The MicroPlex Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS is 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 Cosmos consist of an implant coil made of platinum alloy. The coils are designed in 3D spherical structure in various loop sizes and lengths. The coil is attached to a V-Traker MCS delivery pusher via a polymer filament. The delivery pusher contains radiopaque positioning markers at the distal end. The proximal end is inserted into a hand held battery powered V-Grip 10 Detachment Controller. The implant segment detaches upon activation of the Detachment Controller.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the MicroPlex Coil System - Cosmos, a neurovascular embolization device. The submission aims to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Bench Testing	Acceptance Criteria	Reported Device Performance
Visual Inspection	Established criteria	Met established criteria
Dimensional Measurement	Established criteria	Met established criteria
Simulated Use	Established criteria	Met established criteria
Detachment Test	Established criteria	Met established criteria
Detachment Zone Tensile	Established criteria	Met established criteria
Advancement/Retraction Force	Established criteria	Met established criteria
Coil to Coupler Weld Tensile	Established criteria	Met established criteria
Spring Constant	Established criteria	Met established criteria

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

The document does not provide details on the specific sample sizes used for each of the bench tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for these tests. The tests appear to be laboratory-based bench tests rather than clinical studies involving patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This document describes bench testing, not clinical studies involving human-derived ground truth. Therefore, information about the number or qualifications of experts establishing ground truth for a test set is not applicable and not provided. The "ground truth" for the bench tests would have been the technical specifications and expected performance defined by the manufacturer for each test.

4. Adjudication Method for the Test Set

Since the document focuses on bench testing and not human interpretation of data, an adjudication method (such as 2+1 or 3+1) is not applicable and not mentioned. The tests would have been evaluated against predefined technical specifications.

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

No, an MRMC comparative effectiveness study was not conducted or reported in this document. This submission is a 510(k) for a device, and the focus is on demonstrating substantial equivalence through bench testing, not on comparative effectiveness with human readers or AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This document is about a physical neurovascular embolization device, not an algorithm or AI system. Therefore, a "standalone algorithm performance" study is not applicable and not mentioned.

7. The Type of Ground Truth Used

For the bench tests, the "ground truth" used was the established criteria/specifications for each test, as determined by the manufacturer based on engineering and design requirements. This is inferred from the "Met established criteria" results. It's not expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

This document describes a medical device, not an AI model. Therefore, the concept of a "training set" in the context of machine learning is not applicable and not mentioned.

9. How the Ground Truth for the Training Set Was Established

As this document does not pertain to an AI model, the concept of a training set and its ground truth establishment is not applicable and not mentioned. The "ground truth" for the device's design and manufacturing would be based on engineering principles, material science, and performance specifications.

Summary

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K09089

510(k) Summary

JUN 2222009

Trade Name:	MicroPlex Coil System – Cosmos
Generic Name:	Neurovascular Embolization Device, accessory
Classification:	Class II, 21 CFR 882.5950
Submitted By:	MicroVention, Inc75 ColumbiaAliso Viejo, California U.S.A.
Contact:	Naomi Gong

Predicate Device:

な

Number	Description	Clearance Date
K082461	MicroPlex Coil System - Bare PlatinumFraming Coil	October 2, 2008

Device Description

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Indication For Use

The Cosmos is a member of the MicroPlex Coil System (MCS). The intended use as stated in the product labeling is as follows:

Verification and Test Summary Table

Bench Testing	Result
Visual Inspection	Met established criteria
Dimensional Measurement	Met established criteria
Simulated Use	Met established criteria
Detachment Test	Met established criteria
Detachment Zone Tensile	Met established criteria
Advancement/Retraction Force	Met established criteria
Coil to Coupler Weld Tensile	Met established criteria
Spring Constant	Met established criteria

Summary of Substantial Equivalence

The data presented in this submission demonstrates the technological similarity and equivalency of the Cosmos coils when compared with the predicate device MicroVention MicroPlex Bare Platinum Framing Coils (K082461).

The devices,

· Have the same intended use,
Use the same operating principle, .
Incorporate the same basic design, .
Use similar construction and material, ◆
Are packaged and sterilized using same material and processes. .

In summary, the Cosmos coils described in this submission is, in our opinion, substantially equivalent to the predicate device.

Page 16 of 141

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MicroVention, Inc. c/o Ms. Naomi Gong Regulatory Affairs Project Manager 75 Columbia. Suite A Aliso Viejo, CA 92656

JUN 22 2009

. Ja

Re: K090891

Trade Name: MicroPlex Coil System (MCS) - Cosmos Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: Class II Product Code: HCG Dated: May 15, 2009 Received: May 18, 2009

Dear Ms. Gong:

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 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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Malvina B. Eydelman, M Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):_ K090891

Device Name: MicroPlex Coil System (MCS) - Cosmos

Indications For Use:

Prescription Use X (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)

KRISTEN BOWSHER
(Division Sign-Off)
Division of Ophthalmic and Ear,
Nose and Throat Devices

K09089

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).