VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT

K981591 · International Regulatory Consultants · FAD · Oct 9, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K981591
• Device Name: VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT
• Applicant: International Regulatory Consultants
• Product Code: FAD · Gastroenterology, Urology
• Decision Date: Oct 9, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.4620
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ureteral double loop stent are intended for drainage of the upper urinary tract where indicated such as in the case of ureteral obstruction, fistula, calculus debris/fragmentation, tumor, etc. The "flush" ureteric configuration with certain models (reference numbers) is intended to flush the lithiasis to the kidney before ESWL.

Device Story

VORTEK and BIOSOFT ureteral double loop stents are passive medical devices designed for upper urinary tract drainage. Stents are inserted by urologists to bypass obstructions, manage fistulas, or facilitate drainage following calculus fragmentation. The device functions as a conduit to maintain ureteral patency. The 'flush' configuration allows for irrigation to reposition lithiasis prior to extracorporeal shock wave lithotripsy (ESWL). These devices are used in clinical or surgical settings. They provide mechanical relief of obstruction and support patient recovery by preventing hydronephrosis and associated complications.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ureteral double loop stents; VORTEK and BIOSOFT material variants; passive drainage design; intended for temporary indwelling use.

Indications for Use

Indicated for drainage of the upper urinary tract in patients with ureteral obstruction, fistula, calculus debris/fragmentation, or tumor. Certain models indicated for flushing lithiasis to the kidney prior to ESWL.

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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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure with three faces in profile, stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

OCT

Porges, S.A.

Managing Director

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K981591

VORTEK® and BIOSOFT® Ureteral Double Loop Stents Dated: September 11, 1998 Received: September 17, 1998 Regulatory Class: II 21 CFR 876.4620/Procode: 78 FAD

Dear Mr. Grabarz:

9 1998

c/o Mr. Donald F. Grabarz

Salt Lake City, UT 84117-0801

International Regulatory Consultants, L.C.

2471 E. Shadow Wood Circle, P.O. Box 17801

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 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 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/cdrb/dsmaldsmamain.html".

Sincerely yours.

Lillian Yin Ph D

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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VORTEK / BIOSOFT Ureteral Double Loop Stent 510(k) Submission

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## E.1 Intended Use:

Both the VORTEK and BIOSOFT versions of the ureteral double loop stent are intended for the exact same use as the current silicone ureteral double loop stent.

The ureteral double loop stent are intended for drainage of the upper urinary tract where indicated such as in the case of ureteral obstruction, fistula, calculus debris/fragmentation, tumor, etc. The "flush" ureteric configuration with certain models (reference numbers) is intended to flush the lithiasis to the kidney before ESWL.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT
and Radiological Devices
510(k) Number K981591/51

Prescription Use✗
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_

(Optional Format 1-2-96)