(948 days)
Not Found
Not Found
No
The device description and summary of performance studies focus on the physical characteristics and material properties of a microcatheter, with no mention of AI or ML capabilities.
No.
The device is indicated for the selective infusion of therapeutic agents, but it is not a therapeutic device itself. It is a microcatheter designed to deliver other agents.
No
The device is a microcatheter used for the infusion of diagnostic, therapeutic, and embolic agents. While it can deliver diagnostic agents, it is not described as performing any diagnostic function itself (e.g., imaging, measuring, or analyzing).
No
The device description clearly outlines physical components like a Pebax body, stainless steel and platinum wire, PTFE lumen, and a radiopaque tip, indicating it is a hardware device.
Based on the provided information, the VasCon Roamer Microcatheters are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the "selective infusion of various diagnostic, therapeutic, and embolic agents into the peripheral, coronary, and neurovasculature." This describes a device used within the body for delivering substances, not for testing samples outside the body.
- Device Description: The description details a catheter designed for insertion into blood vessels, with features like a lubricious inner lumen and a soft tip to reduce vessel injury. This aligns with an invasive medical 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 information about a patient's health status based on such analysis.
IVD devices are typically used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The VasCon Roamer Microcatheter's function is to deliver substances directly into the body's vasculature.
N/A
Intended Use / Indications for Use
The VasCon Roamer Microcatheters are indicated for the selective infusion of various diagnostic, therapeutic, and embolic agents into the peripheral, coronary, and neurovasculature.
Product codes
KRA
Device Description
The VasCon Roamer Microcatheters are single lumen catheters, incorporating a Pebax body reinforced with stainless steel and platinum wire, a PTFE lubricious inner lumen, and a soft radiopaque tip to reduce potential vessel injury. They are available in French sizes of 2.3/1.9, 2.8/2.3, 3.0/2.8, 2.4/2.0, and 2.8/2.7 and in lengths of 105 cm, 135 cm, and 150 cm. The inside diameters are 0.017, 0.019, 0.021, and 0.027 inches. They have a hydrophilic coating to provide lubricity during use. 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
peripheral, coronary, 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)
Laboratory testing has been performed on the VasCon Roamer Microcatheter to assure compliance to the specifications. In addition, laboratory testing has been performed on the materials to assure biocompatibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Cordis Catheters (MassTransit®, Prowler® Plus, and the Prowler® 14)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).
0
KD 53210
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.
JUL - 3 2008 |
|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Preparation Date | 18 November 2005 |
| Name of Device | Classification Name: Continuous Flush Catheter
Trade Name: VasCon Roamer Microcatheter |
| Predicate Device | Cordis Catheters (MassTransit®, Prowler® Plus, and the Prowler® 14) |
| Intended Use | The VasCon Roamer Microcatheters are indicated for the selective
infusion of various diagnostic, therapeutic, and embolic agents into the
peripheral, coronary, and neurovasculature. |
| Device
Description and
Summary of
Technological
Characteristics | The VasCon Roamer Microcatheters are single lumen catheters,
incorporating a Pebax body reinforced with stainless steel and
platinum wire, a PTFE lubricious inner lumen, and a soft radiopaque
tip to reduce potential vessel injury. They are available in French sizes
of 2.3/1.9, 2.8/2.3, 3.0/2.8, 2.4/2.0, and 2.8/2.7 and in lengths of 105
cm, 135 cm, and 150 cm. The inside diameters are 0.017, 0.019,
0.021, and 0.027 inches. They have a hydrophilic coating to provide
lubricity during use. The technological characteristics are equivalent to
the predicate device. |
| Testing
Summary | Laboratory testing has been performed on the VasCon Roamer
Microcatheter 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 demonstrates that, like the predicate
devices, the VasCon Roamer Microcatheters are safe and effective for
its intended use. |
.
.
:
1
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 stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
VasCon LLC c/o Stephen F. Vadas, PhD Vice President 9344 NW 13th Street Miami, FL 33172
Re: K053310
Trade/Device Name: VasCon Roamer Microcatheter Regulation Number: 21 CFR 870.1210 Regulation Name: catheter, continuous flush Regulatory Class: Class II Product Code: KRA Dated: March 12, 2008 Received: April 7, 2008
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 he 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
2
Page 2 - Dr. Stephen F. Vadas
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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) premarket notification. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0210. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Anrley B. Boan
for
Bram D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Usc
510(k) Number (if known):
VasCon Roamer Microcatheter Device Name:
Indications For Use:
The VasCon Roamer Microcatheters are indicated for the selective infusion of various diagnostic, therapeutic, and embolic agents into the peripheral, coronary, and neurovasculature.
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)
Andree Brown for BDZ