URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12

K071822 · Uroplasty, Inc. · NAM · Aug 20, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K071822
• Device Name: URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12
• Applicant: Uroplasty, Inc.
• Product Code: NAM · Gastroenterology, Urology
• Decision Date: Aug 20, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Urgent PC Neuromodulation System is intended to treat patients suffering from urinary urgency, urinary frequency, and urge incontinence.

Device Story

Urgent PC Neuromodulation System provides percutaneous tibial nerve stimulation (PTNS) to treat overactive bladder symptoms. System consists of battery-operated external pulse generator (Urgent PC Stimulator) and single-use stimulation lead set (including needle electrode). Device delivers retrograde access to sacral nerve via electrical stimulation of tibial nerve. Used in clinical setting; operated by healthcare professionals. Output is electrical current delivered to patient; affects clinical decision-making by providing non-surgical neuromodulation therapy for urinary symptoms.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and identical design to predicate device.

Technological Characteristics

Percutaneous tibial nerve stimulator; battery-operated external pulse generator; single-use needle electrode lead set; delivers electrical stimulation to tibial nerve for retrograde sacral nerve access.

Indications for Use

Indicated for patients suffering from urinary urgency, urinary frequency, and urge incontinence.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Urgent® PC Neuromodulation System (K061333)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a sequence of handwritten digits and letters. The sequence is K0718222. The characters are written in black ink on a white background. The image also contains the text "Page 6 of 21".

Uroplasty, Inc. Premarket Notification [510(k)] Submission Urgent® PC Neuromodulation System

# Section 5: 510(k) Summary

AUG 2 0 2007

| Date Prepared | July 2, 2007 |
|------------------|--------------------------------------------------------------------------------------------------------|
| New Device Name | Urgent® PC Neuromodulation System |
| Predicate Device | Urgent® PC Neuromodulation System (K061333) |
| Contact | Uroplasty, Inc.<br>5420 Feltl Road<br>Minnetonka, MN 55343 USA<br>Tel: [phone]; Fax: [phone] |

## 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 the same intended use and principles of action. Only the Instructions for Use differs between this device and the predicate.

#### 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. (K061333).

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

# AUG 2 0 2007

Ms. Lisa Gallatin Regulatory Affairs Project Manager Uroplasty、Inc. 5420 Feltl Road MINNETONKA MN 55343-7982

Re: K071822

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: July 2, 2007 Received: July 3, 2007

Dear Ms. Gallatin:

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.

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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/1/Picture/10 description: The image shows a circular seal with the text "1906-2006" at the top and "FDA Centennial" in the center. There are three stars below the word "Centennial". The text around the circle reads "U.S. Department of Health & Human Services". The seal appears to be a commemorative emblem for the centennial of the Food and Drug Administration (FDA).

{2}------------------------------------------------

Page 2 -

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); 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.

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|----------------|---------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone]

or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Uroplasty, Inc. Premarket Notification [510(k)] Submission Urgent® PC Neuromodulation System

## Section 4: Indications for Use Statement

510(k) Number (if known):

Device Name:

Indications for Use:

# Section 4. Indications for Use Statement

K071822

Urgent® PC Neuromodulation System

The Urgent PC Neuromodulation System is intended to treat patients suffering from 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)

Nancy C. Brogdon
(Division Sign. Off.)

Division of Reproductive, Abde and Radiological Device 510(k) Number

Submission Date: July 2007