(97 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
Explanation: The device is designed to facilitate the placement of guidewires and other interventional devices for accessing regions of the vasculature, not to provide a direct therapeutic effect itself.
No
The device description indicates its use for facilitating the placement of guidewires and other interventional devices within the vasculature, which are procedural rather than diagnostic functions.
No
The device description clearly details a physical catheter with lumens, markers, coatings, and a stiffening mandrel, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for accessing and facilitating procedures within the coronary and peripheral arterial vasculature. This is a therapeutic or interventional use, not a diagnostic test performed on samples in vitro (outside the body).
- Device Description: The description details a catheter designed for insertion into blood vessels, with lumens for guidewires and markers for positioning. This aligns with an interventional device, not a device for analyzing biological samples.
- Anatomical Site: The specified anatomical site is the "coronary and peripheral arterial vasculature," which are locations within the living body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely mechanical and procedural within the body.
N/A
Intended Use / Indications for Use
The Twin-Pass Dual Access Catheter is to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement of guidewires and other interventional devices, and for use during two guidewire procedures.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Twin-Pass Dual Access Catheter is a 3F O.D. catheter that has two lumens-a short distal lumen and a second full length lumen-each of which are compatible with a 0.014" standard quide wire. The Twin-Pass catheter has a working length of 135cm and contains positioning markers at 95 and 105cm which provide a visual indication of the relative positions of Twin Pass and the end of a standard 105cm guide catheter. Two radiopaque marker bands at the end of each wire lumen provide for a radiographic means of locating the position of each lumen. The softer, distal end of the catheter is coated with a hydrophilic coating to assist passage through the guide catheter and vessels while the proximal end of the catheter contains a strain relief and a standard luer hub. A 126cm stiffening mandrel is included which provides support and pushability to the Twin-Pass.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral arterial vasculature
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)
Summary of Non-Clinical Testing: Testing conducted included assessments of the design verification of the Twin-Pass Dual Access Catheter along with biocompatibility assessments. The results of this battery of tests confirmed the suitability of the Twin-Pass Dual Access Catheter for its intended use.
Summary of Clinical Testing: No clinical evaluations of this product have been conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
The Lumend Percutaneous Catheter, the Quick-Cross Catheter, and the Dual Lumen Catheter.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
052257 Appendix E: Summary of Safety and Effectiveness
NOV 2 3 2005
Common/Usual Name: Intravascular Catheter
Twin-Pass™ Dual Access Catheter Product Trade Name:
- Unclassified Classification Name: Product Code: DQY
- Manufacturer: Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, Minnesota 55369 USA
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 Twin-Pass Dual Access Catheter is a 3F O.D. catheter that has two lumens-a short distal lumen and a second full length lumen-each of which are compatible with a 0.014" standard quide wire. The Twin-Pass catheter has a working length of 135cm and contains positioning markers at 95 and 105cm which provide a visual indication of the relative positions of Twin Pass and the end of a standard 105cm guide catheter. Two radiopaque marker bands at the end of each wire lumen provide for a radiographic means of locating the position of each lumen. The softer, distal end of the catheter is coated with a hydrophilic coating to assist passage through the guide catheter and vessels while the proximal end of the catheter contains a strain relief and a standard luer hub. A 126cm stiffening mandrel is included which provides support and pushability to the Twin-Pass.
1
Intended Use:
The Twin-Pass Dual Access Catheter is to be used in conjunction with steerable quidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement of guidewires and other interventional devices, and for use during two guidewire procedures.
Summary of Non-Clinical Testing:
Testing conducted included assessments of the design verification of the Twin-Pass Dual Access Catheter along with biocompatibility assessments. The results of this battery of tests confirmed the suitability of the Twin-Pass Dual Access Catheter for its intended use.
Summary of Clinical Testing:
No clinical evaluations of this product have been conducted.
Predicate Device:
The Twin-Pass Dual Access Catheter is similar in intended use and function to the Lumend Percutaneous Catheter, the Quick-Cross Catheter, and the Dual Lumen Catheter.
Conclusions:
The Twin-Pass Dual Access Catheter is substantially equivalent to the Lumend Percutaneous Catheter, the Quick-Cross Catheter, and the Dual Lumen Catheter. The testing performed confirms that the Twin-Pass Dual Access Catheter will perform as intended.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the edge. In the center of the seal is a stylized image of a caduceus, a symbol of medicine, with a single snake winding around a staff.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 3 2005
Vascular Solutions, Inc. c/o Ms. Sara L. Coon Senior Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, MN 55369
K052257 Re:
Twin-Pass™ Dual Access Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: DQY Dated: September 30, 2005 Received: October 3, 2005
Dear Ms. Coon:
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 general controls provisions of the Act include requirements for annual registration, listing of 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.
3
Page 2 - Ms. Sara L. Coon
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I rease of advised and I Dr o resum that your device complies with other requirements of the Act that I DA has made a as a legulations administered by other Federal agencies. You must of ally it cacal statutes and regenments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITY at 6077, moening (21 CFR Part 820); and if applicable, the electronic as a secon product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product raction of one of to begin marketing your device as described in your Section 510(k) I ms leter with and motification. The 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 yours,
oning R. Wolmer
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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II. Indications For Use Statement
510(k) Number:
Device Name:
Vascular Solutions Twin-Pass Dual Access Catheter
Indications for Use:
The Twin-Pass Dual Access Catheter is to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement of guidewires and other interventional devices, and for use during two guidewire procedures.
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 IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Donna R. LaClair
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K052257
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