(70 days)
No
The document describes a physical catheter for contrast delivery and pressure measurement, with no mention of software, algorithms, or AI/ML capabilities.
No
This device is for diagnostic purposes (delivery of contrast and pressure measurement) rather than for treating a condition.
Yes
The device is described as useful in determining "transvalvular, intravascular and intraventricular pressure gradients," which is a form of diagnosis in medical contexts. It also explicitly mentions "diagnostic" in its predicate device names and its own description.
No
The device description clearly describes a physical catheter with lumens, hubs, adapters, and side ports, indicating it is a hardware device.
Based on the provided information, the Vascular Solutions Langston™ Dual Lumen Pigtail Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites." This involves direct interaction with the patient's circulatory system for imaging and physiological measurement.
- Device Description: The description details a catheter designed for insertion into blood vessels and heart chambers. It's a physical device used within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. This device does not process or analyze biological specimens in this manner.
The device is clearly an invasive medical device used for diagnostic procedures performed in vivo (within the living body).
N/A
Intended Use / Indications for Use
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.
Product codes
DQO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Clinical Testing: No clinical evaluations of this product have been conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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: | Unclassified |
| Product Code, DQO | |
| Manufacturer: | Vascular Solutions, Inc. |
| 6464 Sycamore Court | |
| Minneapolis, Minnesota 55369 | |
| Establishment Registration: | 2134812 |
| Contact: | Sara L. Coon |
| Senior Regulatory Affairs Associate | |
| (763) 656-4300 phone | |
| (763) 656-4200 fax | |
| Performance Standards: | No performance standards have been developed under |
| section 514 for this device. |
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.
Intended Use:
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.
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:
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.
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
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