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 Detachable 18 Peripheral Coil System consists of an implantable coil attached to a delivery pusher.

The implantable coil is made of platinum alloy with an inner hydrogel core. The implantable coils are designed in 3D spherical structure in various loop sizes and lengths. They are delivered to the treatment site through the microcatheter. The proximal end of the delivery pusher is inserted to the AZUR Detachment Controller, which is activated by the user and this detaches the coil. The AZUR Detachment Controller is packaged and sold separately.

AI/ML Overview

The provided document is a 510(k) summary for the AZUR CX Detachable 18 Peripheral Coil System, which is a vascular embolization device. This type of document is a premarket notification for a medical device and primarily focuses on demonstrating "substantial equivalence" to a predicate device rather than providing a detailed clinical study with acceptance criteria for device performance as one might find for a novel diagnostic AI algorithm.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/diagnostic device validation, are not directly addressed in this regulatory submission for a physical embolization coil.

However, I can extract the relevant information that is present and indicate where the requested information is not applicable or not provided.

Here's an analysis of the document in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria and reported device performance in the context of clinical endpoints or diagnostic accuracy, as it's a submission for a physical medical device (an embolization coil) seeking substantial equivalence, not a diagnostic AI algorithm. The "performance" here refers to physical and mechanical characteristics tested against the predicate device.

The document states: "Bench testing was undertaken to demonstrate the substantial equivalence of the subject device to the AZUR CX Detachable 18 Peripheral Coil System when used according to the Instructions for Use."

The evaluations included:

Visual Inspection
Simulated Use Testing
Advance/Retract force testing

While specific acceptance criteria (e.g., maximum force, defect rate for visual inspection) are not detailed in this summary, they would have been defined internally by MicroVention as part of their design verification and validation program. The "reported device performance" in this context would be that the device met these internal criteria, allowing the manufacturer to conclude substantial equivalence.

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

This information is not provided in a way that aligns with testing a diagnostic AI algorithm. For a physical device like this, "test set" would refer to the number of coils or components tested in bench studies. The document does not specify the sample size for the visual inspection, simulated use testing, or advance/retract force testing.

Data provenance (country of origin, retrospective/prospective) is not applicable here as these are bench tests, not clinical studies with patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. For a physical device like an embolization coil, "ground truth" isn't established by experts in the sense of image interpretation or diagnosis. Performance is measured mechanistically (e.g., force required, visual defects, successful deployment in a simulated vessel). While engineers and technicians would conduct and assess these tests, they are not "experts establishing ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving discrepancies in expert interpretations, typically in diagnostic studies. Here, the tests are objective physical measurements and observations.

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

Not applicable. An MRMC study compares human readers' performance, often with and without AI assistance. This document is for a physical medical device (embolization coil), not a diagnostic algorithm, and therefore such a study was not performed or necessary for this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Not applicable. This is not an algorithm, so "standalone performance" doesn't apply.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance would be:

Engineering specifications / Design Requirements: The device correctly performs its intended mechanical functions within predefined tolerances (e.g., specific force required for detachment, absence of visual defects).
Comparison to Predicate Device: The subject device performs similarly or equivalently to the predicate device in the tested physical and mechanical characteristics.

This is not "expert consensus, pathology, or outcomes data" in the typical sense for a diagnostic device.

8. The Sample Size for the Training Set

Not applicable. This is not an AI algorithm; 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 type of device.

Summary of Device and Study Focus from the Document:

Device: AZUR CX Detachable 18 Peripheral Coil System, a vascular embolization device.
Purpose of Submission: To demonstrate "substantial equivalence" to a legally marketed predicate device (AZUR CX Detachable 18 Peripheral Coil System, K123384). This means showing the new device is as safe and effective as the predicate and does not raise new questions of safety or effectiveness.
Key Design Changes (Line Extension): Primarily changes in coil outer diameter (from 4-20mm to 2-3mm) and coil length (from 13-40cm to 2-8cm), and catheter compatibility.
Study Type: Pre-clinical bench testing.
Tests Performed: Visual Inspection, Simulated Use Testing, Advance/Retract force testing.
Conclusion: The manufacturer concluded that the subject device is substantially equivalent to the predicate device based on these tests, and any differences in technological characteristics do not raise new concerns of safety or effectiveness.

