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.

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 MicroPlex Coil System (MCS) is provided in two basic coil configurations, complex and helical. The MCS-CC-2D and MCS-CC-1D are platinum complex coils that establish the initial framework in the treatment of vascular abnormalities (e.g., intracranial aneurysms). The MCS-HC-R, MCS-HC-S and MCS-HC-SX are platinum helical coils that provide 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 complex and helical coils 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.

AI/ML Overview

The provided document is a 510(k) summary for the MicroPlex™ Coil System (MCS) with the MCS-HC-SX Helical Coil. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study.

Therefore, many of the requested elements for describing specific acceptance criteria and a study proving those criteria are not applicable or extractable from this particular 510(k) submission.

Here's a breakdown of what can be inferred and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not explicit in document. The document states that performance testing "demonstrated that the MicroPlex Coil System (MCS) with the MCS-HC-SX helical coil has equivalent performance to the predicate device." However, the specific quantitative acceptance criteria (e.g., tensile strength thresholds, detachment force, etc.) for this equivalence are not detailed.	* Tensile Strength: Demonstrated equivalence to predicate device. (Specific values not provided)
	* Coil Detachment: Demonstrated equivalence to predicate device. (Specific values not provided)
	* Simulated Use: Demonstrated equivalence to predicate device. (Specific details not provided)

2. Sample size used for the test set and the data provenance:

Not Applicable/Not Provided. This document does not describe a clinical study with a "test set" in the context of typical AI/medical device performance evaluation. The performance data mentioned (tensile strength, coil detachment, simulated use) refers to engineering/bench testing, not a study on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable/Not Provided. This information is not relevant to the type of performance data presented in this 510(k) summary (bench testing for equivalence).

4. Adjudication method for the test set:

Not Applicable/Not Provided. This information is not relevant to the type of performance data presented in this 510(k) summary.

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. This document describes a medical device (embolization coil), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study with human readers and AI assistance would not be applicable.

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

No. This device is an embolization coil, which is a physical implant, not an algorithm.

7. The type of ground truth used:

Not Applicable in the traditional sense. For the bench testing, the "ground truth" would be established by validated testing methods and specifications for the physical properties of the device (tensile strength, detachment force, etc.).
For the "substantial equivalence" claim, the ground truth is the performance of the predicate device (MicroPlex Coil System, K012145).

8. The sample size for the training set:

Not Applicable/Not Provided. There is no "training set" in the context of this device's development or the type of performance data presented.

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

Not Applicable/Not Provided. Similarly, there is no training set mentioned.

Summary of the Study Proving Substantial Equivalence (as described in the document):

The "study" or performance data proving the device meets the acceptance criteria of substantial equivalence (not specific clinical performance criteria) is characterized as follows:

Type of Study: Bench testing and simulated use.
Purpose: To demonstrate that the MicroPlex Coil System (MCS) with the MCS-HC-SX helical coil has equivalent performance to its predicate device (MicroPlex Coil System, K012145).
Tests Performed:
- Tensile Strength
- Coil Detachment
- Simulated Use
Outcomes: The testing "demonstrated that the MicroPlex Coil System (MCS) with the MCS-HC-SX helical coil has equivalent performance to the predicate device."
Ground Truth (for equivalence): The performance characteristics of the previously cleared MicroPlex Coil System (K012145). This equivalence approach eliminates the need for separate clinical studies to establish safety and effectiveness for characteristics already demonstrated by the predicate.

In essence, this 510(k) is a declaration that the new coil is functionally identical to an already approved one, based on engineering and performance tests, not clinical trial data against defined "acceptance criteria" for a novel device.

Summary

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K021914 (p. 1 of 2)

มมเลิ 9 2002

Section 2 - Summary of Safety and Effectiveness

Company Information (1)

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

(2) Contact Information

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

(3) Device Name

Trade/Proprietary Name:	MicroPlex™ Coil System (MCS) with the MCS-HC-SX Helical Coil
Common/Usual Name:	Embolization Coil
Classification Name:	Device, Artificial Embolization

(4) Device Description

The MicroPlex Coil System (MCS) is provided in two basic coil configurations, complex and helical. The MCS-CC-2D and MCS-CC-1D are platinum complex coils that establish the initial framework in the treatment of vascular abnormalities (e.g., intracranial aneurysms). The MCS-HC-R, MCS-HC-S and MCS-HC-SX are platinum helical coils that provide 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.

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K021914 (P.2 of 2)

The complex and helical coils 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.

(5) 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.

Name of Predicate or Legally Marketed Device (6)

The MicroPlex Coil System (MCS) with the MCS-HC-SX helical coil is substantially equivalent to the MicroPlex Coil System (MCS) that was determined to be substantially equivalent on October 29, 2001 (reference K012145).

(7) Technological Characteristics and Substantial Equivalence

The MicroPlex Coil System (MCS) with the MCS-HC-SX helical coil is substantially equivalent in operating principle, method of applications for use, design, packaging and sterilization to the predicate device.

(8) Performance Data Summary

Performance testing including tensile strength, coil detachment and simulated use demonstrated that the MicroPlex Coil System (MCS) with the MCS-HC-SX helical coil has equivalent performance to the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, stacked on top of each other.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K021914

Trade/Device Name: MicroPlex™ Coil System (MCS) Regulation Number: 882.5950 Regulation Name: Artificial Embolization Device Regulatory Class: III Product Code: HCG Dated: June 7, 2002 Received: June 11, 2002

JUL - 9 2002?

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 (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) 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,

Net Rr oglen

Z. Colin McWhirter, Ph.D., M.D.

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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Indications For Use

510(k) Number: K021914

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

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

NKA Lormer

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

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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).