The Skyway Support Catheter is to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature and to facilitate placement of guidewires and other interventional devices.

Device Description

The Skyway Support Catheters are 3F O.D. catheters that taper to a 1.9F tip and are compatible with a 0.014" standard guide wires. The Skyway catheters have a working length of 130-135cm and contains positioning markers at 95 and 105cm which provide a visual indication of the relative positions of Skyway and the end of a standard 105cm guide catheter. A single radiopaque markerband at tip of the catheter provide for a radiographic means of locating the tip position. 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. The catheters are provided in both an over-the-wire (OTW) and rapid exchange (RX) versions. The RX version has a uniquely designed RX port to facilitate exchange of short guidewires. A 120cm stiffening mandrel is included with the Skyway RX version to provide support and pushability.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Skyway™ Support Catheter. It indicates that no clinical evaluations of this product have been conducted. Therefore, it is impossible to provide the requested information about acceptance criteria and a study proving the device meets them, as such a study was not performed.

The submission relies on non-clinical testing and substantial equivalence to predicate devices (Lumend Percutaneous Catheter and Quick-Cross Catheter) to establish safety and effectiveness.

Here's a breakdown of why the requested information cannot be provided based on the given text:

A table of acceptance criteria and the reported device performance: Not available. The document states, "Testing conducted included assessments of the design verification of the Skyway Support Catheter along with biocompatibility assessments. The results of this battery of tests confirmed the suitability of the Skyway Support Catheter for its intended use." However, specific acceptance criteria or performance metrics are not listed.
Sample size used for the test set and the data provenance: Not available. No clinical test set was used. "Non-clinical testing" is mentioned, which typically refers to bench or animal studies, but no details on sample size or data provenance are provided for these.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set was used.
Adjudication method: Not applicable, as no clinical test set was used.
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 is a medical device (catheter), not an AI-powered diagnostic tool. No MRMC study was conducted.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
The type of ground truth used: For non-clinical testing, ground truth would be established through engineering specifications, material analyses, and established testing protocols. Specific types (e.g., pathology, outcomes data) are not mentioned as they relate to clinical studies, which were not performed.
The sample size for the training set: Not applicable. This refers to AI/machine learning models, which are not relevant to this device submission.
How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission demonstrates substantial equivalence primarily through non-clinical testing (design verification and biocompatibility) and comparison to predicate devices, rather than through a clinical study with defined acceptance criteria and performance data as would be typically required for a novel device or AI software.

Summary

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K052258

p/2

DEC 1 3 2005

Summary of Safety and Effectiveness

Date Prepared:	October 28, 2005
Common/Usual Name:	Intravascular Catheter
Product Trade Name:	Skyway™ Support Catheter
Classification Name:	Percutaneous CatheterProduct Code: DQY
Manufacturer:	Vascular Solutions, Inc.6464 Sycamore CourtMinneapolis, Minnesota 55369USA

Establishment Registration:

Sara L. Coon Contact: Senior Requlatory 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:

Intended Use:

The Skyway Support Catheter is to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral

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K052253

p 21-

arterial vasculature and to facilitate placement of guidewires and other interventional devices.

Summary of Non-Clinical Testing:

Testing conducted included assessments of the design verification of the Skyway Support Catheter along with biocompatibility assessments. The results of this battery of tests confirmed the suitability of the Skyway Support Catheter for its intended use.

Summary of Clinical Testing:

No clinical evaluations of this product have been conducted.

Predicate Device:

The Skyway Support Catheter is similar in intended use and function to the Lumend Percutaneous Catheter and the Quick-Cross Catheter.

Technological Characteristics compared to Predicates:

The Skyway Support Catheter is similar to the Lumend Percutaneous Catheter (K011562) and the Quick-Cross Catheter )K033678) in shape, size, indications, materials and catheter type.

Conclusions:

The Skyway Support Catheter is substantially equivalent to the Lumend Percutaneous Catheter and the Quick-Cross Catheter. The testing performed confirms that the Skyway Support Catheter will perform as intended.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

DEC 1 3 2005

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vascular Solutions, Inc. c/o Ms. Sara L. Coon Senior Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, MN 55369

K052258 Skyway™ Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: II Product Code: DQY Dated: November 28, 2005 Received: November 29, 2005

Dear Ms. Coon:

Re:

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 Please be advised had I DA 3 issuates of a bevice complies with other requirements of the Act that IDA has made a cocornmation as administered by other Federal agencies. You must of ally I cuttal statutes and regaranents, including, but not limited to: registration and listing (21 Comply with an the Pet 870 cm . Beath (1); good manufacturing practice requirements as set CTN Fart 607), idocing (21 CFR Part 820), and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product tadiation control provisions (overing your device as described in your Section 510(k) I his icter will anow you to organization of substantial equivalence of your device to a legally prematket notification. The PDF mining of cation 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 If you desire specific darreliance 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 other general miorinational 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,

eli. Mall

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 II.

K052258 510(k) Number:

Vascular Solutions Skyway™ Support Catheter Device Name:

Indications for Use:

The Skyway Support Catheter is to be used in conjunction with steerable The SKyway Support Oatherei 16 to be acca in official.
guidewires in order to access discrete regions of the coronary and peripheral guidewires in order to access ilitate placement of guidewires and other interventional devices.

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)

el.gmell

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number

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).