Summary

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

March 3, 2017

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

Re: K162524

Trade/Device Name: AZUR CX Detachable 18 Peripheral Coil System Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: January 30, 2017 Received: February 1, 2017

Dear Ms. Laraine 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

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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,

Fernando Aguel-S
Fernando Aguel

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) K162524

Device Name

AZUR CX Detachable 18 Peripheral Coil System

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

Trade Name:	AZUR CX Detachable 18 Peripheral Coil System
Generic Name:	Vascular Embolization Device
Classification:	Class II, 21 CFR 870.3300
Date Submitted:	September 1, 2016
Submitted By:	MicroVention, Inc1311 Valencia AvenueTustin, California 92780 U.S.A.
Contact:	Laraine PangelinaSr. Regulatory Affairs ManagerMicroVention, Inc.PH: 714-247-8150
Predicate Device:	AZUR CX Detachable 18 Peripheral Coil System (K123384)
Reference Device:	K120630, AZUR Peripheral Coil System - Detachable 18
Indications for Use:	The AZUR Peripheral Coil System is intended to reduce or block the rate ofblood flow in vessels of the peripheral vasculature. It is intended for use inthe interventional radiologic management of arteriovenous malformations,arteriovenous fistulae, aneurysms, and other lesions of the peripheralvasculature.
Device Description:	The AZUR CX Detachable 18 Peripheral Coil System consists of animplantable coil attached to a delivery pusher.The implantable coil is made of platinum alloy with an inner hydrogel core.The implantable coils are designed in 3D spherical structure in various loopsizes and lengths. They are delivered to the treatment site through themicrocatheter. The proximal end of the delivery pusher is inserted to theAZUR Detachment Controller, which is activated by the user and thisdetaches the coil. The AZUR Detachment Controller is packaged and soldseparately.

Predicate / Subject Technological Comparison:

Design Feature	Cleared Device (K123384)	Line Extension (subject device)
Coil shape	3D spherical	Same
Coil OD (mm)	4 – 20	2 - 3
Coil Length, restrained (cm)	13 - 40	2 - 8
Method of Coil Delivery	Coil attached to a delivery pusher. The proximalend of the delivery pusher is inserted to the AZURDetachment Controller, which is activated to detachand deliver the coil. The AZUR DetachmentController is packaged and sold separately.	Same
Catheter Compatibility	Compatible with microcatheters having an ID of >0.021"	Compatible with microcatheters havingan ID of 0.019" - 0.027"
Method of Supply	Sterile, single use	Same
Package Configuration	Dispenser coil, pouch & shipping carton	Same

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Pre-Clinical Testing: Microvention developed a design verification and validation program for the AZUR CX Detachable 18 Peripheral Coil System Line Extension with reference to the FDA Guidance for Vascular and Neurovascular Embolization Devices. Bench testing was undertaken to demonstrate the substantial equivalence of the subject device to the AZUR CX Detachable 18 Peripheral Coil System when used according to the Instructions for Use. The design verification and validation program included the evaluations listed below:

. Visual Inspection
. Simulated Use Testing
. Advance/Retract force testing

Summary of Substantial Equivalence:

The data presented in this submission demonstrates the substantial equivalence of the subject device to the predicate device, the AZUR CX Detachable 18 Peripheral Coil System (K123384) with regard to intended use, principal of operation, materials, manufacturing processes, packaging configuration, and sterilization method. Based on the supportive data provided in this 510(k), it can be concluded that any differences in technological characteristics do not raise new concerns of safety or effectiveness. Therefore it is our conclusion that the subject device is substantially equivalent to the predicate device.

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).