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 Description

The AZUR PURE Peripheral Coil System, Pushable 18, consists of an implantable coil housed in an introducer. A stainless steel stylet is used to deploy the coil from the introducer into a delivery catheter. The coil is delivered to the treatment site through the delivery catheter using a standard guidewire.

The subject of this Special 510(k) is the addition of a platinum overcoil to the AZUR PURE Pushable 18 device. The purpose is to improve tracking performance of the coil implant during delivery.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the AZUR PURE Peripheral Coil System, Pushable 18:

1. Table of Acceptance Criteria and Reported Device Performance

Test / Test Description	Acceptance Criteria	Reported Device Performance
Simulate Use (Introduction, Tracking, Deployment, Compartmentalizing, Frame Movement, Microcatheter movement, Detachment, Overall Performance)	All performance ratings shall be ≥ 3	PASS, acceptance criteria met
Advancement Force (Measure the force required to advance the coil into the microcatheter)	< 0.3 lbf	PASS, acceptance criteria met
Tensile Strength at Glue Joint (Test the tensile strength platinum coil glue joint)	0.05 lbf minimum	PASS, acceptance criteria met
Expansion Characteristics (Determine the expansion over time)	Fully hydrated (≥ 20 min.) ≤ 0.026"	PASS, acceptance criteria met

2. Sample Size Used for the Test Set and Data Provenance

The provided text describes pre-clinical bench testing. It does not explicitly state the numerical sample size for each test. However, it indicates these are bench tests, which are performed in a controlled laboratory setting.

Test Set Sample Size: Not explicitly stated as a concrete number of devices for each test, but implied to be sufficient for demonstrating compliance with acceptance criteria.
Data Provenance: This is prospective bench test data generated in a laboratory setting by MicroVention, Inc. There is no mention of country of origin for the data beyond the company's US location (Tustin, California).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable to the provided information. The tests conducted are bench tests evaluating physical and mechanical properties of the device. Ground truth is established by objective measurements against predefined engineering specifications (the acceptance criteria), not by expert consensus or interpretation of subjective data.

4. Adjudication Method for the Test Set

This section is not applicable. Since the tests are objective bench tests with quantifiable acceptance criteria, there is no need for an adjudication method by human experts. The results are either a pass or a fail based on measurements.

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

This section is not applicable. The device is an embolization coil, a physical medical device, not an AI-powered diagnostic or decision-support tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This section is not applicable. As mentioned above, the device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the acceptance criteria and bench tests is objective engineering specifications and physical measurements. For example, the advancement force is measured against a threshold of "less than 0.3 lbf," and tensile strength against a "0.05 lbf minimum."

8. The Sample Size for the Training Set

This section is not applicable. The device is a physical medical product, not an AI/machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable. As stated, there is no "training set" for this type of device.

Summary

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510(K) SUMMARY

K133626

Trade Name:	AZUR PURE Peripheral Coil System, Pushable 18	DEC 2 0 2013
Generic Name:	Vascular Embolization Device, accessory
Classification andProduct Code:	Class II, 21 CFR 870.3300Product Code KRD
Date Submitted:	November 22, 2013
Submitted By:	MicroVention, Inc1311 Valencia AvenueTustin, California 92780U.S.APhone: 714-247-8000
Contact:	Laraine PangelinaSr. Regulatory Affairs Project ManagerMicroVention, 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 invessels of the peripheral vasculature. It is intended for use in theinterventional radiologic management of arteriovenous malformations,arteriovenous fistulae, aneurysms, and other lesions of the peripheralvasculature.
Device Description:	The AZUR PURE Peripheral Coil System, Pushable 18, consists of animplantable coil housed in an introducer. A stainless steel stylet is used todeploy the coil from the introducer into a delivery catheter. The coil isdelivered to the treatment site through the delivery catheter using astandard guidewire.The subject of this Special 510(k) is the addition of a platinum overcoil tothe AZUR PURE Pushable 18 device. The purpose is to improve trackingperformance of the coil implant during delivery.With the exception of the modification to add the platinum overcoil, themodified devices are identical to the cleared predicate devices with regardto intended use, principal of operation, materials, manufacturingprocesses, 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 & AcceptanceCriteria same aspredicate device? Y/N	Result
Simulate UseIntroduction, Tracking, Deployment,Compartmentalizing, Frame Movement,Microcatheter movement, Detachment, OverallPerformance	All performanceratings shall be ≥ 3	Y	PASS, acceptancecriteria met
Advancement ForceMeasure the force required to advance the coilinto the microcatheter	< 0.3 lbf	Y	PASS, acceptancecriteria met
Tensile Strength at Glue JointTest the tensile strength platinum coil glue joint	0.05 lbf minimum	Y	PASS, acceptancecriteria met
Expansion CharacteristicsDetermine the expansion over time	Fully hydrated (≥ 20min.) ≤ 0.026"	Y	PASS, acceptancecriteria met
CONCLUSION: The results of the bench testing demonstrate that the subject device is safe and effective when usedaccording to the instructions for use and performs equivalent to the predicate device. The testing was used in supportof 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 bloodflow in vessels of the peripheral vasculature. It is intended for usein the interventional radiologic management of arteriovenousmalformations, arteriovenous fistulae, aneurysms, and otherlesions of the peripheral vasculature	Same
Device Overview	The AZUR PURE Peripheral Coil System, Pushable 18, consists ofan implantable coil housed in an introducer. A stainless steelstylet is used to deploy the coil from the introducer into a deliverycatheter. The coil is delivered to the treatment site through thedelivery 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 deliveryusing 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 (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" (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 (800) 638-2041 or (301) 796-7100 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:

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

Regulation Number and Section

§ 870.3300 Vascular embolization device.

(a)
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.(b)
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).