(90 days)
Not Found
No
The summary describes a physical medical device (coils and delivery system) and its mechanical performance characteristics. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
Yes
The device is described as an endovascular embolization system intended for permanent obstruction of blood flow to treat anatomical abnormalities, which constitutes a therapeutic intervention.
No
The provided text describes a medical device called the MicroPlex Coil System/Cosmos coils, which is intended for endovascular embolization and vascular occlusion to treat conditions like aneurysms and arteriovenous malformations. These are therapeutic actions, not diagnostic ones. The device is used to obstruct blood flow or fill vascular malformations, which is a treatment, not a means of identifying or characterizing a disease.
No
The device description clearly outlines physical components such as platinum alloy coils, a delivery pusher, and a battery-powered detachment controller, indicating it is a hardware-based medical device.
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 and interventional procedure performed directly on the patient.
- Device Description: The device is an implantable coil system designed to be delivered into blood vessels. This is consistent with a medical device used for treatment, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) for therapeutic purposes.
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 (comma separated list FDA assigned to the subject device)
KRD, HCG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial, neurovascular, 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, Dimensional Measurement, Simulated Use (Introduction, Tracking, Deployment, Frame tumbling, Microcatheter movement, Microcatheter manipulation, Compartmentalization, Periphery fill, Basket formation, Shape retention, Overall performance), Detachment Zone Tensile, Advancement/Retraction Force, Coil to Coupler Weld Tensile, Spring Constant.
Key Results: Met same specifications 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.
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
§ 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).
0
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, Inc |
| 1311 Valencia Avenue | |
| Tustin, California 92780 U.S.A. | |
| Contact: | Laraine Pangelina |
| Predicate Device: | MicroPlex Coil System (MCS) - Cosmos 18 (K093358, K090891) |
1102368#### 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.
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.
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 |
1
| 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, and | |
| shipping 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
2
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.
3
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
4
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