(149 days)
The ANGIODYNAMICS WorkHorse™ Percutaneous Transluminal Angioplasty Balloon is indicated for general Percutaneous Transluminal Angioplasty (PTA) of the Iliac, Femoral, and Renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. These catheters are not designed to be used in the coronary arteries.
WorkHorse™ Percutaneous Transluminal Angioplasty Balloon Catheter
This document is a 510(k) clearance letter from the FDA for a medical device called the "WorkHorse™ Percutaneous Transluminal Angioplasty Balloon Catheter." It is dated September 29, 1999.
This document does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria.
This type of FDA letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a predicate device, and does not raise different questions of safety and effectiveness. The 510(k) process typically relies on demonstrating substantial equivalence rather than requiring extensive clinical trials or performance studies with predefined acceptance criteria as might be seen for a PMA (Premarket Approval) submission.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details based on the provided text. The document is solely a regulatory clearance letter.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 9 1999
Ms. Teri Juckett Regulatory Affairs Associate AngioDynamics® Incorporated 603 Queensbury Ave. Queensbury, NY 12804
K991540 Re:
WorkHorse™ Percutaneous Transluminal Angioplasty Trade Name: Balloon Catheter Regulatory Class: II Product Code: LIT Dated: July 26, 1999 Received: July 28, 1999
Dear Ms. Juckett:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The qeneral 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Please note: this response to your premarket Federal Register. notification submission does not affect any obligation you might have
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Page 2 - Ms. Terry Juckett
under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Application: New Application
Device Name: WorkHorse™ Percutaneous Transluminal Angioplasty Balloon
Indications for Use:
The ANGIODYNAMICS WorkHorse™ Percutaneous Transluminal Angioplasty Balloon is indicated for general Percutaneous Transluminal Angioplasty (PTA) of the Iliac, Femoral, and Renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. These catheters are not designed to be used in the coronary arteries.
Please do not write below this line - continue on another page if needed
Concurrence of CDRH, Office of Device
Oli-to/sm/Ahr-for Callahan
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use
§ 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).