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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the Twin-Pass Dual Access Catheter. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not a report of a clinical study or performance evaluation with human subjects that would typically involve acceptance criteria for AI/ML devices or specific clinical endpoints.

Therefore, the information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, and human reader performance for an AI/ML device is not applicable to this document.

The document describes device performance verification tests to demonstrate substantial equivalence to a predicate device, rather than clinical efficacy/effectiveness trials for an AI/ML diagnostic or prognostic tool.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance: This information is not presented in a table with specific quantitative acceptance criteria and reported performance values. Instead, the document lists various verification tests performed and states that "The results of the verification tests met the specified acceptance criteria and did not raise new questions of safety or effectiveness." The specific numerical acceptance criteria and corresponding numerical results are not detailed in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not provided. The "test set" in this context refers to physical device samples for engineering and biocompatibility testing, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" in this context would relate to the validation of a diagnostic or prognostic capability, which is not the purpose of this device's submission. The tests are engineering and biocompatibility evaluations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically for clinical endpoint assessment by multiple experts, which is not described here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a catheter, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for the device's performance is based on established engineering standards (e.g., ISO 10555-1, ISO 594) and biocompatibility testing.
8. The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

Summary of Device Performance Verification (as provided in the document):

The device performance was verified through the following tests, and the results "met the specified acceptance criteria":

Deliverability:
- 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

Biocompatibility Tests (in accordance with ISO 10993-1):

Cytotoxicity
Sensitization
Irritation
Systemic Toxicity
Material Mediated Pyrogenicity
Hemolysis
Complement Activation
Thrombogenicity

Summary

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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

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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)

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

Intended Use

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.

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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.

Regulation Number and Section

§ 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).