(230 days)
No
The summary describes a physical medical device (catheter) and its mechanical properties and performance. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the device is intended "to subselectively infuse/deliver diagnostic or therapeutic agents."
No
The device is a catheter intended to facilitate placement/exchange of guidewires and other interventional devices, and to infuse/deliver diagnostic or therapeutic agents. While it can deliver diagnostic agents, its primary function is not to perform a diagnosis itself, but to enable the delivery of agents that might be used for diagnostic purposes.
No
The device description clearly details a physical catheter with lumens, coatings, and marker bands, indicating it is a hardware device, not software only.
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 within the body (in the coronary and peripheral arterial vasculature) to facilitate procedures and deliver agents. IVDs are used to examine specimens from the body (like blood, urine, tissue) to diagnose conditions.
- Device Description: The description details a catheter with lumens, coatings, and markers, all consistent with an invasive medical device used for access and delivery within the vascular system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the Twin-Pass catheter is an invasive medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Twin-Pass catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial 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.
Product codes
DQY
Device Description
The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the peripheral and coronary vasculature. The Twin-Pass catheter consists of an over-the-wire (OTW) lumen that runs the length of the catheter and a rapid exchange (RX) delivery lumen on the distal segment. The Twin-Pass catheter has a hydrophilic coating on the distal 18cm of the catheter. The Twin-Pass catheter has a working length of 135cm and have white positioning marks located at 95cm (single mark) and 105cm (double marks) from the distal tip, respectively. The Twin-Pass catheter has a platinum-iridium marker band located 1mm from the distal tip and a second platinum-iridium marker band located 11mm from the distal tip, identifying the distal end of the OTW lumen.
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
The technological differences between the subject and predicate/reference devices have been evaluated through performance and biocompatibility tests to provide evidence of substantial equivalence for the Twin-pass catheter.
The device performance was verified through the following tests:
- Deliverability
- O Track Force
- Kink Resistance
- Guide Catheter Compatibility
- Guidewire Movement
- Hydrophilic Coating Evaluation
- Particulate
- Coating Lubricity/Durability
- Drops of Fluid
- Tensile Strength
- Shaft
- Tip
- Hub
- Torque Robustness
- Hub Markings
- ISO 10555-1 Verification
- Working Length
- Crossing Profile
- Radiopacity
- Aspiration
- Liquid Leak
- Static Pressure
- Dynamic Pressure
- Surface Defects
- ISO 594 Hub Verification
- Luer Gage
- Air Leakage During Aspiration
- Liquid Leakage Under Pressure
- Separation Force of Luer Fitting
- Unscrewing Torque
- Ease of Luer Fitting Assembly
- Resistance to Overriding
- Stress Cracking
Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1:
- Cytotoxicity
- Sensitization
- Irritation
- Systemic Toxicity
- Material Mediated Pyrogenicity Hemolysis
- Complement Activation
- Thrombogenicity
Key results: The results of the verification tests met the specified acceptance criteria and did not raise new questions of safety or effectiveness; the Twin-Pass catheter is substantially equivalent to the predicate and reference devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
June 29, 2020
Vascular Solutions LLC Iroquois Ledbeter Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, Minnesota 55369
Re: K193119
Trade/Device Name: Twin-Pass Dual Access Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: May 28, 2020 Received: May 29, 2020
Dear Iroquois Ledbeter:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Interventional Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K193119
Device Name Twin-Pass Dual Access Catheter
Indications for Use (Describe)
The Twin-Pass catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K193119 Page 1 of 2
510(k) Summary
[As required by 21 CFR 807.92]
Date Prepared: January 03, 2020
510(k) Number: K193119
Submitter's Name / Contact Person
Manufacturer Vascular Solutions LLC 6464 Sycamore Court North Minneapolis, MN 55369 USA Establishment Registration # 2134812 Contact Person Iroquois Ledbeter Regulatory Product Specialist Tel: 763-656-4300 Fax: 763-251-0363
| General Information | |
|---|---|
| Trade Name | Twin-Pass Dual Access Catheter |
| Common / Usual Name | Catheter |
| Classification Name | 21 CFR 870.1250, DQY, Percutaneous catheter, Class II |
| Predicate Device | K060327, Twin-Pass dual access catheter (Vascular Solutions, Inc.) |
| Reference Device | K162467, Twin-Pass Torque dual access catheter (Vascular Solutions, Inc.) |
Device Description
The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the peripheral and coronary vasculature. The Twin-Pass catheter consists of an over-the-wire (OTW) lumen that runs the length of the catheter and a rapid exchange (RX) delivery lumen on the distal segment. The Twin-Pass catheter has a hydrophilic coating on the distal 18cm of the catheter. The Twin-Pass catheter has a working length of 135cm and have white positioning marks located at 95cm (single mark) and 105cm (double marks) from the distal tip, respectively. The Twin-Pass catheter has a platinum-iridium marker band located 1mm from the distal tip and a second platinum-iridium marker band located 11mm from the distal tip, identifying the distal end of the OTW lumen.
Intended Use
The Twin-Pass catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial 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.
Technological Characteristics Comparison
The key technological differences between the Twin-Pass catheter and the predicate and reference devices are a change to distance between distal tip wire exit ports, device outer diameter, shaft materials, lubricious coat length, and hub and strain relief process and materials.
4
Substantial Equivalence and Summary of Studies
The technological differences between the subject and predicate/reference devices have been evaluated through performance and biocompatibility tests to provide evidence of substantial equivalence for the Twin-pass catheter.
The device performance was verified through the following tests:
- Deliverability .
- O Track Force
- Kink Resistance o
- Guide Catheter Compatibility O
- Guidewire Movement O
- . Hydrophilic Coating Evaluation
- o Particulate
- Coating Lubricity/Durability о
- Drops of Fluid O
- Tensile Strength
- Shaft O
- O Tip
- O Hub
- Torque Robustness ●
- Hub Markings
- ISO 10555-1 Verification
- o Working Length
- Crossing Profile o
- Radiopacity o
- Aspiration o
- Liquid Leak o
- O Static Pressure
- Dynamic Pressure O
- Surface Defects O
- ISO 594 Hub Verification
- o Luer Gage
- Air Leakage During Aspiration o
- Liquid Leakage Under Pressure O
- Separation Force of Luer Fitting o
- Unscrewing Torque o
- o Ease of Luer Fitting Assembly
- O Resistance to Overriding
- Stress Cracking O
Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1:
- Cytotoxicity
- Sensitization
- Irritation
- Systemic Toxicity
- Material Mediated Pyrogenicity Hemolysis ●
- Complement Activation
- Thrombogenicity
The results of the verification tests met the specified acceptance criteria and did not raise new questions of safety or effectiveness; the Twin-Pass catheter is substantially equivalent to the predicate and reference devices.