(200 days)
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.
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.
This 510(k) summary describes a software update (Neuro Urodynamic Suite for Duet / Duet MultiP version 8.1) and does not contain detailed acceptance criteria, performance data from a specific study, information on sample sizes, expert involvement for ground truth, or adjudication methods typically found in studies for new medical devices establishing clinical efficacy. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study against predefined acceptance criteria.
However, based on the provided text, here's a breakdown of what can be inferred and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or report specific performance metrics for the Neuro Urodynamic Suite. Instead, it relies on demonstrating equivalence to a predicate device. The primary performance claim is that the "enhanced system performs as its predicate system."
| Aspect | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Overall Performance | Equivalent to predicate system. | "Verifications results shows that the enhanced system performs as its predicate system." (Section 7) |
| Safety and Effectiveness | No new issues regarding performance or safety compared to predicate. | "This new software version does not raise any new issues regarding performance or safety that can not be tested in-house." (Section 8) |
| Calculated Parameters | Able to calculate a subset of parameters as the predicate device. | "Latency, velocity, response, amplitude and duration" are calculated. (Section 6, Table: Calculated parameters) |
2. Sample Size and Data Provenance:
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified. The verification results are mentioned as "in-house" testing (Section 8), implying internal testing rather than external or patient-specific clinical data.
3. Number of Experts and Qualifications for Ground Truth:
- Not applicable/Not specified. The document does not describe the use of experts to establish ground truth for a test set in the context of a new performance study. The evaluation relies on verification of the software's functionality and comparison to a predicate device.
4. Adjudication Method for the Test Set:
- Not applicable/Not specified. No adjudication method is mentioned as there's no described study involving multiple interpretations for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The document explicitly states: "Clinical evaluation not performed." (Section 8). Therefore, no MRMC study, human-in-the-loop performance, or effect sizes of AI assistance are reported.
6. Standalone Performance Study (Algorithm Only):
- A standalone performance study was conducted, but it's referred to as "Verifications results" and "in-house" testing (Section 7 and 8). The exact methodology, metrics, and quantitative results of this "verification" are not provided in detail. The claim is that it performs as the predicate system. It's an algorithm-only evaluation as it's a software update.
7. Type of Ground Truth Used:
- The ground truth for the "verification results" is not explicitly defined in terms of clinical outcomes or pathology. Given that it's a software update for electrophysiological testing, the "ground truth" for the verification likely refers to whether the software accurately processes and displays expected electrophysiological signals and calculates parameters correctly, compared to a known good reference or the predicate device's behavior. It's a functional and performance comparison against the predicate, not a clinical diagnostic accuracy assessment.
8. Sample Size for the Training Set:
- Not applicable/Not specified. This device is a software program for signal processing and parameter calculation in electrophysiology, not an AI/ML model that typically requires a training set of data.
9. How Ground Truth for the Training Set Was Established:
- Not applicable/Not specified. No training set is described for this device.
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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 | ClassificationNumber | Class | RegulationNumber |
|---|---|---|---|
| Neuro Urodynamic Suite | 84 GWF84 GWP | II | 21 CFR882.155021 CFR882.1870 |
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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K992715
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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 FunctionalDiagnostics A/S | - |
|---|---|---|---|
| 510(k) number | Predicate devices- Keypoint(only softwaremodules EMG,MCV)- K 944547 | Modified Device- Duet /Duet MultiP withNeuro Urodynamic SuiteK number to be decided | |
| General: | Predicate devices:- Keypoint | Modified Device- Duet with NeuroUrodynamic Suite | Explanation of the differencescomparedto the Predicate devices |
| Intended Use /Indication of Use | Electrophysiologicaltesting. | Electrophysiological testing ofthe pelvic floor field. | This suite will be used with theother usages for Duet (i.eurodynamics and anorectalmanometry). |
| IntendedPopulations | Pediatric to Adults | Same | -- |
| Sterilization | Accessories aresupplied both sterile andnon sterile, OEMmanufacturer label theaccessories withcleaning instructions. | Same | -- |
| Biocompatibility | The Sensors are theonly part that comes intocontact with the patients. | Same | -- |
| TechnicalFeatures: | Predicate devices | Modified Device | Explanation of the differencescomparedto the Predicate devices |
| Signals to analyze | Electrophysiologicalsignals | Same | -- |
| User commands | Menu selections,keyboard combinations,screen "buttons" | Same | Modified Device is running underWindows |
2 (4)
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K992715
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510(k) Notification Neuro Urodynamic Suite for Duet / Duet MultiP version 8.1
| Test programs | - MCVMotor nerve conductionvelocity a conventionalmethod to diagnosegeneralizedpolyneuropathy or localentrapment. | -Nerve Conduction- Sacral ReflexSame | New names, same content in testprogram. |
|---|---|---|---|
| - EMGStudies muscle function.The test is made atmuscle rest, duringslight activity and duringstrong voluntarilyactivity. | - Free Run EMGSame | ||
| Calculatedparameters | Impulse, velocity,response amplitude andarea, decay andduration. | Latency, velocity, response,amplitude and duration | Modified Device offers a subset ofPredicate Device. |
| Reports | Signal tracings andreports. Optionallyselections only. | Same, reports In Word format | Modified Device is running underWindows. |
| Patient database | Relational database withlogical patient- recordingrelations | Same, database in Wordformat | Modified Device is running underWindows |
| Additional data | User definable additionalpatient/recordingparameters | Same | - |
| User help system | Online help system withdescriptions ofprocedures | No | Printed Instructions for Use |
| Signal reviewmethod | Time - tracing based | Same | --- |
| Recording control | Real time monitoring ofsignals | Same | --- |
| Calibration. | Adjustable and fixedgain method. Monitoringof calibration result forrange and resolutionrequirement. | Same | --- |
| Recordingconfiguration | A template is used foreach type of recording.User definable. Onceused, not possible tochange, ensuringrecording 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.
4(4)
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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)
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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:
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 |
§ 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.