The Twin-Pass OTW 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, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents.

Device Description

The Vascular Solutions Twin-Pass OTW Catheter is a sterile single use device designed for use in the arterial vasculature. The catheter provides support for 0.014"/0.36mm guidewires during interventional procedures, and the dual lumen design allows for the delivery of a second guidewire, contrast, or medication into distal vasculature while leaving the initial guidewire in place.

AI/ML Overview

The provided 510(k) summary is for a medical device (Twin-Pass™ OTW Dual Access Catheter) and does not describe an AI/ML powered device or a study involving such a device. Therefore, most of the requested information regarding AI/ML device performance, ground truth, expert adjudication, training/test sets, and MRMC studies is not applicable.

Here's the information that can be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" with numerical targets for each test. Instead, it lists the non-clinical tests conducted and states that "The results of this testing confirmed the suitability of the Twin-Pass OTW Catheter for its intended use."

The non-clinical tests performed are:

Acceptance Criteria Category	Reported Device Performance
Tortuosity	Confirmed suitability for intended use
Catheter Kink Resistance	Confirmed suitability for intended use
Radiopaque Markerband	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
Fluid Leak Under Pressure	Confirmed suitability for intended use
Air Leak During Aspiration	Confirmed suitability for intended use
Flow Rate (Infuse and Distal Lumen)	Confirmed suitability for intended use
Infuse Lumen Flow Rate	Confirmed suitability for intended use
Guidewire Interface	Confirmed suitability for intended use
Guide Catheter Interface	Confirmed suitability for intended use

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 document mentions "testing conducted," but does not specify sample sizes for these tests, nor the provenance of any data (as it's non-clinical bench testing).

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. This is not an AI/ML device, and no human "experts" were used to establish ground truth for clinical performance; the testing was non-clinical bench testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not an AI/ML device, and no human adjudication was involved in the bench testing.

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. No clinical testing was conducted, and this is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical testing, the "ground truth" would be established by engineering specifications, physical measurements, and industry standards for catheter performance (e.g., flow rate measurements, kink resistance thresholds). The document simply states that the tests "confirmed the suitability."

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device, so there is no training set or associated ground truth establishment process.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Vascular Solutions. The logo consists of the word "Vascular" in a bold, serif font, with the word "SOLUTIONS" in a smaller, sans-serif font underneath. Above the text is an abstract design made up of small, black squares arranged in a vertical column. The squares are not uniform in size or spacing, creating a textured effect.

V % 1 2007

510(k) Summary

510(k) Number:___ หงว 2 6 | 8

Date Prepared September 14, 2007

Submitter Information

Submitter's Name/ Address:

Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369

Establishment Registration 2134812

Contact Person:

Alyssa Malinski amalinski@vascularsolutions.com

Device Information

Trade Name: Twin-Pass™ OTW Dual Access Catheter Common Name: Percutaneous Catheter Classification Name: Unclassified Product Code: DQY Regulation: 21 CFR 870.1250

Predicate Device(s)

Twin-Pass™ Dual Access Catheter (K052257) Twin-Pass™ Dual Access Catheter (K060327)

Device Description

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delivery of a second guidewire, contrast, or medication into distal vasculature while leaving the initial guidewire in place.

Intended Use/Indications for Use

Summary of Non-Clinical Testing

Testing conducted included assessments of the design verification of the Twin-Pass OTW Catheter along with biocompatibility assessments. Shelf life testing was leveraged from the Twin Pass Dual Access Catheter (K052257 and K060327). The results of this testing confirmed the suitability of the Twin-Pass OTW Catheter for its intended use. Each bench test that was conducted is listed, below:

Tortuosity .
. Catheter Kink Resistance
Radiopaque Markerband ●
Hub-to-proximal-shaft Bond Strength .
. Proximal-to-distal-shaft Bond Strength
Fluid Leak Under Pressure .
Air Leak During Aspiration .
. Flow Rate (Infuse and Distal Lumen)
. Infuse Lumen Flow Rate
Guidewire Interface .
Guide Catheter Interface .

Summary of Clinical Testing

No Clinical Testing was conducted for Twin-Pass™ OTW Catheter.

Statement of Equivalence

The Twin-Pass OTW Catheter is considered to be substantially equivalent to the Twin-Pass Dual Access Catheter (K052257 and K060327). The indications for use selected for the Twin-Pass OTW Catheter are a combination of the indications for use of the predicates. In addition, the products are covered by the same regulation, are made of same materials, have similar sizes and have similar features.

Conclusion

The data submitted in the following sections demonstrates that the Twin-Pass OTW Catheter is a safe and effective means delivering supporting stecrable 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 and to subselectively infuse/deliver diagnostic or therapeutic agents.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 1 2007

Vascular Solutions, Inc. c/o Ms. Alyssa Malinski Regulatory Affairs Assistant 6464 Sycamore Court Minneapolis, MN 55369

Re: K072618

Trade/Device Name: Twin-Pass™ OTW Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: November 15, 2007 Received: November 16, 2007

Dear Ms. Malinski:

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.

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

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Page 2 -- Ms. Alyssa Malinski

forth in the quality systems (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

R. lechner

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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Indications for Use Statement

510(k) Number (if known): __ Ko 7 2 G / 8

Device Name: Twin-Pass™ OTW Catheter

Indications for Use:

The TwinPass OTW 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, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents.

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)

uana R. lanes

(Division Sign-Off) (Division Sign-Sill)
Division of Cardiovascular Devices

510(k) Number K072618

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).