(200 days)
K 944547
Not Found
No
The summary describes standard electrophysiological testing and software enhancements without mentioning AI or ML capabilities.
No
The device is indicated for diagnostic testing (electrophysiological testing of pelvic organs) and is not intended to treat or prevent a disease or condition.
Yes
The device is indicated for "electrophysiological testing" and "urodynamic functions and examination of the motor innervation of the spincters and the pelvic floor and the sensory innervation of pelvic structures," all of which are diagnostic activities used to identify or characterize medical conditions.
No
The device description explicitly states that "The whole system includes transducers, devices, tubing, catheters and electrodes," indicating it is a system with hardware components, not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body (like blood, urine, tissue) in vitro (outside the body).
- This device performs electrophysiological testing on the patient's body in vivo (within the body). It uses electrodes and transducers to measure electrical activity and responses directly from the pelvic organs and nerves.
The description clearly indicates it's a system for performing tests on the patient, not analyzing samples from the patient.
N/A
Intended Use / 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 frec-run EMG tests.
Product codes (comma separated list FDA assigned to the subject device)
84 GWF, 84 GWP, 78 FEN, 84 JXE
Device Description
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic organs, spincters, pelvic floor
Indicated Patient Age Range
Pediatric to Adults
Intended User / Care Setting
Not Found
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)
Assessment of non-clinical performance data for equivalence:
Verifications results shows that the enhanced system performs as its predicate system.
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.
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.
K 944547
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.
Not Found
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
§ 876.1620 Urodynamics measurement system.
(a)
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.(b)
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.
0
K992715
Page 1 of 4
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
ion
Number | Class | Regulation
Number |
|------------------------|------------------------------|-------|------------------------------------------|
| Neuro Urodynamic Suite | 84 GWF
84 GWP | II | 21 CFR
882.1550
21 CFR
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.
1
K992715
Page 2 of 4
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
Diagnostics A/S | - |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| 510(k) number | Predicate devices
- Keypoint
(only software
modules EMG,
MCV) - K 944547 | Modified Device
- Duet /Duet MultiP with
Neuro Urodynamic Suite
K number to be decided | |
| General: | Predicate devices: - Keypoint | Modified Device
- Duet with Neuro
Urodynamic Suite | Explanation of the differences
compared
to the Predicate devices |
| Intended Use /
Indication of Use | Electrophysiological
testing. | Electrophysiological testing of
the pelvic floor field. | This suite will be used with the
other usages for Duet (i.e
urodynamics and anorectal
manometry). |
| Intended
Populations | Pediatric to Adults | Same | -- |
| Sterilization | Accessories are
supplied both sterile and
non sterile, OEM
manufacturer label the
accessories with
cleaning instructions. | Same | -- |
| Biocompatibility | The Sensors are the
only part that comes into
contact with the patients. | Same | -- |
| Technical
Features: | Predicate devices | Modified Device | Explanation of the differences
compared
to the Predicate devices |
| Signals to analyze | Electrophysiological
signals | Same | -- |
| User commands | Menu selections,
keyboard combinations,
screen "buttons" | Same | Modified Device is running under
Windows |
2 (4)
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K992715
Page 3 of 4
510(k) Notification Neuro Urodynamic Suite for Duet / Duet MultiP version 8.1
| Test programs | - MCV
Motor nerve conduction
velocity a conventional
method to diagnose
generalized
polyneuropathy or local
entrapment. | -Nerve Conduction
- Sacral Reflex
Same | New names, same content in test
program. |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|---------------------------------------------------------|
| | - EMG
Studies muscle function.
The test is made at
muscle rest, during
slight activity and during
strong voluntarily
activity. | - Free Run EMG
Same | |
| Calculated
parameters | Impulse, velocity,
response amplitude and
area, decay and
duration. | Latency, velocity, response,
amplitude and duration | Modified Device offers a subset of
Predicate Device. |
| Reports | Signal tracings and
reports. Optionally
selections only. | Same, reports In Word format | Modified Device is running under
Windows. |
| Patient database | Relational database with
logical patient- recording
relations | Same, database in Word
format | Modified Device is running under
Windows |
| Additional data | User definable additional
patient/recording
parameters | Same | - |
| User help system | Online help system with
descriptions of
procedures | No | Printed Instructions for Use |
| Signal review
method | Time - tracing based | Same | --- |
| Recording control | Real time monitoring of
signals | Same | --- |
| Calibration
. | Adjustable and fixed
gain method. Monitoring
of calibration result for
range and resolution
requirement. | Same | --- |
| Recording
configuration | A template is used for
each type of recording.
User definable. Once
used, not possible to
change, ensuring
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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K992715
Page 4 of 4
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.
4(4)
ﺘﺮ ﻟﺘ
4
Image /page/4/Picture/2 description: The image shows a partial logo of the Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined strands and a wing-like structure at the top. The text "DEPARTMENT OF HEALTH &" is visible around the logo.
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 (301) 594-4591. 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" (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 (800) 638-2041 or (301) 443-6597 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)
5
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:
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
(Per 21 CFR 801.109) | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
|---|
| (Division Sign-Off)
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
|---|---|
| 510(k) Number | K992715 / S 001 |