(91 days)
Not Found
Not Found
No
The device description and intended use are for a physical guiding catheter, and there is no mention of AI, ML, image processing, or any software-based analytical capabilities.
No
The device is described as a guiding catheter intended for the introduction of other devices, not for directly treating a medical condition itself.
No
Explanation: The device is a guiding catheter used for the introduction of other devices, not for diagnosing medical conditions itself. While it facilitates the use of diagnostic devices, it is not a diagnostic device.
No
The device description clearly states it is a physical catheter made of nylon, stainless steel, and PTFE, with a radiopaque tip. This indicates it is a hardware device, not software only.
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 the "intravascular introduction of interventional / diagnostic devices into the coronary or peripheral vascular systems." This describes a device used within the body for procedural guidance, not a device used to test samples outside the body to diagnose a condition.
- Device Description: The description details a physical catheter designed for insertion into blood vessels. This aligns with an in-vivo medical device, not an in-vitro diagnostic.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in-vitro diagnostics.
In-vitro diagnostics are devices used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This guiding catheter does not fit that description.
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 (comma separated list FDA assigned to the subject device)
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. The technological characteristics are equivalent to the predicate device.
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
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)
Laboratory testing has been performed on the VasCon Polaris™ Guiding Catheters to assure compliance to the specifications. In addition, laboratory testing has been performed on the materials to assure biocompatibility. The testing as discussed above demonstrate that, like the predicate devices, the VasCon Polaris™ Guiding Catheters are safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Cordis Guiding Catheters (Vista BRITE TIP®)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
FEB 1 8 2004
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 | 18 November 2003 |
| Name of Device | Common Name: Guiding Catheter
Classification Name: Percutaneous Catheter
Trade Name: VasCon Polaris™ Guiding Catheter |
| Predicate Device | Cordis Guiding Catheters (Vista BRITE TIP®) |
| 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.
In addition, laboratory testing has been performed on the materials
to assure biocompatibility. |
| Conclusions | The testing as discussed above demonstrate that, like the predicate
devices, the VasCon Polaris™ Guiding Catheters are safe and
effective for its intended use. |
1
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 2004
VasCon LLC c/o Stephen P. Vadas, Ph.D. Vice President, Product Assurance & Regulatory Affairs 9344 NW 13th Street Miami, FL 33172
Re: K033633
Trade Name: VasCon Polaris Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutancous Regulatory Class: Class II (two) Product Code: DQY Dated: November18, 2003 Received: November 19, 2003
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.
2
Page 2 - Stephen P. Vadas, Ph.D.
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 that I Dri has made a aoth regulations administered by other Federal agencies. You must or any I cach stututed and regaranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050. [rouder latiation control pro herens (evens (evens (evice as described in your Section 510(k) I his icher will anow you to begin manusing of substantial equivalence of your device to a legally premarket notification: "The PDF 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 if you desire spicente at (301) 594-4648. 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 mionnation 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/dsma/dsmamain.html
Sincerely yours,
R. Vochner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
| 510(k) Number (if known): K033633 | |
|---|---|
| Device Name: | VasCon Polaris™ Guiding Catheter |
| Indications For Use: | The guiding catheter is intended for use for intravascular |
| introduction of interventional / diagnostic devices into the | |
| coronary or peripheral vascular systems. |
× 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duuna R. bochner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K033633
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