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.

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.

AI/ML Overview

The Twin-Pass™ .023" Dual Access Catheter is a medical device, and its acceptance criteria are established through a series of bench tests. These tests assess the physical properties and functional performance of the device to ensure it meets its intended use and is substantially equivalent to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for each test. Instead, it lists the types of bench tests performed and a general statement that "The results of the tests confirmed the suitability of the device for its intended use." Therefore, the reported device performance for each criterion is implicitly passing the respective test, indicating suitability for intended use.

Acceptance Criterion (Bench Test)	Reported Device Performance
Tortuosity	Confirmed suitability for intended use
Catheter Kink Resistance	Confirmed suitability for intended use
Hub-to-proximal-shaft Bond Strength	Confirmed suitability for intended use
Proximal-to-distal-shaft Bond Strength	Confirmed suitability for intended use
Stiffening Mandrel Assembly Bond Strength	Confirmed suitability for intended use
Stiffening Mandrel Removal Force	Confirmed suitability for intended use
Fluid Leak Under Pressure	Confirmed suitability for intended use
Air Leak During Aspiration	Confirmed suitability for intended use
Frequency Response	Confirmed suitability for intended use
Flow Rate	Confirmed suitability for intended use
Guidewire Interface	Confirmed suitability for intended use
Guide Catheter Interface	Confirmed suitability for intended use
Packaging - Packaging Mandrel Removal Force	Confirmed suitability for intended use
Packaging - Pouch Visual Appearance after Distribution Testing	Confirmed suitability for intended use
Packaging - Product Containment after Distribution Testing	Confirmed suitability for intended use
Packaging - Product Visual Appearance after Distribution Testing	Confirmed suitability for intended use
Packaging - Labeling Legibility after Distribution Testing	Confirmed suitability for intended use

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes used for each bench test. It generally states that "Bench testing was conducted on the Twin-Pass .023" catheter." The data provenance can be inferred as prospective, laboratory-based testing performed by the manufacturer, Vascular Solutions, Inc., in the United States (Minneapolis, MN).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The acceptance criteria are based on objective bench tests, not expert interpretation of diagnostic images or clinical outcomes. Therefore, the concept of "experts establishing ground truth" in this context is not directly applicable in the way it might be for AI-driven diagnostic devices. The ground truth for device performance is established by the ability of the device to meet predefined physical and functional specifications during testing.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or studies involving human interpretation (e.g., radiology reads) to resolve discrepancies and establish a consensus ground truth. Since the acceptance criteria are based on objective bench tests, there is no need for such adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those involving human interpretation, often with AI assistance) to assess the improvement in human performance with the device. The Twin-Pass .023" catheter is an interventional/diagnostic catheter, and its evaluation focuses on its physical and functional properties, not on improving human reader performance.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done

This question is not applicable. The Twin-Pass .023" catheter is a physical medical device, not a software algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this device. Its performance is inherent to its physical design and manufacturing.

7. The Type of Ground Truth Used

The ground truth used for this device is based on objective measurements and observations from controlled bench tests against pre-defined engineering specifications and functional requirements. This is analogous to "engineering specifications and functional performance data." It is not based on expert consensus, pathology, or outcomes data in the way a diagnostic imaging device might be.

8. The Sample Size for the Training Set

This information is not applicable. The concept of a "training set" is relevant for machine learning algorithms. The Twin-Pass .023" catheter is a manufactured physical device, not an AI or software product. Its design and development would involve engineering prototypes and testing, not a "training set" in the computational sense.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated in point 8.

Summary

{0}------------------------------------------------

K062877

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 CourtMinneapolis, 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

{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

{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 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

Regulation Number and Section

§ 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).