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 & 35, consists of an implantable all-polymer 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.

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 & 35:

Based on the provided K122543 510(k) summary, this document describes a medical device (a vascular embolization coil) and its submission for FDA clearance. The information provided outlines the verification and validation tests performed to demonstrate substantial equivalence to a predicate device, rather than a clinical study evaluating the device's performance in a diagnostic or AI-assisted context.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) are not applicable to this type of device and submission. The provided information focuses on engineering and biocompatibility testing.

Here's the breakdown of the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Simulated Use	Established criteria (details not provided)	Met established criteria
Dimensional Characteristics	Established criteria (details not provided)	Met established criteria
Tensile Strength	Established criteria (details not provided)	Met established criteria
Advancement Force	Established criteria (details not provided)	Met established criteria
FTIR	Established criteria (details not provided)	Met established criteria
HydroStability	Established criteria (details not provided)	Met established criteria
MRI Compatibility	Established criteria (details not provided)	Met established criteria
Electrical Conductivity	Established criteria (details not provided)	Met established criteria
Packaging Validation	Established criteria (details not provided)	Met established criteria
Sterilization Validation	Established criteria (details not provided)	Met established criteria
Shelf Life	Established criteria (details not provided)	Met established criteria
Biocompatibility	Established criteria (details not provided)	Met established criteria
Acute & Chronic Animal Testing	Established criteria (details not provided)	Met established criteria

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

Sample Size: Not explicitly stated for each test beyond "Met established criteria." The tests are primarily engineering and benchtop tests, along with animal testing.
Data Provenance: The tests are conducted by the manufacturer, MicroVention, Inc., in Tustin, California, USA, as part of their 510(k) submission. This is not clinical data but verification and validation testing for device safety and performance.

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

Not Applicable: For this type of device (vascular embolization coil) and the tests described (engineering, biocompatibility, animal testing), the concept of "experts establishing ground truth" in the clinical sense (e.g., radiologists interpreting images) is not relevant. The "ground truth" for these tests would be defined by the pre-established engineering specifications, regulatory standards, and animal study protocols.

4. Adjudication Method for the Test Set

Not Applicable: Adjudication methods like 2+1 or 3+1 are used for clinical image interpretation or diagnostic tasks involving human readers. For the engineering and animal tests described, the results are typically objectively measured and compared against predefined performance specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No: An MRMC comparative effectiveness study is not mentioned. Such studies are typically performed for diagnostic devices (e.g., AI in radiology) to evaluate reader performance with and without AI assistance. This device is a therapeutic implant.

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

Not Applicable: This device is a physical medical implant, not a software algorithm. Therefore, "standalone performance" in the context of AI algorithms is not relevant.

7. The Type of Ground Truth Used

For the engineering tests (Dimensional Characteristics, Tensile Strength, etc.), the "ground truth" is based on pre-defined engineering specifications, performance standards, and material science properties.
For Biocompatibility, the "ground truth" is established through recognized biological safety standards and in vitro/in vivo testing protocols.
For Acute & Chronic Animal Testing, the "ground truth" is established through histopathological analysis, observation of physiological responses, and adverse event reporting in animal models, as defined by the study protocol.

8. The Sample Size for the Training Set

Not Applicable: This device is not an AI algorithm, so there is no "training set."

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

Not Applicable: As above, there is no training set for this device.

Summary

{0}------------------------------------------------

K122543 page 1 of 2 15 , MicroVention

510(K) SUMMARY

NOV 2 8 2012

Trade Name:	AZUR PURE Peripheral Coil System, Pushable 18 & 35
Generic Name:	Vascular Embolization Coil
Classification:	Class II, 21 CFR 870.3300
Submitted By:	MicroVention, Inc1311 Valencia AvenueTustin, California 92780 U.S.A.
Contact:	Laraine Pangelina
Predicate Device:	AZUR Peripheral HydroCoil Endovascular Embolization Coil System,Pushable 18 and 35 (K071939, K091882)

Device Description:

Indications for Use:

Test	Result
Simulated Use	Met established criteria
Dimensional Characteristics	Met established criteria
Tensile Strength	Met established criteria
Advancement Force	Met established criteria
FTIR	Met established criteria
HydroStability	Met established criteria
MRI Compatibility	Met established criteria
Electrical Conductivity	Met established criteria
Packaging Validation	Met established criteria
Sterilization validation	Met established criteria
Shelf Life	Met established criteria
Biocompatibility	Met established criteria
Acute & Chronic Animal Testing	Met established criteria

Verification and Validation Test Summary:

{1}------------------------------------------------

MicroVentour
TERUMO

AZUR PURE Peripheral Coil System, Pushable 18 & 35 Traditional 510(k)

	Predicate Devices (K071939, K091882	AZUR PURE, 510(k) Subject Device
Coil Shape	Helical	Same
Coil OD (mm)	AZUR 18: 2 - 10AZUR 35: 3 - 16	AZUR 18: 3 - 10AZUR 35: 4 - 15
Coil Length (cm)	AZUR 18: 2 - 14AZUR 35: 4 - 14	AZUR 18: 2 - 20AZUR 35: 4 - 14
Delivery Method	Coil housed in an introducer with proximalhub. Pushable delivery using guidewire.	Same
Hydrogel ImplantMaterial	Hydrophilic copolymer	Same
PackagingConfiguration	Placed in capped coil introducer, placed onpackaging card, into pouch, into box, 5/box	Same

Technological comparison, subject and predicate device:

Summary of Substantial Equivalence:

The AZUR PURE Peripheral Coil System, Pushable 18 & 35 is substantially equivalent to the predicate device with regard to intended use, patient population, device design, materials, processes, and operating principal

CONFIDENTIAL

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

NOV 2 8 2012 -

Microvention, Inc. % Laraine Pangelina 1311 Valencia Ave Tustin, CA 92780 US

Re: K122543

Trade/Device Name: AZUR PURE peripheral coil system Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: November 2, 2012 Received: November 8, 2012

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 for ass stated or 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 r ou may a 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 I lease of actived a determination that your device complies with other requirements of the Act that I Dr Haral statutes and regulations administered by other Federal agencies. You must or any I oderal statuation and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CI K Fat 607), fucemig (21 CFR 803); good manufacturing practice requirements as set

{3}------------------------------------------------

Page 2 - Ms. Laraine Pangelina .

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 If you desire specific advice for your do riters offices/CDRH/CDRHOffices/ucm115809.htm for go to into://www.ida.gov/rt8odio.org/w/index.php?tice of Compliance. Also, please
the Center for Devices and Radiological Health's (CDRH's) Office of CDRH Ball the Center for Devices und Radionogicular by reference to premarket notification" (21CFR Part flore the regulation entined, "Miordinance 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 Tou thay obtain other generers, 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Matthew G. Hillebrenner

for Bram D. Zuckerman, M.D.

Director

Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiològical Health

Enclosure

{4}------------------------------------------------

AZUR PURE Peripheral Coil System, Pushable 18 & 35 Traditional 510(k)

INDICATIONS FOR USE

510(k) Number (if known):

K122543 · ·

Device Name:

Indications for Use:

AZUR PURE Peripheral Coil System, Pushable 18 & 35

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. of Killeber

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K122543

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).