AZUR Vascular Plug

K191680 · MicroVention, Inc. · KRD · Mar 20, 2020 · Cardiovascular

Device Facts

• Record ID: K191680
• Device Name: AZUR Vascular Plug
• Applicant: MicroVention, Inc.
• Product Code: KRD · Cardiovascular
• Decision Date: Mar 20, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AZUR Vascular Plug is indicated for use to reduce or block the rate of blood flow in arteries of the peripheral vasculature.

Device Story

The AZUR Vascular Plug is an embolization device used to reduce or block blood flow in peripheral arteries. It consists of a self-expanding nitinol braided wire frame covered by a flexible, occlusive membrane (PTFE/PET). The device is delivered via a microcatheter using a detachable delivery wire. A separately provided detachment controller uses thermoelectric energy to release the implant at the target site. Radiopaque markers allow for visual confirmation of placement. The device is intended for use by clinicians in an interventional setting. By physically obstructing the vessel, the plug facilitates embolization, which can be used to manage blood flow in specific peripheral vascular conditions.

Clinical Evidence

No clinical data (human trials) provided. Evidence consists of biocompatibility testing per ISO 10993-1, extensive bench testing (including simulated use, deployment, detachment, migration resistance, and radial force), and animal studies (porcine and rabbit models) to verify performance and safety.

Technological Characteristics

Implant: self-expanding nitinol braided wire frame, PTFE and PET cover, platinum radiopaque markers. Delivery system: 185cm wire, thermoelectric detachment. Materials: Nitinol, ePTFE, PET, Platinum, Dymax 1128, Polyolefin. Sterilization: Ethylene Oxide (EtO). Compatible with 0.027" ID microcatheters.

Indications for Use

Indicated for use to reduce or block the rate of blood flow in arteries of the peripheral vasculature.

Regulatory Classification

Identification

A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.

Special Controls

*Classification.* Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).

Predicate Devices

• Medtronic Micro Vascular Plug (K150108)

Reference Devices

• MicroVention AZUR CX D35 Peripheral Coil System (K151358)

Submission Summary (Full Text)

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March 20, 2020

MicroVention Inc. Ganesh Balachander Regulatory Affairs Specialist 35 Enterprise Aliso Viejo, California 92656

Re: K191680

Trade/Device Name: AZUR Vascular Plug Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: June 21, 2019 Received: June 24, 2019

# Dear Ganesh Balachander:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Misti Malone Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K191680

Device Name AZUR Vascular Plug

Indications for Use (Describe)

The AZUR Vascular Plug is indicated for use to reduce or block the rate of blood flow in arteries of the peripheral vasculature

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

#### SUBMITTER

MicroVention Inc. 35 Enterprise, Aliso Viejo, CA, 92656 Phone:[phone] Contact Person: Ganesh Balachandar Date Prepared: March 19, 2020

## DEVICE

Name of the Device: AZUR Vascular Plug Common Name: Vascular Embolization Device Classification Name: Device, Embolization, arterial Regulatory Class: Class II, 21 CFR 870.3300 Product Code: KRD

#### PREDICATE DEVICE

Medtronic Micro Vascular Plug (K150108)

#### REFERENCE DEVICE

MicroVention AZUR CX D35 Peripheral Coil System (K151358)

#### DEVICE DESCRIPTON

The AZUR Vascular Plug consists of an AZUR vascular occlusion plug implant that is attached to a delivery wire which is intended to be delivered to the treatment site through a microcatheter.

The AZUR Vascular Plug implant is an embolization device consisting of a conformable, self-expanding nitinol braided wire frame surrounding a flexible, occlusive membrane. The implant comes in three sizes, small (5 mm), medium (8 mm) and large (10 mm). The implant is deployed in an appropriately sized vessel to reduce or block the flow of blood. The implant has radiopaque markers to provide visual confirmation of deployment location during the interventional treatment. The implant is delivered through a microcatheter on a detachable delivery system.

The delivery wire attached to the AZUR Vascular Plug implant is 185cm in length and an outer diameter suitable for delivery through a 0.027" ID microcatheter.

A detachment controller powers the delivery pusher to detach the implant. The microcatheter and the detachment controller are provided separately.

#### INDICATIONS FOR USE

The AZUR Vascular Plug is indicated for use to reduce or block the rate of blood flow in arteries of the peripheral vasculature.

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## COMPARISION OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE

The subject device, AZUR Vascular Plug has the following similarities to the predicate device, Micro Vascular Plug (K150108), same device classification, same indications for use, same principle of operation, same device design, similar materials and same sterility assurance level and method of sterilization and hence the subject device is substantially equivalent to the predicate device (Table 1).

