LANGSTON DUAL LUMEN CATHETER by VASCULAR SOLUTIONS, INC.

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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Langston™ Dual Lumen Catheter:

Summary of Acceptance Criteria and Study Details:

The provided 510(k) summary for the Langston™ Dual Lumen Catheter does not present specific, quantifiable acceptance criteria or a dedicated study designed to prove the device meets those criteria in the traditional sense of a clinical trial or a detailed performance validation study.

Instead, the submission relies on the concept of substantial equivalence to predicate devices. The "study" referenced is largely a summary of non-clinical testing that confirmed physical properties and suitability for intended use, as well as a comparison to the predicate devices.

Here's a breakdown of the requested information based on the provided text:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not explicitly defined as quantifiable criteria. The overall "acceptance criteria" appear to be implicit in demonstrating substantial equivalence to predicate devices and suitability for intended use through non-clinical testing.	"The results of the tests confirmed the suitability of the device for its intended use." "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."

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not specified. The document mentions "non-clinical testing" without detailing sample sizes for physical property tests or comparisons.
- Data Provenance: Not specified, but implied to be from internal lab testing conducted by the manufacturer (Vascular Solutions, Inc. in Minneapolis, Minnesota, USA). The testing is non-clinical, so concepts like retrospective/prospective clinical data do not apply.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. The non-clinical testing for this device would involve engineering and quality control personnel, not medical experts establishing ground truth for diagnostic or clinical performance in this context. The "ground truth" for physical properties would be engineering specifications and established test methods.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used in clinical studies or studies involving expert interpretation of medical images/data. This submission focuses on non-clinical engineering and comparison studies.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This type of study (MRMC, AI assistance) is not relevant to an intravascular diagnostic catheter that performs physical measurements and delivers contrast. The device itself is not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical instrument, not an algorithm, and intrinsically requires human operation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Non-Clinical Testing: The "ground truth" would be engineering specifications, material standards, and established physical performance benchmarks (e.g., pressure ratings, flow rates, dimensional tolerances).
- For Substantial Equivalence: The "ground truth" is the performance and characteristics of the legally marketed predicate devices (Langston 8F/5F, 7F/4F, and 6F/4F dual lumen catheters).
The sample size for the training set:
- Not applicable. This is a physical device, not an AI/machine learning model that requires a "training set."
How the ground truth for the training set was established:
- Not applicable for the same reason as above.

In summary: The 510(k) submission for the Langston™ Dual Lumen Catheter focuses on demonstrating substantial equivalence to existing predicate devices already on the market. The "study" mentioned is a "Summary of Non-Clinical Testing" which assessed physical properties and confirmed the device's suitability for its intended use, rather than a clinical effectiveness study or an AI performance study with strict, quantifiable acceptance criteria. The acceptance criteria are implicitly met by demonstrating that the new device is fundamentally similar in function, materials, dimensions, and performance characteristics to the already-approved predicate devices.

Summary

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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 (763) 656-4228 Fax (763) 656-4253
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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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

510(k) Number داخا ناد انانا کانان ک

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
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.(b)
Classification. Class II (performance standards).