(57 days)
Not Found
No
The summary describes a physical medical device (coil system) and its delivery mechanism, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an implantable coil system intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities to permanently obstruct blood flow. This direct intervention to treat a medical condition categorizes it as a therapeutic device.
No
The device is described as an implantable coil system for embolization and vascular occlusion, which are therapeutic procedures, not diagnostic ones.
No
The device description clearly states it is an implantable coil made of platinum alloy, a delivery pusher, and a battery-powered detachment controller, all of which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The MicroPlex Coil System is an implantable medical device made of platinum alloy. It is used for the physical embolization (blocking) of blood vessels.
- Intended Use: The intended use clearly states that the device is for "endovascular embolization" and "vascular occlusion" within the body. This is a therapeutic intervention, not a diagnostic test performed on a sample outside the body.
The device is a therapeutic medical device used for treatment, not a diagnostic device used for testing samples.
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 embolization in the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
HCG
Device Description
The MCS VFC consists of an implantable coil made of bare platinum alloy. The MCS VFC 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:
Visual/Dimensional Inspection: Perform visual inspection and measurments using device drawing - PASS, acceptance criteria met
Simulate Use: Introduction, Tracking, Deployment, Compartmentalizing, Frame Movement, Microcatheter movement, Detachment, Overall Performance - PASS, acceptance criteria met
Detachment Test: Confirm successful detachment according using V-Grip Detachment Controller during simulated use testing - PASS, acceptance criteria met
Coil-to-Coupler Weld Test: Test the tensile strength of the coil/coupler weld - PASS, acceptance criteria met
Spring Constant: Measure the spring constant force of the coil - PASS, acceptance criteria met
CONCLUSION: The results of the bench testing demonstrate that the subject device is safe and effective when used according to the instructions for use and performs equivalent to the predicate device. The testing was used in support of the risk analysis documentation for the subject device.
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.
MicroPlex Coil System (MCS) (K111451)
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
P 2 0 2013
510(K) SUMMARY
Trade Name:
Class II, 21 CFR 882.5950
August 22, 2013
MicroVention, Inc 1311 Valencia Avenue Tustin, California 92780
MicroPlex Coil System (MCS), VFC
Neurovascular Embolization Device
Generic Name:
Classification:
Date Submitted
Submitted By:
Contact: Laraine Pangelina
Predicate Device: MicroPlex Coil System (MCS) (K111451)
U.S.A.
Indications for Use:
Bench Test Summary:
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.
The MCS VFC consists of an implantable coil made of bare platinum alloy. Device Description: The MCS VFC 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.
| Test | Results |
|---|---|
| Visual/Dimensional Inspection | |
| Perform visual inspection and measurments using | |
| device drawing | PASS, acceptance criteria met |
| Simulate Use | |
| Introduction, Tracking, Deployment, | |
| Compartmentalizing, Frame Movement, Microcatheter | |
| movement, Detachment, Overall Performance | PASS, acceptance criteria met |
| Detachment Test | |
| Confirm successful detachment according using V-Grip | |
| Detachment Controller during simulated use testing | PASS, acceptance criteria met |
| Coil-to-Coupler Weld Test | |
| Test the tensile strength of the coil/coupler weld | PASS, acceptance criteria met |
| Spring Constant | |
| Measure the spring constant force of the coil | PASS, acceptance criteria met |
| CONCLUSION: The results of the bench testing demonstrate that the subject device is saf | |
| and effective when used according to the instructions for use and performs equivalent to th | |
| predicate device. The testing was used in support of the risk analysis documentation for the | |
| subject device. |
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1
| Predicate / Subject
Technological
Comparison: | . .
Feature
ﺎ ﺗ
ﺇ | Predicate Devices | Subject Device |
|-----------------------------------------------------|-----------------------------------|-------------------------------------------|----------------|
| | Coil shape | 3D | Same |
| | Coil OD (mm) | 3 - 15 | 1 |
| | Restrained coil length (cm) | 6 - 45 | 3 |
| | Main coil wire material | Platinum/Tungsten (92/8%) alloy | Same |
| | Coupler Material | Platinum (90%)/ iridium (10%) | Same |
| | Adhesive Material | DYMAX 1128-AM-VT UV Adhesive | Same |
| | Stretch resistance filar material | Polyolefin Elastomer or PET | Same |
| | Implant-to-pusher material | Polyolefin elastomer | Same |
| | Delivery method | V-Trak delivery pusher | Same |
| | MRI compatibility | Yes | Yes |
| | Method of supply | Sterile, single use | Same |
| | Packaging configuration | Dispenser coil, pouch,
shipping carton | Same |
Summary of Substantial Equivalence: The devices that are the subject of this submission 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/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a bird-like figure, which is the department's symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 20, 2013
MicroVention, Inc. Ms. Laraine Pangelina Sr. Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, CA 92780
Re: K132317
Trade/Device Name: MicroPlex Coil System (MCS), VFC Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG Dated: August 22, 2013 Received: August 23, 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, 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.
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
Page 2 - Ms. Laraine Pangelina
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" (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 yours,
Joyce M. Whang -S
for 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): K132317
Device Name: MicroPlex Coil System (MCS), VFC
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 embolization in the peripheral vasculature.
AND/OR Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Joyce M.
(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)
510(k) Number K132317
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