, EMG	Same
Analyzing signals	Pressure data is analyzed in termsof physiological properties,comparison with normal values,etc.	No analysis or interparetationis made - only calculations(max, min, duration, etc valuesof tracings. The following testsare specified:Sphincter ProfileResting PressureRectal Balloon TestSqueeze TestBalloon Expulsion TestRecto-Anal Inhibitory Reflex	Modified Device presentsrecorded signals and resultsonly. It does not containnormal values and nocomparison is made.
Data displayed	Raw signal data	Same	---
User commandsSoftwareEnvironment	Menu selectionsDos and Windows	SameWindows	---Modified Device runs underWindows 95 / 98
Reports	Signal tracings and reports.	Same	---
Patient database	Database	Relational database withlogical patient- recordingrelations	Modified Device uses MSAccess (ODBCII Driver)
Additional patientdata	Comment field	Same	---
User help system	Separate command description	Same	---
Signal reviewmethod	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 ...

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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

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and head. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

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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:

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)

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

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).