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.

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-Trak™ 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™ Detachment Controller. The implant segment detaches upon activation of the Detachment Controller.

AI/ML Overview

The provided 510(k) summary describes a neurovascular embolization device, the MicroPlex Coil System - Cosmos, and primarily focuses on demonstrating its substantial equivalence to a predicate device through bench testing. As such, the study does not involve AI or human reader performance.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test	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 the data provenance

The document does not specify the exact sample sizes used for each bench test. The data provenance is laboratory-based testing of the device components. There is no information regarding country of origin of data or whether it was retrospective or prospective, as these are not relevant to bench testing.

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

Not applicable. Bench testing does not involve human experts to establish ground truth in the way clinical studies or AI performance validations do. The "ground truth" for bench tests is defined by established engineering and manufacturing specifications and test methods.

4. Adjudication method for the test set

Not applicable. Adjudication methods like "2+1" are used in clinical trials or evaluations where there's subjectivity and disagreement among human reviewers. Bench tests follow objective, predefined protocols and measurements.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a physical medical device (neurovascular embolization coil), not an AI-powered diagnostic or assistive tool. Therefore, there is no discussion of human reader improvement with or without AI assistance.

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

No, a standalone (algorithm only) performance study was not done. This device is a physical medical device, not an algorithm.

7. The type of ground truth used

The ground truth used for these bench tests would be the pre-defined engineering specifications, material properties, and functional performance requirements for the device. These are objective and measurable parameters established during the device's design and development.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm, so there is no "training set."

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

Not applicable, as there is no training set for a physical medical device.

Summary

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

K093358
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Trade Name: MicroPlex Coil System - Cosmos

Generic Name: Neurovascular Embolization Device, accessory

Classification: Class II, 21 CFR 882.5950 JAN 1 5 2010

Submitted By: MicroVention, Inc
1311 Valencia Avenue
Tustin, California 92780
U.S.A.

Contact: Laraine Pangelina

Predicate Device: MicroPlex Coil System (MCS) - Cosmos (K090891)

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-Trak™ 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™ Detachment Controller. The implant segment detaches
upon activation of the Detachment Controller.

Indications 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:

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.

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Bench Test Summary:

Test	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 Cosmos Coils are substantially equivalent to the predicate device with regard to intended use, patient population, device design, materials, processes, and operating principal

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Laraine Pangelina Regulatory Affairs Project Manager MicroVention, Inc. 1311 Valencia Ave. Tustin, CA 92780

JAN 1 6 2010

Re: K093358

Trade/Device Name: MicroPlex Coil System (MCS) - Cosmos 18 Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: II Product Code: HCG Dated: October 27, 2009 Received: October 28, 2009

Dear Ms. Pangelina:

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 (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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your devices of the result offices/ucm115809.htm for a go to http://www.lua.gov/About/Drb Centers (CDRH's) Office of Compliance. Also, please
the Center for Devices and Radiological Health's (CDRH's) colust retification" (21CFR the Center for Devices and Radiological Hound of Concernation of (21CFR Party of the MDP requirition (2) note the regulation entitled, "Misolanding by recents under the MDR regulation (21
807.97). For questions regarding the reporting of adverse events office of 807.97). For questions regarding the open and of 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 You may 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,

Kesia Alexander Jr

Malvina B. Eydelman, M.D. 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):	K093358
Device Name:	MicroPlex Coil System (MCS) – Cosmos
Indications for Use:	The MicroPlex Coil System is intended for the endovascularembolization of intracranial aneurysms and otherneurovascular abnormalities such as arteriovenousmalformations and arteriovenous fistulae. The MCS is alsointended for vascular occlusion of blood vessels within theneurovascular system to permanently obstruct blood flow to ananeurysm or other vascular malformation and for arterial.

Prescription Use _X (Per 21 CFR 801.109) AND/OR

Over-The-Counter Use (Optional Format 1-2-96)

(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, Neurological and Ear, Nose and Throat Devices

510(k) Number_k 09 3358

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).