AZUR CX Detachable 35 Coils

K151358 · MicroVention, Inc. · KRD · Sep 25, 2015 · Cardiovascular

Device Facts

• Record ID: K151358
• Device Name: AZUR CX Detachable 35 Coils
• Applicant: MicroVention, Inc.
• Product Code: KRD · Cardiovascular
• Decision Date: Sep 25, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AZUR Peripheral Coil System is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.

Device Story

The AZUR CX Peripheral Coil System (Detachable 35) is an implantable vascular embolization device used in interventional radiology. The system consists of a 3D spherical platinum alloy coil with an inner hydrogel core, attached to a delivery pusher. The device is delivered to the target lesion via a microcatheter. Once positioned, the user activates an external, separately sold AZUR Detachment Controller to release the coil from the pusher. The hydrogel core expands upon contact with blood, facilitating vessel occlusion. The device is used by physicians in clinical settings to manage peripheral vascular lesions, potentially benefiting patients by reducing or blocking blood flow to malformations, fistulae, or aneurysms.

Clinical Evidence

Bench testing only. Testing included simulated use, advance/retract performance, gel expansion, appendix strength, spring constant, and pusher sleeve retention. Extensive biocompatibility testing was performed according to ISO 10993 standards, including cytotoxicity, sensitization, irritation, hemocompatibility, systemic toxicity, genetic toxicology, and intramuscular implantation.

Technological Characteristics

Implantable 3D spherical coil made of platinum/tungsten alloy or platinum alloy-clad tantalum. Features a hydrophilic acrylic copolymer hydrogel core. Delivery system uses a polyolefin elastomer. Compatible with microcatheters (0.041"-0.047" ID). Sterile, single-use. Detachment via external electronic controller. Materials comply with ISO 10993 biocompatibility standards.

Indications for Use

Indicated for patients requiring reduction or occlusion of blood flow in peripheral vasculature lesions, including arteriovenous malformations, arteriovenous fistulae, and aneurysms.

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

• AZUR Peripheral HydroCoil Endovascular Embolization System - Detachable 18 (K123384)
• AZUR Peripheral HydroCoil Endovascular Embolization System - Pushable 18 & 35 (K130577)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 25, 2015

MicroVention, Inc. Cynthia Valenzuela Project Manager, Regulatory Affairs 1311 Valencia Avenue Tustin, California 92780

Re: K151358

Trade/Device Name: AZUR CX Peripheral Coil System - Detachable 35 Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: August 18, 2015 Received: August 20, 2015

Dear Cynthia Valenzuela:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kenneth J. Cavanaugh -S

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) K151358

Device Name

AZUR CX Peripheral Coil System - Detachable 35

Indications for Use (Describe)

The AZUR Peripheral Coil System is intended to reduce or blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.

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

| <span style="font-size:100%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-------------------------------------------------------------------------------------|
| <span style="font-size:100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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### 510(K) Summary of Safety and Effectiveness

### Date Prepared: 11SEP2015

## 510(K) Summary

| Trade Name: | AZUR CX Peripheral Coil System - Detachable 3- |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------|
| Generic Name: | Vascular Embolization Device |
| Classification: | Class II, 21 CFR 870.3300 |
| Submitted By: | MicroVention, Inc.<br>1311 Valencia Avenue<br>Tustin, California U.S.A. |
| Contact: | Cynthia Valenzuela<br>Project Manager, Regulatory Affairs<br>MicroVention, Inc.<br>Direct: 714-247-8053<br>Cell: 949-413-0071 |

#### Predicate Device:

| Number | Description | Clearance Date |
|---------|-------------------------------------------------------------------------------------|----------------|
| K123384 | AZUR Peripheral HydroCoil<br>Endovascular Embolization System -<br>Detachable 18 | 28NOV2015 |
| K130577 | AZUR Peripheral HydroCoil<br>Endovascular Embolization System -<br>Pushable 18 & 35 | 17JUN2013 |

### Device Description

The AZUR CX Coils consist of implant coil made of platinum alloy with inner hydrogel core. The coils are designed in 3D spherical structure in various loop sizes and lengths. The AZUR CX Coil System (Detachable) consists of an implantable coil attached to a delivery pusher. The coil system is delivered to the treatment site through the microcatheter. The proximal end of the delivery pusher is inserted to the AZUR detachment controller. The detachment controller is activated by the user and this detaches the coil. The AZUR coils are designed for use with the AZUR Detachment Controller (Also known as AZUR Detachment Controller), specifically designed for coil detachment and is sold separately.

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### Indication For Use

The intended use as stated in the product labeling is as follows:

The AZUR Peripheral Coil System is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.

