LMI IRRIGATION CATHETER (IGR)

K972623 · Lucas Medical, Inc. · DXE · Nov 19, 1997 · Cardiovascular

Device Facts

• Record ID: K972623
• Device Name: LMI IRRIGATION CATHETER (IGR)
• Applicant: Lucas Medical, Inc.
• Product Code: DXE · Cardiovascular
• Decision Date: Nov 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LMI Irrigation Catheter is intended for intra-operative procedures requiring irrigation in either arterial or venous blood vessels.

Device Story

LMI Irrigation Catheter is a single-use, stainless steel wire-reinforced silicone tube; features rounded leading nose, female luer connector, strain relief, and four side ports with central lumens for fluid delivery. Used intra-operatively by physicians to flush arterial or venous blood vessels following thrombectomy. Physician accesses vessel surgically, inserts catheter, advances to target region, infuses irrigating media via syringe, and withdraws catheter. Device facilitates clearing of thrombotic debris; improves surgical site visualization and vessel patency.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Stainless steel wire-reinforced silicone tube; female luer connector; four side ports; EtO sterilized; single-use; non-pyrogenic.

Indications for Use

Indicated for intra-operative irrigation of arterial or venous blood vessels during surgical procedures, specifically to facilitate flushing of the immediate area following a thrombectomy.

Regulatory Classification

Identification

An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.

Predicate Devices

• Fogarty Irrigation Catheter
• Intimax Irrigating Catheter
• LMI Arterial Bi-Lumen Irrigation Embolectomy Catheter (K955499)

Submission Summary (Full Text)

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## 510K SUMMARY

NOV 1 9 1997

PURPOSE: Pursuant to the Federal Food, Drug, and Cosmetic Act, as amended May 28, 1976, Section 510(k), please consider the attached document as Lucas Medical, Inc.'s notification of intent to introduce the LMI Irrigation Catheter for commercial distribution. The common names for the device are silicone irrigation catheter.

MANUFACTURING & STERILIZATION SITES: The manufacturing and packaging facility is: Lucas Medical Inc., 1751 S. Douglass Road, Anaheim CA 92806. The establishment registration number is: 2029386. Sterilization will be performed by Griffith MicroScience (Establishment Registration Number: 2011171) 4900 S. Gilford, Los Angeles CA 90058.

DESCRIPTION: The catheter consists of a stainless steel wire reinforced silicone tube that is end formed to create a rounded leading nose. The proximal end of the catheter consists of a female luer connector and a strain relief that are bonded to the silicone shaft. The distal end of the catheter has four side ports as well as central lumens that provide openings for irrigating fluid. The "DEVICE" is packaged in an ElO breathable tray for protection and then sealed in an EtO breathable pouch. It is E.O sterilized and non-pyrogenic. The "DEVICE" is for Single Use Only and is used only By or On the Order of a Physician.

CLASSIFICATION: The "DEVICE" is a Class II Medical device and has a classification number of 74DXE and is reviewed by the Cardiovascular Review Panel.

LABELING & INTENDED USE : Labeling including the Instructions for Use are included in this submission. The device is intended for intra-operative procedures requiring irrigation in blood vessels, namely arteries and veins.

Irrigation catheters are generally used in procedures to facilitate the use of irrigating PRINCIPLE OF OPERATION: media in either arterial or venous blood vessels, to flush the immediate area of a thrombectomy. The affected blood vessed is accessed surgically proximal to the desired region. The appropriately sized irrigating cathere for the blood vessel is selected. The catheter is inserted into the vessel and advanced distaily to the desired region. The irrigating media is then infused into the catheter via a syringe. Then pulled back toward the venous'arterial incision and removed. Additional irrigating media may be infused by utilizing the same technique.

SUBSTANTIAL EQUIVALENCE: The "DEVICE" is substantially equivalent to the Fogarty Irrigation Catheter and Intimax Irrigating Catheter currently in the materials of construction, methods of construction and the packaging and sterilization of the "DEVICE" are identical to the approved LMI Arterial Bi-Lumen Irrigation Embolectorny Catheter (510k -K955499). The Indicated Use of the Device is substantially equivalent to the Fogarty Irrigation Catheter manufactured by Baxter Healthcare and the Intimax Irrigation Catheter manufactured by Applied Vascular.

Please Address all correspondence and questions to:

Mr. Daniel R. Lucas, President Lucas Medical, Incorporated 1751 S. Douglass Road Anaheim CA 92806 Phone: [phone] FAX:

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV I 9 1997

Mr. Daniel R. Lucas Lucas Medical, Inc. 1751 S. Douglass Road 92806 Anaheim, California

K972623 Re: LMI Irrigation Catheter Requlatory Class: II (two) Product Code: 74 DXE October 26, 1997 Dated: Received: October 30, 1997

Dear Mr. Lucas:

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 A substantially equivalent determination assumes compliance to 895. with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 EFR 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 requlatory 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.

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Page 2 - Mr. Daniel R. Lucas

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/dsmamain.html".

Sincerely yours,

Sincerely yours,

Thomas J. Callahan

allahan, Ph.D. Thomas J. C Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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LUCAS MEDICAL, INC.

## INDICATIONS FOR USE

The LMI Irrigation Catheter is intended for intra-operative procedures requiring irrigation in either arterial or venous blood vessels.

T.A.R

(Division Sign-Off) Division of Cardiovascul and Neurological Device 510(k) Number