(91 days)
The guiding catheter is intended for use for intravascular introduction of interventional / diagnostic devices into the coronary or peripheral vascular systems.
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.
The provided 510(k) summary for the VasCon Polaris™ Guiding Catheter does not include information about specific acceptance criteria or an associated study conducted to prove the device meets these criteria in the context of AI/ML performance.
Instead, this submission is for a traditional medical device (a guiding catheter) and focuses on demonstrating substantial equivalence to a predicate device. The acceptance criteria and testing summary refer to engineering and biocompatibility tests, not studies related to AI/ML performance.
Therefore, I cannot populate the table or answer the subsequent questions related to AI/ML acceptance criteria and studies based on the provided text. The document clearly states:
- "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 technological characteristics are equivalent to the predicate device."
This indicates a focus on physical, mechanical, and biological properties, and substantial equivalence to a pre-existing non-AI device.
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FEB 1 8 2004
510(k) SUMMARY
| Submitter'sInformation | VasCon LLC9344 NW 13 StreetMiami, Florida 33172 USATelephone: 1.305.477.2406Fax: 1.305.592.6605Contact: Stephen F. Vadas, Ph.D. |
|---|---|
| Preparation Date | 18 November 2003 |
| Name of Device | Common Name: Guiding CatheterClassification Name: Percutaneous CatheterTrade Name: VasCon Polaris™ Guiding Catheter |
| Predicate Device | Cordis Guiding Catheters (Vista BRITE TIP®) |
| Intended Use | The guiding catheter is intended for use for intravascular introductionof interventional / diagnostic devices into the coronary or peripheralvascular systems. |
| DeviceDescription andSummary ofTechnologicalCharacteristics | The VasCon Polaris™ Guiding Catheters are single lumencatheters, incorporating a nylon body reinforced with a stainlesssteel wire braid, a PTFE lubricious inner lumen, and a softradiopaque tip to reduce potential vessel injury. They are available in5Fr, 6Fr, 7Fr, and 8Fr, 100 cm in length, and in a variety of shapes.The technological characteristics are equivalent to the predicatedevice. |
| TestingSummary | 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 materialsto assure biocompatibility. |
| Conclusions | The testing as discussed above demonstrate that, like the predicatedevices, the VasCon Polaris™ Guiding Catheters are safe andeffective for its intended use. |
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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.
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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
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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 intravascularintroduction of interventional / diagnostic devices into thecoronary 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
Page 1 of __ 1__
§ 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).