(178 days)
Not Found
Not Found
No
The device description and performance studies focus on the mechanical and material properties of the catheter, with no mention of AI or ML.
No
The device is a guiding catheter intended for the introduction of other diagnostic or interventional devices, not to perform therapy itself.
No
The device, a guiding catheter, is intended to facilitate the introduction of other interventional/diagnostic devices, not to perform diagnosis itself. Its description focuses on its structural properties as a tool for delivery, not for diagnostic measurement or imaging.
No
The device description clearly describes a physical catheter made of materials like PEBAX® and stainless steel, indicating it is a hardware device, not software-only.
Based on the provided information, the VasCon NeuroPath™ Guiding Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "intravascular introduction of interventional/diagnostic devices" within the body (coronary, peripheral, and neurovasculature). This is an in vivo use, meaning it's used within a living organism.
- Device Description: The description details a physical catheter designed to be inserted into blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not to directly interact with the body internally for the purpose of introducing other devices.
N/A
Intended Use / Indications for Use
VasCon NeuroPath™ Guiding Catheter is intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices.
Product codes
DQY
Device Description
The VasCon NeuroPath™ Guiding Catheter is a single lumen catheter, incorporating a PEBAX® body reinforced with a stainless steel wire braid. The intermediate segment is also PEBAX® with a stainless steel coil to reduce kinking and to promote improved torque response. The tip is composed of radiopaque 35D PEBAX® to reduce potential vessel injury. They are available in 5Fr and 6Fr, 90 and 100 cm in length, and in a variety of shapes. The technological characteristics are equivalent to the predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary, peripheral, and neurovasculature
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)
Mechanical laboratory testing has been performed on the VasCon NeuroPath™ Guiding Catheter to assure compliance to the specifications. In addition, testing has been performed on the materials to assure biocompatibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Cordis Guiding Catheter (ENVOY® series), VasCon Guiding Catheter (Polaris™)
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
JAN 1 9 2006
510(k) SUMMARY
| Submitter's
Information | VasCon LLC
9344 NW 13 Street
Miami, Florida 33172 USA
Telephone: 1-305-477-2406
Contact: Stephen F. Vadas, Ph.D. |
|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Preparation Date | July 6, 2005 |
| Name of Device | Common Name: Guiding Catheter
Classification Name: Percutaneous Catheter
Trade Name: VasCon NeuroPath™ Guiding Catheter |
| Predicate Devices | Cordis Guiding Catheter (ENVOY® series)
VasCon Guiding Catheter (Polaris™) |
| Intended Use | VasCon NeuroPath™ Guiding Catheter is intended for use in the
coronary, peripheral, and neurovasculature for intravascular
introduction of interventional/diagnostic devices. |
| Device Description
and Summary of
Technological
Characteristics | The VasCon NeuroPath™ Guiding Catheter is a single lumen
catheter, incorporating a PEBAX® body reinforced with a stainless
steel wire braid. The intermediate segment is also PEBAX® with a
stainless steel coil to reduce kinking and to promote improved
torque response. The tip is composed of radiopaque 35D PEBAX®
to reduce potential vessel injury. They are available in 5Fr and
6Fr, 90 and 100 cm in length, and in a variety of shapes. The
technological characteristics are equivalent to the predicate
devices. |
| Testing Summary | Mechanical laboratory testing has been performed on the VasCon
NeuroPath™ Guiding Catheter to assure compliance to the
specifications. In addition, testing has been performed on the
materials to assure biocompatibility. |
| Conclusions | The non-clinical tests as discussed above demonstrate that, like the
predicate devices, the VasCon NeuroPath™ Guiding Catheter is
safe and effective for its intended use. |
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 9 2006
VasCon LLC c/o Stephen F. Vadas, Ph.D. Vice President, Product Assurance & Regulatory Affairs 9344 N.W. 13 Street, Suite 200 Miami, FL 33172
K052004 Re: VasCon NeuroPath™ Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: II Product Code: DQY Dated: December 27, 2005 Received: December 29, 2005
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 F. Vadas, Ph.D.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r reaso be actived 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 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) remarket notification. The FDA finding of substantial equivalence of your device to a legally premated 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 Mace gacturers, 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,
R. Wehner
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):
Device Name: VasCon NeuroPath™ Guiding Catheter
Indications for Use:
VasCon NeuroPath™ Guiding Catheter is intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices.
Prescription Use __ x (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 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)
Duna R. Vachner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) number K052004