(79 days)
Not Found
No
The summary describes a physical medical device (coils and delivery system) and its mechanical properties. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is described as being used for "endovascular embolization of intracranial aneurysms and other neurovascular abnormalities" and for "vascular occlusion" to permanently obstruct blood flow, which are therapeutic interventions.
No
The device description and intended use indicate it is an embolization coil system for treating neurovascular abnormalities, not for diagnosing them. It is used to obstruct blood flow, which is a therapeutic intervention.
No
The device description explicitly details physical components such as an implant coil, delivery pusher, and a hand-held battery-powered detachment controller, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Description and Intended Use: The provided information clearly describes a device that is implanted inside the body (in vivo) to treat conditions within the neurovascular system. It's a physical implant used for embolization and occlusion of blood vessels.
The device's function is entirely focused on a therapeutic intervention within the body, not on analyzing biological samples in a lab setting.
N/A
Intended Use / 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.
Product codes
HCG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial, neurovascular system
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
Bench Test Summary:
- 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
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
ي
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.
1
Bench Test Summary:
i
| 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
2
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.
3
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 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. |
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