(55 days)
The ANGIODYNAMICS WorkHorse™ II 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.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the WorkHorse™ II Percutaneous Transluminal Angioplasty Balloon Catheter. This type of document does not contain the detailed information about acceptance criteria or a specific study proving the device meets those criteria in the typical format of a scientific study report.
Instead, a 510(k) clearance means the device has been found "substantially equivalent" to a legally marketed predicate device. This equivalence is often demonstrated through a comparison of technological characteristics and performance data (bench testing, some animal studies, or limited clinical data if necessary to address specific performance concerns). The FDA relies on the manufacturer to submit data proving the device is safe and effective for its intended use, typically by showing it performs as well as a predicate device.
Therefore, the specific information requested in your prompt (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set sizes, and ground truth establishment for training set) is not present in this FDA clearance letter.
The letter focuses on:
- Acknowledging the 510(k) submission.
- Stating the device is substantially equivalent to predicate devices.
- Providing the regulation number, name, and class.
- Listing the indications for use.
- Reminding the manufacturer of ongoing regulatory compliance requirements.
To obtain the detailed study information you're asking for, one would typically need to review the actual 510(k) submission document itself (which is often voluminous and not publicly released in its entirety), or a summary thereof, rather than just the clearance letter.
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AUG 2 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AngioDynamics, Inc. c/o Ms. Teri Juckett Regulatory Affairs Manager 603 Queensbury Ave. Queensbury, NY 12804
Re: K032069
WorkHorse™ II Percutaneous Transluminal Angioplasty Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: August 13, 2003 Received: August 19, 2003
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 (301) 594-4648. Also, please note the regulation entitled, "Mishranding 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.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Bram D. Zuckerman, MD
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
WorkHorse™ II Percutaneous Transluminal Angioplasty Device Name: Balloon
Indications for Use:
The ANGIODYNAMICS WorkHorse™ II 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 Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular | Devices |
| 510(k) Number | K032069 |
| 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).