Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the physical properties and materials of the embolic coils and their delivery system. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML. The performance studies are bench tests evaluating physical characteristics and simulated use, not algorithmic performance.

Therapeutic

Yes
The device is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, and for vascular occlusion of blood vessels to permanently obstruct blood flow. These actions directly treat medical conditions, fitting the definition of a therapeutic device.

Diagnostic

No

The device description indicates it is an implantable coil system for embolization and vascular occlusion, which are therapeutic procedures, not diagnostic ones.

SaMD (Software as a Medical Device)

No

The device description clearly details physical components including implantable coils made of platinum alloy, a delivery pusher, and a battery-powered detachment controller. These are hardware components, not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
Device Description and Intended Use: The provided description clearly states that this device is an implantable coil used for the endovascular embolization of intracranial aneurysms and other vascular abnormalities. It is designed to be placed inside the body to obstruct blood flow.
Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens taken from the patient.

Therefore, based on the provided information, this device is a therapeutic implant, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS and HES 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 embolization in the peripheral vasculature.

Product codes (comma separated list FDA assigned to the subject device)

HCG

Device Description

The MCS Cosmos 10 consists of an implantable coil made of bare platinum alloy. The HES HydroFrame 10 consists of implantable coil made of platinum alloy with a biologically inert and stable inner hydrogel core. Both the Cosmos 10 and the HydroFrame 10 coils are available in various loop sizes and lengths. The coil is attached to a V-Trak delivery pusher. The proximal end of the delivery pusher is inserted into a hand held battery powered V-Grip Detachment Controller (sold separately). The implantable coil detaches upon activation of the Detachment Controller.

Both the Cosmos 10 and the HydroFrame 10 coil implants have a PET member within the primary coil to provide stretch resistance properties. Both feature a 3-dimensional shape that creates a frame when placed within an aneurysm.

The HydroFrame 10 also has a hydrogel core member that runs parallel with the stretch resistant member within the coil. The expansion properties of the hydrogel allow for improved filling properties of the implanted coil.

The table below provides information about the physical properties of the Cosmos 10 and HydroFrame 10, with a comparison to their respective predicate devices.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Intracranial, neurovascular system, peripheral vasculature

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench Test Summary:

Visual Inspection: Met same criteria as predicate
Dimensional Measurement: Met same criteria as predicate
Simulated Use: Introduction, Tracking, Deployment, Frame tumbling, Microcatheter movement, Microcatheter manipulation, Compartmentalization, Periphery fill, Basket formation, Shape retention, Overall performance - Met same criteria as predicate
Spring Constant: Met same criteria as predicate
Gel Expansion (HES only): Met same criteria as predicate
Weld Tensile: Met same criteria as predicate

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K093919, K090357

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

t

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

| Trade Name: | MicroPlex Coil System – Cosmos 10
HydroCoil Embolic System - HydroFrame 10 | |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Generic Name: | Neurovascular Embolization Device, accessory | |
| Classification: | Class II, 21 CFR 882.5950 | |
| Submitted By: | MicroVention, Inc
1311 Valencia Avenue
Tustin, California 92780 U.S.A.
714-247-8000 | |
| Contact: | Laraine Pangelina | |
| Date Prepared: | April 20, 2011 | |
| Predicate Device: | MicroPlex Coil System, Cosmos 10 (K093919)
HydroCoil Embolic System, HydroFrame 10 (K090357) | |
| Indications for Use: | Intended for the endovascular embolization of intracranial
aneurysms and other neurovascular abnormalities such as
arteriovenous malformations and artiovenous fistula. The MCS and
HES are 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 embolization in the peripheral vasculature. | |
| Device Description: | The MCS Cosmos 10 consists of an implantable coil made of bare
platinum alloy. The HES HydroFrame 10 consists of implantable coil
made of platinum alloy with a biologically inert and stable inner hydrogel
core. Both the Cosmos 10 and the HydroFrame 10 coils are available in
various loop sizes and lengths. The coil is attached to a V-Trak delivery
pusher. The proximal end of the delivery pusher is inserted into a hand
held battery powered V-Grip Detachment Controller (sold separately). The
implantable coil detaches upon activation of the Detachment Controller.

Both the Cosmos 10 and the HydroFrame 10 coil implants have a PET
member within the primary coil to provide stretch resistance properties.
Both feature a 3-dimensional shape that creates a frame when placed
within an aneurysm.

The HydroFrame 10 also has a hydrogel core member that runs parallel
with the stretch resistant member within the coil. The expansion
properties of the hydrogel allow for improved filling properties of the
implanted coil.

1

MicroVention, Inc. Special 510(k) – MCS & HES Line Extension

t

Bench Test Summary:	Test	Result
	Visual Inspection	Met same criteria as predicate
	Dimensional Measurement	Met same criteria as predicate
	Simulated Use:
Introduction, Tracking, Deployment, Frame tumbling,
Microcatheter movement, Microcatheter manipulation,
Compartmentalization, Periphery fill, Basket formation,
Shape retention, Overall performance	Met same criteria as predicate
	Spring Constant	Met same criteria as predicate
	Gel Expansion (HES only)	Met same criteria as predicate
	Weld Tensile	Met same criteria as predicate

Summary of Substantial Equivalence:

The Cosmos 10 and HydroFrame 10 coils that are the subject of this submission are substantially equivalent to the predicate device with regard to intended use, patient population, device design, materials, processes, and operating principal.

2

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

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

Microention, Inc. Laraine Pangelina Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, CA 92780

APR 2 8 2011

Re: K103758

Trade/Device Name: Microplex Coil System-Cosmos 10 and, Hydrocoil System-Hydroframe 10 Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: Class II Product Code: HCG Dated: March 25, 2011 Received: March 29, 2011

Dear Ms. Pangelina

We have reviewed your Section 510(k) premarket notification of intent to market the device m & re review 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 I ou may, mereleve, mains 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 addition. Vie 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.

3

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 100-1050,

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/CDRH/CDRHOffices/ucm1 1 5809.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 inte (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Rick Remmers

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

4

Indications for Use

510(k) Number (if known): K103758

Device Name: MicroPlex Coil System (MCS) - Cosmos 10 HydroCoil Embolic System (HES) - HydroFrame 10 ·

Indications For Use:

Intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS and HES 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 embolization in the peripheral vasculature.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

JEFFREY Toy

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

510(k) Number K103758