The MicroPlex® Coil System (MCS) and HydroCoil® Embolic System (HES) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

The MCS and HES are also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other neurovascular abnormality, and for arterial and venous embolizations in the peripheral vasculature.

Device Description

The MicroPlex® Coil System (MCS) and HydroCoil® Embolic System (HES) consist of an implantable coil attached to a delivery system called a Delivery Pusher. The Delivery Pusher is powered by a hand-held, battery-powered Detachment Controller designed specifically for the MCS and HES. The Detachment Controller is provided separately.

The coil is delivered to treatment site on the Delivery Pusher through standard neurointerventional micro-catheters. A removable introducer sheath on the outside of the Delivery Pusher assists in the placement of the MCS and HES into the micro-catheter. During deployment, the proximal end of the Delivery Pusher is connected to the Detachment Controller. When the controller is turned on, the coil detaches.

AI/ML Overview

The provided documentation describes a 510(k) premarket notification for the MicroPlex® Coil System (MCS) and HydroCoil® Embolic System (HES). This type of submission relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria and conducting a primary study to prove that the device meets those criteria.

Therefore, much of the requested information regarding specific acceptance criteria, detailed study designs, and performance metrics in the typical sense of a de novo or PMA submission is not explicitly available in this document. The document emphasizes equivalence through design, materials, and existing performance.

Here's an analysis based on the information provided, highlighting what is and isn't available:

There are no specific acceptance criteria for performance metrics (such as sensitivity, specificity, accuracy) provided in this document as it is a 510(k) for substantial equivalence. The "performance data" referred to is primarily comparative testing against predicate devices to demonstrate equivalent performance, rather than a standalone study establishing new performance benchmarks.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated as quantifiable metrics. The implicit acceptance criterion is demonstration of substantial equivalence to predicate devices.	"Performance testing has demonstrated that the MicroPlex® Coil System (MCS) and HydroCoil® Embolic System (HES) with a modified detachment system are equivalent in performance to the predicate devices."

Study Information (Based on Substantial Equivalence Approach)

Sample size used for the test set and the data provenance:
- Not Applicable (N/A) / Not provided in this document. No "test set" in the sense of a clinical or analytical performance study is detailed. The performance data mentioned relates to comparative testing for substantial equivalence, likely bench or animal testing, not a clinical trial with a defined test set of patients or medical images.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A / Not provided. Ground truth establishment by experts is typically done for diagnostic or prognostic devices, often involving human interpretation of medical data. This document describes a medical device for embolization, where performance is assessed through engineering and possibly animal studies, not expert ground truth on a test set.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A / Not provided. As no clinical "test set" requiring expert interpretation and adjudication is described, this information is not relevant to this submission type.
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, an MRMC study was not done. This device is an embolization coil system, not an AI-assisted diagnostic or imaging system. Therefore, MRMC studies are not applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A / Not applicable. This is a physical medical device, not a software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A / Not explicitly stated for performance testing. For a mechanical device, ground truth often relates to engineering specifications, material properties, detachment mechanisms, and possibly animal studies demonstrating successful embolization. The document only vaguely mentions "performance testing."
The sample size for the training set:
- N/A / Not applicable. There is no "training set" in the context of an AI/ML algorithm or a device that learns from data.
How the ground truth for the training set was established:
- N/A / Not applicable. As there is no training set, this information is not relevant.

In summary: The provided document is a 510(k) submission for substantial equivalence. It does not detail specific acceptance criteria or a comprehensive study with the types of metrics and methodologies commonly found in submissions for AI/ML devices or novel diagnostic tools. The "performance data" mentioned refers to comparative testing that established equivalence to predicate devices in design, materials, manufacturing, and intended use.

