AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35

K133626 · MicroVention, Inc. · KRD · Dec 20, 2013 · Cardiovascular

Device Facts

• Record ID: K133626
• Device Name: AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35
• Applicant: MicroVention, Inc.
• Product Code: KRD · Cardiovascular
• Decision Date: Dec 20, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AZUR PURE 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

AZUR PURE Peripheral Coil System, Pushable 18 is a vascular embolization device; consists of an implantable hydrogel-coated coil housed in an introducer. Physician uses a stainless steel stylet to deploy the coil from the introducer into a delivery catheter; coil is advanced to the treatment site via standard guidewire. The device modification adds a platinum overcoil to improve tracking performance during delivery. Used in interventional radiology settings to reduce or block blood flow in peripheral vessels. The device provides mechanical occlusion of lesions; the hydrogel component facilitates vessel wall interaction. Clinical benefit includes effective management of peripheral vascular malformations and aneurysms.

Clinical Evidence

Bench testing only. Testing included simulated use (introduction, tracking, deployment, detachment), advancement force, tensile strength of the platinum coil glue joint, and expansion characteristics. All tests met acceptance criteria equivalent to the predicate device. Biological safety was verified per ISO 10993-1.

Technological Characteristics

Implantable helical coil with hydrophilic copolymer hydrogel coating. Features a platinum overcoil for improved tracking. Delivery system includes an introducer and stainless steel stylet. Dimensions: 3-16 mm OD, 6-14 cm length. Non-powered, mechanical device. Sterilization method not specified but stated as identical to predicate.

Indications for Use

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

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 PURE Peripheral Coil System, Pushable 18 (K122543)

Submission Summary (Full Text)

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# 510(K) SUMMARY

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:

K133626

| Trade Name: | AZUR PURE Peripheral Coil System, Pushable 18 | DEC 2 0 2013 |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Generic Name: | Vascular Embolization Device, accessory | |
| Classification and<br>Product Code: | Class II, 21 CFR 870.3300<br>Product Code KRD | |
| Date Submitted: | November 22, 2013 | |
| Submitted By: | MicroVention, Inc<br>1311 Valencia Avenue<br>Tustin, California 92780<br>U.S.A<br>Phone: [phone] | |
| Contact: | Laraine Pangelina<br>Sr. Regulatory Affairs Project Manager<br>MicroVention, Inc. | |
| Predicate Device: | AZUR PURE Peripheral Coil System, Pushable 18 (K122543) | |
| Indications for Use: | The AZUR PURE is intended to reduce or block the rate of blood flow in<br>vessels of the peripheral vasculature. It is intended for use in the<br>interventional radiologic management of arteriovenous malformations,<br>arteriovenous fistulae, aneurysms, and other lesions of the peripheral<br>vasculature. | |
| Device Description: | The AZUR PURE Peripheral Coil System, Pushable 18, consists of an<br>implantable coil housed in an introducer. A stainless steel stylet is used to<br>deploy the coil from the introducer into a delivery catheter. The coil is<br>delivered to the treatment site through the delivery catheter using a<br>standard guidewire.<br><br>The subject of this Special 510(k) is the addition of a platinum overcoil to<br>the AZUR PURE Pushable 18 device. The purpose is to improve tracking<br>performance of the coil implant during delivery.<br><br>With the exception of the modification to add the platinum overcoil, the<br>modified devices are identical to the cleared predicate devices with regard<br>to intended use, principal of operation, materials, manufacturing<br>processes, packaging configuration, and sterilization method. | |

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#### Pre-Clinical Testing:

| Design Verification and Validation Bench Test Summary | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|----------------------------------------------------------------|----------------------------------|
| Test / Test Description | Acceptance Criteria | Test & Acceptance<br>Criteria same as<br>predicate device? Y/N | Result |
| Simulate Use<br>Introduction, Tracking, Deployment,<br>Compartmentalizing, Frame Movement,<br>Microcatheter movement, Detachment, Overall<br>Performance | All performance<br>ratings shall be ≥ 3 | Y | PASS, acceptance<br>criteria met |
| Advancement Force<br>Measure the force required to advance the coil<br>into the microcatheter | < 0.3 lbf | Y | PASS, acceptance<br>criteria met |
| Tensile Strength at Glue Joint<br>Test the tensile strength platinum coil glue joint | 0.05 lbf minimum | Y | PASS, acceptance<br>criteria met |
| Expansion Characteristics<br>Determine the expansion over time | Fully hydrated (≥ 20<br>min.) ≤ 0.026" | Y | PASS, acceptance<br>criteria met |
| CONCLUSION: The results of the bench testing demonstrate that the subject device is safe and effective when used<br>according to the instructions for use and performs equivalent to the predicate device. The testing was used in support<br>of the risk analysis documentation for the subject device. | | | |

Note: The biological safety of the subject device has previously been verified in accordance with the ISO10993-1, Biological Evaluation of Medical Devices, using similar 510(k) cleared devices.

### Predicate / Subject Technological Comparison:

| Feature | Azur PURE 18 Predicate Devices | Subject Devices |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Indications for Use | The AZUR PURE is intended to reduce or block the rate of blood<br>flow in vessels of the peripheral vasculature. It is intended for use<br>in the interventional radiologic management of arteriovenous<br>malformations, arteriovenous fistulae, aneurysms, and other<br>lesions of the peripheral vasculature | Same |
| Device Overview | The AZUR PURE Peripheral Coil System, Pushable 18, consists of<br>an implantable coil housed in an introducer. A stainless steel<br>stylet is used to deploy the coil from the introducer into a delivery<br>catheter. The coil is delivered to the treatment site through the<br>delivery catheter using a standard guidewire. | Same |
| Coil shape | Helical | Same |
| Coil OD (mm) | 3 - 16 | Same |
| Coil Length (cm) | 6 - 14 | Same |
| Hydrogel Implant Material | Hydrophilic copolymer | Same |
| Overcoil | None | Platinum¹ |
| Delivery Method | Coil housed in an introducer with proximal hub. Pushable delivery<br>using guidewire. | Same |

Summary of Substantial Equivalence: With the exception of the modification to add the platinum overcoil, the modified devices are identical to the cleared predicate devices with regard to intended use, principal of operation, materials, manufacturing processes, packaging configuration, and sterilization method. Any differences in technological characteristics do not introduce any new issues of safety or effectiveness. Therefore, it is our conclusion that the subject device is substantially equivalent to the predicate device

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

### December 20, 2013

MicroVention Inc Ms. Laraine Pangelina Sr. Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, California 92780

Re: K133626

Trade/Device Name: AZUR PURE Peripheral Coil System, Pushable 18 Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: November 22, 2013 Received: November 26, 2013

## Dear Ms. Pangelina:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Laraine Pangelina

forth in 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

MADA

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):

K133626

Device Name:

AZUR PURE Peripheral Coil System, Pushable 18

Indications for Use:

The AZUR PURE 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.

Prescription Use _ X (Per 21 CFR 801.109)

-

AND/OR

Over-The-Counter Use (Optional Format 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. FDA