UROSURGE SPIRALFLO URETERAL STENT

K992391 · Urosurge, Inc. · FAD · Aug 18, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K992391
• Device Name: UROSURGE SPIRALFLO URETERAL STENT
• Applicant: Urosurge, Inc.
• Product Code: FAD · Gastroenterology, Urology
• Decision Date: Aug 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4620
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The UroSurge SpiraFlo Ureteral Stent has no holes in the walls along the side of the stent. This is in addition to the fact that it will be used for temporary drainage from the ureteropelvic junction to the bladder. Double pigtail stents have been employed to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. These stents may be placed using endoscopic, percutaneous, or even surgical techniques. These stents must not remain indwelling for more than 29 days. This product is intended for one-time use only. If the patient's status permits, the stent may be replaced with a new stent.

Device Story

UroSurge SpiraFlo Ureteral Stent is a double pigtail stent designed for temporary ureteral drainage. Device features a solid wall design without side holes. Placed by physicians via endoscopic, percutaneous, or surgical techniques to relieve ureteral obstruction caused by benign, malignant, or post-traumatic conditions. Stent facilitates urine flow from ureteropelvic junction to bladder. Intended for single-use only; maximum indwelling duration of 29 days. Clinical benefit includes relief of obstruction and restoration of urinary drainage.

Clinical Evidence

No clinical data provided. Substantial equivalence based on design and intended use comparison to existing legally marketed ureteral stents.

Technological Characteristics

Double pigtail ureteral stent; solid wall design (no side holes); intended for temporary drainage; single-use; non-implantable beyond 29 days.

Indications for Use

Indicated for temporary drainage from the ureteropelvic junction to the bladder in patients with ureteral obstruction due to benign, malignant, or post-traumatic conditions. Contraindicated for indwelling use exceeding 29 days.

Regulatory Classification

Identification

A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 8 1999

Mr. Steven J. Preiss Vice President, Clinical & Regulatory Affairs UroSurge, Inc. 2660 Crosspark Road Coralville, IA 52241

Re: K992391 UroSurge SpiraFlo Ureteral Stent Dated: July 15, 1999 Received: July 19, 1999 Regulatory Class: II 21 CFR §876.4620/Procode: 78 FAD

Dear Mr. Preiss:

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 Food, Drug, and Cosmetic Act). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), piease contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours.

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K992391

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## Indications For Use Statement

TO BE ASSIGNED 510(k) Number (if known):

Device Name:

UroSurge SpiraFlo Ureteral Stent

## Indications For Use:

The UroSurge SpiraFlo Ureteral Stent has no holes in the walls along the side of the stent. This is in addition to the fact that it will be used for temporary drainage from the ureteropelvic junction to the bladder. Double pigtail stents have been employed to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. These stents may be placed using endoscopic, percutaneous, or even surgical techniques. These stents must not remain indwelling for more than 29 days.

This product is intended for one-time use only. If the patient's status permits, the stent may be replaced with a new stent.

## (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_

David A. Bynum

Reproductive, Abdominal, ENT, 510(k) Number

(Optional Format 1-2-96)