LEMAITRE BILIARY CATHETER

K992941 · Vascutech, Inc. · LQR · Jan 12, 2000 · Gastroenterology, Urology

Device Facts

• Record ID: K992941
• Device Name: LEMAITRE BILIARY CATHETER
• Applicant: Vascutech, Inc.
• Product Code: LQR · Gastroenterology, Urology
• Decision Date: Jan 12, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LeMaitre Biliary Catheter is indicated for the removal of stones and ductal debris.

Device Story

LeMaitre Biliary Catheter is a medical device used for the removal of stones and ductal debris from the biliary system. It is intended for use by clinicians in a hospital or clinical setting. The device functions as a mechanical tool to facilitate the extraction of obstructions within the bile ducts. By enabling the removal of stones and debris, the catheter helps restore proper biliary drainage and function, potentially alleviating symptoms and complications associated with biliary obstruction. The device is operated by a physician or qualified healthcare professional during endoscopic or surgical procedures.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on 510(k) notification and regulatory review.

Technological Characteristics

Biliary catheter for stone and debris removal. Class II device (21 CFR 876.5010). Mechanical device; no software or electronic components described.

Indications for Use

Indicated for the removal of stones and ductal debris from the biliary tract in patients requiring such intervention.

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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 2 2000

Mr. Trent G. Kamke Vice President - Operations VASCUTECH 164 Middlesex Turnpike Burlington, MA 01803

Re: K992941

LeMaitre Biliary Catheter Dated: December 6, 1999 Received: December 8, 1999 Requlatory Class: II 21 CFR §876,5010/Procode: 78 LQR

Dear Mr. Kamke:

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 (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 vour 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 Requlations, 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 [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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## STATEMENT OF INDICATIONS FOR USE

Device Name LeMaitre Biliary Catheter

Indications for Use The LeMaitre Biliary Catheter is indicated for the removal of stones and ductal debris.

**Prescription Use**
(Per 21 CFR 801.109)

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Device 8 510(k) Number.