The Vascular Solutions Langston™ Dual Lumen Pigtail 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 Pigtail 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 pigtail catheter and outer lumen are joined together using a 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 the outer tube is perforated with side holes to allow pressure measurement simultaneously with the sideholes at the tip of the pigtail. The dual lumen pigtail catheter is deployed through standard 8Fr guide catheters and will accommodate standard 0.038" diameter guidewires.

AI/ML Overview

Acceptance criteria and the study proving the device meets them:

This submission is for a K041909 Dual Lumen Pigtail Catheter.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Intended Use: For delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites (to determine transvalvular, intravascular, and intraventricular pressure gradients).	The "Summary of Non-Clinical Testing" states: "Testing conducted included assessments of the design verification of the Dual Lumen Pigtail Catheter along with biocompatibility assessments. The results of this battery of tests confirmed the suitability of the Dual Lumen Pigtail Catheter for its intended use."
Safety: Device is safe for its intended use.	Biocompatibility assessments were conducted as part of the non-clinical testing. (Specific safety metrics or thresholds are not provided in the document.)
Performance: Device performs as intended.	Non-clinical testing included "design verification" which confirmed "the suitability of the Dual Lumen Pigtail Catheter for its intended use."
Substantial Equivalence: Similar in intended use and function to predicate devices (Cordis Dual Lumen Pressure Monitoring Catheter (K914141), USCI Cardiovascular Catheter (K943739), and Merit Medical Softouch Diagnostic Intravascular Catheter (K810412)).	The submission concludes, "The Dual Lumen Pigtail Catheter is substantially equivalent to the Cordis Dual Lumen Pressure Monitoring Catheter, the USCI Cardiovascular Catheter and the Merit Medical Softouch Diagnostic Intravascular Catheter."

2. Sample size used for the test set and the data provenance:

Sample size for the test set: Not applicable for clinical data. The document explicitly states, "No clinical evaluations of this product have been conducted." For non-clinical testing, specific sample sizes for design verification or biocompatibility testing are not provided in this summary.
Data provenance: Not applicable for clinical data. For non-clinical data, the provenance is internal testing performed by Vascular Solutions, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no clinical evaluations were conducted that would require experts to establish ground truth from patient data. Non-clinical testing would have relied on design specifications and engineering standards.

4. Adjudication method for the test set:

Not applicable, as no clinical evaluations were conducted that would require adjudication of patient data.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an intravascular diagnostic catheter, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No, a standalone algorithm-only performance study was not done. This device is a physical medical instrument, not a software algorithm.

7. The type of ground truth used:

For the non-clinical testing, the "ground truth" would be established by engineering specifications, material standards, and performance benchmarks relevant to physical medical devices (e.g., pressure measurement accuracy based on calibrated instruments, material compatibility based on established biocompatibility standards).
No clinical ground truth (e.g., expert consensus, pathology, outcomes data) was used, as no clinical studies were performed.

8. The sample size for the training set:

Not applicable, as this is a physical medical device and not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as this is a physical medical device and not an AI/machine learning model whose training set would require ground truth establishment.

Summary

{0}------------------------------------------------

K04/909
ss page 1 of 2

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Common/Usual Name:	Intravascular Diagnostic Catheter
Product Trade Name:	Dual Lumen Pigtail Catheter
Classification Name:	UnclassifiedProduct Code, DQO
Manufacturer:	Vascular Solutions, Inc.6464 Sycamore CourtMinneapolis, Minnesota 55369
Establishment Registration:	2134812
Contact:	Sara L. CoonSenior Regulatory Affairs Associate(763) 656-4300 phone(763) 656-4200 fax
Performance Standards:	No performance standards have been developed undersection 514 for this device.

Device Description:

Intended Use:

Summary of Non-Clinical Testing:

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

{1}------------------------------------------------

K04/1909
page 2 of 2

Summary of Clinical Testing:

No clinical evaluations of this product have been conducted.

Predicate Devices:

The Dual Lumen Pigtail catheter is similar in intended use and function to the Cordis Dual Lumen Pressure Monitoring Catheter (K914141), the USCI Cardiovascular Catheter (K943739), and the Merit Medical Softouch Diagnostic Intravascular Catheter (K810412).

Conclusions:

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

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image is a black and white emblem for the U.S. Department of Health & Human Services. The emblem is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three lines representing its wings.

SEP 2 3 2004

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: K041909

K041909
Trade Name: Vascular Solutions Langston Dual Lumen Pigtail Catheter (DLP) Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: II (two) Product Code: DQO Dated: July 13, 2004 Received: July 15, 2004

Dear Ms. Coon:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 3 ro(x) premained 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 commerce proc to May 20, 1976, the encordance with the provisions of the Federal Food. Drug, devices mat have been recuire in assee approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applica You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, merciole, market the devices, colorements for annual registration, listing of general controls provisions of the revelopment of the manage of the 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 crassified (see above) and existing major regulations affecting your device can may be subject to satil adaltonial connovincions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous cements concerning your device in the Federal Register.

{3}------------------------------------------------

Page 2 -Ms. Sara L. Coon

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oc advised that I Dris blossantes byour device complies with other requirements of the Act that TDA has Inade a dolorimiation administered by other Federal agencies. You must of any I coloral statutes and regaranents ancluding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITY art 6077, nuocing (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (events (ever as described in your Section 510(k) This icter will anow you to begin mained of substantial equivalence of your device to a legally premailed notification: "The PDF intembly sification 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 If you desire spoonly and 101 - 501 (301) 594-4648. Also, please note the regulation entitled, Connect the Office of Come to premarket notification" (21CFR Part 807.97). You may obtain Whisoranding of reference to presidentibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Ovess http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use Statement

510(k) Number:

K 041909

Device Name:

Vascular Solutions Langston™ Dual Lumen Pigtail Catheter

Indications for Use:

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)

B. Bimmerma

Division of Cardiovascular

510(k) Number k0841109

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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).