NEURO URODYNAMIC SUITE, MODEL 9032E0101

K992715 · Medtronic Functional Diagnostics A/S · FEN · Feb 28, 2000 · Gastroenterology, Urology

Device Facts

• Record ID: K992715
• Device Name: NEURO URODYNAMIC SUITE, MODEL 9032E0101
• Applicant: Medtronic Functional Diagnostics A/S
• Product Code: FEN · Gastroenterology, Urology
• Decision Date: Feb 28, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1620
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Neuro-Urodynamics Suite for Duet / Duet MultiP is indicated for electrophysiological testing of the pelvic organs including motor nerve conduction, sacral reflex, and free-run EMG tests.

Device Story

Neuro Urodynamic Suite is a software extension for the Duet/Duet MultiP system; enables electrophysiological testing of pelvic organs. Inputs include electrophysiological signals captured via transducers, catheters, and electrodes. Software processes signals to perform motor nerve conduction, sacral reflex, and free-run EMG tests. System provides real-time signal monitoring, time-tracing based review, and automated calculation of parameters like latency, velocity, and response amplitude. Operated by clinicians in clinical settings; output displayed as signal tracings and reports in Word format. Assists in diagnosing motor innervation of sphincters and pelvic floor and sensory innervation of pelvic structures. Benefits include standardized diagnostic testing for pelvic floor function.

Clinical Evidence

No clinical data performed. Equivalence established via bench testing and verification of software performance.

Technological Characteristics

Software-based suite for electrophysiological signal analysis. Operates on Duet/Duet MultiP hardware. Signals processed via transducers, catheters, and electrodes. Complies with EN 60601-1:1990 (and amendments). Software runs on Windows platform. No patient-contacting components in the software itself; accessories are commercially available.

Indications for Use

Indicated for electrophysiological testing of pelvic organs, including motor nerve conduction, sacral reflex, and free-run EMG, in patients ranging from pediatric to adult populations.

Regulatory Classification

Identification

A urodynamics measurement system is a device used to measure volume and pressure in the urinary bladder when it is filled through a catheter with carbon dioxide or water. The device controls the supply of carbon dioxide or water and may also record the electrical activity of the muscles associated with urination. The device system may include transducers, electronic signal conditioning and display equipment, a catheter withdrawal device to enable a urethral pressure profile to be obtained, and special catheters for urethral profilometry and electrodes for electromyography. This generic type of device includes the cystometric gas (carbon dioxide) device, the cystometric hydrualic device, and the electrical recording cystometer, but excludes any device that uses air to fill the bladder.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

Predicate Devices

• Keypoint (K944547)

Submission Summary (Full Text)

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K992715
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### 510(k) Notification Neuro Urodynamic Suite for Duet / Duet MultiP version 8.1

# 510(k) SUMMARY

as required per 807.92(c)

#### 1. Submitters Name, Address:

Medtronic Functional Diagnostics A/S Tonsbakken 16-18 DK-2740 SKOVLUNDE Tcl: (+ 45 ) 44 57 90 00 Fax: (+ 45 ) 44 57 90 10 Contact person for this submission: Ann-Christine Jonsson Date submission was prepared: 6th August, 1999

#### 2. Trade Name, Common Name and Classification Name:

A. Trade Name: Neuro Urodynamic Suite for Duet 8.1

#### B. Common Name, Classification Name, Class and Requlation Number:

| Common Name | Classificat<br>ion<br>Number | Class | Regulation<br>Number |
|------------------------|------------------------------|-------|------------------------------------------|
| Neuro Urodynamic Suite | 84 GWF<br>84 GWP | II | 21 CFR<br>882.1550<br>21 CFR<br>882.1870 |

#### Predicato Device Identification: 3.

The functionality and intended use of the Neuro Urodynamic Suite for Duet/Duet MultiP version 8.1 is equivalent to the two software test programs Motor Nerve conduction (MCV) and Electromyography (EMG) in Medtronic Dantecs Keypoint (K 944547).

#### 4. Device Description:

r

The Duet version 8.1 is enhanced with a new suite of test programs for EMG and Motor Nerve conduction measurements. The suite is called Neuro Urodynamics Suite and consists of the following predefined testprogram:

- Neuro Free Run EMG
- Neuro Motor Nerve Conduction
- Neuro Sacral Reflex

The Neuro Urodynamic Suite is together with Duet MultiP intended to record a patients urodynamic functions and examination of the motor innervation of the spincters and the pelvic floor and the sensory innervation of pelvic structures.

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The whole system includes transducers, devices, tubing, catheters and electrodes. The tests are operated just like the urodynamic and anorectal tests. A license number is required to enable the software for the Neuro Urodynamic Suite.

#### 5. Intended Use:

The Neuro-Urodynamics Suite for Duet / Duet MultiP is indicated for electrophysiological testing of the pelvic organs including motor nerve conduction, sacral reflex, and frec-run EMG tests.

