(99 days)
Not Found
No
The summary describes a mechanical coil system for embolization and a battery-powered detachment controller. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies are bench tests focused on physical properties and detachment.
Yes
The device is described as "intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities," as well as "vascular occlusion... to permanently obstruct blood flow." These descriptions indicate that the device is directly involved in treating medical conditions or restoring normal function.
No
The device description and intended use indicate that the MicroPlex Coil System is an implantable device used for endovascular embolization and vascular occlusion, which are therapeutic procedures, not diagnostic ones.
No
The device description clearly states it consists of an implantable coil made of platinum alloy and a delivery pusher, which are physical hardware components. It also mentions a separate hand-held battery-powered detachment controller. This is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for 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 a medical device used for intervention, not for testing samples outside the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The information provided describes a medical device used for a therapeutic intervention, not an in vitro diagnostic test.
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, KRD
Device Description
The MCS devices consist of an implantable coil made of platinum alloy (MCS) or a platinum allot with an inner hydrogel core (HES). The coil is attached to a V-Trak delivery pusher via a polymer filament. The proximal end of the pusher 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
neurovascular system, intracranial, 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
Bench Test Summary:
Visual Inspection: Met the same acceptance criteria as the predicate devices
Dimensional Measurement: Met the same acceptance criteria as the predicate devices
Simulated Use: Met the same acceptance criteria as the predicate devices
Detachment Test: Met the same acceptance criteria as the predicate devices
Coil to Coupler Weld Tensile: Met the same acceptance criteria as the predicate devices
Spring Constant: Met the same acceptance criteria as the predicate devices
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
Special 510(k) MicroPlex Embolic System (MCS) Line Extension , MicroVention
OCT 0 4 2013
131948
510(K) SUMMARY
Trade Name:
MicroPlex Coil System (MCS)
Class II, 21 CFR 882.5950
MicroPlex Coil System (MCS)
MicroVention, Inc 1311 Valencia Avenue Tustin, California 92780
Laraine Pangelina
Neurovascular Embolization Device
Generic Name:
Classification:
Submitted By:
Contact:
U.S.A.
Indications for Use:
Predicate Device:
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.
Device Description:
The MCS devices consist of an implantable coil made of platinum alloy (MCS) or a platinum allot with an inner hydrogel core (HES). The coil is attached to a V-Trak delivery pusher via a polymer filament. The proximal end of the pusher is inserted into a hand held battery powered V-Grip Detachment Controller (sold separately). The implant segment detaches upon activation of the Detachment Controller.
| Test | Result |
|---|---|
| Visual Inspection | Met the same acceptance criteria as the predicate devices |
| Dimensional | |
| Measurement | Met the same acceptance criteria as the predicate devices |
| Simulated Use | Met the same acceptance criteria as the predicate devices |
| Detachment Test | Met the same acceptance criteria as the predicate devices |
| Coil to Coupler Weld | |
| Tensile | Met the same acceptance criteria as the predicate devices |
| Spring Constant | Met the same acceptance criteria as the predicate devices |
Bench Test Summary:
1
MicroPlex Embolic System (MCS) Line Extension
Predicate / Subject Technological Comparison:
| Design Feature | Predicate Device
(K091641) | Predicate Device
(K103758) | Line Extension
(MCS HyperSoft 3D) |
|------------------------------------------|--------------------------------------|----------------------------------------------------------------------|--------------------------------------|
| Coil shape | Helical | 3D | 3D |
| Coil Filar Size | 0.00125 - 0.00150 | 0.00200 - 0.00225* | 0.00125* |
| Coil Implant Diameter | 1 - 8 mm | 2 - 12 mm | 1.0 - 1.5 mm |
| Coil Restrained Length | 1 - 10 cm | 2 - 45 cm | 1.5 - 4.5 mm |
| Main Coil Wire Material | Platinum/Tungsten
(92/8%) alloy | Same | Same |
| Coupler Material | Platinum (90%)/ iridium
(10%) | Same | Same |
| Adhesive Material | DYMAX 1128-AM-VT
UV Adhesive | Same | Same |
| Stretch Resistance Filar
Material | PET | Polyolefin Elastomer (3-
12mm coils) or PET (2.0-
2.5mm coils) | PET |
| Implant-to-V-Trak
Attachment Material | Confidential | Same | Same |
| Delivery Method | V-Trak delivery pusher | Same | Same |
| Package Configuration | Dispenser hoop, pouch,
and carton | Same | Same |
| MRI Compatibility | Yes | Yes | Yes |
| Method of Supply | Sterile, single use | Same | Same |
Summary of Substantial Equivalence:
Based on a comparison of technical specifications and device testing results, the MCS HyperSoft 3D devices are substantially equivalent to legally marketed predicate devices.
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 consists of a stylized eagle with three wavy lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 4, 2013
Ms. Laraine Pangelina Sr. Regulatory Affairs Project Manager MicroVention, Inc 1311 Valencia Avenue Tustin, California 92780
Re: K131948
Trade/Device Name: MicroPlex Coil System (MCS): MCS HyperSoft 3D Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG and KRD Dated: July 16, 2013 Received: September 6, 2013
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. Iisting 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Laraine Pangelina
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 1000-1000.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFF) Pass 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 yours,
Victor Krauthamer -S
Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): K131948 Device Name: MicroPlex Coil System (MCS) Indications for Use: The MicroPiex 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.
Preseription Use X (Per 21 CFR 801.109) AND/OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
| Victor Krauthamer | SVA |
|---|---|
| 2013.10.04 10:46:26-04'00' |
(Division Sign Off)
Division of Neurological and Physical Medicine Devices (DNPMD)
| 510(k) Number | |
|---|---|
| --------------- | -- |