| Table 1: Comparison of Technological Characteristics with Predicate Device | | | | |
|----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Device<br>Attributes | MicroVention AZUR<br>Vascular Plug<br>(Subject Device) | Medtronic Micro<br>Vascular Plug<br>(Predicate Device) | Rationale for Difference<br>(If Present) | |
| FDA Medical Device Classification | | | | |
| Device<br>Classification | Class II, KRD, 21 CFR<br>870.3300 | Class II, KRD, 21 CFR<br>870.3300 | No difference. Identical device<br>classification | |
| Indications for Use | | | | |
| Intended Use<br>Statement | Indicated for use to reduce<br>or block the rate of blood<br>flow in arteries of the<br>peripheral vasculature. | Intended to reduce or<br>block the rate of blood<br>flow in vessels of the<br>peripheral vasculature. | No difference. Identical<br>Intended use statement. | |
| Principle of Operation/Fundamental Scientific Technology | | | | |
| Function | Allows the device to<br>obstruct or reduce the rate<br>of blood flow | Allows the device to<br>obstruct or reduce the rate<br>of blood flow | No difference. Identical<br>function. | |
| Anatomical<br>Location | Peripheral Vasculature | Peripheral Vasculature | No difference. Identical<br>anatomical vessels. | |
| Device Design | | | | |
| Plug (implant<br>description) | Self-expandable nitinol<br>frame with a PTFE and<br>PET cover over the<br>internal wire frame | Self-expandable nitinol<br>frame with a PTFE cover<br>over the proximal section | Similar device design.<br>The results of comparative<br>bench testing, physician<br>usability study and animal study<br>establish the substantial<br>equivalency of the subject<br>device, AZUR Vascular Plug | |
| Plug Diameter,<br>Unconstrained | Small: 5 mm<br>Medium: 8 mm<br>Large: 10 mm | MVP-5Q: 6.5 mm<br>MVP-7Q: 9.2 mm<br>MVP-9Q: 13.0 mm | | |
| Target Vessel<br>Diameter | Small: 2.5-4.5mm<br>Medium:4.5mm-6.5mm<br>Large: 6.5mm-8.0mm | MVP-5Q: 3-5mm<br>MVP-7Q: 5-7mm<br>MVP-9Q: 7-9mm | and the predicate device, Micro<br>Vascular Plug. | |
| Radiopaque<br>Markers | Platinum marker bands at<br>each end of the plug | Platinum marker bands at<br>each end of the plug | Identical marker bands | |
| Method of<br>placement | Delivery wire through a<br>0.027" ID Microcatheter | Delivery wire through a<br>0.027" to 0.043" ID<br>Percutaneous catheter | The AZUR Vascular Plug is<br>designed to be delivered<br>through a smaller ID (0.027"<br>inner diameter) microcatheter. | |
| Detachment<br>System | Thermoelectric<br>Detachment | Mechanical Detachment | The results of bench testing.<br>and physician usability study<br>establish the substantial<br>equivalency of the subject<br>device, AZUR Vascular Plug<br>and the predicate device, Micro<br>Vascular Plug. | |
| Device Material | | | | |
| Materials of<br>Construction | Nitinol, ePTFE, PET,<br>Platinum, Dymax 1128<br>and Polyolefin | Nitinol, PTFE, Platinum,<br>SS301, Solder,<br>Polypropylene sheath,<br>Urethane and<br>Cyanoacrylate | Similar device material. The<br>materials used for the AZUR<br>Vascular Plug was shown to be<br>biocompatible per ISO<br>10993 testing. | |
| Other Attributes | | | | |
| Sterilization<br>Process | EtO (Ethylene Oxide) | EtO (Ethylene Oxide) | No difference. Identical<br>sterilization process. | |
| Method of<br>Supply | Sterile, single use | Sterile, single use | No difference. Identical method<br>of supply. | |
| Accessories | No accessories | Torquer | AZUR Vascular Plug does not<br>use a torque device. | |

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# K191680

# COMPARISION OF TECHNOLOGICAL CHARACTERISTICS WITH REFERENCE DEVICE

The subject device, AZUR Vascular Plug has the following similarities to the reference device AZUR CX D35 Peripheral Coil System (K151358) :same principle of operation, same delivery wire length,

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same delivery wire materials, same detachment mechanism and similar delivery wire catheter compatibility and hence the subject device is substantially equivalent to the reference device. PERFORMANCE DATA

## Biocompatibility testing

The biocompatibility evaluation for the AZUR Vascular Plug device was conducted in accordance with ISO 10993-1 Biological Evaluation of Medical Devices-Part 1: Guidance on Selection of Tests. The implant is considered a permanent implant blood contacting device, and the pusher is considered an external communicating device, limited (<24hour) circulating blood contacting device.

The battery of testing for the device included the following tests:

## Implant

- . Cytotoxicity
- Sensitization
- Irritation or Intracutaneous Reactivity
- Acute Systemic Toxicity ●
- Subacute/Subchronic Toxicity ●
- Genotoxicity
- . Material Mediated Pyrogenicity
- Implantation ●
- Hemocompatibility
- Carcinogenicity

## Pusher

- . Cytotoxicity
- Hemocompatibility ●
- Subacute/Subchronic toxicity ●

# HDPE Introducer sheath

- . Cytotoxicity
# Mechanical, Visual, and Material Characterization testing

Bench testing conducted for the AZUR Vascular Plug device included the following:

- . Visual/Dimensional Inspection
- . Electrical Resistance
- Exhaustive Extraction Study ●
- Simulated Use
- Preparation/Flush ●
- Introduction ●
- Tracking
- . Advancement
- . Kink Resistance
- Flexibility ●
- Catheter Compatibility
- Deployment ●
- Retraction ●
- Detachment ●
- Wall Apposition ●

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- Migration Resistance ●
- Overall performance
- Radial force ●
- Attachment strength
- . Implant joint Tensile Strength
- . Pusher Sleeve Retention
- . Particulate
- Nickel Ion Release
- Corrosion
- Magnetic Resonance (MR) Testing
- Radiopacity
- Occlusion Time ●
- Shelf Life

# Animal Study

The AZUR Vascular Plug was evaluated in a number of animal studies including multiple animal species and implantation sites. This analysis included the following studies:

- Porcine large animal study
- Intramuscular implant rabbit study

## CONCLUSION

The AZUR Vascular Plug is substantially equivalent to the identified predicate device based on the same intended use, design, materials, principle of operation and overall technological characteristics. The nonclinical data support the substantial equivalence of the subject device and the verification and validation testing demonstrate that the subject device should perform as intended when used as instructed in the instructions for use.