AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters

K173762 · AngioDynamics, Inc. · DQO · Jul 18, 2018 · Cardiovascular

Device Facts

• Record ID: K173762
• Device Name: AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters
• Applicant: AngioDynamics, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Jul 18, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The intended use of the AngioDynamics Angiographic Catheters is to deliver radiopaque contrast media to the vasculature during angiographic procedures.

Device Story

AngioDynamics Angiographic Catheters (Soft-Vu and Mariner) are sterile, single-use, disposable intravascular catheters. They function by delivering radiopaque contrast media to selected vascular sites to facilitate angiographic diagnosis. The devices are used in clinical settings by healthcare professionals. The subject device introduces modifications to the braided catheter shaft, specifically a change in colorant and the addition of heat and light stabilizers, alongside the introduction of new tip shapes (ARC, NaviGate, Omega, Sharp Angle). The catheters are available in various French sizes (4F-6F), lengths (25cm-150cm), and configurations (braided/non-braided, coated/non-coated).

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including static pressure, hub/injector connection, tip stability, tensile testing, coating activation, friction, particulate testing, and biocompatibility per ISO 10993-1.

Technological Characteristics

Intravascular diagnostic catheters; braided and non-braided shaft configurations; coated and non-coated options; sizes 4F-6F; lengths 25cm-150cm. Materials include colorants and heat/light stabilizers. Biocompatibility per ISO 10993-1. Sterile, single-use, disposable.

Indications for Use

Indicated for use where angiographic diagnosis is indicated in patients requiring vascular contrast media delivery.

Regulatory Classification

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.

Predicate Devices

• AngioDynamics Angiographic Catheters (Soft-Vu and Mariner) (K161596)

Submission Summary (Full Text)

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July 18, 2018

AngioDynamics, Inc. Ms. Teri Juckett Sr. Regulatory Affairs Manager 603 Oueensbury Avenue Queensbury, New York 12804

# Re: K173762

Trade/Device Name: AngioDynamics, Inc. Angiographic Catheters (Soft-Vu and Mariner) Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: DQO Dated: June 28, 2018 Received: July 2, 2018

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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K173762

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Gregory O'Connell 2018.07.18 08:43:24 -04'00 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) K173762

#### Device Name

AngioDynamics, Inc. Angiographic Catheters (Soft-Vu and Mariner)

Indications for Use (Describe)

AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.

Type of Use (Select one or both, as applicable)

X 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. ANGIOGRAPHIC CATHETERS (SOFT-VU AND MARINER) K173762

Date Prepared: 17 July 2018

## A. Sponsor:

AngioDynamics, Inc. 603 Queensbury Avenue Queensbury, NY 12804

Phone Number: 518-795-1142

## B. Contact:

Teri L. Juckett Sr. Manager, Regulatory Affairs Tel: [phone] Email: [e-mail]

#### C. Device Name:

| Trade Name: | AngioDynamics Angiographic Catheters<br>(Soft-Vu and Mariner) |
|-------------------------|---------------------------------------------------------------------------------|
| Common/Usual Name: | Angiographic Catheters |
| Classification Name: | Catheter, Intravascular, Diagnostic<br>(21CFR§870.1200, Class II, Pro-Code DQO) |
| Classification Panel: | Cardiovascular |
| D. Predicate Device: | |
| Trade Name: | AngioDynamics Angiographic Catheters<br>(Soft-Vu and Mariner) |
| Common/Usual Name: | Angiographic Catheters |
| Classification Name: | Catheter, Intravascular, Diagnostic<br>(21CFR§870.1200, Class II, Pro-Code DQO) |
| Classification Panel: | Cardiovascular |
| Premarket Notification: | K161596 |

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#### E. Device Description:

AngioDynamics Angiographic Catheters are sterile, single use, disposable devices designed to deliver radiopaque contrast media to selected sites in the vascular system. AngioDynamics Soft-Vu and Mariner Catheters come in the following sizes/structures:

| | Soft-Vu | Mariner |
|-------------|-------------------------|-------------------------|
| French Size | 4F, 5F, 6F | 4F, 5F |
| Shaft | Braided and Non-Braided | Braided and Non-Braided |
| Tip | Non-Braided | Non-Braided |
| Coating | Non-Coated | Coated |
| Lengths | 25cm - 150cm | 25cm - 150cm |

The only change presented in this 510(k) submission is a change to the colorant and the addition of heat and light stabilizers to the braided catheter shaft.

#### F. Indications for Use:

AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.

#### G. Intended Use:

The intended use of the AngioDynamics 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 device. The purpose of this 510(k) submission is to introduce into commercial distribution modified AngioDynamics Soft-Vu and Mariner braided catheters with a change to the colorant and the addition of heat and light stabilizers to the shaft. This change also introduces four new tip shapes including the following: ARC, NaviGate 1,2,3,4,5, Omega, and Sharp Angle.

#### L Performance Data:

The proposed AngioDynamics Angiographic Catheters and the predicate AngioDynamics Angiographic Catheters 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 ●
- Hub/Injector Connection ●
- Tip Stability
- Tensile
- Coating Activation ●
- 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.