(28 days)
The Fox Plus PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal, and profunda arteries and native or synthetic arteriovenous dialysis fistulae. This catheter is not intended for the expansion or delivery of stents.
The Fox Plus PTA Catheter is a standard over-the-wire PTA catheter. The double lumen catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the second lumen allows access to the distal tip of the catheter for guidewire insertion (max 0.035"). The balloon material expands to a known diameter at specific pressure.
This document is a 510(k) summary for a medical device called the Fox Plus PTA Catheter. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, device performance results, sample sizes for testing or training, ground truth establishment, or any comparative effectiveness studies as requested in the prompt.
Therefore, I cannot provide the requested table and information based on the provided text. The submission focuses on demonstrating substantial equivalence through non-clinical testing, but the details of those tests and their outcomes are not included here.
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APPENDIX A. 510(k) SUMMARY
| Sponsor/Submitter: | Abbott Laboratories (Perclose, Inc.)Abbott Vascular Devices400 Saginaw DriveRedwood City, CA 94063 |
|---|---|
| Contact Person: | Joanna KuskowskiRegulatory Affairs CoordinatorPhone:(650) 474-3331Fax:(650) 474-3020 |
| Date of Submission: | April 9, 2004 |
| Device Trade Name: | Fox Plus PTA Catheter |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 870.1250 |
| Classification Name: | Percutaneous Transluminal Angioplasty Catheter |
| Product Code: | LIT |
| Predicate Device: | Fox PTA Catheter (K020854) |
| Intended Use: | The Fox Plus PTA Catheter is intended for dilatation of lesions inthe femoral, renal, iliac, popliteal, peroneal, and profunda arteriesand native or synthetic arteriovenous dialysis fistulae. This catheter isnot intended for the expansion or delivery of stents. |
| Device Description: | The Fox Plus PTA Catheter is a standard over-the-wire PTAcatheter. The double lumen catheter has a balloon located near thedistal tip. One lumen is used for inflation of the balloon, while thesecond lumen allows access to the distal tip of the catheter forguidewire insertion (max 0.035"). The balloon material expands toa known diameter at specific pressure. |
| Summary of SubstantialEquivalence: | The Fox Plus PTA Catheter is substantially equivalent to thepredicate device. Substantial equivalence was confirmed throughnon-clinical testing. |
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Image /page/1/Picture/2 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 abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 11 2004
Abbott Laboratories, Inc. c/o Ms. Joanna Kuskowski Abbott Vascular Devices (Perclose, Inc.) 800 Saginaw Drive Redwood City, CA 94063
Re: K040954
Fox Plus PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Angioplasty, Peripheral, Transluminal Regulatory Class: Class II (two) Product Code: LIT Dated: April 9, 2004 Received: April 13, 2004
Dear Ms. Kuskowski:
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 - Ms. Joanna Kuskowski
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 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) 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 Office of Compliance 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 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Duna R. Lochner
| 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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Appendix B. Indications for Use
510(k) Number (if known): K040954 Fox Plus PTA Catheter Device Name: The Fox Plus PTA Catheter is intended for dilatation of lesions in Indications For Use: the femoral, renal, iliac, popliteal, peroneal, and profunda arteries and native or synthetic arteriovenous dialysis fistulae.
This catheter is not intended for the expansion or delivery of stents.
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)
R. Vocher
Olvision Sign-Off) Division Sign-Sill, Sixtinovascular Devices
510(k) Number Kodo 954
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 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).