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 vascular malformation 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 fluid injection delivery system called a delivery pusher. The delivery pusher is a variable stiffness stainless steel tube with several outer layers of PET tubing. A luer hub at the proximal end of the pusher is used for system de-airing and coil detachment. The proximal end of the coil incorporates a coupler for attachment to the delivery pusher. PET tubing is heat-shrunk over the coupler/pusher junction in order to attach the coil to the delivery pusher. The coil is delivered to treatment site on the delivery pusher through standard neuro-interventional micro-catheters. An introducer sheath on the outside of the delivery pusher assists in the placement of the MCS and HES into the micro-catheter. A 1.0-cc syringe is used for system de-airing and a 0.25-cc syringe is used for coil detachment.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, but it's important to note that the document is a 510(k) summary, not a detailed clinical study report. Therefore, specific details like sample sizes for test/training sets, expert qualifications, and adjudication methods are not present in this type of document.

This summary focuses on showing substantial equivalence to predicate devices, rather than establishing performance against novel criteria through detailed human reader studies.

Acceptance Criteria and Device Performance (Inferred from Substantial Equivalence)

Since this is a 510(k) submission, the "acceptance criteria" are primarily based on demonstrating substantial equivalence to a legally marketed predicate device. The performance data presented in such submissions is typically comparative rather than absolute, aiming to show that the new device performs at least as well as, or equivalently to, the predicate.

Acceptance Criteria Category	Reported Device Performance
Operating Principle	Substantially Equivalent to Predicate: The MicroPlex™ Coil System (MCS) and HydroCoil® Embolic System (HES) with expanded indications for use are substantially equivalent in operating principle to the predicate devices (MicroPlex™ Coil System, K020434, and MicroCoil System, K031578). Both involve an implantable coil delivered via a fluid injection system to embolize neurovascular abnormalities or occlude blood vessels.
Method of Application	Substantially Equivalent to Predicate: The device's method of application (delivery on a delivery pusher through standard neuro-interventional micro-catheters for coil delivery and detachment) is substantially equivalent to the predicate devices.
Indications for Use	Expanded but Substantially Equivalent in Principle: While the current submission indicates expanded uses (vascular occlusion of blood vessels within the neurovascular system and for arterial and venous embolizations in the peripheral vasculature) beyond the initial intracranial aneurysm/neurovascular abnormality indications, these expanded indications are considered substantially equivalent in their underlying biomedical application and risk profile to the predicate devices' established uses. The previous predicate devices likely covered the core embolization concept.
Design	Substantially Equivalent to Predicate: The design, including components like the implantable coil, fluid injection delivery system (delivery pusher with PET tubing and luer hub for de-airing/detachment), and introducer sheath, is substantially equivalent to the predicate devices.
Packaging and Sterilization	Substantially Equivalent to Predicate: The device's packaging and sterilization methods are substantially equivalent to the predicate devices.
Performance Data (Mechanical/Functional)	Equivalent to Predicate: Performance testing documented in prior 510(k)s (K012145, K021914, and K020434)—including tensile strength, coil detachment, simulated use, and animal testing—demonstrated that the MCS and HES with expanded indications for use are equivalent in performance to the predicate devices. This implies meeting similar mechanical and functional benchmarks as the legally marketed predicate devices.

Here's a breakdown of the specific questions based on the provided text:

A table of acceptance criteria and the reported device performance
- See the table above. The "acceptance criteria" for a 510(k) are implicitly tied to demonstrating "substantial equivalence" to a predicate device across various characteristics (operating principle, method of application, indications for use, design, packaging, sterilization, and performance). The reported performance is that the device is substantially equivalent and has equivalent performance in specific tests.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified in the provided document. 510(k) summaries typically do not contain this level of detail for performance testing. The "Performance Data Summary" refers to testing documented in previous 510(k)s (K012145, K021914, K020434) and states "tensile strength, coil detachment, simulated use and animal testing." Details about the number of coils tested, the number of animals used, or the origin/nature of that data are not included in this high-level summary.
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)
- Not applicable/Not specified. This document describes a medical device (embolization coil), not an AI or diagnostic imaging device that would typically rely on expert ground truth for performance evaluation in a clinical setting. The performance testing mentioned (tensile strength, coil detachment, simulated use, animal testing) are engineering and pre-clinical tests, not human-read clinical studies.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. As mentioned above, this type of adjudication is relevant for studies involving human interpretation (e.g., radiology readers) where a consensus ground truth needs to be established. The tests described are objective engineering and animal tests.
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, this was not done. This is a physical medical device (embolization coil), not an AI algorithm or diagnostic aid that would involve human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the "performance data" mentioned (tensile strength, coil detachment, simulated use, animal testing), the "ground truth" would be established by objective physical measurements (e.g., force required for detachment, dimensions, material integrity post-simulation) and observation of physiological effects/outcomes in animal models, rather than expert consensus on clinical images or pathology.
The sample size for the training set
- Not applicable/Not specified. This pertains to machine learning algorithms, which this device is not. The "performance data" refers to validation testing, not training of an algorithm.
How the ground truth for the training set was established
- Not applicable/Not specified. This pertains to machine learning algorithms.

Summary

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OCT 2 2 2003

K032590
P/2

Section 2 - Summary of Safety and Effectiveness

Company Information (1)

MicroVention, Inc. 75 Columbia Aliso Viejo, CA 92656 Telephone: (949) 768-1184 Fax: (949) 768-0464 www.microvention.com

Contact Information (2)

Vincent Cutarelli Telephone: (949) 768-1184 ext. 105 Fax: (949) 768-0464 E-mail: vinc@microvention.com

Device Name (3)

Classification Name:	Device, Artificial Embolization
Trade/Proprietary Name:	MicroPlex™ Coil System (MCS)HydroCoil® Embolic System (HES)
Common/Usual Name:	Embolization Coil

Device Description (4)

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K032590
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(5) Indications for Use

(6) Name of Predicate or Legally Marketed Device

The MicroVention MicroPlex™ Coil System (MCS) and HydroCoil® Embolic System (HES) with expanded indications for use are substantially equivalent to the MicroPlex™ Coil System that was determined to be substantially equivalent on July 29, 2002 (reference K020434) and the 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 expanded indications for use are substantially equivalent in operating principle, method of application, indications for use, design, packaging and sterilization to the predicate devices.

Performance Data Summary (8)

Performance testing documented in K012145, K021914 and K020434, including tensile strength, coil detachment, simulated use and animal testing, has demonstrated that the MicroPlex™ Coil System (MCS) and HydroCoil® Embolic System (HES) with expanded indications for use are equivalent in performance to the predicate devices.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Public Health Service

OCT 2 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Vincent Cutarelli Vice President, Regulatory Affairs, Quality Assurance and Clinical Affairs MicroVention, Inc. 72 Argonaut Aliso Viejo, California 92656

Re: K032590

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: III Product Code: HCG Dated: August 19, 2003 Received: August 22, 2003

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 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); good manufacturing practice requirements as set forth in 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.

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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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 contact the Office of Compliance at (301) 594-4659. 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Mark N Millkan

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K 032590

Indications For Use

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

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

Indications for Use: 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.

Concurrence of CDRH, Office of Device Evaluation (ODE):

for Mark N. Melkner

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

Prescription Use: __ X_ (Per 21 CFR 801.109)

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).