(116 days)
No
The device description and intended use focus on the physical characteristics and function of a support catheter, with no mention of AI/ML capabilities or data processing beyond basic radiographic localization.
No
The device is a support catheter used to facilitate the placement of guidewires and other interventional devices, rather than directly treating a medical condition.
No
Explanation: The device, Skyway Support Catheter, is described as an interventional device used to facilitate placement of guidewires and other interventional devices in the coronary and peripheral arterial vasculature. Its primary function is mechanical support and delivery, not to diagnose a medical condition or disease.
No
The device description clearly details a physical catheter with specific dimensions, materials, and features (luer hub, strain relief, radiopaque markerband, hydrophilic coating, stiffening mandrel). This indicates a hardware medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral arterial vasculature and to facilitate placement of guidewires and other interventional devices. This describes a device used within the body for a procedural purpose, not a device used to test samples outside the body to diagnose a condition.
- Device Description: The description details a catheter designed for insertion into blood vessels, with features like a tapering tip, radiopaque markers, and a hydrophilic coating to aid in navigation within the vasculature. This aligns with an interventional device, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis.
In summary, the Skyway Support Catheter is an interventional medical device used to assist in procedures within the circulatory system, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for 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 arterial vasculature and to facilitate placement of guidewires and other interventional devices.
Product codes
DQY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral arterial vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical evaluations of this product have been conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 Catheter |
| Product Code: DQY | |
| Manufacturer: | Vascular Solutions, Inc. |
| 6464 Sycamore Court | |
| Minneapolis, Minnesota 55369 | |
| USA |
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:
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.
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
1
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.
2
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.
3
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
4
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 ____________________________________________________________________________________________________________________________________________________________________