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.

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.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the AZUR CX Peripheral Coil System - Detachable 35. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

The document provides a "Verification of Test Summary" and "Biocompatibility Summary" which can be interpreted as the acceptance criteria and the results of tests performed.

Acceptance Criteria Category	Specific Test / Standard	Reported Device Performance
Bench Testing	1. Simulated use	Passed
	2. Advance/Retract	Passed
	3. Gel Expansion	Passed
	4. Appendix Strength	Passed
	5. Spring Constant	Passed
	6. Pusher Sleeve Retention	Passed
Biocompatibility - Coil Implant Segment	1. Cytotoxicity (MEM Elution Test, ISO Cell Culture Agar Overlay)	Passed (implied by "Summary of Substantial Equivalence")
	2. Sensitization (Guinea Pig Maximization Test)	Passed (implied)
	3. Irritation (ISO Intracutaneous Reactivity Evaluation Test)	Passed (implied)
	4. Hemocompatibility (Hemolysis, Prothrombin Time Assay)	Passed (implied)
	5. Systemic Toxicity (IV injection, Rabbit Pyrogen Test)	Passed (implied)
	6. Genetic Toxicology (Bacteria Reverse Mutation Assay)	Passed (implied)
	7. Intramuscular Implantation (7-day, 13-week, 26-week)	Passed (implied)
Biocompatibility - Delivery Pusher Segment	1. Cytotoxicity (MEM Elution Test, ISO Cell Culture Agar Overlay)	Passed (implied)
	2. Sensitization (Guinea Pig Maximization Test)	Passed (implied)
	3. Irritation (ISO Intracutaneous Reactivity Evaluation Test)	Passed (implied)
	4. Hemocompatibility (Hemolysis, Prothrombin Time Assay)	Passed (implied)
	5. Systemic Toxicity (IV injection, Rabbit Pyrogen Test)	Passed (implied)

Note: The document explicitly states "Passed" for bench tests. For biocompatibility, it lists test methods and standards, and the "Summary of Substantial Equivalence" implies that these tests were passed and support the equivalency claim.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The provided document does not specify the sample sizes used for the bench tests or biocompatibility tests. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature) for these tests. This information would typically be found in the detailed test reports, which are not included in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This document describes a medical device, the AZUR CX Peripheral Coil System, which is an implantable coil for embolization. The tests conducted are primarily mechanical/physical bench tests and biocompatibility tests, not studies involving expert interpretation of medical images or clinical outcomes that would require a ground truth established by medical experts for a test set. Therefore, this question is not applicable in the context of the information provided.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

As the tests are primarily bench and biocompatibility tests, there is no adjudication method described or relevant for establishing a clinical "ground truth" for a test set by human experts. The results are typically objectively measured or observed (e.g., a "pass" or "fail" for a mechanical test, or quantitative results against a standard for biocompatibility).

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:

No MrMC comparative effectiveness study was done or is mentioned in this document. This filing is for a physical medical device (embolization coil), not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical implant, not an algorithm, so standalone performance in the context of AI is irrelevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the bench tests, the "ground truth" is defined by engineering specifications and performance requirements for the device's physical and functional characteristics. For biocompatibility tests, the "ground truth" is established by international standards (ISO 10993 series), which define acceptable biological responses to medical devices. There isn't a "ground truth" in the sense of clinical diagnoses or outcomes used in AI or clinical trials with human subjects.

8. The sample size for the training set:

Not applicable. The device is a physical medical implant, not an AI model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. As there is no AI model or training set, there is no ground truth to establish for a training set.

Summary

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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 (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" (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 (800) 638-2041 or (301) 796-7100 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)

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ 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.1311 Valencia AvenueTustin, California U.S.A.
Contact:	Cynthia ValenzuelaProject Manager, Regulatory AffairsMicroVention, Inc.Direct: 714-247-8053Cell: 949-413-0071

Predicate Device:

Number	Description	Clearance Date
K123384	AZUR Peripheral HydroCoilEndovascular Embolization System -Detachable 18	28NOV2015
K130577	AZUR Peripheral HydroCoilEndovascular Embolization System -Pushable 18 & 35	17JUN2013

Device Description

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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& 35 (K130577)	Cleared AZUR CX (D18)(K123384)	AZUR CX (D35)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(inch)	18: 0.012035: 0.0220	0.0140 - 0.0150	0.0290
3D Coil OD (mm)	18: 2 – 10mm35: 4 – 16mm	4 - 20*	4 - 20*
Restrained Coil Length(cm)	18: 2 – 20mm35: 4 – 20mm	13 - 40*	7 - 39
Pusher Length	18: 2 - 10mm35: 4 - 16mm	175cm	162cm
Materials
Main Coil Wire	18: Platinum (92%)/ Tungsten(8%)	Platinum/Tungsten alloy(92/8)	4mm - 8mm:Platinum/Tungsten alloy (92/8)
	35: Platinum alloy-clad tantalum[Platinum (90%)/Iridium (10%)]		10mm -20mm:Platinum alloy-clad tantalum[Platinum (90%)/Iridium (10%)]
	35 (4 mm): Platinum (92%)/Tungsten (8%)
Coil-to-Pusher Coupler	-	Platinum / Iridium (90/10)	No coupler
Adhesive	UV cure adhesive (DYMAX 1128-AM-VT)	UV cure adhesive (DYMAX1128-AM-VT)	UV cure adhesive (DYMAX1128-AM-VT)
Implant to the pusher	-	Polyolefin Elastomer	Polyolefin Elastomer
Stretch Resistant Filament	-	Polyolefin Elastomer	Polyolefin Elastomer
Hydrogel	Hydrophilic acrylic copolymer(cross-linked copolymer ofpolyethylene glycol diacrylamideand acrylic acid)	Hydrophilic acryliccopolymer (cross-linkedcopolymer of polyethyleneglycol diacrylamide andacrylic acid)	Hydrophilic acrylic copolymer(cross-linked copolymer ofpolyethylene glycoldiacrylamide and acrylic acid)
General
Catheter Compatibility	18: 0.021" - 0.022" ID35: 0.041" - 0.047" ID	Compatible withmicrocatheters having anID of > .019"	Compatible with cathetershaving 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 (ethyleneterephthalate) pouch coated withsilica or aluminum oxide andplaced in a shipping carton	Dispenser coil, pouch &shipping carton	Dispenser coil, pouch &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(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.

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).