(114 days)
Not Found
No
The description focuses on the physical design and function of a catheter for accessing vasculature and measuring pressure. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
The device facilitates the placement of other interventional devices and the infusion/delivery of diagnostic or therapeutic agents, but it is not itself a therapeutic device. It is primarily an access and delivery tool, also used for diagnostic pressure measurement.
Yes
The intended use explicitly states, "The Twin-Pass .023" catheter is additionally intended to be used to measure intraarterial pressure within the peripheral and coronary vasculature," which is a diagnostic function.
No
The device description clearly details a physical catheter with lumens, a luer hub, radiopaque markerband, and a stiffening mandrel assembly. This indicates a hardware medical device, not a software-only one.
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 manipulating the coronary and peripheral vasculature, facilitating procedures, and measuring intraarterial pressure.
- Device Description: The description details a catheter designed for insertion into blood vessels, with lumens for guidewires and delivery of agents. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on biological samples outside the body. This device is designed for direct interaction with the patient's internal anatomy.
N/A
Intended Use / Indications for Use
The Twin-Pass .023″ catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and other infuse/deliver diagnostic or therapeutic agents.
The Twin-Pass .023" catheter is additionally intended to be used to measure intraarterial pressure within the peripheral and coronary vasculature.
Product codes
DQO
Device Description
The Twin-Pass .023" catheter has a polymeric dual-lumen design. The over-the wire lumen extends from the luer hub to the catheter's distal end and accommodates ≤0.018 guidewires. The rapid-exchange lumen is on the distal 20cm of the catheter and accommodates ≤0.014 guidwires. The Twin-Pass .023" catheter is compatible with ≥6F guide catheters and has a working length of approximately 135cm. Each catheter has a single radiopaque markerband near its distal tip and printed positioning marks at 95cm and 105cm from the catheter's distal tip. Each catheter is supplied with a stiffening mandrel assembly that is inserted into the over-the-wire lumen to provide added support while placing the catheter at its desired location. The Twin Pass .023" catheter is provided sterile and intended for a single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral 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)
Bench testing was conducted on the Twin-Pass .023" catheter and included an 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. Each bench test that was conducted is listed, below.
| Tortuosity | Flow Rate |
|---|---|
| Catheter Kink Resistance | Guidewire Interface |
| Hub-to-proximal-shaft Bond Strength | Guide Catheter Interface |
| Proximal-to-distal-shaft Bond Strength | Packaging-Packaging Mandrel Removal Force |
| Stiffening Mandrel Assembly Bond Strength | Packaging-Pouch Visual Appearance after Distribution Testing |
| Stiffening Mandrel Removal Force | Packaging-Product Containment after Distribution Testing |
| Fluid Leak Under Pressure | Packaging-Product Visual Appearance after Distribution Testing |
| Air Leak During Aspiration | Packaging-Labeling Legibility after Distribution Testing |
| Frequency Response |
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
Section 5. 510(k) Summary
:
The 510(k) Summary is provided on the following page.
:
JAN 1 8 2007
Vascular Solutions, Inc. Twin Pass .023" Catheter 510(k) Premarket Notification September 25, 2006
1
510(k) Summary (As required by 21 CFR 807.92(c))
(As Required by 14 CFR 9079.21 (c))
510(k) Number: K062087
Date Prepared
September 25, 2006
Submitter Information
| Submitter's Name: | Vascular Solutions, Inc. |
|---|---|
| Address: | 6464 Sycamore Court |
| Minneapolis, MN 55369 |
Contact Person:
Julie Tapper Regulatory Affairs Associate Phone 763-656-4228 Fax 763-656-4253
Device Information
| Trade Name: | Twin-Pass TM .023" Dual Access Catheter |
|---|---|
| Common Name: | Diagnostic intravascular catheter |
| Class: | II |
| Classification Name: | Diagnostic intravascular catheter (21 CFR 870.1200, Product Code DQO) |
Predicate Devices
Twin-Pass Dual Access Catheter (K052257), manufactured by Vascular Solutions, Inc. Langston Dual Lumen Catheter (K061565), manufactured by Vascular Solutions, Inc.
Device Description
The Twin-Pass .023" catheter has a polymeric dual-lumen design. The over-the wire lumen extends from the luer hub to the catheter's distal end and accommodates ≤0.018 guidewires. The rapid-exchange lumen is on the distal 20cm of the catheter and accommodates ≤0.014 guidwires. The Twin-Pass .023" catheter is compatible with ≥6F guide catheters and has a working length of approximately 135cm. Each catheter has a single radiopaque markerband near its distal tip and printed positioning marks at 95cm and 105cm from the catheter's distal tip. Each catheter is supplied with a stiffening mandrel assembly that is inserted into the over-the-wire lumen to provide added support while placing the catheter at its desired location. The Twin Pass .023" catheter is provided sterile and intended for a single use.
2
Intended Use/Indications for Use
The Twin-Pass .023" catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents.
Additionally, the Twin-Pass .023" catheter is intended to be used to measure intraarterial pressure within the peripheral and coronary vasculature.
Summary of Testing
Bench testing was conducted on the Twin-Pass .023" catheter and included an 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. Each bench test that was conducted is listed, below.
| Tortuosity | Flow Rate |
|---|---|
| Catheter Kink Resistance | Guidewire Interface |
| Hub-to-proximal-shaft Bond Strength | Guide Catheter Interface |
| Proximal-to-distal-shaft Bond Strength | Packaging-Packaging Mandrel Removal Force |
| Stiffening Mandrel Assembly Bond Strength | Packaging-Pouch Visual Appearance |
| after Distribution Testing | |
| Stiffening Mandrel Removal Force | Packaging-Product Containment |
| after Distribution Testing | |
| Fluid Leak Under Pressure | Packaging-Product Visual Appearance |
| after Distribution Testing | |
| Air Leak During Aspiration | Packaging-Labeling Legibility |
| after Distribution Testing | |
| Frequency Response |
Statement of Equivalence
The Twin-Pass .023" catheter is substantially equivalent to the currently marketed Twin-Pass and Langston catheters, based on comparisons of the device classifications, indications for use, technological characteristics, and sterilization methods.
Conclusion
The Twin-Pass .023" catheter is substantially equivalent to the currently marketed Twin-Pass and Langston catheters, based on comparisons of the device classifications, indications for use, technological characteristics, and sterilization methods. Bench tests confirmed the suitability of the device for its intended use.
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle or bird-like figure, with stylized wings and tail feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 8 2007
Vascular Solutions, Inc. c/o Ms. Julie Tapper Regulatory Affairs Associate 6464 Sycamore Court North Minneapolis, MN 55369
Re: K062877
Twin-Pass™ .023" Dual Access Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II (two) Product Code: DQO Dated: December 20, 2006 Received: December 21, 2006
Dear Ms. Tapper:
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.
4
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 or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Duna R. Vohunes.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number: K062877
Device Name:
Twin-Pass™ .023" Dual Access Catheter
Indications for Use:
The Twin-Pass .023″ catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and other infuse/deliver diagnostic or therapeutic agents.
The Twin-Pass .023" catheter is additionally intended to be used to measure intraarterial pressure within the peripheral and coronary vasculature.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
uma R. Vchmes
Division Sign-Off Division of Cardiovascular Devices
10/k) Number KDG28