(69 days)
VasCon Polaris™ Guiding Catheters, K033633
No
The summary describes a standard guiding catheter with no mention of AI or ML capabilities. The device description focuses on material and structural components, and the performance studies are standard laboratory tests.
No
The device is described as a guiding catheter intended for the "intravascular introduction of interventional / diagnostic devices," which means its primary function is to facilitate the delivery of other devices, not to provide therapy itself.
No
Explanation: The device description states its intended use is for the intravascular introduction of interventional/diagnostic devices, not for diagnosing conditions itself. It's a tool for delivering other devices.
No
The device description clearly states it is a physical catheter made of nylon, stainless steel, and PTFE, which are hardware components.
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 for "intravascular introduction of interventional / diagnostic devices into the coronary or peripheral vascular systems." This describes a device used within the body for delivering other devices, not for testing samples outside the body to diagnose a condition.
- Device Description: The description details a catheter with physical components (nylon body, wire braid, PTFE lumen, radiopaque tip) designed for insertion into blood vessels. This aligns with an interventional or diagnostic tool used in vivo, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of the device being used with biological samples (blood, urine, tissue, etc.), reagents, or for performing tests to detect or measure substances or characteristics in those samples.
IVD devices are specifically designed to be used in vitro (outside the living body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely in vivo (within the living body).
N/A
Intended Use / Indications for Use
The guiding catheter is intended for use for intravascular introduction of interventional / diagnostic devices into the coronary or peripheral vascular systems.
Product codes
DQY
Device Description
The VasCon Polaris™ Guiding Catheters are single lumen catheters, incorporating a nylon body reinforced with a stainless steel wire braid, a PTFE lubricious inner lumen, and a soft radiopaque tip to reduce potential vessel injury. They are available in 5Fr, 6Fr, 7Fr, and 8Fr, 100 cm in length, and in a variety of shapes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary or peripheral vascular systems
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Laboratory testing has been performed on the VasCon Polaris™ Guiding Catheters to assure compliance to the specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
VasCon Polaris™ Guiding Catheters, 510(k) K033633
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).
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FEB 1 6 2005
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string starts with the letter 'K', followed by the number '043387'. The number '7' is written in a cursive style.
510(k) SUMMARY
| Submitter's Information | VasCon LLC
9344 NW 13 Street
Miami, Florida 33172 USA
Telephone: 1.305.477.2406
Fax: 1.305.592.6605
Contact: Stephen F. Vadas, Ph.D. |
|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Preparation Date | 08 December 2004 |
| Name of Device | Common Name: Guiding Catheter
Classification Name: Percutaneous Catheter
Trade Name: VasCon Polaris™ Guiding Catheter |
| Predicate Device | VasCon Polaris™ Guiding Catheters, 510(k) K033633 |
| Intended Use | The guiding catheter is intended for use for intravascular introduction
of interventional / diagnostic devices into the coronary or peripheral
vascular systems. |
| Device Description and
Summary of
Technological
Characteristics | The VasCon Polaris™ Guiding Catheters are single lumen
catheters, incorporating a nylon body reinforced with a stainless
steel wire braid, a PTFE lubricious inner lumen, and a soft
radiopaque tip to reduce potential vessel injury. They are available in
5Fr, 6Fr, 7Fr, and 8Fr, 100 cm in length, and in a variety of shapes.
The technological characteristics are equivalent to the predicate
device. |
| Testing Summary | Laboratory testing has been performed on the VasCon Polaris™
Guiding Catheters to assure compliance to the specifications. |
| Conclusions | The testing as discussed above demonstrate that, like the predicate
device, the VasCon Polaris™ Guiding Catheters are safe and
effective for its intended use. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring three stylized birds in flight, arranged in a vertical stack. The birds are depicted in a simple, abstract manner, with flowing lines suggesting movement and freedom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 6 2005
Stephen F. Vadas, Ph.D., P.E. Vice President, Product Assurance and Regulatory Affairs VasCon LLC 9344 NW 13 Street Miami, FL 33172
K043387 Re:
Trade/Device Name: VasCon Polaris™ Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: DQY Dated: December 8, 2004 Received: December 9, 2004
Dear Dr. Vadas:
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 - Stephen F. Vadas, Ph.D., P.E.
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) I mb lokel with and in 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,
Dana R. Lachner
Bram D. Zuckerman, M.D. SD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ¥043387
VasCon Polaris™ Guiding Catheter Device Name: The guiding catheter is intended for use for Indications For Use: intravascular introduction of interventional / diagnostic devices into the coronary or peripheral vascular systems.
Prescription Use X (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
DIANNA R. Ladner
(Divisi 1 Sign-Off) (Division of Cardiovascular Devices
16111 Number_K043383
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