LANGSTON DUAL LUMEN CATHETER

K061565 · Vascular Solutions, Inc. · DQO · Aug 2, 2006 · Cardiovascular

Device Facts

• Record ID: K061565
• Device Name: LANGSTON DUAL LUMEN CATHETER
• Applicant: Vascular Solutions, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Aug 2, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The Langston™ Dual Lumen Catheter is indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressure measurement is useful in determining transvalvular, intravascular and intraventricular pressure gradients.

Device Story

Langston™ Dual Lumen Catheter functions as diagnostic intravascular catheter; delivers contrast media; enables simultaneous pressure measurement from two sites. Device consists of Merit Medical Softouch Diagnostic Intravascular Catheter (inner lumen) joined to Vascular Solutions-designed extruded outer lumen via adapter junction. Adapter junction includes side port with stopcock/tube assembly for fluid flow and pressure monitoring. Distal end of each lumen features side holes for simultaneous pressure sensing. Deployed through standard guide catheters; accommodates 0.038" guidewires. Used by clinicians in angiographic settings to assess pressure gradients (transvalvular, intravascular, intraventricular). Output allows physician to evaluate hemodynamic status and inform clinical decision-making regarding cardiac or vascular pathology.

Clinical Evidence

Bench testing only. Assessment of physical properties and functional performance confirmed suitability for intended use.

Technological Characteristics

Dual lumen diagnostic intravascular catheter; 7F outer lumen, 5F inner lumen. Components include Merit Medical Softouch catheter (inner) and extruded outer lumen joined by adapter junction. Features side holes at distal end for pressure sensing; side port with stopcock/tube assembly. Compatible with 0.038" guidewires. Non-powered, mechanical device.

Indications for Use

Indicated for patients undergoing angiographic studies requiring contrast medium delivery and simultaneous pressure measurement at two sites to determine transvalvular, intravascular, or intraventricular pressure gradients.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• Langston 8F/5F dual lumen catheter (K041909)
• Langston 7F/4F dual lumen catheter (K050168)
• Langston 6F/4F dual lumen catheter (K051395)

Reference Devices

• Merit Medical Softouch Diagnostic Intravascular Catheter (K943739)

Submission Summary (Full Text)

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## 510(k) Summary

K061565

Common/Usual Name: Intravascular diagnostic catheter

Product Trade Name: Langston™ Dual Lumen Catheter

Classification Name: Diagnostic intravascular catheter; 21 CFR 870.1200; DQO

Manufacturer: Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, Minnesota 55369

Establishment Registration: 2134812

AUG 0 2 2006

- Contact: Julie Tapper Regulatory Affairs Associate Phone [phone] Fax [phone]
Performance Standards: No performance standards have been developed under section 514 for this device.

Device Description: The Vascular Solutions Langston™ Dual Lumen Catheter is intended for use as a pressure measurement catheter and for delivery of contrast media during angiographic studies. The Langston catheter consists of the Merit Medical Softouch Diagnostic Intravascular Catheter (K943739) as the inner lumen and an extruded outer lumen designed by Vascular Solutions. The inner lumen and hub assembly are purchased from Merit Medical in a non-sterile state. The pigtail catheter and outer lumen are joined together using an adapter junction placed near the proximal end of the pigtail catheter. The adapter junction incorporates a side port fitted with a stopcock/tube assembly for fluid flow and pressure measurement within the outer tube. The distal end of each lumen is perforated with side holes to allow pressurement simultaneously. The Langston catheter is deployed through standard guide catheters and will accommodate standard 0.038" diameter guidewires.

Intended Use: The Langston™ Dual Lumen Catheter is indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressure measurement is useful in determining transvalvular, intravascular and intraventricular pressure gradients.

Summary of Non-Clinical Testing: Testing included assessment of the physical properties of the device and its ability to achieve its intended use. The results of the tests confirmed the suitability of the device for its intended use.

Predicate Devices: The Langston 7F/5F dual lumen catheter is substantially equivalent to the Langston 8F/5F (K041909), 7F/4F (K050168), and 6F/4F (K051395) dual lumen catheters.

Conclusions: The Langston 7F outer lumen and 5F inner lumen is substantially equivalent to the currently marketed Langston catheters, based on a comparison of the indications for use, construction materials, catheter dimensions, injection pressure ratings, and sterilization methods.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 0 2 2006

Vascular Solutions, Inc. c/o Ms. Julie Tapper Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, MN 55369

> K061565 Langston™ Dual Lumen Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II Product Code: DQO Dated: June 1.2006 Received: June 5, 2006

Dear Ms. Tapper:

Re:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The gencral controls provisions of the Act include requirements for annual registration. Une Act. 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 (PMA). 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 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Julie Tapper

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act that I Dr Has made a and regulations administered by other Federal agencies. You must or any I ederal states and a requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (21 CFR Part 820); and if applicable, the electronic forth in the quarty of every of provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product ratially.it will allow you to begin marketing your device as described in your Section 510(k) I mis leter with and your your e 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the 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/cdrh/industry/support/index.html.

Sincerely vours,

Dinar R. bilinen

- A Bram D. Zuckerman, M.D.
Radiological Health

Director

Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and

Enclosure

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## Indications for Use Statement

510(k) Number: K061565

Device Name: Langston™ Dual Lumen Catheter

Indications for Use: The Langston™ Dual Lumen Catheter is indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressure measurement is useful in determining transvalvular, intravascular and intraventricular pressure orgrivents.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH. Office of Device Evaluation (ODE)

DWM in R. Lulmer

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(Division Sign-Off) (Division Oigh of Cardiovascular Devices

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