(31 days)
The ANGIODYNAMICS Profiler® PTA Balloon Catheter 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.
AngioDynamics Profiler® PTA Balloon Catheter
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for the AngioDynamics Profiler® PTA Balloon Catheter. The document is an FDA 510(k) clearance letter, which confirms substantial equivalence but does not detail the specific performance studies, acceptance criteria, or methodology of such studies.
Therefore, I cannot provide:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
- Whether a standalone performance study was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT -6 2006
AngioDynamics, Inc. c/o Ms. Teri Juckett Regulatory Affairs Manager 603 Queensbury Avenue Oueensbury, NY 12804
Re: K062609
Trade Name: AngioDynamics Profiler® PTA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: II (two) Product Code: DQY, LIT Dated: September 1, 2006 Received: September 5, 2006
Dear Ms. Juckett:
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. Teri Juckett
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 (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 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.
uma R. hichner
Image /page/1/Picture/5 description: The image contains a handwritten signature or symbol on the left, followed by the words "Br" and "Di" on the right. The signature appears to be a series of connected, curved lines, possibly representing initials or a stylized mark. The text "Br" and "Di" are positioned next to the signature, suggesting they might be related to the person or entity associated with the signature.
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) Application: Special 510(k) Device Modification K 0 626 0 9
AngioDynamics Profiler® PTA Balloon Catheter Device Name:
Indications for Use:
The ANGIODYNAMICS Profiler® PTA Balloon Catheter 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.
Prescription Use X (Per 21 CFR 801.109)
Over-the-Counter Use
Please do not write below this line - continue on another page if needed
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Vachner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K062609
§ 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).