GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATHETER; NEPHROSTOMY CATHETER; BILIARY CATHETER

K053245 · Uresil, LLC · FGE · Dec 20, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K053245
• Device Name: GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATHETER; NEPHROSTOMY CATHETER; BILIARY CATHETER
• Applicant: Uresil, LLC
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Dec 20, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For percutaneous drainage of abscesses, nephrostomy and other fluids.

Device Story

General purpose drainage catheter designed for percutaneous access to body cavities or organs. Device facilitates drainage of abscesses, nephrostomy, and other fluid collections. Operated by physicians in clinical or hospital settings. Provides a conduit for fluid evacuation to aid in patient treatment and symptom relief.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

General purpose drainage catheter; percutaneous access design; materials and dimensions consistent with standard drainage catheters for biliary and related applications.

Indications for Use

Indicated for percutaneous drainage of abscesses, nephrostomy, and other fluids in patients requiring such drainage.

Regulatory Classification

Identification

A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.

Special Controls

*Classification.* Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boutevard Rockville MD 20850

DEC 2 0 2005

Mr. Matthew Mahon Manager, RA/QA UreSil, LLC 5418 W. Touhy Ave SKOKIE IL 60077

RE: K053245

Trade/Device Name: General purpose drainage catheter Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE and LJE; 79 GBO and GBX Dated: November 18, 2005 Received: November 23, 2005

## Dear Mr. Mahon:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your booties is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to the enorstate) to regary manufate of the Medical Device Amendments, or to devices that have been May 20, 1770, all onlinent add on aversions 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 do not require approval or a provisions of the Act. The general controls provisions of the Act de nec, subjos to the generaliation, 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 If your device is elassilled (500 as in additional controls. Existing major regulations affecting your Apploval), it thay oc solose to sour aderal Regulations, Title 21, Parts 800 to 898. In addition, FDA acrroo built of rether announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I Rase be advisour and I Dr vior that your device complies with other requirements of the Act or any FDA lias made a decemination and your as a so be other Federal agencies. You must comply with all the r catal statues and regalations administed to registration and listing (21 CFR Part 807); labeling Act s requirements, medding, but not manufacturing practice requirements as set forth in the quality systems (QS) (21 CFR Part 801); good manaracting product radiation control product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equire and thus, per premarket notification. The IDA Inding of sabstantial vice 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
r the regulation of the fitter following purphers, based on the regulatio If you desire specific advice for your device on our loosing ong 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, please note the regulation entitled, "Nisotanants of the sunder the Act from the 807.97). You may obtain other general information on your reply.
Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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

Enclosure

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K053245

## Indications for Use

510(k) Number (if known): _ Device Name: General Purpose Drainage Catheter Indications for Use:

For percutaneous drainage of abscesses, nephrostomy and other fluids.

Over-The-Counter Use Prescription Use Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR
PLEASE DO NOT WDITE PELOW THIS (21 CFR 801 Subpart C) (P) EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel R. Syverson

(Division Sign-Off Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number .