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

| Manufacturer | Dantec Medical A/S | Medtronic Functional<br>Diagnostics A/S | - |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| 510(k) number | Predicate devices<br>- Keypoint<br>(only software<br>modules EMG,<br>MCV)<br>- K 944547 | Modified Device<br>- Duet /Duet MultiP with<br>Neuro Urodynamic Suite<br>K number to be decided | |
| General: | Predicate devices:<br>- Keypoint | Modified Device<br>- Duet with Neuro<br>Urodynamic Suite | Explanation of the differences<br>compared<br>to the Predicate devices |
| Intended Use /<br>Indication of Use | Electrophysiological<br>testing. | Electrophysiological testing of<br>the pelvic floor field. | This suite will be used with the<br>other usages for Duet (i.e<br>urodynamics and anorectal<br>manometry). |
| Intended<br>Populations | Pediatric to Adults | Same | -- |
| Sterilization | Accessories are<br>supplied both sterile and<br>non sterile, OEM<br>manufacturer label the<br>accessories with<br>cleaning instructions. | Same | -- |
| Biocompatibility | The Sensors are the<br>only part that comes into<br>contact with the patients. | Same | -- |
| Technical<br>Features: | Predicate devices | Modified Device | Explanation of the differences<br>compared<br>to the Predicate devices |
| Signals to analyze | Electrophysiological<br>signals | Same | -- |
| User commands | Menu selections,<br>keyboard combinations,<br>screen "buttons" | Same | Modified Device is running under<br>Windows |

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### 510(k) Notification Neuro Urodynamic Suite for Duet / Duet MultiP version 8.1

| Test programs | - MCV<br>Motor nerve conduction<br>velocity a conventional<br>method to diagnose<br>generalized<br>polyneuropathy or local<br>entrapment. | -Nerve Conduction<br>- Sacral Reflex<br>Same | New names, same content in test<br>program. |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|---------------------------------------------------------|
| | - EMG<br>Studies muscle function.<br>The test is made at<br>muscle rest, during<br>slight activity and during<br>strong voluntarily<br>activity. | - Free Run EMG<br>Same | |
| Calculated<br>parameters | Impulse, velocity,<br>response amplitude and<br>area, decay and<br>duration. | Latency, velocity, response,<br>amplitude and duration | Modified Device offers a subset of<br>Predicate Device. |
| Reports | Signal tracings and<br>reports. Optionally<br>selections only. | Same, reports In Word format | Modified Device is running under<br>Windows. |
| Patient database | Relational database with<br>logical patient- recording<br>relations | Same, database in Word<br>format | Modified Device is running under<br>Windows |
| Additional data | User definable additional<br>patient/recording<br>parameters | Same | - |
| User help system | Online help system with<br>descriptions of<br>procedures | No | Printed Instructions for Use |
| Signal review<br>method | Time - tracing based | Same | --- |
| Recording control | Real time monitoring of<br>signals | Same | --- |
| Calibration<br>. | Adjustable and fixed<br>gain method. Monitoring<br>of calibration result for<br>range and resolution<br>requirement. | Same | --- |
| Recording<br>configuration | A template is used for<br>each type of recording.<br>User definable. Once<br>used, not possible to<br>change, ensuring<br>recording Integrity | Same | --- |

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

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

# 8. Assessment of clinical performance data for equivalence:

Clinical evaluation not performed. This new software version does not raise any new issues regarding performance or safety that can not be tested in-house.

#### 9. Biocompatability:

-

This new Neuro Urodynamic Suite is an extension of the software and there is no contact with the patient. The only parts 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

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# 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 Neuro Urodynamic suite is a purc software enabling and doesn't affect the hardware.

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FEB 2 8 2000

Ms. Tove Kiaer Regulatory Affairs Specialist Medtronic Functional Diagnostics A/S Tonsbakken 16-18 DK-2740 Skovlunde DENMARK

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K992715 Medtronic Duet/Duet MultiP Version 8.1 with Neuro-Urodynamics Suite Dated: November 25, 1999 Received: November 30, 1999 Regulatory Class: II 21 CFR §876.1620/Procode: 78 FEN 21 CFR §882.1870/Procode: 84 GWF 21 CFR §882.1550/Procode: 84 JXE

Dear Ms. Kjaer:

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 Pood, 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 (Special Controls) or class III (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 requirements, as set forth in the Quality System Requlation (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 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 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance 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" (21CFR 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,

Daniel G. Schultz, M.D.

Daniel G. Schultz, M.D. Captain, USPHS Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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# Indication for Use Statement

Page 1 of 1 510(k) Number (if Known):

Device Name: Neuro Urodynamic Suite

Indications for Use:

The Neuro-Urodynamics Suite for Duet / Duet MultiP is indicated for electrophysiological testing of the pelvic organs including motor nerve conduction, sacral reflex, and free-run EMG tests.

## MRI Compatibility Statement:

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The Duet with Neuro Urodynamic 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)

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) |
|------------------------------------------|----|--------------------------------------------------|
|------------------------------------------|----|--------------------------------------------------|

| (Division Sign-Off)<br>Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
|-------------------------------------------------------------------------------------------|----------------------------|
| 510(k) Number | K992715 / S ⁰⁰¹ |