(118 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of the coil and delivery system, with no mention of AI or ML.
Yes
The device is described as an implantable coil intended for "endovascular embolization of intracranial aneurysms and other neurovascular abnormalities", as well as "vascular occlusion of blood vessels" to "permanently obstruct blood flow." These actions are directly aimed at treating medical conditions and restoring health, which aligns with the definition of a therapeutic device.
No
The device is used for the embolization and occlusion of intracranial aneurysms and neurovascular abnormalities, which are treatment procedures rather than diagnostic ones.
No
The device description clearly states it consists of an implantable coil and a delivery pusher, which are hardware components. It also mentions a separate hand-held battery-powered detachment controller. This is not a software-only 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. This is a therapeutic procedure performed directly on the patient's vascular system.
- Device Description: The device is an implantable coil designed to be placed inside blood vessels. This is an invasive medical device, not a diagnostic tool used to examine specimens outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), performing tests on samples, or providing diagnostic information based on laboratory analysis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to physically block blood flow within the body, which is a therapeutic intervention.
N/A
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 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)
HCG
Device Description
The MCS Vector consists of an implantable coil made of bare platinum alloy. The Vector implantable coils has a 3D shape in various loop sizes and lengths. The coil is attached to a V-Trak delivery pusher. 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 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:
Test: Dimensional Measurement, Result: Met same criteria as predicate
Test: Simulated Use: Introduction, Tracking, Deployment, Frame movement, Microcatheter movement, Microcatheter manipulation, Compartmentalization, Detachment, Overall performance, Result: Met same criteria as predicate
Test: Spring Constant, Result: Met same criteria as predicate
Test: Weld Tensile Strength, Result: Met same criteria as predicate
Test: Detachment Zone Tensile Strength, Result: 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.
K082461, K093919, K103758, K090891, K093358
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
§ 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
K///451
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| Trade Name: | MicroPlex Coil System - Vector | SEP 2 0 2011 |
|---|---|---|
| Generic Name: | Neurovascular Embolization Device | |
| 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 - Cosmos 10 (K082461, K093919, K103758) | |
| MicroPlex Coil System - Cosmos 18 (K090891, K093358) |
Device Description:
The MCS Vector consists of an implantable coil made of bare platinum alloy. The Vector implantable coils has a 3D shape in various loop sizes and lengths. The coil is attached to a V-Trak delivery pusher. 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.
The table below provides information about the physical properties of the MCS Vector with a comparison to the predicate devices.
| Feature | MCS - Cosmos 10 | MCS - Cosmos 18 | MCS - Vector |
|---|---|---|---|
| Coil shape | 3D | Same | Same |
| Coil implant diameter | 2-12mm | 6-24mm | 3-15mm |
| Coil restrained length | 2-45cm | 17-68cm | 6-60cm |
| Deliver pusher length | 185cm | Same | Same |
| Main coil wire material | Platinum/Tungsten | ||
| alloy | Same | Same | |
| Coupler material | Platinum/Iridium | Same | Same |
| Adhesive material | Utraviolet cure | Same | Same |
| Implant to pusher material | Polyolefin elastomer | Same | Same |
| Stretch resistant filar | |||
| material | Polyolefin elastomer | Same | Same |
| MRI compatibility | Yes | Yes | Yes |
| Method of supply | Sterile, single use | Same | Same |
| Packaging configuration | Dispenser coil; | ||
| pouch, shipping | |||
| carton | Same | Same |
1
ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﺘﻲ ﺗﺸﺎﺭﻳﺲ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍ
្រុក
| Indications for Use: | Intended for the endovascular embolization of intracranial
aneurysms and other neurovascular abnormalities such as
arteriovenous malformations and artiovenous fistula. 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 embolization in the peripheral vasculature. | |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Bench Test Summary: | Test | Result |
| | Dimensional Measurement | Met same criteria as predicate |
| | Simulated Use:
Introduction, Tracking,
Deployment, Frame movement,
Microcatheter movement,
Microcatheter manipulation,
Compartmentalization,
Detachment, Overall performance | Met same criteria as predicate |
| | Spring Constant | Met same criteria as predicate |
| | Weld Tensile Strength | Met same criteria as predicate |
| | Detachment Zone Tensile Strength | Met same criteria as predicate |
.
.
Summary of Substantial Equivalence:
The MCS Vector is substantially equivalent to the predicate devices with regard to intended use, patient population, device design, materials, processes, and operating principal.
・ - -
2
Image /page/2/Picture/1 description: The image shows a stylized drawing of a bird in flight. The bird is depicted with three curved lines forming its body and wings, suggesting movement and dynamism. A dotted circle surrounds the bird, possibly indicating a border or a symbolic representation of the bird's environment or trajectory.
11:00:22 Ad: 0 10963 New Hampsince Acenne Documents online Room Welodsono Silver Spring, MD 20003-0000
Microvention, Inc. c/o Ms. Laraine Pangelina 1311 Valencia Ave Tustin. CA 92780
SEP 2 0 2011
Re: K111451
Trade/Device Name: Microplex Coil System-Vector Regulation Number: 21 CFR 882.5950 Regulation Name: Device. Neurovascular embolization Regulatory Class: Class II Product Code: HCG Dated: August 9, 2011 Received: August 10. 2011
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. Ilisting 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.
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 -
3
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 331-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Pari 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.html 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.lda.gov/MedicalDevices/Safetv/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Eaton m. f.
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):
Device Name:
Indications for Use:
KIII45|
MicroPlex Coil System - Vector
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 K111451