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 coils 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™ 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 (sold separately). The implant segment detaches upon activation of the Detachment Controller.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study details as requested:

Device: MicroPlex Coil System - Cosmos 18 (Neurovascular Embolization Device)

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device submission (K102365), the acceptance criteria and reported performance are based on equivalence to the predicate device (MicroPlex Coil System - Cosmos 18, K093358, K090891). The study conducted was primarily a bench test comparison rather than a clinical study with performance metrics in terms of accuracy or clinical outcomes.

Acceptance Criteria (Bench Test Category)	Reported Device Performance (as compared to predicate)
Visual Inspection	Met same specifications as predicate
Dimensional Measurement	Met same specifications as predicate
Simulated Use: - Introduction, Tracking, Deployment - Frame tumbling - Microcatheter movement - Microcatheter manipulation - Compartmentalization - Periphery fill - Basket formation - Shape retention - Overall performance	Met same specifications as predicate
Detachment Zone Tensile	Met same specifications as predicate
Advancement/Retraction Force	Met same specifications as predicate
Coil to Coupler Weld Tensile	Met same specifications as predicate
Spring Constant	Met same specifications as predicate

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

Sample Size: Not explicitly stated. The bench tests are typically conducted on a set number of devices to demonstrate consistency and adherence to specifications. However, the exact quantity of coils tested is not provided in this summary.
Data Provenance: The data is presumed to be from prospective bench testing conducted by MicroVention, Inc. at their facility in Tustin, California, U.S.A. It is not patient or clinical data.

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

This information is not applicable as the study was a bench test comparison to a predicate device, not a study requiring expert clinical ground truth on patient data. The "ground truth" here is adherence to engineering specifications.

4. Adjudication Method for the Test Set

This information is not applicable as the study was a bench test, not a clinical study involving human assessment that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This submission is for a device modification (larger coil sizes) demonstrated through bench testing and comparison to an existing predicate device, not for an AI-assisted diagnostic tool or a therapy where human reader performance improvements would be measured.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

No, a standalone performance study was not done. This device is a physical medical implant (a coil system), not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" used for this submission is based on engineering specifications and performance characteristics of the predicate device. The new device's performance was compared to meet the same specifications as the predicate.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical medical device, not an AI or machine learning model that requires a training set.

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

This information is not applicable as there is no training set for this type of device.

Summary of the Study:

The submission for the MicroPlex Coil System - Cosmos 18 (K102365) primarily relies on bench testing to demonstrate substantial equivalence to its predicate device (K093358, K090891). The new device introduces larger coil outer diameters and lengths but maintains the same design attributes, materials, and operating principles as the predicate. The "study" consisted of a series of standard engineering performance tests (e.g., visual inspection, dimensional measurement, simulated use, tensile strength, spring constant) where the subject device was shown to meet the same specifications as the predicate device. This approach is common for 510(k) submissions of modified devices where material or fundamental operating principles have not significantly changed, and clinical performance is assumed to be equivalent to the predicate.

Summary

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

NOV 1 8 2010

Trade Name:	MicroPlex Coil System - Cosmos 18
Generic Name:	Neurovascular Embolization Device, accessory
Classification:	Class II, 21 CFR 882.5950
Submitted By:	MicroVention, Inc1311 Valencia AvenueTustin, California 92780 U.S.A.
Contact:	Laraine Pangelina
Predicate Device:	MicroPlex Coil System (MCS) - Cosmos 18 (K093358, K090891)

1102368#### Device Description:

Indications for Use:

Bench Test Summary:

Visual Inspection	Met same specifications as predicate
Dimensional Measurement	Met same specifications as predicate
Simulated Use:Introduction, Tracking, Deployment, Frame tumbling,Microcatheter movement, Microcatheter manipulation, Compartmentalization, Periphery fill, .Basket formation, Shape retention, Overall performance	Met same specifications as predicate
Detachment Zone Tensile	Met same specifications as predicate
Advancement/Retraction Force	Met same specifications as predicate
Coil to Coupler Weld Tensile	Met same specifications as predicate
Spring Constant	Met same specifications as predicate

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Feature	Predicate Device	510(k) Subject Device
Design Attributes
Coil Shape	3D- spherical	Same
Coil OD	6-13 mm	14-24 mm
Coil Length	17-47 cm	51-68 cm
Pusher length	185 cm	Same
Materials
Main Coil Wire	Platinum/Tungsten (92/8%) alloy	Same
Coil to Pusher Coupler	Platinum (90%)/ iridium (10%)	Same
Adhesive	Ultraviolet curing adhesive(DYMAX 1128-AM-VT)	Same
Implant to Pusher Attachment	Polyolefin elastomer	Same
General
MRI compatibility	Yes	Same
Method of Supply	Sterile, single use	Same
Package Configuration	Placed in dispenser coil, pouch, andshipping carton	Same

Technological comparison, subject and predicate device:

Summary of Substantial Equivalence:

The MCS 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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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 features a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.

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

MicroVention, Inc. c/o Ms. Laraine Pangelina Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, California 92780

1 8 2010 NOV

K102365 Re:

Trade/Device Name: MicroPlex Coil System - Cosmos 18 Regulation Number: 21 CFR 870.3300

·Regulation Name: Vascular-Embolization-Device Regulatory Class: Class II Product Code: KRD, HCG Dated: August 19, 2010 Received: August 20, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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Page 2 - Ms. Laraine Pangelina

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.

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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

inna R. Vachner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known):	K102365
	NOV 18 2010
Device Name:	MicroPlex Coil System (MCS) - Cosmos
Indications for Use:	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.

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)

Dune R. Vuchner
Division Sign-On

(Division Sign-Off) . Division of Cardiovascular Devices

510(k) Number_K102 36 رَدَهُ وَ

Regulation Number and Section

§ 870.3300 Vascular embolization device.

(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(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 § 870.1(e).