(110 days)
Angiodynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.
The intended use of the AngioDynamics Mariner Angiographic Catheters is to deliver radiopaque contrast media to the vasculature during angiographic procedures.
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.
This document is a 510(k) premarket notification for a medical device called the "AngioDynamics Mariner Angiographic Catheter." It is focused on demonstrating substantial equivalence to an existing predicate device rather than presenting a study where acceptance criteria for device performance are evaluated against a specified performance range based on clinical outcomes or a standalone algorithm's accuracy.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria, as typically understood in the context of AI/ML or diagnostic performance (e.g., sensitivity, specificity, clinical endpoints), is largely not applicable to this document. The "performance data" referred to in Section I is primarily engineering and material testing to ensure the modified device functions safely and equivalently to its predecessor.
Here's a breakdown of why and what information can be extracted relative to the context of this document:
1. A table of acceptance criteria and the reported device performance:
This document does not present acceptance criteria in terms of clinical performance metrics like sensitivity or specificity. Instead, the "performance data" refers to non-clinical performance and material testing. The acceptance criteria for these tests would typically be specific engineering and material standards or internal company specifications, which are not detailed in this summary.
| Acceptance Criteria (Implied - Engineering/Material Standards) | Reported Device Performance (Implied - Met Standards) |
|---|---|
| Static Pressure (Standard/Specification for catheter integrity) | Passed / Compliant |
| Tensile Strength (Standard/Specification for material strength) | Passed / Compliant |
| Friction (Standard/Specification for catheter movement) | Passed / Compliant |
| Particulate (Standard/Specification for cleanliness) | Passed / Compliant |
| Biocompatibility (ISO 10993-1) | Passed / Compliant |
Explanation: The document states, "The proposed... and predicate... 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." This implies that the new device met the acceptance criteria (likely predefined engineering and material standards) for each of these tests, demonstrating substantial equivalence to the predicate. The specific numerical values or acceptance ranges are not provided in this summary.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable in the traditional sense of a clinical or image-based diagnostic study. The "test set" here refers to the physical units of the device subjected to non-clinical engineering and material tests. The specific number of catheters tested for each performance characteristic (Static Pressure, Tensile, etc.) is not detailed in this summary.
- Data Provenance: Not applicable. These are laboratory-based, non-clinical tests rather than data collected from patients or external sources.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. Ground truth, in the context of clinical or diagnostic accuracy, is not established for these types of engineering performance tests. The "truth" for these tests is determined by standardized measurement protocols and instruments.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. This concept is relevant for reconciling discrepancies in expert opinions for ground truth establishment, which isn't part of these engineering tests.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No. This document is for a physical medical device (angiographic catheter), not an AI/ML diagnostic algorithm. Therefore, an MRMC study is not relevant.
- Effect Size of Human Reader Improvement: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: No. This is a physical medical device and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: For the engineering and material tests, the "ground truth" is defined by the physical properties and performance specifications of the device, measured by calibrated equipment according to established test methods and standards (e.g., ISO 10993-1 for biocompatibility). There is no "expert consensus" or "pathology" ground truth in this context.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: Not applicable.
In summary: This 510(k) submission describes physical performance and material testing for a catheter to demonstrate substantial equivalence to a predicate device, focusing on safety and function rather than diagnostic accuracy or AI/ML performance. Thus, many of the requested items related to clinical study design, expert ground truth, and AI validation are not relevant to the information provided in this document.
{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
{2}------------------------------------------------
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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 |
{4}------------------------------------------------
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.
§ 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).