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.

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.

AI/ML Overview

This document does not contain an acceptance criteria table or information about a study proving device performance in the context of device outputs (e.g., diagnostic accuracy metrics like sensitivity, specificity, or AUC) against a set of predetermined criteria. This is primarily because the submitted document is a 510(k) premarket notification for a medical catheter (Twin-Pass Dual Access Catheter), not a diagnostic algorithm or AI-powered device.

For a medical device like the Twin-Pass Dual Access Catheter, performance is generally established through design verification testing (non-clinical testing) and substantial equivalence to predicate devices, not through studies that involve human readers, ground truth consensus, or metrics like sensitivity/specificity for disease detection.

Here's why the requested information is not applicable or cannot be extracted from the provided text:

Acceptance Criteria & Reported Device Performance (Table): Not present. The document summarizes non-clinical testing for design verification and states the device is suitable for its intended use based on these tests. It does not provide specific performance metrics in the way a diagnostic algorithm would (e.g., "Sensitivity > X%").
Sample Size for Test Set & Data Provenance: No clinical test set as such was used for performance evaluation that would require this. The non-clinical tests would have involved samples of the device itself.
Number of Experts & Qualifications for Ground Truth: Not applicable, as there was no clinical study involving human assessment of device outputs against a ground truth.
Adjudication method for Test Set: Not applicable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is for evaluating diagnostic algorithms, not passive medical devices like catheters.
Standalone (algorithm only) Performance: Not applicable. This device is a catheter, not an algorithm.
Type of Ground Truth Used: Not applicable. The "ground truth" for a catheter is its ability to perform its mechanical function as intended during design verification.
Sample Size for Training Set: Not applicable. There is no algorithm to train.
How Ground Truth for Training Set Was Established: Not applicable.

What the document does state regarding device evaluation:

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." This indicates engineering and materials testing, not accuracy testing against a clinical "ground truth."
Clinical Testing: "No clinical evaluations of this product have been conducted." This explicitly states that clinical studies were not performed to evaluate this product's performance in humans.
Predicate Device: The device demonstrates "substantial equivalence" to existing legally marketed predicate devices (Lumend Percutaneous Catheter, Quick-Cross Catheter, and Dual Lumen Catheter). This is the primary means of clearance for this type of device.

In summary, the provided document describes a 510(k) clearance for a medical catheter based on non-clinical testing and substantial equivalence to predicate devices, not on a clinical performance study with human readers or AI algorithms.

Summary

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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:

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Intended Use:

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.

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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.

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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:

K052257

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

Page 1 of

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).