### Technological Comparison Chart

| Features | Cleared AZUR Pushable 18<br>& 35 (K130577) | Cleared AZUR CX (D18)<br>(K123384) | AZUR CX (D35)<br>Proposed device |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Design Attributes | | | |
| Coil Shape | Helical | 3D - Spherical | 3D - Spherical |
| Coil Filar OD (inch) | 0.00275 - 0.0050 | 0.00250 - 0.00400 | 0.0035 - 0.0050 |
| Primary Coil Wind OD<br>(inch) | 18: 0.0120<br>35: 0.0220 | 0.0140 - 0.0150 | 0.0290 |
| 3D Coil OD (mm) | 18: 2 – 10mm<br>35: 4 – 16mm | 4 - 20* | 4 - 20* |
| Restrained Coil Length<br>(cm) | 18: 2 – 20mm<br>35: 4 – 20mm | 13 - 40* | 7 - 39 |
| Pusher Length | 18: 2 - 10mm<br>35: 4 - 16mm | 175cm | 162cm |
| Materials | | | |
| Main Coil Wire | 18: Platinum (92%)/ Tungsten<br>(8%) | Platinum/Tungsten alloy<br>(92/8) | 4mm - 8mm:<br>Platinum/Tungsten alloy (92/8) |
| | 35: Platinum alloy-clad tantalum<br>[Platinum (90%)/Iridium (10%)] | | 10mm -20mm:<br>Platinum alloy-clad tantalum<br>[Platinum (90%)/Iridium (10%)] |
| | 35 (4 mm): Platinum (92%)/<br>Tungsten (8%) | | |
| Coil-to-Pusher Coupler | - | Platinum / Iridium (90/10) | No coupler |
| Adhesive | UV cure adhesive (DYMAX 1128-AM-VT) | UV cure adhesive (DYMAX<br>1128-AM-VT) | UV cure adhesive (DYMAX<br>1128-AM-VT) |
| Implant to the pusher | - | Polyolefin Elastomer | Polyolefin Elastomer |
| Stretch Resistant Filament | - | Polyolefin Elastomer | Polyolefin Elastomer |
| Hydrogel | Hydrophilic acrylic copolymer<br>(cross-linked copolymer of<br>polyethylene glycol diacrylamide<br>and acrylic acid) | Hydrophilic acrylic<br>copolymer (cross-linked<br>copolymer of polyethylene<br>glycol diacrylamide and<br>acrylic acid) | Hydrophilic acrylic copolymer<br>(cross-linked copolymer of<br>polyethylene glycol<br>diacrylamide and acrylic acid) |
| General | | | |
| Catheter Compatibility | 18: 0.021" - 0.022" ID<br>35: 0.041" - 0.047" ID | Compatible with<br>microcatheters having an<br>ID of > .019" | Compatible with catheters<br>having an ID of 0.041"-0.047" |
| Method of Supply | Sterile, single use | Sterile, single use | Sterile, single use |
| Package Configuration | Sealed in a poly (ethylene<br>terephthalate) pouch coated with<br>silica or aluminum oxide and<br>placed in a shipping carton | Dispenser coil, pouch &<br>shipping carton | Dispenser coil, pouch &<br>shipping carton |

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# Verification of Test Summary

| Bench Testing | Result |
|-------------------------|--------|
| Simulated use | Passed |
| Advance/Retract | Passed |
| Gel Expansion | Passed |
| Appendix Strength | Passed |
| Spring Constant | Passed |
| Pusher Sleeve Retention | Passed |

# Biocompatibility Coil Implant Segment - Biocompatibility Summary

| Test Method | Standard |
|-----------------------------------------------|--------------|
| Cytotoxicity | |
| MEM Elution Test | ISO 10993-5 |
| ISO Cell Culture Agar Overlay | ISO 10993-5 |
| Sensitization | |
| Sensitization-Guinea Pig Maximization Test | ISO 10993-10 |
| Irritation | |
| ISO Intracutaneous Reactivity Evaluation Test | ISO 10993-10 |

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# Coil Implant Segment - Biocompatibility Summary

| Test Method | Standard |
|-----------------------------------------|--------------|
| Hemocompatibility | |
| Hemolysis | ISO 10993-4 |
| Prothrombin Time Assay - ISO | ISO 10993-4 |
| Systemic Toxicity | |
| Systemic toxicity (IV injection) | ISO 10993-11 |
| Rabbit Pyrogen Test (material mediated) | ISO 10993-11 |

| Test Method | Standard |
|---------------------------------------------|-------------|
| Genetic Toxicology | |
| Bacteria Reverse Mutation Assay (Ames Test) | ISO 10993-3 |
| Intramuscular Implantation | |
| 7-day Muscle Implantation | ISO 10993-6 |
| 13-week Intramuscular Implantation Test | ISO 10993-6 |
| 26-week Intramuscular Implantation Test | ISO 10993-6 |

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# Biocompatibility Summary for Delivery Pusher Segment

| Test Method | Standard |
|-----------------------------------------------|--------------|
| Cytotoxicity | |
| MEM Elution Test | ISO 10993-5 |
| ISO Cell Culture Agar Overlay | ISO 10993-5 |
| Sensitization | |
| Sensitization-Guinea Pig Maximization Test | ISO 10993-10 |
| Irritation | |
| ISO Intracutaneous Reactivity Evaluation Test | ISO 10993-10 |
| Hemocompatibility | |
| Blood compatibility Evaluation (Hemolysis) | ISO 10993-4 |
| Prothrombin Time Assay - ISO | ISO 10993-4 |
| Systemic Toxicity | |
| Systemic toxicity<br>(IV injection) | ISO 10993-11 |
| Rabbit Pyrogen Test (material mediated) | ISO 10993-11 |

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### Summary of Substantial Equivalence:

The data presented in this submission demonstrates the technological similarity and equivalency of the AZUR Peripheral Coils System - CX Detachable 35 Coils when compared with the predicate devices, MicroVention, Inc. AZUR CX Detachable 18 (K1223384) and AZUR Pushable 18 & 35 (K130577).

- The device, ●
- Has the same intended use, ●
- Uses the same operating principle, ●
- Incorporates the same basic design, ●
- Uses similar construction and material, ●
- Are packaged and sterilized using the same material and processes. .

In summary, the AZUR Peripheral Coil System – CX Detachable 35 Coils described in this submission is, in our opinion equivalent to the predicate devices.