(32 days)
The UroSurge FilaStent TM 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.
UroSurge FilaStent™ Ureteral Stent
The provided text is a 510(k) premarket notification approval letter for the UroSurge FilaStent Ureteral Stent. This document details the FDA's decision regarding the device's substantial equivalence to previously marketed devices. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 29 1998
UroSurge, Inc. c/o Mr. Thomas Becze President Princeton Regulatory Associates 116 Village Boulevard, Suite 200 Princeton, NJ 08540
Re: K981491 UroSurge FilaStent™ Ureteral Stent Dated: April 6, 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 (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), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrb/dsmaldsmam.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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Page 1 of 1
Indications For Use Statement
TO BE ASSIGNED 510(k) Number (if known):
Device Name:
UroSurge FilaStent TM Ureteral Stent
Indications For Use:
The UroSurge FilaStent TM 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Robert R. Sating | |
|---|---|
| (Division Sign-Off) |
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K981491 |
|---|---|
| --------------- | --------- |
| Prescription Use | ✓ | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) |
(Optional Format 1-2-96)
000008
§ 876.4620 Ureteral stent.
(a)
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.(b)
Classification. Class II (performance standards).