(65 days)
Not Found
Not Found
No
The summary describes a catheter and does not mention any software, image processing, or AI/ML terms.
No
The device is described as an "Angiographic Catheter" for "angiographic diagnosis," indicating it is used for diagnostic purposes rather than for treating a condition.
Yes
The "Intended Use / Indications for Use" states that the catheters are "for use where angiographic diagnosis is indicated," directly linking them to a diagnostic purpose.
No
The device description clearly states it is a physical catheter, which is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "where angiographic diagnosis is indicated." Angiography is a medical imaging technique that visualizes blood vessels. This is an in vivo (within the living body) procedure, not an in vitro (outside the living body) test.
- Device Description: The device is described as "Angiographic Catheters." Catheters are instruments used to access internal body structures, again indicating an in vivo application.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information about a patient's health status based on laboratory analysis
Therefore, the AngioDynamics Angiographic Catheters are medical devices used for an in vivo diagnostic procedure (angiography), not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.
Product codes
DQO
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 4 2006
AngioDynamics, Inc. c/o Ms. Teri Juckett Regulatory Affairs Manager 603 Queensbury Ave Oueensbury, NY 12804
Re: K061733
AngioDynamics Soft-Vu and AngioDynamics Mariner Hydrophilic Coated Catheters Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II Product Code: DQO Dated: July 26, 2006 Received: August 2, 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.
1
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,
vina R. buchner
A 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
K 061733
510(k) Application: Special 510(k) Device Modification
Device Name: ANGIODYNAMICS Soft-Vu and ANGIODYNAMICS Mariner Hydrophilic Coated Catheters
Indications for Use:
AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.
Prescription Use X (Per 21 CFR 801.109)
OR
Over-the-Counter Use
Please do not write below this line - continue on another page if needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
Diana R. Vachner
(Division Sign-Off Division of Cardiovascular Devices
510(k) Number K061733
Soft-Vu Product Line Extension 510(k) Design History File 350