(58 days)
No
The description focuses on the physical construction and function of a catheter for contrast delivery and pressure measurement, with no mention of AI or ML.
No.
The device is indicated for delivery of contrast medium and for simultaneous pressure measurement, not for therapeutic interventions.
Yes
The device is indicated for "delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites," which is "useful in determining transvalvular, intravascular and intraventricular pressure gradients." These measurements provide information about the patient's condition, making it a diagnostic device.
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 Langston™ Dual Lumen Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is performed outside of the body.
- Device Function: The Langston™ Dual Lumen Catheter is used within the body for:
- Delivering contrast medium during angiographic studies (an imaging procedure).
- Measuring pressure directly from anatomical sites within the body (transvalvular, intravascular, intraventricular).
- Lack of Specimen Testing: The device does not involve the collection or analysis of specimens taken from the body. Its function is directly related to procedures performed inside the patient.
Therefore, the Langston™ Dual Lumen Catheter falls under the category of an in vivo medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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 gradients.
Product codes
DQO
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.
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
Prescription Use
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
510(k) Summary
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.
1
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.
2
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
3
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
Page 1 of 1
(Division Sign-Off) (Division Oigh of Cardiovascular Devices
510(k) Number داخا ناد انانا کانان ک