(30 days)
Not Found
No
The summary describes a physical medical device (coils and delivery system) and its intended use for embolization. There is no mention of software, algorithms, image processing, AI, ML, or any data-driven decision-making components. The performance studies are bench tests of the physical device's properties.
Yes
The device is used for embolization and occlusion of blood vessels to treat various vascular abnormalities, which are therapeutic interventions.
No
The device is used for embolization and occlusion of blood vessels, which are interventional treatments, not diagnostic procedures.
No
The device description clearly details physical components such as an implant coil, delivery pusher, and a battery-powered detachment controller, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for endovascular embolization and vascular occlusion within the body (intracranial, neurovascular system, peripheral vasculature). This is a therapeutic procedure performed directly on the patient.
- Device Description: The device is an implantable coil and a delivery system. This is consistent with a medical device used for intervention within the body, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is to physically obstruct blood flow.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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 and for arterial and venous embolizations in the peripheral vasculature.
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, 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:
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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MicroPlex Coil System (MCS) - Cosmos (K082461 and K090891)
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
i
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
JAN 2 1 2010
| Trade Name: | MicroPlex Coil System - Cosmos |
|---|---|
| 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. | |
| Contact: | Laraine Pangelina |
| Predicate Device: | MicroPlex Coil System (MCS) - Cosmos (K082461 and 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 and for arterial and venous embolizations in the | |
| peripheral vasculature. |
1
Bench
1
ﻠﻨﺪ ﺗﺤ
| 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
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
MicroVention Terumo c/o Ms. Laraine Pangelina Regulatory Affairs Project Manager 1311 Valencia Ave. Tustin, CA 92780
JAN 2 1 2010
Re: K093919
Trade/Device Name: MicroPlex Coil System - Cosmos, Models: 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, and 101245CSSR-V
Regulation Number: 21 CFR 882.5950
Regulation Name: Neurovascular Embolization Device Regulatory Class: II Product Code: HCG Dated: December 21, 2009 Received: December 22, 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 elass 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.
3
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/cdrl/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.D.
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
4
INDICATIONS FOR USE
| 510(k) Number (if known): | K093919 |
|---|---|
| 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)
.
Jeffrey Toy
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K093919