(149 days)
Not Found
None
No
The 510(k) summary describes a standard angioplasty balloon catheter and contains no mention of AI, ML, image processing, or performance metrics typically associated with AI/ML devices.
Yes
The device is indicated for "Percutaneous Transluminal Angioplasty (PTA)" and "treatment of obstructive lesions," which are therapeutic procedures.
No
This device is a therapeutic device (angioplasty balloon) used for treatment, not for diagnosing conditions.
No
The device description clearly identifies it as a "Percutaneous Transluminal Angioplasty Balloon Catheter," which is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The description clearly states that the ANGIODYNAMICS WorkHorse™ Percutaneous Transluminal Angioplasty Balloon is a catheter used for Percutaneous Transluminal Angioplasty (PTA). This is a procedure performed inside the body to widen narrowed or blocked blood vessels.
- Lack of IVD Characteristics: The provided information does not mention any testing of samples, analysis of bodily fluids, or any other activity typically associated with IVDs.
Therefore, based on the provided information, the ANGIODYNAMICS WorkHorse™ Percutaneous Transluminal Angioplasty Balloon is a therapeutic medical device used for a procedure performed within the body, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
LIT
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Iliac, Femoral, and Renal arteries; native or synthetic arteriovenous dialysis fistulae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 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 a stylized caduceus or a representation of human figures.
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
1
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
2
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