(110 days)
Not Found
No
The summary describes a physical catheter for delivering contrast media and focuses on material and performance testing, with no mention of AI or ML.
No
The device is used to deliver contrast media for diagnostic angiographic procedures, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the catheters are "for use where angiographic diagnosis is indicated," and their intended use is to "deliver radiopaque contrast media to the vasculature during angiographic procedures." The contrast media allows for imaging that aids in diagnosis.
No
The device description explicitly states it is a "sterile, single use, disposable device" and mentions physical characteristics like a hydrophilic coating and performance testing related to static pressure, tensile strength, friction, and particulate matter. These are characteristics of a physical 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 to "deliver radiopaque contrast media to the vasculature during angiographic procedures." This describes a device used in vivo (within the body) for a diagnostic imaging procedure.
- Device Description: The description confirms it's a catheter designed to deliver contrast media into the vascular system. This is a medical device used for a procedure, not for testing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are typically used to test these samples to diagnose diseases or conditions.
Therefore, the AngioDynamics Angiographic Catheter is a medical device used for an in vivo diagnostic imaging procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Angiodynamics Angiographic Catheter are for use where angiographic diagnosis is indicated.
Product codes
DOO
Device Description
AngioDynamics Mariner Angiographic Catheters are sterile, single use, disposable devices designed to delivery radiopaque contrast media to selected sites in the vascular system. The AngioDynamics Mariner Angiographic Catheter is hydrophilicly coated at the distal end.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
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)
The proposed AngioDynamics Mariner Angiographic Catheter and the predicate AngioDynamics Mariner Angiographic Catheter are substantially equivalent to the specified predicate devices based on a comparison of technological characteristics and the results of non-clinical performance and material testing, which include:
- Static Pressure
- Tensile
- Friction
- Particulate
- Biocompatibility per ISO 10993-1
The results of the non-clinical testing and a comparison of similarities and differences demonstrate that the proposed and predicate devices are substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three faces in profile, one behind the other, with a stylized design above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 14, 2015
AngioDynamics, Inc. Teri Juckett Regulatory Affairs Manager 603 Queensbury Ave. Queensbury, New York 12804
Re: K151724
Trade/Device Name: AngioDynamics Mariner Angiographic Catheters Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DOO Dated: September 11, 2015 Received: September 14, 2015
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
M.A. Hillebrand
for
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) Number (if known) K151724
Device Name
Angiodynamics Mariner Angiographic Catheters
Indications for Use (Describe) Angiodynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY FOR THE ANGIODYNAMICS, INC. MARINER ANGIOGRAPHIC CATHETERS
Date Prepared: 14 October 2015
A. Sponsor:
AngioDynamics, Inc. 603 Queensbury Avenue Queensbury, NY 12804
B. Contact:
Teri L. Juckett Manager, Global Regulatory Affairs Tel: 518-795-1142 Fax: 518-742-4323 Email: tjuckett@angiodynamics.com
C. Device Name:
| Trade Name: | AngioDynamics Mariner Angiographic Catheters |
|---|---|
| Common/Usual Name: | Angiographic Catheters |
| Classification Name: | Catheter, Intravascular, Diagnosis |
| (21CFR§870.1200, Class II, Pro-Code DQO) | |
| Classification Panel: | Cardiovascular |
| D. Predicate Device: | |
| Trade Name: | AngioDynamics Mariner Angiographic Catheter |
| Common/Usual Name: | Angiographic Catheters |
| Classification Name: | Catheter, Intravascular, Diagnosis |
| (21CFR§878.4810, Class II, Pro-Code GEX) | |
| Classification Panel: | Cardiovascular |
| Premarket Notification: | K112452 |
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E. Device Description:
AngioDynamics Mariner Angiographic Catheters are sterile, single use, disposable devices designed to delivery radiopaque contrast media to selected sites in the vascular system. The AngioDynamics Mariner Angiographic Catheter is hydrophilicly coated at the distal end.
F. Indications for Use:
AngioDynamics Angiographic Catheter are for use where angiographic diagnosis is indicated.
G. Intended Use:
The intended use of the AngioDynamics Mariner Angiographic Catheters is to deliver radiopaque contrast media to the vasculature during angiographic procedures.
H. Summary of Similarities and Differences in Technology Characteristics and Performance:
The proposed device has similar materials, design, and technical characteristics as the predicate The purpose of this 510(k) submission is to introduce into commercial distribution a device. modified AngioDynamics Mariner Angiographic Catheter which includes a material change to the compound, used in the extrusion of the outer layer of the non-braided shaft.
I. Performance Data:
The proposed AngioDynamics Mariner Angiographic Catheter and the predicate AngioDynamics Mariner Angiographic Catheter are substantially equivalent to the specified predicate devices based on a comparison of technological characteristics and the results of non-clinical performance and material testing, which include:
- Static Pressure
- Tensile
- . Friction
- . Particulate
- Biocompatibility per ISO 10993-1 ●
J. Conclusion:
The results of the non-clinical testing and a comparison of similarities and differences demonstrate that the proposed and predicate devices are substantially equivalent.