(30 days)
Not Found
Not Found
No
The provided 510(k) summary describes a PTA balloon catheter, a mechanical device used for angioplasty. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The description focuses on the physical device and its intended use in specific anatomical locations.
Yes
The device is used for Percutaneous Transluminal Angioplasty (PTA) to treat obstructive lesions in arteries and fistulae, which is a therapeutic intervention.
No
Explanation: The device is a balloon catheter used for Percutaneous Transluminal Angioplasty (PTA) to treat obstructive lesions in arteries and fistulae. This is a therapeutic procedure, not a diagnostic one.
No
The 510(k) summary describes a balloon catheter, which is a physical medical device, not software.
Based on the provided information, the ANGIODYNAMICS Profiler™ PTA Balloon Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a procedure performed on the patient's body (Percutaneous Transluminal Angioplasty) to treat blockages in arteries and fistulae. This is an in vivo procedure, not an in vitro (outside the body) diagnostic test.
- Device Description: While the description is "Not Found," the name "Balloon Catheter" strongly suggests a device used within the body for mechanical intervention.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on laboratory analysis
Therefore, the ANGIODYNAMICS Profiler™ PTA Balloon Catheter is a medical device used for therapeutic intervention within the body, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
DQY
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; 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 and Human Services. The logo consists of a stylized eagle with three lines representing its wings or feathers. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 6 2005
Angiodynamics, Inc. c/o Ms. Teri Juckett Regulatory Affairs Manager 603 Queensbury Ave. Queensbury, NY 12804
Re: K051060
Trade Name: Angiodynamics Profiler™ PTA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: II (two) Product Code: DQY Dated: April 22, 2005 Received: April 26, 2005
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 - Mr. Mark Job
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 may be obtained 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, M.D.
Director
Division of Cardiovascular Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
2
Indications for Use
are not designed to be used in the coronary arteries.
510(k) Number (if known): Special 510(k) Device Modification
AngioDynamics Profiler™ PTA Balloon Catheter Device Name: The ANGIODYNAMICS Profiler™ PTA Balloon Catheter is Indications For Use: 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
Prescription Use X (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)
eQnDe
(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number KOSIOSO
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