The MicroPlex Coil System (MCS) is intended for embolization of those intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be very high risk for management by traditional operative techniques or inoperable. The MCS is also intended for embolization of other neuro-vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae and for arterial and venous embolizations in the peripheral vasculature.

Device Description

The MicroVention MicroPlex Coil System (MCS) consists of an implantable coil attached to a fluid injection delivery system called a Delivery Pusher. The Delivery Pusher consists of a variable stiffness tube with a retention sleeve that attaches the pusher to the implantable coil. A peel-away introducer sheath assists in the delivery of the implantable coil into the microcatheter.

The MCS-CC is a platinum complex coil that establishes the initial framework in the treatment of vascular abnormalities (e.g., intracranial aneurysms). The MCS-HC is a platinum helical coil that provides additional filling once the initial framework has been established by one or more complex coils. The complex and helical coils are provided in a number of diameters and lengths. The MCS-HCP is a platinum helical coil with an outer layer of a hydrophilic, acrylic polymer that also provides additional filling once the initial framework has been established by placement of one or more MCS-CC complex coils.

The MCS-CC and MCS-HC are available in 18- and 10-compatible systems. The 18compatible systems may be delivered through 14- and 18-type micro-catheters. The 10compatible systems may be delivered through 10- and 14-type micro-catheters. The MCS-HCP is available in 14-compatible systems and may be delivered through 14-type micro-catheters.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device, the MicroPlex™ Coil System (MCS). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a clinical study in the way a PMA (Premarket Approval) might require.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/algorithm-based device. The document is for a physical embolization coil system.

Here's a breakdown of why the requested information cannot be extracted from the provided text, based on the nature of a 510(k) for a physical medical device:

Table of acceptance criteria and reported device performance: This document does not present specific acceptance criteria in a quantitative table format. It states that "Performance testing including tensile strength, coil detachment, simulated use, biocompatibility and animal testing demonstrated that the MicroPlex Coil System (MCS) has equivalent performance to the predicate devices." This implies that the performance was deemed acceptable if it was equivalent to the predicate, but no specific numerical targets or results are provided.
Sample size used for the test set and data provenance: Not applicable. The "test set" here refers to the physical device being tested (e.g., coils for tensile strength). The document does not specify sample sizes for these tests, nor the provenance of such "data" in the epidemiological sense.
Number of experts used to establish ground truth & qualifications: Not applicable. Ground truth, in the context of AI or diagnostic studies, refers to the definitive determination of a condition. For a physical device like an embolization coil, ground truth would be established through engineering tests, material science evaluations, and potentially animal studies, not typically by human experts adjudicating cases of patient data as described.
Adjudication method: Not applicable, as there's no diagnostic task involving human expert review of cases.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is relevant for diagnostic devices (especially those involving image interpretation by human readers, sometimes aided by AI) to assess inter-reader variability and the impact of the device on reader performance. The MCS is a therapeutic device.
Standalone (algorithm only) performance: Not applicable. The MCS is a physical medical device, not an algorithm.
Type of ground truth used: For the performance tests mentioned (tensile strength, coil detachment, simulated use, biocompatibility, animal testing), the "ground truth" would be established by the physical measurements, chemical analyses, and physiological responses observed in the animal models, rather than expert consensus, pathology, or outcomes data from human subjects in a clinical trial for a diagnostic device.
Sample size for the training set: Not applicable. The MCS is not an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) notification for a physical medical device. The types of questions asked are highly specific to AI/ML software as a medical device (SaMD) or diagnostic devices that involve human interpretation. This document does not contain information relevant to those types of questions.

Summary

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

Kozory34

Section 2 - Summary of Safety and Effectiveness

Company Information (1)

MicroVention, Inc. 72 Argonaut Aliso Viejo, CA 92656 Telephone: (949) 768-1184 Fax: (949) 768-0464 www.microvent.com

Contact Information (2)

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

(3) Device Name

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

(4) Device Description

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

KO204 34

Indications for Use (5)

Name of Predicate or Legally Marketed Device (0)

The MicroPlex Coil System (MCS) with the expanded indications for use and the additional model numbers is substantially equivalent to the Guglielmi Detachable Coil (GDC) that was determined to be substantially equivalent on January 21, 2000 (reference K993417), the MicroPlex Coil System (MCS) that was determined to be substantially equivalent on October 29, 2001 (reference K012145) and the Matrix Detachable Coil System that was determined to be substantially equivalent on February 1, 2001 (reference K012985).

(7) Technological Characteristics and Substantial Equivalence

The MicroPlex Coil System (MCS) is 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 including tensile strength, coil detachment, simulated use, biocompatibility and animal testing demonstrated that the MicroPlex Coil System (MCS) has equivalent performance to the predicate devices.

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

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 9 2002

MicroVention, Inc. Vincent Cutarelli 72 Argonaut Aliso Viejo, California 92656

Re: K020434

Trade Name: MicroPlex™ Coil System (MCS) Regulation Number: 887.5950 Regulation Name: Artificial Embolization Device : 2002 Regulatory Class: III Product Code: HCG Dated: May 17, 2002 Received: May 20, 2002

Dear Mr. Cutarelli:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (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.

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

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours.

Sincerely yours,

for Mark N. Milburn

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

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

KO30434

Indications For Use

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: MicroPlex™ Coil System (MCS)

Indications for Use: The MicroPlex Coil System (MCS) is intended for embolization of those intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be very high risk for management by traditional operative techniques or inoperable. The MCS is also intended for embolization of other neuro-vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae and for arterial and venous embolizations in the peripheral vasculature.

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

for Mark N. Milkersen

Division Sign-Off) Division of General. Restorative and Neurological Devic

510(k) Number K020434

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).