(112 days)
Not Found
No
The summary describes a hardware-based neuromodulation system with no mention of AI or ML in its function or description.
Yes
The device is described as treating patients with Overactive Bladder (OAB) and associated symptoms, which is a therapeutic purpose.
No
This 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 with Overactive Bladder (OAB)." It provides therapy rather than diagnosing a condition.
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:
- Intended Use: The intended use is to treat patients with Overactive Bladder (OAB) by stimulating nerves. This is a therapeutic treatment applied directly to the patient's body.
- Device Description: The device is a neuromodulation system that delivers electrical stimulation to nerves. This is an active medical device used for treatment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or compatibility.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic or other information. The Urgent PC Neuromodulation System is a therapeutic device used to treat a condition by directly interacting with the patient's nervous system.
N/A
Intended Use / Indications for Use
The Urgent PC Neuromodulation System is intended to treat patients with Overactive Bladder (OAB) and associated symptoms of 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
sacral nerve, tibial 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
The Urgent PC Neuromodulation System and Stimulation Lead Set allows for the successful performance of the product's intended use.
Key Metrics
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. Premarket Notification [510(k)] Submission Urgent® PC Neuromodulation System
Page 7 of 36
Section 5: 510(k) Summary
| Date Prepared | October 8, 2010 | |
|---|---|---|
| New Device Name | Urgent® PC Neuromodulation System | OCT 2 1 2010 |
| Predicate Device | Urgent® PC Neuromodulation System (K071822) | |
| Contact | Uroplasty, Inc. | |
| 5420 Feltl Road | ||
| Minnetonka, MN 55343 USA | ||
| Tel: 952.426.6140; Fax: 952.426.6199 |
Intended Use
i
The Urgent PC Neuromodulation System is intended to treat patients with Overactive Bladder (OAB) and associated symptoms of 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 primary difference between the new and predicate devices is the wording of indications statement. The new device indications statement incorporates the overactive bladder terminology listed in the intended use. This difference in indication statement represents an update in wording rather than a change in the device patient population.
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 the same intended use and principles of action. Only the wording of the indications statement differs between this device and the predicate.
1
Uroplasty, Inc.
Premarket Notification [510(k)] Submission Urgent® PC Neuromodulation System
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 of the 510(k) submission is substantially equivalent to the previously cleared Urgent PC Neuromodulation System by Uroplasty, Inc. (K071822).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized representation of a human figure, composed of three curved lines, positioned to the right of the department's name. The text "DEPARTMENT OF HEALTH & HUMAN" is arranged vertically along the left side of the logo, with "SERVICES" completing the circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G60 Silver Spring, MD 20993-0002
Mr. Michael Morrell, RAC Director of Regulatory Affairs and Quality Assurance Uroplasty. Inc., 5420 Feltl Road MINNETONKA MN 55343
OCT 2 1 2010
Re: K101847
Trade/Device Name: Urgent® PC Neuromodulation System Regulation Number: 21 CFR 8876,5310 Regulation Name: Non-implanted, peripheral electrical continence device Regulatory Class: II Product Code: NAM Dated: October 8, 2010 Received: October 14, 2010
Dear Mr. Morrell:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced 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 . 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related
3
Page 2
adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Hubert Lemmer MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Uroplasty, Inc.
Premarket Notification [510(k)] Submission Urgent® PC Neuromodulation System
Page 6 of 36
Section 4: Indications for Use Statement
510(k) Number (if known): K101847
OCT 2 1 2010
Device Name:
Urgent® PC Neuromodulation System
The Urgent PC Neuromodulation System is intended to treat patients Indications for Use: with Overactive Bladder (OAB) and associated symptoms of urinary urgency, urinary frequency, and urge incontinence.
Prescription Use X (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)
HReinu
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K101847
CONFIDENTIAL