Summary

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Section 2 - Summary of Safety and Effectiveness

Company Information (1)

MicroVention, Inc. 75 Columbia Aliso Viejo, CA 92656 Telephone: (949) 461-3314 Fax: (949) 461-3329 www.microvention.com

(2) Contact Information

Vincent Cutarelli Telephone: (949) 461-3314 ext. 105 Fax: (949) 461-3329 E-mail: vinc@microvention.com

(3) Device Name

Trade/Proprietary Name:	MicroPlexTM Coil System (MCS)HydroCoil® Embolic System (HES)
Classification Name:	Device, Artificial EmbolizationDevice, Embolization, Arterial
Common/Usual Name:	Endovascular Embolization Coil

Device Description (4)

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Indications for Use (ર)

The MicroPlex® Coil System (MCS) and HydroCoil® Embolic System (HES) are I he Micror tex - Son eystelar embolization of intracranial aneurysms and other meurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

The MCS and HES are also intended for vascular occlusion of blood vessels within the The MCS and TIES are also more the obstruct blood flow to an aneurysm or other neurovascular system to permainterial and venous embolizations in the peripheral vasculature.

Name of Predicate or Legally Marketed Device (6)

The MicroVention MicroPlex® Coil System (MCS) and HydroCoil® Embolic System The Micro Vention Microl Tex - Och System are substantially equivalent to the MicroPlex
(HES) with a modified detachment system are substantially equivaled indiants a (1123) with a modified court in Embolic System (HES) with expanded indications Con System (MCC) and 11/21/2008 substantially equivalent on October 22, 2003 (reference K032590), the HydroCoil® Embolic System (HES) with HES-HC-S (10) Coils that was determined to be substantially equivalent on December 30, 2003 (reference K033836), the HydroCoil® Embolic System (HES) that was determined to be K053830), the Hydrocon - Emoche 8041551) and the Micros MicroCoil System that was determined to be substantially equivalent on August 1, 2003 (reference K031578).

Technological Characteristics and Substantial Equivalence (7)

The MicroPlex® Coil System (MCS) and HydroCoil® Embolic System (HES) with a modified detachment system are substantially equivalent in design, materials, operating mouthed detaction of applications for use, packaging and sterilization to the predicate devices.

Performance Data Summary (8)

Performance testing has demonstrated that the MicroPlex® Coil System (MCS) and I cronmailed testing has demoneys) with a modified detachment system are equivalent in performance to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 28 2005

Mr. Vincent Cutarelli Vice President, Regulatory Affairs and Quality Assurance MicroVention Incorporated 75 Columbia, Suite A Aliso Viejo, California 92656

Re: K050954

Trade/Device Name: MicroPlex® Coil System (MCS) and HydroCoil® Embolic System (HES) Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial embolization device Regulatory Class: II Product Code: HCG Dated: April 14, 2005 Received: April 15, 2005

Dear Mr. Cutarelli:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Drilas Internations 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); 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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Page 2 - Mr. Vincent Cutarelli

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you'ls ough mating of substantial equivalence of your device to a legally prematics notification. "The PDs in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please in you atem of Compliance at (240) 276-0115 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers; internet and ddress http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Signature

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K050954

Device Name: MicroPlex® Coil System (MCS) and HydroCoil® Embolic System (HES)

Indications for Use: The MicroPlex® Coil System (MCS) and HydroCoil® Embolic indications for USe. "The Micror Tox" Our Syctem (intracranial aneurysms
System (HES) are intended for the endovascular embolization of intractions and System (TICo) are intended for the onatoruler of the results matformations and arteriovenous fistulae.

The MCS and HES are also intended for vascular occlusion of blood vessels within the The MOS and TILO are also internation for to an aneury smanently program or other neurovascular system to pormanently one embolizations in the peripheral vasculature.

X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use_ (21 CFR 807 Subpart C)

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

(Division Sign-Off) Division of General, Restorative nd Neurological Devices

Number K6 50954

Page 1 of 1

Regulation Number and Section

§ 882.5950 Neurovascular embolization device.

(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(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 § 882.1(e).