UROSURGE SPIRASTENT PLUS URETERAL STENT

K981489 · Urosurge, Inc. · FAD · May 29, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K981489
• Device Name: UROSURGE SPIRASTENT PLUS URETERAL STENT
• Applicant: Urosurge, Inc.
• Product Code: FAD · Gastroenterology, Urology
• Decision Date: May 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4620
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The UroSurge SpiraStent Plus™ Ureteral Stent, has a reinforcing filament which increases its tensile strength, thereby minimizing the probability of the stent breaking during removal. 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. The duration of the placement of these stents must not remain indwelling more than twenty-nine (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 SpiraStent Plus is a double-pigtail ureteral stent featuring a reinforcing filament to increase tensile strength and reduce breakage risk during removal. Device provides temporary drainage from ureteropelvic junction to bladder. Placed by clinicians via endoscopic, percutaneous, or surgical techniques. Intended for short-term use (up to 29 days) to relieve obstructions caused by benign, malignant, or post-traumatic conditions. Benefits include improved structural integrity during extraction and effective temporary urinary diversion.

Clinical Evidence

No clinical data provided; device relies on design equivalence to existing ureteral stents.

Technological Characteristics

Double-pigtail ureteral stent with integrated reinforcing filament for increased tensile strength. Designed for temporary indwelling use (max 29 days).

Indications for Use

Indicated for temporary drainage from the ureteropelvic junction to the bladder in patients requiring relief of ureteral obstruction due to benign, malignant, or post-traumatic conditions. Indwelling duration limited to 29 days. Single-use only.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

29 1998 MAY

UroSurge, Inc. c/o Mr. Thomas Becze President Princeton Regulatory Associates 116 Village Boulevard, Suite 200 Princeton, NJ 08540

Re: K981489 UroSurge SpiraStent™ PLUS Dated: April 9, 1998 Received: April 27, 1998 Regulatory Class: II 21 CFR \$876.4620/Procode: 78 FAD

Dear Mr. Becze:

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 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). 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 (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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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. Thease note: this response to your premarket notification submission does not affect any obligation you might have under sections 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), please 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/dsmaldsmamain.html".

Sincerely yours

Lillian Yin, Ph.D.

Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## lications For Use Statement

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

Device Name:

UroSurge SpiraStent Plus™ Ureteral Stent

Indications For Use:

The UroSurge SpiraStent Plus™ Ureteral Stent, has a reinforcing filament which increases its tensile strength, thereby minimizing the probability of the stent breaking during removal. 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. The duration of the placement of these stents must not remain indwelling more than twenty-nine (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.

P

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | Robert D Ratting |
|--------------------------------------------------------------------|-------------------------------------|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K981489 |
| Prescription Use | <label>(Per 21 CFR 801.109)</label> |
| | OR |
| Over-The-Counter Use | |
| | (Optional Format 1-2-96) |

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