ANORECTAL MANOMETRY SUITE, MODEL 9032S0201

K991389 · Medtronic Functional Diagnostics A/S · FFX · Jul 15, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K991389
• Device Name: ANORECTAL MANOMETRY SUITE, MODEL 9032S0201
• Applicant: Medtronic Functional Diagnostics A/S
• Product Code: FFX · Gastroenterology, Urology
• Decision Date: Jul 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1725
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Anorectal Manometry Suite is a software-enabled diagnostic tool for use with the Duet/Duet MultiP system. It records pressure, volume, flow, and EMG signals from the anorectal region. The system utilizes transducers, tubing, catheters, and electrodes to capture physiological data. It performs predefined tests: Sphincter Profile, Resting Pressure, Rectal Balloon test, Balloon Expulsion Test, Squeeze Test, and Recto-Anal Inhibitory Test. Operated in clinical settings, the software requires a license to enable functionality. It processes raw signal data to calculate values such as maximums, minimums, and durations. Results are displayed as signal tracings and reports for clinician review to assist in diagnosing anorectal function. The device does not perform automated interpretations or comparisons against normal values.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Software-enabled diagnostic suite for Duet/Duet MultiP hardware. Records pressure, volume, flow, and EMG. Connectivity via Windows 95/98 PC environment. Uses MS Access (ODBCII driver) for database management. Complies with EN 60601-1:1990 (and amendments A1, A11, A12, A13). Accessories are non-sterile.

Indications for Use

Indicated for pediatric to adult patients requiring diagnostic measurement and recording of urinary tract and anorectal function, including pressure, volume, flow, and EMG signals.

Regulatory Classification

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.

Predicate Devices

• Medtronic Synectics Anorectal Manometry Analysis Module (K972439)

Submission Summary (Full Text)

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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 | Classification<br>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

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#### 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

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# 6. Table of Device Similarities and differences to predicate device

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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

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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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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

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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 | <div> </div> |
|----------------------|--------------|
| (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