(82 days)
Not Found
No
The description focuses on electrical stimulation and hardware components, with no mention of AI/ML terms or functionalities.
Yes
The device is described as treating patients suffering from urinary urgency, urinary frequency, and urge incontinence, which indicates a therapeutic purpose.
No
The device is described as a "neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve," intended to "treat patients suffering from urinary urgency, urinary frequency, and urge incontinence." This indicates a therapeutic, not a diagnostic, purpose.
No
The device description explicitly states it is a "combination of the Urgent PC Stimulator and the Urgent PC Stimulation Lead Set," which are hardware components (external pulse generator, lead set, needle electrode).
Based on the provided information, the Urgent PC Neuromodulation System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Urgent PC Function: The Urgent PC Neuromodulation System is a therapeutic device. It delivers electrical stimulation to nerves to treat symptoms of urinary urgency, frequency, and incontinence. It does not analyze any biological samples.
- Device Description: The description clearly outlines a system for delivering electrical current to nerves, not for analyzing samples.
- Intended Use: The intended use is to treat patients, not to diagnose or monitor conditions through sample analysis.
Therefore, the Urgent PC Neuromodulation System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Urgent PC Neuromodulation System is intended to treat patients suffering from urinary urgency, urinary frequency, and urge incontinence.
Product codes
NAM
Device Description
The Urgent® PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
The Urgent PC Neuromodulation System is a combination of the Urgent PC Stimulator and the Urgent PC Stimulation Lead Set. The Urgent PC Stimulator is a battery-operated external pulse generator and is designed, constructed, and manufactured for multiple use, only in conjunction with the Urgent PC Stimulation Lead Set. The Urgent PC Stimulation Lead Set transfers the electrical current from the Urgent PC Stimulator to the tibial nerve via the Needle Electrode. The entire Stimulation Lead Set is intended for single use only and is not to be reused.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tibial nerve (for retrograde access to the sacral nerve)
Indicated Patient Age Range
Not Found
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)
The Urgent PC Neuromodulation System and Stimulation Lead Set allows for the successful performance of the product's intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5310 Nonimplanted, peripheral electrical continence device.
(a)
Identification. A nonimplanted, peripheral electrical continence device is a device that consists of an electrode that is connected by an electrical cable to a battery-powered pulse source. The electrode is placed onto or inserted into the body at a peripheral location and used to stimulate the nerves associated with pelvic floor function to maintain urinary continence. When necessary, the electrode may be removed by the user.(b)
Classification. Class II, subject to the following special controls:(1) That sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter.
(2) That the labeling must bear all information required for the safe and effective use of the device as outlined in § 801.109(c) of this chapter, including a detailed summary of the clinical information upon which the instructions are based.
0
Uroplasty, Inc. OCT 17 2005 Premarket Notification [510(k)] Submission Urgent® PC Neuromodulation System
Page 34 of 35
PAGE- I UF: I
Section 9: 510(k) Summary
| Date Prepared | July 26, 2005 |
|---|---|
| New Device Name | Urgent® PC Neuromodulation System |
| Predicate Device | UroSurge® Percutaneous SANS™ Device (K992069) |
| Contact | Uroplasty, Inc. |
| 2718 Summer Street NE | |
| Minneapolis, MN 55413-2820 | |
| Telephone: (612) 378-1180, Facsimile: (612) 378-2027 |
Intended Use
The Urgent PC Neuromodulation System is intended to treat patients suffering from urinary urgency, urinary frequency, and urge incontinence.
Device Description
The Urgent® PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
The Urgent PC Neuromodulation System is a combination of the Urgent PC Stimulator and the Urgent PC Stimulation Lead Set. The Urgent PC Stimulator is a battery-operated external pulse generator and is designed, constructed, and manufactured for multiple use, only in conjunction with the Urgent PC Stimulation Lead Set. The Urgent PC Stimulation Lead Set transfers the electrical current from the Urgent PC Stimulator to the tibial nerve via the Needle Electrode. The entire Stimulation Lead Set is intended for single use only and is not to be reused.
Indications Statement
The Urgent PC Neuromodulation System is intended to treat patients suffering from urinary urgency, urinary frequency, and urge incontinence by delivering retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve.
Technological Characteristics
The new and predicate devices are technologically the same; they are percutaneous tibial nerve stimulator devices with lead sets intended to deliver retrograde access to the sacral nerve for the overactive bladder symptoms of urinary urgency, urinary frequency, and urge incontinence. Both devices have similar intended uses and principles of action. In the few instances where the devices differ, no concerns about safety or effectiveness are raised.
Performance
The Urgent PC Neuromodulation System and Stimulation Lead Set allows for the successful performance of the product's intended use.
Conclusion
The subject device, the Urgent PC Neuromodulation System is substantially equivalent to the previously cleared system by UroSurge, Inc. (K992069).
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
OCT 1 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael Morrell Director of Regulatory Affairs Uroplasty, Inc. 2718 Summer Street MINNEAPOLIS MN 55413-2820
Re: K052025
Trade/Device Name: Urgent® PC Neuromodulation System Regulation Number: 21 CFR §876.5310 Regulation Name: Nonimplanted, peripheral electrical continence device Regulatory Class: II Product Code: NAM Dated: September 15, 2005 Received: September 19, 2005
Dear Mr. Morrell:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reveal above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the entriously of 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 and Cosmedo Free (110) - Forently) nare responsible to determine that the medical devices you provisions of the rear to the bit have either been determined as substantially equivalent under the use as components in the mess (Section 510(k) of the act), or were legally on the market prior to premaired in the coactment date of the Medical Device Amendments. Please note: If you May 26, 1970, the chacinent ants in bulk (i.e., unfinished) and further process (e.g., sterilize) purenase your at a new 510(k) before including these components in your kit. The general you must suchine a now of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 -- Mr. Michael Morrell
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be devices and tetermination that your device complies with other requirements of the Act that I Drinas ... statutes and regulations administered by other federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration (21 CFR Part 807); listing (21 CFR Part 807), labeling (21 CFR Part 801); good manufacturing practice 007); insting (21 CF R rain in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form in and faradiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This icter will anow you to ough mading of substantial equivalence of your device to a legally premarket notification - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - murice to proceed to the market. If you desire specific advice for your device on the labeling active to please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation, prease contact and one by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may obtain of Small Manufacturers, International and Consumer Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Nancy C brigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
| 510(k) Number (if known): | K052025 |
|---|---|
| Device Name: | Urgent® PC Neuromodulation System |
| Indications for Use: | The Urgent PC Neuromodulation System is intended to |
| treat patients suffering from urinary urgency, urinary | |
| frequency, and urge incontinence. |
Prescription Use × (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sigh-Off)
Division of Reproductive, Abdominal and Radiological Devices
510(k) Number K05202
Page 1 of 1