LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER

K051395 · Vascular Solutions, Inc. · DQO · Jun 24, 2005 · Cardiovascular

Device Facts

• Record ID: K051395
• Device Name: LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER
• Applicant: Vascular Solutions, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Jun 24, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The Vascular Solutions Langston™ Dual Lumen Pressure Monitoring 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

The Langston Dual Lumen Pressure Monitoring Catheter is an intravascular diagnostic device used during angiographic procedures. It consists of a Merit Medical Softouch Diagnostic Intravascular Catheter (inner lumen) joined to a custom-extruded outer lumen via an adapter junction. The distal end of the outer tube features side holes for pressure sensing, allowing simultaneous pressure measurement alongside the catheter tip. The device is deployed through standard guide catheters and accommodates 0.038'' guidewires. It is operated by clinicians in a clinical setting to measure pressure gradients (transvalvular, intravascular, intraventricular) and deliver contrast media. The output is a pressure reading used by the physician to assess hemodynamic status and inform clinical decision-making during cardiac or vascular interventions.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Dual-lumen intravascular catheter; consists of Merit Softouch inner lumen and extruded outer lumen joined by an adapter junction. Features side holes for distal pressure measurement. Compatible with 0.038'' guidewires. Non-sterile components assembled into final device. No performance standards developed under section 514.

Indications for Use

Indicated for patients undergoing angiographic studies requiring contrast media 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 Dual Lumen Pigtail Catheters
• Cordis Dual Lumen Pressure Monitoring Catheter
• Merit Medical Softouch Diagnostic Intravascular Catheter (K943739)

Submission Summary (Full Text)

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K051395

## JUN 2 4 2005

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

| Common/Usual Name: | Intravascular Diagnostic Catheter |
|-----------------------------|---------------------------------------------------------------------------------------------------|
| Product Trade Name: | LangstonTM Dual Lumen Pressure Monitoring Catheter |
| Classification Name: | Unclassified<br>Product Code: DQO |
| Manufacturer: | Vascular Solutions, Inc.<br>6464 Sycamore Court<br>Minneapolis, Minnesota 55369<br>USA |
| Establishment Registration: | 2134812 |
| Contact: | Sara L. Coon<br>Senior Regulatory Affairs Associate<br>[phone] phone<br>[phone] fax |
| Performance Standards: | No performance standards have been developed under<br>section 514 for this device. |

#### Device Description:

The Vascular Solutions Langston™ Dual Lumen Pressure Monitoring catheter is intended for use as a pressure measurement catheter and for delivery of contrast media during angiographic studies. The DLP 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 Merit Softouch catheter and outer lumen are joined together using an adapter junction placed near the proximal end of the Merit Softouch 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 the outer tube is perforated with side holes to allow pressure measurement simultaneously with the sideholes at the tip of the catheter. The dual lumen catheter is deployed through standard guide catheters and will accommodate standard 0.038'' diameter guidewires.

#### Intended Use:

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

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### Summary of Non-Clinical Testing:

Testing conducted included assessments of the design verification of the Dual Lumen Pressure Monitoring Catheter along with biocompatibility assessments. The results of this battery of tests confirmed the suitability of the Dual Lumen Pressure Monitoring Catheter for its intended use.

### Summary of Clinical Testing:

No clinical evaluations of this product have been conducted.

### Predicate Device

The Dual Lumen Pressure Monitoring catheter is similar in intended use and function to the Langston Dual Lumen Pigtail Catheters, the Cordis Dual Lumen Pressure Monitoring Catheter, and the Merit Medical Softouch Diagnostic Intravascular Catheter.

#### Conclusions:

The Langston Dual Lumen Pressure Monitoring Catheter is substantially equivalent to the Langston Dual Lumen Pigtail Catheters, the Cordis Dual Lumen Pressure Monitoring Catheter and the Merit Medical Softouch Diagnostic Intravascular Catheter. The testing performed confirms that the Langston Dual Lumen Pressure Monitoring Catheter will perform as intended.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem consisting of three curved shapes that resemble a bird in flight or flowing ribbons. The emblem is positioned in the center of the seal.

JUN 2 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vascular Solutions, Inc. c/o Ms. Sara L. Coon Sr. Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, MN 55369

Re: K051395

Langston™ Dual Lumen Pressure Monitoring Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II (two) Product Code: DQO Dated: May 26, 2005 Received: May 27, 2005

### Dear Ms. Coon:

We have reviewed your Section 510(k) premarket notification of intent to market the indicati We have reviewed your Section - 10(tr) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regarly manated producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food Track commerce prior to May 28, 1970, the chacinent with the provisions of the Federal Food. Drug, devices that have been reclassined in accerdance was a premarket approval application (PMA).).
and Cosmetic Act (Act) that do not require approval of a presidions of the Act and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The You may, therefore, market the do rest, soloject to the month registration, listing of
general controls provisions of the Act include requirements for annual registration, l general controls provisions of the free 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 If your device is Classified (secure) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller Entralians, Title 21, Parts 800 to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to be found in the Code of Poderal Registerning your device in the Federal Register.

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Page 2 - Ms. Sara L. Coon

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please of advised that IDA s issualled of a succession with other requirements of the Act that IDA has made a dolorimisations administered by other Federal agencies. You must or any Federal statutes and regulations adminities out not limited to: registration and listing (21 comply with an the Act 31equirements, newslager, which and the requirements as set CFR Part 807); labeling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Declions of a described in your Section 510(k)
This letter will allow you to begin marketing your device as described in your section 51 I his letter will anow you to begin maneting your and equivalence of your device to a legally premarket notification. The PDA midning of backers 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 If you desire specific advice for your ac not the case note the regulation entitled, and Contact the Office of Comphalled at (217) = if & = = = = 807.97). You may obtain "Misbranding by reference to premation inculties. Included the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or Manufacturers, International and Consumer Provinces of contraction of the many of the status of the status

Sincerely yours,

Bhimima foi

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number:

K051395

Device Name:

Langston™ Dual Lumen Pressure Monitoring Catheter

Indications for Use:

The Vascular Solutions Langston™ Dual Lumen Pressure Monitoring 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.

Prescription Use X (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)

Blimmerman
(Division Sign-Off)

n of Cardlovascular Devices

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