SKYLARK URO PROBE

K053007 · Skylark Device & Systems Co., Ltd. · KPI · Dec 5, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K053007
• Device Name: SKYLARK URO PROBE
• Applicant: Skylark Device & Systems Co., Ltd.
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Dec 5, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Skylark Uro Probe is indicated for pelvic floor stimulation use in the treatment of urinary incontinence and allows assessment of EMG activity of the pelvic floor muscles.

Device Story

Skylark Uro Probe is a nonimplanted electrical continence device; used for pelvic floor muscle stimulation to treat urinary incontinence; provides assessment of pelvic floor muscle EMG activity; operated by healthcare professionals in clinical settings; device delivers electrical stimulation to pelvic floor muscles; output allows clinicians to monitor muscle activity and adjust treatment parameters; intended to improve patient continence through muscle stimulation therapy.

Technological Characteristics

Nonimplanted electrical continence device; electrical stimulation delivery system; EMG sensing capability; class II device; product code KPI.

Indications for Use

Indicated for patients with urinary incontinence requiring pelvic floor muscle stimulation and EMG activity assessment.

Regulatory Classification

Identification

A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows a logo with a stylized bird in flight. The bird is composed of three curved lines that suggest feathers or wings. To the left of the bird, there is text arranged in a circular fashion, likely the name of an organization or department. The text is oriented vertically, following the curve of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 5 2005

2005

George Chang, Ph.D. President Skylark Device & Systems Co., LTD 4th Fl., No. 34, Sec. 3 Chung Shan North Rd. Taipei TAIWAN 104

Re: K053007

Trade/Device Name: Skylark Uro Probe Regulation Number: 21 CFR §876.5320 Regulation Name: Nonimplanted electrical continence device Regulatory Class: II Product Code: KPI Dated: September 15, 2005 Received: October 27, 2005

Dear Dr. Chang:

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.

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.

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

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to ough mattering of substantial equivalence of your device to a legally prematication. The I Dri mailig of online of our 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 11 you desire specific advice for your of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, proase note togetting there), formation on your responsibilities under the Act from the 001:37). I od may oodlin only golder 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. Brogdon

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

Enclosure

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

## Indications for Use

510(k) Number (if known): Kos 3_007

Device Name: Skylark Uro Probe

Indications for Use:

The Skylark Uro Probe is indicated for pelvic floor stimulation use in the treatment of urinary incontinence and allows assessment of EMG activity of the pelvic floor muscles.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE D() NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page __ of

Nancy Britton

(Posted November 13, 2003)

and Radiological Devi 510(k) Number